Health and Human Services Acquisition Regulations, 72149-72189 [2015-28214]
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Vol. 80
Wednesday,
No. 222
November 18, 2015
Part II
Department of Health and Human Services
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48 CFR Chapter 3
Health and Human Services Acquisition Regulations; Final Rule
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
48 CFR Chapter 3
RIN 0991–AB86
Health and Human Services
Acquisition Regulations
Department of Health and
Human Services.
ACTION: Final rule.
AGENCY:
The Department of Health and
Human Services (HHS) is issuing a final
rule to amend its Federal Acquisition
Regulation (FAR) Supplement, the HHS
Acquisition Regulation (HHSAR), to
update its regulation to current FAR
requirements; to remove information
from the HHSAR that consists of
material that is internal, administrative,
and procedural in nature; to add or
revise definitions; to correct certain
terminology; and to delete outdated
material or material duplicative of the
FAR.
DATES: Effective December 18, 2015.
FOR FURTHER INFORMATION CONTACT:
Deborah Griffin, Procurement Analyst,
Department of Health and Human
Services, Office of the Assistant
Secretary for Financial Resources, Office
of Grants and Acquisition Policy and
Accountability, Division of Acquisition,
deborah.griffin@hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
HHS published a proposed rule in the
Federal Register at 80 FR 11266 on
March 2, 2015, to conform to current
statutory and FAR requirements. This
final rule changes the HHSAR to
conform to these new requirements and
to align the requirements with the
current FAR. In addition, the procedural
materials that were deemed internal or
non-regulatory in nature are moved to
internal procedures for departmentwide application.
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II. Discussion and Analysis
HHS reviewed the comments in the
development of this final rule. A
discussion of the comments and the
changes made to the rule as a result of
those comments are provided as
follows:
A. Summary of Significant Changes to
the Proposed Rule
HHSAR 311.71, Public
Accommodations and Commercial
Facilities, and the relevant clause at
352.211–1, Public Accommodations and
Commercial Facilities, are renamed and
revised to clarify public accommodation
and the use of commercial facilities.
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HHSAR 302.101, Definitions, is
revised to clarify the definition of
‘‘agency head or head of the agency’’ as
the Secretary of HHS or specified
designee. This allows for the delegation
to the appropriate acquisition official
within HHS.
HHSAR 303.704, Policy, is clarified to
specify the HCA as the designee for
voiding and rescinding contracts;
however, coordination is required with
the SPE.
HHSAR 306.202, Establishing or
maintaining alternative sources, is
revised to clarify that the ‘‘agency head’’
as specified in FAR 6.202(a) is the SPE
rather than the Competition Advocate.
HHSAR 306.302–7, Public interest, is
deleted. The information is considered
duplicative of the FAR.
HHSAR 309.403, Definitions, is
revised to delete the definition of
‘‘acquiring agency’s head or designee.’’
HHSAR 317.108, Congressional
notification, is revised to clarify that the
SPE shall give the approval of the
notification required by FAR 17.108(a)
and that the HCA shall finalize and sign
the congressional notification letter and
provide it to the appropriate House and
Senate committees.
HHSAR 317.204, Contracts, is revised
to clarify that a request to exceed the 5year limitation specified in FAR
17.204(e) must follow the guidance in
FAR 1.7.
HHSAR 324.70, Health Insurance
Portability and Accountability Act of
1996, is revised to clarify the references
to controlling law.
In addition, several editorial changes
were made to the rule.
B. Analysis of Public Comments
HHSAR 315.305, Proposal Evaluation
The respondent states that the
coverage in HHSAR 315.305, concerning
advisors who are brought in to assist in
proposal evaluation has a different set of
restrictions and requirements than are
found in Part 337, Service ContractingGeneral, citing those found in FAR
37.203, Policy. The provisions of
HHSAR 315.305 specifically address
those circumstances when HHS must
use a statutorily mandated contractor
selection process of Peer Review. As
such, the respondent is correct that the
primary focus of this HHSAR section
deals with potential conflicts which
must be avoided in source selection.
HHS does not believe that any change
to the coverage is necessary. FAR
15.305, Proposal Evaluation, already
contains a cross reference to FAR part
37, Service Contracting.
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´ ´
319.270–1, Mentor Protege Program
Solicitation Provision and Contract
Clause
The respondent notes that the HHS
´ ´
Mentor Protege Program is currently
suspended and requests that the
suspension be lifted or, alternatively,
the section be removed from the
HHSAR. HHS has retained the HHSAR
coverage as currently written with
intent to reinstate the program at a later
date.
352.204–70(c)(5), Prevention and Public
Health Fund-Reporting Requirements
The respondent believes the language
in the clause at 352.204–70(c)(5),
Prevention and Public Health FundReporting Requirements, is duplicative
and should be deleted and replaced
with the requirement to report
subcontract information in the Federal
Funding Accountability and
Transparency Act Subaward Reporting
System. The requirement in the HHSAR
is specific to Prevention and Public
Health Fund funding, and the reporting
requirement is contained within the
structure of the program. Therefore, the
language in the proposed rule is
retained.
352.211–1, Public Accommodations and
Commercial Facilities
The respondent supports HHS’
inclusion of HHSAR coverage to provide
accessible meeting locations. However,
HHS believes further clarification is
necessary for public accommodation
and commercial facilities. Therefore, the
language in HHSAR 311.71, Public
Accommodations and Commercial
Facilities and the related clause at
352.211–1, Public Accommodations and
Commercial Facilities, is revised.
352.237–74, Non-Discrimination in
Service Delivery
The clause at 352.237–74, NonDiscrimination in Service Delivery,
specifies that the contractor may not
discriminate on several bases to include
sex, gender, religion, and others as are
often found in such clauses and relate
to specific non-discrimination Federal
laws. Several respondents provided
comments that are mostly identical and
suggested two modifications. The first is
to expand the enumerated areas of
prohibited discrimination to include
genetics, politics, and veteran status
among others. It then suggests ‘‘that
nothing in this clause limits the ability
of a recipient to target assistance to
certain populations as defined in the
award.’’ Thus the respondents ask that
HHS go beyond the current
requirements of Federal law in
prohibiting other possible forms of
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discrimination and then asks that the
benefits distributed NOT be subject to
this restriction in that certain benefits
are, by design, targeted to go to certain
defined groups. Another comment also
‘‘reiterates that prohibiting contractors
from discrimination while delivering
taxpayer-funded services in no way
violates religious liberty protections.’’
No change is being made to the
coverage. HHS intends to comply with
all applicable Federal legislation
regarding this subject.
352.270–5a, Notice to Offerors of
Requirement for Compliance With the
Public Health Service Policy on
Humane Care and Use of Laboratory
Animals, and 352.270–5b, Care of Live
Vertebrate Animals
The respondent asks for further
consideration to repeal using animals in
research. No change is being made to
the coverage. HHS intends to comply
with all applicable federal legislation
regarding this subject.
352.270–9, Non-Discrimination for
Conscience
Several respondents commented on
the clause at 352.270–9, NonDiscrimination for Conscience. Most of
the comments are identical. Each notes
that their concern is with the statute,
not the regulation implementing it.
They further ask that the law be
‘‘robustly operationalized.’’ HHS
intends to enforce section 7631(d) of the
Leadership Act. Therefore, no change is
being made to the coverage.
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352.270–12, Needle Exchange
The respondent commented on the
clause at 352.270–12, Needle Exchange,
which prevents Federal funds from
being used for safe needle exchange.
The respondent believes that safe needle
exchanges at HHS locations make
logical sense. HHS intends to comply
with all applicable Federal legislation
regarding this subject. Therefore, no
change is being made to the coverage.
352.270–13, Continued Ban on Funding
Abortion and Continued Ban on
Funding of Human Embryo Research
Several respondents commented on
the clause at 352.270–13, Continued
Ban on Funding Abortion and
Continued Ban on Funding of Human
Embryo Research. All but one of the
comments were identical. The
remaining comment was more
expansive. This clause prohibits the use
of Federal funds for abortion, creating
embryos for the purpose of harvesting
cells from them (commonly referred to
as ‘‘stem cell research’’), and the cloning
of humans.
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The respondents want the rule
changed as to abortion to permit
abortion in the case of incest, rape, and
life endangerment ‘‘pursuant to
prevailing law.’’ HHS intends to comply
with all applicable Federal legislation
regarding this subject. Therefore, no
change is being made to the coverage.
III. Executive Orders 12866 and 13563
Executive Orders (E.O.s) 12866 and
13563 direct agencies to assess all costs
and benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). E.O. 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility.
This is not a significant regulatory
action and, therefore, is not subject to
review under section 6(b) of Executive
Order 12866, Regulatory Planning and
Review, dated September 30, 1993. This
rule is not a major rule under 5 U.S.C.
804.
IV. Regulatory Flexibility Act
A final regulatory flexibility analysis
has been prepared consistent with 5
U.S.C. 604.
1. Statement of the Need for, and the
Objectives of, the Rule
The Department of Health and Human
Services (HHS) is revising its Federal
Acquisition Regulation (FAR)
Supplement, the HHS Acquisition
Regulation (HHSAR), to update its
regulation to current FAR requirements;
to remove information from the HHSAR
that consists of material that is internal
administrative and procedural in nature;
to add or revise definitions; to correct
certain terminology; and to delete
outdated material or material
duplicative of the FAR.
2. Statement of the Significant Issues
Raised by the Public Comments in
Response to the Initial Regulatory
Flexibility Analysis, a Statement of the
Assessment of the Agency of Such
Issues, and a Statement of any Changes
Made to the Rule as a Result of Such
Comments
No issues were raised by the public in
response to the initial regulatory
flexibility analysis.
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3. The Response of the Agency to Any
Comments Filed by the Chief Counsel
for Advocacy of the Small Business
Administration in Response to the Rule,
and a Detailed Statement of any Change
Made in the Final Rule as a Result of the
Comments
No issues were raised by the Chief
Counsel for Advocacy of the Small
Business Administration in response to
the rule.
4. Description of and an Estimate of the
Number of Small Entities to Which This
Rule Will Apply
HHS awarded approximately 95,836
contract actions in FY 2014; over 44
percent (42,467) of those actions were
for small businesses acting as prime
contractors; therefore, it is estimated
that the rule will apply to over 42,000
small business entities.
5. Description of the Projected
Reporting, Recordkeeping, and Other
Compliance Requirements of the Rule
There are no new reporting,
recordkeeping, or other compliance
requirements in the final rule. The
reporting and recordkeeping
requirements are the same as those prior
to the proposed rule.
6. Description of the Steps the Agency
Has Taken To Minimize the Significant
Economic Impact on Small Entities
Consistent With the Stated Objectives of
Applicable Statutes
The final rule does not revise or place
any new requirements on small business
entities. Therefore, this final rule should
have no significant economic impact on
a substantial number of small business
entities.
V. Paperwork Reduction Act
The Paperwork Reduction Act (44
U.S.C. Chapter 35) applies. The rule
contains information collection
requirements. OMB has cleared these
information collection requirements
under OMB Control Numbers 0990–
0430, 0990–0431, 0990–0432, 0990–
0433, 0990–0434, and 0990–0436.
List of Subjects in 48 CFR Parts 301
Through 370
Government procurement.
Dated: October 29, 2015.
Angela Billups,
Associate Deputy Assistant Secretary—
Acquisition.
For the reasons stated in the
preamble, HHS is revising 48 CFR
chapter 3 to read as follows:
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PART 332—CONTRACT FINANCING
PART 333—PROTESTS, DISPUTES,
AND APPEALS
Title 48—Federal Acquisition
Regulations System
CHAPTER 3—HEALTH AND HUMAN
SERVICES
SUBCHAPTER F—SPECIAL CATEGORIES
OF CONTRACTING
SUBCHAPTER A—GENERAL
PART 301—HHS ACQUISITION
REGULATION SYSTEM
PART 302—DEFINITIONS OF WORDS
AND TERMS
PART 303—IMPROPER BUSINESS
PRACTICES AND PERSONAL
CONFLICTS OF INTEREST
PART 304—ADMINISTRATIVE
MATTERS
SUBCHAPTER B—COMPETITION AND
ACQUISITION PLANNING
PART 305—PUBLICIZING CONTRACT
ACTIONS
PART 306—COMPETITION
REQUIREMENTS
PART 307—ACQUISITION PLANNING
PART 308—REQUIRED SOURCES OF
SUPPLIES AND SERVICES
PART 309—CONTRACTOR
QUALIFICATIONS
PART 310—MARKET RESEARCH
PART 311—DESCRIBING AGENCY
NEEDS
PART 312—ACQUISITION OF
COMMERCIAL ITEMS
SUBCHAPTER C—CONTRACTING
METHODS AND CONTRACT TYPES
PART 313—SIMPLIFIED ACQUISITION
PROCEDURES
PART 314—SEALED BIDDING
PART 315—CONTRACTING BY
NEGOTIATION
PART 316—TYPES OF CONTRACTS
PART 317—SPECIAL CONTRACTING
METHODS
SUBCHAPTER D—SOCIOECONOMIC
PROGRAMS
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PART 319—SMALL BUSINESS
PROGRAMS
PART 322—APPLICATION OF LABOR
LAWS TO GOVERNMENT
ACQUISITIONS
PART 323—ENVIRONMENT, ENERGY
AND WATER EFFICIENCY,
RENEWABLE ENERGY
TECHNOLOGIES,
OCCUPATIONAL SAFETY, AND
DRUG–FREE WORKPLACE
PART 324—PROTECTION OF PRIVACY
AND FREEDOM OF
INFORMATION
PART 326—OTHER SOCIOECONOMIC
PROGRAMS
SUBCHAPTER E—GENERAL
CONTRACTING REQUIREMENTS
PART 327—PATENTS, DATA, AND
COPYRIGHTS
PART 328—RESERVED
PART 330—COST ACCOUNTING
STANDARDS
PART 331—CONTRACT COST
PRINCIPLES AND PROCEDURES
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PART 334—MAJOR SYSTEM
ACQUISITION
PART 335—RESEARCH AND
DEVELOPMENT CONTRACTING
PART 336—CONSTRUCTION AND
ARCHITECT–ENGINEER
CONTRACTS
PART 337—SERVICE CONTRACTING—
GENERAL
PART 339—ACQUISITION OF
INFORMATION TECHNOLOGY
SUBCHAPTER G—CONTRACT
MANAGEMENT
PART 342—CONTRACT
ADMINISTRATION
SUBCHAPTER H—CLAUSES AND FORMS
PART 352—SOLICITATION
PROVISIONS AND CONTRACT
CLAUSES
PART 353—FORMS
SUBCHAPTERS I—L [RESERVED]
SUBCHAPTER M—HHS
SUPPLEMENTATIONS
PART 370—SPECIAL PROGRAMS
AFFECTING ACQUISITION
SUBCHAPTER A—GENERAL
PART 301—HHS ACQUISITION
REGULATION SYSTEM
Subpart 301.1 Purpose, Authority, and
Issuance
Sec.
301.101 Purpose.
301.103 Authority.
301.106 Office of Management and Budget
approval under the Paperwork Reduction
Act.
Subpart 301.2—[Reserved]
Subpart 301.4—Deviations from the FAR
301.401 Deviations.
Subpart 301.6—Career Development,
Contracting Authority, and Responsibilities
301.602 Contracting officers.
301.602–3 Ratification of unauthorized
commitments.
301.603 Selection, appointment, and
termination of appointment of
contracting officers.
301.603–1 General.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 301.1—Purpose, Authority,
and Issuance
301.101
Purpose.
(a) The Department of Health and
Human Services (HHS) Acquisition
Regulation (HHSAR) establishes
uniform HHS acquisition policies and
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procedures that implement and
supplement the Federal Acquisition
Regulation (FAR).
(b)(1) The HHSAR contains HHS
policies that govern the acquisition
process or otherwise control acquisition
relationships between HHS’ contracting
activities and contractors. The HHSAR
contains—
(i) Requirements of law;
(ii) HHS-wide policies;
(iii) Deviations from FAR
requirements; and
(iv) Policies that have a significant
effect beyond the internal procedures of
HHS or a significant cost or
administrative impact on contractors or
offerors.
(2) Relevant internal procedures,
guidance, and information not meeting
the criteria in paragraph (b)(1) of this
section are issued by HHS in other
announcements, internal procedures,
guidance, or information.
301.103
Authority.
(b) The Assistant Secretary for
Financial Resources (ASFR) prescribes
the HHSAR under the authority of 5
U.S.C. 301 and section 205(c) of the
Federal Property and Administrative
Services Act of 1949, as amended (40
U.S.C. 121(c)(2)), as delegated by the
Secretary).
(c) The HHSAR is issued in the Code
of Federal Regulations (CFR) as chapter
3 of title 48, Department of Health and
Human Services Acquisition Regulation.
It may be referenced as ‘‘48 CFR chapter
3.’’
301.106 Office of Management and Budget
approval under the Paperwork Reduction
Act.
(a) The Paperwork Reduction Act of
1980 (44 U.S.C. 3501 et seq.) imposes a
requirement on Federal agencies to
obtain approval from the Office of
Management and Budget (OMB) before
collecting the same information from 10
or more members of the public.
(b) The following OMB control
numbers apply to the information
collection and recordkeeping
requirements contained in this chapter:
HHSAR Segment
311.7102 ...............
311.7202(b) ..........
311.7300 ...............
337.103(d)(3) ........
337.103(d)(4) ........
370.301 .................
370.401 .................
352.211–1 .............
352.211–2 .............
352.211–3 .............
352.227–11 ...........
352.227–14 ...........
352.227–71 ...........
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OMB Control No.
0990–0434
0990–0434
0990–0436
0990–0430
0990–0433
0990–0431
0990–0432
0990–0434
0990–0434
0990–0436
0990–0419
0990–0419
0990–0430
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HHSAR Segment
352.237–72
352.237–73
352.270–4a
352.270–4b
352.270–10
352.270–11
352.270–5a
352.270–5b
OMB Control No.
...........
...........
...........
...........
...........
...........
...........
...........
0990–0433
0990–0431
0990–0431
0990–0431
0990–0431
0990–0432
0990–0432
0990–0432
Subpart 301.2—[Reserved]
Subpart 301.4—Deviations from the
FAR
301.401
Deviations.
Contracting officers are not permitted
to deviate from the FAR or HHSAR
without seeking proper approval. With
full acknowledgement of FAR 1.102(d)
regarding innovative approaches, any
deviation to FAR or the HHSAR requires
approval by the Senior Procurement
Executive (SPE).
301.603 Selection, appointment, and
termination of appointment of contracting
officers.
delegated broad authority regarding the
conduct of acquisition functions.
301.603–1
PART 303—IMPROPER BUSINESS
PRACTICES AND PERSONAL
CONFLICTS OF INTEREST
General.
(a) The Agency head has delegated
broad authority to the Chief Acquisition
Officer, who in turn has further
delegated this authority to the SPE. The
SPE has further delegated specific
acquisition authority to the Operating
and Staff Division heads and the HCAs.
The HCA (non-delegable) shall select,
appoint, and terminate the appointment
of contracting officers.
(b) To ensure proper control of
redelegated acquisition authorities,
HCAs shall maintain a file containing
successive delegations of HCA authority
through the contracting officer level.
PART 302—DEFINITIONS OF WORDS
AND TERMS
Subpart 302.1—Definitions
Sec.
302.101 Definitions.
Subpart 301.6—Career Development,
Contracting Authority, and
Responsibilities
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
301.602
302.101
Contracting officers.
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301.602–3 Ratification of unauthorized
commitments.
(b) Policy. (1) The Government is not
bound by agreements with, or
contractual commitments made to,
prospective contractors by individuals
who do not have delegated contracting
authority. Unauthorized commitments
do not follow the appropriate process
for the expenditure of Government
funds. Consequently, the Government
may not be able to ratify certain actions,
putting a contractor at risk for taking
direction from a Federal official other
than the contracting officer. See FAR
1.602–1. Government employees
responsible for unauthorized
commitments are subject to disciplinary
action. Contractors perform at their own
risk when accepting direction from
unauthorized officials. Failure to follow
statutory and regulatory processes for
the expenditure of Government funds is
a very serious matter.
(2) The head of the contracting
activity (HCA) is the official authorized
to ratify an unauthorized commitment.
No other re-delegations are authorized.
(c) Limitations. (5) The HCA shall
coordinate the request for ratification
with the Office of General Counsel,
General Law Division and submit a copy
to the SPE.
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Subpart 302.1—Definitions
Definitions.
(a) Agency head or head of the
agency, unless otherwise stated, means
the Secretary of Health and Human
Services or specified designee.
(b) Contracting Officer’s
Representative (COR) is a Federal
employee designated in writing by a
contracting officer to act as the
contracting officer’s representative in
monitoring and administering specified
aspects of contractor performance after
award of a contract or order. In
accordance with local procedures,
operating divisions (OPDIVs) or staff
divisions (STAFFDIVs) may designate
CORs for firm fixed-price contracts or
orders. COR’s responsibilities may
include verifying that:
(1) The contractor’s performance
meets the standards set forth in the
contract or order;
(2) The contractor meets the contract
or order’s technical requirements by the
specified delivery date(s) or within the
period of performance; and
(3) The contractor performs within
cost ceiling stated in the contract or
order. CORs must meet the training and
certification requirements specified in
301.604.
(c) Head of the Contracting Activity
(HCA) is an official having overall
responsibility for managing a
contracting activity, i.e. the organization
within an OPDIV or STAFFDIV or other
HHS organization which has been
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Subpart 303.1—Safeguards
Sec.
303.101 Standards of conduct.
303.101–3 Agency regulations.
303.104–7 Violations or possible violations
of the Procurement Integrity Act.
Subpart 303.2—Contractor Gratuities to
Government Personnel
303.203 Reporting suspected violations of
the Gratuities clause.
Subpart 303.6—Contracts with Government
Employees or Organizations Owned or
Controlled by Them
303.602 Exceptions.
Subpart 303.7—Voiding and Rescinding
Contracts
303.704 Policy.
Subpart 303.8—Limitation on the Payment
of Funds to Influence Federal Transactions
303.808–70 Solicitation provision and
contract clause.
Subpart 303.10—Contractor Code of
Business Ethics and Conduct
303.1003 Requirements.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 303.1—Safeguards
303.101
Standards of conduct.
303.101–3
Agency regulations.
(a)(3) The HHS Standards of Conduct
are prescribed in 45 CFR part 73.
303.104–7 Violations or possible
violations of the Procurement Integrity Act.
(a)(1) The contracting officer shall
submit to the head of the contracting
activity (HCA) for review and
concurrence the determination (along
with supporting documentation) that a
reported violation or possible violation
of the statutory prohibitions has no
impact on the pending award or
selection of a contractor for award.
(2) The contracting officer shall refer
the determination that a reported
violation or possible violation of the
statutory prohibitions has an impact on
the pending award or selection of a
contractor, along with all related
information available, to the HCA. The
HCA shall—
(i) Refer the matter immediately to the
Associate Deputy Assistant Secretary—
Acquisition (ADAS–A) for review, who
may consult with the appropriate legal
office representative and the Office of
Inspector General (OIG) as appropriate;
and
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(ii) Determine the necessary action in
accordance with FAR 3.104–7(c) and
(d). The HCA shall obtain the approval
or concurrence of the ADAS–A before
proceeding with an action.
(b) The HCA (non-delegable) shall act
with respect to actions taken under the
Federal Acquisition Regulation (FAR)
clause at 52.203–10, Price or Fee
Adjustment for Illegal or Improper
Authority.
Subpart 303.2—Contractor Gratuities
to Government Personnel
303.203 Reporting suspected violations of
the Gratuities clause.
HHS personnel shall report suspected
violations of the clause at FAR 52.203–
3, Gratuities, to the contracting officer,
who will in turn report the matter to the
Office of General Counsel (OGC), Ethics
Division for disposition.
PART 304—ADMINISTRATIVE
MATTERS
Subpart 304.16—Unique Procurement
Instrument Identifiers
Subpart 304.6—Contract Reporting
304.1600
Sec.
304.602
304.604
Subpart 304.13—Personal Identity
Verification
304.1300
303.602
Exceptions.
304.1600
Subpart 304.71—Review and Approval
of Proposed Contract Actions
Policy.
303.808–70 Solicitation provision and
contract clause.
The contracting officer shall insert the
clause at 352.203–70, Anti-lobbying, in
solicitations and contracts that exceed
the simplified acquisition threshold.
Subpart 303.10—Contractor Code of
Business Ethics and Conduct
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(b) The contracting officer, when
notified of a possible contractor
violation, in accordance with FAR
3.1003(b), shall notify the OIG and the
HCA.
(c)(2) The contracting officer shall
specify the title of HHS’ OIG hotline
poster and the Web site where the
poster can be obtained in paragraph
(b)(3) of the clause at FAR 52.203–14.
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Scope of subpart.
Procedures.
Contract clause.
304.604
Responsibilities.
The Department of Health and Human
Services (HHS) acquisition officials and
staff shall report their contract
information in FPDS accurately and
timely.
Subpart 304.13—Personal Identity
Verification
Policy.
To ensure compliance with Homeland
Security Presidential Directive-12:
Policy for a Common Identification
Standard for Federal Employees and
Contractors (HSPD–12) and the
Presidential Cross Agency Priority for
strong authentication, contracting
officers shall provide in each
acquisition those HSPD–12
requirements necessary for contract
performance.
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Subpart 304.71—Review and Approval
of Proposed Contract Actions
Policy.
In accordance with HHS delegated
acquisition authority, the FAR, this
regulation, internal policies and
guidance, the head of the contracting
activity (non-delegable) shall establish
review and approval procedures for
proposed contract actions to ensure
that—
(a) Contractual documents are in
conformance with law, established
policies and procedures, and sound
business practices;
(b) Contract actions properly reflect
the mutual understanding of the parties;
and
(c) The contracting officer is informed
of deficiencies and items of
questionable acceptability, and takes
corrective action.
General.
Follow internal department
procedures for reporting information to
the Federal Procurement Data System
(FPDS) and for resolving technical or
policy issues relating to FPDS contract
reporting.
304.1300
Requirements.
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Subpart 304.72—Affordable Care Act
Prevention and Public Health Fund—
Reporting Requirements
304.602
Subpart 303.8—Limitation on the
Payment of Funds to Influence Federal
Transactions
303.1003
Policy.
Subpart 304.6—Contract Reporting
(a) For purposes of supplementing
FAR subpart 3.7, the HCA (nondelegable) is the designee. Coordination
with the Senior Procurement Executive
is required.
Subpart 304.70—[Reserved]
304.7100
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 303.7—Voiding and
Rescinding Contracts
303.704
Scope of subpart.
Subpart 304.70—[Reserved]
Sec.
304.7200
304.7201
304.7202
The HCA (non-delegable) is the
official authorized to approve an
exception to the policy stated in FAR
3.601.
Policy.
Subpart 304.16—Unique Procurement
Instrument Identifiers
304.7100
Subpart 303.6—Contracts with
Government Employees or
Organizations Owned or Controlled by
Them
General.
Responsibilities.
Scope of subpart.
This subpart provides guidance for
assigning identification numbers to
solicitation or contract actions. The
Senior Procurement Executive shall be
responsible for establishing a numbering
system within the department that
conforms to Federal Acquisition
Regulation (FAR) subpart 4.16.
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Subpart 304.72—Affordable Care Act
Prevention and Public Health Fund—
Reporting Requirements
304.7200
Scope of subpart.
This subpart implements Section 220
of Public Law 112–74, FY 2012 Labor,
HHS and Education Appropriations Act,
which requires, semi-annual reporting
on the use of funds from the Prevention
and Public Health Fund (PPHF), Public
Law 111–148, sec. 4002. Contractors
that receive awards (or modifications to
existing awards) with a value of $25,000
or more funded, in whole or in part,
from the PPHF, shall report information
specified in the clause at 352.204–70,
Prevention and Public Health Fund—
Reporting Requirements, including, but
not limited to—
(a) The dollar amount of contractor
invoices;
(b) The supplies delivered and
services performed; and
(c) Specific information on
subcontracts with a value of $25,000 or
more.
304.7201
Procedures.
(a) In any contract action funded in
whole or in part by the PPHF, the
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SUBCHAPTER B—COMPETITION AND
ACQUISITION PLANNING
304.7202
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contracting officer shall indicate that the
contract action is being made under the
PPHF, and indicate which products or
services are funded under the PPHF.
This requirement applies whenever
PPHF funds are used, regardless of the
contract instrument.
(b) To maximize transparency of
PPHF funds that shall be reported by the
contractor, the contracting officer shall
structure contract awards to allow for
separately tracking PPHF funds. For
example, the contracting officer may
consider awarding dedicated separate
contracts when using PPHF funds or
establishing contract line item number
structures to prevent commingling of
PPHF funds with other funds.
(c) Contracting officers shall ensure
that the contractor complies with the
reporting requirements of 352.204–70.
Upon receipt of each report, the
contracting officer shall review it for
completeness, address any clarity or
completeness issues with the contractor,
and submit the final approved report in
Section 508 compliant format to an
Assistant Secretary for Public Affairs
point-of-contact for posting on HHS’
PPHF Web site at https://www.hhs.gov/
open/prevention/ no later
than 30 days after the end of the
reporting period. If the contractor fails
to comply with the reporting
requirements, the contracting officer
shall exercise appropriate contractual
remedies.
(d) The contracting officer shall make
the contractor’s failure to comply with
the reporting requirements a part of the
contractor’s performance information
under FAR subpart 42.15.
305.7001
Contract clause.
Insert the clause at 352.204–70,
Prevention and Public Health Fund—
Reporting Requirements, in all
solicitations and contract actions
funded in whole or in part with PPHF
funds, except classified solicitations and
contracts. This includes, but is not
limited to, awarding or modifying
orders against existing or new contracts
issued under FAR subparts 8.4 and 16.5
that will be funded with PPHF funds.
Contracting officers shall include this
clause in any existing contract or order
that will be funded with PPHF funds.
This clause is not required for any
contract or order which contains a prior
version of the clause at 352.204–70.
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PART 305—PUBLICIZING CONTRACT
ACTIONS
Subpart 305.3—Synopses of Contract
Awards
Sec.
305.303 Announcement of contract awards.
Subpart 305.5—Paid Advertisements
305.502 Authority.
Subpart 305.70—Publicizing Requirements
Funded From the Affordable Care Act
Prevention and Public Health Fund
305.7001 Scope.
305.7002 Applicability.
305.7003 Publicizing preaward.
305.7004 Publicizing postaward.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 305.3—Synopses of Contract
Awards
305.303 Announcement of contract
awards.
(a) Public announcement. The
contracting officer shall report awards,
not exempt under Federal Acquisition
Regulation (FAR) 5.303, to the Office of
the Assistant Secretary for Legislation
(Congressional Liaison Office.)
Subpart 305.5—Paid Advertisements
305.502
Authority.
Written approval at least one level
above the contracting officer shall be
obtained prior to placing advertisements
or notices in newspapers.
Subpart 305.70—Publicizing
Requirements Funded From the
Affordable Care Act Prevention and
Public Health Fund
Scope.
Pursuant to appropriations acts, this
subpart prescribes requirements for
posting presolicitation and award
notices for actions funded in whole or
in part from the Prevention and Public
Health Fund (PPHF). The requirements
of this subpart enhance transparency to
the public.
305.7002
Applicability.
This subpart applies to all actions
funded in whole or in part by the PPHF.
305.7003
Publicizing preaward.
Notices of all proposed contract
actions, funded in whole or in part by
the PPHF, shall be identified on HHS’
Prevention and Public Health Fund Web
site at https://www.hhs.gov/open/
prevention/ no later than 1day after issuance of the solicitation or
other request for proposal or quotation
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document. When applicable, the notice
shall provide a link to the full text; for
example, a link to the FedBizOpps
notice required by FAR 5.201.
305.7004
Publicizing postaward.
Notices of contract actions exceeding
$25,000, funded in whole or in part by
the PPHF, shall be identified on HHS’
PPHF Web site at https://www.hhs.gov/
open/prevention/ no later
than 5 days after the contract action
occurs.
PART 306—COMPETITION
REQUIREMENTS
Subpart 306.2—Full and Open Competition
After Exclusion of Sources
Sec.
306.202 Establishing or maintaining
alternative sources.
Subpart 306.3—Other Than Full and Open
Competition
306.302 Circumstances permitting other
than full and open competition.
306.302–1 Only one responsible source and
no other supplies or services will satisfy
agency requirements.
Subpart 306.5—Competition Advocates
306.501 Requirement.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 306.2—Full and Open
Competition After Exclusion of
Sources
306.202 Establishing or maintaining
alternative sources.
(a) The Senior Procurement Executive
(SPE) shall make the determination
required in Federal Acquisition
Regulation (FAR) 6.202(a).
(b)(1) The contracting officer shall
prepare the required determination and
findings (D&F), see FAR 6.202(b)(1),
based on the data provided by program
personnel. The appropriate Competition
Advocate (CA) (non-delegable) shall
sign the D&F, indicating concurrence.
The final determination will be made by
the SPE.
Subpart 306.3—Other Than Full and
Open Competition
306.302 Circumstances permitting other
than full and open competition.
306.302–1 Only one responsible source
and no other supplies or services will
satisfy agency requirements. See FAR
6.302–1.
For acquisitions covered by 42 U.S.C.
247d–6a(b)(2)(A), ‘‘available from only
one responsible source’’ shall be
deemed to mean ‘‘available from only
one responsible source or only from a
limited number of responsible sources’’.
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review and clearance of print and
electronic publications, printing and
related supplies, audiovisual products,
and communication service contracts.
See FAR 8.802 for exceptions.
Subpart 306.5—Competition
Advocates
306.501
Requirement.
The Department Competition
Advocate for Health and Human
Services is located in the Division of
Acquisition.
308.801
PART 307—ACQUISITION PLANNING
Sec.
307.105 Contents of written acquisition
plans.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
307.105
plans.
Federal Acquisition Regulation 7.105
specifies the content requirements for a
written Acquisition Plan (AP). The
Department of Health and Human
Services requires a written AP for all
acquisitions above the simplified
acquisition threshold.
PART 308—REQUIRED SOURCES OF
SUPPLIES AND SERVICES
Subpart 308.4—Federal Supply
Schedules
Sec.
308.405–6 Limited source justification and
approval.
Subpart 308.8—Acquisition of Printing and
Related Supplies
308.800 Scope of subpart.
308.801 Definitions.
308.802 Policy.
308.803 Solicitation provision and contract
clause.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 308.4—Federal Supply
Schedules
308.405–6
approval.
Limited source justification and
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(d)(1) As required by Federal
Acquisition Regulation (FAR) 8.405–1
or 8.405–2, the responsible program
office must provide a written
justification for an acquisition under the
Federal Supply Service program that
restricts the number of schedule
contractors or when procuring an item
peculiar to one manufacturer.
Subpart 308.8—Acquisition of Printing
and Related Supplies
308.800
Scope of subpart.
This subpart provides the Department
of Health and Human Services (HHS)
policy for the acquisition of Government
printing and related supplies. The HHS
Office of the Assistant Secretary for
Public Affairs is responsible for the
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The terms ‘‘printing’’ and
‘‘duplicating/copying’’ are defined in
the Government Printing and Binding
Regulations of the Joint Committee on
Printing. The regulations are available at
https://www.gpo.gov.
308.802
Contents of written acquisition
Definitions.
Policy.
In accordance with FAR 8.802(b), the
Central Printing and Publications
Management Organization at Program
Support Center is the HHS designated
central printing authority.
308.803 Solicitation provision and
contract clause.
The contracting officer shall insert the
clause at 352.208–70, Printing and
Duplication, in all solicitations,
contracts, and orders over the simplified
acquisition threshold, unless printing or
increased duplication is authorized by
statute.
PART 309—CONTRACTOR
QUALIFICATIONS
Subpart 309.4—Debarment, Suspension,
and Ineligibility
Sec.
309.403 Definitions.
309.404 System for Award Management
(SAM) exclusions.
309.405 Effect of listing (compelling reason
determinations).
309.406 Debarment.
309.406–3 Procedures.
309.407 Suspension.
309.407–3 Procedures.
309.470 Reporting of suspected causes for
debarment or suspension or the taking of
evasive actions.
309.470–1 Situations where reports are
required.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 309.4 Debarment, Suspension,
and Ineligibility
309.403
Definitions.
The following definition applies to
this subpart:
The HHS Suspension and Debarment
Official is the Deputy Assistant
Secretary (DAS) for the Office of Grants
and Acquisition Policy and
Accountability (OGAPA).
309.404 System for Award Management
(SAM) exclusions.
(c) For actions made by HHS pursuant
to FAR 9.406 and 9.407, the Office of
Recipient Integrity Coordination shall
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perform the actions required by FAR
9.404(c).
309.405 Effect of listing (compelling
reason determinations).
(a) The head of the contracting
activity (HCA) (non-delegable) may,
with the written concurrence of the
Suspension and Debarment Official,
make the determinations referenced in
FAR 9.405(a) regarding contracts.
(1) If a contracting officer considers it
necessary to award a contract, or
consent to a subcontract with a debarred
or suspended contractor, the contracting
officer shall prepare a determination,
including all pertinent documentation,
and submit it through appropriate
acquisition channels to the HCA. The
documentation shall include the date by
which approval is required and a
compelling reason for the proposed
action. Compelling reasons for award of
a contract or consent to a subcontract
with a debarred or suspended contractor
include the following:
(i) Only the cited contractor can
provide the property or services, and
(ii) The urgency of the requirement
dictates that HHS conduct business with
the cited contractor.
(2) If the HCA decides to approve the
requested action, the HCA shall request
the concurrence of the Suspension and
Debarment Official and, if given, shall
inform the contracting officer in writing
of the determination within the required
time period.
309.406
Debarment.
309.406–3
Procedures.
Refer all matters appropriate for
consideration by an agency Suspension
and Debarment Official as soon as
practicable to the appropriate
Suspension and Debarment Official
identified in 309.403. Any person may
refer a matter to the Suspension and
Debarment Official.
309.407
Suspension.
309.407–3
Procedures.
Refer all matters appropriate for
consideration by an agency Suspension
and Debarment Official as soon as
practicable to the appropriate
Suspension and Debarment Official
identified in 309.403. Any person may
refer a matter to the Suspension and
Debarment Official.
309.470 Reporting of suspected causes
for debarment or suspension or the taking
of evasive actions.
309.470–1
required.
Situations where reports are
The contracting officer shall report to
the HCA and the Associate Deputy
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Assistant Secretary—Acquisition
whenever the contracting officer—
(a) Knows or suspects that a
contractor is committing or has
committed any of the acts described in
FAR 9.406–2 or 9.407–2; or
(b) Suspects a contractor is attempting
to evade the prohibitions of debarment
or suspension imposed under FAR
9.405, or any other comparable
regulation, by changes of address,
multiple addresses, formation of new
companies, or by other devices.
PART 310—MARKET RESEARCH
Sec.
310.001
Policy.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
310.001
Policy.
Market research shall be conducted as
prescribed in Federal Acquisition
Regulation part 10.
Subpart 311.70—Section 508 Accessibility
Standards
Sec.
311.7000 Defining electronic information
technology requirements.
Subpart 311.71—Public Accommodations
and Commercial Facilities
Policy.
Responsibilities.
Contract clause.
Subpart 311.72—Conference Funding and
Sponsorship
311.7200
311.7201
311.7202
Policy.
Funding and sponsorship.
Contract clause.
Subpart 311.70—Section 508
Accessibility Standards
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Contract clause.
The contracting officer shall insert the
clause at 352.211–1, Public
Accommodations and Commercial
Facilities, in solicitations, contracts, and
orders requiring the contractor to
conduct events in accordance with
311.7100(b).
311.7201
311.7000 Defining electronic and
information technology requirements.
The contracting officer shall ensure
that requiring activities specify agency
needs for electronic and information
technology (EIT) supplies and services,
and document market research,
document EIT requirements, and
identify the applicable Section 508
accessibility standards. See FAR
11.002(f) and HHSAR subpart 339.2.
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311.7102
Policy.
HHS policy requires that all
conferences the agency funds or
sponsors shall: be consistent with HHS
missions, objectives, and policies;
represent an efficient and effective use
of taxpayer funds; and withstand public
scrutiny.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
19:27 Nov 17, 2015
Responsibilities.
The contractor shall submit a plan
assuring that any event held will meet
or exceed the minimum accessibility
standards set forth in 28 CFR part 36. A
consolidated or master plan for
contracts requiring numerous events in
public accommodations and commercial
facilities is acceptable.
311.7200
Policy.
Contract clause.
VerDate Sep<11>2014
Policy.
(a) It is HHS policy that all contractors
comply with current and any future
changes to 28 CFR part 36—
Nondiscrimination on the Basis of
Disability by Public Accommodations
and in Commercial Facilities. For the
purpose of this policy, accessibility is
defined as both physical access to
public accommodations and commercial
facilities, and access to aids and services
enabling individuals with sensory
disabilities to fully participate in events
in public accommodations and
commercial facilities.
(b) This policy applies to all contracts
requiring contractors to conduct events
in public accommodations and
commercial facilities open to the public
or involving HHS personnel, but not ad
hoc meetings necessary or incidental to
contract performance.
Subpart 311.72—Conference Funding
and Sponsorship
Subpart 311.73—Contractor Collection of
Information
311.7300
311.7301
311.7100
311.7101
PART 311—DESCRIBING AGENCY
NEEDS
311.7100
311.7101
311.7102
Subpart 311.71—Public
Accommodations and Commercial
Facilities.
Funding and sponsorship.
Funding a conference through a HHS
contract does not automatically imply
HHS sponsorship, unless the conference
is funded entirely by the agency. Also,
HHS staff attendance or participation at
a conference does not imply HHS
conference sponsorship. Accordingly,
for non-conference contracts funded
entirely by HHS prior to a contractor
claiming HHS sponsorship, the
contractor must provide the contracting
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officer a written request for permission
to designate HHS the conference
sponsor. The OPDIV or STAFFDIV
(operating division or staff division)
head, or designee, shall approve such
requests. The determination on what
constitutes a ‘‘conference contract’’ or a
‘‘non-conference contract’’ shall be
made by the contracting officer.
311.7202
Contract clause.
To ensure that a contractor:
(a) Properly requests approval to
designate HHS the conference sponsor,
where HHS is not the sole provider of
conference funding; and
(b) Includes an appropriate Federal
funding disclosure and content
disclaimer statement for conference
materials, the contracting officer shall
include the clause at 352.211–2,
Conference Sponsorship Request and
Conference Materials Disclaimer, in
solicitations, contracts, and orders
providing funding which partially or
fully supports a conference.
Subpart 311.73—Contractor Collection
of Information
311.7300
Policy.
In accordance with the Paperwork
Reduction Act (PRA), contractors shall
not proceed with collecting information
from surveys, questionnaires, or
interviews until the COR obtains an
Office of Management and Budget
clearance and the contracting officer
issues written approval to proceed. For
any contract involving a requirement to
collect or record information calling
either for answers to identical questions
from 10 or more persons other than
Federal employees, or information from
Federal employees which is outside the
scope of their employment, for use by
the Federal Government or disclosure to
third parties, the contracting officer
must comply with the PRA of 1995 (44
U.S.C. 3501 et seq.).
311.7301
Contract clause.
The contracting officer shall insert the
clause at 352.211–3, Paperwork
Reduction Act, in solicitations,
contracts, and orders that require a
contractor to collect the same
information from 10 or more persons.
PART 312—ACQUISITION OF
COMMERCIAL ITEMS
Subpart 312.1—Acquisition of Commercial
Items—General
Sec.
312.101 Policy.
Subpart 312.2—Special Requirements for
the Acquisition of Commercial Items
312.202(d) Market research and description
of agency need.
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Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 312.1—Acquisition of
Commercial Items—General
312.101
Policy.
Contracting offices shall use the HHS
Smarter Buying Program to the
maximum extent practicable. See HHS
Acquisition Regulation part 307,
Acquisition Planning.
Subpart 312.2—Special Requirements
for the Acquisition of Commercial
Items
312.202(d) Market research and
description of agency need.
Whenever a requiring activity
specifies electronic and information
technology (EIT) supplies and services
subject to Section 508 of the
Rehabilitation Act of 1973, as amended,
the requiring activity shall acquire
commercially available supplies and
services to the maximum extent possible
while ensuring Section 508 compliance.
See part 339.
SUBCHAPTER C—CONTRACTING
METHODS AND CONTRACT TYPES
PART 313—SIMPLIFIED ACQUISITION
PROCEDURES
Sec.
313.003
Policy.
Policy.
Subpart 313.3—Simplified Acquisition
Methods
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313.301 Government-wide commercial
purchase card.
(b) Make all HHS transactions
utilizing the government-wide
commercial purchase card in
accordance with the HHS Purchase Card
Program.
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314.103
Policy.
Electronic and information
technology (EIT) supplies and services
acquired using sealed-bid procedures
shall comply with Section 508 of the
Rehabilitation Act of 1973, as amended.
See part 339.
Subpart 314.4—Opening of Bids and
Award of Contract
314.404
Rejection of bids.
314.404–1
opening.
Cancellation of invitations after
(c) The head of the contracting
activity (HCA) shall make the
determinations specified in FAR
14.404–1(c).
314.407
Mistakes in bids.
314.407–3 Other mistakes disclosed
before award.
Mistakes after award.
(c) The HCA has the authority to make
administrative determinations in
connection with alleged post-award
mistakes.
Electronic and information
technology (EIT) supplies and services
acquired pursuant to Federal
Acquisition Regulation part 13 shall
comply with Section 508 of the
Rehabilitation Act of 1973, as amended.
See part 339.
Subpart 314.1—Use of Sealed Bidding
Sec.
314.103 Policy.
Subpart 314.1—Use of Sealed Bidding
314.407–4
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
PART 314—SEALED BIDDING
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
(e) The HCA has the authority to make
determinations under paragraphs (a),
(b), (c), and (d) of FAR 14.407–3.
Subpart 313.3—Simplified Acquisition
Methods
313.301 Government-wide commercial
purchase card.
313.003
Subpart 314.4—Opening of Bids and Award
of Contract
314.404 Rejection of bids.
314.404–1 Cancellation of invitations after
opening.
314.407 Mistakes in bids.
314.407–3 Other mistakes disclosed before
award.
314.407–4 Mistakes after award.
PART 315—CONTRACTING BY
NEGOTIATION
Subpart 315.2—Solicitation and Receipt of
Proposals and Information
Sec.
315.204–5 Part IV—Representations and
instructions.
315.208 Submission, modification, revision,
and withdrawal of proposals.
Subpart 315.3—Source Selection
315.303–70 Policy.
315.304 Evaluation factors and significant
subfactors.
315.305 Proposal evaluation.
Subpart 315.4—Contract Pricing
315.404 Proposal analysis.
315.404–2 Information to support proposal
analysis.
Subpart 315.6—Unsolicited Proposals
315.605 Content of unsolicited proposals.
315.606 Agency procedures.
315.606–1 Receipt and initial review.
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Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 315.2—Solicitation and
Receipt of Proposals and Information
315.204–5 Part IV—Representations and
instructions.
(c) Section M, Evaluation factors for
award. (1) The requiring activity shall
develop technical evaluation factors and
submit them to the contracting officer as
part of the acquisition plan or other
acquisition request documentation for
inclusion in a solicitation. The requiring
activity shall indicate the relative
importance or weight of the evaluation
factors based on the requirements of an
individual acquisition.
(2) Only a formal amendment to a
solicitation can change the evaluation
factors.
315.208 Submission, modification,
revision, and withdrawal of proposals.
(b) In addition to the provision in
Federal Acquisition Regulation (FAR)
52.215–1, Instructions to Offerors—
Competitive Acquisition, if the head of
the contracting activity (HCA)
determines that biomedical or
behavioral research and development
(R&D) acquisitions are subject to
conditions other than those specified in
FAR 52.215–1(c)(3), the HCA may
authorize for use in competitive
solicitations for R&D, the provision at
352.215–70, Late Proposals and
Revisions. This is an authorized FAR
deviation.
(2) When the provision at 352.215–70
is included in the solicitation and if the
HCA intends to consider a proposal or
proposals received after the exact time
specified for receipt, the contracting
officer, with the assistance of cost or
technical personnel as appropriate, shall
determine in writing that the proposal(s)
meets the requirements of the provision
at 352.215–70.
Subpart 315.3—Source Selection
315.303–70
Policy.
(a) If an operating division (OPDIV) is
required by statute to use peer review
for technical review of proposals, the
requirements of those statutes, any
implementing regulatory requirements,
the Federal Advisory Committee Act,
and as applicable, any approved
Department of Health and Human
Services Acquisition Regulation
(HHSAR) deviation(s) from this subpart
take precedence over the otherwise
applicable requirements of this subpart.
(b) The statutes that require such
review and implementing regulations
are as follows: National Institutes of
Health—42 U.S.C. 289a, Peer Review
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Requirements and 42 CFR part 52h,
Scientific Peer Review of Research
Grant Applications and Research and
Development Contract Projects;
Substance Abuse and Mental Health
Services Administration—42 U.S.C.
290aa–3, Peer Review and Agency for
Healthcare Research and Quality—42
U.S.C. 299c–1, Peer review with respect
to grants and contracts.
315.304 Evaluation factors and significant
subfactors.
When acquiring electronic and
information technology supplies and
services (EIT) using negotiated
procedures, contracting officers shall
comply with Section 508 of the
Rehabilitation Act of 1973, as amended.
315.305
Proposal evaluation.
(c) Use of non-Federal evaluators. (1)
Except when peer review is required by
statute as provided in 315.303–70(a),
decisions to disclose proposals to nonFederal evaluators shall be made by the
official responsible for appointing
Source Selection Evaluation Team
members in accordance with OPDIV
procedures. The avoidance of
organizational and personal conflicts of
interest must be taken into
consideration when making the decision
to use non-Federal evaluators.
(2) When a solicited proposal will be
disclosed outside the Government to a
contractor or a contractor employee for
evaluation purposes, the following or
similar conditions shall be part of the
written agreement with the contractor
prior to disclosure:
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CONDITIONS FOR EVALUATING
PROPOSALS
The contractor agrees that it and its
employees, as well as any
subcontractors and their employees (in
these conditions, ‘‘evaluator’’) will use
the data (trade secrets, business data,
and technical data) contained in the
proposal for evaluation purposes only.
The foregoing requirement does not
apply to data obtained from another
source without restriction. Any notice
or legend placed on the proposal by
either HHS or the offeror shall be
applied to any reproduction or abstract
provided to the evaluator or made by
the evaluator. Upon completion of the
evaluation, the evaluator shall return to
the Government the furnished copy of
the proposal or abstract, and all copies
thereof, to the HHS office which
initially furnished the proposal for
evaluation. The evaluator shall not
contact the offeror concerning any
aspects of a proposal’s contents.
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Subpart 315.4—Contract Pricing
315.404
Proposal analysis.
315.404–2
analysis.
Information to support proposal
72159
(This warranty shall be signed by a
responsible management official of the
proposing organization who is a person
authorized to contractually obligate the
organization.)
(a)(2) When some or all information
sufficient to determine the
reasonableness of the proposed cost or
price is already available or can be
obtained from the cognizant audit
agency, or by other means including
data obtained through market research
(See FAR part 10 and HHSAR part 310)
the contracting officer may request lessthan-complete field pricing support
(specifying in the request the
information needed) or may waive in
writing the requirement for audit and
field pricing support by documenting
the file to indicate what information
will be used. When field-pricing
support is required, contracting officers
shall make the request through the HCA.
315.606
Subpart 315.6—Unsolicited Proposals
PART 316—TYPES OF CONTRACTS
315.605
Subpart 316.3—Cost-Reimbursement
Contracts
Sec.
316.307 Contract clauses.
Content of unsolicited proposals.
(d) Warranty by offeror. To ensure
against contacts between HHS personnel
and prospective offerors that would
exceed the limits of advance guidance
set forth in FAR 15.604 and potentially
result in an unfair advantage to an
offeror, the prospective offeror of an
unsolicited proposal must include the
following warranty in any unsolicited
proposal. Contracting officers receiving
an unsolicited proposal without this
warranty shall not process the proposal
until the offeror is notified of the
missing language and given an
opportunity to submit a proper
warranty. If no warranty is provided in
a reasonable time, the contracting officer
shall reject the unsolicited proposal,
notify the offeror of the rejection, and
document the actions in the file.
UNSOLICITED PROPOSAL
WARRANTY BY OFFEROR
This is to warrant that—
(a) This proposal has not been
prepared under Government
supervision;
(b) The methods and approaches
stated in the proposal were developed
by this offeror;
(c) Any contact with HHS personnel
has been within the limits of
appropriate advance guidance set forth
in FAR 15.604; and,
(d) No prior commitments were
received from HHS personnel regarding
acceptance of this proposal.
Agency procedures.
(a) The HCA is responsible for
establishing procedures to comply with
FAR 15.606(a).
(b) The HCA or designee shall be the
point of contact for coordinating the
receipt and processing of unsolicited
proposals.
315.606–1
Receipt and initial review.
(d) OPDIVs may consider an
unsolicited proposal even though an
organization initially submitted it as a
grant application. However, OPDIVs
shall not award contracts based on
unsolicited proposals that have been
rejected for grant awards due to lack of
scientific merit.
Subpart 316.5—Indefinite-Delivery
Contracts
316.505 Ordering.
Subpart 316.6—Time-and-Materials, LaborHour, and Letter Contracts
316.603 Letter contracts.
316.603–3 Limitations.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 316.3—Cost-Reimbursement
Contracts
316.307
Contract clauses.
(a)(1) If a contract for research and
development is with a hospital (profit or
nonprofit), the contracting officer shall
modify the ‘‘Allowable Cost and
Payment’’ clause at FAR 52.216–7 by
deleting from paragraph (a) the words
‘‘Federal Acquisition Regulation (FAR)
subpart 31.2’’ and substituting ‘‘45 CFR
part 75.’’
(2) The contracting officer shall also
insert the clause at 352.216–70,
Additional Cost Principles for Hospitals
(Profit or Non-Profit), in solicitations
and contracts with a hospital (profit or
non-profit) when a cost-reimbursement
contract is contemplated.
Subpart 316.5—Indefinite-Delivery
Contracts
316.505 Ordering.
Date: llllllllllllllllll
(b)(8) The Department of Health and
Organization: llllllllllllll
Name: lllllllllllllllll Human Services (HHS) Competition
Title: llllllllllllllllll Advocate is the task-order and delivery-
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order ombudsman for the department.
Ombudsmen for each of the HHS
contracting activities shall be designated
in writing by the head of the contracting
activity. See part 306.
Subpart 316.6—Time-and-Materials,
Labor-Hour, and Letter Contracts
well-documented justification for the
estimated cancellation ceiling. When
the estimated cancellation ceiling
exceeds $12.5 million, the
determination shall accompany a draft
congressional notification letter
pursuant to FAR 17.108 and 317.108.
317.107
316.603
Letter contracts.
316.603–3
Limitations.
An official one level above the
contracting officer shall make the
written determination, to be included in
the contract file, that no other contract
type is suitable and to approve all letter
contract modifications. No letter
contract or modification can exceed the
limits prescribed in FAR 16.603–2(c).
PART 317—SPECIAL CONTRACTING
METHODS
Subpart 317.1—Multi-Year Contracting
Sec.
317.104 General.
317.105 Policy.
317.105–1 Uses.
317.107 Options.
317.108 Congressional notification.
Subpart 317.1—Multi-Year Contracting
General.
(b) The Senior Procurement Executive
(SPE) is the agency approving official
for determinations under Federal
Acquisition Regulation (FAR) 17.104(b).
Policy.
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317.105–1
Uses.
(a) Each head of the contracting
activity (HCA) determination to use
multi-year contracting, as defined in
FAR 17.103, is limited to individual
acquisitions where the full estimated
cancellation ceiling does not exceed 20
percent of the total contract value over
the multi-year term or $12.5 million,
whichever is less. Cancellation ceiling
provisions shall conform to the
requirements of FAR 17.106–1(c). The
determination is not delegable and shall
address the issues in FAR 17.105–1(a).
(b)(1) SPE approval is required for
any—
(i) Individual determination to use
multi-year contracting with a
cancellation ceiling in excess of the
limits in 317.105–1(a); or
(ii) Class determination (see FAR
subpart 1.7).
(2) A determination involving a
cancellation ceiling in excess of the
limits in 317.105–1(a) shall present a
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Congressional notification.
(a) The SPE shall give the approval of
the written notification required by FAR
17.108(a). Upon approval of the
determination required by 317.105–
1(b)(1), the HCA will finalize and sign
the congressional notification letter and
provide it to the appropriate House and
Senate committees.
317.204
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
317.105
317.108
Subpart 317.2—Options
Subpart 317.2—Options
317.204 Contracts.
317.104
Options.
When included as part of a multi-year
contract, use of options shall not extend
the performance of the original
requirement beyond 5 years. Options
may serve as a means to acquire related
services (severable or non-severable)
and, upon their exercise, shall receive
funding from the then-current fiscal
year’s appropriation.
Contracts.
(e)(1) Information technology
contracts. Notwithstanding FAR
17.204(e), the 5-year limitations apply
also to information technology contracts
unless a longer period is authorized by
statute.
(2) Requests to exceed 5-year
limitation. A request to exceed the 5year limitation specified in FAR
17.204(e) must follow guidance in FAR
Part 1.7.
(3) Approval authority. All requests to
exceed the 5-year limitations specified
in FAR 17.204(e) must be supported
with a Determination and Finding and
approved by:
(i) The HCA; and
(ii) The HHS SPE.
SUBCHAPTER D—SOCIOECONOMIC
PROGRAMS
PART 319—SMALL BUSINESS
PROGRAMS
Subpart 319.2—Policies
Sec.
319.201 General policy.
´ ´
319.270–1 Mentor Protege Program
Solicitation provision and contract
clause.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 319.2—Policies
319.201
General policy.
(d) The functional management
responsibilities for the Department of
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Health and Human Services’ (HHS)
small business program are delegated to
the Office of Small and Disadvantaged
Business Utilization (OSDBU) Director.
(e)(1) The HHS OSDBU Director shall
exercise full management authority over
the small business program. The small
business specialist (SBS) shall review
and make recommendations for all
acquisitions, unless exempted by
statute, that are not being set aside for
small business in accordance with
Federal Acquisition Regulation (FAR)
19.502. The review must take place
prior to issuing the solicitation.
(2) Within the Indian Health Service
(IHS), the primary SBSs are responsible
for IHS’ overall implementation of the
HHS small business program; however,
each IHS contracting office will assign
a small business technical advisor
(SBTA) to perform those functions and
responsibilities necessary to implement
the small business program. The
primary IHS SBS shall assist and
provide guidance to respective SBTAs.
´ ´
319.270–1 Mentor Protege Program
Solicitation provision and contract clause.
(a) The contacting officer shall insert
the provision at 352.219–70, Mentor´ ´
Protege Program, in solicitations that
include the clause at FAR 52.219–9,
Small Business Subcontracting Plan.
The provision requires offerors to
provide the contracting officer a copy of
their HHS Office of OSDBU-approved
´ ´
mentor-protege agreement in response
to a solicitation.
(b) The contacting officer shall insert
the clause at 352.219–71, Mentor´ ´
Protege Program Reporting
Requirements, in contracts that include
the clause at FAR 52.219–9, Small
Business Subcontracting Plan, and
which are awarded to a contractor with
an HHS OSDBU-approved mentor´ ´
protege agreement.
PART 322—APPLICATION OF LABOR
LAWS TO GOVERNMENT
ACQUISITIONS
Subpart 322.8—Equal Employment
Opportunity
Sec.
322.810 Solicitation provisions and
contract clauses.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 322.8—Equal Employment
Opportunity
322.810 Solicitation provisions and
contract clauses.
(h) The contracting officer shall insert
the clause at 352.222–70, Contractor
Cooperation in Equal Employment
Opportunity Investigations, in
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solicitations, contracts, and orders that
include the clause at FAR 52.222–26,
Equal Opportunity.
PART 323—ENVIRONMENT, ENERGY
AND WATER EFFICIENCY,
RENEWABLE ENERGY
TECHNOLOGIES, OCCUPATIONAL
SAFETY, AND DRUG-FREE
WORKPLACE
Subpart 323.70—Safety and Health
Sec.
323.7000
323.7001
323.7002
Scope of subpart.
Policy.
Actions required.
Subpart 323.71—Sustainable Acquisition
Requirements
323.7100 Policy.
323.7101 Applicability.
323.7102 Procedures.
323.7103 Solicitation Provision.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
323.7000
Scope of subpart.
This subpart provides procedures for
administering safety and health
requirements.
323.7001
Policy.
The contracting officer shall follow
the guidance in this subpart when
additional requirements for safety and
health are necessary for an acquisition.
323.7002
Actions required.
Contracting activities. The contracting
officer shall insert the clause at
352.223–70, Safety and Health, or a
clause substantially the same, in
solicitations and contracts that involve
hazardous materials or hazardous
operations for the following types of
requirements:
(a) Services or products.
(b) Research, development, or test
projects.
(c) Transportation of hazardous
materials.
(d) Construction, including
construction of facilities on the
contractor’s premises.
Subpart 323.71—Sustainable
Acquisition Requirements
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323.7100
Policy.
This subpart provides procedures for
sustainable acquisitions and use of the
following: Designated recycled content;
energy efficient, environmentally
preferred, Electronic Product
Environmental Assessment Tool
(EPEAT)-registered, bio-based, water
efficient, non-ozone depleting products
and services; and alternate fuel vehicles
and fuels. The Department of Health
and Human Services (HHS) has
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designated product and service codes
for supplies and services having
sustainable acquisition attributes. See
FAR part 23.
323.7101
Applicability.
It is HHS policy to include a
solicitation provision and to include an
evaluation factor for an offeror’s
Sustainable Action Plan when acquiring
sustainable products and services. This
applies only to new contracts and orders
above the micro-purchase threshold.
Such contracts and orders include, but
are not limited to: Office supplies;
construction, renovation or repair;
building operations and maintenance;
landscaping services; pest management;
electronic equipment, including leasing;
fleet maintenance; janitorial services;
laundry services; cafeteria operations;
and meetings and conference services. If
using a product or service code
designated for supplies or services
having sustainable acquisition attributes
but a review of the requirement
determines that no opportunity exists to
acquire sustainable acquisition supplies
or services, document the determination
in the contract file and make note in the
solicitation.
323.7102
Procedures.
(a) When required by the solicitation,
offerors or quoters must include a
Sustainable Acquisition Plan in their
technical proposal addressing the
environmental products and services for
delivery under the resulting contract.
(b) The contracting officer shall
incorporate the final Sustainable
Acquisition Plan into the contract.
(c) The contracting officer shall
ensure that sustainability is included as
an evaluation factor in all applicable
new contracts and orders when the
acquisition utilizes a product or service
code designated by HHS for supplies or
services having sustainable acquisition
attributes.
323.7103
Solicitation Provision.
The contracting officer shall insert the
provision at 352.223–71, Instruction to
Offerors—Sustainable Acquisition, in
solicitations above the micro-purchase
threshold when the acquisition utilizes
a product or service code designated by
HHS as having sustainable acquisition
attributes.
PART 324—PROTECTION OF PRIVACY
AND FREEDOM OF INFORMATION
Subpart 324.1—Protection of Individual
Privacy
Sec.
324.103 Procedures for the Privacy Act.
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324.104 Restrictions on Contractor Access
to Government or Third Party
Information.
324.105 Contract clauses.
Subpart 324.70—Health Insurance
Portability and Accountability Act of 1996
(HIPAA)
324.7000 Scope of subpart.
324.7001 Policy on Compliance with
HIPAA Business Associate Contract
Requirements.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 324.1—Protection of Individual
Privacy
324.103
Procedures for the Privacy Act.
(a) The contracting officer shall
review all acquisition request
documentation to determine whether
the requirements of the Privacy Act of
1974 (5 U.S.C. 552a) are applicable. The
Privacy Act requirements apply when a
contract or order requires the contractor
to design, develop, or operate any
Privacy Act system of records on
individuals to accomplish an agency
function. When applicable, the
contracting officer shall include the two
Privacy Act clauses required by Federal
Acquisition Regulation (FAR) 24.104 in
the solicitation and contract or order. In
addition, the contracting officer shall
include the two FAR Privacy Act
clauses, and other pertinent information
specified in this subpart, in any
modification which results in the
Privacy Act requirements becoming
applicable to a contract or order.
(b) The contracting officer shall
ensure that the statement of work or
performance work statement (SOW or
PWS) specifies the system(s) of records
or proposed system(s) of records to
which the Privacy Act and the
implementing regulations are applicable
or may be applicable. The contracting
officer shall send the contractor a copy
of 45 CFR part 5b, which includes the
rules of conduct and other Privacy Act
requirements.
(c) The contracting officer shall
ensure that the contract SOW or PWS
specifies for both the Privacy Act and
the Federal Records Act the disposition
to be made of the system(s) of records
upon completion of contract
performance. The contract SOW or PWS
may require the contractor to destroy
the records, remove personal identifiers,
or turn the records over to the
contracting officer. If there is a
legitimate need for a contractor to keep
copies of the records after completion of
a contract, the contractor must take
measures, as approved by the
contracting officer, to keep the records
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confidential and protect the individuals’
privacy.
(d) For any acquisition subject to
Privacy Act requirements, the requiring
activity prior to award shall prepare and
have published in the Federal Register
a ‘‘system notice,’’ describing the
Department of Health and Human
Services’ (HHS) intent to establish a
new system of records on individuals, to
make modifications to an existing
system, or to disclose information in
regard to an existing system. The
requiring activity shall attach a copy of
the system notice to the acquisition plan
or other acquisition request
documentation. If a system notice is not
attached, the contracting officer shall
inquire about its status and shall obtain
a copy from the requiring activity for
inclusion in the contract file. If a notice
for the system of records has not been
published in the Federal Register, the
contracting officer may proceed with the
acquisition but shall not award the
contract until the system notice is
published and the contracting officer
verifies its publication.
324.104 Restrictions on Contractor
Access to Government or Third Party
Information.
The contracting officer shall establish
the restrictions that govern the
contractor employees’ access to
Government or third party information
in order to protect the information from
unauthorized use or disclosure.
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324.105
Contract clauses.
(a) The contracting officer shall insert
the clause at 352.224–70, Privacy Act, in
solicitations, contracts, and orders that
require the design, development, or
operation of a system of records to
notify the contractor that it and its
employees are subject to criminal
penalties for violations of the Privacy
Act (5 U.S.C. 552a(i)) to the same extent
as HHS employees. The clause also
requires the contractor to ensure each of
its employees knows the prescribed
rules of conduct in 45 CFR part 5b and
each contractor employee is aware that
he or she is subject to criminal penalties
for violations of the Privacy Act. These
requirements also apply to all
subcontracts awarded under the
contract or order that require the design,
development, or operation of a system
of records.
(b) The contracting officer shall insert
the clause at 352.224–71, Confidential
Information, in solicitations, contracts,
and orders that require access to
Government or to third party
information.
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Subpart 324.70—Health Insurance
Portability and Accountability Act of
1996
324.7000
Scope of subpart.
All individually identifiable health
information that is Protected Health
Information (PHI), as defined in 45 CFR
160.103 shall be administered in
accordance with the Health Insurance
Portability and Accountability Act of
1996 (HIPAA) implementing regulations
at 45 CFR parts 160 and 164 (the HIPAA
Privacy, Security, and Breach
Notification Rules). The term ‘‘HIPAA’’
is used in this part to refer to title II,
subtitle F of the HIPAA statute, at part
C of title XI of the Social Security Act,
42 U.S.C. 1320d et seq., section 264 of
HIPAA, subtitle D of title XIII of the
American Recovery and Reinvestment
Act of 2009, and regulations under such
provisions.
324.7001 Policy on Compliance with
HIPAA business associate contract
requirements.
(a) HHS is a HIPAA ‘‘covered entity’’
that is a ‘‘hybrid entity’’ as these terms
are defined at sections 160.103 and
164.103 respectively. As such, only the
portions of HHS that the Secretary has
designated as ‘‘health care components’’
(HCC) as defined at section 164.103, are
subject to HIPAA. HHS’ HCCs may
utilize persons or entities known as
‘‘business associates,’’ as defined at
section 160.103. Generally, ‘‘business
associate’’ means a ‘‘person’’ as defined
by section 160.103 (including
contractors, and third-party vendors,
etc.) if or when the person or entity:
(1) Creates, receives, maintains, or
transmits ‘‘protected health
information’’, as the term is defined at
section 160.103, on behalf of an HHS
HCC to carry out HHS HIPAA ‘‘covered
functions’’ as that term is defined at
164.103; or
(2) Provides certain services to an
HHS HCC that involve PHI.
(b) Where the Department as a
covered entity is required by 45 CFR
164.502(e)(1) and 164.504(e) and, if
applicable, sections 164.308(b)(3) and
164.314(a), to enter into a HIPAA
business associate contract, the relevant
HCC contracting officer, acting on behalf
of the Department, shall ensure that
such contract meets the requirements at
section 164.504(e)(2) and, if applicable,
section 164.314(a)(2).
PART 326—OTHER SOCIOECONOMIC
PROGRAMS
Subpart 326.5—Indian Preference in
Employment, Training, and Subcontracting
Opportunities
Sec.
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326.501
326.502
326.503
326.504
326.505
Statutory requirements.
Definitions.
Compliance enforcement.
Tribal Preference requirement.
Applicability.
Subpart 326.6—Acquisitions Under the Buy
Indian Act
326.600 Scope of subpart.
326.601 Policy.
326.602 Definitions.
326.603 Requirements.
326.604 Competition.
326.605 Responsibility determinations.
Subpart 326.7—Acquisitions Requiring the
Native American Graves Protection and
Repatriation Act
326.700 Scope of subpart.
326.701 Applicability.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 326.5—Indian Preference in
Employment, Training, and
Subcontracting Opportunities
326.501
Statutory requirements.
Any contract or subcontract pursuant
to subchapter II, chapter 14, title 25 of
the United States Code, the Act of April
16, 1934 (48 Stat. 596), as amended, or
any other Act authorizing Federal
contracts with or grants to Indian
organizations or for the benefit of
Indians, shall, to the greatest extent
feasible, comply with section 7(b) of the
Indian Self-Determination and
Education Assistance Act, Public Law
93–638, 88 Stat. 2205, 25 U.S.C. 450e(b)
which provides preferences and
opportunities for training and
employment in connection with the
administration of such contracts, and
preference in the award of subcontracts
in connection with the administration of
such contracts to Indian organizations
and to Indian-owned economic
enterprises as defined in section 1452 of
title 25, United States Code.
326.502
Definitions.
For purposes of this subpart, the
following definitions shall apply:
(a) Indian means a person who is a
member of an Indian tribe. If the
contractor has reason to doubt that a
person seeking employment preference
is an Indian, the contractor shall grant
the preference but shall require the
individual provide evidence within 30
days from the tribe concerned that the
person is a member of the tribe.
(b) Indian tribe means an Indian tribe,
pueblo, band, nation, or other organized
group or community, including any
Alaska Native Village or regional or
village corporation as defined in or
established pursuant to the Alaska
Native Claims Settlement Act (85 Stat.
688, 43 U.S.C. 1601), which the United
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States recognizes as eligible for special
programs and services because of its
status as Indian.
(c) Indian organization means the
governing body of any Indian tribe, or
entity established or recognized by such
governing body, in accordance with the
Indian Financing Act of 1974 (88 Stat.
77, 25 U.S.C. 1451).
(d) Indian-owned economic enterprise
means any Indian-owned commercial,
industrial, or business activity
established or organized for the purpose
of profit, provided that such Indian
ownership shall constitute not less than
51 percent of the enterprise, and the
ownership shall encompass active
operation and control of the enterprise.
(e) Indian reservation includes Indian
reservations, public domain Indian
allotments, former Indian reservations
in Oklahoma, and land held by
incorporated Native groups, regional
corporations, and village corporations
under the provisions of the Alaska
Native Claims Settlement Act (85 Stat.
688, 43 U.S.C. 1601 et seq.).
(f) On or near an Indian reservation
means on a reservation or reservations
or within that area surrounding an
Indian reservation(s) where a person
seeking employment could reasonably
commute to and from in the course of
a work day.
326.503
Compliance enforcement.
The contracting officer shall promptly
investigate and resolve written
complaints of noncompliance with the
requirements of the clauses at 352.226–
1, Indian Preference and 352.226–2,
Indian Preference Program filed with
the contracting activity.
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326.504
Tribal preference requirements.
(a) When the contractor will perform
work under a contract on an Indian
reservation, the contracting officer may
supplement the clause at 352.226–2,
Indian Preference Program by adding
specific Indian preference requirements
of the tribe on whose reservation the
contractor will work. The contracting
activity and the tribe shall jointly
develop supplemental requirements for
the contract. Supplemental preference
requirements shall represent a further
implementation of the requirements of
section 7(b) of Public Law 93–638 and
require the approval of the affected
program director and the appropriate
legal office, or a regional attorney,
before the contracting officer adds them
to a solicitation and resultant contract.
Any supplemental preference
requirements the contracting officer
adds to the clause at 352.226–2, Indian
Preference Program shall also clearly
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identify in the solicitation the
additional requirements.
(b) Nothing in this part shall preclude
tribes from independently developing
and enforcing their own tribal
preference requirements. Such
independently-developed tribal
preference requirements shall not,
except as provided in paragraph (a) of
this section, become a requirement in
contracts covered under this subpart,
and shall not conflict with any Federal
statutory or regulatory requirement
concerning the award and
administration of contracts.
326.505
Applicability.
The contracting officer shall insert the
clause at 352.226–1, Indian Preference,
and the clause at 352.226–2, Indian
Preference Program, in contracts to
implement section 7(b) of Public Law
93–638 for all Department of Health and
Human Services (HHS) activities.
Contracting activities shall use the
clauses as follows, except for those
exempted solicitations and contracts
issued and or awarded pursuant to Title
I of Public Law 93–638 (25 U.S.C. 450
et seq.):
(a) The contracting officer shall insert
the clause at 352.226–1, Indian
Preference, in solicitations, contracts,
and orders when—
(1) The award is (or will be) pursuant
to an act specifically authorizing such
awards with Indian organizations; or
(2) The work is specifically for the
benefit of Indians and is in addition to
any incidental benefits which might
otherwise accrue to the general public.
(b) The contracting officer shall insert
the clause at 352.226–2, Indian
Preference Program, in solicitations,
contracts, and orders when—
(1) The dollar amount of the
acquisition is expected to equal or
exceed $650,000 for non-construction
work or $1.5 million for construction
work;
(2) The solicitation, contract, or order
includes the Indian Preference clause;
and
(3) The contracting officer makes the
determination, prior to solicitation, that
performance will take place in whole or
in substantial part on or near an Indian
reservation(s). In addition, the
contracting officer may insert the Indian
Preference Program clause in
solicitations, contracts, and orders
below the $650,000 or $1.5 million level
for non-construction or construction
contracts, respectively, but which meet
the requirements of paragraphs (b)(2)
and (3) of this section, and in the
opinion of the contracting officer, offer
substantial opportunities for Indian
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72163
employment, training, and
subcontracting.
Subpart 326.6—Acquisitions Under the
Buy Indian Act
326.600
Scope of subpart.
This subpart sets forth the policy on
preferential acquisition from Indians
under the negotiation authority of the
Buy Indian Act. This subpart applies
only to acquisitions made by or on
behalf of Indian Health Service (IHS).
326.601
Policy.
(a) IHS shall utilize the negotiation
authority of the Buy Indian Act to give
preference to Indians whenever
authorized and practicable. The Buy
Indian Act, 25 U.S.C. 47, prescribes the
application of the advertising
requirements of 41 U.S.C. 6101 to the
acquisition of Indian supplies. As
specified in 25 U.S.C. 47, the Buy
Indian Act provides that, so far as
practicable, the Government shall
employ Indian labor and, at the
discretion of the Secretary of the
Interior, purchase products of Indian
industry (including, but not limited to
printing, notwithstanding any other
law) from the open market.
(b) Due to the transfer of authority
from the Department of the Interior to
HHS, the Secretary of HHS may use the
Buy Indian Act to acquire products of
Indian industry in connection with the
maintenance and operation of Indian
hospital and health facilities, and for the
overall conservation of Indian health.
This authority is exclusively delegated
to IHS and is not available for use by
any other HHS component (unless that
component makes an acquisition on
behalf of IHS). However, the Buy Indian
Act itself does not exempt IHS from
meeting the statutorily mandated small
business goals.
(c) Subsequent legislation,
particularly Public Law 94–437 and
Public Law 96–537, emphasize using
the Buy Indian Act negotiation
authority.
326.602
Definitions.
(a) Buy Indian contract means any
contract involving activities covered by
the Buy Indian Act and negotiated
under the provisions of 41 U.S.C. 3104
and 25 U.S.C. 47 between an Indian firm
and a contracting officer representing
IHS.
(b) Indian means a member of any
tribe, pueblo, band, group, village, or
community recognized by the Secretary
of the Interior as being Indian or any
individual or group of individuals
recognized by the Secretary of the
Interior or the Secretary of HHS. The
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Secretary of HHS in making
determinations may take into account
the determination of the tribe with
which affiliation is claimed.
(c) Indian firm means a sole
enterprise, partnership, corporation, or
other type of business organization
owned, controlled, and operated by:
(1) One or more Indians (including,
for the purpose of sections 301 and 302
of Public Law 94–437, former or
currently federally recognized Indian
tribes in the State of New York); or
(2) By an Indian firm (as defined in
paragraph (1) of this definition); or
(3) A nonprofit firm organized for the
benefit of Indians and controlled by
Indians (see 326.601(a)).
(d) Product of Indian industry means
anything produced by Indians through
either physical labor or intellectual
effort involving the use and application
of their skills. To classify as a product
of Indian industry, the total cost of the
item’s production must equal or exceed
51 percent Indian effort.
asabaliauskas on DSK5VPTVN1PROD with RULES
326.603
Requirements.
(a) Indian ownership. Indian
ownership shall constitute at least 51
percent of an Indian firm during the
period covered by a Buy Indian
contract.
(b) Joint ventures. An Indian firm may
enter into a joint venture with other
entities for specific projects as long as
the Indian firm is the managing partner.
However, the contracting officer shall
approve the joint venture prior to the
award of a contract under the Buy
Indian Act.
(c) Bonds. In the case of contracts for
the construction, alteration, or repair of
public buildings or public works, the
Miller Act (40 U.S.C. 3131 et seq.) and
Federal Acquisition Regulation (FAR)
part 28 require performance and
payment bonds. Bonds are not required
in the case of contracts with Indian
tribes or public nonprofit organizations
serving as governmental
instrumentalities of an Indian tribe.
However, bonds are required when
dealing with private business entities
owned by an Indian tribe or members of
an Indian tribe. The contracting officer
may require bonds of private business
entities that are joint ventures with, or
subcontractors of, an Indian tribe or a
public nonprofit organization serving as
a governmental instrumentality of an
Indian tribe. A bid guarantee or bid
bond is required only when a
performance or payment bond is
required.
(d) Indian preference in employment,
training and subcontracting. Contracts
awarded under the Buy Indian Act are
subject to the requirements of section
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7(b) of the Indian Self-Determination
and Education Assistance Act 25 U.S.C.
450e, which requires giving preference
to Indians in employment, training, and
subcontracting. The contracting officer
shall include the Indian Preference
clause specified at 326.505(a) in all Buy
Indian solicitations and resultant
contracts. The contracting officer shall
use the Indian Preference Program
clause specified at 326.505(b). The
contracting officer shall follow all
requirements specified in subpart 326.2
which apply to a Buy Indian acquisition
(e.g., 326.604 and 326.605).
(e) Subcontracting. A contractor shall
not subcontract more than 50 percent of
the work under a prime contract
awarded pursuant to the Buy Indian Act
to non-Indian firms. For this purpose,
contract work does not include the
provision of materials, supplies, or
equipment.
(f) Wage rates. The contracting officer
shall include a determination of the
minimum wage rates by the Secretary of
Labor as required by the Davis-Bacon
Act (40 U.S.C. 276a) in all contracts
awarded under the Buy Indian Act for
over $2,000 for construction, alteration,
or repair, including painting and
decorating, of public buildings and
public works, except contracts with
Indian tribes or public nonprofit
organizations serving as governmental
instrumentalities of an Indian tribe.
The contracting officer shall include
the wage rate determination in contracts
with private business entities, even
when owned by an Indian tribe or a
member of an Indian tribe and in
connection with joint ventures with, or
subcontractors of, an Indian tribe or a
public nonprofit organization serving as
a governmental instrumentality of an
Indian tribe.
326.604
Competition.
(a) Contracts awarded under the Buy
Indian Act are subject to competition
among Indians or Indian firms to the
maximum extent practicable. When the
contracting officer determines that
competition is not practicable, a
justification and approval is required in
accordance with subpart 306.3.
(b) The contracting officer shall:
Synopsize and publicize solicitations in
the Government point of entry and
provide copies of the synopses to the
tribal office of the Indian tribal
government directly concerned with the
proposed acquisition as well as to
Indian firms and others having a
legitimate interest. The synopses shall
state that the acquisitions are restricted
to Indian firms under the Buy Indian
Act.
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326.605
Responsibility determinations.
(a) The contracting officer may award
a contract under the Buy Indian Act
only if it is determined that the
contractor will likely perform
satisfactorily and properly complete or
maintain the contracted project or
function.
(b) The contracting officer shall make
the written determination specified in
paragraph (a) of this section prior to the
award of a contract. The determination
shall reflect an analysis of FAR 9.104–
1 standards.
Subpart 326.7—Acquisitions Requiring
the Native American Graves Protection
and Repatriation Act
326.700
Scope of subpart.
Public Law 101–601, dated November
16, 1990, also known as the Native
American Graves Protection and
Repatriation Act, imposes certain
responsibilities on individuals and
organizations when they discover
Native American cultural items
(including human remains) on Federal
or tribal lands.
326.701
Applicability.
The contracting officer shall insert the
clause at 352.226–3, Native American
Graves Protection and Repatriation Act,
in solicitations, contracts, and orders
requiring performance on tribal lands or
those for construction projects on
Federal or tribal lands.
SUBCHAPTER E—GENERAL
CONTRACTING REQUIREMENTS
PART 327—PATENTS, DATA, AND
COPYRIGHTS
Subpart 327.3—Patent Rights Under
Government Contracts
Sec.
327.303 Solicitation provision and contract
clause.
Subpart 327.4—Rights in Data and
Copyrights
327.404–70 Solicitation provision and
contract clause.
327.409 Solicitation provision and contract
clause.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 327.3—Patent Rights Under
Government Contracts
327.303 Solicitation provision and
contract clause.
The contracting officer shall insert the
clause at 352.227–11, Patent Rights—
Exceptional Circumstances and any
appropriate alternates in lieu of Federal
Acquisition Regulation (FAR) 52.227–11
whenever a Determination of
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Exceptional Circumstances (DEC)
involving the provision of materials that
has been executed in accordance with
Agency policy and procedures calls for
its use and the clause at 352.227–11,
Patent Rights—Exceptional
Circumstances, appropriately covers the
circumstances. The contracting officer
should reference the DEC in the
solicitation and shall attach a copy of
the executed DEC to the contract.
Subpart 327.4—Rights in Data and
Copyrights
327.404–70 Solicitation provision and
contract clause.
The contracting officer shall insert the
clause at 352.227–70, Publications and
Publicity, in solicitations, contracts, and
orders that involve requirements which
could lead to the contractor’s publishing
the results of its work under the
contract.
327.409 Solicitation provision and
contract clause.
The contracting officer shall insert the
clause at 352.227–14, Rights in Data—
Exceptional Circumstances, and any
appropriate alternates in lieu of the FAR
clause at 52.227–14, Rights in DataGeneral, whenever a DEC executed in
accordance with Agency policy and
procedures calls for its use. Prior to
using this clause, a DEC must be
executed in accordance with Agency
policy and procedures. The contracting
officer should reference the DEC in the
solicitation and shall attach a copy of
the executed DEC to the contract.
PART 328—[RESERVED]
PART 330—COST ACCOUNTING
STANDARDS
Subpart 330.2—CAS Program Requirements
Sec.
330.201 Contract requirements.
330.201–5 Waiver.
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Waiver.
The Senior Procurement Executive
(SPE) shall exercise the waiver authority
under Federal Acquisition Regulation
30.201–5(a)(2). Operating Divisions and
Staff Divisions shall forward waiver
requests to the SPE.
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Subpart 331.1—Applicability
332.501
Sec.
331.101–70
332.501–2
Salary rate limitation.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
331.101–70
Salary rate limitation.
(a) Beginning in fiscal year 1990,
Congress has stipulated in the
Department of Health and Human
Services appropriations acts and
continuing resolutions that, under
applicable contracts, appropriated funds
cannot be used to pay the direct salary
of an individual above the stipulated
rates. The applicable rates for each year
are identified at www.opm.gov.
(b) The contracting officer shall insert
the clause at 352.231–70, Salary Rate
Limitation, in solicitations and contracts
when a cost-reimbursement; fixed-price
level-of-effort; time-and-materials; or
labor-hour contract is contemplated.
PART 332—CONTRACT FINANCING
Subpart 332.4—Advance Payments for NonCommercial Items
Sec.
332.402
332.407
General.
Interest.
Subpart 332.5—Progress Payments Based
on Cost
332.501 General.
332.501–2 Unusual progress payments.
Subpart 332.7—Contract Funding
332.702 Policy.
332.703 Contract funding requirements.
332.703–1 General.
332.703–71 Incrementally funded costreimbursement contracts.
332.703–72 Incremental Funding Table.
332.706 Solicitation provision and contract
clauses.
332.706–2 Provision and clauses for
limitation of cost or funds.
General.
(e) The head of the contracting
activity (HCA) (non-delegable) shall
make determinations related to
advanced payments and assure
compliance with FAR 32.402.
332.407
Interest.
(d) The HCA (non-delegable) shall
make the determinations in FAR
32.407(d).
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General.
Unusual progress payments.
(a)(3) The HCA (non-delegable) shall
approve unusual progress payments.
Subpart 332.7—Contract Funding
Subpart 331.1—Applicability
332.402
Contract requirements.
330.201–5
Subpart 332.5—Progress Payments
Based on Cost
Subpart 332.4—Advance Payments for
Non-Commercial Items
Subpart 330.2—CAS Program
Requirements
330.201
PART 331—CONTRACT COST
PRINCIPLES AND PROCEDURES
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
72165
332.702
Policy.
Departmental employees shall report
any suspected violation of the AntiDeficiency Act (31 U.S.C. 1341, 13
U.S.C. 1342, and 31 U.S.C. 1517)
immediately to the Operating Division’s
Chief Financial Officer (CFO), who in
turn will report the matter to the HHS
Deputy CFO.
332.703
Contract funding requirements.
332.703–1
General.
(b) The following requirements govern
all solicitations and contracts using
incremental funding, as appropriate:
(1) The contracting officer shall
consider the estimated total cost of the
contract, including all planned
increments of performance when
determining the requirements that must
be met before contract execution (e.g.,
Justification and Approvals, clearances,
and approvals).
(2) The solicitation and resultant
contract shall include a statement of
work or performance work statement
that describes the total project, covers
all proposed increments of performance,
and contains a schedule of planned
increments of performance. No funding
increment may exceed 1 year, and the
services rendered during each
increment of performance must provide
a specific material benefit that can stand
alone if the remaining effort is not
funded. The resultant contract shall also
include the corresponding amount of
funds planned for obligation for each
increment of performance.
(3) The contracting officer shall
request that offerors respond to the
solicitation with technical and cost
proposals for the entire project, and
shall require distinct technical and cost
break-outs of the planned increments of
performance.
(4) Proposals shall be evaluated and
any discussions and negotiations shall
be conducted based upon the total
project, including all planned
increments of performance.
332.703–71 Incrementally funded costreimbursement contracts.
Incremental funding may be used in
cost-reimbursement contracts for
severable services only when all of the
following circumstances are present:
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(a) Funding of increments after the
initial increment of performance is
provided from the appropriation
account available for obligation at that
time;
(b) The project represents a bona fide
need of the fiscal year in which the
contract is awarded and initially funded
(i.e., the initial increment of
performance) and is also a bona fide
need of each subsequent fiscal year
whose appropriation will be used; and
(c) The project’s significance provides
reasonable assurance that subsequent
year appropriations will be made
available to fund the project’s
continuation and completion.
CLIN,
task number, or
description
332.703–72
Incremental Funding Table.
(a) The contracting officer shall insert
substantially the following language in
Section B: Supplies or Services and
Prices or Costs, Table 1, in all costreimbursement contracts for severable
services using incremental funding. The
language requires the contracting officer
to:
(1) Insert the initial funding obligated
by the award;
(2) Identify the increment of
performance covered by the funding
provided; and
(3) Specify the start and end dates for
each increment of performance, as
required by the ‘‘Limitation of Funds’’
clause at FAR 52.232–22.
(b) Modification of the language is
permitted to fit specific circumstances
of the contract, including but not
limited to language necessary to reflect
the specific type of cost reimbursement
contract awarded, but the language may
not be omitted completely.
Table 1—B. llEstimated Cost—
Incrementally Funded Contract
(a) The total estimated cost to the
Government for full performance of this
contract, including all allowable direct
and indirect costs, is $ll [insert full
amount].
(b) The following represents the
schedule* by which the Government
expects to allot funds to this contract:
Start date of
increment of
performance
End date of
increment of
performance
Estimated cost ($)
Fee ($)
(as appropriate)
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
...................................
[Total] ........................
[Total] ........................
* To be inserted after negotiation
(c) Total funds currently obligated
and available for payment under this
contract are $ll [insert amount
funded to date].
(d) The contracting officer may issue
unilateral modifications to obligate
additional funds to the contract and
make related changes to paragraphs (b)
and/or (c) above.
(e) Until this contract is fully funded,
the requirements of the clause at FAR
52.232–22, Limitation of Funds, shall
govern. Once the contract is fully
funded, the requirements of the clause
at FAR 52.232–20, Limitation of Cost,
govern.
332.706 Solicitation provision and
contract clauses.
asabaliauskas on DSK5VPTVN1PROD with RULES
332.706–2 Provision and clauses for
limitation of cost or funds.
(b) In addition to the clause at FAR
52.232–22, Limitation of Funds, the
contracting officer shall insert the
provision at 352.232–70, Incremental
Funding, in all solicitations when a
cost-reimbursement contract for
severable services using incremental
funding is contemplated. The provision
requires the contracting officer to insert
a specific increment of performance that
the initial funding is expected to cover.
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PART 333—PROTESTS, DISPUTES,
AND APPEALS
Subpart 333.1—Protests
Sec.
333.102
333.103
General.
Protests to the agency.
Subpart 333.2—Disputes and Appeals
333.203 Applicability.
333.209 Suspected fraudulent claims.
333.215–70 Contract clauses.
333.103
Estimated cost
plus fee
($) (as appropriate)
[Total]
Protests to the agency.
(f)(1) Protests to the contracting officer
must be in writing. The contracting
officer is authorized to make the
determination, using the criteria in
Federal Acquisition Regulation
33.104(b), to award a contract
notwithstanding the protest after
obtaining the concurrence of the
contracting activity’s protest control
officer and consulting with the
appropriate legal office.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 333.2—Disputes and Appeals
Subpart 333.1—Protests
333.203
333.102
General.
(g)(1) The Office of General CounselGeneral Law Division serves as the
liaison for protests lodged with the
Government Accountability Office
(GAO); is designated as the office
responsible for all protests within the
Department of Health and Human
Services; and serves as the notification
point with GAO for all protests.
(2) The contracting officer will follow
the direction of the Operating Division’s
protest control officer for responding to
protests whether they are filed with
GAO or directly with the contracting
officer.
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Applicability.
(c) The Civilian Board of Contract
Appeals is the authorized ‘‘Board’’ to
hear and determine disputes for the
Department.
333.209
Suspected fraudulent claims.
The contracting officer shall submit
any instance of a contractor’s suspected
fraudulent claim to the Office of
Inspector General for investigation.
333.215–70
Contract clauses.
(a) The contracting officer shall insert
the clause at 352.233–70, Choice of Law
(Overseas), in solicitations and contracts
when performance will be outside the
United States, its possessions, and
Puerto Rico, except as otherwise
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provided in a government-togovernment agreement.
(b) The contracting officer shall insert
the clause at 352.233–71, Litigation and
Claims, in solicitations and contracts
when a cost-reimbursement, time-andmaterials, or labor-hour contract is
contemplated (other than a contract for
a commercial item).
SUBCHAPTER F—SPECIAL CATEGORIES
OF CONTRACTING
PART 334—MAJOR SYSTEM
ACQUISITION
Subpart 334.2—Earned Value Management
System
Sec.
334.201 Policy.
334.202 Integrated Baseline Reviews (IBRs).
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 334.2—Earned Value
Management System
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334.201
PART 335—RESEARCH AND
DEVELOPMENT CONTRACTING
Policy.
The Department of Health and Human
Services applies the earned value
management system requirement as
follows:
(a) For cost or incentive contracts and
subcontracts valued at $20 million or
more, the contractor’s earned value
management system shall comply with
the guidelines in the American National
Standards Institute/Electronic Industries
Alliance Standard 748, Earned Value
Management Systems (ANSI/EIA–748).
(b) For cost or incentive contracts and
subcontracts valued at $50 million or
more, the contractor shall have an
earned value management system that
has been determined by the cognizant
Federal agency to be in compliance with
the guidelines in ANSI/EIA–748.
(c) For cost or incentive contracts and
subcontracts valued at less than $20
million—
(1) The application of earned value
management is optional at the
discretion of the program/project
manager and is a risk-based decision
that must be supported by a cost/benefit
analysis; and
(2) A decision to apply earned value
management shall be documented in the
contract file.
(d) For firm-fixed-price contracts and
subcontracts of any dollar value the
application of earned value management
is discouraged.
334.202
(IBRs).
Integrated Baseline Reviews
(a) An IBR normally should be
conducted as a post-award activity. A
pre-award IBR may be conducted only
if—
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(1) The acquisition plan contains
documentation that demonstrates the
need and rationale for a pre-award IBR,
including an assessment of the impact
on the source selection schedule and the
expected benefits;
(2) The use of a pre-award IBR is
approved in writing by the head of the
contracting activity prior to the issuance
of the solicitation;
(3) The source selection plan and
solicitation specifically addresses how
the results of a pre-award IBR will be
used during source selection, including
any weight to be given to it in source
evaluation; and
(4) Specific arrangements are made,
and budget authority is provided, to
compensate all offerors who prepare for
or participate in a pre-award IBR; and
the solicitation informs prospective
offerors of the means for and conditions
of such compensation.
Sec.
335.070 Cost-sharing.
335.070–1 Policy.
335.070–2 Amount of cost-sharing.
335.070–3 Method of cost-sharing.
335.071 [Reserved]
335.072 Key personnel.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
335.070
Cost-sharing.
335.070–1
Policy.
(a) Contracting activities should
encourage contractors to contribute to
the cost of performing research and
development (R&D), through the use of
cost-sharing contracts, where there is a
probability that the contractor will
receive present or future benefits from
participation as described in Federal
Acquisition Regulation (FAR) 16.303.
Examples include increased technical
know-how, training for employees,
acquisition of goods or services,
development of a commercially viable
product that can be sold in the
commercial market and use of
background knowledge in future
contracts. Cost-sharing is intended to
serve the mutual interests of the
Government and its contractors by
helping to ensure efficient utilization of
the resources available for the conduct
of R&D projects and by promoting sound
planning and prudent fiscal policies of
the contractor. The Government’s
interest includes positive impact on the
community at large.
(b) The contracting officer should use
a cost-sharing contract for R&D
contracts, unless the contracting officer
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determines that a request for costsharing would not be appropriate.
(c) Any determination made by a
contracting officer as described in this
section shall be evidenced by
appropriate documentation in the
contract file.
335.070–2
Amount of cost-sharing.
When cost-sharing is appropriate, the
contracting officer shall use the
following guidelines to determine the
amount of cost participation by the
contractor:
(a) The amount of cost participation
depends on the extent to which the R&D
effort or results are likely to enhance the
contractor’s capability, expertise, or
competitive position, and the value of
this enhancement to the contractor.
Therefore, contractor cost participation
could reasonably range from as little as
one percent or less of the total project
cost to more than 50 percent of the total
project cost. Ultimately, cost-sharing is
a negotiable item. As such, the amount
of cost-sharing shall be proportional to
the anticipated value of the contractor’s
gain.
(b) If the contractor will not acquire
title to, or the right to use, inventions,
patents, or technical information
resulting from the R&D project, it is
normally appropriate to obtain less costsharing than in cases in which the
contractor acquires these rights.
(c) If the R&D is expected to be of only
minor value to the contractor, and if a
statute does not require cost-sharing, it
may be appropriate for the contractor to
make a contribution in the form of a
reduced fee or profit rather than sharing
costs of the project. Alternatively, a
limitation on indirect cost rates might
be appropriate. See FAR 42.707. See
also, FAR 16.303.
(d) The contractor’s participation may
be considered over the total term of the
project, so that a relatively high
contribution in 1 year may be offset by
a relatively low contribution in another.
Care must be exercised that the intent to
cost-share in future years does not
become illusory. Redetermination of the
cost sharing arrangement might be
appropriate depending on future
circumstances.
(e) A relatively low degree of costsharing may be appropriate if an area of
R&D requires special stimulus in the
national interest.
335.070–3
Method of cost-sharing.
Cost-sharing on individual contracts
may be accomplished either by a
contribution of part or all of one or more
elements of allowable cost of the work
being performed or by a fixed amount or
stated percentage of the total allowable
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costs of the project. Contractors shall
not charge costs contributed to the
Government under any other instrument
(e.g., grant or contract), including
allocations to other instruments as part
of any independent R&D program.
335.071
[Reserved]
335.072
Key personnel.
If the contracting officer determines
that the personnel to be assigned to
perform effort on an R&D contract are
critical to the success of the R&D effort,
or were a critical factor in the award of
the contract, then the contracting officer
should consider using the key personnel
clause at 352.237–75, Key Personnel.
PART 336—CONSTRUCTION AND
ARCHITECT-ENGINEER CONTRACTS
Subpart 336.1—General
Sec.
336.104 Policy.
Subpart 336.5—Contract Clause
336.570 Contract clause.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 336.1—General
336.104
Policy.
Contracting officers shall follow the
policies described in Federal
Acquisition Regulation 36.104 and the
guidance promulgated by the
Department of Health and Human
Services Facilities Management.
Subpart 336.5—Contract Clause
336.570
Contract clause.
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(a) The contracting officer shall insert
the clause at 352.236–70, Design-Build
Contracts, in all solicitations and
contracts for all design-build
requirements.
(b) The contracting officer shall use
Alternate I to the clause at 352.236–70,
Design-Build Contracts, in all
solicitations and contracts for
construction when Fast-Track
procedures are being used.
(c) Due to the importance of
maintaining consistency in the
contractor’s personnel during design–
build construction, the contracting
officer should consider including the
clause at 352.237–75, Key personnel.
PART 337—SERVICE
CONTRACTING—GENERAL
Subpart 337.1—Service Contracts—General
Sec.
337.103 Contracting officer responsibility.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
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Subpart 337.1—Service Contracts—
General
PART 339—ACQUISITION OF
INFORMATION TECHNOLOGY
337.103
Subpart 339.1—General
Sec.
339.101 Policy.
Contracting officer responsibility.
(d)(1) The contracting officer shall
insert the clause at 352.237–70, ProChildren Act, in solicitations, contracts,
and orders that involve:
(i) Kindergarten, elementary, or
secondary education or library services;
or
(ii) Health or daycare services that are
provided to children under the age of 18
on a routine or regular basis pursuant to
the Pro-Children Act of 1994 (20 U.S.C.
6081–6084).
(2) The contracting officer shall insert
the clause at 352.237–71, Crime Control
Act—Reporting of Child Abuse, in
solicitations, contracts, and orders that
require performance on Federal land or
in a federally operated (or contracted)
facility and involve the professions/
activities performed by persons
specified in the Crime Control Act of
1990 (42 U.S.C. 13031) including, but
not limited to, teachers, social workers,
physicians, nurses, dentists, health care
practitioners, optometrists,
psychologists, emergency medical
technicians, alcohol or drug treatment
personnel, child care workers and
administrators, emergency medical
technicians and ambulance drivers.
(3) The contracting officer shall insert
the clause at 352.237–72, Crime Control
Act—Requirement for Background
Checks, in solicitations, contracts, and
orders that involve providing child care
services to children under the age of 18,
including social services, health and
mental health care, child- (day) care,
education (whether or not directly
involved in teaching), and rehabilitative
programs covered under the Crime
Control Act of 1990 (42 U.S.C. 13041).
(4) Contracting officers supporting the
Indian Health Service shall insert the
clause at 352.237–73, Indian Child
Protection and Family Violence Act in
all solicitations, contracts, and orders
when performance of the contract may
involve regular contact with or control
over Indian children. The required
declaration shall also be included in
Section J of the solicitation and contract.
(e) The contracting officer shall insert
the clause at 352.237–74, NonDiscrimination in Service Delivery, in
solicitations, contracts, and orders to
deliver services under HHS’ programs
directly to the public.
(f) The contracting officer shall insert
the clause at 352.237–75, Key
Personnel, in solicitations and contracts
when the contracting officer will require
the contractor to designate contractor
key personnel.
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Subpart 339.2—Electronic and Information
Technology
339.203 Applicability.
339.203–70 Contract clauses for electronic
and information technology (EIT)
acquisitions.
339.204 Exceptions.
339.204–1 Approval of exceptions.
339.205 Section 508 accessibility standards
for contracts.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 339.1—General
339.101
Policy
In addition to the regulatory guidance
in Federal Acquisition Regulation part
39, contracting officers shall collaborate
with the requiring activity to ensure
information technology (IT) acquisitions
for supplies, services, and systems meet
the requirements established by the
Department of Health and Human
Services (HHS).
Subpart 339.2—Electronic and
Information Technology
339.203
Applicability.
(a) Electronic and information
technology (EIT) supplies and services
must comply with Section 508 of the
Rehabilitation Act (the Act) of 1973 (29
U.S.C. 794d), as amended by the
Workforce Investment Act of 1998, and
the Architectural and Transportation
Barriers Compliance Board (Access
Board) Electronic and Information
Accessibility Standards (36 CFR part
1194). Requiring activities must consult
with their Section 508 Official or
designee to determine if the contractor
should be responsible for compliance
with EIT accessibility standards which
apply to Web site content and
communications material.
(1) When conducting a procurement
and employing the best value
continuum, the solicitation shall
include a separate technical evaluation
factor developed by the contracting
officer, requiring activity, and the
Operating Division (OPDIV) Section 508
Official or designee.
(2) At a minimum, solicitations for
supplies and services shall require the
submission of a Section 508 Product
Assessment Template (See https://
www.hhs.gov/web/508 for the template).
Solicitations for services shall include
any other pertinent information that the
contracting officer deems necessary to
evaluate the offeror’s ability to meet the
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applicable Section 508 accessibility
standards.
(3) The HHS Operating Division or
Staff Division (OPDIV or STAFFDIV)
Section 508 Official or designee is
responsible for providing technical
assistance in development of Section
508 evaluation factors.
(4) Before conducting negotiations or
making an award, the contracting officer
shall provide a summary of the Source
Selection Evaluation Team’s (SSET)
assessment of offeror responses to the
solicitation’s Section 508 evaluation
factor. This summary shall be submitted
for review by the Section 508 Official or
designee. The Section 508 Official or
designee shall indicate approval or
disapproval of the SSET assessment.
The contracting officer shall coordinate
the resolution of any issues raised by
the Section 508 Official or designee
with the chair of the SSET or requiring
activity representative, as appropriate.
The acquisition process shall not
proceed until the Section 508 Official or
designee approves the SSET assessment.
The contracting officer shall include the
assessment in the official contract file.
See 339.204–1 regarding processing
exception determination requests.
(b) When acquiring commercial items,
if no commercially available supplies or
services meet all of the applicable
Section 508 accessibility standards,
OPDIVs or STAFFDIVs shall, under the
direction and approval of the Section
508 Official or designee, acquire the
supplies and services that best meet the
applicable Section 508 accessibility
standards. Process exception
determinations for EIT supplies and
services not meeting applicable Section
508 accessibility standards in
accordance with 339.204–1.
339.203–70 Contract clauses for electronic
and information technology (EIT)
acquisitions.
(a) The contracting officer shall insert
the provision at 352.239–73, Electronic
and Information Technology
Accessibility Notice, in all solicitations.
(b) The contracting officer shall insert
the clause at 352.239–74, Electronic and
Information Technology Accessibility,
in all contracts and orders.
339.204
Exceptions.
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339.204–1
Approval of exceptions.
(a) Procedures to document exception
and determination requests are set by
the OPDIV Section 508 Official.
(b) In the development of an
acquisition plan (AP) or other
acquisition request document, the
contracting officer shall ensure that all
Section 508 exception determination
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requests for applicable EIT requirements
are:
(1) Documented and certified in
accordance with the requirements of the
HHS Section 508 policy;
(2) Signed by the requestor in the
requiring activity;
(3) Certified and approved by the
OPDIV Section 508 Official or designee;
and
(4) Included in the AP or other
acquisition request document provided
by the requiring activity to the
contracting office.
(c) For instances with an existing
technical evaluation and no
organization’s proposed supplies or
services meet all of the Section 508
accessibility standards; in order to
proceed with the acquisition, the
requiring activity shall provide an
exception determination request along
with the technical evaluation team’s
assessment of the Section 508
evaluation factor to the designated
Section 508 Official or designee for
review and approval or disapproval.
The contracting officer shall include the
Section 508 Official’s or designee’s
approval or disapproval of the exception
determination request in the official
contract file and reference it, as
appropriate, in all source selection
documents. For further information, see
HHS Section 508 Policy on https://
www.hhs.gov/web/508.
339.205 Section 508 accessibility
standards for contracts.
(a) Section 508 of the Rehabilitation
Act of 1973 (29 U.S.C. 794(d)), as
amended by the Workforce Investment
Act of 1998 (Section 508), specifies the
applicable accessibility standards for all
new solicitations and new or existing
contracts or orders, regardless of EIT
dollar amount.
(b) The requiring activity shall consult
with the OPDIV or STAFFDIV Section
508 Official or designee, as necessary, to
determine the applicability of Section
508, identify applicable Section 508
accessibility standards, and resolve any
related issues before forwarding a
request to the contracting or
procurement office for the acquisition of
EIT supplies and services—including
Web site content and communications
material for which the contractor must
meet EIT accessibility standards.
(c) Based on those discussions, the
requiring activity shall provide a
statement in the AP (or other acquisition
request document) for Section 508
applicability. See 307.105. If Section
508 applies to an acquisition, include
the provision at 352.239–73, Electronic
and Information Technology and
Accessibility Notice, language in a
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separate, clearly designated, section of
the statement of work or performance
work statement, along with any
additional information applicable to the
acquisition’s Section 508 accessibility
standards (e.g., the list of applicable
accessibility standards of the Access
Board EIT Accessibility Standards (36
CFR part 1194)). If an AP does not
address Section 508 applicability and it
appears an acquisition involves Section
508, or if the discussion of Section 508
applicability to the acquisition is
inadequate or incomplete, the
contracting officer shall request the
requiring activity modify the AP
accordingly.
(d) Items provided incidental to
contract administration are not subject
to this section.
(e) The OPDIV Section 508 Official or
designee may, at his or her discretion,
require review and approval of
solicitations and contracts for EIT
supplies and services.
SUBCHAPTER G—CONTRACT
MANAGEMENT
PART 342—CONTRACT
ADMINISTRATION
Subpart 342.7—Indirect Cost Rates
Sec.
342.705
Final indirect cost rates.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 342.7—Indirect Cost Rates
342.705
Final indirect cost rates.
Contract actions for which the
Department of Health and Human
Services is the cognizant Federal
agency:
(a) The Financial Management
Services, Division of Cost Allocation,
Program Support Center, shall establish
facilities and administration costs, also
known as indirect cost rates, research
patient care rates, and, as necessary,
fringe benefits, computer, and other
special costing rates for use in contracts
awarded to State and local governments,
colleges and universities, hospitals, and
other nonprofit organizations.
(b) The National Institute of Health,
Division of Financial Advisory Services,
shall establish indirect cost rates and
similar rates for use in contracts
awarded to for profit organizations.
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SUBCHAPTER H—CLAUSES AND
FORMS
PART 352—SOLICITATION
PROVISIONS AND CONTRACT
CLAUSES
Subpart 352.1—Instructions for Using
Provisions and Clauses
Sec.
352.100 Scope of subpart.
352.101–70 Application of provisions and
clauses.
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Subpart 352.2—Texts of Provisions and
Clauses
352.203–70 Anti-Lobbying.
352.204–70 Prevention and Public Health
Fund–Reporting Requirements.
352.208–70 Printing and Duplication.
352.211–1 Public Accommodations and
Commercial Facilities.
352.211–2 Conference Sponsorship Request
and Conference Materials Disclaimer.
352.211–3 Paperwork Reduction Act.
352.215–70 Late Proposals and Revisions.
352.216–70 Additional Cost Principles for
Hospitals (Profit or Non-Profit).
´ ´
352.219–70 Mentor-Protege Program.
´ ´
352.219–71 Mentor-Protege Program
Reporting Requirements.
352.222–70 Contractor Cooperation in
Equal Employment Opportunity
Investigations.
352.223–70 Safety and Health.
352.223–71 Instructions to Offerors–
Sustainable Acquisition.
352.224–70 Privacy Act.
352.224–71 Confidential Information.
352.226–1 Indian Preference.
352.226–2 Indian Preference Program.
352.226–3 Native American Graves
Protection and Repatriation Act.
352.227–11 Patent Rights—Exceptional
Circumstances.
352.227–14 Rights in Data—Exceptional
Circumstances.
352.227–70 Publications and Publicity.
352.231–70 Salary Rate Limitation.
352.232–70 Incremental Funding.
352.233–70 Choice of Law (Overseas).
352.233–71 Litigation and Claims.
352.236–70 Design-Build Contracts.
352.237–70 Pro-Children Act.
352.237–71 Crime Control Act—Reporting
of Child Abuse.
352.237–72 Crime Control Act—
Requirement for Background Checks.
352.237–73 Indian Child Protection and
Family Violence Act.
352.237–74 Non-Discrimination in Service
Delivery.
352.237–75 Key Personnel.
352.239–73 Electronic Information and
Technology Accessibility Notice.
352.239–74 Electronic Information and
Technology Accessibility.
352.270–1 [Reserved]
352.270–2 [Reserved]
352.270–3 [Reserved]
352.270–4a Notice to Offerors, Protection of
Human Subjects.
352.270–4b Protection of Human Subjects.
352.270–5a Notice to Offerors of
Requirement for Compliance with the
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Public Health Service Policy on Humane
Care and Use of Laboratory Animals.
352.270–5b Care of Live Vertebrate
Animals.
352.270–6 Restriction on Use of Human
Subjects.
352.270–7 [Reserved]
352.270–8 [Reserved]
352.270–9 Non-Discrimination for
Conscience.
352.270–10 Notice to Offerors—Protection
of Human Subjects, Research Involving
Human Subjects Committee (RIHSC)
Approval of Research Protocols
Required.
352.270–11 Protection of Human Subjects,
Research Involving Human Subjects
Committee (RIHSC) Approval of
Research Protocols Required.
352.270–12 Needle Exchange.
352.270–13 Continued Ban on Funding
Abortion and Continued Ban on Funding
of Human Embryo Research.
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2).
Subpart 352.1—Instructions for Using
Provisions and Clauses
352.100
Scope of subpart.
This subpart provides guidance for
applying the Department of Health and
Human Services provisions and clauses
in solicitations, contracts, and orders.
352.101–70
clauses.
Application of provisions and
(a) If a clause is included in the
master instrument (e.g., in an indefinite
delivery/indefinite quantity contract or
a blanket purchase agreement), it is not
necessary to also include the clause in
a task order or delivery order
thereunder.
(b) When a dollar amount or dollar
threshold is specified (e.g., $25 million
or simplified acquisition threshold), the
dollar amount of the award (contract or
order) includes any options thereunder.
Subpart 352.2—Texts of Provisions
and Clauses
352.203–70
Anti-Lobbying.
As prescribed in HHSAR 303.808–70,
the Contracting Officer shall insert the
following clause:
Anti-Lobbying (DEC 2015)
Pursuant to the HHS annual appropriations
acts, except for normal and recognized
executive-legislative relationships, the
Contractor shall not use any HHS contract
funds for:
(a) Publicity or propaganda purposes;
(b) The preparation, distribution, or use of
any kit, pamphlet, booklet, publication,
electronic communication, radio, television,
or video presentation designed to support or
defeat the enactment of legislation before the
Congress or any State or local legislature or
legislative body, except in presentation to the
Congress or any state or local legislature
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itself; or designed to support or defeat any
proposed or pending regulation,
administrative action, or order issued by the
executive branch of any state or local
government, except in presentation to the
executive branch of any state or local
government itself; or
(c) Payment of salary or expenses of the
Contractor, or any agent acting for the
Contractor, related to any activity designed to
influence the enactment of legislation,
appropriations, regulation, administrative
action, or Executive order proposed or
pending before the Congress or any state
government, state legislature or local
legislature or legislative body, other than for
normal and recognized executive-legislative
relationships or participation by an agency or
officer of a state, local, or tribal government
in policymaking and administrative
processes within the executive branch of that
government.
(d) The prohibitions in subsections (a), (b),
and (c) above shall include any activity to
advocate or promote any proposed, pending,
or future federal, state, or local tax increase,
or any proposed, pending, or future
requirement for, or restriction on, any legal
consumer product, including its sale or
marketing, including, but not limited to, the
advocacy or promotion of gun control.
(End of clause)
352.204–70 Prevention and Public Health
Fund—Reporting Requirements.
As prescribed in HHSAR 304.7201,
insert the following clause:
Prevention and Public Health Fund—
Reporting Requirements (DEC 2015)
(a) Pursuant to public law this contract
requires the contractor to provide products or
services or both that are funded from the
Prevention and Public Health Fund (PPHF),
Public Law 111–148, sec. 4002. Section
220(b)(5) requires each contractor to report
on its use of these funds under this contract.
These reports will be made available to the
public.
(b) Semi-annual reports from the
Contractor for all work funded, in whole or
in part, by the PPHF, are due no later than
20 days following the end of each 6-month
period. The 6-month reporting periods are
January through June and July through
December. The first report is due no later
than 20 days after the end of the 6-month
period following contract award. Subsequent
reports are due no later than 20 days after the
end of each reporting period. If applicable,
the Contractor shall submit its final report for
the remainder of the contract period no later
than 20 days after the end of the reporting
period in which the contract ended.
(c) The Contractor shall provide the
following information in an electronic and
Section 508 compliant format to the
Contracting Officer.
(1) The Government contract and order
number, as applicable.
(2) The amount of PPHF funds invoiced by
the contractor for the reporting period and
the cumulative amount invoiced for the
contract or order.
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(3) A list of all significant services
performed or supplies delivered, including
construction, for which the contractor
invoiced in the reporting period.
(4) Program or project title, if any.
(5) The Contractor shall report any
subcontract funded in whole or in part with
PPHF funding, that is valued at $25,000 or
more. The Contractor shall advise the
subcontractor that the information will be
made available to the public. The Contractor
shall report:
(i) Name and address of the subcontractor.
(ii) Amount of the subcontract award.
(iii) Date of the subcontract award.
(iv) A description of the products or
services (including construction) being
provided under the subcontract.
(End of clause)
352.208–70
Printing and Duplication.
As prescribed in HHSAR 308.803, the
Contracting Officer shall insert the
following clause:
Printing and Duplication (DEC 2015)
(a) Unless otherwise specified in this
contract, no printing by the Contractor or any
subcontractor is authorized under this
contract. All printing required must be
performed by the Government Printing Office
except as authorized by the Contracting
Officer. The Contractor shall submit cameraready copies to the Contracting Officer’s
Representative (COR). The terms ‘‘printing’’
and ‘‘duplicating/copying’’ are defined in the
Government Printing and Binding
Regulations of the Joint Committee on
Printing.
(b) If necessary for performance of the
contract, the Contractor may duplicate or
copy less than 5,000 production units of only
one page, or less than 25,000 production
units in aggregate of multiple pages for the
use of a department or agency. A production
unit is defined as one sheet, size 8.5 x 11
inches, one side only, and one color. The
pages may not exceed a maximum image size
of 103⁄4 by 141⁄4 inches. This page limit
applies to each printing requirement and not
for all printing requirements under the entire
contract.
(c) Approval for all printing, as well as
duplicating/copying in excess of the stated
limits, shall be obtained from the COR who
will consult with the designated publishing
services office and provide direction to the
contractor. The cost of any unauthorized
printing or duplicating/copying under this
contract will be considered an unallowable
cost for which the Contractor will not be
reimbursed.
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As prescribed in HHSAR 311.7102,
the Contracting Officer shall insert the
following clause:
Public Accommodations and
Commercial Facilities (DEC 2015)
The Contractor agrees as follows:
(a) Except for ad hoc meetings necessary or
incidental to contract performance, the
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(End of clause)
352.211–2 Conference Sponsorship
Requests and Conference Materials
Disclaimer.
As prescribed in HHSAR 311.7202,
the Contracting Officer shall insert the
following clause:
Conference Sponsorship Request and
Conference Materials Disclaimer (DEC
2015)
(a) If HHS is not the sole provider of
funding under this contract, then, prior to the
Contractor claiming HHS conference
sponsorship, the Contractor shall submit a
written request (including rationale) to the
Contracting Officer for permission to claim
such HHS sponsorship.
(b) Whether or not HHS is the conference
sponsor, the Contractor shall include the
following statement on conference materials,
including promotional materials, agendas,
and Web sites:
‘‘This conference was funded, in whole or
in part, through a contract (insert contract
number) with the Department of Health and
Human Services (HHS) (insert name of
OPDIV or STAFFDIV). The views expressed
in written conference materials and by
speakers and moderators at this conference,
do not necessarily reflect the official policies
of HHS, nor does mention of trade names,
commercial practices, or organizations imply
endorsement by the U.S. Government.’’
(c) Unless authorized in writing by the
Contracting Officer, the Contractor shall not
display the HHS logo on any conference
materials.
(End of clause)
352.211–3
Paperwork Reduction Act.
As prescribed in HHSAR 311.7301,
the Contracting Officer shall insert the
following clause:
Paperwork Reduction Act (DEC 2015)
352.211–1 Public Accommodations and
Commercial Facilities.
VerDate Sep<11>2014
Contractor shall develop a plan to assure that
any event held pursuant to this contract will
meet or exceed the minimum accessibility
standards set forth in 28 CFR part 36—
Nondiscrimination on the Basis of Disability
by Public Accommodations and in
Commercial Facilities. The Contractor shall
submit the plan to the Contracting Officer
and must receive approval prior to the event.
The Contractor may submit a consolidated or
master plan for contracts requiring numerous
events in lieu of separate plans.
(b) The Contractor shall manage the
contract in accordance with the standards set
forth in 28 CFR part 36.
(a) This contract involves a requirement to
collect or record information calling either
for answers to identical questions from 10 or
more persons other than Federal employees,
or information from Federal employees
which is outside the scope of their
employment, for use by the Federal
government or disclosure to third parties;
therefore, the Paperwork Reduction Act of
1995 (44 U.S.C. 3501 et seq.) shall apply to
this contract. No plan, questionnaire,
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72171
interview guide or other similar device for
collecting information (whether repetitive or
single time) may be used without the Office
of Management and Budget (OMB) first
providing clearance. Contractors and the
Contracting Officer’s Representative shall be
guided by the provisions of 5 CFR part 1320,
Controlling Paperwork Burdens on the
Public, and seek the advice of the HHS
operating division or Office of the Secretary
Reports Clearance Officer to determine the
procedures for acquiring OMB clearance.
(b) The Contractor shall not expend any
funds or begin any data collection until the
Contracting Officer provides the Contractor
with written notification authorizing the
expenditure of funds and the collection of
data. The Contractor shall allow at least 120
days for OMB clearance. The Contracting
Officer will consider excessive delays caused
by the Government which arise out of causes
beyond the control and without the fault or
negligence of the Contractor in accordance
with the Excusable Delays or Default clause
of this contract.
(End of clause)
352.215–70
Late Proposals and Revisions.
As prescribed in HHSAR 315.208, the
Contracting Officer shall insert the
following provision:
Late Proposals and Revisions (DEC
2015) Deviation
Notwithstanding the procedures contained
in FAR 52.215–1(c)(3) of the provision of this
solicitation entitled Instructions to Offerors–
Competitive Acquisition, the Government
may consider a proposal received after the
date specified for receipt if it appears to offer
significant cost or technical advantage to the
Government and it was received before
proposals were distributed for evaluation, or
within 5 calendar days after the exact time
specified for receipt, whichever is earlier.
(End of provision)
352.216–70 Additional Cost Principles for
Hospitals (Profit and Non-Profit).
As prescribed in HHSAR
316.307(a)(2), the Contracting Officer
shall insert the following clause:
Additional Cost Principles for Hospitals
(Profit or Non-Profit) (DEC 2015)
(a) Bid and proposal (B&P) costs. (1) B&P
costs are the immediate costs of preparing
bids, proposals, and applications for
potential Federal and non-Federal contracts,
grants, and agreements, including the
development of scientific, cost, and other
data needed to support the bids, proposals,
and applications.
(2) B&P costs of the current accounting
period are allowable as indirect costs.
(3) B&P costs of past accounting periods
are unallowable in the current period.
However, if the organization’s established
practice is to treat these costs by some other
method, they may be accepted if they are
found to be reasonable and equitable.
(4) B&P costs do not include independent
research and development (IR&D) costs
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covered by the following paragraph, or preaward costs covered by paragraph 36 of
Attachment B to OMB Circular A–122.
(b) IR&D costs.
(1) IR&D is research and development
conducted by an organization which is not
sponsored by Federal or non-Federal
contracts, grants, or other agreements.
(2) IR&D shall be allocated its
proportionate share of indirect costs on the
same basis as the allocation of indirect costs
to sponsored research and development.
(3) The cost of IR&D, including its
proportionate share of indirect costs, is
unallowable.
(End of clause)
352.219–70
´ ´
Mentor-Protege Program.
As prescribed in HHSAR 319.270–
1(a), the Contracting Officer shall insert
the following provision:
asabaliauskas on DSK5VPTVN1PROD with RULES
´ ´
Mentor-Protege Program (DEC 2015)
(a) Large business prime contractors
serving as mentors in the HHS Mentor´ ´
Protege Program are eligible for HHS
subcontracting plan credit, and shall submit
a copy of their HHS Office of Small and
Disadvantaged Business Utilization
´ ´
(OSDBU)-approved mentor-protege
agreements as part of their offers. The
amount of credit provided by the Contracting
´ ´
Officer to a mentor firm for protege firm
developmental assistance costs shall be
calculated on a dollar for dollar basis and
reported by the mentor firm in the Summary
Subcontract Report via the Electronic
Subcontracting Reporting System (eSRS) at
´ ´
www.esrs.gov. The mentor firm and protege
firm shall submit to the Contracting Officer
a signed joint statement agreeing on the
dollar value of the developmental assistance
the mentor firm provided. (For example, a
mentor firm would report a $10,000
´ ´
subcontract awarded to a protege firm and
provision of $5,000 of developmental
assistance as $15,000 of subcontracting plan
credit.) The mentor firm may use this
additional credit towards attaining its
subcontracting plan participation goal under
this contract.
(b) The program consists of—
(1) Mentor firms—large businesses that:
(i) Demonstrate the interest, commitment,
and capability to provide developmental
´ ´
assistance to small business protege firms;
and
´ ´
(ii) Have a Mentor-Protege agreement
approved by HHS’ OSDBU;
´ ´
(2) Protege firms—firms that:
(i) Seek developmental assistance;
(ii) Qualify as small businesses, veteranowned small businesses, service-disabled
veteran-owned small businesses, HUBZone
small businesses, small disadvantaged
businesses, or woman-owned small
businesses; and
´ ´
(iii) Have a Mentor-Protege agreement
approved by HHS’ OSDBU; and
´ ´
(3) Mentor-Protege agreements—joint
agreements, approved by HHS’ OSDBU,
which detail the specific terms, conditions,
´ ´
and responsibilities of the mentor-protege
relationship.
(End of provision)
VerDate Sep<11>2014
19:27 Nov 17, 2015
Jkt 238001
´ ´
352.219–71 Mentor-Protege Program
Reporting Requirements.
As prescribed in HHSAR 319.270–
1(b), the Contracting Officer shall insert
the following clause:
´ ´
Mentor-Protege Program Reporting
Requirements (January 2010)
The Contractor shall comply with all
reporting requirements specified in its
´ ´
Mentor-Protege agreement approved by HHS’
OSDBU.
(v) Preparing for and providing testimony
in depositions or in hearings before the
MSPB, EEOC and U.S. District Court.
(b) The Contractor shall include the
provisions of this clause in all subcontract
solicitations and subcontracts awarded at any
tier under this contract.
(c) Failure on the part of the Contractor or
its subcontractors to comply with the terms
of this clause may be grounds for the
Contracting Officer to terminate this contract
for default.
(End of clause)
(End of clause)
352.223–70
352.222–70 Contractor Cooperation in
Equal Employment Opportunity
Investigations.
As prescribed in HHSAR 323.7002,
the Contracting Officer shall insert the
following clause:
As prescribed in HHSAR 322.810(h),
the Contracting Officer shall insert the
following clause:
Safety and Health (DEC 2015)
Contractor Cooperation in Equal
Employment Opportunity
Investigations (DEC 2015)
(a) In addition to complying with the
clause at FAR 52.222–26, Equal Opportunity,
the Contractor shall, in good faith, cooperate
with the Department of Health and Human
Services (Agency) in investigations of Equal
Employment Opportunity (EEO) complaints
processed pursuant to 29 CFR part 1614. For
purposes of this clause, the following
definitions apply:
(1) Complaint means a formal or informal
complaint that has been lodged with Agency
management, Agency EEO officials, the Equal
Employment Opportunity Commission
(EEOC), or a court of competent jurisdiction.
(2) Contractor employee means all current
Contractor employees who work or worked
under this contract. The term also includes
current employees of subcontractors who
work or worked under this contract. In the
case of Contractor and subcontractor
employees, who worked under this contract,
but who are no longer employed by the
Contractor or subcontractor, or who have
been assigned to another entity within the
Contractor’s or subcontractor’s organization,
the Contractor shall provide the Agency with
that employee’s last known mailing address,
email address, and telephone number, if that
employee has been identified as a witness in
an EEO complaint or investigation.
(3) Good faith cooperation cited in
paragraph (a) includes, but is not limited to,
making Contractor employees available for:
(i) Formal and informal interviews by EEO
counselors or other Agency officials
processing EEO complaints;
(ii) Formal or informal interviews by EEO
investigators charged with investigating
complaints of unlawful discrimination filed
by Federal employees;
(iii) Reviewing and signing appropriate
affidavits or declarations summarizing
statements provided by such Contractor
employees during the course of EEO
investigations;
(iv) Producing documents requested by
EEO counselors, EEO investigators, Agency
employees, or the EEOC in connection with
a pending EEO complaint; and
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Safety and Health.
(a) To help ensure the protection of the life
and health of all persons, and to help prevent
damage to property, the Contractor shall
comply with all Federal, State, and local laws
and regulations applicable to the work being
performed under this contract. These laws
are implemented or enforced by the
Environmental Protection Agency,
Occupational Safety and Health
Administration (OSHA) and other regulatory/
enforcement agencies at the Federal, State,
and local levels.
(1) In addition, the Contractor shall comply
with the following regulations when
developing and implementing health and
safety operating procedures and practices for
both personnel and facilities involving the
use or handling of hazardous materials and
the conduct of research, development, or test
projects:
(i) 29 CFR 1910.1030, Bloodborne
pathogens; 29 CFR 1910.1450, Occupational
exposure to hazardous chemicals in
laboratories; and other applicable
occupational health and safety standards
issued by OSHA and included in 29 CFR part
1910. These regulations are available at
https://www.osha.gov/.
(ii) Nuclear Regulatory Commission
Standards and Regulations, pursuant to the
Energy Reorganization Act of 1974 (42 U.S.C.
5801 et seq.). The Contractor may obtain
copies from the U.S. Nuclear Regulatory
Commission, Washington, DC 20555–0001.
(2) The following Government guidelines
are recommended for developing and
implementing health and safety operating
procedures and practices for both personnel
and facilities:
(i) Biosafety in Microbiological and
Biomedical Laboratories, CDC. This
publication is available at https://
www.cdc.gov/biosafety/publications/
index.htm.
(ii) Prudent Practices for Safety in
Laboratories (1995), National Research
Council, National Academy Press, 500 Fifth
Street NW., Lockbox 285, Washington, DC
20055 (ISBN 0–309–05229–7). This
publication is available at https://
www.nap.edu/catalog/4911/prudentpractices-in-the-laboratory-handling-anddisposal-of-chemicals.
(b) Further, the Contractor shall take or
cause to be taken additional safety measures
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as the Contracting Officer, in conjunction
with the Contracting Officer’s Representative
or other appropriate officials, determines to
be reasonably necessary. If compliance with
these additional safety measures results in an
increase or decrease in the cost or time
required for performance of any part of work
under this contract, the Contracting Officer
will make an equitable adjustment in
accordance with the applicable ‘‘Changes’’
clause set forth in this contract.
(c) The Contractor shall maintain an
accurate record of, and promptly report to the
Contracting Officer, all accidents or incidents
resulting in the exposure of persons to toxic
substances, hazardous materials or hazardous
operations; the injury or death of any person;
or damage to property incidental to work
performed under the contract resulting from
toxic or hazardous materials and resulting in
any or all violations for which the Contractor
has been cited by any Federal, State or local
regulatory/enforcement agency. The report
citing all accidents or incidents resulting in
the exposure of persons to toxic substances,
hazardous materials or hazardous operations;
the injury or death of any person; or damage
to property incidental to work performed
under the contract resulting from toxic or
hazardous materials and resulting in any or
all violations for which the Contractor has
been cited shall include a copy of the notice
of violation and the findings of any inquiry
or inspection, and an analysis addressing the
impact these violations may have on the
work remaining to be performed. The report
shall also state the required action(s), if any,
to be taken to correct any violation(s) noted
by the Federal, State, or local regulatory/
enforcement agency and the time frame
allowed by the agency to accomplish the
necessary corrective action.
(d) If the Contractor fails or refuses to
comply with the Federal, State or local
regulatory/enforcement agency’s directive(s)
regarding any violation(s) and prescribed
corrective action(s), the Contracting Officer
may issue an order stopping all or part of the
work until satisfactory corrective action (as
approved by the Federal, State, or local
regulatory/enforcement agencies) has been
taken and documented to the Contracting
Officer. No part of the time lost due to any
such stop work order shall form the basis for
a request for extension or costs or damages
by the Contractor.
(e) The Contractor shall insert the
substance of this clause in each subcontract
involving toxic substances, hazardous
materials, or hazardous operations. The
Contractor is responsible for the compliance
of its subcontractors with the provisions of
this clause.
asabaliauskas on DSK5VPTVN1PROD with RULES
(End of clause)
Instructions to Offerors—Sustainable
Acquisition (DEC 2015)
Offerors must include a Sustainable
Acquisition Plan in their technical proposals.
Jkt 238001
352.224–70
Privacy Act.
As prescribed in HHSAR 324.105(a),
the Contracting Officer shall insert the
following clause:
Privacy Act (DEC 2015)
This contract requires the Contractor to
perform one or more of the following: (a)
Design; (b) develop; or (c) operate a Federal
agency system of records to accomplish an
agency function in accordance with the
Privacy Act of 1974 (Act) (5 U.S.C.
552a(m)(1)) and applicable agency
regulations.
The term system of records means a group
of any records under the control of any
agency from which information is retrieved
by the name of the individual or by some
identifying number, symbol, or other
identifying particular assigned to the
individual. Violations of the Act by the
Contractor and/or its employees may result
in the imposition of criminal penalties (5
U.S.C. 552a(i)).
The Contractor shall ensure that each of its
employees knows the prescribed rules of
conduct in 45 CFR part 5b and that each
employee is aware that he/she is subject to
criminal penalties for violation of the Act to
the same extent as Department of Health and
Human Services employees. These
provisions also apply to all subcontracts the
Contractor awards under this contract which
require the design, development or operation
of the designated system(s) of records (5
U.S.C. 552a(m)(1)). The contract work
statement:
(a) Identifies the system(s) of records and
the design, development, or operation work
the Contractor is to perform; and
(b) Specifies the disposition to be made of
such records upon completion of contract
performance.
352.224–71
As prescribed in HHSAR 323.7103,
the Contracting Officer shall insert the
following provision:
19:27 Nov 17, 2015
(End of provision)
(End of clause)
352.223–71 Instructions to Offerors—
Sustainable Acquisition.
VerDate Sep<11>2014
The Plan must describe their approach and
the quality assurance mechanisms in place
for applying FAR 23.1, Sustainable
Acquisition Policy (and other Federal laws,
regulations and Executive Orders governing
sustainable acquisition purchasing) to this
acquisition. The Plan shall clearly identify
those products and services included in
Federal sustainable acquisition preference
programs by categorizing them along with
their respective price/cost in the following
eight groups: Recycled Content, Energy
Efficient, Biobased, Environmentally
Preferable, Electronic Product Environment
Assessment Tool, Water-Efficient, NonOzone Depleting Substances, and Alternative
Fuel Vehicle and Alternative Fuels.
Confidential Information.
As prescribed in HHSAR 324.105(b),
insert the following clause:
Confidential Information (DEC 2015)
(a) Confidential Information, as used in
this clause, means information or data of a
personal nature about an individual, or
proprietary information or data submitted by
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72173
or pertaining to an institution or
organization.
(b) Specific information or categories of
information that the Government will furnish
to the Contractor, or that the Contractor is
expected to generate, which are confidential
may be identified elsewhere in this contract.
The Contracting Officer may modify this
contract to identify Confidential Information
from time to time during performance.
(c) Confidential Information or records
shall not be disclosed by the Contractor until:
(1) Written advance notice of at least 45
days shall be provided to the Contracting
Officer of the Contractor’s intent to release
findings of studies or research, to which an
agency response may be appropriate to
protect the public interest or that of the
agency.
(2) For information provided by or on
behalf of the government,
(i) The publication or dissemination of the
following types of information are restricted
under this contract: [INSERT RESTRICTED
TYPES OF INFORMATION. IF NONE, SO
STATE.]
(ii) The reason(s) for restricting the types
of information identified in subparagraph (i)
is/are: [STATE WHY THE PUBLIC OR
GOVERNMENT INTEREST REQUIRES THE
RESTRICTION OF EACH TYPE OF
INFORMATION. ANY BASIS FOR
NONDISCLOSURE WHICH WOULD BE
VALID UNDER THE FREEDOM OF
INFORMATION ACT IS SUFFICIENT
UNDER THIS CLAUSE.]
(iii) Written advance notice of at least 45
days shall be provided to the Contracting
Officer of the Contractor’s intent to
disseminate or publish information identified
in subparagraph (2)(i). The contractor shall
not disseminate or publish such information
without the written consent of the
Contracting Officer.
(d) Whenever the Contractor is uncertain
with regard to the confidentiality of or a
property interest in information under this
contract, the Contractor should consult with
the Contracting Officer prior to any release,
disclosure, dissemination, or publication.
352.226–1
Indian Preference.
As prescribed in HHSAR 326.505(a),
the Contracting Officer shall insert the
following clause:
Indian Preference (DEC 2015)
(a) The Contractor agrees to give preference
in employment opportunities under this
contract to Indians who can perform required
work, regardless of age (subject to existing
laws and regulations), sex, religion, or tribal
affiliation. To the extent feasible and
consistent with the efficient performance of
this contract, the Contractor further agrees to
give preference in employment and training
opportunities under this contract to Indians
who are not fully qualified to perform
regardless of age (subject to existing laws and
regulations), sex, religion, or tribal affiliation.
The Contractor also agrees to give preference
to Indian organizations and Indian-owned
economic enterprises in the awarding of any
subcontracts to the extent feasible and
consistent with the efficient performance of
this contract. The Contractor shall maintain
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the necessary statistical records to
demonstrate compliance with this paragraph.
(b) In connection with the Indian
employment preference requirements of this
clause, the Contractor shall provide
reasonable opportunities for training,
incident to such employment. Such training
shall include on-the-job, classroom, or
apprenticeship training designed to increase
the vocational effectiveness of an Indian
employee.
(c) If the Contractor is unable to fill its
employment and training opportunities after
giving full consideration to Indians as
required by this clause, the Contractor may
satisfy those needs by selecting non-Indian
persons in accordance with the clause of this
contract entitled ‘‘Equal Opportunity.’’
(d) If no Indian organizations or Indianowned economic enterprises are available
under reasonable terms and conditions,
including price, for awarding of subcontracts
in connection with the work performed
under this contract, the Contractor agrees to
comply with the provisions of this contract
involving utilization of small businesses;
HUBZone small businesses; service-disabled,
veteran-owned small businesses; 8(a) small
businesses; veteran-owned small businesses;
women-owned small businesses; or small
disadvantaged businesses.
(e) As used in this clause,
(1) Indian means a person who is a
member of an Indian tribe. If the Contractor
has reason to doubt that a person seeking
employment preference is an Indian, the
Contractor shall grant the preference but
shall require the individual provide evidence
within 30 days from the tribe concerned that
the person is a member of the tribe.
(2) Indian tribe means an Indian tribe,
pueblo, band, nation, or other organized
group or community, including Alaska
Native village or regional or village
corporation as defined in or established
pursuant to the Alaska Native Claims
Settlement Act (85 Stat. 688; 43 U.S.C. 1601)
which the United States recognizes as
eligible for the special programs and services
provided to Indians because of its status as
Indians.
(3) Indian organization means the
governing body of any Indian Tribe or entity
established or recognized by such governing
body in accordance with the Indian
Financing Act of 1974 (88 Stat. 77; 25 U.S.C.
1451).
(4) Indian-owned economic enterprise
means any Indian-owned commercial,
industrial, or business activity established or
organized for the purpose of profit, provided
that such Indian ownership shall constitute
not less than 51 percent of the enterprise, and
that ownership shall encompass active
operation and control of the enterprise.
(f) The Contractor agrees to include the
provisions of this clause, including this
paragraph (f) of this clause, in each
subcontract awarded at any tier under this
contract.
(g) In the event of noncompliance with this
clause, the Contracting Officer may terminate
the contract in whole or in part or may
pursue any other remedies authorized by law
or by other provisions of the contract.
(End of clause)
VerDate Sep<11>2014
19:27 Nov 17, 2015
Jkt 238001
352.226–2
Indian Preference Program.
As prescribed in HHSAR 326.505(b),
the Contracting Officer shall insert the
following clause:
Indian Preference Program (DEC 2015)
(a) In addition to the requirements of the
clause of this contract entitled ‘‘Indian
Preference,’’ the Contractor agrees to
establish and conduct an Indian preference
program which will expand opportunities for
Indians to receive preference for employment
and training in connection with the work
performed under this contract, and which
will expand the opportunities for Indian
organizations and Indian-owned economic
enterprises to receive a preference in the
awarding of subcontracts. In this connection,
the Contractor shall perform the following:
(1) Designate a liaison officer who will
maintain liaison with the Government and
the Tribe(s) on Indian preference matters;
supervise compliance with the provisions of
this clause; and administer the Contractor’s
Indian preference program.
(2) Advise its recruitment sources in
writing and include a statement in all
employment advertisements that Indian
applicants receive preference in employment
and training incident to such employment.
(3) Not more than 20 calendar days after
award of the contract, post a written notice
setting forth the Contractor’s employment
needs and related training opportunities in
the tribal office of any reservations on or near
the contract work location. The notice shall
include the approximate numbers and types
of employees needed; the approximate dates
of employment; any experience or special
skills required for employment; training
opportunities available; and other pertinent
information necessary to advise prospective
employees of any other employment
requirements. The Contractor shall also
request the tribe(s) on or near whose
reservation(s) the Contractor will perform
contract work to provide assistance filling its
employment needs and training
opportunities. The Contracting Officer will
advise the Contractor of the name, location,
and phone number of the Tribal officials to
contact regarding the posting of notices and
requests for Tribal assistance.
(4) Establish and conduct a subcontracting
program which gives preference to Indian
organizations and Indian-owned economic
enterprises as subcontractors (including
suppliers) under this contract. The
Contractor shall give public notice of existing
subcontracting opportunities and, to the
extent feasible and consistent with the
efficient performance of this contract, shall
solicit bids or proposals from Indian
organizations or Indian-owned economic
enterprises only. The Contractor shall request
assistance and information on Indian firms
qualified as subcontractors (including
suppliers) from the Tribe(s) on or near whose
reservation(s) the Contractor will perform
contract work. The Contracting Officer will
advise the Contractor of the name, location,
and phone number of the Tribal officials to
contact regarding the request for assistance
and information. Public notices and
solicitations for existing subcontracting
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opportunities shall provide an equitable
opportunity for Indian firms to submit bids
or proposals by including—
(i) A clear description of the supplies or
services required, including quantities,
specifications, and delivery schedules that
facilitate the participation of Indian firms;
(ii) A statement indicating that Indian
organizations and Indian-owned economic
enterprises will receive preference in
accordance with section 7(b) of Public Law
93–638; 88 Stat. 2205; 25 U.S.C. 450e(b);
(iii) Definitions for the terms ‘‘Indian
organization’’ and ‘‘Indian-owned economic
enterprise’’ prescribed under the ‘‘Indian
Preference’’ clause of this contract;
(iv) A statement that the bidder or offeror
shall complete certifying that it is an Indian
organization or Indian-owned economic
enterprise; and
(v) A closing date for receipt of bids or
proposals which provides sufficient time for
preparation and submission of a bid or
proposal. If, after soliciting bids or proposals
from Indian organizations and Indian-owned
economic enterprises, the Contractor receives
no responsive bid or acceptable proposal, the
Contractor shall comply with the
requirements of paragraph (d) of the ‘‘Indian
Preference’’ clause of this contract. If the
Contractor receives one or more responsive
bids or conforming proposals, the Contractor
shall award the contract to the low,
responsive, responsible bidder or conforming
offer from a responsible offeror if the price
is reasonable. If the Contractor determines
the low responsive bid or conforming
proposal’s price is unreasonable, the
Contractor shall attempt to negotiate a
reasonable price and award a subcontract. If
parties cannot agree on a reasonable price,
the Contractor shall comply with the
requirements of paragraph (d) of the ‘‘Indian
Preference’’ clause of this contract.
(5) Maintain written records under this
contract which demonstrate—
(i) The numbers of Indians seeking
employment for each employment position
available under this contract;
(ii) The number and types of positions
filled by Indians and non-Indians;
(iii) The total number of Indians employed
under this contract;
(iv) For those positions having both Indian
and non-Indian applicants, and a non-Indian
is selected for employment, the reason(s)
why the Contractor did not select the Indian
applicant;
(v) Actions taken to give preference to
Indian organizations and Indian-owned
economic enterprises for subcontracting
opportunities which exist under this
contract;
(vi) Reasons why Indian subcontractors
and or suppliers did not receive preference
for each requirement where the Contractor
determined that such preference was
inconsistent with efficient contract
performance; and
(vii) The number of Indian organizations
and Indian-owned economic enterprises
contacted, and the number receiving
subcontract awards under this contract.
(6) Submit to the Contracting Officer for
approval a quarterly report summarizing the
Contractor’s Indian preference program and
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indicating the number and types of available
positions filled by Indians and non-Indians,
and the dollar amounts of all subcontracts
awarded to Indian organizations and Indianowned economic enterprises, and to all other
firms.
(7) Maintain records pursuant to this
clause and keep them available for review by
the Government for one year after final
payment under this contract, or for such
longer period in accordance with
requirements of any other clause of this
contract or by applicable law or regulation.
(b) For purposes of this clause, the
following definitions of terms shall apply:
(1) The terms Indian, Indian tribe, Indian
organization, and Indian-owned economic
enterprise are defined in the clause of this
contract entitled Indian Preference.
(2) Indian reservation includes Indian
reservations, public domain Indian
allotments, former Indian reservations in
Oklahoma, and land held by incorporated
Native groups, regional corporations, and
village corporations under the provisions of
the Alaska Native Claims Settlement Act (85
Stat. 688; 43 U.S.C. 1601 et seq.)
(3) On or near an Indian reservation means
on a reservation or reservations or within that
area surrounding an Indian reservation(s)
where a person seeking employment could
reasonably expect to commute to and from in
the course of a work day.
(c) Nothing in the requirements of this
clause shall preclude Indian tribes from
independently developing and enforcing
their own Indian preference requirements.
Such requirements must not conflict with
any Federal statutory or regulatory
requirement dealing with the award and
administration of contracts.
(d) The Contractor agrees to include the
provisions of this clause, including this
paragraph (d), in each subcontract awarded at
any tier under this contract and to notify the
Contracting Officer of such subcontracts.
(e) In the event of noncompliance with this
clause, the Contracting Officer may terminate
the contract in whole or in part or may
pursue any other remedies authorized by law
or by other provisions of the contract.
(End of clause)
352.226–3 Native American Graves
Protection and Repatriation Act.
As prescribed in HHSAR 326.701, the
Contracting Officer shall insert the
following clause:
asabaliauskas on DSK5VPTVN1PROD with RULES
Native American Graves Protection and
Repatriation Act (DEC 2015)
(a) Public Law 101–601, dated November
16, 1990, also known as the Native American
Graves Protection and Repatriation Act,
imposes certain responsibilities on
individuals and organizations when they
discover Native American cultural items
(including human remains) on Federal or
tribal lands.
(b) In the event the Contractor discovers
Native American cultural items (including
human remains, associated funerary objects,
unassociated funerary objects, sacred objects
and cultural patrimony), as defined in the
Act during contract performance, the
Contractor shall—
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(1) Immediately cease activity in the area
of the discovery;
(2) Notify the Contracting Officer of the
discovery; and
(3) Make a reasonable effort to protect the
items discovered before resuming such
activity. Upon receipt of the Contractor’s
discovery notice, the Contracting Officer will
notify the appropriate authorities as required
by the Act.
(c) Unless otherwise specified by the
Contracting Officer, the Contractor may
resume activity in the area on the 31st
calendar day following the date that the
appropriate authorities certify receipt of the
discovery notice. The Contracting Officer
shall provide to the Contractor the date that
the appropriate authorities certify receipt of
the discovery notice and the date on which
the Contractor may resume activities.
352.227–11 Patent Rights—Exceptional
Circumstances.
As prescribed in HHSAR 327.303, the
Contracting Officer shall insert the
following clause:
Patent Rights—Exceptional
Circumstances (SEPT 2014)
This clause applies to all Contractor and
subcontractor (at all tiers) Subject Inventions.
(a) Definitions. As used in this clause—
Agency means the Agency of the U.S.
Department of Health and Human Services
that is entering into this contract.
Class 1 Subject Invention means a Subject
Invention described and defined in the DEC
that will be assigned to a third party assignee,
or assigned as directed by the Agency.
Class 2 Subject Invention means a Subject
Invention described and defined in the DEC.
Class 3 Subject Invention means a Subject
Invention that does not fall into Class 1 or
Class 2 as defined in this clause.
DEC means the Determination of
Exceptional Circumstances signed by [insert
approving official] llll on ll [insert
date] llll and titled ‘‘[insert
description].’’
Invention means any invention or
discovery, which is or may be patentable or
otherwise protectable under Title 35 of
United States Code, or any novel variety of
plant that is or may be protectable under the
Plant Variety Protection Act (7 U.S.C. 2321,
et seq.)
Made means: When used in relation to any
invention other than a plant variety, the
conception or first actual reduction to
practice of such invention; or when used in
relation to a plant variety, that the Contractor
has at least tentatively determined that the
variety has been reproduced with recognized
characteristics.
Material means any proprietary material,
method, product, composition, compound, or
device, whether patented or unpatented,
which is provided to the Contractor under
this contract.
Nonprofit organization means a university
or other institution of higher education or an
organization of the type described in section
501(c)(3) of the Internal Revenue Code of
1954 (26 U.S.C. 501(c)) and exempt from
taxation under section 501(a) of the Internal
Revenue Code (26 U.S.C. 501(a)) or any
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nonprofit scientific or educational
organization qualified under a state nonprofit
organization statute.
Practical application means to
manufacture, in the case of a composition or
product; to practice, in the case of a process
or method, or to operate, in the case of a
machine or system; and, in each case, under
such conditions as to establish that the
invention is being utilized and that its
benefits are, to the extent permitted by law
or Government regulations, available to the
public on reasonable terms.
Small business firm means a small
business concern as defined at section 2 of
Public Law 85–536 (15 U.S.C. 632) and
implementing regulations of the
Administrator of the Small Business
Administration. For the purpose of this
clause, the size standards for small business
concerns involved in Government
procurement and subcontracting at 13 CFR
121.3–8 and 13 CFR 121.3–12, respectively,
will be used.
Subject Invention means any invention of
the Contractor made in the performance of
work under this contract.
Third party assignee means any entity or
organization that may, as described in the
DEC, be assigned Class 1 inventions.
(b) Allocation of principal rights. (1)
Retention of pre-existing rights. Third party
assignees shall retain all preexisting rights to
Material in which the Third party assignee
has a proprietary interest.
(2) Allocation of Subject Invention rights.
(i) Disposition of Class 1 Subject Inventions.
(A) Assignment to the Third party assignee
or as directed by the Agency. The Contractor
shall assign to the Third party assignee
designated by the Agency the entire right,
title, and interest throughout the world to
each Subject Invention, or otherwise dispose
of or transfer those rights as directed by the
Agency, except to the extent that rights are
retained by the Contractor under paragraph
(b)(3) of this clause. Any such assignment or
other disposition or transfer of rights will be
subject to a nonexclusive, nontransferable,
irrevocable, paid-up license to the U.S.
Government to practice or have practiced the
Subject Invention for or on behalf of the U.S.
throughout the world. Any assignment shall
additionally be subject to the ‘‘March-in
rights’’ of 35 U.S.C. 203. If the Contractor is
a U.S. nonprofit organization it may retain a
royalty free, nonexclusive, nontransferable
license to practice the invention for all
nonprofit research including for educational
purposes, and to permit other U.S. nonprofit
organizations to do so.
(B) [Reserved]
(ii) Disposition of Class 2 and 3 Subject
Inventions. Class 2 Subject Inventions shall
be governed by FAR clause 52.227–11, Patent
Rights-Ownership (December 2007)
(incorporated herein by reference). However,
the Contractor shall grant a license in the
Class 2 Subject Inventions to the provider of
the Material or other party designated by the
Agency as set forth in Alternate I.
(iii) Class 3 Subject Inventions shall be
governed by FAR clause 52.227–11, Patent
Rights—Ownership by the Contractor
(December 2007) (previously incorporated
herein by reference).
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(3) Greater Rights Determinations. The
Contractor, or an employee-inventor after
consultation by the Agency with the
Contractor, may request greater rights than
are provided in paragraph (b)(1) of this clause
in accordance with the procedures of FAR
paragraph 27.304–1(c). In addition to the
considerations set forth in paragraph 27.304–
1(c), the Agency may consider whether
granting the requested greater rights will
interfere with rights of the Government or
any Third party assignee or otherwise
impede the ability of the Government or the
Third party assignee to, for example, develop
and commercialize new compounds, dosage
forms, therapies, preventative measures,
technologies, or other approaches with
potential for the diagnosis, prognosis,
prevention, and treatment of human diseases.
A request for a determination of whether
the Contractor or the employee-inventor is
entitled to retain such greater rights must be
submitted to the Agency Contracting Officer
at the time of the first disclosure of the
invention pursuant to paragraph (c)(1) of this
clause, or not later than 8 months thereafter,
unless a longer period is authorized in
writing by the Contracting Officer for good
cause shown in writing by the Contractor.
Each determination of greater rights under
this contract shall be subject to paragraph (c)
of the FAR clause at 52.227–13 (incorporated
herein by reference), and to any reservations
and conditions deemed to be appropriate by
the Agency such as the requirement to assign
or exclusively license the rights to Subject
Inventions to the Third party assignee.
A determination by the Agency denying a
request by the Contractor for greater rights in
a Subject Invention may be appealed within
30 days of the date the Contractor is notified
of the determination to an Agency official at
a level above the individual who made the
determination. If greater rights are granted,
the Contractor must file a patent application
on the invention. Upon request, the
Contractor shall provide the filing date, serial
number and title, a copy of the patent
application (including an English-language
version if filed in a language other than
English), and patent number and issue date
for any Subject Invention in any country for
which the Contractor has retained title. Upon
request, the Contractor shall furnish the
Government an irrevocable power to inspect
and make copies of the patent application
file.
(c) Invention disclosure by Contractor. The
Contractor shall disclose in writing each
Subject Invention to the Agency Contracting
Officer and to the Director, Division of
Extramural Inventions and Technology
Resources (DEITR), if directed by the
Contracting Officer, as provided in paragraph
(j) of this clause within 2 months after the
inventor discloses it in writing to Contractor
personnel responsible for patent matters. The
disclosure to the Agency Contracting Officer
shall be in the form of a written report and
shall identify the contract under which the
invention was Made and all inventors. It
shall be sufficiently complete in technical
detail to convey a clear understanding to the
extent known at the time of the disclosure,
of the nature, purpose, operation, and the
physical, chemical, biological, or electrical
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characteristics of the invention. The
disclosure shall also identify any publication,
on sale (offer for sale), or public use of the
invention and whether a manuscript
describing the invention has been submitted
for publication, and if so, whether it has been
accepted for publication at the time of
disclosure.
In addition, after disclosure to the Agency,
the Contractor will promptly notify the
Contracting Officer and DEITR of the
acceptance of any manuscript describing the
invention for publication or of any on sale or
public use planned by the Contractor. If the
Contractor assigns a Subject Invention to the
Third party assignee, then the Contractor and
its employee inventors shall assist the Third
party assignee in securing patent protection.
All costs of securing the patent, including the
cost of the Contractor’s assistance, are at the
Third party’s expense. Any assistance
provided by the Contractor and its employee
inventors to the Third party assignee or other
costs incurred in securing patent protection
shall be solely at the Third party’s expense
and not billable to the contract.
(d) Contractor action to protect the Third
party assignee’s and the Government’s
interest. (1) The Contractor agrees to execute
or to have executed and promptly deliver to
the Agency all instruments necessary to:
Establish or confirm the rights the
Government has throughout the world in
Subject Inventions pursuant to paragraph (b)
of this clause; convey title to a Third party
assignee in accordance with paragraph (b) of
this clause; and enable the Third party
assignee to obtain patent protection
throughout the world in that Subject
Invention.
(2) The Contractor agrees to require, by
written agreement, its employees, other than
clerical and nontechnical employees, to
disclose promptly in writing to personnel
identified as responsible for the
administration of patent matters and in a
format suggested by the Contractor, each
Subject Invention ‘‘Made’’ under contract in
order that the Contractor can comply with
the disclosure provisions of paragraph (c) of
this clause, and to execute all papers
necessary to file patent applications on
Subject Inventions and to establish the
Government’s rights or a Third party
assignee’s rights in the Subject Inventions.
This disclosure format should require, as a
minimum, the information required by
subparagraph (c)(1) of this clause. The
Contractor shall instruct such employees,
through employee agreements or other
suitable educational programs, on the
importance of reporting inventions in
sufficient time to permit the filing of patent
applications prior to U.S. or foreign statutory
bars.
(3) If the Contractor is granted greater
rights, the Contractor agrees to include,
within the specification of any United States
non-provisional patent application it files,
and any patent issuing thereon, covering a
Subject Invention the following statement:
‘‘This invention was made with Government
support under (identify the Contract)
awarded by (identify the specific Agency).
The Government has certain rights in the
invention.’’
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(4) The Contractor agrees to provide a final
invention statement and certification prior to
the closeout of the contract listing all Subject
Inventions or stating that there were none.
(e) Subcontracts. (1) The Contractor will
include this clause in all subcontracts,
regardless of tier, for experimental,
developmental, or research work. At all tiers,
the clause must be modified to identify the
parties as follows: References to the
Government are not changed, and the
subcontractor has all rights and obligations of
the Contractor in the clause. The Contractor
will not, as part of the consideration for
awarding the contract, obtain rights in the
subcontractor’s Subject Inventions.
(2) In subcontracts, at any tier, the Agency,
the subcontractor, and the Contractor agree
that the mutual obligations of the parties
created by this clause constitute a contract
between the subcontractor and the Agency
with respect to the matters covered by the
clause; provided, however, that nothing in
this paragraph is intended to confer any
jurisdiction under the Contract Disputes Act
in connection with proceedings under
paragraph (c)(1)(ii) of FAR clause 52.227–13.
(f) Reporting on utilization of Subject
Inventions in the event greater rights are
granted to the Contractor. The Contractor
agrees to submit, on request, periodic reports
no more frequently than annually on the
utilization of a Subject Invention or on efforts
at obtaining such utilization that are being
made by the Contractor or its licensees or
assignees when a request under subparagraph
b.3. has been granted by the Agency. Such
reports shall include information regarding
the status of development, date of first
commercial sale or use, gross royalties
received by the Contractor, and such other
data and information as the Agency may
reasonably specify. The Contractor also
agrees to provide additional reports as may
be requested by the Agency in connection
with any march-in proceeding undertaken by
the Agency in accordance with paragraph (h)
of this clause. As required by 35 U.S.C.
202(c)(5), the Agency agrees it will not
disclose such information to persons outside
the Government without permission of the
Contractor.
(g) Preference for United States industry in
the event greater rights are granted to the
Contractor. Notwithstanding any other
provision of this clause, the Contractor agrees
that neither it nor any assignee will grant to
any person the exclusive right to use or sell
any Subject Invention in the United States
unless such person agrees that any product
embodying the Subject Invention or
produced through the use of the Subject
Invention will be manufactured substantially
in the United States. However, in individual
cases, the requirement for such an agreement
may be waived by the Agency upon a
showing by the Contractor or its assignee that
reasonable but unsuccessful efforts have been
made to grant licenses on similar terms to
potential licensees that would be likely to
manufacture substantially in the United
States or that under the circumstances
domestic manufacture is not commercially
feasible.
(h) March-in rights in the event greater
rights are granted to the Contractor. The
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Contractor acknowledges that, with respect to
any Subject Invention in which it has
acquired ownership through the exercise of
the rights specified in paragraph (b)(3) of this
clause, the Agency has the right to require
licensing pursuant to 35 U.S.C. 203 and
210(c), and in accordance with the
procedures in 37 CFR 401.6 and any
supplemental regulations of Agency in effect
on the date of contract award.
(i) Special provisions for contracts with
nonprofit organizations in the event greater
rights are granted to the Contractor. If the
Contractor is a nonprofit organization, it
shall:
(1) Not assign rights to a Subject Invention
in the United States without the written
approval of the Agency, except where an
assignment is made to an organization that
has as one of its primary functions the
management of inventions, provided that the
assignee shall be subject to the same
provisions as the Contractor;
(2) Share royalties collected on a Subject
Invention with the inventor, including
Federal employee co-inventors (but through
their Agency if the Agency deems it
appropriate) when the Subject Invention is
assigned in accordance with 35 U.S.C. 202(e)
and 37 CFR 401.10;
(3) Use the balance of any royalties or
income earned by the Contractor with respect
to Subject Inventions, after payment of
expenses (including payments to inventors)
incidental to the administration of Subject
Inventions for the support of scientific
research or education;
(4) Make efforts that are reasonable under
the circumstances to attract licensees of
Subject Inventions that are small business
concerns, and give a preference to a small
business concern when licensing a Subject
Invention if the Contractor determines that
the small business concern has a plan or
proposal for marketing the invention which,
if executed, is equally as likely to bring the
invention to practical application as any
plans or proposals from applicants that are
not small business concerns; provided, that
the Contractor is also satisfied that the small
business concern has the capability and
resources to carry out its plan or proposal.
The decision whether to give a preference in
any specific case will be at the discretion of
the Contractor; and
(5) Allow the Secretary of Commerce to
review the Contractor’s licensing program
and decisions regarding small business
applicants, and negotiate changes to its
licensing policies, procedures, or practices
with the Secretary of Commerce when the
Secretary’s review discloses that the
Contractor could take reasonable steps to
more effectively implement the requirements
of paragraph (i)(4) of this clause.
(j) Communications. All invention
disclosures and requests for greater rights
shall be sent to the Agency Contracting
Officer, as directed by the Contracting
Officer. Additionally, a copy of all
disclosures, confirmatory licenses to the
Government, face page of the patent
applications, waivers and other routine
communications under this funding
agreement at all tiers must be sent to:
[Insert Agency Address]
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Agency Invention Reporting Web site:
https://public.era.nih.gov/iedison.
Alternate I (Sept 2014). As prescribed in
327.303, the license to Class 2 inventions
recited in 352.227–11(b)(2)(a) is as follows:
[Insert description of license to Class 2
inventions]
(End of clause)
352.227–14 Rights in Data—Exceptional
Circumstances.
As prescribed in HHSAR 327.409,
insert the following clause with any
appropriate alternates:
Rights in Data—Exceptional
Circumstances (SEPT 2014)
(a) Definitions. As used in this clause—
Definitions may be added or modified in
paragraph (a) as applicable.
Computer database or database means a
collection of recorded information in a form
capable of, and for the purpose of, being
stored in, processed, and operated on by a
computer. The term does not include
computer software.
Computer software—(i) Means (A)
Computer programs that comprise a series of
instructions, rules, routines, or statements,
regardless of the media in which recorded,
that allow or cause a computer to perform a
specific operation or series of operations; and
(B) Recorded information comprising
source code listings, design details,
algorithms, processes, flow charts, formulas,
and related material that would enable the
computer program to be produced, created,
or compiled.
(ii) Does not include computer databases or
computer software documentation.
Computer software documentation means
owner’s manuals, user’s manuals, installation
instructions, operating instructions, and
other similar items, regardless of storage
medium, that explain the capabilities of the
computer software or provide instructions for
using the software.
Data means recorded information,
regardless of form or the media on which it
may be recorded. The term includes
technical data and computer software. The
term does not include information incidental
to contract administration, such as financial,
administrative, cost or pricing, or
management information.
Form, fit, and function data means data
relating to items, components, or processes
that are sufficient to enable physical and
functional interchangeability, and data
identifying source, size, configuration,
mating and attachment characteristics,
functional characteristics, and performance
requirements. For computer software it
means data identifying source, functional
characteristics, and performance
requirements but specifically excludes the
source code, algorithms, processes, formulas,
and flow charts of the software.
Limited rights means the rights of the
Government in limited rights data as set forth
in the Limited Rights Notice in Alternate II
paragraph (g)(3) if included in this clause.
‘‘Limited rights data’’ means data, other than
computer software, that embody trade secrets
or are commercial or financial and
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confidential or privileged, to the extent that
such data pertain to items, components, or
processes developed at private expense,
including minor modifications.
Restricted computer software means
computer software developed at private
expense and that is a trade secret, is
commercial or financial and confidential or
privileged, or is copyrighted computer
software, including minor modifications of
the computer software.
Restricted rights, as used in this clause,
means the rights of the Government in
restricted computer software, as set forth in
a Restricted Rights Notice of Alternate III
paragraph (g)(4) if included in this clause, or
as otherwise may be provided in a collateral
agreement incorporated in and made part of
this contract, including minor modifications
of such computer software.
Technical data means recorded
information (regardless of the form or method
of the recording) of a scientific or technical
nature (including computer databases and
computer software documentation). This
term does not include computer software or
financial, administrative, cost or pricing, or
management data or other information
incidental to contract administration. The
term includes recorded information of a
scientific or technical nature that is included
in computer databases (See 41 U.S.C. 403(8)).
Unlimited rights means the rights of the
Government to use, disclose, reproduce,
prepare derivative works, distribute copies to
the public, and perform publicly and display
publicly, in any manner and for any purpose,
and to have or permit others to do so.
(b) Allocation of rights. (1) Except as
provided in paragraph (c) of this clause, the
Government shall have unlimited rights in—
(i) Data first produced in the performance
of this contract;
(ii) Form, fit, and function data delivered
under this contract;
(iii) Data delivered under this contract
(except for restricted computer software) that
constitute manuals or instructional and
training material for installation, operation,
or routine maintenance and repair of items,
components, or processes delivered or
furnished for use under this contract; and
(iv) All other data delivered under this
contract unless provided otherwise for
limited rights data or restricted computer
software in accordance with paragraph (g) of
this clause.
(2) The Contractor shall have the right to—
(i) Assert copyright in data first produced
in the performance of this contract to the
extent provided in paragraph (c)(1) of this
clause;
(ii) Use, release to others, reproduce,
distribute, or publish any data first produced
or specifically used by the Contractor in the
performance of this contract, unless provided
otherwise in paragraph (d) of this clause;
(iii) Substantiate the use of, add, or correct
limited rights, restricted rights, or copyright
notices and to take other appropriate action,
in accordance with paragraphs (e) and (f) of
this clause; and
(iv) Protect from unauthorized disclosure
and use those data that are limited rights data
or restricted computer software to the extent
provided in paragraph (g) of this clause.
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(c) Copyright—(1) Data first produced in
the performance of this contract. (i) Unless
provided otherwise in paragraph (d) of this
clause, the Contractor may, without prior
approval of the Contracting Officer, assert
copyright in scientific and technical articles
based on or containing data first produced in
the performance of this contract and
published in academic, technical or
professional journals, symposia proceedings,
or similar works. The prior, express written
permission of the Contracting Officer is
required to assert copyright in all other data
first produced in the performance of this
contract.
(ii) When authorized to assert copyright to
the data, the Contractor shall affix the
applicable copyright notices of 17 U.S.C. 401
or 402, and an acknowledgment of
Government sponsorship (including contract
number).
(iii) For data other than computer software,
the Contractor grants to the Government and
others acting on its behalf, a paid-up,
nonexclusive, irrevocable, worldwide license
in such copyrighted data to reproduce,
prepare derivative works, distribute copies to
the public, and perform publicly and display
publicly by or on behalf of the Government.
For computer software, the Contractor grants
to the Government, and others acting on its
behalf, a paid-up, nonexclusive, irrevocable,
worldwide license in such copyrighted
computer software to reproduce, prepare
derivative works, and perform publicly and
display publicly (but not to distribute copies
to the public) by or on behalf of the
Government.
(2) Data not first produced in the
performance of this contract. The Contractor
shall not, without the prior written
permission of the Contracting Officer,
incorporate in data delivered under this
contract any data not first produced in the
performance of this contract unless the
Contractor—
(i) Identifies the data; and
(ii) Grants to the Government, or acquires
on its behalf, a license of the same scope as
set forth in paragraph (c)(1) of this clause or,
if such data are restricted computer software,
the Government shall acquire a copyright
license as set forth in paragraph (g)(4) of this
clause (if included in this contract) or as
otherwise provided in a collateral agreement
incorporated in or made part of this contract.
(3) Removal of copyright notices. The
Government will not remove any authorized
copyright notices placed on data pursuant to
this paragraph (c), and will include such
notices on all reproductions of the data.
(d) Release, publication, and use of data.
The Contractor shall have the right to use,
release to others, reproduce, distribute, or
publish any data first produced or
specifically used by the Contractor in the
performance of this contract, except—
(1) As prohibited by Federal law or
regulation (e.g., export control or national
security laws or regulations);
(2) As expressly set forth in this contract;
or
(3) If the Contractor receives or is given
access to data necessary for the performance
of this contract that contain restrictive
markings, the Contractor shall treat the data
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in accordance with such markings unless
specifically authorized otherwise in writing
by the Contracting Officer or in the following
paragraphs.
(4) In addition to any other provisions, set
forth in this contract, the Contractor shall
ensure that information concerning possible
inventions made under this contract is not
prematurely published thereby adversely
affecting the ability to obtain patent
protection on such inventions. Accordingly,
the Contractor will provide the Contracting
Officer a copy of any publication or other
public disclosure relating to the work
performed under this contract at least 30
days in advance of the disclosure. Upon the
Contracting Officer’s request the Contractor
agrees to delay the public disclosure of such
data or publication of a specified paper for
a reasonable time specified by the
Contracting Officer, not to exceed 6 months,
to allow for the filing of domestic and
international patent applications in
accordance with Clause 352.227–11, Patent
Rights—Exceptional Circumstances
(abbreviated month and year of Final Rule
publication).
(5) Data on Material(s). The Contractor
agrees that in accordance with paragraph
(d)(2), proprietary data on Material(s)
provided to the Contractor under or through
this contract shall be used only for the
purpose for which they were provided,
including screening, evaluation or
optimization and for no other purpose.
(6) Confidentiality. (i) The Contractor shall
take all reasonable precautions to maintain
Confidential Information as confidential, but
no less than the steps Contractor takes to
secure its own confidential information.
(ii) Contractor shall maintain Confidential
Information as confidential unless
specifically authorized otherwise in writing
by the Contracting Officer. Confidential
Information includes/does not include
[Government may define confidential
information here.]
(e) Unauthorized marking of data. (1)
Notwithstanding any other provisions of this
contract concerning inspection or
acceptance, if any data delivered under this
contract are marked with the notices
specified in paragraph (g)(3) or (4) of this
clause (if those alternate paragraphs are
included in this clause), and use of the
notices is not authorized by this clause, or if
the data bears any other restrictive or limiting
markings not authorized by this contract, the
Contracting Officer may cancel or ignore the
markings. However, pursuant to 41 U.S.C.
253d, the following procedures shall apply
prior to canceling or ignoring the markings.
(i) The Contracting Officer will make
written inquiry to the Contractor affording
the Contractor 60 days from receipt of the
inquiry to provide written justification to
substantiate the propriety of the markings;
(ii) If the Contractor fails to respond or fails
to provide written justification to
substantiate the propriety of the markings
within the 60-day period (or a longer time
approved in writing by the Contracting
Officer for good cause shown), the
Government shall have the right to cancel or
ignore the markings at any time after said
period and the data will no longer be made
subject to any disclosure prohibitions.
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(iii) If the Contractor provides written
justification to substantiate the propriety of
the markings within the period set in
paragraph (e)(1)(i) of this clause, the
Contracting Officer will consider such
written justification and determine whether
or not the markings are to be cancelled or
ignored. If the Contracting Officer determines
that the markings are authorized, the
Contractor will be so notified in writing. If
the Contracting Officer determines, with
concurrence of the Head of the Contracting
Activity, that the markings are not
authorized, the Contracting Officer will
furnish the Contractor a written
determination, which determination will
become the final Agency decision regarding
the appropriateness of the markings unless
the Contractor files suit in a court of
competent jurisdiction within 90 days of
receipt of the Contracting Officer’s decision.
The Government will continue to abide by
the markings under this paragraph (e)(1)(iii)
until final resolution of the matter either by
the Contracting Officer’s determination
becoming final (in which instance the
Government will thereafter have the right to
cancel or ignore the markings at any time and
the data will no longer be made subject to
any disclosure prohibitions), or by final
disposition of the matter by court decision if
suit is filed.
(2) The time limits in the procedures set
forth in paragraph (e)(1) of this clause may
be modified in accordance with Agency
regulations implementing the Freedom of
Information Act (5 U.S.C. 552) if necessary to
respond to a request there under.
(3) Except to the extent the Government’s
action occurs as the result of final disposition
of the matter by a court of competent
jurisdiction, the Contractor is not precluded
by this paragraph (e) from bringing a claim,
in accordance with the Disputes clause of
this contract, that may arise as the result of
the Government removing or ignoring
authorized markings on data delivered under
this contract.
(f) Omitted or incorrect markings. (1) Data
delivered to the Government without any
restrictive markings shall be deemed to have
been furnished with unlimited rights. The
Government is not liable for the disclosure,
use, or reproduction of such data.
(2) If the unmarked data has not been
disclosed without restriction outside the
Government, the Contractor may request,
within 6 months (or a longer time approved
by the Contracting Officer in writing for good
cause shown) after delivery of the data,
permission to have authorized notices placed
on the data at the Contractor’s expense. The
Contracting Officer may agree to do so if the
Contractor—
(i) Identifies the data to which the omitted
notice is to be applied;
(ii) Demonstrates that the omission of the
notice was inadvertent;
(iii) Establishes that the proposed notice is
authorized; and
(iv) Acknowledges that the Government
has no liability for the disclosure, use, or
reproduction of any data made prior to the
addition of the notice or resulting from the
omission of the notice.
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(3) If data has been marked with an
incorrect notice, the Contracting Officer
may—
(i) Permit correction of the notice at the
Contractor’s expense if the Contractor
identifies the data and demonstrates that the
correct notice is authorized; or
(ii) Correct any incorrect notices.
(g) Protection of limited rights data and
restricted computer software. (1) The
Contractor may withhold from delivery
qualifying limited rights data or restricted
computer software that are not data
identified in paragraphs (b)(1)(i) through (iii)
of this clause. As a condition to this
withholding, the Contractor shall—
(i) Identify the data being withheld; and
(ii) Furnish form, fit, and function data
instead.
(2) Limited rights data that are formatted as
a computer database for delivery to the
Government shall be treated as limited rights
data and not restricted computer software.
(3) [Reserved]
(h) Subcontracting. The Contractor shall
obtain from its subcontractors all data and
rights therein necessary to fulfill the
Contractor’s obligations to the Government
under this contract. If a subcontractor refuses
to accept terms affording the Government
those rights, the Contractor shall promptly
notify the Contracting Officer of the refusal
and shall not proceed with the subcontract
award without authorization in writing from
the Contracting Officer.
(i) Relationship to patents or other rights.
Nothing contained in this clause shall imply
a license to the Government under any patent
or be construed as affecting the scope of any
license or other right otherwise granted to the
Government.
(End of clause)
Alternate I (Sept 2014). As prescribed
in HHSAR 327.409, substitute the
following definition for ‘‘limited rights
data’’ in paragraph (a) of the basic
clause:
Limited rights data means data, other
than computer software, developed at
private expense that embody trade
secrets or are commercial or financial
and confidential or privileged.
Alternate II (Sept 2014). As prescribed
in HHSAR 327.409, insert the following
paragraph (g)(3) in the basic clause:
(g)(3) Notwithstanding paragraph
(g)(1) of this clause, the contract may
identify and specify the delivery of
limited rights data, or the Contracting
Officer may require by written request
the delivery of limited rights data that
has been withheld or would otherwise
be entitled to be withheld. If delivery of
that data is required, the Contractor
shall affix the following ‘‘Limited Rights
Notice’’ to the data and the Government
will treat the data, subject to the
provisions of paragraphs (e) and (f) of
this clause, in accordance with the
notice:
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Limited Rights Notice (SEPT 2014)
(a) These data are submitted with limited
rights under Government Contract No. ll
(and subcontract ll, if appropriate). These
data may be reproduced and used by the
Government with the express limitation that
they will not, without written permission of
the Contractor, be used for purposes of
manufacture nor disclosed outside the
Government; except that the Government
may disclose these data outside the
Government for the following purposes, if
any; provided that the Government makes
such disclosure subject to prohibition against
further use and disclosure: Agencies may list
additional purposes or if none, so state.
(b) This notice shall be marked on any
reproduction of these data, in whole or in
part.
(End of notice)
Alternate III (Sept 2014). As
prescribed in HHSAR 327.409, insert
the following paragraph (g)(4) in the
basic clause: (g)(4)(i) Notwithstanding
paragraph (g)(1) of this clause, the
contract may identify and specify the
delivery of restricted computer software,
or the Contracting Officer may require
by written request the delivery of
restricted computer software that has
been withheld or would otherwise be
entitled to be withheld. If delivery of
that computer software is required, the
Contractor shall affix the following
‘‘Restricted Rights Notice’’ to the
computer software and the Government
will treat the computer software, subject
to paragraphs (e) and (f) of this clause,
in accordance with the notice:
Restricted Rights Notice (SEPT 2014)
(a) This computer software is submitted
with restricted rights under Government
Contract No. ll (and subcontract ll, if
appropriate). It may not be used, reproduced,
or disclosed by the Government except as
provided in paragraph (b) of this notice or as
otherwise expressly stated in the contract.
(b) This computer software may be—
(1) Used or copied for use with the
computer(s) for which it was acquired,
including use at any Government installation
to which the computer(s) may be transferred;
(2) Used or copied for use with a backup
computer if any computer for which it was
acquired is inoperative;
(3) Reproduced for safekeeping (archives)
or backup purposes;
(4) Modified, adapted, or combined with
other computer software, provided that the
modified, adapted, or combined portions of
the derivative software incorporating any of
the delivered, restricted computer software
shall be subject to the same restricted rights;
(5) Disclosed to and reproduced for use by
support service Contractors or their
subcontractors in accordance with
paragraphs (b)(1) through (4) of this notice;
and
(6) Used or copied for use with a
replacement computer.
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(c) Notwithstanding the foregoing, if this
computer software is copyrighted computer
software, it is licensed to the Government
with the minimum rights set forth in
paragraph (b) of this notice.
(d) Any other rights or limitations
regarding the use, duplication, or disclosure
of this computer software are to be expressly
stated in, or incorporated in, the contract.
(e) This notice shall be marked on any
reproduction of this computer software, in
whole or in part.
(End of notice)
(ii) Where it is impractical to include
the Restricted Rights Notice on
restricted computer software, the
following short-form notice may be used
instead:
Restricted Rights Notice Short Form
(SEPT 2014)
Use, reproduction, or disclosure is subject
to restrictions set forth in Contract No. __
(and subcontract, if appropriate) with __
(name of Contractor and subcontractor).
(End of notice)
(iii) If restricted computer software is
delivered with the copyright notice of
17 U.S.C. 401, it will be presumed to be
licensed to the Government without
disclosure prohibitions, with the
minimum rights set forth in paragraph
(b) of this clause.
Alternate IV Sept 2014). As prescribed in
HHSAR 327.409, substitute the following
paragraph (c)(1) for paragraph (c)(1) of the
basic clause:
(c) Copyright—(1) Data first produced in
the performance of the contract. Except as
otherwise specifically provided in this
contract, the Contractor may assert copyright
in any data first produced in the performance
of this contract. When asserting copyright,
the Contractor shall affix the applicable
copyright notice of 17 U.S.C. 401 or 402, and
an acknowledgment of Government
sponsorship (including contract number), to
the data when such data are delivered to the
Government, as well as when the data are
published or deposited for registration as a
published work in the U.S. Copyright Office.
For data other than computer software, the
Contractor grants to the Government, and
others acting on its behalf, a paid-up,
nonexclusive, irrevocable, worldwide license
for all such data to reproduce, prepare
derivative works, distribute copies to the
public, and perform publicly and display
publicly, by or on behalf of the Government.
For computer software, the Contractor grants
to the Government and others acting on its
behalf, a paid-up, nonexclusive, irrevocable,
worldwide license for all such computer
software to reproduce, prepare derivative
works, and perform publicly and display
publicly (but not to distribute copies to the
public), by or on behalf of the Government.
Alternate V (Sept 2014). As prescribed in
HHSAR 327.409, add the following
paragraph (j) to the basic clause:
(j) The Contractor agrees, except as may be
otherwise specified in this contract for
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As prescribed in HHSAR 327.404–70,
the Contracting Officer shall insert the
following clause:
outside of duties to the Contractor. Direct
salary also excludes fringe benefits,
overhead, and general and administrative
expenses (also referred to as indirect costs or
facilities and administrative costs). The
salary rate limitation does not restrict the
salary that an organization may pay an
individual working under a Department of
Health and Human Services contract or
order; it merely limits the portion of that
salary that may be paid with contract funds.
(c) The salary rate limitation also applies
to individuals under subcontracts.
(d) If this is a multiple-year contract or
order, it may be subject to unilateral
modification by the Contracting Officer to
ensure that an individual is not paid at a rate
that exceeds the salary rate limitation
provision established in the HHS
appropriations act used to fund this contract.
(e) See the salaries and wages pay tables on
the Office of Personnel Management Web site
for Federal Executive Schedule salary levels.
Publications and Publicity (DEC 2015)
(End of clause)
(a) Unless otherwise specified in this
contract, the Contractor may publish the
results of its work under this contract. The
Contractor shall promptly send a copy of
each article submitted for publication to the
Contracting Officer’s Representative. The
Contractor shall also inform the Contracting
Officer’s Representative when the article or
other publication is published, and furnish a
copy of it as finally published.
(b) Unless authorized in writing by the
Contracting Officer, the Contractor shall not
display the HHS logo including Operating
Division or Staff Division logos on any
publications.
(c) The Contractor shall not reference the
product(s) or service(s) awarded under this
contract in commercial advertising, as
defined in FAR 31.205–1, in any manner
which states or implies HHS approval or
endorsement of the product(s) or service(s)
provided.
(d) The contractor shall include this clause,
including this section (d) in all subcontracts
where the subcontractor may propose
publishing the results of its work under the
subcontract.
352.232–70
(End of clause)
(End of provision)
352.231–70
352.233–70
specific data deliverables listed as not subject
to this paragraph, that the Contracting Officer
may, up to 3 years after acceptance of all
deliverables under this contract, inspect at
the Contractor’s facility any data withheld
pursuant to paragraph (g)(1) of this clause, for
purposes of verifying the Contractor’s
assertion of limited rights or restricted rights
status of the data or for evaluating work
performance. When the Contractor whose
data are to be inspected demonstrates to the
Contracting Officer that there would be a
possible conflict of interest if a particular
representative made the inspection, the
Contracting Officer shall designate an
alternate inspector.
(End of clause)
352.227–70
Publications and Publicity.
Salary Rate Limitation.
Incremental Funding.
As prescribed in HHSAR 332.706–
2(b), the Contracting Officer shall insert
the provision provided below in all
solicitations when a cost-reimbursement
contract for severable services using
incremental funding is contemplated.
Incremental Funding (DEC 2015)
The Government intends to negotiate and
award a cost-reimbursement contract using
incremental funding as described in the
clause at FAR 52.232–22, ‘‘Limitation of
Funds’’. The initial obligation of funds under
the contract is expected to cover [insert the
appropriate increment of performance]. The
Government intends to obligate additional
funds up to and including the full estimated
cost of the contract for the remaining periods
of performance by unilateral contract
modification. However, the Government is
not required to reimburse the Contractor for
costs incurred in excess of the total amount
obligated, nor is the Contractor required to
perform beyond the level supported by the
total amount obligated.
Choice of Law (Overseas).
As prescribed in HHSAR 333.215–
70(a), the Contracting Officer shall
insert the following clause:
Salary Rate Limitation (DEC 2015)
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As prescribed in HHSAR 331.101–
70(b), the Contracting Officer shall
insert the following clause:
Choice of Law (Overseas) (DEC 2015)
(a) The Contractor shall not use contract
funds to pay the direct salary of an
individual at a rate in excess of the Federal
Executive Schedule Level II in effect on the
date the funding was obligated.
(b) For purposes of the salary rate
limitation, the terms ‘‘direct salary,’’
‘‘salary,’’ and ‘‘institutional base salary,’’
have the same meaning and are collectively
referred to as ‘‘direct salary,’’ in this clause.
An individual’s direct salary is the annual
compensation that the Contractor pays for an
individual’s direct effort (costs) under the
contract. Direct salary excludes any income
that an individual may be permitted to earn
This contract shall be construed in
accordance with the substantive laws of the
United States of America. By the execution
of this contract, the Contractor expressly
agrees to waive any rights to invoke the
jurisdiction of local national courts where
this contract is performed and agrees to
accept the exclusive jurisdiction of the
United States Civilian Board of Contract
Appeals or the United States Court of Federal
Claims for hearing and determination of any
and all disputes that may arise under the
Disputes clause of this contract.
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(End of clause)
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352.233–71
Litigation and Claims.
As prescribed in HHSAR 333.215–
70(b), the Contracting Officer shall
insert the following clause:
Litigation and Claims (Dec 2015)
(a) The Contractor shall provide written
notification immediately to the Contracting
Officer of any action, including any
proceeding before an administrative agency,
filed against the Contractor arising out of the
performance of this contract, including, but
not limited to the performance of any
subcontract hereunder; and any claim against
the Contractor the cost and expense of which
is allowable under the clause entitled
‘‘Allowable Cost and Payment.’’
(b) Except as otherwise directed by the
Contracting Officer, the Contractor shall
furnish immediately to the Contracting
Officer copies of all pertinent documents
received by the Contractor with respect to
such action or claim. To the extent not in
conflict with any applicable policy of
insurance, the Contractor may, with the
Contracting Officer’s approval, settle any
such action or claim. If required by the
Contracting Officer, the Contractor shall
effect an assignment and subrogation in favor
of the Government of all the Contractor’s
rights and claims (except those against the
Government) arising out of any such action
or claim against the Contractor; and authorize
representatives of the Government to settle or
defend any such action or claim and to
represent the Contractor in, or to take charge
of, any action.
(c) If the Government undertakes a
settlement or defense of an action or claim,
the Contractor shall furnish all reasonable
assistance in effecting a settlement or
asserting a defense. Where an action against
the Contractor is not covered by a policy of
insurance, the Contractor shall, with the
approval of the Contracting Officer, proceed
with the defense of the action in good faith.
The Government shall not be liable for the
expense of defending any action or for any
costs resulting from the loss thereof to the
extent that the Contractor would have been
compensated by insurance which was
required by other terms or conditions of this
contract, by law or regulation, or by written
direction of the Contracting Officer, but
which the Contractor failed to secure through
its own fault or negligence. In any event,
unless otherwise expressly provided in this
contract, the Government shall not reimburse
or indemnify the Contractor for any liability
loss, cost, or expense, which the Contractor
may incur or be subject to by reason of any
loss, injury or damage, to the person or to
real or personal property of any third parties
as may accrue during, or arise from, the
performance of this contract.
(End of clause)
352.236–70
Design-Build Contracts.
As prescribed in HHSAR 336.570(a),
the Contracting Officer shall insert the
following clause:
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Design-Build Contracts (Dec 2015)
(a) General. (1) The contract constitutes
and defines the entire agreement between the
Contractor and the Government. This
contract includes the standard or special
contract clauses and schedules included at
the time of award. This contract incorporates
by reference:
(i) The solicitation in its entirety (with the
exception of instructions to offerors and
evaluation criteria which do not become part
of the award document);
(ii) The specifications and statement of
work;
(iii) All drawings, cuts and illustrations,
included in the solicitation and any
amendments during all proposal phases
leading up to award;
(iv) Exhibits and other attachments; and
(v) The successful Offeror’s accepted
proposal.
(2) In the event of conflict or inconsistency
between any of the requirements of the
various portions of this contract, precedence
shall be given in the following order:
(i) Betterments: Any portions of the
Offeror’s proposal which exceed the
requirements of the solicitation and which go
beyond repair and improve the value of the
property.
(ii) The contract clauses and schedules
included during the solicitation or at the time
of award.
(iii) All requirements (other than
betterments) of the accepted proposal.
(iv) Any design products, including but not
limited to plans, specifications, engineering
studies and analyses, shop drawings,
equipment installation drawings, etc. These
are ‘‘deliverables’’ under the contract and are
not part of the contract itself.
(3) Design products must conform to all
requirements of the contract, in the order of
precedence stated here.
(b) Responsibility of the contractor for
design. (1) The Contractor shall be
responsible for the professional quality,
technical accuracy, and the coordination of
all designs, drawings, specifications, and
other non-construction services furnished by
the Contractor under this contract. The
Contractor shall, without additional
compensation, correct or revise any errors or
deficiency in its designs, drawings,
specifications, and other non-construction
services and perform any necessary rework or
modifications, including any damage to real
or personal property, resulting from the
design error or omission.
(2) Neither the Government’s review,
approval or acceptance of, nor payment for,
the services required under this contract
shall be construed to operate as a waiver of
any rights under this contract or of any cause
of action arising out of the performance of
this contract. The Contractor shall be and
remain liable to the Government in
accordance with applicable law for all
damages to the Government caused by the
Contractor’s negligent performance of any of
these services furnished under this contract.
(3) The rights and remedies of the
Government provided for under this contract
are in addition to any other rights and
remedies provided by law.
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(4) If the Contractor is comprised of more
than one legal entity each such entity shall
be jointly and severally liable with respect to
all rights and remedies of the Government.
(c) Sequence of design—construction. (1)
After receipt of the Contract Award, the
Contractor shall initiate design, comply with
all design submission requirements, and
obtain Government review of each
submission. No construction may be started
until the Government reviews the Final
Design submission and determines it
satisfactory for purposes of beginning
construction. The Contracting Officer will
notify the Contractor when the design is
cleared for construction. The Government
will not grant any time extension for any
design resubmittal required when, in the
opinion of the Contracting Officer, the initial
submission failed to meet the minimum
quality requirements as set forth in the
Contract.
(2) If the Government allows the Contractor
to proceed with limited construction based
on pending minor revisions to the reviewed
Final Design submission, no payment will be
made for any completed or in-progress
construction related to the pending revisions
until they are completed, resubmitted, and
are satisfactory to the Government.
(3) No payment will be made for any
completed or in-progress construction until
all required submittals have been made,
reviewed, and are satisfactory to the
Government.
(d) Constructor’s role during design. The
Contractor’s construction management key
personnel shall be actively involved during
the design process to effectively integrate the
design and construction requirements of this
contract. In addition to the typical required
construction activities, the constructor’s
involvement includes, but is not limited to
actions such as: integrating the design
schedule into the Master Schedule to
maximize the effectiveness of fast-tracking
design and construction (within the limits, if
any, allowed in the contract), ensuring
constructability and economy of the design,
integrating the shop drawing and installation
drawing process into the design, executing
the material and equipment acquisition
programs to meet critical schedules,
effectively interfacing the construction
Quality Control (QC) program with the
design QC program, and maintaining and
providing the design team with accurate, upto-date redline and as-built documentation.
The Contractor shall require and manage the
active involvement of key trade
subcontractors in the above activities.
(e) Preconstruction conference. (1) A
preconstruction conference will be arranged
by the Contracting Officer after award of
contract and before commencement of work.
The Contracting Officer or designated
representative will notify the Contractor of
the time, date, and location for the meeting.
At this conference, the Contractor shall be
oriented with respect to Government
procedures and line of authority, contractual,
administrative, and construction matters.
(2) The Contractor shall bring to this
conference, in completed form, a Certificate
of Insurance, plus the following items in
either completed or draft form:
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(i) Accident Prevention Plan;
(ii) Quality Control Plan;
(iii) Letter Appointing Superintendent;
(iv) Transmittal Register;
(v) Power of Attorney and Certified Copy
of Resolution;
(vi) Network Analysis System, (when
identified in the contract schedule as
applicable);
(vii) List of Subcontractors;
(viii) SF 1413;
(ix) Performance and Payment Bonds; and
(x) Schedule of Values.
(3) A letter of record will be written
documenting all items discussed at the
conference, and a copy will be furnished by
the Contracting Officer to all in attendance.
(f) Payment for design under fixed-price
design-build contracts. (1) The Contracting
Officer may approve progress payments for
work performed during the project design
phase up to the maximum amount of ll
(Contracting Officer to insert percent figure.
If none stated, the amount is four (4) percent)
percent of the contract price.
(2) Contractor invoices for payment must
be accompanied by satisfactory
documentation supporting the amounts for
which payments are requested. Progress
payments approved by the Contracting
Officer during the project design phase in no
way constitute an acceptance of functional
and aesthetic design elements nor acceptance
of a final settlement amount in the event of
a buy-out nor a waiver of any contractual
requirements.
(g) Unscheduled jobsite shutdowns. Due to
security reasons during the life of this
contract the Government may on an
unscheduled basis require the contractor to
shut down its jobsite for 2 days per year at
no additional cost. This shall not constitute
a suspension of work under FAR 52.242–14,
Suspension of Work
(End of clause)
Alternate I (DEC 2015).
When Fast Track procedures are being
used, replace paragraph (c) of the basic
clause with the following:
(c) Sequence of design build. (1) After
receipt of the Contract Award the Contractor
shall initiate design, comply with all design
submissions requirements and obtain
Government review of each submission. The
contractor may begin construction on
portions of the work for which the
Government has reviewed the final design
submission and has determined satisfactory
for purposes of beginning construction. The
Contracting Officer will notify the Contractor
when the design is cleared for construction.
The Government will not grant any time
extension for any design resubmittal required
when, in the opinion of the Contracting
Officer, the initial submission failed to meet
the minimum quality requirements as set
forth in the Contract.
(2) If the Government allows the Contractor
to proceed with the construction based on
pending minor revisions to the reviewed
Final Design submission, no payment will be
made for any in-place construction related to
the pending revisions until they are
completed, resubmitted, and are satisfactory
to the Government.
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(3) No payment will be made for any inplace construction until all required
submittals have been made, reviewed, and
are satisfactory to the Government.
(End of clause)
352.237–70
Pro-Children Act.
As prescribed in HHSAR
337.103(d)(1), the Contracting Officer
shall insert the following clause:
Pro-Children Act (DEC 2015)
(a) Public Law 103–227, Title X, Part C,
also known as the Pro-Children Act of 1994
(Act), 20 U.S.C. 7183, imposes restrictions on
smoking in facilities where certain federally
funded children’s services are provided. The
Act prohibits smoking within any indoor
facility (or portion thereof), whether owned,
leased, or contracted for, that is used for the
routine or regular provision of: (i)
Kindergarten, elementary, or secondary
education or library services or (ii) health or
day care services that are provided to
children under the age of 18. The statutory
prohibition also applies to indoor facilities
that are constructed, operated, or maintained
with Federal funds.
(b) By acceptance of this contract or order,
the Contractor agrees to comply with the
requirements of the Act. The Act also applies
to all subcontracts awarded under this
contract for the specified children’s services.
Accordingly, the Contractor shall ensure that
each of its employees, and any subcontractor
staff, is made aware of, understands, and
complies with the provisions of the Act.
Failure to comply with the Act may result in
the imposition of a civil monetary penalty in
an amount not to exceed $1,000 for each
violation and/or the imposition of an
administrative compliance order on the
responsible entity. Each day a violation
continues constitutes a separate violation.
352.237–71 Crime Control Act—Reporting
of Child Abuse.
As prescribed in HHSAR
337.103(d)(2), the Contracting Officer
shall insert the following clause:
asabaliauskas on DSK5VPTVN1PROD with RULES
Crime Control Act of 1990—Reporting
of Child Abuse (DEC 2015)
(a) Public Law 101–647, also known as the
Crime Control Act of 1990 (Act), imposes
responsibilities on certain individuals who,
while engaged in a professional capacity or
activity, as defined in the Act, on Federal
land or in a federally-operated (or contracted)
facility, learn of facts that give the individual
reason to suspect that a child has suffered an
incident of child abuse.
(b) The Act designates ‘‘covered
professionals’’ as those persons engaged in
professions and activities in eight different
categories including, but not limited to,
teachers, social workers, physicians, dentists,
medical residents or interns, hospital
personnel and administrators, nurses, health
care practitioners, chiropractors, osteopaths,
pharmacists, optometrists, podiatrists,
emergency medical technicians, ambulance
drivers, alcohol or drug treatment personnel,
psychologists, psychiatrists, mental health
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professionals, child care workers and
administrators, and commercial film and
photo processors. The Act defines the term
‘‘child abuse’’ as the physical or mental
injury, sexual abuse or exploitation, or
negligent treatment of a child.
(c) Accordingly, any person engaged in a
covered profession or activity under an HHS
contract or subcontract, regardless of the
purpose of the contract or subcontract, shall
immediately report a suspected child abuse
incident in accordance with the provisions of
the Act. If a child is suspected of being
harmed, the appropriate State Child Abuse
Hotline, local child protective services (CPS),
or law enforcement agency shall be
contacted. For more information about where
and how to file a report, the Childhelp USA,
National Child Abuse Hotline (1–800–4–A–
CHILD) shall be called. Any covered
professional failing to make a timely report
of such incident shall be guilty of a Class B
misdemeanor.
(d) By acceptance of this contract or order,
the Contractor agrees to comply with the
requirements of the Act. The Act also applies
to all applicable subcontracts awarded under
this contract. Accordingly, the Contractor
shall ensure that each of its employees, and
any subcontractor staff, is made aware of,
understands, and complies with the
provisions of the Act.
(End of clause)
352.237–72 Crime Control Act—
Requirement for Background Checks.
As prescribed in HHSAR
337.103(d)(3), the Contracting Officer
shall insert the following clause:
Crime Control Act of 1990—
Requirement for Background Checks
(DEC 2015)
(a) Public Law 101–647, also known as the
Crime Control Act of 1990 (Act), requires that
all individuals involved with the provision of
child care services to children under the age
of 18 undergo a criminal background check.
‘‘Child care services’’ include, but are not
limited to, social services, health and mental
health care, child (day) care, education
(whether or not directly involved in
teaching), and rehabilitative programs. Any
conviction for a sex crime, an offense
involving a child victim, or a drug felony,
may be grounds for denying employment or
for dismissal of an employee providing any
of the services listed above.
(b) The Contracting Officer will provide the
necessary information to the Contractor
regarding the process for obtaining the
background check. The Contractor may hire
a staff person provisionally prior to the
completion of a background check, if at all
times prior to the receipt of the background
check during which children are in the care
of the newly-hired person, the person is
within the sight and under the supervision of
a previously investigated staff person.
(c) By acceptance of this contract or order,
the Contractor agrees to comply with the
requirements of the Act. The Act also applies
to all applicable subcontracts awarded under
this contract. Accordingly, the Contractor
shall ensure that each of its employees, and
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any subcontractor staff, is made aware of,
understands, and complies with the
provisions of the Act.
(End of clause)
352.237–73 Indian Child Protection and
Family Violence Act.
As prescribed in HHSAR
337.103(d)(4) the Contracting Officer
shall insert the following clause:
Indian Child Protection and Family
Violence Act (DEC 2015)
(a) This contract is subject to the Indian
Child Protection and Family Violence Act,
Public Law 101–630 (25 U.S.C. 3201 et seq.)
The duties and responsibilities required by
this contract may involve regular contact
with or control over Indian children. Public
Law 101–630 prohibits employment,
including Personal Service Contracts, with
anyone who has been convicted of any crime
of violence. Any such conviction should
immediately be brought to the attention of
the Contracting Officer. The contractor will
be subject to a character investigation,
conducted by the Indian Health Service,
Office of Human Resources. Until such time
as the contractor has been notified of
completion of the investigation, the
contractor shall have no unsupervised
contact with Indian children. In order to
initiate this background investigation, the
contractor must provide information as
required in this contract or as directed by the
Contracting Officer.
(b) As a prerequisite to providing services
under this contract, the Contractor is
required to complete and sign the declaration
found in Section J of this contract.
(End of clause)
352.237–74
Delivery.
Non-Discrimination in Service
As prescribed in HHSAR 337.103(e),
the Contracting Officer shall insert the
following clause in solicitations and
contracts:
Non-Discrimination In Service Delivery
(DEC 2015)
It is the policy of the Department of Health
and Human Services that no person
otherwise eligible will be excluded from
participation in, denied the benefits of, or
subjected to discrimination in the
administration of HHS programs and services
based on non-merit factors such as race,
color, national origin, religion, sex, gender
identity, sexual orientation, or disability
(physical or mental). By acceptance of this
contract, the contractor agrees to comply
with this policy in supporting the program
and in performing the services called for
under this contract. The contractor shall
include this clause in all sub-contracts
awarded under this contract for supporting or
performing the specified program and
services. Accordingly, the contractor shall
ensure that each of its employees, and any
sub-contractor staff, is made aware of,
understands, and complies with this policy.
(End of clause)
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352.237–75
Key Personnel.
As prescribed in HHSAR 337.103(f),
the Contracting Officer shall insert the
following clause:
Key Personnel (DEC 2015)
The key personnel specified in this
contract are considered to be essential to
work performance. At least 30 days prior to
the contractor voluntarily diverting any of
the specified individuals to other programs
or contracts the Contractor shall notify the
Contracting Officer and shall submit a
justification for the diversion or replacement
and a request to replace the individual. The
request must identify the proposed
replacement and provide an explanation of
how the replacement’s skills, experience, and
credentials meet or exceed the requirements
of the contract (including, when applicable,
Human Subjects Testing requirements). If the
employee of the contractor is terminated for
cause or separates from the contractor
voluntarily with less than thirty days notice,
the Contractor shall provide the maximum
notice practicable under the circumstances.
The Contractor shall not divert, replace, or
announce any such change to key personnel
without the written consent of the
Contracting Officer. The contract will be
modified to add or delete key personnel as
necessary to reflect the agreement of the
parties.
(End of clause)
352.239–73 Electronic Information and
Technology Accessibility Notice.
(a) As prescribed in HHSAR 339.203–
70(a), the Contracting Officer shall
insert the following provision:
asabaliauskas on DSK5VPTVN1PROD with RULES
Electronic and Information Technology
Accessibility Notice (Dec 2015)
(a) Section 508 of the Rehabilitation Act of
1973 (29 U.S.C. 794d), as amended by the
Workforce Investment Act of 1998 and the
Architectural and Transportation Barriers
Compliance Board Electronic and
Information (EIT) Accessibility Standards (36
CFR part 1194), require that when Federal
agencies develop, procure, maintain, or use
electronic and information technology,
Federal employees with disabilities have
access to and use of information and data
that is comparable to the access and use by
Federal employees who are not individuals
with disabilities, unless an undue burden
would be imposed on the agency. Section
508 also requires that individuals with
disabilities, who are members of the public
seeking information or services from a
Federal agency, have access to and use of
information and data that is comparable to
that provided to the public who are not
individuals with disabilities, unless an
undue burden would be imposed on the
agency.
(b) Accordingly, any offeror responding to
this solicitation must comply with
established HHS EIT accessibility standards.
Information about Section 508 is available at
https://www.hhs.gov/web/508. The complete
text of the Section 508 Final Provisions can
be accessed at https://www.access-board.gov/
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guidelines-and-standards/communicationsand-it/about-the-section-508-standards.
(c) The Section 508 accessibility standards
applicable to this solicitation are stated in the
clause at 352.239–74, Electronic and
Information Technology Accessibility.
In order to facilitate the Government’s
determination whether proposed EIT
supplies meet applicable Section 508
accessibility standards, offerors must submit
an HHS Section 508 Product Assessment
Template, in accordance with its completion
instructions. The purpose of the template is
to assist HHS acquisition and program
officials in determining whether proposed
EIT supplies conform to applicable Section
508 accessibility standards. The template
allows offerors or developers to self-evaluate
their supplies and document—in detail—
whether they conform to a specific Section
508 accessibility standard, and any underway
remediation efforts addressing conformance
issues. Instructions for preparing the HHS
Section 508 Evaluation Template are
available under Section 508 policy on the
HHS Web site https://www.hhs.gov/web/508.
In order to facilitate the Government’s
determination whether proposed EIT services
meet applicable Section 508 accessibility
standards, offerors must provide enough
information to assist the Government in
determining that the EIT services conform to
Section 508 accessibility standards,
including any underway remediation efforts
addressing conformance issues.
(d) Respondents to this solicitation must
identify any exception to Section 508
requirements. If a offeror claims its supplies
or services meet applicable Section 508
accessibility standards, and it is later
determined by the Government, i.e., after
award of a contract or order, that supplies or
services delivered do not conform to the
described accessibility standards,
remediation of the supplies or services to the
level of conformance specified in the contract
will be the responsibility of the Contractor at
its expense.
(End of provision)
352.239–74 Electronic and Information
Technology Accessibility.
As prescribed in HHSAR 339.203–
70(b), insert the following clause:
Electronic and Information Technology
Accessibility (DEC 2015)
(a) Pursuant to Section 508 of the
Rehabilitation Act of 1973 (29 U.S.C. 794d),
as amended by the Workforce Investment Act
of 1998, all electronic and information
technology (EIT) supplies and services
developed, acquired, or maintained under
this contract or order must comply with the
‘‘Architectural and Transportation Barriers
Compliance Board Electronic and
Information Technology (EIT) Accessibility
Standards’’ set forth by the Architectural and
Transportation Barriers Compliance Board
(also referred to as the ‘‘Access Board’’) in 36
CFR part 1194. Information about Section
508 is available at https://www.hhs.gov/web/
508. The complete text of Section 508 Final
Provisions can be accessed at https://
www.access-board.gov/guidelines-and-
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Sfmt 4700
72183
standards/communications-and-it/about-thesection-508-standards.
(b) The Section 508 accessibility standards
applicable to this contract or order are
identified in the Statement of Work or
Specification or Performance Work
Statement. The contractor must provide any
necessary updates to the submitted HHS
Product Assessment Template(s) at the end of
each contract or order exceeding the
simplified acquisition threshold (see FAR
2.101) when the contract or order duration is
one year or less. If it is determined by the
Government that EIT supplies and services
provided by the Contractor do not conform
to the described accessibility standards in the
contract, remediation of the supplies or
services to the level of conformance specified
in the contract will be the responsibility of
the Contractor at its own expense.
(c) The Section 508 accessibility standards
applicable to this contract are:
lllllllllllllllllllll
(Contract staff must list applicable standards)
(d) In the event of a modification(s) to this
contract or order, which adds new EIT
supplies or services or revises the type of, or
specifications for, supplies or services, the
Contracting Officer may require that the
contractor submit a completed HHS Section
508 Product Assessment Template and any
other additional information necessary to
assist the Government in determining that
the EIT supplies or services conform to
Section 508 accessibility standards.
Instructions for documenting accessibility via
the HHS Section 508 Product Assessment
Template may be found under Section 508
policy on the HHS Web site: (https://
www.hhs.gov/web/508). If it is determined by
the Government that EIT supplies and
services provided by the Contractor do not
conform to the described accessibility
standards in the contract, remediation of the
supplies or services to the level of
conformance specified in the contract will be
the responsibility of the Contractor at its own
expense.
(e) If this is an Indefinite Delivery contract,
a Blanket Purchase Agreement or a Basic
Ordering Agreement, the task/delivery order
requests that include EIT supplies or services
will define the specifications and
accessibility standards for the order. In those
cases, the Contractor may be required to
provide a completed HHS Section 508
Product Assessment Template and any other
additional information necessary to assist the
Government in determining that the EIT
supplies or services conform to Section 508
accessibility standards. Instructions for
documenting accessibility via the HHS
Section 508 Product Assessment Template
may be found at https://www.hhs.gov/web/
508. If it is determined by the Government
that EIT supplies and services provided by
the Contractor do not conform to the
described accessibility standards in the
provided documentation, remediation of the
supplies or services to the level of
conformance specified in the contract will be
the responsibility of the Contractor at its own
expense.
(End of clause)
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352.270–1
[Reserved]
352.270–2
[Reserved]
352.270–3
[Reserved]
352.270–4a Notice to Offerors, Protection
of Human Subjects.
As prescribed in HHSAR 370.303(a),
the Contracting Officer shall insert the
following provision:
asabaliauskas on DSK5VPTVN1PROD with RULES
Notice to Offerors, Protection of Human
Subjects (DEC 2015)
(a) The Department of Health and Human
Services (HHS) regulations for the protection
of human subjects, 45 CFR part 46, are
available on the Office for Human Research
Protections (OHRP) Web site at: https://
www.hhs.gov/ohrp/.
These regulations provide a systematic
means, based on established ethical
principles, to safeguard the rights and
welfare of human subjects participating in
research activities supported or conducted by
HHS.
(b) The regulations define a human subject
as a living individual about whom an
investigator (whether professional or student)
conducting research obtains data or
identifiable public information through
intervention or interaction with the
individual, or identifiable private
information. In most cases, the regulations
extend to the use of human organs, tissue,
and body fluids from individually
identifiable human subjects as well as to
graphic, written, or recorded information
derived from individually identifiable human
subjects. 45 CFR part 46 does not directly
regulate the use of autopsy materials; instead,
applicable state and local laws govern their
use.
(c) Activities which involve human
subjects in one or more of the categories set
forth in 45 CFR 46.101(b)(1)–(6) are exempt
from complying with 45 CFR part 46. See
https://www.hhs.gov/ohrp/humansubjects/
guidance/45cfr46.html.
(d) Inappropriate designations of the
noninvolvement of human subjects or of
exempt categories of research in a project
may result in delays in the review of a
proposal.
(e) In accordance with 45 CFR part 46,
offerors considered for award shall file an
acceptable Federal-wide Assurance (FWA) of
compliance with OHRP specifying review
procedures and assigning responsibilities for
the protection of human subjects. The FWA
is the only type of assurance that OHRP
accepts or approves. The initial and
continuing review of a research project by an
institutional review board shall ensure that:
The risks to subjects are minimized; risks to
subjects are reasonable in relation to
anticipated benefits, if any, to subjects, and
the importance of the knowledge that may
reasonably be expected to result; selection of
subjects is equitable; and informed consent
will be obtained and documented by
methods that are adequate and appropriate.
Depending on the nature of the research,
additional requirements may apply; see
https://www.hhs.gov/ohrp/humansubjects/
guidance/45cfr46.html#46.111 for additional
VerDate Sep<11>2014
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requirements regarding initial and continuing
review. HHS regulations for the protection of
human subjects (45 CFR part 46), information
regarding OHRP registration and assurance
requirements/processes, and OHRP contact
information is available at the OHRP Web
site (at https://www.hhs.gov/ohrp/assurances/
index.html).
(f) Offerors may consult with OHRP only
for general advice or guidance concerning
either regulatory requirements or ethical
issues pertaining to research involving
human subjects. ONLY the contracting officer
may offer information concerning a
solicitation.
(g) The offeror shall document in its
proposal the approved FWA from OHRP,
related to the designated Institutional Review
Board (IRB) reviewing and overseeing the
research. If the offeror does not have an
approved FWA from OHRP, the offeror must
obtain an FWA before the deadline for
proposal submission. When possible, the
offeror shall also certify the IRB’s review and
approval of the research. If the offeror cannot
obtain this certification by the time of
proposal submission they must include an
explanation in their proposal. Never conduct
research covered by 45 CFR part 46 prior to
receiving certification of the research’s
review and approval by the IRB.
(End of provision)
Alternate I (DEC 2015).
As prescribed in HHSAR 370.303(a), the
Contracting Officer shall substitute the
following paragraph (g) for paragraph (g) of
the basic clause.
(g) The offeror’s proposal shall document
that it has an approved or active FWA from
OHRP, related to the designated IRB
reviewing and overseeing the research. When
possible the offeror shall also certify the IRB
has reviewed and approved the research. If
the offeror cannot make this certification at
the time of proposal submission, its proposal
must include an explanation. Never conduct
research covered by 45 CFR part 46 prior to
receiving certification of the research’s
review and approval by the IRB.
If the offeror does not have an active FWA
from OHRP, the offeror shall take all
necessary steps to obtain an FWA prior to the
deadline for proposal submission. If the
offeror cannot obtain an FWA before the
proposal submission date, the proposal shall
indicate the steps/actions the offeror will
take to obtain OHRP approval within
(Contracting Officer must insert a time period
in which the FWA must be obtained). Upon
obtaining FWA approval, submit the
approval notice to the Contracting Officer.
352.270–4b
Protection of Human Subjects.
As prescribed in HHSAR 370.304(a),
the Contracting Officer shall insert the
following clause:
Protection of Human Subjects (DEC
2015)
(a) The Contractor agrees that the rights
and welfare of human subjects involved in
research under this contract shall be
protected in accordance with 45 CFR part 46
and with the Contractor’s current Federal-
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Fmt 4701
Sfmt 4700
wide Assurance (FWA) on file with the
Office for Human Research Protections
(OHRP), Department of Health and Human
Services. The Contractor further agrees to
provide certification at least annually that the
Institutional Review Board has reviewed and
approved the procedures, which involve
human subjects in accordance with 45 CFR
part 46 and the Assurance of Compliance.
(b) The Contractor shall bear full
responsibility for the performance of all work
and services involving the use of human
subjects under this contract and shall ensure
that work is conducted in a proper manner
and as safely as is feasible. The parties hereto
agree that the Contractor retains the right to
control and direct the performance of all
work under this contract. Nothing in this
contract shall create an agency or employee
relationship between the Government and
the Contractor, or any subcontractor, agent or
employee of the Contractor, or any other
person, organization, institution, or group of
any kind whatsoever. The Contractor agrees
that it has entered into this contract and will
discharge its obligations, duties, and
undertakings and the work pursuant thereto,
whether requiring professional judgment or
otherwise, as an independent Contractor
without creating liability on the part of the
Government for the acts of the Contractor or
its employees.
(c) Contractors involving other agencies or
institutions in activities considered to be
engaged in research involving human
subjects must ensure that such other agencies
or institutions obtain their own FWA if they
are routinely engaged in research involving
human subjects or ensure that such agencies
or institutions are covered by the Contractors’
FWA via designation as agents of the
institution or via individual investigator
agreements (see OHRP Web site at: https://
www.hhs.gov/ohrp/policy/
guidanceonalternativetofwa.pdf).
(d) If at any time during the performance
of this contract the Contractor is not in
compliance with any of the requirements and
or standards stated in paragraphs (a) and (b)
above, the Contracting Officer may
immediately suspend, in whole or in part,
work and further payments under this
contract until the Contractor corrects the
noncompliance. The Contracting Officer may
communicate the notice of suspension by
telephone with confirmation in writing. If the
Contractor fails to complete corrective action
within the period of time designated in the
Contracting Officer’s written notice of
suspension, the Contracting Officer may,
after consultation with OHRP, terminate this
contract in whole or in part.
(End of clause)
352.270–5a Notice to Offerors of
Requirement for Compliance with the Public
Health Service Policy on Humane Care and
Use of Laboratory Animals.
As prescribed in HHSAR 370.403(a),
the Contracting Officer shall insert the
following provision:
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Notice to Offerors of Requirement for
Compliance with the Public Health
Service Policy on Humane Care and
Use of Laboratory Animals (DEC 2015)
The Public Health Service (PHS) Policy on
Humane Care and Use of Laboratory Animals
(PHS Policy) establishes a number of
requirements for research activities involving
animals. Before awarding a contract to an
offeror, the organization shall file, with the
Office of Laboratory Animal Welfare
(OLAW), National Institutes of Health (NIH),
a written Animal Welfare Assurance
(Assurance) which commits the organization
to comply with the provisions of the PHS
Policy, the Animal Welfare Act, and the
Guide for the Care and Use of Laboratory
Animals (National Academy Press,
Washington, DC). In accordance with the
PHS Policy, offerors must establish an
Institutional Animal Care and Use Committee
(IACUC), qualified through the experience
and expertise of its members, to oversee the
institution’s animal program, facilities, and
procedures. Offerors must provide
verification of IACUC approval prior to
receiving an award involving live vertebrate
animals. No award involving the use of
animals shall be made unless OLAW
approves the Assurance and verification of
IACUC approval for the proposed animal
activities has been provided to the
Contracting Officer. Prior to award, the
Contracting Officer will notify Contractor(s)
selected for projects involving live vertebrate
animals of the Assurance and verification of
IACUC approval requirement. The
Contracting Officer will request that OLAW
negotiate an acceptable Assurance with those
Contractor(s) and request verification of
IACUC approval. For further information,
contact OLAW at NIH, 6705 Rockledge Drive,
RKL1, Suite 360, MSC 7982 Bethesda,
Maryland 20892–7982 (Email: olaw@
od.nih.gov; Phone: 301–496–7163).
(End of provision)
352.270–5b
Animals.
Care of Live Vertebrate
(End of clause)
As prescribed in HHSAR 370.404, the
Contracting Officer shall insert the
following clause:
asabaliauskas on DSK5VPTVN1PROD with RULES
Care of Live Vertebrate Animals (DEC
2015)
(a) Before undertaking performance of any
contract involving animal-related activities
where the species is regulated by the United
Sates Department of Agriculture (USDA), the
Contractor shall register with the Secretary of
Agriculture of the United States in
accordance with 7 U.S.C. 2136 and 9 CFR
2.25 through 2.28. The Contractor shall
furnish evidence of the registration to the
Contracting Officer.
(b) The Contractor shall acquire vertebrate
animals used in research from a dealer
licensed by the Secretary of Agriculture
under 7 U.S.C. 2133 and 9 CFR 2.1–2.11, or
from a source that is exempt from licensing
under those sections.
(c) The Contractor agrees that the care, use,
and intended use of any live vertebrate
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animals in the performance of this contract
shall conform with the Public Health Service
(PHS) Policy on Humane Care of Use of
Laboratory Animals (PHS Policy), the current
Animal Welfare Assurance (Assurance), the
Guide for the Care and Use of Laboratory
Animals (National Academy Press,
Washington, DC) and the pertinent laws and
regulations of the United States Department
of Agriculture (see 7 U.S.C. 2131 et seq. and
9 CFR subchapter A, Parts 1–4). In case of
conflict between standards, the more
stringent standard shall govern.
(d) If at any time during performance of
this contract, the Contracting Officer
determines, in consultation with the Office of
Laboratory Animal Welfare (OLAW),
National Institutes of Health (NIH), that the
Contractor is not in compliance with any of
the requirements and standards stated in
paragraphs (a) through (c) above, the
Contracting Officer may immediately
suspend, in whole or in part, work and
further payments under this contract until
the Contractor corrects the noncompliance.
Notice of the suspension may be
communicated by telephone and confirmed
in writing. If the Contractor fails to complete
corrective action within the period of time
designated in the Contracting Officer’s
written notice of suspension, the Contracting
Officer may, in consultation with OLAW,
NIH, terminate this contract in whole or in
part, and the Contractor’s name may be
removed from the list of those contractors
with Animal Welfare Assurances.
Note: The Contractor may request
registration of its facility and a current listing
of licensed dealers from the Regional Office
of the Animal and Plant Health Inspection
Service (APHIS), USDA, for the region in
which its research facility is located. The
location of the appropriate APHIS Regional
Office, as well as information concerning this
program may be obtained by contacting the
Animal Care Staff, USDA/APHIS, 4700 River
Road, Riverdale, Maryland 20737 (Email:
ace@aphis.usda.gov; Web site: (https://
www.aphis.usda.gov/wps/portal/aphis/
ourfocus/animalwelfare).
19:27 Nov 17, 2015
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352.270–6
Subjects.
Restriction on Use of Human
As prescribed in HHSAR 370–304(b),
the Contracting Officer shall insert the
following clause:
Restriction on Use of Human Subjects
(DEC 2015)
Pursuant to 45 CFR part 46, Protection of
Human Research Subjects, the Contractor
shall not expend funds under this award for
research involving human subjects or engage
in any human subjects research activity prior
to the Contracting Officer’s receipt of a
certification that the research has been
reviewed and approved by the Institutional
Review Board (IRB) registered with OHRP.
This restriction applies to all collaborating
sites, whether domestic or foreign, and
subcontractors. The Contractor must ensure
compliance by collaborators and
subcontractors.
(End of clause)
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352.270–7
[Reserved]
352.270–8
72185
[Reserved]
352.270–9 Non-Discrimination for
Conscience.
As prescribed in HHSAR 370.701, the
Contracting Officer shall insert the
following provision:
Non-Discrimination for Conscience
(DEC 2015)
(a) Section 301(d) of the United States
Leadership Against HIV/AIDS, Tuberculosis,
and Malaria Act, as amended, provides that
an organization, including a faith-based
organization, that is otherwise eligible to
receive assistance under section 104A of the
Foreign Assistance Act of 1961, under the
United States Leadership Against HIV/AIDS,
Tuberculosis, and Malaria Act of 2003, under
the Tom Lantos and Henry J. Hyde United
States Global Leadership Against HIV/AIDS,
Tuberculosis, and Malaria Reauthorization
Act of 2008, or under any amendment to the
foregoing Acts for HIV/AIDS prevention,
treatment, or care—
(1) Shall not be required, as a condition of
receiving such assistance, to—
(i) Endorse or utilize a multisectoral or
comprehensive approach to combating HIV/
AIDS; or
(ii) Endorse, utilize, make a referral to,
become integrated with, or otherwise
participate in any program or activity to
which the organization has a religious or
moral objection.
(2) Shall not be discriminated against
under the provisions of law in subparagraph
(a) for refusing to meet any requirement
described in paragraph (a)(1) in this
solicitation.
(b) Accordingly, an offeror who believes
this solicitation contains work requirements
requiring it endorse or utilize a multisectoral
or comprehensive approach to combating
HIV/AIDS, or endorse, utilize, make referral
to, become integrated with, or otherwise
participate in a program or activity to which
it has a religious or moral objection, shall
identify those work requirements it excluded
in its technical proposal.
(c) The Government acknowledges that an
offeror has specific rights, as cited in
paragraph (b), to exclude certain work
requirements in this solicitation from its
proposal. However, the Government reserves
the right to not make an award to an offeror
whose proposal does not comply with the
salient work requirements of the solicitation.
Any exercise of that Government right will be
made by the Head of the Contracting
Activity.
(End of provision)
352.270–10 Notice to Offerors—Protection
of Human Subjects, Research Involving
Human Subjects Committee (RIHSC)
Approval of Research Protocols Required.
As prescribed in HHSAR 370.303(d),
the Contracting Officer shall insert the
following provision:
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Notice to Offerors—Protection of
Human Subjects, Research Involving
Human Subjects Committee (RIHSC)
Approval of Research Protocols
Required (DEC 2015)
(a) All Offerors proposing research
expected to involve human subjects shall
comply with the regulations set forth in 45
CFR part 46, and with the provisions at
HHSAR 352.270–4a.
(b) The Offeror shall have an acceptable
Assurance of Compliance on file with the
Office for Human Research Protections
(OHRP), whenever it submits a proposal to
the FDA for research expected to involve
human subjects. Direct questions regarding
Federal-wide Assurance to OHRP. The
Offeror’s proposal shall include a copy of the
acceptable Assurance of Compliance.
(c) After the contract has been awarded, the
Contractor shall take the following actions:
(1) The Institutional Review Board (IRB)
specified in the Offeror’s Assurance of
Compliance, hereafter referred to as ‘‘the
local IRB,’’ shall review the proposed
research protocol. A letter from the local IRB
stating that the proposed research protocol
has been reviewed and approved, and thus
adequately protects the rights and welfare of
human subjects involved, or a letter stating
that the proposed research is exempt under
45 CFR 46.101(b) shall be submitted to the
Contracting Officer.
(2) Upon award, the successful Offeror,
hereafter ‘‘the Contractor,’’ shall submit its
proposed research protocol to the FDA’s
Research Involving Human Subjects
Committee (RIHSC). The RIHSC or its
designee will review and approve the
research protocol to assure it adequately
protects the rights and welfare of human
subjects involved. The RIHSC or designee
will also determine whether the proposed
research is exempt under 45 CFR 46.101(b).
The Contractor shall submit, to the
Contracting Officer of record, a copy of the
RIHSC’s or its designee’s letter stating that it
reviewed and approved the proposed
research protocol.
(d) The Contractor shall not advertise for,
recruit, or enroll human subjects, or
otherwise commence any research involving
human subjects until RIHSC or its designee
reviews and approves its research. The
Contractor may begin other limited aspects of
contract performance prior to receiving
RIHSC’s or designee’s approval of the
proposed research protocol. Research
involving human subjects may commence
immediately upon the Contractor’s receipt of
RIHSC’s or designee’s approval; however, the
Contractor shall submit a copy of RIHSC’s or
its designee’s approval to the Contracting
Officer within three business days of its
receipt.
(e) A Contractor’s failure to obtain RIHSC’s
or its designee’s approval of its proposed
research may result in termination of its
contract. However, failure to obtain RIHSC’s
or its designee’s approval during initial
review will not automatically result in
termination of the contract. Instead, the
Contractor may correct any deficiencies
identified during the initial RIHSC or
designee review and resubmit the proposed
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Jkt 238001
research protocol to RIHSC or its designee for
a second review. The Contractor is
encouraged to solicit the RIHSC’s or its
designee’s input during the resubmission
process.
(f) The Contractor shall seek RIHSC’s or its
designee’s and local IRB review and approval
whenever making modifications,
amendments or other changes to the research
protocol. Such modifications, amendments
and changes include, but are not limited to
changes in investigators, informed consent
forms, and recruitment advertisements. The
Contractor may institute changes
immediately after receiving both the local
IRB and RIHSC or its designee approval
(except when necessary to eliminate apparent
immediate hazards to the subject); however,
the Contractor shall submit a copy of the
letter evidencing RIHSC’s or its designee’s
approval of the proposed changes to the
Contracting Officer within three business
days of its receipt.
(End of provision)
352.270–11 Protection of Human
Subjects—Research Involving Human
Subjects Committee (RIHSC) Approval of
Research Protocols Required.
As prescribed in HHSAR 370.304(c),
the Contracting Officer shall insert the
following clause:
Protection of Human Subjects—
Research Involving Human Subjects
Committee (RIHSC) Approval of
Research Protocols Required (DEC
2015)
(a) The Contractor agrees to protect the
rights and welfare of human subjects
involved in research under this contract by
complying with 45 CFR part 46 and the
clause at HHSAR 352.270–4b.
(b) Initial proof of compliance with 45 CFR
part 46 shall consist of:
(1) A copy of a current Federal-wide
Assurance on file with OHRP. The copy of
a current Federal–wide Assurance shall be
included with the Contractor’s proposal;
(2) A letter from the Contractor’s local IRB
(the Institutional Review Board (IRB)
specified in the Offeror’s Assurance of
Compliance) stating that it has reviewed and
approved the proposed research protocol.
The letter from the local IRB shall be
submitted to the Contracting Office; and
(3) A copy of a letter from the RIHSC
stating that it or its designee has reviewed
and approved the proposed research
protocol. This shall be submitted to the
Contracting Officer within three business
days of its issuance.
The Contractor shall not advertise for,
recruit, or enroll human subjects, or
otherwise commence any research involving
human subjects under this contract, until
RIHSC has reviewed and approved its
research. The Contractor may commence
other limited aspects of contract performance
prior to receiving RIHSC or its designee
approval of its proposed research protocol.
Research involving human subjects may
commence immediately upon the
Contractor’s receipt of RIHSC or its designee
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approval; however, the Contractor shall
submit a copy of RIHSC’s or its designee’s
letter of approval to the Contracting Officer
within three business days of its receipt.
Failure to obtain RIHSC or its designee
approval of proposed research protocols may
result in the termination of this contract.
(c) The Contractor further agrees that:
(1) The Contractor will provide a letter
from RIHSC, at least annually, stating that
RIHSC or its designee has reviewed and
approved the research protocols for research
performed under this contract. This shall be
submitted to the Contracting Officer for
inclusion in the contract file.
(2) The Contractor will submit all proposed
modifications and amendments to research
protocols for research performed under this
contract to RIHSC for review and approval.
Modifications and amendments include, but
are not limited, to changes to consent forms
and advertising materials, and the addition or
deletion of investigators. Changes may be
instituted immediately after the Contractor
has received both the local IRB and RIHSC
or its designee approval (except when
necessary to eliminate apparent immediate
hazards to the subject); however the
Contractor shall submit a copy of the letter
evidencing RIHSC’s or its designee’s
approval of the proposed changes to the
Contracting Officer within three business
days of its receipt.
(End of clause)
352.270–12
Needle Exchange.
As prescribed in HHSAR 370.304(d),
the Contracting Officer shall insert the
following clause:
Needle Exchange (DEC 2015)
The Contractor shall not use any funds
obligated under this contract to carry out any
program of distributing sterile needles or
syringes for the hypodermic injection of any
illegal drug.
(End of Clause)
352.270–13 Continued Ban on Funding
Abortion and Continued Ban on Funding of
Human Embryo Research.
As prescribed in HHSAR 370.304(e),
the Contracting Officer shall insert the
following clause:
Continued Ban on Funding Abortion
and Continued Ban on Funding of
Human Embryo Research (DEC 2015)
(a) The Contractor shall not use any funds
obligated under this contract for any
abortion.
(b) The Contractor shall not use any funds
obligated under this contract for the
following:
(1) The creation of a human embryo or
embryos for research purposes; or
(2) Research in which a human embryo or
embryos are destroyed, discarded, or
knowingly subjected to risk of injury of death
greater than that allowed for research on
fetuses in utero under 45 CFR part 46 and
Section 498(b) of the Public Health Service
Act (42 U.S.C. 289g(b)).
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(c) The term ‘‘human embryo or embryos’’
includes any organism, not protected as a
human subject under 45 CFR part 46 as of the
date of the enactment of this Act, that is
derived by fertilization, parthenogenesis,
cloning, or any other means from one or more
human gametes of human diploid cells.
(d) The Contractor shall not use any
Federal funds for the cloning of human
beings.
(End of clause)
regulations at 45 CFR 46.103. The
contracting officer shall require a
Federal-wide assurance (FWA),
approved by the HHS Office for Human
Research Protections (OHRP), of each
contractor, subcontractor, or institution
engaged in human subjects research in
performance of a contract. OHRP
administers the assurance covering all
HHS-supported or HHS-conducted
activities involving human subjects.
PART 353—FORMS
370.302
Subpart 353.3—[Reserved]
(a) OHRP-Approved FWAs are found
at the following Web site: https://
ohrp.cit.nih.gov/search/
search.aspx?styp=bsc.
(b) Normally a contractor,
subcontractor, or institution must
provide approval of a FWA before a
contract is awarded. If a contractor,
subcontractor, or institution does not
currently hold an approved FWA, it
shall submit an explanation with its
proposal and an FWA application prior
to submitting a proposal. The
contracting officer, on a case by case
basis, may make award without an
approved assurance in consultation
with OHRP.
(c) A contractor, subcontractor, or
institution must submit all FWAs,
including new FWAs, using the
electronic submission system available
through the OHRP Web site at https://
ohrp.cit.nih.gov/efile/, unless an
institution lacks the ability to do so
electronically. If an institution believes
it lacks the ability to submit its FWA
electronically, it must contact OHRP by
telephone or email (see https://
www.hhs.gov/ohrp/assurances/
index.html) and explain why it is
unable to submit its FWA electronically.
SUBCHAPTERS I—L [RESERVED]
SUBCHAPTER M—HHS
SUPPLEMENTATIONS
PART 370—SPECIAL PROGRAMS
AFFECTING ACQUISITION
Subpart 370.1—[Reserved]
Subpart 370.2—[Reserved]
Subpart 370.3—Acquisitions Involving
Human Subjects
Sec.
370.300 Scope of subpart.
370.301 Policy.
370.302 Federal-wide Assurance (FWA).
370.303 Notice to offerors.
370.304 Contract clauses.
Subpart 370.4—Acquisitions Involving the
Use of Laboratory Animals
370.400 Scope of subpart.
370.401 Policy.
370.402 Assurances.
370.403 Notice to offerors.
370.404 Contract clause.
Subpart 370.5—[Reserved]
Subpart 370.6—[Reserved]
November 17, 2015 Subpart 370.7—
Acquisitions under the Leadership Act
370.700 Scope of subpart.
370.701 Contract clause.
370.702 Solicitation provision.
370.303
Authority: 5 U.S.C. 301; 40 U.S.C.
121(c)(2)
Subpart 370.3—Acquisitions Involving
Human Subjects
370.300
Scope of subpart.
This subpart applies to all research
activities conducted under contracts
involving human subjects. See 45 CFR
46.102(d) and (f).
asabaliauskas on DSK5VPTVN1PROD with RULES
370.301
Policy.
It is the Department of Health and
Human Services (HHS) policy that the
contracting officer shall not award a
contract involving human subjects until
the prospective contractor provides
assurance that the activity will undergo
initial and continuing review by an
appropriate Institutional Review Board
(IRB) in accordance with HHS
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Federal-wide Assurance (FWA).
Notice to offerors.
(a) The contracting officer shall insert
the provision at 352.270–4a, Notice to
Offerors, Protection of Human Subjects,
in solicitations that involve human
subjects. The contracting officer shall
use the clause with its Alternate I when
the agency is prescribing a date later
than the proposal submission by which
the offeror must have an approved
FWA.
(b) Institutions having an OHRPapproved FWA shall certify IRB
approval of submitted proposals in the
manner required by instructions for
completion of the contract proposal; by
completion of an OMB Form No. 0990–
0263, Protection of Human Subjects
Assurance Identification/IRB
Certification/Declaration of Exemption
(Common Rule); or by letter indicating
the institution’s OHRP-assigned FWA
number, the date of IRB review and
approval, and the type of review
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72187
(convened or expedited). The date of
IRB approval must not be more than 12
months prior to the deadline for
proposal submission.
(c) The contracting officer generally
will not request FWAs for contractors,
subcontractors, or institutions prior to
selecting a contract proposal for
negotiation. When a contractor submits
an FWA, it provides certification for the
initial contract period; no additional
documentation is required. If the
contract provides for additional years to
complete the project, the contractor
shall certify annually in the manner
described in 370.303(b).
(d) For the Food and Drug
Administration (FDA), the contracting
officer shall insert the provision at
352.270–10, Notice to Offerors—
Protection of Human Subjects, Research
Involving Human Subjects Committee
(RIHSC) Approval of Research Protocols
Required, in solicitations that involve
human subjects when the research is
subject to RIHSC review and approval.
370.304
Contract clauses.
(a) The contracting officer shall insert
the clause at 352.270–4b, Protection of
Human Subjects, in solicitations,
contracts and orders involving human
subjects.
(b) The contracting officer shall insert
the clause at 352.270–6, Restriction on
Use of Human Subjects, in contracts and
orders if the contractor has an approved
FWA of compliance in place, but cannot
certify prior to award that an IRB
registered with OHRP reviewed and
approved the research, because definite
plans for involvement of human
subjects are not set forth in the proposal
(e.g., projects in which human subjects’
involvement will depend upon
completion of instruments, prior animal
studies, or purification of compounds).
Under these conditions, the contracting
officer may make the award without the
requisite certification, as long as the
contracting officer includes appropriate
conditions in the contract or order.
(c) For FDA, the contracting officer
shall insert the clause at 352.270–11,
Protection of Human Subjects, Research
Involving Human Subjects Committee
(RIHSC) Approval of Research Protocols
Required, in contracts and orders that
involve human subjects when the
research is subject to RIHSC review and
approval.
(d) The contracting officer shall insert
the clause at 352.270–12, Needle
Exchange, in solicitations, contracts,
and orders involving human subjects.
(e) The contracting officer shall insert
the clause at 352.270–13, Continued
Ban on Funding Abortion and
Continued Ban on Funding of Human
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Embryo Research, in solicitations,
contracts, and orders involving human
subjects.
Subpart 370.4—Acquisitions Involving
the Use of Laboratory Animals
370.400
Scope of subpart.
This subpart applies to all research,
research training, biological testing,
housing and maintenance, and other
activities involving live vertebrate
animals conducted under contract.
Additional information can be found in
Public Health Service (PHS) Policy on
Humane Care and Use of Laboratory
Animals https://grants.nih.gov/grants/
olaw/references/phspolicylab
animals.pdf.
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370.401
Policy.
(a) It is HHS policy that contracting
activities shall not award a contract
involving live vertebrate animals until
the Contractor provides acceptable
assurance the contract work is subject to
initial and continuing review by an
appropriate Institutional Animal Care
and Use Committee (IACUC) as
described in the PHS Policy at IV.B.6
and 7. The contracting officer shall
require an applicable Animal Welfare
Assurance approved by the Office of
Laboratory Animal Welfare (OLAW),
National Institutes of Health (NIH), of
each contractor, subcontractor, or
institution having responsibility for
animal care and use involved in
performance of the contract. Normally
the assurance shall be approved before
award. The contracting officer, on a
case-by-case basis, may make award
without an approved assurance in
consultation with OLAW. For additional
information see PHS Policy II., IV.A,
and V.B.
(b) The OLAW, NIH, is responsible for
negotiating assurances covering all
HHS/PHS-supported or HHS/PHSconducted activities involving the care
and use of live vertebrate animals.
OLAW shall provide guidance to
contracting officers regarding adequate
animal care and use, approval,
disapproval, restriction, or withdrawal
of approval of assurances. For
additional information see PHS Policy
V.A.
(c) If using live vertebrate animals,
HHS policy requires that offerors
address the points in the Vertebrate
Animal Section (VAS) of the Technical
Proposal. Each of the points must be
addressed in the VAS portion of the
Technical Proposal. For additional
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information see PHS Policy and use
Contract Proposal VAS Worksheet.
https://grants.nih.gov/grants/olaw/
references/phspol.htm#Information
RequiredinApplications-Proposalsfor
AwardsSubmittedtoPHS and https://
grants.nih.gov/grants/olaw/
VAScontracts.pdf.
370.402
Assurances.
(a) Animal Welfare Assurances may
be one of three types:
(1) Domestic Assurance (DA). A DA
describes the institution’s animal care
and use program, including but not
limited to the lines of authority and
responsibility, veterinary care, IACUC
composition and procedures,
occupational health and safety, training,
facilities, and species housed. A DA
listed in OLAW’s list of institutions
with an approved DA is acceptable for
purposes of this policy.
(2) Inter-institutional Assurance (IA).
The offeror, its proposed subcontractor,
or institution shall submit an IA when
it does not have a proprietary animal
care and use program, facilities to house
animals or IACUC, and does not
conduct animal research on-site. The
offeror will perform the animal activity
at an institution with an Animal Welfare
Assurance named as a performance site.
An IA approval extends to the full
period of contract performance (up to 5
years) limited to the specific award or
single project.
(3) Foreign Assurance (FA). The
Foreign Assurance is required for
institutions outside the U.S. that receive
PHS funds directly through a contract
award. The Foreign Assurance also
applies to institutions outside the U.S.
that receive PHS funds indirectly
(named as a performance site). An FA
listed in OLAW’s list of institutions
with an approved FA is acceptable for
purposes of this policy.
(b) The contracting officer shall
forward copies of proposals selected for
negotiation and requiring an assurance
to OLAW at olawdoa@od.nih.gov, as
early as possible to secure the necessary
assurances.
(c) A contractor providing animal care
services at an institution with an
Animal Welfare Assurance, such as a
Government-owned, Contractoroperated (GOCO) site, does not need a
separate assurance. GOCO site
assurances normally cover such
contractor services.
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370.403
Notice to offerors.
(a) The contracting officer shall insert
the provision at 352.270–5a, Notice to
Offerors of Requirement for Compliance
with the Public Health Service Policy on
Humane Care and Use of Laboratory
Animals, in solicitations involving live
vertebrate animals.
(b) Offerors having a DA on file with
OLAW shall submit IACUC approval of
the use of animals in the manner
required by the solicitation, but prior to
award. The date of IACUC approval
must not be more than 36 months prior
to award.
(c) It is not necessary for offerors
lacking an Animal Welfare Assurance to
submit assurances or IACUC approval
with proposals. OLAW shall contact
contractors, subcontractors, and
institutions to negotiate necessary
assurances and verify IACUC approvals
when requested by the contracting
officer.
370.404
Contract clause.
The contracting officer shall insert the
clause at 352.270–5b, Care of Live
Vertebrate Animals, in solicitations,
contracts, and orders that involve live
vertebrate animals.
Subpart 370.5—[Reserved]
Subpart 370.6—[Reserved]
Subpart 370.7—Acquisitions Under the
Leadership Act
370.700
Scope of subpart.
This subpart sets forth the acquisition
requirements regarding implementation
of Human Immunodeficiency Virus/
Acquired Immune Deficiency Syndrome
(HIV/AIDS) programs under the
President’s Emergency Plan for AIDS
Relief as established by the United
States Leadership Against HIV/AIDS,
Tuberculosis and Malaria Act of 2003,
as amended (Pub. L. 108–25, Pub. L.
110–293, Pub. L. 113–56).
370.701
Solicitation provision.
The contracting officer shall insert the
provision at 352.270–9, NonDiscrimination for Conscience, in
solicitations valued at more than the
micro-purchase threshold:
(a) In connection with the
implementation of HIV/AIDS programs
under the President’s Emergency Plan
for AIDS Relief established by the
United States Leadership Against HIV/
AIDS, Tuberculosis and Malaria Act of
2003, as amended; or
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(b) Where the contractor will receive
funding under the United States
Leadership Against HIV/AIDS,
Tuberculosis and Malaria Act of 2003,
as amended. In resolving any issues or
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complaints that offerors may raise
regarding meeting the requirements
specified in the provision, the
contracting officer shall consult with the
Office of Global Health Affairs, Office of
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the General Counsel, the Program
Manager, and other HHS officials, as
appropriate.
[FR Doc. 2015–28214 Filed 11–17–15; 8:45 am]
BILLING CODE 4150–28–P
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]]>Agencies
[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)]
[Rules and Regulations]
[Pages 72149-72189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28214]
[[Page 72149]]
Vol. 80
Wednesday,
No. 222
November 18, 2015
Part II
Department of Health and Human Services
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48 CFR Chapter 3
Health and Human Services Acquisition Regulations; Final Rule
Federal Register / Vol. 80 , No. 222 / Wednesday, November 18, 2015 /
Rules and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
48 CFR Chapter 3
RIN 0991-AB86
Health and Human Services Acquisition Regulations
AGENCY: Department of Health and Human Services.
ACTION: Final rule.
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SUMMARY: The Department of Health and Human Services (HHS) is issuing a
final rule to amend its Federal Acquisition Regulation (FAR)
Supplement, the HHS Acquisition Regulation (HHSAR), to update its
regulation to current FAR requirements; to remove information from the
HHSAR that consists of material that is internal, administrative, and
procedural in nature; to add or revise definitions; to correct certain
terminology; and to delete outdated material or material duplicative of
the FAR.
DATES: Effective December 18, 2015.
FOR FURTHER INFORMATION CONTACT: Deborah Griffin, Procurement Analyst,
Department of Health and Human Services, Office of the Assistant
Secretary for Financial Resources, Office of Grants and Acquisition
Policy and Accountability, Division of Acquisition,
deborah.griffin@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
HHS published a proposed rule in the Federal Register at 80 FR
11266 on March 2, 2015, to conform to current statutory and FAR
requirements. This final rule changes the HHSAR to conform to these new
requirements and to align the requirements with the current FAR. In
addition, the procedural materials that were deemed internal or non-
regulatory in nature are moved to internal procedures for department-
wide application.
II. Discussion and Analysis
HHS reviewed the comments in the development of this final rule. A
discussion of the comments and the changes made to the rule as a result
of those comments are provided as follows:
A. Summary of Significant Changes to the Proposed Rule
HHSAR 311.71, Public Accommodations and Commercial Facilities, and
the relevant clause at 352.211-1, Public Accommodations and Commercial
Facilities, are renamed and revised to clarify public accommodation and
the use of commercial facilities.
HHSAR 302.101, Definitions, is revised to clarify the definition of
``agency head or head of the agency'' as the Secretary of HHS or
specified designee. This allows for the delegation to the appropriate
acquisition official within HHS.
HHSAR 303.704, Policy, is clarified to specify the HCA as the
designee for voiding and rescinding contracts; however, coordination is
required with the SPE.
HHSAR 306.202, Establishing or maintaining alternative sources, is
revised to clarify that the ``agency head'' as specified in FAR
6.202(a) is the SPE rather than the Competition Advocate.
HHSAR 306.302-7, Public interest, is deleted. The information is
considered duplicative of the FAR.
HHSAR 309.403, Definitions, is revised to delete the definition of
``acquiring agency's head or designee.''
HHSAR 317.108, Congressional notification, is revised to clarify
that the SPE shall give the approval of the notification required by
FAR 17.108(a) and that the HCA shall finalize and sign the
congressional notification letter and provide it to the appropriate
House and Senate committees.
HHSAR 317.204, Contracts, is revised to clarify that a request to
exceed the 5-year limitation specified in FAR 17.204(e) must follow the
guidance in FAR 1.7.
HHSAR 324.70, Health Insurance Portability and Accountability Act
of 1996, is revised to clarify the references to controlling law.
In addition, several editorial changes were made to the rule.
B. Analysis of Public Comments
HHSAR 315.305, Proposal Evaluation
The respondent states that the coverage in HHSAR 315.305,
concerning advisors who are brought in to assist in proposal evaluation
has a different set of restrictions and requirements than are found in
Part 337, Service Contracting-General, citing those found in FAR
37.203, Policy. The provisions of HHSAR 315.305 specifically address
those circumstances when HHS must use a statutorily mandated contractor
selection process of Peer Review. As such, the respondent is correct
that the primary focus of this HHSAR section deals with potential
conflicts which must be avoided in source selection. HHS does not
believe that any change to the coverage is necessary. FAR 15.305,
Proposal Evaluation, already contains a cross reference to FAR part 37,
Service Contracting.
319.270-1, Mentor Prot[eacute]g[eacute] Program Solicitation Provision
and Contract Clause
The respondent notes that the HHS Mentor Prot[eacute]g[eacute]
Program is currently suspended and requests that the suspension be
lifted or, alternatively, the section be removed from the HHSAR. HHS
has retained the HHSAR coverage as currently written with intent to
reinstate the program at a later date.
352.204-70(c)(5), Prevention and Public Health Fund-Reporting
Requirements
The respondent believes the language in the clause at 352.204-
70(c)(5), Prevention and Public Health Fund-Reporting Requirements, is
duplicative and should be deleted and replaced with the requirement to
report subcontract information in the Federal Funding Accountability
and Transparency Act Subaward Reporting System. The requirement in the
HHSAR is specific to Prevention and Public Health Fund funding, and the
reporting requirement is contained within the structure of the program.
Therefore, the language in the proposed rule is retained.
352.211-1, Public Accommodations and Commercial Facilities
The respondent supports HHS' inclusion of HHSAR coverage to provide
accessible meeting locations. However, HHS believes further
clarification is necessary for public accommodation and commercial
facilities. Therefore, the language in HHSAR 311.71, Public
Accommodations and Commercial Facilities and the related clause at
352.211-1, Public Accommodations and Commercial Facilities, is revised.
352.237-74, Non-Discrimination in Service Delivery
The clause at 352.237-74, Non-Discrimination in Service Delivery,
specifies that the contractor may not discriminate on several bases to
include sex, gender, religion, and others as are often found in such
clauses and relate to specific non-discrimination Federal laws. Several
respondents provided comments that are mostly identical and suggested
two modifications. The first is to expand the enumerated areas of
prohibited discrimination to include genetics, politics, and veteran
status among others. It then suggests ``that nothing in this clause
limits the ability of a recipient to target assistance to certain
populations as defined in the award.'' Thus the respondents ask that
HHS go beyond the current requirements of Federal law in prohibiting
other possible forms of
[[Page 72151]]
discrimination and then asks that the benefits distributed NOT be
subject to this restriction in that certain benefits are, by design,
targeted to go to certain defined groups. Another comment also
``reiterates that prohibiting contractors from discrimination while
delivering taxpayer-funded services in no way violates religious
liberty protections.'' No change is being made to the coverage. HHS
intends to comply with all applicable Federal legislation regarding
this subject.
352.270-5a, Notice to Offerors of Requirement for Compliance With the
Public Health Service Policy on Humane Care and Use of Laboratory
Animals, and 352.270-5b, Care of Live Vertebrate Animals
The respondent asks for further consideration to repeal using
animals in research. No change is being made to the coverage. HHS
intends to comply with all applicable federal legislation regarding
this subject.
352.270-9, Non-Discrimination for Conscience
Several respondents commented on the clause at 352.270-9, Non-
Discrimination for Conscience. Most of the comments are identical. Each
notes that their concern is with the statute, not the regulation
implementing it. They further ask that the law be ``robustly
operationalized.'' HHS intends to enforce section 7631(d) of the
Leadership Act. Therefore, no change is being made to the coverage.
352.270-12, Needle Exchange
The respondent commented on the clause at 352.270-12, Needle
Exchange, which prevents Federal funds from being used for safe needle
exchange. The respondent believes that safe needle exchanges at HHS
locations make logical sense. HHS intends to comply with all applicable
Federal legislation regarding this subject. Therefore, no change is
being made to the coverage.
352.270-13, Continued Ban on Funding Abortion and Continued Ban on
Funding of Human Embryo Research
Several respondents commented on the clause at 352.270-13,
Continued Ban on Funding Abortion and Continued Ban on Funding of Human
Embryo Research. All but one of the comments were identical. The
remaining comment was more expansive. This clause prohibits the use of
Federal funds for abortion, creating embryos for the purpose of
harvesting cells from them (commonly referred to as ``stem cell
research''), and the cloning of humans.
The respondents want the rule changed as to abortion to permit
abortion in the case of incest, rape, and life endangerment ``pursuant
to prevailing law.'' HHS intends to comply with all applicable Federal
legislation regarding this subject. Therefore, no change is being made
to the coverage.
III. Executive Orders 12866 and 13563
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). E.O.
13563 emphasizes the importance of quantifying both costs and benefits,
of reducing costs, of harmonizing rules, and of promoting flexibility.
This is not a significant regulatory action and, therefore, is not
subject to review under section 6(b) of Executive Order 12866,
Regulatory Planning and Review, dated September 30, 1993. This rule is
not a major rule under 5 U.S.C. 804.
IV. Regulatory Flexibility Act
A final regulatory flexibility analysis has been prepared
consistent with 5 U.S.C. 604.
1. Statement of the Need for, and the Objectives of, the Rule
The Department of Health and Human Services (HHS) is revising its
Federal Acquisition Regulation (FAR) Supplement, the HHS Acquisition
Regulation (HHSAR), to update its regulation to current FAR
requirements; to remove information from the HHSAR that consists of
material that is internal administrative and procedural in nature; to
add or revise definitions; to correct certain terminology; and to
delete outdated material or material duplicative of the FAR.
2. Statement of the Significant Issues Raised by the Public Comments in
Response to the Initial Regulatory Flexibility Analysis, a Statement of
the Assessment of the Agency of Such Issues, and a Statement of any
Changes Made to the Rule as a Result of Such Comments
No issues were raised by the public in response to the initial
regulatory flexibility analysis.
3. The Response of the Agency to Any Comments Filed by the Chief
Counsel for Advocacy of the Small Business Administration in Response
to the Rule, and a Detailed Statement of any Change Made in the Final
Rule as a Result of the Comments
No issues were raised by the Chief Counsel for Advocacy of the
Small Business Administration in response to the rule.
4. Description of and an Estimate of the Number of Small Entities to
Which This Rule Will Apply
HHS awarded approximately 95,836 contract actions in FY 2014; over
44 percent (42,467) of those actions were for small businesses acting
as prime contractors; therefore, it is estimated that the rule will
apply to over 42,000 small business entities.
5. Description of the Projected Reporting, Recordkeeping, and Other
Compliance Requirements of the Rule
There are no new reporting, recordkeeping, or other compliance
requirements in the final rule. The reporting and recordkeeping
requirements are the same as those prior to the proposed rule.
6. Description of the Steps the Agency Has Taken To Minimize the
Significant Economic Impact on Small Entities Consistent With the
Stated Objectives of Applicable Statutes
The final rule does not revise or place any new requirements on
small business entities. Therefore, this final rule should have no
significant economic impact on a substantial number of small business
entities.
V. Paperwork Reduction Act
The Paperwork Reduction Act (44 U.S.C. Chapter 35) applies. The
rule contains information collection requirements. OMB has cleared
these information collection requirements under OMB Control Numbers
0990-0430, 0990-0431, 0990-0432, 0990-0433, 0990-0434, and 0990-0436.
List of Subjects in 48 CFR Parts 301 Through 370
Government procurement.
Dated: October 29, 2015.
Angela Billups,
Associate Deputy Assistant Secretary--Acquisition.
For the reasons stated in the preamble, HHS is revising 48 CFR
chapter 3 to read as follows:
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Title 48--Federal Acquisition Regulations System
CHAPTER 3--HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
PART 301--HHS ACQUISITION REGULATION SYSTEM
PART 302--DEFINITIONS OF WORDS AND TERMS
PART 303--IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF
INTEREST
PART 304--ADMINISTRATIVE MATTERS
SUBCHAPTER B--COMPETITION AND ACQUISITION PLANNING
PART 305--PUBLICIZING CONTRACT ACTIONS
PART 306--COMPETITION REQUIREMENTS
PART 307--ACQUISITION PLANNING
PART 308--REQUIRED SOURCES OF SUPPLIES AND SERVICES
PART 309--CONTRACTOR QUALIFICATIONS
PART 310--MARKET RESEARCH
PART 311--DESCRIBING AGENCY NEEDS
PART 312--ACQUISITION OF COMMERCIAL ITEMS
SUBCHAPTER C--CONTRACTING METHODS AND CONTRACT TYPES
PART 313--SIMPLIFIED ACQUISITION PROCEDURES
PART 314--SEALED BIDDING
PART 315--CONTRACTING BY NEGOTIATION
PART 316--TYPES OF CONTRACTS
PART 317--SPECIAL CONTRACTING METHODS
SUBCHAPTER D--SOCIOECONOMIC PROGRAMS
PART 319--SMALL BUSINESS PROGRAMS
PART 322--APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS
PART 323--ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY
TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE
PART 324--PROTECTION OF PRIVACY AND FREEDOM OF INFORMATION
PART 326--OTHER SOCIOECONOMIC PROGRAMS
SUBCHAPTER E--GENERAL CONTRACTING REQUIREMENTS
PART 327--PATENTS, DATA, AND COPYRIGHTS
PART 328--RESERVED
PART 330--COST ACCOUNTING STANDARDS
PART 331--CONTRACT COST PRINCIPLES AND PROCEDURES
PART 332--CONTRACT FINANCING
PART 333--PROTESTS, DISPUTES, AND APPEALS
SUBCHAPTER F--SPECIAL CATEGORIES OF CONTRACTING
PART 334--MAJOR SYSTEM ACQUISITION
PART 335--RESEARCH AND DEVELOPMENT CONTRACTING
PART 336--CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS
PART 337--SERVICE CONTRACTING--GENERAL
PART 339--ACQUISITION OF INFORMATION TECHNOLOGY
SUBCHAPTER G--CONTRACT MANAGEMENT
PART 342--CONTRACT ADMINISTRATION
SUBCHAPTER H--CLAUSES AND FORMS
PART 352--SOLICITATION PROVISIONS AND CONTRACT CLAUSES
PART 353--FORMS
SUBCHAPTERS I--L [RESERVED]
SUBCHAPTER M--HHS SUPPLEMENTATIONS
PART 370--SPECIAL PROGRAMS AFFECTING ACQUISITION
SUBCHAPTER A--GENERAL
PART 301--HHS ACQUISITION REGULATION SYSTEM
Subpart 301.1 Purpose, Authority, and Issuance
Sec.
301.101 Purpose.
301.103 Authority.
301.106 Office of Management and Budget approval under the Paperwork
Reduction Act.
Subpart 301.2--[Reserved]
Subpart 301.4--Deviations from the FAR
301.401 Deviations.
Subpart 301.6--Career Development, Contracting Authority, and
Responsibilities
301.602 Contracting officers.
301.602-3 Ratification of unauthorized commitments.
301.603 Selection, appointment, and termination of appointment of
contracting officers.
301.603-1 General.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 301.1--Purpose, Authority, and Issuance
301.101 Purpose.
(a) The Department of Health and Human Services (HHS) Acquisition
Regulation (HHSAR) establishes uniform HHS acquisition policies and
procedures that implement and supplement the Federal Acquisition
Regulation (FAR).
(b)(1) The HHSAR contains HHS policies that govern the acquisition
process or otherwise control acquisition relationships between HHS'
contracting activities and contractors. The HHSAR contains--
(i) Requirements of law;
(ii) HHS-wide policies;
(iii) Deviations from FAR requirements; and
(iv) Policies that have a significant effect beyond the internal
procedures of HHS or a significant cost or administrative impact on
contractors or offerors.
(2) Relevant internal procedures, guidance, and information not
meeting the criteria in paragraph (b)(1) of this section are issued by
HHS in other announcements, internal procedures, guidance, or
information.
301.103 Authority.
(b) The Assistant Secretary for Financial Resources (ASFR)
prescribes the HHSAR under the authority of 5 U.S.C. 301 and section
205(c) of the Federal Property and Administrative Services Act of 1949,
as amended (40 U.S.C. 121(c)(2)), as delegated by the Secretary).
(c) The HHSAR is issued in the Code of Federal Regulations (CFR) as
chapter 3 of title 48, Department of Health and Human Services
Acquisition Regulation. It may be referenced as ``48 CFR chapter 3.''
301.106 Office of Management and Budget approval under the Paperwork
Reduction Act.
(a) The Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.)
imposes a requirement on Federal agencies to obtain approval from the
Office of Management and Budget (OMB) before collecting the same
information from 10 or more members of the public.
(b) The following OMB control numbers apply to the information
collection and recordkeeping requirements contained in this chapter:
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HHSAR Segment OMB Control No.
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311.7102....................................... 0990-0434
311.7202(b).................................... 0990-0434
311.7300....................................... 0990-0436
337.103(d)(3).................................. 0990-0430
337.103(d)(4).................................. 0990-0433
370.301........................................ 0990-0431
370.401........................................ 0990-0432
352.211-1...................................... 0990-0434
352.211-2...................................... 0990-0434
352.211-3...................................... 0990-0436
352.227-11..................................... 0990-0419
352.227-14..................................... 0990-0419
352.227-71..................................... 0990-0430
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352.237-72..................................... 0990-0433
352.237-73..................................... 0990-0431
352.270-4a..................................... 0990-0431
352.270-4b..................................... 0990-0431
352.270-10..................................... 0990-0431
352.270-11..................................... 0990-0432
352.270-5a..................................... 0990-0432
352.270-5b..................................... 0990-0432
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Subpart 301.2--[Reserved]
Subpart 301.4--Deviations from the FAR
301.401 Deviations.
Contracting officers are not permitted to deviate from the FAR or
HHSAR without seeking proper approval. With full acknowledgement of FAR
1.102(d) regarding innovative approaches, any deviation to FAR or the
HHSAR requires approval by the Senior Procurement Executive (SPE).
Subpart 301.6--Career Development, Contracting Authority, and
Responsibilities
301.602 Contracting officers.
301.602-3 Ratification of unauthorized commitments.
(b) Policy. (1) The Government is not bound by agreements with, or
contractual commitments made to, prospective contractors by individuals
who do not have delegated contracting authority. Unauthorized
commitments do not follow the appropriate process for the expenditure
of Government funds. Consequently, the Government may not be able to
ratify certain actions, putting a contractor at risk for taking
direction from a Federal official other than the contracting officer.
See FAR 1.602-1. Government employees responsible for unauthorized
commitments are subject to disciplinary action. Contractors perform at
their own risk when accepting direction from unauthorized officials.
Failure to follow statutory and regulatory processes for the
expenditure of Government funds is a very serious matter.
(2) The head of the contracting activity (HCA) is the official
authorized to ratify an unauthorized commitment. No other re-
delegations are authorized.
(c) Limitations. (5) The HCA shall coordinate the request for
ratification with the Office of General Counsel, General Law Division
and submit a copy to the SPE.
301.603 Selection, appointment, and termination of appointment of
contracting officers.
301.603-1 General.
(a) The Agency head has delegated broad authority to the Chief
Acquisition Officer, who in turn has further delegated this authority
to the SPE. The SPE has further delegated specific acquisition
authority to the Operating and Staff Division heads and the HCAs. The
HCA (non-delegable) shall select, appoint, and terminate the
appointment of contracting officers.
(b) To ensure proper control of redelegated acquisition
authorities, HCAs shall maintain a file containing successive
delegations of HCA authority through the contracting officer level.
PART 302--DEFINITIONS OF WORDS AND TERMS
Subpart 302.1--Definitions
Sec.
302.101 Definitions.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 302.1--Definitions
302.101 Definitions.
(a) Agency head or head of the agency, unless otherwise stated,
means the Secretary of Health and Human Services or specified designee.
(b) Contracting Officer's Representative (COR) is a Federal
employee designated in writing by a contracting officer to act as the
contracting officer's representative in monitoring and administering
specified aspects of contractor performance after award of a contract
or order. In accordance with local procedures, operating divisions
(OPDIVs) or staff divisions (STAFFDIVs) may designate CORs for firm
fixed-price contracts or orders. COR's responsibilities may include
verifying that:
(1) The contractor's performance meets the standards set forth in
the contract or order;
(2) The contractor meets the contract or order's technical
requirements by the specified delivery date(s) or within the period of
performance; and
(3) The contractor performs within cost ceiling stated in the
contract or order. CORs must meet the training and certification
requirements specified in 301.604.
(c) Head of the Contracting Activity (HCA) is an official having
overall responsibility for managing a contracting activity, i.e. the
organization within an OPDIV or STAFFDIV or other HHS organization
which has been delegated broad authority regarding the conduct of
acquisition functions.
PART 303--IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF
INTEREST
Subpart 303.1--Safeguards
Sec.
303.101 Standards of conduct.
303.101-3 Agency regulations.
303.104-7 Violations or possible violations of the Procurement
Integrity Act.
Subpart 303.2--Contractor Gratuities to Government Personnel
303.203 Reporting suspected violations of the Gratuities clause.
Subpart 303.6--Contracts with Government Employees or Organizations
Owned or Controlled by Them
303.602 Exceptions.
Subpart 303.7--Voiding and Rescinding Contracts
303.704 Policy.
Subpart 303.8--Limitation on the Payment of Funds to Influence Federal
Transactions
303.808-70 Solicitation provision and contract clause.
Subpart 303.10--Contractor Code of Business Ethics and Conduct
303.1003 Requirements.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 303.1--Safeguards
303.101 Standards of conduct.
303.101-3 Agency regulations.
(a)(3) The HHS Standards of Conduct are prescribed in 45 CFR part
73.
303.104-7 Violations or possible violations of the Procurement
Integrity Act.
(a)(1) The contracting officer shall submit to the head of the
contracting activity (HCA) for review and concurrence the determination
(along with supporting documentation) that a reported violation or
possible violation of the statutory prohibitions has no impact on the
pending award or selection of a contractor for award.
(2) The contracting officer shall refer the determination that a
reported violation or possible violation of the statutory prohibitions
has an impact on the pending award or selection of a contractor, along
with all related information available, to the HCA. The HCA shall--
(i) Refer the matter immediately to the Associate Deputy Assistant
Secretary--Acquisition (ADAS-A) for review, who may consult with the
appropriate legal office representative and the Office of Inspector
General (OIG) as appropriate; and
[[Page 72154]]
(ii) Determine the necessary action in accordance with FAR 3.104-
7(c) and (d). The HCA shall obtain the approval or concurrence of the
ADAS-A before proceeding with an action.
(b) The HCA (non-delegable) shall act with respect to actions taken
under the Federal Acquisition Regulation (FAR) clause at 52.203-10,
Price or Fee Adjustment for Illegal or Improper Authority.
Subpart 303.2--Contractor Gratuities to Government Personnel
303.203 Reporting suspected violations of the Gratuities clause.
HHS personnel shall report suspected violations of the clause at
FAR 52.203-3, Gratuities, to the contracting officer, who will in turn
report the matter to the Office of General Counsel (OGC), Ethics
Division for disposition.
Subpart 303.6--Contracts with Government Employees or Organizations
Owned or Controlled by Them
303.602 Exceptions.
The HCA (non-delegable) is the official authorized to approve an
exception to the policy stated in FAR 3.601.
Subpart 303.7--Voiding and Rescinding Contracts
303.704 Policy.
(a) For purposes of supplementing FAR subpart 3.7, the HCA (non-
delegable) is the designee. Coordination with the Senior Procurement
Executive is required.
Subpart 303.8--Limitation on the Payment of Funds to Influence
Federal Transactions
303.808-70 Solicitation provision and contract clause.
The contracting officer shall insert the clause at 352.203-70,
Anti-lobbying, in solicitations and contracts that exceed the
simplified acquisition threshold.
Subpart 303.10--Contractor Code of Business Ethics and Conduct
303.1003 Requirements.
(b) The contracting officer, when notified of a possible contractor
violation, in accordance with FAR 3.1003(b), shall notify the OIG and
the HCA.
(c)(2) The contracting officer shall specify the title of HHS' OIG
hotline poster and the Web site where the poster can be obtained in
paragraph (b)(3) of the clause at FAR 52.203-14.
PART 304--ADMINISTRATIVE MATTERS
Subpart 304.6--Contract Reporting
Sec.
304.602 General.
304.604 Responsibilities.
Subpart 304.13--Personal Identity Verification
304.1300 Policy.
Subpart 304.16--Unique Procurement Instrument Identifiers
304.1600 Scope of subpart.
Subpart 304.70--[Reserved]
Subpart 304.71--Review and Approval of Proposed Contract Actions
304.7100 Policy.
Subpart 304.72--Affordable Care Act Prevention and Public Health
Fund--Reporting Requirements
Sec.
304.7200 Scope of subpart.
304.7201 Procedures.
304.7202 Contract clause.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 304.6--Contract Reporting
304.602 General.
Follow internal department procedures for reporting information to
the Federal Procurement Data System (FPDS) and for resolving technical
or policy issues relating to FPDS contract reporting.
304.604 Responsibilities.
The Department of Health and Human Services (HHS) acquisition
officials and staff shall report their contract information in FPDS
accurately and timely.
Subpart 304.13--Personal Identity Verification
304.1300 Policy.
To ensure compliance with Homeland Security Presidential Directive-
12: Policy for a Common Identification Standard for Federal Employees
and Contractors (HSPD-12) and the Presidential Cross Agency Priority
for strong authentication, contracting officers shall provide in each
acquisition those HSPD-12 requirements necessary for contract
performance.
Subpart 304.16--Unique Procurement Instrument Identifiers
304.1600 Scope of subpart.
This subpart provides guidance for assigning identification numbers
to solicitation or contract actions. The Senior Procurement Executive
shall be responsible for establishing a numbering system within the
department that conforms to Federal Acquisition Regulation (FAR)
subpart 4.16.
Subpart 304.70--[Reserved]
Subpart 304.71--Review and Approval of Proposed Contract Actions
304.7100 Policy.
In accordance with HHS delegated acquisition authority, the FAR,
this regulation, internal policies and guidance, the head of the
contracting activity (non-delegable) shall establish review and
approval procedures for proposed contract actions to ensure that--
(a) Contractual documents are in conformance with law, established
policies and procedures, and sound business practices;
(b) Contract actions properly reflect the mutual understanding of
the parties; and
(c) The contracting officer is informed of deficiencies and items
of questionable acceptability, and takes corrective action.
Subpart 304.72--Affordable Care Act Prevention and Public Health
Fund--Reporting Requirements
304.7200 Scope of subpart.
This subpart implements Section 220 of Public Law 112-74, FY 2012
Labor, HHS and Education Appropriations Act, which requires, semi-
annual reporting on the use of funds from the Prevention and Public
Health Fund (PPHF), Public Law 111-148, sec. 4002. Contractors that
receive awards (or modifications to existing awards) with a value of
$25,000 or more funded, in whole or in part, from the PPHF, shall
report information specified in the clause at 352.204-70, Prevention
and Public Health Fund--Reporting Requirements, including, but not
limited to--
(a) The dollar amount of contractor invoices;
(b) The supplies delivered and services performed; and
(c) Specific information on subcontracts with a value of $25,000 or
more.
304.7201 Procedures.
(a) In any contract action funded in whole or in part by the PPHF,
the
[[Page 72155]]
contracting officer shall indicate that the contract action is being
made under the PPHF, and indicate which products or services are funded
under the PPHF. This requirement applies whenever PPHF funds are used,
regardless of the contract instrument.
(b) To maximize transparency of PPHF funds that shall be reported
by the contractor, the contracting officer shall structure contract
awards to allow for separately tracking PPHF funds. For example, the
contracting officer may consider awarding dedicated separate contracts
when using PPHF funds or establishing contract line item number
structures to prevent commingling of PPHF funds with other funds.
(c) Contracting officers shall ensure that the contractor complies
with the reporting requirements of 352.204-70. Upon receipt of each
report, the contracting officer shall review it for completeness,
address any clarity or completeness issues with the contractor, and
submit the final approved report in Section 508 compliant format to an
Assistant Secretary for Public Affairs point-of-contact for posting on
HHS' PPHF Web site at https://www.hhs.gov/open/prevention/ no
later than 30 days after the end of the reporting period. If the
contractor fails to comply with the reporting requirements, the
contracting officer shall exercise appropriate contractual remedies.
(d) The contracting officer shall make the contractor's failure to
comply with the reporting requirements a part of the contractor's
performance information under FAR subpart 42.15.
304.7202 Contract clause.
Insert the clause at 352.204-70, Prevention and Public Health
Fund--Reporting Requirements, in all solicitations and contract actions
funded in whole or in part with PPHF funds, except classified
solicitations and contracts. This includes, but is not limited to,
awarding or modifying orders against existing or new contracts issued
under FAR subparts 8.4 and 16.5 that will be funded with PPHF funds.
Contracting officers shall include this clause in any existing contract
or order that will be funded with PPHF funds. This clause is not
required for any contract or order which contains a prior version of
the clause at 352.204-70.
SUBCHAPTER B--COMPETITION AND ACQUISITION PLANNING
PART 305--PUBLICIZING CONTRACT ACTIONS
Subpart 305.3--Synopses of Contract Awards
Sec.
305.303 Announcement of contract awards.
Subpart 305.5--Paid Advertisements
305.502 Authority.
Subpart 305.70--Publicizing Requirements Funded From the Affordable
Care Act Prevention and Public Health Fund
305.7001 Scope.
305.7002 Applicability.
305.7003 Publicizing preaward.
305.7004 Publicizing postaward.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 305.3--Synopses of Contract Awards
305.303 Announcement of contract awards.
(a) Public announcement. The contracting officer shall report
awards, not exempt under Federal Acquisition Regulation (FAR) 5.303, to
the Office of the Assistant Secretary for Legislation (Congressional
Liaison Office.)
Subpart 305.5--Paid Advertisements
305.502 Authority.
Written approval at least one level above the contracting officer
shall be obtained prior to placing advertisements or notices in
newspapers.
Subpart 305.70--Publicizing Requirements Funded From the Affordable
Care Act Prevention and Public Health Fund
305.7001 Scope.
Pursuant to appropriations acts, this subpart prescribes
requirements for posting presolicitation and award notices for actions
funded in whole or in part from the Prevention and Public Health Fund
(PPHF). The requirements of this subpart enhance transparency to the
public.
305.7002 Applicability.
This subpart applies to all actions funded in whole or in part by
the PPHF.
305.7003 Publicizing preaward.
Notices of all proposed contract actions, funded in whole or in
part by the PPHF, shall be identified on HHS' Prevention and Public
Health Fund Web site at https://www.hhs.gov/open/prevention/
no later than 1-day after issuance of the solicitation or other request
for proposal or quotation document. When applicable, the notice shall
provide a link to the full text; for example, a link to the FedBizOpps
notice required by FAR 5.201.
305.7004 Publicizing postaward.
Notices of contract actions exceeding $25,000, funded in whole or
in part by the PPHF, shall be identified on HHS' PPHF Web site at
https://www.hhs.gov/open/prevention/ no later than 5 days
after the contract action occurs.
PART 306--COMPETITION REQUIREMENTS
Subpart 306.2--Full and Open Competition After Exclusion of Sources
Sec.
306.202 Establishing or maintaining alternative sources.
Subpart 306.3--Other Than Full and Open Competition
306.302 Circumstances permitting other than full and open
competition.
306.302-1 Only one responsible source and no other supplies or
services will satisfy agency requirements.
Subpart 306.5--Competition Advocates
306.501 Requirement.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 306.2--Full and Open Competition After Exclusion of Sources
306.202 Establishing or maintaining alternative sources.
(a) The Senior Procurement Executive (SPE) shall make the
determination required in Federal Acquisition Regulation (FAR)
6.202(a).
(b)(1) The contracting officer shall prepare the required
determination and findings (D&F), see FAR 6.202(b)(1), based on the
data provided by program personnel. The appropriate Competition
Advocate (CA) (non-delegable) shall sign the D&F, indicating
concurrence. The final determination will be made by the SPE.
Subpart 306.3--Other Than Full and Open Competition
306.302 Circumstances permitting other than full and open competition.
306.302-1 Only one responsible source and no other supplies or
services will satisfy agency requirements. See FAR 6.302-1.
For acquisitions covered by 42 U.S.C. 247d-6a(b)(2)(A), ``available
from only one responsible source'' shall be deemed to mean ``available
from only one responsible source or only from a limited number of
responsible sources''.
[[Page 72156]]
Subpart 306.5--Competition Advocates
306.501 Requirement.
The Department Competition Advocate for Health and Human Services
is located in the Division of Acquisition.
PART 307--ACQUISITION PLANNING
Sec.
307.105 Contents of written acquisition plans.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
307.105 Contents of written acquisition plans.
Federal Acquisition Regulation 7.105 specifies the content
requirements for a written Acquisition Plan (AP). The Department of
Health and Human Services requires a written AP for all acquisitions
above the simplified acquisition threshold.
PART 308--REQUIRED SOURCES OF SUPPLIES AND SERVICES
Subpart 308.4--Federal Supply Schedules
Sec.
308.405-6 Limited source justification and approval.
Subpart 308.8--Acquisition of Printing and Related Supplies
308.800 Scope of subpart.
308.801 Definitions.
308.802 Policy.
308.803 Solicitation provision and contract clause.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 308.4--Federal Supply Schedules
308.405-6 Limited source justification and approval.
(d)(1) As required by Federal Acquisition Regulation (FAR) 8.405-1
or 8.405-2, the responsible program office must provide a written
justification for an acquisition under the Federal Supply Service
program that restricts the number of schedule contractors or when
procuring an item peculiar to one manufacturer.
Subpart 308.8--Acquisition of Printing and Related Supplies
308.800 Scope of subpart.
This subpart provides the Department of Health and Human Services
(HHS) policy for the acquisition of Government printing and related
supplies. The HHS Office of the Assistant Secretary for Public Affairs
is responsible for the review and clearance of print and electronic
publications, printing and related supplies, audiovisual products, and
communication service contracts. See FAR 8.802 for exceptions.
308.801 Definitions.
The terms ``printing'' and ``duplicating/copying'' are defined in
the Government Printing and Binding Regulations of the Joint Committee
on Printing. The regulations are available at https://www.gpo.gov.
308.802 Policy.
In accordance with FAR 8.802(b), the Central Printing and
Publications Management Organization at Program Support Center is the
HHS designated central printing authority.
308.803 Solicitation provision and contract clause.
The contracting officer shall insert the clause at 352.208-70,
Printing and Duplication, in all solicitations, contracts, and orders
over the simplified acquisition threshold, unless printing or increased
duplication is authorized by statute.
PART 309--CONTRACTOR QUALIFICATIONS
Subpart 309.4--Debarment, Suspension, and Ineligibility
Sec.
309.403 Definitions.
309.404 System for Award Management (SAM) exclusions.
309.405 Effect of listing (compelling reason determinations).
309.406 Debarment.
309.406-3 Procedures.
309.407 Suspension.
309.407-3 Procedures.
309.470 Reporting of suspected causes for debarment or suspension or
the taking of evasive actions.
309.470-1 Situations where reports are required.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 309.4 Debarment, Suspension, and Ineligibility
309.403 Definitions.
The following definition applies to this subpart:
The HHS Suspension and Debarment Official is the Deputy Assistant
Secretary (DAS) for the Office of Grants and Acquisition Policy and
Accountability (OGAPA).
309.404 System for Award Management (SAM) exclusions.
(c) For actions made by HHS pursuant to FAR 9.406 and 9.407, the
Office of Recipient Integrity Coordination shall perform the actions
required by FAR 9.404(c).
309.405 Effect of listing (compelling reason determinations).
(a) The head of the contracting activity (HCA) (non-delegable) may,
with the written concurrence of the Suspension and Debarment Official,
make the determinations referenced in FAR 9.405(a) regarding contracts.
(1) If a contracting officer considers it necessary to award a
contract, or consent to a subcontract with a debarred or suspended
contractor, the contracting officer shall prepare a determination,
including all pertinent documentation, and submit it through
appropriate acquisition channels to the HCA. The documentation shall
include the date by which approval is required and a compelling reason
for the proposed action. Compelling reasons for award of a contract or
consent to a subcontract with a debarred or suspended contractor
include the following:
(i) Only the cited contractor can provide the property or services,
and
(ii) The urgency of the requirement dictates that HHS conduct
business with the cited contractor.
(2) If the HCA decides to approve the requested action, the HCA
shall request the concurrence of the Suspension and Debarment Official
and, if given, shall inform the contracting officer in writing of the
determination within the required time period.
309.406 Debarment.
309.406-3 Procedures.
Refer all matters appropriate for consideration by an agency
Suspension and Debarment Official as soon as practicable to the
appropriate Suspension and Debarment Official identified in 309.403.
Any person may refer a matter to the Suspension and Debarment Official.
309.407 Suspension.
309.407-3 Procedures.
Refer all matters appropriate for consideration by an agency
Suspension and Debarment Official as soon as practicable to the
appropriate Suspension and Debarment Official identified in 309.403.
Any person may refer a matter to the Suspension and Debarment Official.
309.470 Reporting of suspected causes for debarment or suspension or
the taking of evasive actions.
309.470-1 Situations where reports are required.
The contracting officer shall report to the HCA and the Associate
Deputy
[[Page 72157]]
Assistant Secretary--Acquisition whenever the contracting officer--
(a) Knows or suspects that a contractor is committing or has
committed any of the acts described in FAR 9.406-2 or 9.407-2; or
(b) Suspects a contractor is attempting to evade the prohibitions
of debarment or suspension imposed under FAR 9.405, or any other
comparable regulation, by changes of address, multiple addresses,
formation of new companies, or by other devices.
PART 310--MARKET RESEARCH
Sec.
310.001 Policy.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
310.001 Policy.
Market research shall be conducted as prescribed in Federal
Acquisition Regulation part 10.
PART 311--DESCRIBING AGENCY NEEDS
Subpart 311.70--Section 508 Accessibility Standards
Sec.
311.7000 Defining electronic information technology requirements.
Subpart 311.71--Public Accommodations and Commercial Facilities
311.7100 Policy.
311.7101 Responsibilities.
311.7102 Contract clause.
Subpart 311.72--Conference Funding and Sponsorship
311.7200 Policy.
311.7201 Funding and sponsorship.
311.7202 Contract clause.
Subpart 311.73--Contractor Collection of Information
311.7300 Policy.
311.7301 Contract clause.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 311.70--Section 508 Accessibility Standards
311.7000 Defining electronic and information technology requirements.
The contracting officer shall ensure that requiring activities
specify agency needs for electronic and information technology (EIT)
supplies and services, and document market research, document EIT
requirements, and identify the applicable Section 508 accessibility
standards. See FAR 11.002(f) and HHSAR subpart 339.2.
Subpart 311.71--Public Accommodations and Commercial Facilities.
311.7100 Policy.
(a) It is HHS policy that all contractors comply with current and
any future changes to 28 CFR part 36--Nondiscrimination on the Basis of
Disability by Public Accommodations and in Commercial Facilities. For
the purpose of this policy, accessibility is defined as both physical
access to public accommodations and commercial facilities, and access
to aids and services enabling individuals with sensory disabilities to
fully participate in events in public accommodations and commercial
facilities.
(b) This policy applies to all contracts requiring contractors to
conduct events in public accommodations and commercial facilities open
to the public or involving HHS personnel, but not ad hoc meetings
necessary or incidental to contract performance.
311.7101 Responsibilities.
The contractor shall submit a plan assuring that any event held
will meet or exceed the minimum accessibility standards set forth in 28
CFR part 36. A consolidated or master plan for contracts requiring
numerous events in public accommodations and commercial facilities is
acceptable.
311.7102 Contract clause.
The contracting officer shall insert the clause at 352.211-1,
Public Accommodations and Commercial Facilities, in solicitations,
contracts, and orders requiring the contractor to conduct events in
accordance with 311.7100(b).
Subpart 311.72--Conference Funding and Sponsorship
311.7200 Policy.
HHS policy requires that all conferences the agency funds or
sponsors shall: be consistent with HHS missions, objectives, and
policies; represent an efficient and effective use of taxpayer funds;
and withstand public scrutiny.
311.7201 Funding and sponsorship.
Funding a conference through a HHS contract does not automatically
imply HHS sponsorship, unless the conference is funded entirely by the
agency. Also, HHS staff attendance or participation at a conference
does not imply HHS conference sponsorship. Accordingly, for non-
conference contracts funded entirely by HHS prior to a contractor
claiming HHS sponsorship, the contractor must provide the contracting
officer a written request for permission to designate HHS the
conference sponsor. The OPDIV or STAFFDIV (operating division or staff
division) head, or designee, shall approve such requests. The
determination on what constitutes a ``conference contract'' or a ``non-
conference contract'' shall be made by the contracting officer.
311.7202 Contract clause.
To ensure that a contractor:
(a) Properly requests approval to designate HHS the conference
sponsor, where HHS is not the sole provider of conference funding; and
(b) Includes an appropriate Federal funding disclosure and content
disclaimer statement for conference materials, the contracting officer
shall include the clause at 352.211-2, Conference Sponsorship Request
and Conference Materials Disclaimer, in solicitations, contracts, and
orders providing funding which partially or fully supports a
conference.
Subpart 311.73--Contractor Collection of Information
311.7300 Policy.
In accordance with the Paperwork Reduction Act (PRA), contractors
shall not proceed with collecting information from surveys,
questionnaires, or interviews until the COR obtains an Office of
Management and Budget clearance and the contracting officer issues
written approval to proceed. For any contract involving a requirement
to collect or record information calling either for answers to
identical questions from 10 or more persons other than Federal
employees, or information from Federal employees which is outside the
scope of their employment, for use by the Federal Government or
disclosure to third parties, the contracting officer must comply with
the PRA of 1995 (44 U.S.C. 3501 et seq.).
311.7301 Contract clause.
The contracting officer shall insert the clause at 352.211-3,
Paperwork Reduction Act, in solicitations, contracts, and orders that
require a contractor to collect the same information from 10 or more
persons.
PART 312--ACQUISITION OF COMMERCIAL ITEMS
Subpart 312.1--Acquisition of Commercial Items--General
Sec.
312.101 Policy.
Subpart 312.2--Special Requirements for the Acquisition of Commercial
Items
312.202(d) Market research and description of agency need.
[[Page 72158]]
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 312.1--Acquisition of Commercial Items--General
312.101 Policy.
Contracting offices shall use the HHS Smarter Buying Program to the
maximum extent practicable. See HHS Acquisition Regulation part 307,
Acquisition Planning.
Subpart 312.2--Special Requirements for the Acquisition of
Commercial Items
312.202(d) Market research and description of agency need.
Whenever a requiring activity specifies electronic and information
technology (EIT) supplies and services subject to Section 508 of the
Rehabilitation Act of 1973, as amended, the requiring activity shall
acquire commercially available supplies and services to the maximum
extent possible while ensuring Section 508 compliance. See part 339.
SUBCHAPTER C--CONTRACTING METHODS AND CONTRACT TYPES
PART 313--SIMPLIFIED ACQUISITION PROCEDURES
Sec.
313.003 Policy.
Subpart 313.3--Simplified Acquisition Methods
313.301 Government-wide commercial purchase card.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
313.003 Policy.
Electronic and information technology (EIT) supplies and services
acquired pursuant to Federal Acquisition Regulation part 13 shall
comply with Section 508 of the Rehabilitation Act of 1973, as amended.
See part 339.
Subpart 313.3--Simplified Acquisition Methods
313.301 Government-wide commercial purchase card.
(b) Make all HHS transactions utilizing the government-wide
commercial purchase card in accordance with the HHS Purchase Card
Program.
PART 314--SEALED BIDDING
Subpart 314.1--Use of Sealed Bidding
Sec.
314.103 Policy.
Subpart 314.4--Opening of Bids and Award of Contract
314.404 Rejection of bids.
314.404-1 Cancellation of invitations after opening.
314.407 Mistakes in bids.
314.407-3 Other mistakes disclosed before award.
314.407-4 Mistakes after award.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 314.1--Use of Sealed Bidding
314.103 Policy.
Electronic and information technology (EIT) supplies and services
acquired using sealed-bid procedures shall comply with Section 508 of
the Rehabilitation Act of 1973, as amended. See part 339.
Subpart 314.4--Opening of Bids and Award of Contract
314.404 Rejection of bids.
314.404-1 Cancellation of invitations after opening.
(c) The head of the contracting activity (HCA) shall make the
determinations specified in FAR 14.404-1(c).
314.407 Mistakes in bids.
314.407-3 Other mistakes disclosed before award.
(e) The HCA has the authority to make determinations under
paragraphs (a), (b), (c), and (d) of FAR 14.407-3.
314.407-4 Mistakes after award.
(c) The HCA has the authority to make administrative determinations
in connection with alleged post-award mistakes.
PART 315--CONTRACTING BY NEGOTIATION
Subpart 315.2--Solicitation and Receipt of Proposals and Information
Sec.
315.204-5 Part IV--Representations and instructions.
315.208 Submission, modification, revision, and withdrawal of
proposals.
Subpart 315.3--Source Selection
315.303-70 Policy.
315.304 Evaluation factors and significant subfactors.
315.305 Proposal evaluation.
Subpart 315.4--Contract Pricing
315.404 Proposal analysis.
315.404-2 Information to support proposal analysis.
Subpart 315.6--Unsolicited Proposals
315.605 Content of unsolicited proposals.
315.606 Agency procedures.
315.606-1 Receipt and initial review.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 315.2--Solicitation and Receipt of Proposals and
Information
315.204-5 Part IV--Representations and instructions.
(c) Section M, Evaluation factors for award. (1) The requiring
activity shall develop technical evaluation factors and submit them to
the contracting officer as part of the acquisition plan or other
acquisition request documentation for inclusion in a solicitation. The
requiring activity shall indicate the relative importance or weight of
the evaluation factors based on the requirements of an individual
acquisition.
(2) Only a formal amendment to a solicitation can change the
evaluation factors.
315.208 Submission, modification, revision, and withdrawal of
proposals.
(b) In addition to the provision in Federal Acquisition Regulation
(FAR) 52.215-1, Instructions to Offerors--Competitive Acquisition, if
the head of the contracting activity (HCA) determines that biomedical
or behavioral research and development (R&D) acquisitions are subject
to conditions other than those specified in FAR 52.215-1(c)(3), the HCA
may authorize for use in competitive solicitations for R&D, the
provision at 352.215-70, Late Proposals and Revisions. This is an
authorized FAR deviation.
(2) When the provision at 352.215-70 is included in the
solicitation and if the HCA intends to consider a proposal or proposals
received after the exact time specified for receipt, the contracting
officer, with the assistance of cost or technical personnel as
appropriate, shall determine in writing that the proposal(s) meets the
requirements of the provision at 352.215-70.
Subpart 315.3--Source Selection
315.303-70 Policy.
(a) If an operating division (OPDIV) is required by statute to use
peer review for technical review of proposals, the requirements of
those statutes, any implementing regulatory requirements, the Federal
Advisory Committee Act, and as applicable, any approved Department of
Health and Human Services Acquisition Regulation (HHSAR) deviation(s)
from this subpart take precedence over the otherwise applicable
requirements of this subpart.
(b) The statutes that require such review and implementing
regulations are as follows: National Institutes of Health--42 U.S.C.
289a, Peer Review
[[Page 72159]]
Requirements and 42 CFR part 52h, Scientific Peer Review of Research
Grant Applications and Research and Development Contract Projects;
Substance Abuse and Mental Health Services Administration--42 U.S.C.
290aa-3, Peer Review and Agency for Healthcare Research and Quality--42
U.S.C. 299c-1, Peer review with respect to grants and contracts.
315.304 Evaluation factors and significant subfactors.
When acquiring electronic and information technology supplies and
services (EIT) using negotiated procedures, contracting officers shall
comply with Section 508 of the Rehabilitation Act of 1973, as amended.
315.305 Proposal evaluation.
(c) Use of non-Federal evaluators. (1) Except when peer review is
required by statute as provided in 315.303-70(a), decisions to disclose
proposals to non-Federal evaluators shall be made by the official
responsible for appointing Source Selection Evaluation Team members in
accordance with OPDIV procedures. The avoidance of organizational and
personal conflicts of interest must be taken into consideration when
making the decision to use non-Federal evaluators.
(2) When a solicited proposal will be disclosed outside the
Government to a contractor or a contractor employee for evaluation
purposes, the following or similar conditions shall be part of the
written agreement with the contractor prior to disclosure:
CONDITIONS FOR EVALUATING PROPOSALS
The contractor agrees that it and its employees, as well as any
subcontractors and their employees (in these conditions, ``evaluator'')
will use the data (trade secrets, business data, and technical data)
contained in the proposal for evaluation purposes only. The foregoing
requirement does not apply to data obtained from another source without
restriction. Any notice or legend placed on the proposal by either HHS
or the offeror shall be applied to any reproduction or abstract
provided to the evaluator or made by the evaluator. Upon completion of
the evaluation, the evaluator shall return to the Government the
furnished copy of the proposal or abstract, and all copies thereof, to
the HHS office which initially furnished the proposal for evaluation.
The evaluator shall not contact the offeror concerning any aspects of a
proposal's contents.
Subpart 315.4--Contract Pricing
315.404 Proposal analysis.
315.404-2 Information to support proposal analysis.
(a)(2) When some or all information sufficient to determine the
reasonableness of the proposed cost or price is already available or
can be obtained from the cognizant audit agency, or by other means
including data obtained through market research (See FAR part 10 and
HHSAR part 310) the contracting officer may request less-than-complete
field pricing support (specifying in the request the information
needed) or may waive in writing the requirement for audit and field
pricing support by documenting the file to indicate what information
will be used. When field-pricing support is required, contracting
officers shall make the request through the HCA.
Subpart 315.6--Unsolicited Proposals
315.605 Content of unsolicited proposals.
(d) Warranty by offeror. To ensure against contacts between HHS
personnel and prospective offerors that would exceed the limits of
advance guidance set forth in FAR 15.604 and potentially result in an
unfair advantage to an offeror, the prospective offeror of an
unsolicited proposal must include the following warranty in any
unsolicited proposal. Contracting officers receiving an unsolicited
proposal without this warranty shall not process the proposal until the
offeror is notified of the missing language and given an opportunity to
submit a proper warranty. If no warranty is provided in a reasonable
time, the contracting officer shall reject the unsolicited proposal,
notify the offeror of the rejection, and document the actions in the
file.
UNSOLICITED PROPOSAL
WARRANTY BY OFFEROR
This is to warrant that--
(a) This proposal has not been prepared under Government
supervision;
(b) The methods and approaches stated in the proposal were
developed by this offeror;
(c) Any contact with HHS personnel has been within the limits of
appropriate advance guidance set forth in FAR 15.604; and,
(d) No prior commitments were received from HHS personnel regarding
acceptance of this proposal.
Date:------------------------------------------------------------------
Organization:----------------------------------------------------------
Name:------------------------------------------------------------------
Title:-----------------------------------------------------------------
(This warranty shall be signed by a responsible management official
of the proposing organization who is a person authorized to
contractually obligate the organization.)
315.606 Agency procedures.
(a) The HCA is responsible for establishing procedures to comply
with FAR 15.606(a).
(b) The HCA or designee shall be the point of contact for
coordinating the receipt and processing of unsolicited proposals.
315.606-1 Receipt and initial review.
(d) OPDIVs may consider an unsolicited proposal even though an
organization initially submitted it as a grant application. However,
OPDIVs shall not award contracts based on unsolicited proposals that
have been rejected for grant awards due to lack of scientific merit.
PART 316--TYPES OF CONTRACTS
Subpart 316.3--Cost-Reimbursement Contracts
Sec.
316.307 Contract clauses.
Subpart 316.5--Indefinite-Delivery Contracts
316.505 Ordering.
Subpart 316.6--Time-and-Materials, Labor-Hour, and Letter Contracts
316.603 Letter contracts.
316.603-3 Limitations.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 316.3--Cost-Reimbursement Contracts
316.307 Contract clauses.
(a)(1) If a contract for research and development is with a
hospital (profit or nonprofit), the contracting officer shall modify
the ``Allowable Cost and Payment'' clause at FAR 52.216-7 by deleting
from paragraph (a) the words ``Federal Acquisition Regulation (FAR)
subpart 31.2'' and substituting ``45 CFR part 75.''
(2) The contracting officer shall also insert the clause at
352.216-70, Additional Cost Principles for Hospitals (Profit or Non-
Profit), in solicitations and contracts with a hospital (profit or non-
profit) when a cost-reimbursement contract is contemplated.
Subpart 316.5--Indefinite-Delivery Contracts
316.505 Ordering.
(b)(8) The Department of Health and Human Services (HHS)
Competition Advocate is the task-order and delivery-
[[Page 72160]]
order ombudsman for the department. Ombudsmen for each of the HHS
contracting activities shall be designated in writing by the head of
the contracting activity. See part 306.
Subpart 316.6--Time-and-Materials, Labor-Hour, and Letter Contracts
316.603 Letter contracts.
316.603-3 Limitations.
An official one level above the contracting officer shall make the
written determination, to be included in the contract file, that no
other contract type is suitable and to approve all letter contract
modifications. No letter contract or modification can exceed the limits
prescribed in FAR 16.603-2(c).
PART 317--SPECIAL CONTRACTING METHODS
Subpart 317.1--Multi-Year Contracting
Sec.
317.104 General.
317.105 Policy.
317.105-1 Uses.
317.107 Options.
317.108 Congressional notification.
Subpart 317.2--Options
317.204 Contracts.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 317.1--Multi-Year Contracting
317.104 General.
(b) The Senior Procurement Executive (SPE) is the agency approving
official for determinations under Federal Acquisition Regulation (FAR)
17.104(b).
317.105 Policy.
317.105-1 Uses.
(a) Each head of the contracting activity (HCA) determination to
use multi-year contracting, as defined in FAR 17.103, is limited to
individual acquisitions where the full estimated cancellation ceiling
does not exceed 20 percent of the total contract value over the multi-
year term or $12.5 million, whichever is less. Cancellation ceiling
provisions shall conform to the requirements of FAR 17.106-1(c). The
determination is not delegable and shall address the issues in FAR
17.105-1(a).
(b)(1) SPE approval is required for any--
(i) Individual determination to use multi-year contracting with a
cancellation ceiling in excess of the limits in 317.105-1(a); or
(ii) Class determination (see FAR subpart 1.7).
(2) A determination involving a cancellation ceiling in excess of
the limits in 317.105-1(a) shall present a well-documented
justification for the estimated cancellation ceiling. When the
estimated cancellation ceiling exceeds $12.5 million, the determination
shall accompany a draft congressional notification letter pursuant to
FAR 17.108 and 317.108.
317.107 Options.
When included as part of a multi-year contract, use of options
shall not extend the performance of the original requirement beyond 5
years. Options may serve as a means to acquire related services
(severable or non-severable) and, upon their exercise, shall receive
funding from the then-current fiscal year's appropriation.
317.108 Congressional notification.
(a) The SPE shall give the approval of the written notification
required by FAR 17.108(a). Upon approval of the determination required
by 317.105-1(b)(1), the HCA will finalize and sign the congressional
notification letter and provide it to the appropriate House and Senate
committees.
Subpart 317.2--Options
317.204 Contracts.
(e)(1) Information technology contracts. Notwithstanding FAR
17.204(e), the 5-year limitations apply also to information technology
contracts unless a longer period is authorized by statute.
(2) Requests to exceed 5-year limitation. A request to exceed the
5-year limitation specified in FAR 17.204(e) must follow guidance in
FAR Part 1.7.
(3) Approval authority. All requests to exceed the 5-year
limitations specified in FAR 17.204(e) must be supported with a
Determination and Finding and approved by:
(i) The HCA; and
(ii) The HHS SPE.
SUBCHAPTER D--SOCIOECONOMIC PROGRAMS
PART 319--SMALL BUSINESS PROGRAMS
Subpart 319.2--Policies
Sec.
319.201 General policy.
319.270-1 Mentor Prot[eacute]g[eacute] Program Solicitation
provision and contract clause.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 319.2--Policies
319.201 General policy.
(d) The functional management responsibilities for the Department
of Health and Human Services' (HHS) small business program are
delegated to the Office of Small and Disadvantaged Business Utilization
(OSDBU) Director.
(e)(1) The HHS OSDBU Director shall exercise full management
authority over the small business program. The small business
specialist (SBS) shall review and make recommendations for all
acquisitions, unless exempted by statute, that are not being set aside
for small business in accordance with Federal Acquisition Regulation
(FAR) 19.502. The review must take place prior to issuing the
solicitation.
(2) Within the Indian Health Service (IHS), the primary SBSs are
responsible for IHS' overall implementation of the HHS small business
program; however, each IHS contracting office will assign a small
business technical advisor (SBTA) to perform those functions and
responsibilities necessary to implement the small business program. The
primary IHS SBS shall assist and provide guidance to respective SBTAs.
319.270-1 Mentor Prot[eacute]g[eacute] Program Solicitation provision
and contract clause.
(a) The contacting officer shall insert the provision at 352.219-
70, Mentor-Prot[eacute]g[eacute] Program, in solicitations that include
the clause at FAR 52.219-9, Small Business Subcontracting Plan. The
provision requires offerors to provide the contracting officer a copy
of their HHS Office of OSDBU-approved mentor-prot[eacute]g[eacute]
agreement in response to a solicitation.
(b) The contacting officer shall insert the clause at 352.219-71,
Mentor-Prot[eacute]g[eacute] Program Reporting Requirements, in
contracts that include the clause at FAR 52.219-9, Small Business
Subcontracting Plan, and which are awarded to a contractor with an HHS
OSDBU-approved mentor-prot[eacute]g[eacute] agreement.
PART 322--APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS
Subpart 322.8--Equal Employment Opportunity
Sec.
322.810 Solicitation provisions and contract clauses.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 322.8--Equal Employment Opportunity
322.810 Solicitation provisions and contract clauses.
(h) The contracting officer shall insert the clause at 352.222-70,
Contractor Cooperation in Equal Employment Opportunity Investigations,
in
[[Page 72161]]
solicitations, contracts, and orders that include the clause at FAR
52.222-26, Equal Opportunity.
PART 323--ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE
ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE
Subpart 323.70--Safety and Health
Sec.
323.7000 Scope of subpart.
323.7001 Policy.
323.7002 Actions required.
Subpart 323.71--Sustainable Acquisition Requirements
323.7100 Policy.
323.7101 Applicability.
323.7102 Procedures.
323.7103 Solicitation Provision.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
323.7000 Scope of subpart.
This subpart provides procedures for administering safety and
health requirements.
323.7001 Policy.
The contracting officer shall follow the guidance in this subpart
when additional requirements for safety and health are necessary for an
acquisition.
323.7002 Actions required.
Contracting activities. The contracting officer shall insert the
clause at 352.223-70, Safety and Health, or a clause substantially the
same, in solicitations and contracts that involve hazardous materials
or hazardous operations for the following types of requirements:
(a) Services or products.
(b) Research, development, or test projects.
(c) Transportation of hazardous materials.
(d) Construction, including construction of facilities on the
contractor's premises.
Subpart 323.71--Sustainable Acquisition Requirements
323.7100 Policy.
This subpart provides procedures for sustainable acquisitions and
use of the following: Designated recycled content; energy efficient,
environmentally preferred, Electronic Product Environmental Assessment
Tool (EPEAT)-registered, bio-based, water efficient, non-ozone
depleting products and services; and alternate fuel vehicles and fuels.
The Department of Health and Human Services (HHS) has designated
product and service codes for supplies and services having sustainable
acquisition attributes. See FAR part 23.
323.7101 Applicability.
It is HHS policy to include a solicitation provision and to include
an evaluation factor for an offeror's Sustainable Action Plan when
acquiring sustainable products and services. This applies only to new
contracts and orders above the micro-purchase threshold. Such contracts
and orders include, but are not limited to: Office supplies;
construction, renovation or repair; building operations and
maintenance; landscaping services; pest management; electronic
equipment, including leasing; fleet maintenance; janitorial services;
laundry services; cafeteria operations; and meetings and conference
services. If using a product or service code designated for supplies or
services having sustainable acquisition attributes but a review of the
requirement determines that no opportunity exists to acquire
sustainable acquisition supplies or services, document the
determination in the contract file and make note in the solicitation.
323.7102 Procedures.
(a) When required by the solicitation, offerors or quoters must
include a Sustainable Acquisition Plan in their technical proposal
addressing the environmental products and services for delivery under
the resulting contract.
(b) The contracting officer shall incorporate the final Sustainable
Acquisition Plan into the contract.
(c) The contracting officer shall ensure that sustainability is
included as an evaluation factor in all applicable new contracts and
orders when the acquisition utilizes a product or service code
designated by HHS for supplies or services having sustainable
acquisition attributes.
323.7103 Solicitation Provision.
The contracting officer shall insert the provision at 352.223-71,
Instruction to Offerors--Sustainable Acquisition, in solicitations
above the micro-purchase threshold when the acquisition utilizes a
product or service code designated by HHS as having sustainable
acquisition attributes.
PART 324--PROTECTION OF PRIVACY AND FREEDOM OF INFORMATION
Subpart 324.1--Protection of Individual Privacy
Sec.
324.103 Procedures for the Privacy Act.
324.104 Restrictions on Contractor Access to Government or Third
Party Information.
324.105 Contract clauses.
Subpart 324.70--Health Insurance Portability and Accountability Act of
1996 (HIPAA)
324.7000 Scope of subpart.
324.7001 Policy on Compliance with HIPAA Business Associate Contract
Requirements.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 324.1--Protection of Individual Privacy
324.103 Procedures for the Privacy Act.
(a) The contracting officer shall review all acquisition request
documentation to determine whether the requirements of the Privacy Act
of 1974 (5 U.S.C. 552a) are applicable. The Privacy Act requirements
apply when a contract or order requires the contractor to design,
develop, or operate any Privacy Act system of records on individuals to
accomplish an agency function. When applicable, the contracting officer
shall include the two Privacy Act clauses required by Federal
Acquisition Regulation (FAR) 24.104 in the solicitation and contract or
order. In addition, the contracting officer shall include the two FAR
Privacy Act clauses, and other pertinent information specified in this
subpart, in any modification which results in the Privacy Act
requirements becoming applicable to a contract or order.
(b) The contracting officer shall ensure that the statement of work
or performance work statement (SOW or PWS) specifies the system(s) of
records or proposed system(s) of records to which the Privacy Act and
the implementing regulations are applicable or may be applicable. The
contracting officer shall send the contractor a copy of 45 CFR part 5b,
which includes the rules of conduct and other Privacy Act requirements.
(c) The contracting officer shall ensure that the contract SOW or
PWS specifies for both the Privacy Act and the Federal Records Act the
disposition to be made of the system(s) of records upon completion of
contract performance. The contract SOW or PWS may require the
contractor to destroy the records, remove personal identifiers, or turn
the records over to the contracting officer. If there is a legitimate
need for a contractor to keep copies of the records after completion of
a contract, the contractor must take measures, as approved by the
contracting officer, to keep the records
[[Page 72162]]
confidential and protect the individuals' privacy.
(d) For any acquisition subject to Privacy Act requirements, the
requiring activity prior to award shall prepare and have published in
the Federal Register a ``system notice,'' describing the Department of
Health and Human Services' (HHS) intent to establish a new system of
records on individuals, to make modifications to an existing system, or
to disclose information in regard to an existing system. The requiring
activity shall attach a copy of the system notice to the acquisition
plan or other acquisition request documentation. If a system notice is
not attached, the contracting officer shall inquire about its status
and shall obtain a copy from the requiring activity for inclusion in
the contract file. If a notice for the system of records has not been
published in the Federal Register, the contracting officer may proceed
with the acquisition but shall not award the contract until the system
notice is published and the contracting officer verifies its
publication.
324.104 Restrictions on Contractor Access to Government or Third Party
Information.
The contracting officer shall establish the restrictions that
govern the contractor employees' access to Government or third party
information in order to protect the information from unauthorized use
or disclosure.
324.105 Contract clauses.
(a) The contracting officer shall insert the clause at 352.224-70,
Privacy Act, in solicitations, contracts, and orders that require the
design, development, or operation of a system of records to notify the
contractor that it and its employees are subject to criminal penalties
for violations of the Privacy Act (5 U.S.C. 552a(i)) to the same extent
as HHS employees. The clause also requires the contractor to ensure
each of its employees knows the prescribed rules of conduct in 45 CFR
part 5b and each contractor employee is aware that he or she is subject
to criminal penalties for violations of the Privacy Act. These
requirements also apply to all subcontracts awarded under the contract
or order that require the design, development, or operation of a system
of records.
(b) The contracting officer shall insert the clause at 352.224-71,
Confidential Information, in solicitations, contracts, and orders that
require access to Government or to third party information.
Subpart 324.70--Health Insurance Portability and Accountability Act
of 1996
324.7000 Scope of subpart.
All individually identifiable health information that is Protected
Health Information (PHI), as defined in 45 CFR 160.103 shall be
administered in accordance with the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) implementing regulations at 45 CFR
parts 160 and 164 (the HIPAA Privacy, Security, and Breach Notification
Rules). The term ``HIPAA'' is used in this part to refer to title II,
subtitle F of the HIPAA statute, at part C of title XI of the Social
Security Act, 42 U.S.C. 1320d et seq., section 264 of HIPAA, subtitle D
of title XIII of the American Recovery and Reinvestment Act of 2009,
and regulations under such provisions.
324.7001 Policy on Compliance with HIPAA business associate contract
requirements.
(a) HHS is a HIPAA ``covered entity'' that is a ``hybrid entity''
as these terms are defined at sections 160.103 and 164.103
respectively. As such, only the portions of HHS that the Secretary has
designated as ``health care components'' (HCC) as defined at section
164.103, are subject to HIPAA. HHS' HCCs may utilize persons or
entities known as ``business associates,'' as defined at section
160.103. Generally, ``business associate'' means a ``person'' as
defined by section 160.103 (including contractors, and third-party
vendors, etc.) if or when the person or entity:
(1) Creates, receives, maintains, or transmits ``protected health
information'', as the term is defined at section 160.103, on behalf of
an HHS HCC to carry out HHS HIPAA ``covered functions'' as that term is
defined at 164.103; or
(2) Provides certain services to an HHS HCC that involve PHI.
(b) Where the Department as a covered entity is required by 45 CFR
164.502(e)(1) and 164.504(e) and, if applicable, sections 164.308(b)(3)
and 164.314(a), to enter into a HIPAA business associate contract, the
relevant HCC contracting officer, acting on behalf of the Department,
shall ensure that such contract meets the requirements at section
164.504(e)(2) and, if applicable, section 164.314(a)(2).
PART 326--OTHER SOCIOECONOMIC PROGRAMS
Subpart 326.5--Indian Preference in Employment, Training, and
Subcontracting Opportunities
Sec.
326.501 Statutory requirements.
326.502 Definitions.
326.503 Compliance enforcement.
326.504 Tribal Preference requirement.
326.505 Applicability.
Subpart 326.6--Acquisitions Under the Buy Indian Act
326.600 Scope of subpart.
326.601 Policy.
326.602 Definitions.
326.603 Requirements.
326.604 Competition.
326.605 Responsibility determinations.
Subpart 326.7--Acquisitions Requiring the Native American Graves
Protection and Repatriation Act
326.700 Scope of subpart.
326.701 Applicability.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 326.5--Indian Preference in Employment, Training, and
Subcontracting Opportunities
326.501 Statutory requirements.
Any contract or subcontract pursuant to subchapter II, chapter 14,
title 25 of the United States Code, the Act of April 16, 1934 (48 Stat.
596), as amended, or any other Act authorizing Federal contracts with
or grants to Indian organizations or for the benefit of Indians, shall,
to the greatest extent feasible, comply with section 7(b) of the Indian
Self-Determination and Education Assistance Act, Public Law 93-638, 88
Stat. 2205, 25 U.S.C. 450e(b) which provides preferences and
opportunities for training and employment in connection with the
administration of such contracts, and preference in the award of
subcontracts in connection with the administration of such contracts to
Indian organizations and to Indian-owned economic enterprises as
defined in section 1452 of title 25, United States Code.
326.502 Definitions.
For purposes of this subpart, the following definitions shall
apply:
(a) Indian means a person who is a member of an Indian tribe. If
the contractor has reason to doubt that a person seeking employment
preference is an Indian, the contractor shall grant the preference but
shall require the individual provide evidence within 30 days from the
tribe concerned that the person is a member of the tribe.
(b) Indian tribe means an Indian tribe, pueblo, band, nation, or
other organized group or community, including any Alaska Native Village
or regional or village corporation as defined in or established
pursuant to the Alaska Native Claims Settlement Act (85 Stat. 688, 43
U.S.C. 1601), which the United
[[Page 72163]]
States recognizes as eligible for special programs and services because
of its status as Indian.
(c) Indian organization means the governing body of any Indian
tribe, or entity established or recognized by such governing body, in
accordance with the Indian Financing Act of 1974 (88 Stat. 77, 25
U.S.C. 1451).
(d) Indian-owned economic enterprise means any Indian-owned
commercial, industrial, or business activity established or organized
for the purpose of profit, provided that such Indian ownership shall
constitute not less than 51 percent of the enterprise, and the
ownership shall encompass active operation and control of the
enterprise.
(e) Indian reservation includes Indian reservations, public domain
Indian allotments, former Indian reservations in Oklahoma, and land
held by incorporated Native groups, regional corporations, and village
corporations under the provisions of the Alaska Native Claims
Settlement Act (85 Stat. 688, 43 U.S.C. 1601 et seq.).
(f) On or near an Indian reservation means on a reservation or
reservations or within that area surrounding an Indian reservation(s)
where a person seeking employment could reasonably commute to and from
in the course of a work day.
326.503 Compliance enforcement.
The contracting officer shall promptly investigate and resolve
written complaints of noncompliance with the requirements of the
clauses at 352.226-1, Indian Preference and 352.226-2, Indian
Preference Program filed with the contracting activity.
326.504 Tribal preference requirements.
(a) When the contractor will perform work under a contract on an
Indian reservation, the contracting officer may supplement the clause
at 352.226-2, Indian Preference Program by adding specific Indian
preference requirements of the tribe on whose reservation the
contractor will work. The contracting activity and the tribe shall
jointly develop supplemental requirements for the contract.
Supplemental preference requirements shall represent a further
implementation of the requirements of section 7(b) of Public Law 93-638
and require the approval of the affected program director and the
appropriate legal office, or a regional attorney, before the
contracting officer adds them to a solicitation and resultant contract.
Any supplemental preference requirements the contracting officer adds
to the clause at 352.226-2, Indian Preference Program shall also
clearly identify in the solicitation the additional requirements.
(b) Nothing in this part shall preclude tribes from independently
developing and enforcing their own tribal preference requirements. Such
independently-developed tribal preference requirements shall not,
except as provided in paragraph (a) of this section, become a
requirement in contracts covered under this subpart, and shall not
conflict with any Federal statutory or regulatory requirement
concerning the award and administration of contracts.
326.505 Applicability.
The contracting officer shall insert the clause at 352.226-1,
Indian Preference, and the clause at 352.226-2, Indian Preference
Program, in contracts to implement section 7(b) of Public Law 93-638
for all Department of Health and Human Services (HHS) activities.
Contracting activities shall use the clauses as follows, except for
those exempted solicitations and contracts issued and or awarded
pursuant to Title I of Public Law 93-638 (25 U.S.C. 450 et seq.):
(a) The contracting officer shall insert the clause at 352.226-1,
Indian Preference, in solicitations, contracts, and orders when--
(1) The award is (or will be) pursuant to an act specifically
authorizing such awards with Indian organizations; or
(2) The work is specifically for the benefit of Indians and is in
addition to any incidental benefits which might otherwise accrue to the
general public.
(b) The contracting officer shall insert the clause at 352.226-2,
Indian Preference Program, in solicitations, contracts, and orders
when--
(1) The dollar amount of the acquisition is expected to equal or
exceed $650,000 for non-construction work or $1.5 million for
construction work;
(2) The solicitation, contract, or order includes the Indian
Preference clause; and
(3) The contracting officer makes the determination, prior to
solicitation, that performance will take place in whole or in
substantial part on or near an Indian reservation(s). In addition, the
contracting officer may insert the Indian Preference Program clause in
solicitations, contracts, and orders below the $650,000 or $1.5 million
level for non-construction or construction contracts, respectively, but
which meet the requirements of paragraphs (b)(2) and (3) of this
section, and in the opinion of the contracting officer, offer
substantial opportunities for Indian employment, training, and
subcontracting.
Subpart 326.6--Acquisitions Under the Buy Indian Act
326.600 Scope of subpart.
This subpart sets forth the policy on preferential acquisition from
Indians under the negotiation authority of the Buy Indian Act. This
subpart applies only to acquisitions made by or on behalf of Indian
Health Service (IHS).
326.601 Policy.
(a) IHS shall utilize the negotiation authority of the Buy Indian
Act to give preference to Indians whenever authorized and practicable.
The Buy Indian Act, 25 U.S.C. 47, prescribes the application of the
advertising requirements of 41 U.S.C. 6101 to the acquisition of Indian
supplies. As specified in 25 U.S.C. 47, the Buy Indian Act provides
that, so far as practicable, the Government shall employ Indian labor
and, at the discretion of the Secretary of the Interior, purchase
products of Indian industry (including, but not limited to printing,
notwithstanding any other law) from the open market.
(b) Due to the transfer of authority from the Department of the
Interior to HHS, the Secretary of HHS may use the Buy Indian Act to
acquire products of Indian industry in connection with the maintenance
and operation of Indian hospital and health facilities, and for the
overall conservation of Indian health. This authority is exclusively
delegated to IHS and is not available for use by any other HHS
component (unless that component makes an acquisition on behalf of
IHS). However, the Buy Indian Act itself does not exempt IHS from
meeting the statutorily mandated small business goals.
(c) Subsequent legislation, particularly Public Law 94-437 and
Public Law 96-537, emphasize using the Buy Indian Act negotiation
authority.
326.602 Definitions.
(a) Buy Indian contract means any contract involving activities
covered by the Buy Indian Act and negotiated under the provisions of 41
U.S.C. 3104 and 25 U.S.C. 47 between an Indian firm and a contracting
officer representing IHS.
(b) Indian means a member of any tribe, pueblo, band, group,
village, or community recognized by the Secretary of the Interior as
being Indian or any individual or group of individuals recognized by
the Secretary of the Interior or the Secretary of HHS. The
[[Page 72164]]
Secretary of HHS in making determinations may take into account the
determination of the tribe with which affiliation is claimed.
(c) Indian firm means a sole enterprise, partnership, corporation,
or other type of business organization owned, controlled, and operated
by:
(1) One or more Indians (including, for the purpose of sections 301
and 302 of Public Law 94-437, former or currently federally recognized
Indian tribes in the State of New York); or
(2) By an Indian firm (as defined in paragraph (1) of this
definition); or
(3) A nonprofit firm organized for the benefit of Indians and
controlled by Indians (see 326.601(a)).
(d) Product of Indian industry means anything produced by Indians
through either physical labor or intellectual effort involving the use
and application of their skills. To classify as a product of Indian
industry, the total cost of the item's production must equal or exceed
51 percent Indian effort.
326.603 Requirements.
(a) Indian ownership. Indian ownership shall constitute at least 51
percent of an Indian firm during the period covered by a Buy Indian
contract.
(b) Joint ventures. An Indian firm may enter into a joint venture
with other entities for specific projects as long as the Indian firm is
the managing partner. However, the contracting officer shall approve
the joint venture prior to the award of a contract under the Buy Indian
Act.
(c) Bonds. In the case of contracts for the construction,
alteration, or repair of public buildings or public works, the Miller
Act (40 U.S.C. 3131 et seq.) and Federal Acquisition Regulation (FAR)
part 28 require performance and payment bonds. Bonds are not required
in the case of contracts with Indian tribes or public nonprofit
organizations serving as governmental instrumentalities of an Indian
tribe. However, bonds are required when dealing with private business
entities owned by an Indian tribe or members of an Indian tribe. The
contracting officer may require bonds of private business entities that
are joint ventures with, or subcontractors of, an Indian tribe or a
public nonprofit organization serving as a governmental instrumentality
of an Indian tribe. A bid guarantee or bid bond is required only when a
performance or payment bond is required.
(d) Indian preference in employment, training and subcontracting.
Contracts awarded under the Buy Indian Act are subject to the
requirements of section 7(b) of the Indian Self-Determination and
Education Assistance Act 25 U.S.C. 450e, which requires giving
preference to Indians in employment, training, and subcontracting. The
contracting officer shall include the Indian Preference clause
specified at 326.505(a) in all Buy Indian solicitations and resultant
contracts. The contracting officer shall use the Indian Preference
Program clause specified at 326.505(b). The contracting officer shall
follow all requirements specified in subpart 326.2 which apply to a Buy
Indian acquisition (e.g., 326.604 and 326.605).
(e) Subcontracting. A contractor shall not subcontract more than 50
percent of the work under a prime contract awarded pursuant to the Buy
Indian Act to non-Indian firms. For this purpose, contract work does
not include the provision of materials, supplies, or equipment.
(f) Wage rates. The contracting officer shall include a
determination of the minimum wage rates by the Secretary of Labor as
required by the Davis-Bacon Act (40 U.S.C. 276a) in all contracts
awarded under the Buy Indian Act for over $2,000 for construction,
alteration, or repair, including painting and decorating, of public
buildings and public works, except contracts with Indian tribes or
public nonprofit organizations serving as governmental
instrumentalities of an Indian tribe.
The contracting officer shall include the wage rate determination
in contracts with private business entities, even when owned by an
Indian tribe or a member of an Indian tribe and in connection with
joint ventures with, or subcontractors of, an Indian tribe or a public
nonprofit organization serving as a governmental instrumentality of an
Indian tribe.
326.604 Competition.
(a) Contracts awarded under the Buy Indian Act are subject to
competition among Indians or Indian firms to the maximum extent
practicable. When the contracting officer determines that competition
is not practicable, a justification and approval is required in
accordance with subpart 306.3.
(b) The contracting officer shall: Synopsize and publicize
solicitations in the Government point of entry and provide copies of
the synopses to the tribal office of the Indian tribal government
directly concerned with the proposed acquisition as well as to Indian
firms and others having a legitimate interest. The synopses shall state
that the acquisitions are restricted to Indian firms under the Buy
Indian Act.
326.605 Responsibility determinations.
(a) The contracting officer may award a contract under the Buy
Indian Act only if it is determined that the contractor will likely
perform satisfactorily and properly complete or maintain the contracted
project or function.
(b) The contracting officer shall make the written determination
specified in paragraph (a) of this section prior to the award of a
contract. The determination shall reflect an analysis of FAR 9.104-1
standards.
Subpart 326.7--Acquisitions Requiring the Native American Graves
Protection and Repatriation Act
326.700 Scope of subpart.
Public Law 101-601, dated November 16, 1990, also known as the
Native American Graves Protection and Repatriation Act, imposes certain
responsibilities on individuals and organizations when they discover
Native American cultural items (including human remains) on Federal or
tribal lands.
326.701 Applicability.
The contracting officer shall insert the clause at 352.226-3,
Native American Graves Protection and Repatriation Act, in
solicitations, contracts, and orders requiring performance on tribal
lands or those for construction projects on Federal or tribal lands.
SUBCHAPTER E--GENERAL CONTRACTING REQUIREMENTS
PART 327--PATENTS, DATA, AND COPYRIGHTS
Subpart 327.3--Patent Rights Under Government Contracts
Sec.
327.303 Solicitation provision and contract clause.
Subpart 327.4--Rights in Data and Copyrights
327.404-70 Solicitation provision and contract clause.
327.409 Solicitation provision and contract clause.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 327.3--Patent Rights Under Government Contracts
327.303 Solicitation provision and contract clause.
The contracting officer shall insert the clause at 352.227-11,
Patent Rights--Exceptional Circumstances and any appropriate alternates
in lieu of Federal Acquisition Regulation (FAR) 52.227-11 whenever a
Determination of
[[Page 72165]]
Exceptional Circumstances (DEC) involving the provision of materials
that has been executed in accordance with Agency policy and procedures
calls for its use and the clause at 352.227-11, Patent Rights--
Exceptional Circumstances, appropriately covers the circumstances. The
contracting officer should reference the DEC in the solicitation and
shall attach a copy of the executed DEC to the contract.
Subpart 327.4--Rights in Data and Copyrights
327.404-70 Solicitation provision and contract clause.
The contracting officer shall insert the clause at 352.227-70,
Publications and Publicity, in solicitations, contracts, and orders
that involve requirements which could lead to the contractor's
publishing the results of its work under the contract.
327.409 Solicitation provision and contract clause.
The contracting officer shall insert the clause at 352.227-14,
Rights in Data--Exceptional Circumstances, and any appropriate
alternates in lieu of the FAR clause at 52.227-14, Rights in Data-
General, whenever a DEC executed in accordance with Agency policy and
procedures calls for its use. Prior to using this clause, a DEC must be
executed in accordance with Agency policy and procedures. The
contracting officer should reference the DEC in the solicitation and
shall attach a copy of the executed DEC to the contract.
PART 328--[RESERVED]
PART 330--COST ACCOUNTING STANDARDS
Subpart 330.2--CAS Program Requirements
Sec.
330.201 Contract requirements.
330.201-5 Waiver.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 330.2--CAS Program Requirements
330.201 Contract requirements.
330.201-5 Waiver.
The Senior Procurement Executive (SPE) shall exercise the waiver
authority under Federal Acquisition Regulation 30.201-5(a)(2).
Operating Divisions and Staff Divisions shall forward waiver requests
to the SPE.
PART 331--CONTRACT COST PRINCIPLES AND PROCEDURES
Subpart 331.1--Applicability
Sec.
331.101-70 Salary rate limitation.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 331.1--Applicability
331.101-70 Salary rate limitation.
(a) Beginning in fiscal year 1990, Congress has stipulated in the
Department of Health and Human Services appropriations acts and
continuing resolutions that, under applicable contracts, appropriated
funds cannot be used to pay the direct salary of an individual above
the stipulated rates. The applicable rates for each year are identified
at www.opm.gov.
(b) The contracting officer shall insert the clause at 352.231-70,
Salary Rate Limitation, in solicitations and contracts when a cost-
reimbursement; fixed-price level-of-effort; time-and-materials; or
labor-hour contract is contemplated.
PART 332--CONTRACT FINANCING
Subpart 332.4--Advance Payments for Non-Commercial Items
Sec.
332.402 General.
332.407 Interest.
Subpart 332.5--Progress Payments Based on Cost
332.501 General.
332.501-2 Unusual progress payments.
Subpart 332.7--Contract Funding
332.702 Policy.
332.703 Contract funding requirements.
332.703-1 General.
332.703-71 Incrementally funded cost-reimbursement contracts.
332.703-72 Incremental Funding Table.
332.706 Solicitation provision and contract clauses.
332.706-2 Provision and clauses for limitation of cost or funds.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 332.4--Advance Payments for Non-Commercial Items
332.402 General.
(e) The head of the contracting activity (HCA) (non-delegable)
shall make determinations related to advanced payments and assure
compliance with FAR 32.402.
332.407 Interest.
(d) The HCA (non-delegable) shall make the determinations in FAR
32.407(d).
Subpart 332.5--Progress Payments Based on Cost
332.501 General.
332.501-2 Unusual progress payments.
(a)(3) The HCA (non-delegable) shall approve unusual progress
payments.
Subpart 332.7--Contract Funding
332.702 Policy.
Departmental employees shall report any suspected violation of the
Anti-Deficiency Act (31 U.S.C. 1341, 13 U.S.C. 1342, and 31 U.S.C.
1517) immediately to the Operating Division's Chief Financial Officer
(CFO), who in turn will report the matter to the HHS Deputy CFO.
332.703 Contract funding requirements.
332.703-1 General.
(b) The following requirements govern all solicitations and
contracts using incremental funding, as appropriate:
(1) The contracting officer shall consider the estimated total cost
of the contract, including all planned increments of performance when
determining the requirements that must be met before contract execution
(e.g., Justification and Approvals, clearances, and approvals).
(2) The solicitation and resultant contract shall include a
statement of work or performance work statement that describes the
total project, covers all proposed increments of performance, and
contains a schedule of planned increments of performance. No funding
increment may exceed 1 year, and the services rendered during each
increment of performance must provide a specific material benefit that
can stand alone if the remaining effort is not funded. The resultant
contract shall also include the corresponding amount of funds planned
for obligation for each increment of performance.
(3) The contracting officer shall request that offerors respond to
the solicitation with technical and cost proposals for the entire
project, and shall require distinct technical and cost break-outs of
the planned increments of performance.
(4) Proposals shall be evaluated and any discussions and
negotiations shall be conducted based upon the total project, including
all planned increments of performance.
332.703-71 Incrementally funded cost-reimbursement contracts.
Incremental funding may be used in cost-reimbursement contracts for
severable services only when all of the following circumstances are
present:
[[Page 72166]]
(a) Funding of increments after the initial increment of
performance is provided from the appropriation account available for
obligation at that time;
(b) The project represents a bona fide need of the fiscal year in
which the contract is awarded and initially funded (i.e., the initial
increment of performance) and is also a bona fide need of each
subsequent fiscal year whose appropriation will be used; and
(c) The project's significance provides reasonable assurance that
subsequent year appropriations will be made available to fund the
project's continuation and completion.
332.703-72 Incremental Funding Table.
(a) The contracting officer shall insert substantially the
following language in Section B: Supplies or Services and Prices or
Costs, Table 1, in all cost-reimbursement contracts for severable
services using incremental funding. The language requires the
contracting officer to:
(1) Insert the initial funding obligated by the award;
(2) Identify the increment of performance covered by the funding
provided; and
(3) Specify the start and end dates for each increment of
performance, as required by the ``Limitation of Funds'' clause at FAR
52.232-22.
(b) Modification of the language is permitted to fit specific
circumstances of the contract, including but not limited to language
necessary to reflect the specific type of cost reimbursement contract
awarded, but the language may not be omitted completely.
Table 1--B. __Estimated Cost--Incrementally Funded Contract
(a) The total estimated cost to the Government for full performance
of this contract, including all allowable direct and indirect costs, is
$__ [insert full amount].
(b) The following represents the schedule* by which the Government
expects to allot funds to this contract:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Start date of Estimated cost plus
CLIN, task number, or description increment of End date of increment Estimated cost ($) Fee ($) (as fee ($) (as
performance of performance appropriate) appropriate)
--------------------------------------------------------------------------------------------------------------------------------------------------------
...................... ...................... ..................... ..................... .....................
--------------------------------------------------------------------------------------------------------------------
...................... ...................... ..................... ..................... .....................
--------------------------------------------------------------------------------------------------------------------
...................... ...................... ..................... ..................... .....................
--------------------------------------------------------------------------------------------------------------------
...................... ...................... ..................... ..................... .....................
--------------------------------------------------------------------------------------------------------------------
...................... ...................... ..................... ..................... .....................
--------------------------------------------------------------------------------------------------------------------
...................... ...................... [Total].............. [Total].............. [Total]
--------------------------------------------------------------------------------------------------------------------------------------------------------
* To be inserted after negotiation
(c) Total funds currently obligated and available for payment under
this contract are $__ [insert amount funded to date].
(d) The contracting officer may issue unilateral modifications to
obligate additional funds to the contract and make related changes to
paragraphs (b) and/or (c) above.
(e) Until this contract is fully funded, the requirements of the
clause at FAR 52.232-22, Limitation of Funds, shall govern. Once the
contract is fully funded, the requirements of the clause at FAR 52.232-
20, Limitation of Cost, govern.
332.706 Solicitation provision and contract clauses.
332.706-2 Provision and clauses for limitation of cost or funds.
(b) In addition to the clause at FAR 52.232-22, Limitation of
Funds, the contracting officer shall insert the provision at 352.232-
70, Incremental Funding, in all solicitations when a cost-reimbursement
contract for severable services using incremental funding is
contemplated. The provision requires the contracting officer to insert
a specific increment of performance that the initial funding is
expected to cover.
PART 333--PROTESTS, DISPUTES, AND APPEALS
Subpart 333.1--Protests
Sec.
333.102 General.
333.103 Protests to the agency.
Subpart 333.2--Disputes and Appeals
333.203 Applicability.
333.209 Suspected fraudulent claims.
333.215-70 Contract clauses.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 333.1--Protests
333.102 General.
(g)(1) The Office of General Counsel-General Law Division serves as
the liaison for protests lodged with the Government Accountability
Office (GAO); is designated as the office responsible for all protests
within the Department of Health and Human Services; and serves as the
notification point with GAO for all protests.
(2) The contracting officer will follow the direction of the
Operating Division's protest control officer for responding to protests
whether they are filed with GAO or directly with the contracting
officer.
333.103 Protests to the agency.
(f)(1) Protests to the contracting officer must be in writing. The
contracting officer is authorized to make the determination, using the
criteria in Federal Acquisition Regulation 33.104(b), to award a
contract notwithstanding the protest after obtaining the concurrence of
the contracting activity's protest control officer and consulting with
the appropriate legal office.
Subpart 333.2--Disputes and Appeals
333.203 Applicability.
(c) The Civilian Board of Contract Appeals is the authorized
``Board'' to hear and determine disputes for the Department.
333.209 Suspected fraudulent claims.
The contracting officer shall submit any instance of a contractor's
suspected fraudulent claim to the Office of Inspector General for
investigation.
333.215-70 Contract clauses.
(a) The contracting officer shall insert the clause at 352.233-70,
Choice of Law (Overseas), in solicitations and contracts when
performance will be outside the United States, its possessions, and
Puerto Rico, except as otherwise
[[Page 72167]]
provided in a government-to-government agreement.
(b) The contracting officer shall insert the clause at 352.233-71,
Litigation and Claims, in solicitations and contracts when a cost-
reimbursement, time-and-materials, or labor-hour contract is
contemplated (other than a contract for a commercial item).
SUBCHAPTER F--SPECIAL CATEGORIES OF CONTRACTING
PART 334--MAJOR SYSTEM ACQUISITION
Subpart 334.2--Earned Value Management System
Sec.
334.201 Policy.
334.202 Integrated Baseline Reviews (IBRs).
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 334.2--Earned Value Management System
334.201 Policy.
The Department of Health and Human Services applies the earned
value management system requirement as follows:
(a) For cost or incentive contracts and subcontracts valued at $20
million or more, the contractor's earned value management system shall
comply with the guidelines in the American National Standards
Institute/Electronic Industries Alliance Standard 748, Earned Value
Management Systems (ANSI/EIA-748).
(b) For cost or incentive contracts and subcontracts valued at $50
million or more, the contractor shall have an earned value management
system that has been determined by the cognizant Federal agency to be
in compliance with the guidelines in ANSI/EIA-748.
(c) For cost or incentive contracts and subcontracts valued at less
than $20 million--
(1) The application of earned value management is optional at the
discretion of the program/project manager and is a risk-based decision
that must be supported by a cost/benefit analysis; and
(2) A decision to apply earned value management shall be documented
in the contract file.
(d) For firm-fixed-price contracts and subcontracts of any dollar
value the application of earned value management is discouraged.
334.202 Integrated Baseline Reviews (IBRs).
(a) An IBR normally should be conducted as a post-award activity. A
pre-award IBR may be conducted only if--
(1) The acquisition plan contains documentation that demonstrates
the need and rationale for a pre-award IBR, including an assessment of
the impact on the source selection schedule and the expected benefits;
(2) The use of a pre-award IBR is approved in writing by the head
of the contracting activity prior to the issuance of the solicitation;
(3) The source selection plan and solicitation specifically
addresses how the results of a pre-award IBR will be used during source
selection, including any weight to be given to it in source evaluation;
and
(4) Specific arrangements are made, and budget authority is
provided, to compensate all offerors who prepare for or participate in
a pre-award IBR; and the solicitation informs prospective offerors of
the means for and conditions of such compensation.
PART 335--RESEARCH AND DEVELOPMENT CONTRACTING
Sec.
335.070 Cost-sharing.
335.070-1 Policy.
335.070-2 Amount of cost-sharing.
335.070-3 Method of cost-sharing.
335.071 [Reserved]
335.072 Key personnel.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
335.070 Cost-sharing.
335.070-1 Policy.
(a) Contracting activities should encourage contractors to
contribute to the cost of performing research and development (R&D),
through the use of cost-sharing contracts, where there is a probability
that the contractor will receive present or future benefits from
participation as described in Federal Acquisition Regulation (FAR)
16.303. Examples include increased technical know-how, training for
employees, acquisition of goods or services, development of a
commercially viable product that can be sold in the commercial market
and use of background knowledge in future contracts. Cost-sharing is
intended to serve the mutual interests of the Government and its
contractors by helping to ensure efficient utilization of the resources
available for the conduct of R&D projects and by promoting sound
planning and prudent fiscal policies of the contractor. The
Government's interest includes positive impact on the community at
large.
(b) The contracting officer should use a cost-sharing contract for
R&D contracts, unless the contracting officer determines that a request
for cost-sharing would not be appropriate.
(c) Any determination made by a contracting officer as described in
this section shall be evidenced by appropriate documentation in the
contract file.
335.070-2 Amount of cost-sharing.
When cost-sharing is appropriate, the contracting officer shall use
the following guidelines to determine the amount of cost participation
by the contractor:
(a) The amount of cost participation depends on the extent to which
the R&D effort or results are likely to enhance the contractor's
capability, expertise, or competitive position, and the value of this
enhancement to the contractor. Therefore, contractor cost participation
could reasonably range from as little as one percent or less of the
total project cost to more than 50 percent of the total project cost.
Ultimately, cost-sharing is a negotiable item. As such, the amount of
cost-sharing shall be proportional to the anticipated value of the
contractor's gain.
(b) If the contractor will not acquire title to, or the right to
use, inventions, patents, or technical information resulting from the
R&D project, it is normally appropriate to obtain less cost-sharing
than in cases in which the contractor acquires these rights.
(c) If the R&D is expected to be of only minor value to the
contractor, and if a statute does not require cost-sharing, it may be
appropriate for the contractor to make a contribution in the form of a
reduced fee or profit rather than sharing costs of the project.
Alternatively, a limitation on indirect cost rates might be
appropriate. See FAR 42.707. See also, FAR 16.303.
(d) The contractor's participation may be considered over the total
term of the project, so that a relatively high contribution in 1 year
may be offset by a relatively low contribution in another. Care must be
exercised that the intent to cost-share in future years does not become
illusory. Redetermination of the cost sharing arrangement might be
appropriate depending on future circumstances.
(e) A relatively low degree of cost-sharing may be appropriate if
an area of R&D requires special stimulus in the national interest.
335.070-3 Method of cost-sharing.
Cost-sharing on individual contracts may be accomplished either by
a contribution of part or all of one or more elements of allowable cost
of the work being performed or by a fixed amount or stated percentage
of the total allowable
[[Page 72168]]
costs of the project. Contractors shall not charge costs contributed to
the Government under any other instrument (e.g., grant or contract),
including allocations to other instruments as part of any independent
R&D program.
335.071 [Reserved]
335.072 Key personnel.
If the contracting officer determines that the personnel to be
assigned to perform effort on an R&D contract are critical to the
success of the R&D effort, or were a critical factor in the award of
the contract, then the contracting officer should consider using the
key personnel clause at 352.237-75, Key Personnel.
PART 336--CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS
Subpart 336.1--General
Sec.
336.104 Policy.
Subpart 336.5--Contract Clause
336.570 Contract clause.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 336.1--General
336.104 Policy.
Contracting officers shall follow the policies described in Federal
Acquisition Regulation 36.104 and the guidance promulgated by the
Department of Health and Human Services Facilities Management.
Subpart 336.5--Contract Clause
336.570 Contract clause.
(a) The contracting officer shall insert the clause at 352.236-70,
Design-Build Contracts, in all solicitations and contracts for all
design-build requirements.
(b) The contracting officer shall use Alternate I to the clause at
352.236-70, Design-Build Contracts, in all solicitations and contracts
for construction when Fast-Track procedures are being used.
(c) Due to the importance of maintaining consistency in the
contractor's personnel during design-build construction, the
contracting officer should consider including the clause at 352.237-75,
Key personnel.
PART 337--SERVICE CONTRACTING--GENERAL
Subpart 337.1--Service Contracts--General
Sec.
337.103 Contracting officer responsibility.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 337.1--Service Contracts--General
337.103 Contracting officer responsibility.
(d)(1) The contracting officer shall insert the clause at 352.237-
70, Pro-Children Act, in solicitations, contracts, and orders that
involve:
(i) Kindergarten, elementary, or secondary education or library
services; or
(ii) Health or daycare services that are provided to children under
the age of 18 on a routine or regular basis pursuant to the Pro-
Children Act of 1994 (20 U.S.C. 6081-6084).
(2) The contracting officer shall insert the clause at 352.237-71,
Crime Control Act--Reporting of Child Abuse, in solicitations,
contracts, and orders that require performance on Federal land or in a
federally operated (or contracted) facility and involve the
professions/activities performed by persons specified in the Crime
Control Act of 1990 (42 U.S.C. 13031) including, but not limited to,
teachers, social workers, physicians, nurses, dentists, health care
practitioners, optometrists, psychologists, emergency medical
technicians, alcohol or drug treatment personnel, child care workers
and administrators, emergency medical technicians and ambulance
drivers.
(3) The contracting officer shall insert the clause at 352.237-72,
Crime Control Act--Requirement for Background Checks, in solicitations,
contracts, and orders that involve providing child care services to
children under the age of 18, including social services, health and
mental health care, child- (day) care, education (whether or not
directly involved in teaching), and rehabilitative programs covered
under the Crime Control Act of 1990 (42 U.S.C. 13041).
(4) Contracting officers supporting the Indian Health Service shall
insert the clause at 352.237-73, Indian Child Protection and Family
Violence Act in all solicitations, contracts, and orders when
performance of the contract may involve regular contact with or control
over Indian children. The required declaration shall also be included
in Section J of the solicitation and contract.
(e) The contracting officer shall insert the clause at 352.237-74,
Non-Discrimination in Service Delivery, in solicitations, contracts,
and orders to deliver services under HHS' programs directly to the
public.
(f) The contracting officer shall insert the clause at 352.237-75,
Key Personnel, in solicitations and contracts when the contracting
officer will require the contractor to designate contractor key
personnel.
PART 339--ACQUISITION OF INFORMATION TECHNOLOGY
Subpart 339.1--General
Sec.
339.101 Policy.
Subpart 339.2--Electronic and Information Technology
339.203 Applicability.
339.203-70 Contract clauses for electronic and information
technology (EIT) acquisitions.
339.204 Exceptions.
339.204-1 Approval of exceptions.
339.205 Section 508 accessibility standards for contracts.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 339.1--General
339.101 Policy
In addition to the regulatory guidance in Federal Acquisition
Regulation part 39, contracting officers shall collaborate with the
requiring activity to ensure information technology (IT) acquisitions
for supplies, services, and systems meet the requirements established
by the Department of Health and Human Services (HHS).
Subpart 339.2--Electronic and Information Technology
339.203 Applicability.
(a) Electronic and information technology (EIT) supplies and
services must comply with Section 508 of the Rehabilitation Act (the
Act) of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment
Act of 1998, and the Architectural and Transportation Barriers
Compliance Board (Access Board) Electronic and Information
Accessibility Standards (36 CFR part 1194). Requiring activities must
consult with their Section 508 Official or designee to determine if the
contractor should be responsible for compliance with EIT accessibility
standards which apply to Web site content and communications material.
(1) When conducting a procurement and employing the best value
continuum, the solicitation shall include a separate technical
evaluation factor developed by the contracting officer, requiring
activity, and the Operating Division (OPDIV) Section 508 Official or
designee.
(2) At a minimum, solicitations for supplies and services shall
require the submission of a Section 508 Product Assessment Template
(See https://www.hhs.gov/web/508 for the template). Solicitations for
services shall include any other pertinent information that the
contracting officer deems necessary to evaluate the offeror's ability
to meet the
[[Page 72169]]
applicable Section 508 accessibility standards.
(3) The HHS Operating Division or Staff Division (OPDIV or
STAFFDIV) Section 508 Official or designee is responsible for providing
technical assistance in development of Section 508 evaluation factors.
(4) Before conducting negotiations or making an award, the
contracting officer shall provide a summary of the Source Selection
Evaluation Team's (SSET) assessment of offeror responses to the
solicitation's Section 508 evaluation factor. This summary shall be
submitted for review by the Section 508 Official or designee. The
Section 508 Official or designee shall indicate approval or disapproval
of the SSET assessment. The contracting officer shall coordinate the
resolution of any issues raised by the Section 508 Official or designee
with the chair of the SSET or requiring activity representative, as
appropriate. The acquisition process shall not proceed until the
Section 508 Official or designee approves the SSET assessment. The
contracting officer shall include the assessment in the official
contract file. See 339.204-1 regarding processing exception
determination requests.
(b) When acquiring commercial items, if no commercially available
supplies or services meet all of the applicable Section 508
accessibility standards, OPDIVs or STAFFDIVs shall, under the direction
and approval of the Section 508 Official or designee, acquire the
supplies and services that best meet the applicable Section 508
accessibility standards. Process exception determinations for EIT
supplies and services not meeting applicable Section 508 accessibility
standards in accordance with 339.204-1.
339.203-70 Contract clauses for electronic and information technology
(EIT) acquisitions.
(a) The contracting officer shall insert the provision at 352.239-
73, Electronic and Information Technology Accessibility Notice, in all
solicitations.
(b) The contracting officer shall insert the clause at 352.239-74,
Electronic and Information Technology Accessibility, in all contracts
and orders.
339.204 Exceptions.
339.204-1 Approval of exceptions.
(a) Procedures to document exception and determination requests are
set by the OPDIV Section 508 Official.
(b) In the development of an acquisition plan (AP) or other
acquisition request document, the contracting officer shall ensure that
all Section 508 exception determination requests for applicable EIT
requirements are:
(1) Documented and certified in accordance with the requirements of
the HHS Section 508 policy;
(2) Signed by the requestor in the requiring activity;
(3) Certified and approved by the OPDIV Section 508 Official or
designee; and
(4) Included in the AP or other acquisition request document
provided by the requiring activity to the contracting office.
(c) For instances with an existing technical evaluation and no
organization's proposed supplies or services meet all of the Section
508 accessibility standards; in order to proceed with the acquisition,
the requiring activity shall provide an exception determination request
along with the technical evaluation team's assessment of the Section
508 evaluation factor to the designated Section 508 Official or
designee for review and approval or disapproval. The contracting
officer shall include the Section 508 Official's or designee's approval
or disapproval of the exception determination request in the official
contract file and reference it, as appropriate, in all source selection
documents. For further information, see HHS Section 508 Policy on
https://www.hhs.gov/web/508.
339.205 Section 508 accessibility standards for contracts.
(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C.
794(d)), as amended by the Workforce Investment Act of 1998 (Section
508), specifies the applicable accessibility standards for all new
solicitations and new or existing contracts or orders, regardless of
EIT dollar amount.
(b) The requiring activity shall consult with the OPDIV or STAFFDIV
Section 508 Official or designee, as necessary, to determine the
applicability of Section 508, identify applicable Section 508
accessibility standards, and resolve any related issues before
forwarding a request to the contracting or procurement office for the
acquisition of EIT supplies and services--including Web site content
and communications material for which the contractor must meet EIT
accessibility standards.
(c) Based on those discussions, the requiring activity shall
provide a statement in the AP (or other acquisition request document)
for Section 508 applicability. See 307.105. If Section 508 applies to
an acquisition, include the provision at 352.239-73, Electronic and
Information Technology and Accessibility Notice, language in a
separate, clearly designated, section of the statement of work or
performance work statement, along with any additional information
applicable to the acquisition's Section 508 accessibility standards
(e.g., the list of applicable accessibility standards of the Access
Board EIT Accessibility Standards (36 CFR part 1194)). If an AP does
not address Section 508 applicability and it appears an acquisition
involves Section 508, or if the discussion of Section 508 applicability
to the acquisition is inadequate or incomplete, the contracting officer
shall request the requiring activity modify the AP accordingly.
(d) Items provided incidental to contract administration are not
subject to this section.
(e) The OPDIV Section 508 Official or designee may, at his or her
discretion, require review and approval of solicitations and contracts
for EIT supplies and services.
SUBCHAPTER G--CONTRACT MANAGEMENT
PART 342--CONTRACT ADMINISTRATION
Subpart 342.7--Indirect Cost Rates
Sec.
342.705 Final indirect cost rates.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 342.7--Indirect Cost Rates
342.705 Final indirect cost rates.
Contract actions for which the Department of Health and Human
Services is the cognizant Federal agency:
(a) The Financial Management Services, Division of Cost Allocation,
Program Support Center, shall establish facilities and administration
costs, also known as indirect cost rates, research patient care rates,
and, as necessary, fringe benefits, computer, and other special costing
rates for use in contracts awarded to State and local governments,
colleges and universities, hospitals, and other nonprofit
organizations.
(b) The National Institute of Health, Division of Financial
Advisory Services, shall establish indirect cost rates and similar
rates for use in contracts awarded to for profit organizations.
[[Page 72170]]
SUBCHAPTER H--CLAUSES AND FORMS
PART 352--SOLICITATION PROVISIONS AND CONTRACT CLAUSES
Subpart 352.1--Instructions for Using Provisions and Clauses
Sec.
352.100 Scope of subpart.
352.101-70 Application of provisions and clauses.
Subpart 352.2--Texts of Provisions and Clauses
352.203-70 Anti-Lobbying.
352.204-70 Prevention and Public Health Fund-Reporting Requirements.
352.208-70 Printing and Duplication.
352.211-1 Public Accommodations and Commercial Facilities.
352.211-2 Conference Sponsorship Request and Conference Materials
Disclaimer.
352.211-3 Paperwork Reduction Act.
352.215-70 Late Proposals and Revisions.
352.216-70 Additional Cost Principles for Hospitals (Profit or Non-
Profit).
352.219-70 Mentor-Prot[eacute]g[eacute] Program.
352.219-71 Mentor-Prot[eacute]g[eacute] Program Reporting
Requirements.
352.222-70 Contractor Cooperation in Equal Employment Opportunity
Investigations.
352.223-70 Safety and Health.
352.223-71 Instructions to Offerors-Sustainable Acquisition.
352.224-70 Privacy Act.
352.224-71 Confidential Information.
352.226-1 Indian Preference.
352.226-2 Indian Preference Program.
352.226-3 Native American Graves Protection and Repatriation Act.
352.227-11 Patent Rights--Exceptional Circumstances.
352.227-14 Rights in Data--Exceptional Circumstances.
352.227-70 Publications and Publicity.
352.231-70 Salary Rate Limitation.
352.232-70 Incremental Funding.
352.233-70 Choice of Law (Overseas).
352.233-71 Litigation and Claims.
352.236-70 Design-Build Contracts.
352.237-70 Pro-Children Act.
352.237-71 Crime Control Act--Reporting of Child Abuse.
352.237-72 Crime Control Act--Requirement for Background Checks.
352.237-73 Indian Child Protection and Family Violence Act.
352.237-74 Non-Discrimination in Service Delivery.
352.237-75 Key Personnel.
352.239-73 Electronic Information and Technology Accessibility
Notice.
352.239-74 Electronic Information and Technology Accessibility.
352.270-1 [Reserved]
352.270-2 [Reserved]
352.270-3 [Reserved]
352.270-4a Notice to Offerors, Protection of Human Subjects.
352.270-4b Protection of Human Subjects.
352.270-5a Notice to Offerors of Requirement for Compliance with the
Public Health Service Policy on Humane Care and Use of Laboratory
Animals.
352.270-5b Care of Live Vertebrate Animals.
352.270-6 Restriction on Use of Human Subjects.
352.270-7 [Reserved]
352.270-8 [Reserved]
352.270-9 Non-Discrimination for Conscience.
352.270-10 Notice to Offerors--Protection of Human Subjects,
Research Involving Human Subjects Committee (RIHSC) Approval of
Research Protocols Required.
352.270-11 Protection of Human Subjects, Research Involving Human
Subjects Committee (RIHSC) Approval of Research Protocols Required.
352.270-12 Needle Exchange.
352.270-13 Continued Ban on Funding Abortion and Continued Ban on
Funding of Human Embryo Research.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 352.1--Instructions for Using Provisions and Clauses
352.100 Scope of subpart.
This subpart provides guidance for applying the Department of
Health and Human Services provisions and clauses in solicitations,
contracts, and orders.
352.101-70 Application of provisions and clauses.
(a) If a clause is included in the master instrument (e.g., in an
indefinite delivery/indefinite quantity contract or a blanket purchase
agreement), it is not necessary to also include the clause in a task
order or delivery order thereunder.
(b) When a dollar amount or dollar threshold is specified (e.g.,
$25 million or simplified acquisition threshold), the dollar amount of
the award (contract or order) includes any options thereunder.
Subpart 352.2--Texts of Provisions and Clauses
352.203-70 Anti-Lobbying.
As prescribed in HHSAR 303.808-70, the Contracting Officer shall
insert the following clause:
Anti-Lobbying (DEC 2015)
Pursuant to the HHS annual appropriations acts, except for
normal and recognized executive-legislative relationships, the
Contractor shall not use any HHS contract funds for:
(a) Publicity or propaganda purposes;
(b) The preparation, distribution, or use of any kit, pamphlet,
booklet, publication, electronic communication, radio, television,
or video presentation designed to support or defeat the enactment of
legislation before the Congress or any State or local legislature or
legislative body, except in presentation to the Congress or any
state or local legislature itself; or designed to support or defeat
any proposed or pending regulation, administrative action, or order
issued by the executive branch of any state or local government,
except in presentation to the executive branch of any state or local
government itself; or
(c) Payment of salary or expenses of the Contractor, or any
agent acting for the Contractor, related to any activity designed to
influence the enactment of legislation, appropriations, regulation,
administrative action, or Executive order proposed or pending before
the Congress or any state government, state legislature or local
legislature or legislative body, other than for normal and
recognized executive-legislative relationships or participation by
an agency or officer of a state, local, or tribal government in
policymaking and administrative processes within the executive
branch of that government.
(d) The prohibitions in subsections (a), (b), and (c) above
shall include any activity to advocate or promote any proposed,
pending, or future federal, state, or local tax increase, or any
proposed, pending, or future requirement for, or restriction on, any
legal consumer product, including its sale or marketing, including,
but not limited to, the advocacy or promotion of gun control.
(End of clause)
352.204-70 Prevention and Public Health Fund--Reporting Requirements.
As prescribed in HHSAR 304.7201, insert the following clause:
Prevention and Public Health Fund--Reporting Requirements (DEC 2015)
(a) Pursuant to public law this contract requires the contractor
to provide products or services or both that are funded from the
Prevention and Public Health Fund (PPHF), Public Law 111-148, sec.
4002. Section 220(b)(5) requires each contractor to report on its
use of these funds under this contract. These reports will be made
available to the public.
(b) Semi-annual reports from the Contractor for all work funded,
in whole or in part, by the PPHF, are due no later than 20 days
following the end of each 6-month period. The 6-month reporting
periods are January through June and July through December. The
first report is due no later than 20 days after the end of the 6-
month period following contract award. Subsequent reports are due no
later than 20 days after the end of each reporting period. If
applicable, the Contractor shall submit its final report for the
remainder of the contract period no later than 20 days after the end
of the reporting period in which the contract ended.
(c) The Contractor shall provide the following information in an
electronic and Section 508 compliant format to the Contracting
Officer.
(1) The Government contract and order number, as applicable.
(2) The amount of PPHF funds invoiced by the contractor for the
reporting period and the cumulative amount invoiced for the contract
or order.
[[Page 72171]]
(3) A list of all significant services performed or supplies
delivered, including construction, for which the contractor invoiced
in the reporting period.
(4) Program or project title, if any.
(5) The Contractor shall report any subcontract funded in whole
or in part with PPHF funding, that is valued at $25,000 or more. The
Contractor shall advise the subcontractor that the information will
be made available to the public. The Contractor shall report:
(i) Name and address of the subcontractor.
(ii) Amount of the subcontract award.
(iii) Date of the subcontract award.
(iv) A description of the products or services (including
construction) being provided under the subcontract.
(End of clause)
352.208-70 Printing and Duplication.
As prescribed in HHSAR 308.803, the Contracting Officer shall
insert the following clause:
Printing and Duplication (DEC 2015)
(a) Unless otherwise specified in this contract, no printing by
the Contractor or any subcontractor is authorized under this
contract. All printing required must be performed by the Government
Printing Office except as authorized by the Contracting Officer. The
Contractor shall submit camera-ready copies to the Contracting
Officer's Representative (COR). The terms ``printing'' and
``duplicating/copying'' are defined in the Government Printing and
Binding Regulations of the Joint Committee on Printing.
(b) If necessary for performance of the contract, the Contractor
may duplicate or copy less than 5,000 production units of only one
page, or less than 25,000 production units in aggregate of multiple
pages for the use of a department or agency. A production unit is
defined as one sheet, size 8.5 x 11 inches, one side only, and one
color. The pages may not exceed a maximum image size of 10\3/4\ by
14\1/4\ inches. This page limit applies to each printing requirement
and not for all printing requirements under the entire contract.
(c) Approval for all printing, as well as duplicating/copying in
excess of the stated limits, shall be obtained from the COR who will
consult with the designated publishing services office and provide
direction to the contractor. The cost of any unauthorized printing
or duplicating/copying under this contract will be considered an
unallowable cost for which the Contractor will not be reimbursed.
352.211-1 Public Accommodations and Commercial Facilities.
As prescribed in HHSAR 311.7102, the Contracting Officer shall
insert the following clause:
Public Accommodations and Commercial Facilities (DEC 2015)
The Contractor agrees as follows:
(a) Except for ad hoc meetings necessary or incidental to
contract performance, the Contractor shall develop a plan to assure
that any event held pursuant to this contract will meet or exceed
the minimum accessibility standards set forth in 28 CFR part 36--
Nondiscrimination on the Basis of Disability by Public
Accommodations and in Commercial Facilities. The Contractor shall
submit the plan to the Contracting Officer and must receive approval
prior to the event. The Contractor may submit a consolidated or
master plan for contracts requiring numerous events in lieu of
separate plans.
(b) The Contractor shall manage the contract in accordance with
the standards set forth in 28 CFR part 36.
(End of clause)
352.211-2 Conference Sponsorship Requests and Conference Materials
Disclaimer.
As prescribed in HHSAR 311.7202, the Contracting Officer shall
insert the following clause:
Conference Sponsorship Request and Conference Materials Disclaimer (DEC
2015)
(a) If HHS is not the sole provider of funding under this
contract, then, prior to the Contractor claiming HHS conference
sponsorship, the Contractor shall submit a written request
(including rationale) to the Contracting Officer for permission to
claim such HHS sponsorship.
(b) Whether or not HHS is the conference sponsor, the Contractor
shall include the following statement on conference materials,
including promotional materials, agendas, and Web sites:
``This conference was funded, in whole or in part, through a
contract (insert contract number) with the Department of Health and
Human Services (HHS) (insert name of OPDIV or STAFFDIV). The views
expressed in written conference materials and by speakers and
moderators at this conference, do not necessarily reflect the
official policies of HHS, nor does mention of trade names,
commercial practices, or organizations imply endorsement by the U.S.
Government.''
(c) Unless authorized in writing by the Contracting Officer, the
Contractor shall not display the HHS logo on any conference
materials.
(End of clause)
352.211-3 Paperwork Reduction Act.
As prescribed in HHSAR 311.7301, the Contracting Officer shall
insert the following clause:
Paperwork Reduction Act (DEC 2015)
(a) This contract involves a requirement to collect or record
information calling either for answers to identical questions from
10 or more persons other than Federal employees, or information from
Federal employees which is outside the scope of their employment,
for use by the Federal government or disclosure to third parties;
therefore, the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.) shall apply to this contract. No plan, questionnaire,
interview guide or other similar device for collecting information
(whether repetitive or single time) may be used without the Office
of Management and Budget (OMB) first providing clearance.
Contractors and the Contracting Officer's Representative shall be
guided by the provisions of 5 CFR part 1320, Controlling Paperwork
Burdens on the Public, and seek the advice of the HHS operating
division or Office of the Secretary Reports Clearance Officer to
determine the procedures for acquiring OMB clearance.
(b) The Contractor shall not expend any funds or begin any data
collection until the Contracting Officer provides the Contractor
with written notification authorizing the expenditure of funds and
the collection of data. The Contractor shall allow at least 120 days
for OMB clearance. The Contracting Officer will consider excessive
delays caused by the Government which arise out of causes beyond the
control and without the fault or negligence of the Contractor in
accordance with the Excusable Delays or Default clause of this
contract.
(End of clause)
352.215-70 Late Proposals and Revisions.
As prescribed in HHSAR 315.208, the Contracting Officer shall
insert the following provision:
Late Proposals and Revisions (DEC 2015) Deviation
Notwithstanding the procedures contained in FAR 52.215-1(c)(3)
of the provision of this solicitation entitled Instructions to
Offerors-Competitive Acquisition, the Government may consider a
proposal received after the date specified for receipt if it appears
to offer significant cost or technical advantage to the Government
and it was received before proposals were distributed for
evaluation, or within 5 calendar days after the exact time specified
for receipt, whichever is earlier.
(End of provision)
352.216-70 Additional Cost Principles for Hospitals (Profit and Non-
Profit).
As prescribed in HHSAR 316.307(a)(2), the Contracting Officer shall
insert the following clause:
Additional Cost Principles for Hospitals (Profit or Non-Profit) (DEC
2015)
(a) Bid and proposal (B&P) costs. (1) B&P costs are the
immediate costs of preparing bids, proposals, and applications for
potential Federal and non-Federal contracts, grants, and agreements,
including the development of scientific, cost, and other data needed
to support the bids, proposals, and applications.
(2) B&P costs of the current accounting period are allowable as
indirect costs.
(3) B&P costs of past accounting periods are unallowable in the
current period. However, if the organization's established practice
is to treat these costs by some other method, they may be accepted
if they are found to be reasonable and equitable.
(4) B&P costs do not include independent research and
development (IR&D) costs
[[Page 72172]]
covered by the following paragraph, or pre-award costs covered by
paragraph 36 of Attachment B to OMB Circular A-122.
(b) IR&D costs.
(1) IR&D is research and development conducted by an
organization which is not sponsored by Federal or non-Federal
contracts, grants, or other agreements.
(2) IR&D shall be allocated its proportionate share of indirect
costs on the same basis as the allocation of indirect costs to
sponsored research and development.
(3) The cost of IR&D, including its proportionate share of
indirect costs, is unallowable.
(End of clause)
352.219-70 Mentor-Prot[eacute]g[eacute] Program.
As prescribed in HHSAR 319.270-1(a), the Contracting Officer shall
insert the following provision:
Mentor-Prot[eacute]g[eacute] Program (DEC 2015)
(a) Large business prime contractors serving as mentors in the
HHS Mentor-Prot[eacute]g[eacute] Program are eligible for HHS
subcontracting plan credit, and shall submit a copy of their HHS
Office of Small and Disadvantaged Business Utilization (OSDBU)-
approved mentor-prot[eacute]g[eacute] agreements as part of their
offers. The amount of credit provided by the Contracting Officer to
a mentor firm for prot[eacute]g[eacute] firm developmental
assistance costs shall be calculated on a dollar for dollar basis
and reported by the mentor firm in the Summary Subcontract Report
via the Electronic Subcontracting Reporting System (eSRS) at
www.esrs.gov. The mentor firm and prot[eacute]g[eacute] firm shall
submit to the Contracting Officer a signed joint statement agreeing
on the dollar value of the developmental assistance the mentor firm
provided. (For example, a mentor firm would report a $10,000
subcontract awarded to a prot[eacute]g[eacute] firm and provision of
$5,000 of developmental assistance as $15,000 of subcontracting plan
credit.) The mentor firm may use this additional credit towards
attaining its subcontracting plan participation goal under this
contract.
(b) The program consists of--
(1) Mentor firms--large businesses that:
(i) Demonstrate the interest, commitment, and capability to
provide developmental assistance to small business
prot[eacute]g[eacute] firms; and
(ii) Have a Mentor-Prot[eacute]g[eacute] agreement approved by
HHS' OSDBU;
(2) Prot[eacute]g[eacute] firms--firms that:
(i) Seek developmental assistance;
(ii) Qualify as small businesses, veteran-owned small
businesses, service-disabled veteran-owned small businesses, HUBZone
small businesses, small disadvantaged businesses, or woman-owned
small businesses; and
(iii) Have a Mentor-Prot[eacute]g[eacute] agreement approved by
HHS' OSDBU; and
(3) Mentor-Prot[eacute]g[eacute] agreements--joint agreements,
approved by HHS' OSDBU, which detail the specific terms, conditions,
and responsibilities of the mentor-prot[eacute]g[eacute]
relationship.
(End of provision)
352.219-71 Mentor-Prot[eacute]g[eacute] Program Reporting
Requirements.
As prescribed in HHSAR 319.270-1(b), the Contracting Officer shall
insert the following clause:
Mentor-Prot[eacute]g[eacute] Program Reporting Requirements (January
2010)
The Contractor shall comply with all reporting requirements
specified in its Mentor-Prot[eacute]g[eacute] agreement approved by
HHS' OSDBU.
(End of clause)
352.222-70 Contractor Cooperation in Equal Employment Opportunity
Investigations.
As prescribed in HHSAR 322.810(h), the Contracting Officer shall
insert the following clause:
Contractor Cooperation in Equal Employment Opportunity Investigations
(DEC 2015)
(a) In addition to complying with the clause at FAR 52.222-26,
Equal Opportunity, the Contractor shall, in good faith, cooperate
with the Department of Health and Human Services (Agency) in
investigations of Equal Employment Opportunity (EEO) complaints
processed pursuant to 29 CFR part 1614. For purposes of this clause,
the following definitions apply:
(1) Complaint means a formal or informal complaint that has been
lodged with Agency management, Agency EEO officials, the Equal
Employment Opportunity Commission (EEOC), or a court of competent
jurisdiction.
(2) Contractor employee means all current Contractor employees
who work or worked under this contract. The term also includes
current employees of subcontractors who work or worked under this
contract. In the case of Contractor and subcontractor employees, who
worked under this contract, but who are no longer employed by the
Contractor or subcontractor, or who have been assigned to another
entity within the Contractor's or subcontractor's organization, the
Contractor shall provide the Agency with that employee's last known
mailing address, email address, and telephone number, if that
employee has been identified as a witness in an EEO complaint or
investigation.
(3) Good faith cooperation cited in paragraph (a) includes, but
is not limited to, making Contractor employees available for:
(i) Formal and informal interviews by EEO counselors or other
Agency officials processing EEO complaints;
(ii) Formal or informal interviews by EEO investigators charged
with investigating complaints of unlawful discrimination filed by
Federal employees;
(iii) Reviewing and signing appropriate affidavits or
declarations summarizing statements provided by such Contractor
employees during the course of EEO investigations;
(iv) Producing documents requested by EEO counselors, EEO
investigators, Agency employees, or the EEOC in connection with a
pending EEO complaint; and
(v) Preparing for and providing testimony in depositions or in
hearings before the MSPB, EEOC and U.S. District Court.
(b) The Contractor shall include the provisions of this clause
in all subcontract solicitations and subcontracts awarded at any
tier under this contract.
(c) Failure on the part of the Contractor or its subcontractors
to comply with the terms of this clause may be grounds for the
Contracting Officer to terminate this contract for default.
(End of clause)
352.223-70 Safety and Health.
As prescribed in HHSAR 323.7002, the Contracting Officer shall
insert the following clause:
Safety and Health (DEC 2015)
(a) To help ensure the protection of the life and health of all
persons, and to help prevent damage to property, the Contractor
shall comply with all Federal, State, and local laws and regulations
applicable to the work being performed under this contract. These
laws are implemented or enforced by the Environmental Protection
Agency, Occupational Safety and Health Administration (OSHA) and
other regulatory/enforcement agencies at the Federal, State, and
local levels.
(1) In addition, the Contractor shall comply with the following
regulations when developing and implementing health and safety
operating procedures and practices for both personnel and facilities
involving the use or handling of hazardous materials and the conduct
of research, development, or test projects:
(i) 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450,
Occupational exposure to hazardous chemicals in laboratories; and
other applicable occupational health and safety standards issued by
OSHA and included in 29 CFR part 1910. These regulations are
available at https://www.osha.gov/.
(ii) Nuclear Regulatory Commission Standards and Regulations,
pursuant to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et
seq.). The Contractor may obtain copies from the U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001.
(2) The following Government guidelines are recommended for
developing and implementing health and safety operating procedures
and practices for both personnel and facilities:
(i) Biosafety in Microbiological and Biomedical Laboratories,
CDC. This publication is available at https://www.cdc.gov/biosafety/publications/index.htm.
(ii) Prudent Practices for Safety in Laboratories (1995),
National Research Council, National Academy Press, 500 Fifth Street
NW., Lockbox 285, Washington, DC 20055 (ISBN 0-309-05229-7). This
publication is available at https://www.nap.edu/catalog/4911/prudent-practices-in-the-laboratory-handling-and-disposal-of-chemicals.
(b) Further, the Contractor shall take or cause to be taken
additional safety measures
[[Page 72173]]
as the Contracting Officer, in conjunction with the Contracting
Officer's Representative or other appropriate officials, determines
to be reasonably necessary. If compliance with these additional
safety measures results in an increase or decrease in the cost or
time required for performance of any part of work under this
contract, the Contracting Officer will make an equitable adjustment
in accordance with the applicable ``Changes'' clause set forth in
this contract.
(c) The Contractor shall maintain an accurate record of, and
promptly report to the Contracting Officer, all accidents or
incidents resulting in the exposure of persons to toxic substances,
hazardous materials or hazardous operations; the injury or death of
any person; or damage to property incidental to work performed under
the contract resulting from toxic or hazardous materials and
resulting in any or all violations for which the Contractor has been
cited by any Federal, State or local regulatory/enforcement agency.
The report citing all accidents or incidents resulting in the
exposure of persons to toxic substances, hazardous materials or
hazardous operations; the injury or death of any person; or damage
to property incidental to work performed under the contract
resulting from toxic or hazardous materials and resulting in any or
all violations for which the Contractor has been cited shall include
a copy of the notice of violation and the findings of any inquiry or
inspection, and an analysis addressing the impact these violations
may have on the work remaining to be performed. The report shall
also state the required action(s), if any, to be taken to correct
any violation(s) noted by the Federal, State, or local regulatory/
enforcement agency and the time frame allowed by the agency to
accomplish the necessary corrective action.
(d) If the Contractor fails or refuses to comply with the
Federal, State or local regulatory/enforcement agency's directive(s)
regarding any violation(s) and prescribed corrective action(s), the
Contracting Officer may issue an order stopping all or part of the
work until satisfactory corrective action (as approved by the
Federal, State, or local regulatory/enforcement agencies) has been
taken and documented to the Contracting Officer. No part of the time
lost due to any such stop work order shall form the basis for a
request for extension or costs or damages by the Contractor.
(e) The Contractor shall insert the substance of this clause in
each subcontract involving toxic substances, hazardous materials, or
hazardous operations. The Contractor is responsible for the
compliance of its subcontractors with the provisions of this clause.
(End of clause)
352.223-71 Instructions to Offerors--Sustainable Acquisition.
As prescribed in HHSAR 323.7103, the Contracting Officer shall
insert the following provision:
Instructions to Offerors--Sustainable Acquisition (DEC 2015)
Offerors must include a Sustainable Acquisition Plan in their
technical proposals. The Plan must describe their approach and the
quality assurance mechanisms in place for applying FAR 23.1,
Sustainable Acquisition Policy (and other Federal laws, regulations
and Executive Orders governing sustainable acquisition purchasing)
to this acquisition. The Plan shall clearly identify those products
and services included in Federal sustainable acquisition preference
programs by categorizing them along with their respective price/cost
in the following eight groups: Recycled Content, Energy Efficient,
Biobased, Environmentally Preferable, Electronic Product Environment
Assessment Tool, Water-Efficient, Non-Ozone Depleting Substances,
and Alternative Fuel Vehicle and Alternative Fuels.
(End of provision)
352.224-70 Privacy Act.
As prescribed in HHSAR 324.105(a), the Contracting Officer shall
insert the following clause:
Privacy Act (DEC 2015)
This contract requires the Contractor to perform one or more of
the following: (a) Design; (b) develop; or (c) operate a Federal
agency system of records to accomplish an agency function in
accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1))
and applicable agency regulations.
The term system of records means a group of any records under
the control of any agency from which information is retrieved by the
name of the individual or by some identifying number, symbol, or
other identifying particular assigned to the individual. Violations
of the Act by the Contractor and/or its employees may result in the
imposition of criminal penalties (5 U.S.C. 552a(i)).
The Contractor shall ensure that each of its employees knows the
prescribed rules of conduct in 45 CFR part 5b and that each employee
is aware that he/she is subject to criminal penalties for violation
of the Act to the same extent as Department of Health and Human
Services employees. These provisions also apply to all subcontracts
the Contractor awards under this contract which require the design,
development or operation of the designated system(s) of records (5
U.S.C. 552a(m)(1)). The contract work statement:
(a) Identifies the system(s) of records and the design,
development, or operation work the Contractor is to perform; and
(b) Specifies the disposition to be made of such records upon
completion of contract performance.
(End of clause)
352.224-71 Confidential Information.
As prescribed in HHSAR 324.105(b), insert the following clause:
Confidential Information (DEC 2015)
(a) Confidential Information, as used in this clause, means
information or data of a personal nature about an individual, or
proprietary information or data submitted by or pertaining to an
institution or organization.
(b) Specific information or categories of information that the
Government will furnish to the Contractor, or that the Contractor is
expected to generate, which are confidential may be identified
elsewhere in this contract. The Contracting Officer may modify this
contract to identify Confidential Information from time to time
during performance.
(c) Confidential Information or records shall not be disclosed
by the Contractor until:
(1) Written advance notice of at least 45 days shall be provided
to the Contracting Officer of the Contractor's intent to release
findings of studies or research, to which an agency response may be
appropriate to protect the public interest or that of the agency.
(2) For information provided by or on behalf of the government,
(i) The publication or dissemination of the following types of
information are restricted under this contract: [INSERT RESTRICTED
TYPES OF INFORMATION. IF NONE, SO STATE.]
(ii) The reason(s) for restricting the types of information
identified in subparagraph (i) is/are: [STATE WHY THE PUBLIC OR
GOVERNMENT INTEREST REQUIRES THE RESTRICTION OF EACH TYPE OF
INFORMATION. ANY BASIS FOR NONDISCLOSURE WHICH WOULD BE VALID UNDER
THE FREEDOM OF INFORMATION ACT IS SUFFICIENT UNDER THIS CLAUSE.]
(iii) Written advance notice of at least 45 days shall be
provided to the Contracting Officer of the Contractor's intent to
disseminate or publish information identified in subparagraph
(2)(i). The contractor shall not disseminate or publish such
information without the written consent of the Contracting Officer.
(d) Whenever the Contractor is uncertain with regard to the
confidentiality of or a property interest in information under this
contract, the Contractor should consult with the Contracting Officer
prior to any release, disclosure, dissemination, or publication.
352.226-1 Indian Preference.
As prescribed in HHSAR 326.505(a), the Contracting Officer shall
insert the following clause:
Indian Preference (DEC 2015)
(a) The Contractor agrees to give preference in employment
opportunities under this contract to Indians who can perform
required work, regardless of age (subject to existing laws and
regulations), sex, religion, or tribal affiliation. To the extent
feasible and consistent with the efficient performance of this
contract, the Contractor further agrees to give preference in
employment and training opportunities under this contract to Indians
who are not fully qualified to perform regardless of age (subject to
existing laws and regulations), sex, religion, or tribal
affiliation. The Contractor also agrees to give preference to Indian
organizations and Indian-owned economic enterprises in the awarding
of any subcontracts to the extent feasible and consistent with the
efficient performance of this contract. The Contractor shall
maintain
[[Page 72174]]
the necessary statistical records to demonstrate compliance with
this paragraph.
(b) In connection with the Indian employment preference
requirements of this clause, the Contractor shall provide reasonable
opportunities for training, incident to such employment. Such
training shall include on-the-job, classroom, or apprenticeship
training designed to increase the vocational effectiveness of an
Indian employee.
(c) If the Contractor is unable to fill its employment and
training opportunities after giving full consideration to Indians as
required by this clause, the Contractor may satisfy those needs by
selecting non-Indian persons in accordance with the clause of this
contract entitled ``Equal Opportunity.''
(d) If no Indian organizations or Indian-owned economic
enterprises are available under reasonable terms and conditions,
including price, for awarding of subcontracts in connection with the
work performed under this contract, the Contractor agrees to comply
with the provisions of this contract involving utilization of small
businesses; HUBZone small businesses; service-disabled, veteran-
owned small businesses; 8(a) small businesses; veteran-owned small
businesses; women-owned small businesses; or small disadvantaged
businesses.
(e) As used in this clause,
(1) Indian means a person who is a member of an Indian tribe. If
the Contractor has reason to doubt that a person seeking employment
preference is an Indian, the Contractor shall grant the preference
but shall require the individual provide evidence within 30 days
from the tribe concerned that the person is a member of the tribe.
(2) Indian tribe means an Indian tribe, pueblo, band, nation, or
other organized group or community, including Alaska Native village
or regional or village corporation as defined in or established
pursuant to the Alaska Native Claims Settlement Act (85 Stat. 688;
43 U.S.C. 1601) which the United States recognizes as eligible for
the special programs and services provided to Indians because of its
status as Indians.
(3) Indian organization means the governing body of any Indian
Tribe or entity established or recognized by such governing body in
accordance with the Indian Financing Act of 1974 (88 Stat. 77; 25
U.S.C. 1451).
(4) Indian-owned economic enterprise means any Indian-owned
commercial, industrial, or business activity established or
organized for the purpose of profit, provided that such Indian
ownership shall constitute not less than 51 percent of the
enterprise, and that ownership shall encompass active operation and
control of the enterprise.
(f) The Contractor agrees to include the provisions of this
clause, including this paragraph (f) of this clause, in each
subcontract awarded at any tier under this contract.
(g) In the event of noncompliance with this clause, the
Contracting Officer may terminate the contract in whole or in part
or may pursue any other remedies authorized by law or by other
provisions of the contract.
(End of clause)
352.226-2 Indian Preference Program.
As prescribed in HHSAR 326.505(b), the Contracting Officer shall
insert the following clause:
Indian Preference Program (DEC 2015)
(a) In addition to the requirements of the clause of this
contract entitled ``Indian Preference,'' the Contractor agrees to
establish and conduct an Indian preference program which will expand
opportunities for Indians to receive preference for employment and
training in connection with the work performed under this contract,
and which will expand the opportunities for Indian organizations and
Indian-owned economic enterprises to receive a preference in the
awarding of subcontracts. In this connection, the Contractor shall
perform the following:
(1) Designate a liaison officer who will maintain liaison with
the Government and the Tribe(s) on Indian preference matters;
supervise compliance with the provisions of this clause; and
administer the Contractor's Indian preference program.
(2) Advise its recruitment sources in writing and include a
statement in all employment advertisements that Indian applicants
receive preference in employment and training incident to such
employment.
(3) Not more than 20 calendar days after award of the contract,
post a written notice setting forth the Contractor's employment
needs and related training opportunities in the tribal office of any
reservations on or near the contract work location. The notice shall
include the approximate numbers and types of employees needed; the
approximate dates of employment; any experience or special skills
required for employment; training opportunities available; and other
pertinent information necessary to advise prospective employees of
any other employment requirements. The Contractor shall also request
the tribe(s) on or near whose reservation(s) the Contractor will
perform contract work to provide assistance filling its employment
needs and training opportunities. The Contracting Officer will
advise the Contractor of the name, location, and phone number of the
Tribal officials to contact regarding the posting of notices and
requests for Tribal assistance.
(4) Establish and conduct a subcontracting program which gives
preference to Indian organizations and Indian-owned economic
enterprises as subcontractors (including suppliers) under this
contract. The Contractor shall give public notice of existing
subcontracting opportunities and, to the extent feasible and
consistent with the efficient performance of this contract, shall
solicit bids or proposals from Indian organizations or Indian-owned
economic enterprises only. The Contractor shall request assistance
and information on Indian firms qualified as subcontractors
(including suppliers) from the Tribe(s) on or near whose
reservation(s) the Contractor will perform contract work. The
Contracting Officer will advise the Contractor of the name,
location, and phone number of the Tribal officials to contact
regarding the request for assistance and information. Public notices
and solicitations for existing subcontracting opportunities shall
provide an equitable opportunity for Indian firms to submit bids or
proposals by including--
(i) A clear description of the supplies or services required,
including quantities, specifications, and delivery schedules that
facilitate the participation of Indian firms;
(ii) A statement indicating that Indian organizations and
Indian-owned economic enterprises will receive preference in
accordance with section 7(b) of Public Law 93-638; 88 Stat. 2205; 25
U.S.C. 450e(b);
(iii) Definitions for the terms ``Indian organization'' and
``Indian-owned economic enterprise'' prescribed under the ``Indian
Preference'' clause of this contract;
(iv) A statement that the bidder or offeror shall complete
certifying that it is an Indian organization or Indian-owned
economic enterprise; and
(v) A closing date for receipt of bids or proposals which
provides sufficient time for preparation and submission of a bid or
proposal. If, after soliciting bids or proposals from Indian
organizations and Indian-owned economic enterprises, the Contractor
receives no responsive bid or acceptable proposal, the Contractor
shall comply with the requirements of paragraph (d) of the ``Indian
Preference'' clause of this contract. If the Contractor receives one
or more responsive bids or conforming proposals, the Contractor
shall award the contract to the low, responsive, responsible bidder
or conforming offer from a responsible offeror if the price is
reasonable. If the Contractor determines the low responsive bid or
conforming proposal's price is unreasonable, the Contractor shall
attempt to negotiate a reasonable price and award a subcontract. If
parties cannot agree on a reasonable price, the Contractor shall
comply with the requirements of paragraph (d) of the ``Indian
Preference'' clause of this contract.
(5) Maintain written records under this contract which
demonstrate--
(i) The numbers of Indians seeking employment for each
employment position available under this contract;
(ii) The number and types of positions filled by Indians and
non-Indians;
(iii) The total number of Indians employed under this contract;
(iv) For those positions having both Indian and non-Indian
applicants, and a non-Indian is selected for employment, the
reason(s) why the Contractor did not select the Indian applicant;
(v) Actions taken to give preference to Indian organizations and
Indian-owned economic enterprises for subcontracting opportunities
which exist under this contract;
(vi) Reasons why Indian subcontractors and or suppliers did not
receive preference for each requirement where the Contractor
determined that such preference was inconsistent with efficient
contract performance; and
(vii) The number of Indian organizations and Indian-owned
economic enterprises contacted, and the number receiving subcontract
awards under this contract.
(6) Submit to the Contracting Officer for approval a quarterly
report summarizing the Contractor's Indian preference program and
[[Page 72175]]
indicating the number and types of available positions filled by
Indians and non-Indians, and the dollar amounts of all subcontracts
awarded to Indian organizations and Indian-owned economic
enterprises, and to all other firms.
(7) Maintain records pursuant to this clause and keep them
available for review by the Government for one year after final
payment under this contract, or for such longer period in accordance
with requirements of any other clause of this contract or by
applicable law or regulation.
(b) For purposes of this clause, the following definitions of
terms shall apply:
(1) The terms Indian, Indian tribe, Indian organization, and
Indian-owned economic enterprise are defined in the clause of this
contract entitled Indian Preference.
(2) Indian reservation includes Indian reservations, public
domain Indian allotments, former Indian reservations in Oklahoma,
and land held by incorporated Native groups, regional corporations,
and village corporations under the provisions of the Alaska Native
Claims Settlement Act (85 Stat. 688; 43 U.S.C. 1601 et seq.)
(3) On or near an Indian reservation means on a reservation or
reservations or within that area surrounding an Indian
reservation(s) where a person seeking employment could reasonably
expect to commute to and from in the course of a work day.
(c) Nothing in the requirements of this clause shall preclude
Indian tribes from independently developing and enforcing their own
Indian preference requirements. Such requirements must not conflict
with any Federal statutory or regulatory requirement dealing with
the award and administration of contracts.
(d) The Contractor agrees to include the provisions of this
clause, including this paragraph (d), in each subcontract awarded at
any tier under this contract and to notify the Contracting Officer
of such subcontracts.
(e) In the event of noncompliance with this clause, the
Contracting Officer may terminate the contract in whole or in part
or may pursue any other remedies authorized by law or by other
provisions of the contract.
(End of clause)
352.226-3 Native American Graves Protection and Repatriation Act.
As prescribed in HHSAR 326.701, the Contracting Officer shall
insert the following clause:
Native American Graves Protection and Repatriation Act (DEC 2015)
(a) Public Law 101-601, dated November 16, 1990, also known as
the Native American Graves Protection and Repatriation Act, imposes
certain responsibilities on individuals and organizations when they
discover Native American cultural items (including human remains) on
Federal or tribal lands.
(b) In the event the Contractor discovers Native American
cultural items (including human remains, associated funerary
objects, unassociated funerary objects, sacred objects and cultural
patrimony), as defined in the Act during contract performance, the
Contractor shall--
(1) Immediately cease activity in the area of the discovery;
(2) Notify the Contracting Officer of the discovery; and
(3) Make a reasonable effort to protect the items discovered
before resuming such activity. Upon receipt of the Contractor's
discovery notice, the Contracting Officer will notify the
appropriate authorities as required by the Act.
(c) Unless otherwise specified by the Contracting Officer, the
Contractor may resume activity in the area on the 31st calendar day
following the date that the appropriate authorities certify receipt
of the discovery notice. The Contracting Officer shall provide to
the Contractor the date that the appropriate authorities certify
receipt of the discovery notice and the date on which the Contractor
may resume activities.
352.227-11 Patent Rights--Exceptional Circumstances.
As prescribed in HHSAR 327.303, the Contracting Officer shall
insert the following clause:
Patent Rights--Exceptional Circumstances (SEPT 2014)
This clause applies to all Contractor and subcontractor (at all
tiers) Subject Inventions.
(a) Definitions. As used in this clause--
Agency means the Agency of the U.S. Department of Health and
Human Services that is entering into this contract.
Class 1 Subject Invention means a Subject Invention described
and defined in the DEC that will be assigned to a third party
assignee, or assigned as directed by the Agency.
Class 2 Subject Invention means a Subject Invention described
and defined in the DEC.
Class 3 Subject Invention means a Subject Invention that does
not fall into Class 1 or Class 2 as defined in this clause.
DEC means the Determination of Exceptional Circumstances signed
by [insert approving official] ____ on __ [insert date] ____ and
titled ``[insert description].''
Invention means any invention or discovery, which is or may be
patentable or otherwise protectable under Title 35 of United States
Code, or any novel variety of plant that is or may be protectable
under the Plant Variety Protection Act (7 U.S.C. 2321, et seq.)
Made means: When used in relation to any invention other than a
plant variety, the conception or first actual reduction to practice
of such invention; or when used in relation to a plant variety, that
the Contractor has at least tentatively determined that the variety
has been reproduced with recognized characteristics.
Material means any proprietary material, method, product,
composition, compound, or device, whether patented or unpatented,
which is provided to the Contractor under this contract.
Nonprofit organization means a university or other institution
of higher education or an organization of the type described in
section 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C.
501(c)) and exempt from taxation under section 501(a) of the
Internal Revenue Code (26 U.S.C. 501(a)) or any nonprofit scientific
or educational organization qualified under a state nonprofit
organization statute.
Practical application means to manufacture, in the case of a
composition or product; to practice, in the case of a process or
method, or to operate, in the case of a machine or system; and, in
each case, under such conditions as to establish that the invention
is being utilized and that its benefits are, to the extent permitted
by law or Government regulations, available to the public on
reasonable terms.
Small business firm means a small business concern as defined at
section 2 of Public Law 85-536 (15 U.S.C. 632) and implementing
regulations of the Administrator of the Small Business
Administration. For the purpose of this clause, the size standards
for small business concerns involved in Government procurement and
subcontracting at 13 CFR 121.3-8 and 13 CFR 121.3-12, respectively,
will be used.
Subject Invention means any invention of the Contractor made in
the performance of work under this contract.
Third party assignee means any entity or organization that may,
as described in the DEC, be assigned Class 1 inventions.
(b) Allocation of principal rights. (1) Retention of pre-
existing rights. Third party assignees shall retain all preexisting
rights to Material in which the Third party assignee has a
proprietary interest.
(2) Allocation of Subject Invention rights. (i) Disposition of
Class 1 Subject Inventions. (A) Assignment to the Third party
assignee or as directed by the Agency. The Contractor shall assign
to the Third party assignee designated by the Agency the entire
right, title, and interest throughout the world to each Subject
Invention, or otherwise dispose of or transfer those rights as
directed by the Agency, except to the extent that rights are
retained by the Contractor under paragraph (b)(3) of this clause.
Any such assignment or other disposition or transfer of rights will
be subject to a nonexclusive, nontransferable, irrevocable, paid-up
license to the U.S. Government to practice or have practiced the
Subject Invention for or on behalf of the U.S. throughout the world.
Any assignment shall additionally be subject to the ``March-in
rights'' of 35 U.S.C. 203. If the Contractor is a U.S. nonprofit
organization it may retain a royalty free, nonexclusive,
nontransferable license to practice the invention for all nonprofit
research including for educational purposes, and to permit other
U.S. nonprofit organizations to do so.
(B) [Reserved]
(ii) Disposition of Class 2 and 3 Subject Inventions. Class 2
Subject Inventions shall be governed by FAR clause 52.227-11, Patent
Rights-Ownership (December 2007) (incorporated herein by reference).
However, the Contractor shall grant a license in the Class 2 Subject
Inventions to the provider of the Material or other party designated
by the Agency as set forth in Alternate I.
(iii) Class 3 Subject Inventions shall be governed by FAR clause
52.227-11, Patent Rights--Ownership by the Contractor (December
2007) (previously incorporated herein by reference).
[[Page 72176]]
(3) Greater Rights Determinations. The Contractor, or an
employee-inventor after consultation by the Agency with the
Contractor, may request greater rights than are provided in
paragraph (b)(1) of this clause in accordance with the procedures of
FAR paragraph 27.304-1(c). In addition to the considerations set
forth in paragraph 27.304-1(c), the Agency may consider whether
granting the requested greater rights will interfere with rights of
the Government or any Third party assignee or otherwise impede the
ability of the Government or the Third party assignee to, for
example, develop and commercialize new compounds, dosage forms,
therapies, preventative measures, technologies, or other approaches
with potential for the diagnosis, prognosis, prevention, and
treatment of human diseases.
A request for a determination of whether the Contractor or the
employee-inventor is entitled to retain such greater rights must be
submitted to the Agency Contracting Officer at the time of the first
disclosure of the invention pursuant to paragraph (c)(1) of this
clause, or not later than 8 months thereafter, unless a longer
period is authorized in writing by the Contracting Officer for good
cause shown in writing by the Contractor. Each determination of
greater rights under this contract shall be subject to paragraph (c)
of the FAR clause at 52.227-13 (incorporated herein by reference),
and to any reservations and conditions deemed to be appropriate by
the Agency such as the requirement to assign or exclusively license
the rights to Subject Inventions to the Third party assignee.
A determination by the Agency denying a request by the
Contractor for greater rights in a Subject Invention may be appealed
within 30 days of the date the Contractor is notified of the
determination to an Agency official at a level above the individual
who made the determination. If greater rights are granted, the
Contractor must file a patent application on the invention. Upon
request, the Contractor shall provide the filing date, serial number
and title, a copy of the patent application (including an English-
language version if filed in a language other than English), and
patent number and issue date for any Subject Invention in any
country for which the Contractor has retained title. Upon request,
the Contractor shall furnish the Government an irrevocable power to
inspect and make copies of the patent application file.
(c) Invention disclosure by Contractor. The Contractor shall
disclose in writing each Subject Invention to the Agency Contracting
Officer and to the Director, Division of Extramural Inventions and
Technology Resources (DEITR), if directed by the Contracting
Officer, as provided in paragraph (j) of this clause within 2 months
after the inventor discloses it in writing to Contractor personnel
responsible for patent matters. The disclosure to the Agency
Contracting Officer shall be in the form of a written report and
shall identify the contract under which the invention was Made and
all inventors. It shall be sufficiently complete in technical detail
to convey a clear understanding to the extent known at the time of
the disclosure, of the nature, purpose, operation, and the physical,
chemical, biological, or electrical characteristics of the
invention. The disclosure shall also identify any publication, on
sale (offer for sale), or public use of the invention and whether a
manuscript describing the invention has been submitted for
publication, and if so, whether it has been accepted for publication
at the time of disclosure.
In addition, after disclosure to the Agency, the Contractor will
promptly notify the Contracting Officer and DEITR of the acceptance
of any manuscript describing the invention for publication or of any
on sale or public use planned by the Contractor. If the Contractor
assigns a Subject Invention to the Third party assignee, then the
Contractor and its employee inventors shall assist the Third party
assignee in securing patent protection. All costs of securing the
patent, including the cost of the Contractor's assistance, are at
the Third party's expense. Any assistance provided by the Contractor
and its employee inventors to the Third party assignee or other
costs incurred in securing patent protection shall be solely at the
Third party's expense and not billable to the contract.
(d) Contractor action to protect the Third party assignee's and
the Government's interest. (1) The Contractor agrees to execute or
to have executed and promptly deliver to the Agency all instruments
necessary to: Establish or confirm the rights the Government has
throughout the world in Subject Inventions pursuant to paragraph (b)
of this clause; convey title to a Third party assignee in accordance
with paragraph (b) of this clause; and enable the Third party
assignee to obtain patent protection throughout the world in that
Subject Invention.
(2) The Contractor agrees to require, by written agreement, its
employees, other than clerical and nontechnical employees, to
disclose promptly in writing to personnel identified as responsible
for the administration of patent matters and in a format suggested
by the Contractor, each Subject Invention ``Made'' under contract in
order that the Contractor can comply with the disclosure provisions
of paragraph (c) of this clause, and to execute all papers necessary
to file patent applications on Subject Inventions and to establish
the Government's rights or a Third party assignee's rights in the
Subject Inventions. This disclosure format should require, as a
minimum, the information required by subparagraph (c)(1) of this
clause. The Contractor shall instruct such employees, through
employee agreements or other suitable educational programs, on the
importance of reporting inventions in sufficient time to permit the
filing of patent applications prior to U.S. or foreign statutory
bars.
(3) If the Contractor is granted greater rights, the Contractor
agrees to include, within the specification of any United States
non-provisional patent application it files, and any patent issuing
thereon, covering a Subject Invention the following statement:
``This invention was made with Government support under (identify
the Contract) awarded by (identify the specific Agency). The
Government has certain rights in the invention.''
(4) The Contractor agrees to provide a final invention statement
and certification prior to the closeout of the contract listing all
Subject Inventions or stating that there were none.
(e) Subcontracts. (1) The Contractor will include this clause in
all subcontracts, regardless of tier, for experimental,
developmental, or research work. At all tiers, the clause must be
modified to identify the parties as follows: References to the
Government are not changed, and the subcontractor has all rights and
obligations of the Contractor in the clause. The Contractor will
not, as part of the consideration for awarding the contract, obtain
rights in the subcontractor's Subject Inventions.
(2) In subcontracts, at any tier, the Agency, the subcontractor,
and the Contractor agree that the mutual obligations of the parties
created by this clause constitute a contract between the
subcontractor and the Agency with respect to the matters covered by
the clause; provided, however, that nothing in this paragraph is
intended to confer any jurisdiction under the Contract Disputes Act
in connection with proceedings under paragraph (c)(1)(ii) of FAR
clause 52.227-13.
(f) Reporting on utilization of Subject Inventions in the event
greater rights are granted to the Contractor. The Contractor agrees
to submit, on request, periodic reports no more frequently than
annually on the utilization of a Subject Invention or on efforts at
obtaining such utilization that are being made by the Contractor or
its licensees or assignees when a request under subparagraph b.3.
has been granted by the Agency. Such reports shall include
information regarding the status of development, date of first
commercial sale or use, gross royalties received by the Contractor,
and such other data and information as the Agency may reasonably
specify. The Contractor also agrees to provide additional reports as
may be requested by the Agency in connection with any march-in
proceeding undertaken by the Agency in accordance with paragraph (h)
of this clause. As required by 35 U.S.C. 202(c)(5), the Agency
agrees it will not disclose such information to persons outside the
Government without permission of the Contractor.
(g) Preference for United States industry in the event greater
rights are granted to the Contractor. Notwithstanding any other
provision of this clause, the Contractor agrees that neither it nor
any assignee will grant to any person the exclusive right to use or
sell any Subject Invention in the United States unless such person
agrees that any product embodying the Subject Invention or produced
through the use of the Subject Invention will be manufactured
substantially in the United States. However, in individual cases,
the requirement for such an agreement may be waived by the Agency
upon a showing by the Contractor or its assignee that reasonable but
unsuccessful efforts have been made to grant licenses on similar
terms to potential licensees that would be likely to manufacture
substantially in the United States or that under the circumstances
domestic manufacture is not commercially feasible.
(h) March-in rights in the event greater rights are granted to
the Contractor. The
[[Page 72177]]
Contractor acknowledges that, with respect to any Subject Invention
in which it has acquired ownership through the exercise of the
rights specified in paragraph (b)(3) of this clause, the Agency has
the right to require licensing pursuant to 35 U.S.C. 203 and 210(c),
and in accordance with the procedures in 37 CFR 401.6 and any
supplemental regulations of Agency in effect on the date of contract
award.
(i) Special provisions for contracts with nonprofit
organizations in the event greater rights are granted to the
Contractor. If the Contractor is a nonprofit organization, it shall:
(1) Not assign rights to a Subject Invention in the United
States without the written approval of the Agency, except where an
assignment is made to an organization that has as one of its primary
functions the management of inventions, provided that the assignee
shall be subject to the same provisions as the Contractor;
(2) Share royalties collected on a Subject Invention with the
inventor, including Federal employee co-inventors (but through their
Agency if the Agency deems it appropriate) when the Subject
Invention is assigned in accordance with 35 U.S.C. 202(e) and 37 CFR
401.10;
(3) Use the balance of any royalties or income earned by the
Contractor with respect to Subject Inventions, after payment of
expenses (including payments to inventors) incidental to the
administration of Subject Inventions for the support of scientific
research or education;
(4) Make efforts that are reasonable under the circumstances to
attract licensees of Subject Inventions that are small business
concerns, and give a preference to a small business concern when
licensing a Subject Invention if the Contractor determines that the
small business concern has a plan or proposal for marketing the
invention which, if executed, is equally as likely to bring the
invention to practical application as any plans or proposals from
applicants that are not small business concerns; provided, that the
Contractor is also satisfied that the small business concern has the
capability and resources to carry out its plan or proposal. The
decision whether to give a preference in any specific case will be
at the discretion of the Contractor; and
(5) Allow the Secretary of Commerce to review the Contractor's
licensing program and decisions regarding small business applicants,
and negotiate changes to its licensing policies, procedures, or
practices with the Secretary of Commerce when the Secretary's review
discloses that the Contractor could take reasonable steps to more
effectively implement the requirements of paragraph (i)(4) of this
clause.
(j) Communications. All invention disclosures and requests for
greater rights shall be sent to the Agency Contracting Officer, as
directed by the Contracting Officer. Additionally, a copy of all
disclosures, confirmatory licenses to the Government, face page of
the patent applications, waivers and other routine communications
under this funding agreement at all tiers must be sent to:
[Insert Agency Address]
Agency Invention Reporting Web site: https://public.era.nih.gov/iedison.
Alternate I (Sept 2014). As prescribed in 327.303, the license
to Class 2 inventions recited in 352.227-11(b)(2)(a) is as follows:
[Insert description of license to Class 2 inventions]
(End of clause)
352.227-14 Rights in Data--Exceptional Circumstances.
As prescribed in HHSAR 327.409, insert the following clause with
any appropriate alternates:
Rights in Data--Exceptional Circumstances (SEPT 2014)
(a) Definitions. As used in this clause--Definitions may be
added or modified in paragraph (a) as applicable.
Computer database or database means a collection of recorded
information in a form capable of, and for the purpose of, being
stored in, processed, and operated on by a computer. The term does
not include computer software.
Computer software--(i) Means (A) Computer programs that comprise
a series of instructions, rules, routines, or statements, regardless
of the media in which recorded, that allow or cause a computer to
perform a specific operation or series of operations; and
(B) Recorded information comprising source code listings, design
details, algorithms, processes, flow charts, formulas, and related
material that would enable the computer program to be produced,
created, or compiled.
(ii) Does not include computer databases or computer software
documentation.
Computer software documentation means owner's manuals, user's
manuals, installation instructions, operating instructions, and
other similar items, regardless of storage medium, that explain the
capabilities of the computer software or provide instructions for
using the software.
Data means recorded information, regardless of form or the media
on which it may be recorded. The term includes technical data and
computer software. The term does not include information incidental
to contract administration, such as financial, administrative, cost
or pricing, or management information.
Form, fit, and function data means data relating to items,
components, or processes that are sufficient to enable physical and
functional interchangeability, and data identifying source, size,
configuration, mating and attachment characteristics, functional
characteristics, and performance requirements. For computer software
it means data identifying source, functional characteristics, and
performance requirements but specifically excludes the source code,
algorithms, processes, formulas, and flow charts of the software.
Limited rights means the rights of the Government in limited
rights data as set forth in the Limited Rights Notice in Alternate
II paragraph (g)(3) if included in this clause. ``Limited rights
data'' means data, other than computer software, that embody trade
secrets or are commercial or financial and confidential or
privileged, to the extent that such data pertain to items,
components, or processes developed at private expense, including
minor modifications.
Restricted computer software means computer software developed
at private expense and that is a trade secret, is commercial or
financial and confidential or privileged, or is copyrighted computer
software, including minor modifications of the computer software.
Restricted rights, as used in this clause, means the rights of
the Government in restricted computer software, as set forth in a
Restricted Rights Notice of Alternate III paragraph (g)(4) if
included in this clause, or as otherwise may be provided in a
collateral agreement incorporated in and made part of this contract,
including minor modifications of such computer software.
Technical data means recorded information (regardless of the
form or method of the recording) of a scientific or technical nature
(including computer databases and computer software documentation).
This term does not include computer software or financial,
administrative, cost or pricing, or management data or other
information incidental to contract administration. The term includes
recorded information of a scientific or technical nature that is
included in computer databases (See 41 U.S.C. 403(8)).
Unlimited rights means the rights of the Government to use,
disclose, reproduce, prepare derivative works, distribute copies to
the public, and perform publicly and display publicly, in any manner
and for any purpose, and to have or permit others to do so.
(b) Allocation of rights. (1) Except as provided in paragraph
(c) of this clause, the Government shall have unlimited rights in--
(i) Data first produced in the performance of this contract;
(ii) Form, fit, and function data delivered under this contract;
(iii) Data delivered under this contract (except for restricted
computer software) that constitute manuals or instructional and
training material for installation, operation, or routine
maintenance and repair of items, components, or processes delivered
or furnished for use under this contract; and
(iv) All other data delivered under this contract unless
provided otherwise for limited rights data or restricted computer
software in accordance with paragraph (g) of this clause.
(2) The Contractor shall have the right to--
(i) Assert copyright in data first produced in the performance
of this contract to the extent provided in paragraph (c)(1) of this
clause;
(ii) Use, release to others, reproduce, distribute, or publish
any data first produced or specifically used by the Contractor in
the performance of this contract, unless provided otherwise in
paragraph (d) of this clause;
(iii) Substantiate the use of, add, or correct limited rights,
restricted rights, or copyright notices and to take other
appropriate action, in accordance with paragraphs (e) and (f) of
this clause; and
(iv) Protect from unauthorized disclosure and use those data
that are limited rights data or restricted computer software to the
extent provided in paragraph (g) of this clause.
[[Page 72178]]
(c) Copyright--(1) Data first produced in the performance of
this contract. (i) Unless provided otherwise in paragraph (d) of
this clause, the Contractor may, without prior approval of the
Contracting Officer, assert copyright in scientific and technical
articles based on or containing data first produced in the
performance of this contract and published in academic, technical or
professional journals, symposia proceedings, or similar works. The
prior, express written permission of the Contracting Officer is
required to assert copyright in all other data first produced in the
performance of this contract.
(ii) When authorized to assert copyright to the data, the
Contractor shall affix the applicable copyright notices of 17 U.S.C.
401 or 402, and an acknowledgment of Government sponsorship
(including contract number).
(iii) For data other than computer software, the Contractor
grants to the Government and others acting on its behalf, a paid-up,
nonexclusive, irrevocable, worldwide license in such copyrighted
data to reproduce, prepare derivative works, distribute copies to
the public, and perform publicly and display publicly by or on
behalf of the Government. For computer software, the Contractor
grants to the Government, and others acting on its behalf, a paid-
up, nonexclusive, irrevocable, worldwide license in such copyrighted
computer software to reproduce, prepare derivative works, and
perform publicly and display publicly (but not to distribute copies
to the public) by or on behalf of the Government.
(2) Data not first produced in the performance of this contract.
The Contractor shall not, without the prior written permission of
the Contracting Officer, incorporate in data delivered under this
contract any data not first produced in the performance of this
contract unless the Contractor--
(i) Identifies the data; and
(ii) Grants to the Government, or acquires on its behalf, a
license of the same scope as set forth in paragraph (c)(1) of this
clause or, if such data are restricted computer software, the
Government shall acquire a copyright license as set forth in
paragraph (g)(4) of this clause (if included in this contract) or as
otherwise provided in a collateral agreement incorporated in or made
part of this contract.
(3) Removal of copyright notices. The Government will not remove
any authorized copyright notices placed on data pursuant to this
paragraph (c), and will include such notices on all reproductions of
the data.
(d) Release, publication, and use of data. The Contractor shall
have the right to use, release to others, reproduce, distribute, or
publish any data first produced or specifically used by the
Contractor in the performance of this contract, except--
(1) As prohibited by Federal law or regulation (e.g., export
control or national security laws or regulations);
(2) As expressly set forth in this contract; or
(3) If the Contractor receives or is given access to data
necessary for the performance of this contract that contain
restrictive markings, the Contractor shall treat the data in
accordance with such markings unless specifically authorized
otherwise in writing by the Contracting Officer or in the following
paragraphs.
(4) In addition to any other provisions, set forth in this
contract, the Contractor shall ensure that information concerning
possible inventions made under this contract is not prematurely
published thereby adversely affecting the ability to obtain patent
protection on such inventions. Accordingly, the Contractor will
provide the Contracting Officer a copy of any publication or other
public disclosure relating to the work performed under this contract
at least 30 days in advance of the disclosure. Upon the Contracting
Officer's request the Contractor agrees to delay the public
disclosure of such data or publication of a specified paper for a
reasonable time specified by the Contracting Officer, not to exceed
6 months, to allow for the filing of domestic and international
patent applications in accordance with Clause 352.227-11, Patent
Rights--Exceptional Circumstances (abbreviated month and year of
Final Rule publication).
(5) Data on Material(s). The Contractor agrees that in
accordance with paragraph (d)(2), proprietary data on Material(s)
provided to the Contractor under or through this contract shall be
used only for the purpose for which they were provided, including
screening, evaluation or optimization and for no other purpose.
(6) Confidentiality. (i) The Contractor shall take all
reasonable precautions to maintain Confidential Information as
confidential, but no less than the steps Contractor takes to secure
its own confidential information.
(ii) Contractor shall maintain Confidential Information as
confidential unless specifically authorized otherwise in writing by
the Contracting Officer. Confidential Information includes/does not
include [Government may define confidential information here.]
(e) Unauthorized marking of data. (1) Notwithstanding any other
provisions of this contract concerning inspection or acceptance, if
any data delivered under this contract are marked with the notices
specified in paragraph (g)(3) or (4) of this clause (if those
alternate paragraphs are included in this clause), and use of the
notices is not authorized by this clause, or if the data bears any
other restrictive or limiting markings not authorized by this
contract, the Contracting Officer may cancel or ignore the markings.
However, pursuant to 41 U.S.C. 253d, the following procedures shall
apply prior to canceling or ignoring the markings.
(i) The Contracting Officer will make written inquiry to the
Contractor affording the Contractor 60 days from receipt of the
inquiry to provide written justification to substantiate the
propriety of the markings;
(ii) If the Contractor fails to respond or fails to provide
written justification to substantiate the propriety of the markings
within the 60-day period (or a longer time approved in writing by
the Contracting Officer for good cause shown), the Government shall
have the right to cancel or ignore the markings at any time after
said period and the data will no longer be made subject to any
disclosure prohibitions.
(iii) If the Contractor provides written justification to
substantiate the propriety of the markings within the period set in
paragraph (e)(1)(i) of this clause, the Contracting Officer will
consider such written justification and determine whether or not the
markings are to be cancelled or ignored. If the Contracting Officer
determines that the markings are authorized, the Contractor will be
so notified in writing. If the Contracting Officer determines, with
concurrence of the Head of the Contracting Activity, that the
markings are not authorized, the Contracting Officer will furnish
the Contractor a written determination, which determination will
become the final Agency decision regarding the appropriateness of
the markings unless the Contractor files suit in a court of
competent jurisdiction within 90 days of receipt of the Contracting
Officer's decision. The Government will continue to abide by the
markings under this paragraph (e)(1)(iii) until final resolution of
the matter either by the Contracting Officer's determination
becoming final (in which instance the Government will thereafter
have the right to cancel or ignore the markings at any time and the
data will no longer be made subject to any disclosure prohibitions),
or by final disposition of the matter by court decision if suit is
filed.
(2) The time limits in the procedures set forth in paragraph
(e)(1) of this clause may be modified in accordance with Agency
regulations implementing the Freedom of Information Act (5 U.S.C.
552) if necessary to respond to a request there under.
(3) Except to the extent the Government's action occurs as the
result of final disposition of the matter by a court of competent
jurisdiction, the Contractor is not precluded by this paragraph (e)
from bringing a claim, in accordance with the Disputes clause of
this contract, that may arise as the result of the Government
removing or ignoring authorized markings on data delivered under
this contract.
(f) Omitted or incorrect markings. (1) Data delivered to the
Government without any restrictive markings shall be deemed to have
been furnished with unlimited rights. The Government is not liable
for the disclosure, use, or reproduction of such data.
(2) If the unmarked data has not been disclosed without
restriction outside the Government, the Contractor may request,
within 6 months (or a longer time approved by the Contracting
Officer in writing for good cause shown) after delivery of the data,
permission to have authorized notices placed on the data at the
Contractor's expense. The Contracting Officer may agree to do so if
the Contractor--
(i) Identifies the data to which the omitted notice is to be
applied;
(ii) Demonstrates that the omission of the notice was
inadvertent;
(iii) Establishes that the proposed notice is authorized; and
(iv) Acknowledges that the Government has no liability for the
disclosure, use, or reproduction of any data made prior to the
addition of the notice or resulting from the omission of the notice.
[[Page 72179]]
(3) If data has been marked with an incorrect notice, the
Contracting Officer may--
(i) Permit correction of the notice at the Contractor's expense
if the Contractor identifies the data and demonstrates that the
correct notice is authorized; or
(ii) Correct any incorrect notices.
(g) Protection of limited rights data and restricted computer
software. (1) The Contractor may withhold from delivery qualifying
limited rights data or restricted computer software that are not
data identified in paragraphs (b)(1)(i) through (iii) of this
clause. As a condition to this withholding, the Contractor shall--
(i) Identify the data being withheld; and
(ii) Furnish form, fit, and function data instead.
(2) Limited rights data that are formatted as a computer
database for delivery to the Government shall be treated as limited
rights data and not restricted computer software.
(3) [Reserved]
(h) Subcontracting. The Contractor shall obtain from its
subcontractors all data and rights therein necessary to fulfill the
Contractor's obligations to the Government under this contract. If a
subcontractor refuses to accept terms affording the Government those
rights, the Contractor shall promptly notify the Contracting Officer
of the refusal and shall not proceed with the subcontract award
without authorization in writing from the Contracting Officer.
(i) Relationship to patents or other rights. Nothing contained
in this clause shall imply a license to the Government under any
patent or be construed as affecting the scope of any license or
other right otherwise granted to the Government.
(End of clause)
Alternate I (Sept 2014). As prescribed in HHSAR 327.409, substitute
the following definition for ``limited rights data'' in paragraph (a)
of the basic clause:
Limited rights data means data, other than computer software,
developed at private expense that embody trade secrets or are
commercial or financial and confidential or privileged.
Alternate II (Sept 2014). As prescribed in HHSAR 327.409, insert
the following paragraph (g)(3) in the basic clause:
(g)(3) Notwithstanding paragraph (g)(1) of this clause, the
contract may identify and specify the delivery of limited rights data,
or the Contracting Officer may require by written request the delivery
of limited rights data that has been withheld or would otherwise be
entitled to be withheld. If delivery of that data is required, the
Contractor shall affix the following ``Limited Rights Notice'' to the
data and the Government will treat the data, subject to the provisions
of paragraphs (e) and (f) of this clause, in accordance with the
notice:
Limited Rights Notice (SEPT 2014)
(a) These data are submitted with limited rights under
Government Contract No. __ (and subcontract __, if appropriate).
These data may be reproduced and used by the Government with the
express limitation that they will not, without written permission of
the Contractor, be used for purposes of manufacture nor disclosed
outside the Government; except that the Government may disclose
these data outside the Government for the following purposes, if
any; provided that the Government makes such disclosure subject to
prohibition against further use and disclosure: Agencies may list
additional purposes or if none, so state.
(b) This notice shall be marked on any reproduction of these
data, in whole or in part.
(End of notice)
Alternate III (Sept 2014). As prescribed in HHSAR 327.409, insert
the following paragraph (g)(4) in the basic clause: (g)(4)(i)
Notwithstanding paragraph (g)(1) of this clause, the contract may
identify and specify the delivery of restricted computer software, or
the Contracting Officer may require by written request the delivery of
restricted computer software that has been withheld or would otherwise
be entitled to be withheld. If delivery of that computer software is
required, the Contractor shall affix the following ``Restricted Rights
Notice'' to the computer software and the Government will treat the
computer software, subject to paragraphs (e) and (f) of this clause, in
accordance with the notice:
Restricted Rights Notice (SEPT 2014)
(a) This computer software is submitted with restricted rights
under Government Contract No. __ (and subcontract __, if
appropriate). It may not be used, reproduced, or disclosed by the
Government except as provided in paragraph (b) of this notice or as
otherwise expressly stated in the contract.
(b) This computer software may be--
(1) Used or copied for use with the computer(s) for which it was
acquired, including use at any Government installation to which the
computer(s) may be transferred;
(2) Used or copied for use with a backup computer if any
computer for which it was acquired is inoperative;
(3) Reproduced for safekeeping (archives) or backup purposes;
(4) Modified, adapted, or combined with other computer software,
provided that the modified, adapted, or combined portions of the
derivative software incorporating any of the delivered, restricted
computer software shall be subject to the same restricted rights;
(5) Disclosed to and reproduced for use by support service
Contractors or their subcontractors in accordance with paragraphs
(b)(1) through (4) of this notice; and
(6) Used or copied for use with a replacement computer.
(c) Notwithstanding the foregoing, if this computer software is
copyrighted computer software, it is licensed to the Government with
the minimum rights set forth in paragraph (b) of this notice.
(d) Any other rights or limitations regarding the use,
duplication, or disclosure of this computer software are to be
expressly stated in, or incorporated in, the contract.
(e) This notice shall be marked on any reproduction of this
computer software, in whole or in part.
(End of notice)
(ii) Where it is impractical to include the Restricted Rights
Notice on restricted computer software, the following short-form notice
may be used instead:
Restricted Rights Notice Short Form (SEPT 2014)
Use, reproduction, or disclosure is subject to restrictions set
forth in Contract No. __ (and subcontract, if appropriate) with __
(name of Contractor and subcontractor).
(End of notice)
(iii) If restricted computer software is delivered with the
copyright notice of 17 U.S.C. 401, it will be presumed to be licensed
to the Government without disclosure prohibitions, with the minimum
rights set forth in paragraph (b) of this clause.
Alternate IV Sept 2014). As prescribed in HHSAR 327.409,
substitute the following paragraph (c)(1) for paragraph (c)(1) of
the basic clause:
(c) Copyright--(1) Data first produced in the performance of the
contract. Except as otherwise specifically provided in this
contract, the Contractor may assert copyright in any data first
produced in the performance of this contract. When asserting
copyright, the Contractor shall affix the applicable copyright
notice of 17 U.S.C. 401 or 402, and an acknowledgment of Government
sponsorship (including contract number), to the data when such data
are delivered to the Government, as well as when the data are
published or deposited for registration as a published work in the
U.S. Copyright Office. For data other than computer software, the
Contractor grants to the Government, and others acting on its
behalf, a paid-up, nonexclusive, irrevocable, worldwide license for
all such data to reproduce, prepare derivative works, distribute
copies to the public, and perform publicly and display publicly, by
or on behalf of the Government. For computer software, the
Contractor grants to the Government and others acting on its behalf,
a paid-up, nonexclusive, irrevocable, worldwide license for all such
computer software to reproduce, prepare derivative works, and
perform publicly and display publicly (but not to distribute copies
to the public), by or on behalf of the Government.
Alternate V (Sept 2014). As prescribed in HHSAR 327.409, add the
following paragraph (j) to the basic clause:
(j) The Contractor agrees, except as may be otherwise specified
in this contract for
[[Page 72180]]
specific data deliverables listed as not subject to this paragraph,
that the Contracting Officer may, up to 3 years after acceptance of
all deliverables under this contract, inspect at the Contractor's
facility any data withheld pursuant to paragraph (g)(1) of this
clause, for purposes of verifying the Contractor's assertion of
limited rights or restricted rights status of the data or for
evaluating work performance. When the Contractor whose data are to
be inspected demonstrates to the Contracting Officer that there
would be a possible conflict of interest if a particular
representative made the inspection, the Contracting Officer shall
designate an alternate inspector.
(End of clause)
352.227-70 Publications and Publicity.
As prescribed in HHSAR 327.404-70, the Contracting Officer shall
insert the following clause:
Publications and Publicity (DEC 2015)
(a) Unless otherwise specified in this contract, the Contractor
may publish the results of its work under this contract. The
Contractor shall promptly send a copy of each article submitted for
publication to the Contracting Officer's Representative. The
Contractor shall also inform the Contracting Officer's
Representative when the article or other publication is published,
and furnish a copy of it as finally published.
(b) Unless authorized in writing by the Contracting Officer, the
Contractor shall not display the HHS logo including Operating
Division or Staff Division logos on any publications.
(c) The Contractor shall not reference the product(s) or
service(s) awarded under this contract in commercial advertising, as
defined in FAR 31.205-1, in any manner which states or implies HHS
approval or endorsement of the product(s) or service(s) provided.
(d) The contractor shall include this clause, including this
section (d) in all subcontracts where the subcontractor may propose
publishing the results of its work under the subcontract.
(End of clause)
352.231-70 Salary Rate Limitation.
As prescribed in HHSAR 331.101-70(b), the Contracting Officer shall
insert the following clause:
Salary Rate Limitation (DEC 2015)
(a) The Contractor shall not use contract funds to pay the
direct salary of an individual at a rate in excess of the Federal
Executive Schedule Level II in effect on the date the funding was
obligated.
(b) For purposes of the salary rate limitation, the terms
``direct salary,'' ``salary,'' and ``institutional base salary,''
have the same meaning and are collectively referred to as ``direct
salary,'' in this clause. An individual's direct salary is the
annual compensation that the Contractor pays for an individual's
direct effort (costs) under the contract. Direct salary excludes any
income that an individual may be permitted to earn outside of duties
to the Contractor. Direct salary also excludes fringe benefits,
overhead, and general and administrative expenses (also referred to
as indirect costs or facilities and administrative costs). The
salary rate limitation does not restrict the salary that an
organization may pay an individual working under a Department of
Health and Human Services contract or order; it merely limits the
portion of that salary that may be paid with contract funds.
(c) The salary rate limitation also applies to individuals under
subcontracts.
(d) If this is a multiple-year contract or order, it may be
subject to unilateral modification by the Contracting Officer to
ensure that an individual is not paid at a rate that exceeds the
salary rate limitation provision established in the HHS
appropriations act used to fund this contract.
(e) See the salaries and wages pay tables on the Office of
Personnel Management Web site for Federal Executive Schedule salary
levels.
(End of clause)
352.232-70 Incremental Funding.
As prescribed in HHSAR 332.706-2(b), the Contracting Officer shall
insert the provision provided below in all solicitations when a cost-
reimbursement contract for severable services using incremental funding
is contemplated.
Incremental Funding (DEC 2015)
The Government intends to negotiate and award a cost-
reimbursement contract using incremental funding as described in the
clause at FAR 52.232-22, ``Limitation of Funds''. The initial
obligation of funds under the contract is expected to cover [insert
the appropriate increment of performance]. The Government intends to
obligate additional funds up to and including the full estimated
cost of the contract for the remaining periods of performance by
unilateral contract modification. However, the Government is not
required to reimburse the Contractor for costs incurred in excess of
the total amount obligated, nor is the Contractor required to
perform beyond the level supported by the total amount obligated.
(End of provision)
352.233-70 Choice of Law (Overseas).
As prescribed in HHSAR 333.215-70(a), the Contracting Officer shall
insert the following clause:
Choice of Law (Overseas) (DEC 2015)
This contract shall be construed in accordance with the
substantive laws of the United States of America. By the execution
of this contract, the Contractor expressly agrees to waive any
rights to invoke the jurisdiction of local national courts where
this contract is performed and agrees to accept the exclusive
jurisdiction of the United States Civilian Board of Contract Appeals
or the United States Court of Federal Claims for hearing and
determination of any and all disputes that may arise under the
Disputes clause of this contract.
(End of clause)
352.233-71 Litigation and Claims.
As prescribed in HHSAR 333.215-70(b), the Contracting Officer shall
insert the following clause:
Litigation and Claims (Dec 2015)
(a) The Contractor shall provide written notification
immediately to the Contracting Officer of any action, including any
proceeding before an administrative agency, filed against the
Contractor arising out of the performance of this contract,
including, but not limited to the performance of any subcontract
hereunder; and any claim against the Contractor the cost and expense
of which is allowable under the clause entitled ``Allowable Cost and
Payment.''
(b) Except as otherwise directed by the Contracting Officer, the
Contractor shall furnish immediately to the Contracting Officer
copies of all pertinent documents received by the Contractor with
respect to such action or claim. To the extent not in conflict with
any applicable policy of insurance, the Contractor may, with the
Contracting Officer's approval, settle any such action or claim. If
required by the Contracting Officer, the Contractor shall effect an
assignment and subrogation in favor of the Government of all the
Contractor's rights and claims (except those against the Government)
arising out of any such action or claim against the Contractor; and
authorize representatives of the Government to settle or defend any
such action or claim and to represent the Contractor in, or to take
charge of, any action.
(c) If the Government undertakes a settlement or defense of an
action or claim, the Contractor shall furnish all reasonable
assistance in effecting a settlement or asserting a defense. Where
an action against the Contractor is not covered by a policy of
insurance, the Contractor shall, with the approval of the
Contracting Officer, proceed with the defense of the action in good
faith. The Government shall not be liable for the expense of
defending any action or for any costs resulting from the loss
thereof to the extent that the Contractor would have been
compensated by insurance which was required by other terms or
conditions of this contract, by law or regulation, or by written
direction of the Contracting Officer, but which the Contractor
failed to secure through its own fault or negligence. In any event,
unless otherwise expressly provided in this contract, the Government
shall not reimburse or indemnify the Contractor for any liability
loss, cost, or expense, which the Contractor may incur or be subject
to by reason of any loss, injury or damage, to the person or to real
or personal property of any third parties as may accrue during, or
arise from, the performance of this contract.
(End of clause)
352.236-70 Design-Build Contracts.
As prescribed in HHSAR 336.570(a), the Contracting Officer shall
insert the following clause:
[[Page 72181]]
Design-Build Contracts (Dec 2015)
(a) General. (1) The contract constitutes and defines the entire
agreement between the Contractor and the Government. This contract
includes the standard or special contract clauses and schedules
included at the time of award. This contract incorporates by
reference:
(i) The solicitation in its entirety (with the exception of
instructions to offerors and evaluation criteria which do not become
part of the award document);
(ii) The specifications and statement of work;
(iii) All drawings, cuts and illustrations, included in the
solicitation and any amendments during all proposal phases leading
up to award;
(iv) Exhibits and other attachments; and
(v) The successful Offeror's accepted proposal.
(2) In the event of conflict or inconsistency between any of the
requirements of the various portions of this contract, precedence
shall be given in the following order:
(i) Betterments: Any portions of the Offeror's proposal which
exceed the requirements of the solicitation and which go beyond
repair and improve the value of the property.
(ii) The contract clauses and schedules included during the
solicitation or at the time of award.
(iii) All requirements (other than betterments) of the accepted
proposal.
(iv) Any design products, including but not limited to plans,
specifications, engineering studies and analyses, shop drawings,
equipment installation drawings, etc. These are ``deliverables''
under the contract and are not part of the contract itself.
(3) Design products must conform to all requirements of the
contract, in the order of precedence stated here.
(b) Responsibility of the contractor for design. (1) The
Contractor shall be responsible for the professional quality,
technical accuracy, and the coordination of all designs, drawings,
specifications, and other non-construction services furnished by the
Contractor under this contract. The Contractor shall, without
additional compensation, correct or revise any errors or deficiency
in its designs, drawings, specifications, and other non-construction
services and perform any necessary rework or modifications,
including any damage to real or personal property, resulting from
the design error or omission.
(2) Neither the Government's review, approval or acceptance of,
nor payment for, the services required under this contract shall be
construed to operate as a waiver of any rights under this contract
or of any cause of action arising out of the performance of this
contract. The Contractor shall be and remain liable to the
Government in accordance with applicable law for all damages to the
Government caused by the Contractor's negligent performance of any
of these services furnished under this contract.
(3) The rights and remedies of the Government provided for under
this contract are in addition to any other rights and remedies
provided by law.
(4) If the Contractor is comprised of more than one legal entity
each such entity shall be jointly and severally liable with respect
to all rights and remedies of the Government.
(c) Sequence of design--construction. (1) After receipt of the
Contract Award, the Contractor shall initiate design, comply with
all design submission requirements, and obtain Government review of
each submission. No construction may be started until the Government
reviews the Final Design submission and determines it satisfactory
for purposes of beginning construction. The Contracting Officer will
notify the Contractor when the design is cleared for construction.
The Government will not grant any time extension for any design
resubmittal required when, in the opinion of the Contracting
Officer, the initial submission failed to meet the minimum quality
requirements as set forth in the Contract.
(2) If the Government allows the Contractor to proceed with
limited construction based on pending minor revisions to the
reviewed Final Design submission, no payment will be made for any
completed or in-progress construction related to the pending
revisions until they are completed, resubmitted, and are
satisfactory to the Government.
(3) No payment will be made for any completed or in-progress
construction until all required submittals have been made, reviewed,
and are satisfactory to the Government.
(d) Constructor's role during design. The Contractor's
construction management key personnel shall be actively involved
during the design process to effectively integrate the design and
construction requirements of this contract. In addition to the
typical required construction activities, the constructor's
involvement includes, but is not limited to actions such as:
integrating the design schedule into the Master Schedule to maximize
the effectiveness of fast-tracking design and construction (within
the limits, if any, allowed in the contract), ensuring
constructability and economy of the design, integrating the shop
drawing and installation drawing process into the design, executing
the material and equipment acquisition programs to meet critical
schedules, effectively interfacing the construction Quality Control
(QC) program with the design QC program, and maintaining and
providing the design team with accurate, up-to-date redline and as-
built documentation. The Contractor shall require and manage the
active involvement of key trade subcontractors in the above
activities.
(e) Preconstruction conference. (1) A preconstruction conference
will be arranged by the Contracting Officer after award of contract
and before commencement of work. The Contracting Officer or
designated representative will notify the Contractor of the time,
date, and location for the meeting. At this conference, the
Contractor shall be oriented with respect to Government procedures
and line of authority, contractual, administrative, and construction
matters.
(2) The Contractor shall bring to this conference, in completed
form, a Certificate of Insurance, plus the following items in either
completed or draft form:
(i) Accident Prevention Plan;
(ii) Quality Control Plan;
(iii) Letter Appointing Superintendent;
(iv) Transmittal Register;
(v) Power of Attorney and Certified Copy of Resolution;
(vi) Network Analysis System, (when identified in the contract
schedule as applicable);
(vii) List of Subcontractors;
(viii) SF 1413;
(ix) Performance and Payment Bonds; and
(x) Schedule of Values.
(3) A letter of record will be written documenting all items
discussed at the conference, and a copy will be furnished by the
Contracting Officer to all in attendance.
(f) Payment for design under fixed-price design-build contracts.
(1) The Contracting Officer may approve progress payments for work
performed during the project design phase up to the maximum amount
of __ (Contracting Officer to insert percent figure. If none stated,
the amount is four (4) percent) percent of the contract price.
(2) Contractor invoices for payment must be accompanied by
satisfactory documentation supporting the amounts for which payments
are requested. Progress payments approved by the Contracting Officer
during the project design phase in no way constitute an acceptance
of functional and aesthetic design elements nor acceptance of a
final settlement amount in the event of a buy-out nor a waiver of
any contractual requirements.
(g) Unscheduled jobsite shutdowns. Due to security reasons
during the life of this contract the Government may on an
unscheduled basis require the contractor to shut down its jobsite
for 2 days per year at no additional cost. This shall not constitute
a suspension of work under FAR 52.242-14, Suspension of Work
(End of clause)
Alternate I (DEC 2015).
When Fast Track procedures are being used, replace paragraph (c)
of the basic clause with the following:
(c) Sequence of design build. (1) After receipt of the Contract
Award the Contractor shall initiate design, comply with all design
submissions requirements and obtain Government review of each
submission. The contractor may begin construction on portions of the
work for which the Government has reviewed the final design
submission and has determined satisfactory for purposes of beginning
construction. The Contracting Officer will notify the Contractor
when the design is cleared for construction. The Government will not
grant any time extension for any design resubmittal required when,
in the opinion of the Contracting Officer, the initial submission
failed to meet the minimum quality requirements as set forth in the
Contract.
(2) If the Government allows the Contractor to proceed with the
construction based on pending minor revisions to the reviewed Final
Design submission, no payment will be made for any in-place
construction related to the pending revisions until they are
completed, resubmitted, and are satisfactory to the Government.
[[Page 72182]]
(3) No payment will be made for any in-place construction until
all required submittals have been made, reviewed, and are
satisfactory to the Government.
(End of clause)
352.237-70 Pro-Children Act.
As prescribed in HHSAR 337.103(d)(1), the Contracting Officer shall
insert the following clause:
Pro-Children Act (DEC 2015)
(a) Public Law 103-227, Title X, Part C, also known as the Pro-
Children Act of 1994 (Act), 20 U.S.C. 7183, imposes restrictions on
smoking in facilities where certain federally funded children's
services are provided. The Act prohibits smoking within any indoor
facility (or portion thereof), whether owned, leased, or contracted
for, that is used for the routine or regular provision of: (i)
Kindergarten, elementary, or secondary education or library services
or (ii) health or day care services that are provided to children
under the age of 18. The statutory prohibition also applies to
indoor facilities that are constructed, operated, or maintained with
Federal funds.
(b) By acceptance of this contract or order, the Contractor
agrees to comply with the requirements of the Act. The Act also
applies to all subcontracts awarded under this contract for the
specified children's services. Accordingly, the Contractor shall
ensure that each of its employees, and any subcontractor staff, is
made aware of, understands, and complies with the provisions of the
Act. Failure to comply with the Act may result in the imposition of
a civil monetary penalty in an amount not to exceed $1,000 for each
violation and/or the imposition of an administrative compliance
order on the responsible entity. Each day a violation continues
constitutes a separate violation.
352.237-71 Crime Control Act--Reporting of Child Abuse.
As prescribed in HHSAR 337.103(d)(2), the Contracting Officer shall
insert the following clause:
Crime Control Act of 1990--Reporting of Child Abuse (DEC 2015)
(a) Public Law 101-647, also known as the Crime Control Act of
1990 (Act), imposes responsibilities on certain individuals who,
while engaged in a professional capacity or activity, as defined in
the Act, on Federal land or in a federally-operated (or contracted)
facility, learn of facts that give the individual reason to suspect
that a child has suffered an incident of child abuse.
(b) The Act designates ``covered professionals'' as those
persons engaged in professions and activities in eight different
categories including, but not limited to, teachers, social workers,
physicians, dentists, medical residents or interns, hospital
personnel and administrators, nurses, health care practitioners,
chiropractors, osteopaths, pharmacists, optometrists, podiatrists,
emergency medical technicians, ambulance drivers, alcohol or drug
treatment personnel, psychologists, psychiatrists, mental health
professionals, child care workers and administrators, and commercial
film and photo processors. The Act defines the term ``child abuse''
as the physical or mental injury, sexual abuse or exploitation, or
negligent treatment of a child.
(c) Accordingly, any person engaged in a covered profession or
activity under an HHS contract or subcontract, regardless of the
purpose of the contract or subcontract, shall immediately report a
suspected child abuse incident in accordance with the provisions of
the Act. If a child is suspected of being harmed, the appropriate
State Child Abuse Hotline, local child protective services (CPS), or
law enforcement agency shall be contacted. For more information
about where and how to file a report, the Childhelp USA, National
Child Abuse Hotline (1-800-4-A-CHILD) shall be called. Any covered
professional failing to make a timely report of such incident shall
be guilty of a Class B misdemeanor.
(d) By acceptance of this contract or order, the Contractor
agrees to comply with the requirements of the Act. The Act also
applies to all applicable subcontracts awarded under this contract.
Accordingly, the Contractor shall ensure that each of its employees,
and any subcontractor staff, is made aware of, understands, and
complies with the provisions of the Act.
(End of clause)
352.237-72 Crime Control Act--Requirement for Background Checks.
As prescribed in HHSAR 337.103(d)(3), the Contracting Officer shall
insert the following clause:
Crime Control Act of 1990--Requirement for Background Checks (DEC 2015)
(a) Public Law 101-647, also known as the Crime Control Act of
1990 (Act), requires that all individuals involved with the
provision of child care services to children under the age of 18
undergo a criminal background check. ``Child care services''
include, but are not limited to, social services, health and mental
health care, child (day) care, education (whether or not directly
involved in teaching), and rehabilitative programs. Any conviction
for a sex crime, an offense involving a child victim, or a drug
felony, may be grounds for denying employment or for dismissal of an
employee providing any of the services listed above.
(b) The Contracting Officer will provide the necessary
information to the Contractor regarding the process for obtaining
the background check. The Contractor may hire a staff person
provisionally prior to the completion of a background check, if at
all times prior to the receipt of the background check during which
children are in the care of the newly-hired person, the person is
within the sight and under the supervision of a previously
investigated staff person.
(c) By acceptance of this contract or order, the Contractor
agrees to comply with the requirements of the Act. The Act also
applies to all applicable subcontracts awarded under this contract.
Accordingly, the Contractor shall ensure that each of its employees,
and any subcontractor staff, is made aware of, understands, and
complies with the provisions of the Act.
(End of clause)
352.237-73 Indian Child Protection and Family Violence Act.
As prescribed in HHSAR 337.103(d)(4) the Contracting Officer shall
insert the following clause:
Indian Child Protection and Family Violence Act (DEC 2015)
(a) This contract is subject to the Indian Child Protection and
Family Violence Act, Public Law 101-630 (25 U.S.C. 3201 et seq.) The
duties and responsibilities required by this contract may involve
regular contact with or control over Indian children. Public Law
101-630 prohibits employment, including Personal Service Contracts,
with anyone who has been convicted of any crime of violence. Any
such conviction should immediately be brought to the attention of
the Contracting Officer. The contractor will be subject to a
character investigation, conducted by the Indian Health Service,
Office of Human Resources. Until such time as the contractor has
been notified of completion of the investigation, the contractor
shall have no unsupervised contact with Indian children. In order to
initiate this background investigation, the contractor must provide
information as required in this contract or as directed by the
Contracting Officer.
(b) As a prerequisite to providing services under this contract,
the Contractor is required to complete and sign the declaration
found in Section J of this contract.
(End of clause)
352.237-74 Non-Discrimination in Service Delivery.
As prescribed in HHSAR 337.103(e), the Contracting Officer shall
insert the following clause in solicitations and contracts:
Non-Discrimination In Service Delivery (DEC 2015)
It is the policy of the Department of Health and Human Services
that no person otherwise eligible will be excluded from
participation in, denied the benefits of, or subjected to
discrimination in the administration of HHS programs and services
based on non-merit factors such as race, color, national origin,
religion, sex, gender identity, sexual orientation, or disability
(physical or mental). By acceptance of this contract, the contractor
agrees to comply with this policy in supporting the program and in
performing the services called for under this contract. The
contractor shall include this clause in all sub-contracts awarded
under this contract for supporting or performing the specified
program and services. Accordingly, the contractor shall ensure that
each of its employees, and any sub-contractor staff, is made aware
of, understands, and complies with this policy.
(End of clause)
[[Page 72183]]
352.237-75 Key Personnel.
As prescribed in HHSAR 337.103(f), the Contracting Officer shall
insert the following clause:
Key Personnel (DEC 2015)
The key personnel specified in this contract are considered to
be essential to work performance. At least 30 days prior to the
contractor voluntarily diverting any of the specified individuals to
other programs or contracts the Contractor shall notify the
Contracting Officer and shall submit a justification for the
diversion or replacement and a request to replace the individual.
The request must identify the proposed replacement and provide an
explanation of how the replacement's skills, experience, and
credentials meet or exceed the requirements of the contract
(including, when applicable, Human Subjects Testing requirements).
If the employee of the contractor is terminated for cause or
separates from the contractor voluntarily with less than thirty days
notice, the Contractor shall provide the maximum notice practicable
under the circumstances. The Contractor shall not divert, replace,
or announce any such change to key personnel without the written
consent of the Contracting Officer. The contract will be modified to
add or delete key personnel as necessary to reflect the agreement of
the parties.
(End of clause)
352.239-73 Electronic Information and Technology Accessibility Notice.
(a) As prescribed in HHSAR 339.203-70(a), the Contracting Officer
shall insert the following provision:
Electronic and Information Technology Accessibility Notice (Dec 2015)
(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C.
794d), as amended by the Workforce Investment Act of 1998 and the
Architectural and Transportation Barriers Compliance Board
Electronic and Information (EIT) Accessibility Standards (36 CFR
part 1194), require that when Federal agencies develop, procure,
maintain, or use electronic and information technology, Federal
employees with disabilities have access to and use of information
and data that is comparable to the access and use by Federal
employees who are not individuals with disabilities, unless an undue
burden would be imposed on the agency. Section 508 also requires
that individuals with disabilities, who are members of the public
seeking information or services from a Federal agency, have access
to and use of information and data that is comparable to that
provided to the public who are not individuals with disabilities,
unless an undue burden would be imposed on the agency.
(b) Accordingly, any offeror responding to this solicitation
must comply with established HHS EIT accessibility standards.
Information about Section 508 is available at https://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can
be accessed at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.
(c) The Section 508 accessibility standards applicable to this
solicitation are stated in the clause at 352.239-74, Electronic and
Information Technology Accessibility.
In order to facilitate the Government's determination whether
proposed EIT supplies meet applicable Section 508 accessibility
standards, offerors must submit an HHS Section 508 Product
Assessment Template, in accordance with its completion instructions.
The purpose of the template is to assist HHS acquisition and program
officials in determining whether proposed EIT supplies conform to
applicable Section 508 accessibility standards. The template allows
offerors or developers to self-evaluate their supplies and
document--in detail--whether they conform to a specific Section 508
accessibility standard, and any underway remediation efforts
addressing conformance issues. Instructions for preparing the HHS
Section 508 Evaluation Template are available under Section 508
policy on the HHS Web site https://www.hhs.gov/web/508.
In order to facilitate the Government's determination whether
proposed EIT services meet applicable Section 508 accessibility
standards, offerors must provide enough information to assist the
Government in determining that the EIT services conform to Section
508 accessibility standards, including any underway remediation
efforts addressing conformance issues.
(d) Respondents to this solicitation must identify any exception
to Section 508 requirements. If a offeror claims its supplies or
services meet applicable Section 508 accessibility standards, and it
is later determined by the Government, i.e., after award of a
contract or order, that supplies or services delivered do not
conform to the described accessibility standards, remediation of the
supplies or services to the level of conformance specified in the
contract will be the responsibility of the Contractor at its
expense.
(End of provision)
352.239-74 Electronic and Information Technology Accessibility.
As prescribed in HHSAR 339.203-70(b), insert the following clause:
Electronic and Information Technology Accessibility (DEC 2015)
(a) Pursuant to Section 508 of the Rehabilitation Act of 1973
(29 U.S.C. 794d), as amended by the Workforce Investment Act of
1998, all electronic and information technology (EIT) supplies and
services developed, acquired, or maintained under this contract or
order must comply with the ``Architectural and Transportation
Barriers Compliance Board Electronic and Information Technology
(EIT) Accessibility Standards'' set forth by the Architectural and
Transportation Barriers Compliance Board (also referred to as the
``Access Board'') in 36 CFR part 1194. Information about Section 508
is available at https://www.hhs.gov/web/508. The complete text of
Section 508 Final Provisions can be accessed at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.
(b) The Section 508 accessibility standards applicable to this
contract or order are identified in the Statement of Work or
Specification or Performance Work Statement. The contractor must
provide any necessary updates to the submitted HHS Product
Assessment Template(s) at the end of each contract or order
exceeding the simplified acquisition threshold (see FAR 2.101) when
the contract or order duration is one year or less. If it is
determined by the Government that EIT supplies and services provided
by the Contractor do not conform to the described accessibility
standards in the contract, remediation of the supplies or services
to the level of conformance specified in the contract will be the
responsibility of the Contractor at its own expense.
(c) The Section 508 accessibility standards applicable to this
contract are:
-----------------------------------------------------------------------
(Contract staff must list applicable standards)
(d) In the event of a modification(s) to this contract or order,
which adds new EIT supplies or services or revises the type of, or
specifications for, supplies or services, the Contracting Officer
may require that the contractor submit a completed HHS Section 508
Product Assessment Template and any other additional information
necessary to assist the Government in determining that the EIT
supplies or services conform to Section 508 accessibility standards.
Instructions for documenting accessibility via the HHS Section 508
Product Assessment Template may be found under Section 508 policy on
the HHS Web site: (https://www.hhs.gov/web/508). If it is determined
by the Government that EIT supplies and services provided by the
Contractor do not conform to the described accessibility standards
in the contract, remediation of the supplies or services to the
level of conformance specified in the contract will be the
responsibility of the Contractor at its own expense.
(e) If this is an Indefinite Delivery contract, a Blanket
Purchase Agreement or a Basic Ordering Agreement, the task/delivery
order requests that include EIT supplies or services will define the
specifications and accessibility standards for the order. In those
cases, the Contractor may be required to provide a completed HHS
Section 508 Product Assessment Template and any other additional
information necessary to assist the Government in determining that
the EIT supplies or services conform to Section 508 accessibility
standards. Instructions for documenting accessibility via the HHS
Section 508 Product Assessment Template may be found at https://www.hhs.gov/web/508. If it is determined by the Government that EIT
supplies and services provided by the Contractor do not conform to
the described accessibility standards in the provided documentation,
remediation of the supplies or services to the level of conformance
specified in the contract will be the responsibility of the
Contractor at its own expense.
(End of clause)
[[Page 72184]]
352.270-1 [Reserved]
352.270-2 [Reserved]
352.270-3 [Reserved]
352.270-4a Notice to Offerors, Protection of Human Subjects.
As prescribed in HHSAR 370.303(a), the Contracting Officer shall
insert the following provision:
Notice to Offerors, Protection of Human Subjects (DEC 2015)
(a) The Department of Health and Human Services (HHS)
regulations for the protection of human subjects, 45 CFR part 46,
are available on the Office for Human Research Protections (OHRP)
Web site at: https://www.hhs.gov/ohrp/.
These regulations provide a systematic means, based on
established ethical principles, to safeguard the rights and welfare
of human subjects participating in research activities supported or
conducted by HHS.
(b) The regulations define a human subject as a living
individual about whom an investigator (whether professional or
student) conducting research obtains data or identifiable public
information through intervention or interaction with the individual,
or identifiable private information. In most cases, the regulations
extend to the use of human organs, tissue, and body fluids from
individually identifiable human subjects as well as to graphic,
written, or recorded information derived from individually
identifiable human subjects. 45 CFR part 46 does not directly
regulate the use of autopsy materials; instead, applicable state and
local laws govern their use.
(c) Activities which involve human subjects in one or more of
the categories set forth in 45 CFR 46.101(b)(1)-(6) are exempt from
complying with 45 CFR part 46. See https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
(d) Inappropriate designations of the noninvolvement of human
subjects or of exempt categories of research in a project may result
in delays in the review of a proposal.
(e) In accordance with 45 CFR part 46, offerors considered for
award shall file an acceptable Federal-wide Assurance (FWA) of
compliance with OHRP specifying review procedures and assigning
responsibilities for the protection of human subjects. The FWA is
the only type of assurance that OHRP accepts or approves. The
initial and continuing review of a research project by an
institutional review board shall ensure that: The risks to subjects
are minimized; risks to subjects are reasonable in relation to
anticipated benefits, if any, to subjects, and the importance of the
knowledge that may reasonably be expected to result; selection of
subjects is equitable; and informed consent will be obtained and
documented by methods that are adequate and appropriate. Depending
on the nature of the research, additional requirements may apply;
see https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111 for additional requirements regarding initial
and continuing review. HHS regulations for the protection of human
subjects (45 CFR part 46), information regarding OHRP registration
and assurance requirements/processes, and OHRP contact information
is available at the OHRP Web site (at https://www.hhs.gov/ohrp/assurances/).
(f) Offerors may consult with OHRP only for general advice or
guidance concerning either regulatory requirements or ethical issues
pertaining to research involving human subjects. ONLY the
contracting officer may offer information concerning a solicitation.
(g) The offeror shall document in its proposal the approved FWA
from OHRP, related to the designated Institutional Review Board
(IRB) reviewing and overseeing the research. If the offeror does not
have an approved FWA from OHRP, the offeror must obtain an FWA
before the deadline for proposal submission. When possible, the
offeror shall also certify the IRB's review and approval of the
research. If the offeror cannot obtain this certification by the
time of proposal submission they must include an explanation in
their proposal. Never conduct research covered by 45 CFR part 46
prior to receiving certification of the research's review and
approval by the IRB.
(End of provision)
Alternate I (DEC 2015).
As prescribed in HHSAR 370.303(a), the Contracting Officer shall
substitute the following paragraph (g) for paragraph (g) of the
basic clause.
(g) The offeror's proposal shall document that it has an
approved or active FWA from OHRP, related to the designated IRB
reviewing and overseeing the research. When possible the offeror
shall also certify the IRB has reviewed and approved the research.
If the offeror cannot make this certification at the time of
proposal submission, its proposal must include an explanation. Never
conduct research covered by 45 CFR part 46 prior to receiving
certification of the research's review and approval by the IRB.
If the offeror does not have an active FWA from OHRP, the
offeror shall take all necessary steps to obtain an FWA prior to the
deadline for proposal submission. If the offeror cannot obtain an
FWA before the proposal submission date, the proposal shall indicate
the steps/actions the offeror will take to obtain OHRP approval
within (Contracting Officer must insert a time period in which the
FWA must be obtained). Upon obtaining FWA approval, submit the
approval notice to the Contracting Officer.
352.270-4b Protection of Human Subjects.
As prescribed in HHSAR 370.304(a), the Contracting Officer shall
insert the following clause:
Protection of Human Subjects (DEC 2015)
(a) The Contractor agrees that the rights and welfare of human
subjects involved in research under this contract shall be protected
in accordance with 45 CFR part 46 and with the Contractor's current
Federal-wide Assurance (FWA) on file with the Office for Human
Research Protections (OHRP), Department of Health and Human
Services. The Contractor further agrees to provide certification at
least annually that the Institutional Review Board has reviewed and
approved the procedures, which involve human subjects in accordance
with 45 CFR part 46 and the Assurance of Compliance.
(b) The Contractor shall bear full responsibility for the
performance of all work and services involving the use of human
subjects under this contract and shall ensure that work is conducted
in a proper manner and as safely as is feasible. The parties hereto
agree that the Contractor retains the right to control and direct
the performance of all work under this contract. Nothing in this
contract shall create an agency or employee relationship between the
Government and the Contractor, or any subcontractor, agent or
employee of the Contractor, or any other person, organization,
institution, or group of any kind whatsoever. The Contractor agrees
that it has entered into this contract and will discharge its
obligations, duties, and undertakings and the work pursuant thereto,
whether requiring professional judgment or otherwise, as an
independent Contractor without creating liability on the part of the
Government for the acts of the Contractor or its employees.
(c) Contractors involving other agencies or institutions in
activities considered to be engaged in research involving human
subjects must ensure that such other agencies or institutions obtain
their own FWA if they are routinely engaged in research involving
human subjects or ensure that such agencies or institutions are
covered by the Contractors' FWA via designation as agents of the
institution or via individual investigator agreements (see OHRP Web
site at: https://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf).
(d) If at any time during the performance of this contract the
Contractor is not in compliance with any of the requirements and or
standards stated in paragraphs (a) and (b) above, the Contracting
Officer may immediately suspend, in whole or in part, work and
further payments under this contract until the Contractor corrects
the noncompliance. The Contracting Officer may communicate the
notice of suspension by telephone with confirmation in writing. If
the Contractor fails to complete corrective action within the period
of time designated in the Contracting Officer's written notice of
suspension, the Contracting Officer may, after consultation with
OHRP, terminate this contract in whole or in part.
(End of clause)
352.270-5a Notice to Offerors of Requirement for Compliance with the
Public Health Service Policy on Humane Care and Use of Laboratory
Animals.
As prescribed in HHSAR 370.403(a), the Contracting Officer shall
insert the following provision:
[[Page 72185]]
Notice to Offerors of Requirement for Compliance with the Public Health
Service Policy on Humane Care and Use of Laboratory Animals (DEC 2015)
The Public Health Service (PHS) Policy on Humane Care and Use of
Laboratory Animals (PHS Policy) establishes a number of requirements
for research activities involving animals. Before awarding a
contract to an offeror, the organization shall file, with the Office
of Laboratory Animal Welfare (OLAW), National Institutes of Health
(NIH), a written Animal Welfare Assurance (Assurance) which commits
the organization to comply with the provisions of the PHS Policy,
the Animal Welfare Act, and the Guide for the Care and Use of
Laboratory Animals (National Academy Press, Washington, DC). In
accordance with the PHS Policy, offerors must establish an
Institutional Animal Care and Use Committee (IACUC), qualified
through the experience and expertise of its members, to oversee the
institution's animal program, facilities, and procedures. Offerors
must provide verification of IACUC approval prior to receiving an
award involving live vertebrate animals. No award involving the use
of animals shall be made unless OLAW approves the Assurance and
verification of IACUC approval for the proposed animal activities
has been provided to the Contracting Officer. Prior to award, the
Contracting Officer will notify Contractor(s) selected for projects
involving live vertebrate animals of the Assurance and verification
of IACUC approval requirement. The Contracting Officer will request
that OLAW negotiate an acceptable Assurance with those Contractor(s)
and request verification of IACUC approval. For further information,
contact OLAW at NIH, 6705 Rockledge Drive, RKL1, Suite 360, MSC 7982
Bethesda, Maryland 20892-7982 (Email: olaw@od.nih.gov; Phone: 301-
496-7163).
(End of provision)
352.270-5b Care of Live Vertebrate Animals.
As prescribed in HHSAR 370.404, the Contracting Officer shall
insert the following clause:
Care of Live Vertebrate Animals (DEC 2015)
(a) Before undertaking performance of any contract involving
animal-related activities where the species is regulated by the
United Sates Department of Agriculture (USDA), the Contractor shall
register with the Secretary of Agriculture of the United States in
accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. The
Contractor shall furnish evidence of the registration to the
Contracting Officer.
(b) The Contractor shall acquire vertebrate animals used in
research from a dealer licensed by the Secretary of Agriculture
under 7 U.S.C. 2133 and 9 CFR 2.1-2.11, or from a source that is
exempt from licensing under those sections.
(c) The Contractor agrees that the care, use, and intended use
of any live vertebrate animals in the performance of this contract
shall conform with the Public Health Service (PHS) Policy on Humane
Care of Use of Laboratory Animals (PHS Policy), the current Animal
Welfare Assurance (Assurance), the Guide for the Care and Use of
Laboratory Animals (National Academy Press, Washington, DC) and the
pertinent laws and regulations of the United States Department of
Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts
1-4). In case of conflict between standards, the more stringent
standard shall govern.
(d) If at any time during performance of this contract, the
Contracting Officer determines, in consultation with the Office of
Laboratory Animal Welfare (OLAW), National Institutes of Health
(NIH), that the Contractor is not in compliance with any of the
requirements and standards stated in paragraphs (a) through (c)
above, the Contracting Officer may immediately suspend, in whole or
in part, work and further payments under this contract until the
Contractor corrects the noncompliance. Notice of the suspension may
be communicated by telephone and confirmed in writing. If the
Contractor fails to complete corrective action within the period of
time designated in the Contracting Officer's written notice of
suspension, the Contracting Officer may, in consultation with OLAW,
NIH, terminate this contract in whole or in part, and the
Contractor's name may be removed from the list of those contractors
with Animal Welfare Assurances.
Note: The Contractor may request registration of its facility
and a current listing of licensed dealers from the Regional Office
of the Animal and Plant Health Inspection Service (APHIS), USDA, for
the region in which its research facility is located. The location
of the appropriate APHIS Regional Office, as well as information
concerning this program may be obtained by contacting the Animal
Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737
(Email: ace@aphis.usda.gov; Web site: (https://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare).
(End of clause)
352.270-6 Restriction on Use of Human Subjects.
As prescribed in HHSAR 370-304(b), the Contracting Officer shall
insert the following clause:
Restriction on Use of Human Subjects (DEC 2015)
Pursuant to 45 CFR part 46, Protection of Human Research
Subjects, the Contractor shall not expend funds under this award for
research involving human subjects or engage in any human subjects
research activity prior to the Contracting Officer's receipt of a
certification that the research has been reviewed and approved by
the Institutional Review Board (IRB) registered with OHRP. This
restriction applies to all collaborating sites, whether domestic or
foreign, and subcontractors. The Contractor must ensure compliance
by collaborators and subcontractors.
(End of clause)
352.270-7 [Reserved]
352.270-8 [Reserved]
352.270-9 Non-Discrimination for Conscience.
As prescribed in HHSAR 370.701, the Contracting Officer shall
insert the following provision:
Non-Discrimination for Conscience (DEC 2015)
(a) Section 301(d) of the United States Leadership Against HIV/
AIDS, Tuberculosis, and Malaria Act, as amended, provides that an
organization, including a faith-based organization, that is
otherwise eligible to receive assistance under section 104A of the
Foreign Assistance Act of 1961, under the United States Leadership
Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003, under the
Tom Lantos and Henry J. Hyde United States Global Leadership Against
HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, or
under any amendment to the foregoing Acts for HIV/AIDS prevention,
treatment, or care--
(1) Shall not be required, as a condition of receiving such
assistance, to--
(i) Endorse or utilize a multisectoral or comprehensive approach
to combating HIV/AIDS; or
(ii) Endorse, utilize, make a referral to, become integrated
with, or otherwise participate in any program or activity to which
the organization has a religious or moral objection.
(2) Shall not be discriminated against under the provisions of
law in subparagraph (a) for refusing to meet any requirement
described in paragraph (a)(1) in this solicitation.
(b) Accordingly, an offeror who believes this solicitation
contains work requirements requiring it endorse or utilize a
multisectoral or comprehensive approach to combating HIV/AIDS, or
endorse, utilize, make referral to, become integrated with, or
otherwise participate in a program or activity to which it has a
religious or moral objection, shall identify those work requirements
it excluded in its technical proposal.
(c) The Government acknowledges that an offeror has specific
rights, as cited in paragraph (b), to exclude certain work
requirements in this solicitation from its proposal. However, the
Government reserves the right to not make an award to an offeror
whose proposal does not comply with the salient work requirements of
the solicitation. Any exercise of that Government right will be made
by the Head of the Contracting Activity.
(End of provision)
352.270-10 Notice to Offerors--Protection of Human Subjects, Research
Involving Human Subjects Committee (RIHSC) Approval of Research
Protocols Required.
As prescribed in HHSAR 370.303(d), the Contracting Officer shall
insert the following provision:
[[Page 72186]]
Notice to Offerors--Protection of Human Subjects, Research Involving
Human Subjects Committee (RIHSC) Approval of Research Protocols
Required (DEC 2015)
(a) All Offerors proposing research expected to involve human
subjects shall comply with the regulations set forth in 45 CFR part
46, and with the provisions at HHSAR 352.270-4a.
(b) The Offeror shall have an acceptable Assurance of Compliance
on file with the Office for Human Research Protections (OHRP),
whenever it submits a proposal to the FDA for research expected to
involve human subjects. Direct questions regarding Federal-wide
Assurance to OHRP. The Offeror's proposal shall include a copy of
the acceptable Assurance of Compliance.
(c) After the contract has been awarded, the Contractor shall
take the following actions:
(1) The Institutional Review Board (IRB) specified in the
Offeror's Assurance of Compliance, hereafter referred to as ``the
local IRB,'' shall review the proposed research protocol. A letter
from the local IRB stating that the proposed research protocol has
been reviewed and approved, and thus adequately protects the rights
and welfare of human subjects involved, or a letter stating that the
proposed research is exempt under 45 CFR 46.101(b) shall be
submitted to the Contracting Officer.
(2) Upon award, the successful Offeror, hereafter ``the
Contractor,'' shall submit its proposed research protocol to the
FDA's Research Involving Human Subjects Committee (RIHSC). The RIHSC
or its designee will review and approve the research protocol to
assure it adequately protects the rights and welfare of human
subjects involved. The RIHSC or designee will also determine whether
the proposed research is exempt under 45 CFR 46.101(b). The
Contractor shall submit, to the Contracting Officer of record, a
copy of the RIHSC's or its designee's letter stating that it
reviewed and approved the proposed research protocol.
(d) The Contractor shall not advertise for, recruit, or enroll
human subjects, or otherwise commence any research involving human
subjects until RIHSC or its designee reviews and approves its
research. The Contractor may begin other limited aspects of contract
performance prior to receiving RIHSC's or designee's approval of the
proposed research protocol. Research involving human subjects may
commence immediately upon the Contractor's receipt of RIHSC's or
designee's approval; however, the Contractor shall submit a copy of
RIHSC's or its designee's approval to the Contracting Officer within
three business days of its receipt.
(e) A Contractor's failure to obtain RIHSC's or its designee's
approval of its proposed research may result in termination of its
contract. However, failure to obtain RIHSC's or its designee's
approval during initial review will not automatically result in
termination of the contract. Instead, the Contractor may correct any
deficiencies identified during the initial RIHSC or designee review
and resubmit the proposed research protocol to RIHSC or its designee
for a second review. The Contractor is encouraged to solicit the
RIHSC's or its designee's input during the resubmission process.
(f) The Contractor shall seek RIHSC's or its designee's and
local IRB review and approval whenever making modifications,
amendments or other changes to the research protocol. Such
modifications, amendments and changes include, but are not limited
to changes in investigators, informed consent forms, and recruitment
advertisements. The Contractor may institute changes immediately
after receiving both the local IRB and RIHSC or its designee
approval (except when necessary to eliminate apparent immediate
hazards to the subject); however, the Contractor shall submit a copy
of the letter evidencing RIHSC's or its designee's approval of the
proposed changes to the Contracting Officer within three business
days of its receipt.
(End of provision)
352.270-11 Protection of Human Subjects--Research Involving Human
Subjects Committee (RIHSC) Approval of Research Protocols Required.
As prescribed in HHSAR 370.304(c), the Contracting Officer shall
insert the following clause:
Protection of Human Subjects--Research Involving Human Subjects
Committee (RIHSC) Approval of Research Protocols Required (DEC 2015)
(a) The Contractor agrees to protect the rights and welfare of
human subjects involved in research under this contract by complying
with 45 CFR part 46 and the clause at HHSAR 352.270-4b.
(b) Initial proof of compliance with 45 CFR part 46 shall
consist of:
(1) A copy of a current Federal-wide Assurance on file with
OHRP. The copy of a current Federal-wide Assurance shall be included
with the Contractor's proposal;
(2) A letter from the Contractor's local IRB (the Institutional
Review Board (IRB) specified in the Offeror's Assurance of
Compliance) stating that it has reviewed and approved the proposed
research protocol. The letter from the local IRB shall be submitted
to the Contracting Office; and
(3) A copy of a letter from the RIHSC stating that it or its
designee has reviewed and approved the proposed research protocol.
This shall be submitted to the Contracting Officer within three
business days of its issuance.
The Contractor shall not advertise for, recruit, or enroll human
subjects, or otherwise commence any research involving human
subjects under this contract, until RIHSC has reviewed and approved
its research. The Contractor may commence other limited aspects of
contract performance prior to receiving RIHSC or its designee
approval of its proposed research protocol. Research involving human
subjects may commence immediately upon the Contractor's receipt of
RIHSC or its designee approval; however, the Contractor shall submit
a copy of RIHSC's or its designee's letter of approval to the
Contracting Officer within three business days of its receipt.
Failure to obtain RIHSC or its designee approval of proposed
research protocols may result in the termination of this contract.
(c) The Contractor further agrees that:
(1) The Contractor will provide a letter from RIHSC, at least
annually, stating that RIHSC or its designee has reviewed and
approved the research protocols for research performed under this
contract. This shall be submitted to the Contracting Officer for
inclusion in the contract file.
(2) The Contractor will submit all proposed modifications and
amendments to research protocols for research performed under this
contract to RIHSC for review and approval. Modifications and
amendments include, but are not limited, to changes to consent forms
and advertising materials, and the addition or deletion of
investigators. Changes may be instituted immediately after the
Contractor has received both the local IRB and RIHSC or its designee
approval (except when necessary to eliminate apparent immediate
hazards to the subject); however the Contractor shall submit a copy
of the letter evidencing RIHSC's or its designee's approval of the
proposed changes to the Contracting Officer within three business
days of its receipt.
(End of clause)
352.270-12 Needle Exchange.
As prescribed in HHSAR 370.304(d), the Contracting Officer shall
insert the following clause:
Needle Exchange (DEC 2015)
The Contractor shall not use any funds obligated under this
contract to carry out any program of distributing sterile needles or
syringes for the hypodermic injection of any illegal drug.
(End of Clause)
352.270-13 Continued Ban on Funding Abortion and Continued Ban on
Funding of Human Embryo Research.
As prescribed in HHSAR 370.304(e), the Contracting Officer shall
insert the following clause:
Continued Ban on Funding Abortion and Continued Ban on Funding of Human
Embryo Research (DEC 2015)
(a) The Contractor shall not use any funds obligated under this
contract for any abortion.
(b) The Contractor shall not use any funds obligated under this
contract for the following:
(1) The creation of a human embryo or embryos for research
purposes; or
(2) Research in which a human embryo or embryos are destroyed,
discarded, or knowingly subjected to risk of injury of death greater
than that allowed for research on fetuses in utero under 45 CFR part
46 and Section 498(b) of the Public Health Service Act (42 U.S.C.
289g(b)).
[[Page 72187]]
(c) The term ``human embryo or embryos'' includes any organism,
not protected as a human subject under 45 CFR part 46 as of the date
of the enactment of this Act, that is derived by fertilization,
parthenogenesis, cloning, or any other means from one or more human
gametes of human diploid cells.
(d) The Contractor shall not use any Federal funds for the
cloning of human beings.
(End of clause)
PART 353--FORMS
Subpart 353.3--[Reserved]
SUBCHAPTERS I--L [RESERVED]
SUBCHAPTER M--HHS SUPPLEMENTATIONS
PART 370--SPECIAL PROGRAMS AFFECTING ACQUISITION
Subpart 370.1--[Reserved]
Subpart 370.2--[Reserved]
Subpart 370.3--Acquisitions Involving Human Subjects
Sec.
370.300 Scope of subpart.
370.301 Policy.
370.302 Federal-wide Assurance (FWA).
370.303 Notice to offerors.
370.304 Contract clauses.
Subpart 370.4--Acquisitions Involving the Use of Laboratory Animals
370.400 Scope of subpart.
370.401 Policy.
370.402 Assurances.
370.403 Notice to offerors.
370.404 Contract clause.
Subpart 370.5--[Reserved]
Subpart 370.6--[Reserved]
November 17, 2015 Subpart 370.7--Acquisitions under the Leadership Act
370.700 Scope of subpart.
370.701 Contract clause.
370.702 Solicitation provision.
Authority: 5 U.S.C. 301; 40 U.S.C. 121(c)(2)
Subpart 370.3--Acquisitions Involving Human Subjects
370.300 Scope of subpart.
This subpart applies to all research activities conducted under
contracts involving human subjects. See 45 CFR 46.102(d) and (f).
370.301 Policy.
It is the Department of Health and Human Services (HHS) policy that
the contracting officer shall not award a contract involving human
subjects until the prospective contractor provides assurance that the
activity will undergo initial and continuing review by an appropriate
Institutional Review Board (IRB) in accordance with HHS regulations at
45 CFR 46.103. The contracting officer shall require a Federal-wide
assurance (FWA), approved by the HHS Office for Human Research
Protections (OHRP), of each contractor, subcontractor, or institution
engaged in human subjects research in performance of a contract. OHRP
administers the assurance covering all HHS-supported or HHS-conducted
activities involving human subjects.
370.302 Federal-wide Assurance (FWA).
(a) OHRP-Approved FWAs are found at the following Web site: https://ohrp.cit.nih.gov/search/search.aspx?styp=bsc.
(b) Normally a contractor, subcontractor, or institution must
provide approval of a FWA before a contract is awarded. If a
contractor, subcontractor, or institution does not currently hold an
approved FWA, it shall submit an explanation with its proposal and an
FWA application prior to submitting a proposal. The contracting
officer, on a case by case basis, may make award without an approved
assurance in consultation with OHRP.
(c) A contractor, subcontractor, or institution must submit all
FWAs, including new FWAs, using the electronic submission system
available through the OHRP Web site at https://ohrp.cit.nih.gov/efile/,
unless an institution lacks the ability to do so electronically. If an
institution believes it lacks the ability to submit its FWA
electronically, it must contact OHRP by telephone or email (see https://www.hhs.gov/ohrp/assurances/) and explain why it is unable to
submit its FWA electronically.
370.303 Notice to offerors.
(a) The contracting officer shall insert the provision at 352.270-
4a, Notice to Offerors, Protection of Human Subjects, in solicitations
that involve human subjects. The contracting officer shall use the
clause with its Alternate I when the agency is prescribing a date later
than the proposal submission by which the offeror must have an approved
FWA.
(b) Institutions having an OHRP-approved FWA shall certify IRB
approval of submitted proposals in the manner required by instructions
for completion of the contract proposal; by completion of an OMB Form
No. 0990-0263, Protection of Human Subjects Assurance Identification/
IRB Certification/Declaration of Exemption (Common Rule); or by letter
indicating the institution's OHRP-assigned FWA number, the date of IRB
review and approval, and the type of review (convened or expedited).
The date of IRB approval must not be more than 12 months prior to the
deadline for proposal submission.
(c) The contracting officer generally will not request FWAs for
contractors, subcontractors, or institutions prior to selecting a
contract proposal for negotiation. When a contractor submits an FWA, it
provides certification for the initial contract period; no additional
documentation is required. If the contract provides for additional
years to complete the project, the contractor shall certify annually in
the manner described in 370.303(b).
(d) For the Food and Drug Administration (FDA), the contracting
officer shall insert the provision at 352.270-10, Notice to Offerors--
Protection of Human Subjects, Research Involving Human Subjects
Committee (RIHSC) Approval of Research Protocols Required, in
solicitations that involve human subjects when the research is subject
to RIHSC review and approval.
370.304 Contract clauses.
(a) The contracting officer shall insert the clause at 352.270-4b,
Protection of Human Subjects, in solicitations, contracts and orders
involving human subjects.
(b) The contracting officer shall insert the clause at 352.270-6,
Restriction on Use of Human Subjects, in contracts and orders if the
contractor has an approved FWA of compliance in place, but cannot
certify prior to award that an IRB registered with OHRP reviewed and
approved the research, because definite plans for involvement of human
subjects are not set forth in the proposal (e.g., projects in which
human subjects' involvement will depend upon completion of instruments,
prior animal studies, or purification of compounds). Under these
conditions, the contracting officer may make the award without the
requisite certification, as long as the contracting officer includes
appropriate conditions in the contract or order.
(c) For FDA, the contracting officer shall insert the clause at
352.270-11, Protection of Human Subjects, Research Involving Human
Subjects Committee (RIHSC) Approval of Research Protocols Required, in
contracts and orders that involve human subjects when the research is
subject to RIHSC review and approval.
(d) The contracting officer shall insert the clause at 352.270-12,
Needle Exchange, in solicitations, contracts, and orders involving
human subjects.
(e) The contracting officer shall insert the clause at 352.270-13,
Continued Ban on Funding Abortion and Continued Ban on Funding of Human
[[Page 72188]]
Embryo Research, in solicitations, contracts, and orders involving
human subjects.
Subpart 370.4--Acquisitions Involving the Use of Laboratory Animals
370.400 Scope of subpart.
This subpart applies to all research, research training, biological
testing, housing and maintenance, and other activities involving live
vertebrate animals conducted under contract. Additional information can
be found in Public Health Service (PHS) Policy on Humane Care and Use
of Laboratory Animals https://grants.nih.gov/grants/olaw/references/phspolicylabanimals.pdf.
370.401 Policy.
(a) It is HHS policy that contracting activities shall not award a
contract involving live vertebrate animals until the Contractor
provides acceptable assurance the contract work is subject to initial
and continuing review by an appropriate Institutional Animal Care and
Use Committee (IACUC) as described in the PHS Policy at IV.B.6 and 7.
The contracting officer shall require an applicable Animal Welfare
Assurance approved by the Office of Laboratory Animal Welfare (OLAW),
National Institutes of Health (NIH), of each contractor, subcontractor,
or institution having responsibility for animal care and use involved
in performance of the contract. Normally the assurance shall be
approved before award. The contracting officer, on a case-by-case
basis, may make award without an approved assurance in consultation
with OLAW. For additional information see PHS Policy II., IV.A, and
V.B.
(b) The OLAW, NIH, is responsible for negotiating assurances
covering all HHS/PHS-supported or HHS/PHS-conducted activities
involving the care and use of live vertebrate animals. OLAW shall
provide guidance to contracting officers regarding adequate animal care
and use, approval, disapproval, restriction, or withdrawal of approval
of assurances. For additional information see PHS Policy V.A.
(c) If using live vertebrate animals, HHS policy requires that
offerors address the points in the Vertebrate Animal Section (VAS) of
the Technical Proposal. Each of the points must be addressed in the VAS
portion of the Technical Proposal. For additional information see PHS
Policy and use Contract Proposal VAS Worksheet. https://grants.nih.gov/grants/olaw/references/phspol.htm#InformationRequiredinApplications-ProposalsforAwardsSubmittedtoPHS and https://grants.nih.gov/grants/olaw/VAScontracts.pdf.
370.402 Assurances.
(a) Animal Welfare Assurances may be one of three types:
(1) Domestic Assurance (DA). A DA describes the institution's
animal care and use program, including but not limited to the lines of
authority and responsibility, veterinary care, IACUC composition and
procedures, occupational health and safety, training, facilities, and
species housed. A DA listed in OLAW's list of institutions with an
approved DA is acceptable for purposes of this policy.
(2) Inter-institutional Assurance (IA). The offeror, its proposed
subcontractor, or institution shall submit an IA when it does not have
a proprietary animal care and use program, facilities to house animals
or IACUC, and does not conduct animal research on-site. The offeror
will perform the animal activity at an institution with an Animal
Welfare Assurance named as a performance site. An IA approval extends
to the full period of contract performance (up to 5 years) limited to
the specific award or single project.
(3) Foreign Assurance (FA). The Foreign Assurance is required for
institutions outside the U.S. that receive PHS funds directly through a
contract award. The Foreign Assurance also applies to institutions
outside the U.S. that receive PHS funds indirectly (named as a
performance site). An FA listed in OLAW's list of institutions with an
approved FA is acceptable for purposes of this policy.
(b) The contracting officer shall forward copies of proposals
selected for negotiation and requiring an assurance to OLAW at
olawdoa@od.nih.gov, as early as possible to secure the necessary
assurances.
(c) A contractor providing animal care services at an institution
with an Animal Welfare Assurance, such as a Government-owned,
Contractor-operated (GOCO) site, does not need a separate assurance.
GOCO site assurances normally cover such contractor services.
370.403 Notice to offerors.
(a) The contracting officer shall insert the provision at 352.270-
5a, Notice to Offerors of Requirement for Compliance with the Public
Health Service Policy on Humane Care and Use of Laboratory Animals, in
solicitations involving live vertebrate animals.
(b) Offerors having a DA on file with OLAW shall submit IACUC
approval of the use of animals in the manner required by the
solicitation, but prior to award. The date of IACUC approval must not
be more than 36 months prior to award.
(c) It is not necessary for offerors lacking an Animal Welfare
Assurance to submit assurances or IACUC approval with proposals. OLAW
shall contact contractors, subcontractors, and institutions to
negotiate necessary assurances and verify IACUC approvals when
requested by the contracting officer.
370.404 Contract clause.
The contracting officer shall insert the clause at 352.270-5b, Care
of Live Vertebrate Animals, in solicitations, contracts, and orders
that involve live vertebrate animals.
Subpart 370.5--[Reserved]
Subpart 370.6--[Reserved]
Subpart 370.7--Acquisitions Under the Leadership Act
370.700 Scope of subpart.
This subpart sets forth the acquisition requirements regarding
implementation of Human Immunodeficiency Virus/Acquired Immune
Deficiency Syndrome (HIV/AIDS) programs under the President's Emergency
Plan for AIDS Relief as established by the United States Leadership
Against HIV/AIDS, Tuberculosis and Malaria Act of 2003, as amended
(Pub. L. 108-25, Pub. L. 110-293, Pub. L. 113-56).
370.701 Solicitation provision.
The contracting officer shall insert the provision at 352.270-9,
Non-Discrimination for Conscience, in solicitations valued at more than
the micro-purchase threshold:
(a) In connection with the implementation of HIV/AIDS programs
under the President's Emergency Plan for AIDS Relief established by the
United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act
of 2003, as amended; or
[[Page 72189]]
(b) Where the contractor will receive funding under the United
States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of
2003, as amended. In resolving any issues or complaints that offerors
may raise regarding meeting the requirements specified in the
provision, the contracting officer shall consult with the Office of
Global Health Affairs, Office of the General Counsel, the Program
Manager, and other HHS officials, as appropriate.
[FR Doc. 2015-28214 Filed 11-17-15; 8:45 am]
BILLING CODE 4150-28-P
