VA Acquisition Regulation: Department of Veterans Affairs Acquisition Regulation System and Research and Development, 10158-10166 [2022-02796]
Download as PDF
10158
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules
khammond on DSKJM1Z7X2PROD with PROPOSALS
I. National Technology Transfer and
Advancement Act (NTTAA) and 1 CFR
Part 51
This rulemaking involves technical
standards. Therefore, the EPA
conducted searches through the
Enhanced NSSN Database managed by
the American National Standards
Institute (ANSI) to determine if there are
voluntary consensus standards (VCS)
that are relevant to this action. The
Agency also contacted VCS
organizations and accessed and
searched their databases. Searches were
conducted for the EPA Methods 9, 12,
and 29 of 40 CFR part 60, appendix A.
No applicable VCS were identified for
EPA Methods 12 and 29 for lead.
During the search, if the title or
abstract (if provided) of the VCS
described technical sampling and
analytical procedures that are similar to
the EPA’s reference method, the EPA
considered it as a potential equivalent
method. All potential standards were
reviewed to determine the practicality
of the VCS for this rule. This review
requires significant method validation
data which meets the requirements of
the EPA Method 301 for accepting
alternative methods or scientific,
engineering and policy equivalence to
procedures in the EPA reference
methods. The EPA may reconsider
determinations of impracticality when
additional information is available for
particular VCS.
One voluntary consensus standard
was identified as acceptable alternative
to EPA test methods for the purposes of
this rule. The voluntary consensus
standard ASTM D7520–16, ‘‘Standard
Test Method for Determining the
Opacity of a Plume in the Outdoor
Ambient Atmosphere’’ is an acceptable
alternative to EPA Method 9 with the
following conditions:
1. During the digital camera opacity
technique (DCOT) certification
procedure outlined in section 9.2 of
ASTM D7520–16, you or the DCOT
vendor must present the plumes in front
of various backgrounds of color and
contrast representing conditions
anticipated during field use such as blue
sky, trees, and mixed backgrounds
(clouds and/or a sparse tree stand).
2. You must also have standard
operating procedures in place including
daily or other frequency quality checks
to ensure the equipment is within
manufacturing specifications as
outlined in section 8.1 of ASTM D7520–
16.
3. You must follow the record keeping
procedures outlined in § 63.10(b)(1) for
the DCOT certification, compliance
report, data sheets, and all raw
VerDate Sep<11>2014
17:39 Feb 22, 2022
Jkt 256001
unaltered JPEGs used for opacity and
certification determination.
4. You or the DCOT vendor must have
a minimum of four (4) independent
technology users apply the software to
determine the visible opacity of the 300
certification plumes. For each set of 25
plumes, the user may not exceed 15
percent opacity of anyone reading and
the average error must not exceed 7.5
percent opacity.
5. This approval does not provide or
imply a certification or validation of any
vendor’s hardware or software. The
onus to maintain and verify the
certification and/or training of the
DCOT camera, software and operator in
accordance with ASTM D7520–16 and
this letter is on the facility, DCOT
operator, and DCOT vendor.
The search identified one VCS that
was potentially applicable for this rule
in lieu of EPA reference methods. After
reviewing the available standards, EPA
determined that one candidate VCS
(ASTM D4358–94 (1999)) identified for
measuring emissions of pollutants or
their surrogates subject to emission
standards in the rule would not be
practical due to lack of equivalency,
documentation, validation data and
other important technical and policy
considerations. Additional information
for the VCS search and determinations
can be found in the memorandum,
Voluntary Consensus Standard Results
for Review of Standards of Performance
for Lead Acid Battery Manufacturing
Plants and National Emission Standards
for Hazardous Air Pollutants for Lead
Acid Battery, which is available in the
docket for this action.
Under 40 CFR 63.7(f) and 40 CFR
68.3(f) of subpart A of the General
Provisions, a source may apply to the
EPA to use alternative test methods or
alternative monitoring requirements in
place of any required testing methods,
performance specifications or
procedures in the final rule or any
amendments. The EPA welcomes
comments on this aspect of the
proposed rulemaking and, specifically,
invites the public to identify potentially
applicable VCS and to explain why such
standards should be used in this
regulation.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
The EPA believes that this action does
not have disproportionately high and
adverse human health or environmental
effects on minority populations, lowincome populations, and/or indigenous
peoples, as specified in Executive Order
12898 (59 FR 7629, February 16, 1994).
PO 00000
Frm 00078
Fmt 4702
Sfmt 4702
The documentation for this decision
is contained in section V.C and V.E of
this preamble. As discussed in section
V.E of this preamble, we performed a
demographic analysis for the lead acid
battery manufacturing source category,
which is an assessment of the proximity
of individual demographic groups living
close to the facilities (within 50 km and
within 5 km). Results of the
demographic analysis indicate that the
following groups above the national
average: Hispanics, Ages 18–64, People
living below the Poverty Level, 25 years
old or greater without a High School
Diploma, and People living in Linguistic
Isolation. However, based on analyses of
emissions and available ambient
monitoring data (described in section
IV.A of this preamble), we conclude
ambient Pb concentrations near the
facilities are all below the National
Ambient Air Quality Standard (NAAQS)
for Pb and therefore the sources are not
likely to pose significant risks to human
health.
Janet G. McCabe,
Deputy Administrator.
[FR Doc. 2022–03396 Filed 2–22–22; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF VETERANS
AFFAIRS
48 CFR Parts 801, 802, 808, 816, 835,
and 852
RIN 2900–AQ23
VA Acquisition Regulation:
Department of Veterans Affairs
Acquisition Regulation System and
Research and Development
Department of Veterans Affairs.
Proposed rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) is proposing to amend and
update its VA Acquisition Regulation
(VAAR) in phased increments to revise
or remove any policy superseded by
changes in the Federal Acquisition
Regulation (FAR), to remove procedural
guidance internal to VA into the VA
Acquisition Manual (VAAM), and to
incorporate any new agency specific
regulations or policies. These changes
seek to streamline and align the VAAR
with the FAR and remove outdated and
duplicative requirements and reduce
burden on contractors. The VAAM
incorporates portions of the removed
VAAR as well as other internal agency
acquisition policy. VA will rewrite
certain parts of the VAAR and VAAM,
and as VAAR parts are rewritten, will
publish them in the Federal Register.
SUMMARY:
E:\FR\FM\23FEP1.SGM
23FEP1
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules
khammond on DSKJM1Z7X2PROD with PROPOSALS
VA will combine related topics, as
appropriate. This rulemaking revises
VAAR coverage concerning Department
of Veterans Affairs Acquisition
Regulation System and Research and
Development. It also revises affected
parts concerning Definitions of Words
and Terms, Required Sources of
Supplies and Services, Types of
Contracts and Solicitation Provisions
and Contract Clauses.
DATES: Comments must be received on
or before April 25, 2022 to be
considered in the formulation of the
final rule.
ADDRESSES: Comments may be
submitted through
www.Regulations.gov. Comments
received will be available at
regulations.gov for public viewing,
inspection or copies.
FOR FURTHER INFORMATION CONTACT: Mr.
Rafael Taylor, Senior Procurement
Analyst, Procurement Policy and
Warrant Management Services, 003A2A,
810 Vermont Avenue NW, Washington,
DC 20420, (202) 714–8560. (This is not
a toll-free number.)
SUPPLEMENTARY INFORMATION:
Background
This rulemaking is issued under the
authority of the Office of Federal
Procurement Policy (OFPP) Act which
provides the authority for an agency
head to issue agency acquisition
regulations that implement or
supplement the FAR.
VA is proposing to revise the VAAR
to add new policy or regulatory
requirements and to remove any
redundant guidance and guidance that
is applicable only to VA’s internal
operating processes or procedures.
Codified acquisition regulations may be
amended and revised only through
rulemaking. All amendments, revisions
and removals have been reviewed and
concurred with VA’s Integrated Product
Team of agency stakeholders.
The VAAR uses the regulatory
structure and arrangement of the FAR
and headings and subject areas are
consistent with FAR content. The VAAR
is divided into subchapters, parts (each
of which covers a separate aspect of
acquisition), subparts and sections.
The Office of Federal Procurement
Policy Act, as codified in 41 U.S.C.
1707, provides the authority for the
Federal Acquisition Regulation and for
the issuance of agency acquisition
regulations consistent with the FAR.
When Federal agencies acquire
supplies and services using
appropriated funds, the purchase is
governed by the FAR, set forth at title
48 Code of Federal Regulations (CFR),
VerDate Sep<11>2014
17:39 Feb 22, 2022
Jkt 256001
chapter 1, parts 1 through 53, and the
agency regulations that implement and
supplement the FAR. The VAAR is set
forth at 48 CFR, chapter 8, parts 801 to
873.
Discussion and Analysis
VA proposes to make the following
changes to the VAAR in this phase of its
revision and streamlining initiative. For
procedural guidance cited below that is
proposed to be deleted from the VAAR,
each section cited for removal has been
considered for inclusion in VA’s
internal agency operating procedures in
accordance with FAR 1.301(a)(2).
Similarly, delegations of authority that
are removed from the VAAR will be
included in the VAAM as internal
agency guidance. The VAAM is being
created in parallel with these revisions
to the VAAR and is not subject to the
rulemaking process as they are internal
VA procedures and guidance. The
VAAM will not be finalized until
corresponding VAAR parts are finalized.
VAAR Part 801—Department of
Veterans Affairs Acquisition Regulation
System
We propose to revise the authorities
cited for this part. The authorities cited
for this part are 38 U.S.C. 8123; 38
U.S.C. 8153; 38 U.S.C. 8303; 40 U.S.C.
121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C.
1702; 41 U.S.C. 1707; and 48 CFR
1.301–1.304. The Title 38 authorities are
cited as they provide the statutory basis
for the exclusions as outlined in
801.104–70. We have retained the
authority from 48 CFR 1.301–1.304 as
this is the FAR subpart outlining the
guidance for agency acquisition
regulations.
Under subpart 801.1, Purpose,
Authority, Issuance, we propose to
revise 801.103, Authority, to add 41
U.S.C. 1707 (the OFFP Act) as an
authority to the publishing of this
regulation. Under 801.104,
Applicability, we propose to revise the
text for clarity and to remove an
unnecessary reference to the VA
Canteen Service.
In 801.104–70, Exclusions, we
propose to retain the first paragraph and
redesignate it as paragraph (a) which
explains that the FAR and VAAR do not
apply to those purchases made using the
General Post Fund when a donor
specifies the exact item to be purchased.
Under 801.104–70, we also propose to
add paragraph (b) to address the
statutory exception at 38 U.S.C. 8123,
Procurement of prosthetic appliances,
which states: ‘‘The VA may procure
prosthetic appliances and necessary
services required in the fitting,
supplying, and training and use of
PO 00000
Frm 00079
Fmt 4702
Sfmt 4702
10159
prosthetic appliances by purchase,
manufacture, contract, or in such other
manner as the VA may determine to be
proper, without regard to any other
provision of law.’’ Finally, under this
section, we propose to add paragraph (c)
to address the statutory exception at 38
U.S.C. 8153, Sharing of health-care
resources, which allows the VA to
secure health-care resources which
otherwise might not be feasibly
available, or to effectively utilize certain
other health-care resources, by using
simplified procedures which were
codified in VAAR part 873, Simplified
Acquisition Procedures For Health-Care
Resources.
We propose to remove 801.105 (no
text) and 801.105–2, Arrangement of
regulations, as the location of this
guidance has been revised to comport
with the placement of the corresponding
FAR guidance. The information that was
covered here has been moved to
801.301, Policy.
In 801.106, OMB approval under the
Paperwork Reduction Act, we propose
to delete the chart that contains the
OMB approval numbers. We propose to
revise this section to add language
directing the reader to the VAAM for the
list of information collection and
recordkeeping requirements associated
with the control numbers. Given the
constant updating of VA’s information
collection requirements and the OMB
control numbers, it is more prudent to
place this information in the VAAM
which doesn’t require rulemaking for
updating.
VA proposes to remove subpart 801.2,
Administration, as it explains the role of
the Defense Acquisition Regulations
Council and the Civilian Agency
Acquisition Council, which is
redundant to the FAR.
We propose to revise the name of
subpart 801.3 from ‘‘Department
Acquisition Regulations’’ to ‘‘Agency
Acquisition Regulations’’ so that the
title comports with the FAR heading.
We propose to add 801.301, Policy,
which states that the VA
implementation and supplementation of
the FAR is issued in the VAAR under
authorization and subject to the
authority, direction, and control of the
Secretary of Veterans Affairs. This
section also explains what the VAAR
contains and introduces and explains
the VAAM.
For 801.304, we propose to revise this
section to change the title from
‘‘Department control and compliance
procedures’’ to ‘‘Agency control and
compliance procedures’’ to comport
with the FAR title of this section. We
also propose to revise the text to reflect
E:\FR\FM\23FEP1.SGM
23FEP1
khammond on DSKJM1Z7X2PROD with PROPOSALS
10160
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules
the roles and titles currently in use in
VA.
We propose to revise the title of
subpart 801.4 from ‘‘Deviations from the
FAR and VAAR’’ to ‘‘Deviations from
the FAR.’’ This change was made to
conform to the FAR title.
We propose to revise 801.403,
Individual deviations, by adding
language specifying that the Senior
Procurement Executive (SPE) may
authorize individual deviations from the
FAR and VAAR when an individual
deviation is in the best interest of the
Government.
Under 801.404, Class deviations, we
propose to revise the language to clarify
that the SPE is the VA authority
designated to comply with FAR 1.404.
Under subpart 801.6, Career
Development, Contracting Authority
and Responsibilities, we propose to
revise 801.601, General, to reflect that
that the SPE has authority to appoint
contracting officers under FAR 1.603
and this authority is further delegated to
the heads of the contracting activities
(HCAs). This revision also removes the
reference to VA’s Contracting Officer
Certification Program (COCP) which no
longer exists. We also propose to revise
the section to remove the material
pertaining to purchase card holders and
to add coverage that HCAs may
authorize ordering officers to place
orders against a contract or agreement
under certain circumstances.
Under 801.602, Contracting officers,
we propose to remove this section as the
policy regarding bills of lading and the
authorization to sell personal property
is outdated and the coverage including
the responsibilities delegated to
contracting officers is not required in
the regulation.
We propose to remove 801.602–2,
Responsibilities, and move this internal
guidance to the VA Acquisition Manual
(VAAM).
We propose to revise 801.602–3,
Ratification of unauthorized
commitments, to update the authorities
within the VA designated to ratify
unauthorized commitments. This
section incorporates the language from
Class Deviation—VAAR 801.602–3,
Ratification of Unauthorized
Commitments, dated May 3, 2013. We
propose to delete the procedural
guidance from this section and move it
to the VAAM.
We propose to remove 801.602–70,
General review requirements, and add it
to the VAAM as it contains VA’s
internal procedures.
We propose to remove 801.602–71,
Basic review requirements, and add it to
the VAAM as it contains VA’s internal
procedures.
VerDate Sep<11>2014
17:39 Feb 22, 2022
Jkt 256001
We propose to remove the following
three sections: 801.602–72, Exceptions
and additional review requirements;
801.602–73, Review requirements for
scarce medical specialist contracts and
contracts for health care resources; and
801.602–74, Review requirements for an
interagency agreement. The three
sections contain policy requiring
reviews at the Departmental level,
inconsistent with current VA policy in
this area.
We propose to remove 801.602–75,
Review requirements—OGC, and the
corresponding table and add it to the
VAAM as it contains VA’s internal
procedures and review thresholds. A
class deviation to update this policy was
signed April 12, 2017.
We propose to delete the sections
listed below as they contain policy
requiring reviews at the Departmental
level, inconsistent with current VA
policy in this area. Various sections are
also specific to only one administration/
organization which is inconsistent with
the objective to establish policies and
procedures at the departmental level.
The sections slated for removal as
described above are as follows:
801.602–76 Business clearance review.
801.602–77 Processing solicitations and
contract documents for legal or technical
review—general.
801.602–78 Processing solicitations and
contract documents for legal or technical
review—Veterans Health Administration
field facilities, Central Office (except Office
of Construction and Facilities
Management), the National Acquisition
Center, and the Denver Acquisition and
Logistics Center.
801.602–79 Processing solicitations and
contract documents for legal or technical
review—Veterans Benefits Administration.
801.602–80 Legal and technical review—
Office of Construction and Facilities
Management and National Cemetery
Administration.
801.602–81 Documents required for
business clearance reviews.
801.602–82 Documents to submit for legal
or technical review—general.
801.602–83 Documents to submit for legal
or technical review—contract
modifications.
801.602–84 Documents to submit for
business clearance reviews.
801.602–85 Results of review.
We also propose to remove section
801.603, Selection, appointment, and
termination of appointment, as this
information includes internal VA
procedures and this information is more
suitable for inclusion in the VAAM. The
sections slated for removal under this
section are as follows:
801.603–1 General.
801.603–70 Representatives of contracting
officers.
PO 00000
Frm 00080
Fmt 4702
Sfmt 4702
801.603–71 Representatives of contracting
officers; receipt of equipment, supplies,
and nonpersonal services.
We propose to renumber and retitle
the proposed for removal 801.603–70, to
801.604, and from ‘‘Representatives of
contracting officers’’ to ‘‘Contracting
Officer’s Representatives (COR),’’ to
comport with the FAR heading and
location. We propose to revise the
section to remove the text stating that
contracting officers can name a
Government employee as a
representative as it is redundant to
guidance at FAR 1.602–2(d). We have
also removed obsolete guidance
allowing contracting officers to delegate
their authority to other Government
contracting officers under centralized
indefinite delivery type contracts. We
also removed outdated guidance
pertaining to centralized contracts for
blood and other contract practices that
are managed at the contracting office
level. We propose to revise the text
prescribing the clause to match the
revised section heading. The clause has
been renumbered from 852.270–1 to
852.201–70 to be consistent with the
numbering convention for VA’s clauses.
We propose to remove 801.670,
Special and limited delegation, for not
adding value to the regulation. It
restates guidance that is provided
elsewhere regarding the delegation of
authority to award contracts.
We propose to remove 801.670–1,
Issuing bills of lading, which rescinds
the authority to issue bills of lading.
This is redundant as the authority to
issue bills of lading was removed from
the VAAR at 801.602. We propose to
remove section 801.670–3, as this policy
is now obsolete.
We propose to remove 801.670–4,
National Cemetery Administration, as it
does not fit the criteria of being
departmental level policy and it also
includes information that is no longer
current.
We propose to remove 801.670–5,
Letters of agreement, as it states that the
authority to utilize letters of agreement
has been rescinded. This guidance is no
longer relevant at this time.
We propose to remove 801.680,
Contracting authority of the Inspector
General, as this information is more
appropriate for the VAAM.
We propose to remove 801.690, VA’s
COCP and the following sections:
801.690–1, Definitions; 801.690–2,
General; 801.690–3, Responsibilities
under the COCP; 801.690–4, Selection;
801.690–5, Requirements for contracting
authority; 801.690–6, Appointment;
801.690–7, Termination; 801.690–8,
Interim appointment provisions; and
801.690–9, Distribution of Certificates of
E:\FR\FM\23FEP1.SGM
23FEP1
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules
Appointment. We propose to delete the
sections listed above as they all describe
a program, the Contracting Officer’s
Certification Program (COCP) that no
longer exists. The guidance previously
located in 801.690–9, Distribution of
Certificates of Appointment, has been
moved to 801.603–3.
We propose to remove 801.695, VA’s
Appointment of HCA’s Program, and the
supporting sections: 801.695–1, Policy;
801.695–2, Procedures for appointment
of HCAs; and 801.695–3, Authority of
the HCA. We propose to remove the
sections listed above and move them to
the VAAM as they include information
that is internal to the VA.
VAAR Part 802—Definitions of Words
and Terms
VA proposes adding the definition of
Ordering Officer to reflect the
introduction and usage of the term in
multiple parts of the VAAR. The
authorities cited for this part are: 40
U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301–1.304.
VAAR Part 808—Required Sources of
Supplies and Services
We propose adding a new section,
808.470, Ordering officers, under
subpart 808.4, Federal Supply
Schedules, to convey that ordering
officers may be authorized to place
orders under established orders and
Blanket Purchase Agreements under a
Federal Supply Schedule award with a
single awardee. The authorities cited for
this part are: 38 U.S.C. 8127–8128; 40
U.S.C. 121(c); 41 U.S.C. 1702; and 48
CFR 1.301 through 1.304.
khammond on DSKJM1Z7X2PROD with PROPOSALS
VAAR Part 816—Types of Contracts
VA proposes to add a new section,
816.570, Ordering officers, under
subpart 816.5, Indefinite-Delivery
Contracts, to convey that ordering
officers may be authorized to place
orders under established IndefiniteDelivery Contracts with a single
awardee. The authorities cited for this
part are: 40 U.S.C. 121(c); 41 U.S.C.
1121(c)(3); 41 U.S.C. 1702; and 48 CFR
1.301–1.304.
VAAR Part 835—Research and
Development
We propose to add a new part 835,
Research and Development. The
authorities cited for this part are 38
U.S.C. 7303, 40 U.S.C. 121(c), 41 U.S.C.
1702 and 48 CFR 1.301–1.304. We
propose to add 835.001–70, VA
definitions, to provide four R&D
definitions crafted for the VA. We
propose to add 835.003–70, Policy, in
which paragraph (a) cites the U.S. Code
that authorizes VA to execute a medical
VerDate Sep<11>2014
17:39 Feb 22, 2022
Jkt 256001
research program to improve the
medical treatment of our Veterans and
paragraph (b) states that the Office of
Research Oversight (ORO) serves as the
primary VHA office that advises the
Under Secretary for Health on all
compliance matters related to: Human
subject protections; laboratory animal
welfare, research safety, research
laboratory security, research
information security, research
misconduct, and other research
improprieties. Also under part 835, we
propose to add 835.003–71, Research
misconduct, which requires the
contracting officer to insert the research
misconduct clause into all R&D
solicitations and contracts and 835.003–
72, Protection of human subjects, which
requires the contracting officer to insert
the ‘‘Protection of Human Subject’’
clause in all R&D solicitations and
contracts.
In 835.003–73, Animal welfare, we
propose to add a prescription requiring
the contracting officer to insert the
Animal Welfare clause, 852.235–72, in
all R&D solicitations and contracts.
Under 835.003–74, Facilities, we
propose to add a prescription requiring
contracting officers to insert clause
852.235–73, Facilities, into R&D
solicitations and contracts when the
facilities to be assigned to perform effort
on an R&D contract are critical to the
success of the R&D effort or are a critical
factor in the award of the contract.
Under 835.003–75, Acknowledgement
of support and disclaimer, we propose
to add a prescription requiring
contracting officers to insert clause
852.235–74, Acknowledgement of
Support and Disclaimer, into R&D
solicitations and contracts. We propose
to add 835.010, Scientific and technical
reports, which includes a prescription
requiring contracting officers to insert
clause 852.235–75, Scientific and
Technical Reports, into R&D
solicitations and contracts.
VAAR Part 852—Solicitation
Provisions and Contract Clauses
In subpart 852.2, Text of Provisions
and Clauses, we propose to add clause
852.201–70, Contracting Officer’s
Representative (COR). This clause
replaces a clause previously numbered
as 852.270–1 and entitled
‘‘Representatives of contracting
officers.’’
We propose to add clause 852.235–70,
Research Misconduct. This clause
requires contractors to notify the
contracting officer if there are any
allegations of research misconduct. The
clause also provides procedures for
contractors to follow if their initial
inquiry into the allegations requires a
PO 00000
Frm 00081
Fmt 4702
Sfmt 4702
10161
full investigation. We propose to add
clause 852.235–71, Protection of Human
Subjects, which makes clear that
research involving human subjects is
not permitted under the award unless
expressly authorized in writing by the
contracting officer.
We propose to add clause 852.235–72,
Animal Welfare, which should be used
in all R&D solicitation and contracts and
directs VA’s contractors to comply with
the United States Department of
Agriculture (USDA) Animal Welfare Act
and Animal Welfare Regulations at
https://www.aphis.usda.gov/animal_
welfare, and the Animal Welfare
Information Center’s (AWIC)
information for improved animal care
and use in research, testing, and
teaching. This clause also directs the
contractor to provide to the contracting
officer a written plan of providing
adequate veterinary care to laboratory
animals, including the frequency of
visits and provisions for after hours,
weekend and holiday veterinary
coverage. We propose to add clause
852.235–73, Facilities, which stipulates
that the facilities specified in the
contract proposal are considered
essential to the work being performed
under the contract and that prior to
changing the facilities, the contractor
must notify the contracting officer in
writing of the intent to remove, replace,
or divert any of the specified facilities
and the contractor cannot make a
change in facilities without the
contracting officer’s written consent.
Under subpart 852.2, we propose to
add 852.235–74, Acknowledgement of
Support and Disclaimer. This clause
requires the contractor to acknowledge
the Government’s support in the
publication of any material based on
research developed under the contract
and it also requires contractors to add a
disclaimer (for all material published
outside of scientific journals and
papers), that ‘‘any opinions, findings,
and conclusions or recommendations
expressed in this material are those of
the author(s) and do not necessarily
reflect the views of the VA.’’ We also
propose to add clause 852.235–75,
Scientific and Technical Reports, which
requires contractors to submit an
electronic copy of the approved
scientific technical reports delivered
under the contract to the National
Technical Information Service (NTIS).
Executive Orders 12866 and 13563
Executive Orders (E.O.s) 12866 and
13563 direct agencies to assess the costs
and benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
E:\FR\FM\23FEP1.SGM
23FEP1
10162
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules
(including potential economic,
environmental, public health and safety
effects, and other advantages;
distributive impacts; and equity). E.O.
13563 (Improving Regulation and
Regulatory Review) emphasizes the
importance of quantifying both costs
and benefits, reducing costs,
harmonizing rules, and promoting
flexibility. The Office of Information
and Regulatory Affairs has determined
that this proposed rule is not a
significant regulatory action under
Executive Order 12866.
The Regulatory Impact Analysis
associated with this rulemaking can be
found as a supporting document at
www.regulations.gov.
khammond on DSKJM1Z7X2PROD with PROPOSALS
Paperwork Reduction Act
This proposed rule contains no
provisions constituting a collection of
information under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521).
Regulatory Flexibility Act
The Secretary hereby certifies that
this proposed rule would not have a
significant economic impact on a
substantial number of small entities as
they are defined in the Regulatory
Flexibility Act (5 U.S.C. 601–612).
Therefore, pursuant to 5 U.S.C. 605(b),
the initial and final regulatory flexibility
analysis requirements of 5 U.S.C. 603
and 604 do not apply.
This rulemaking does not change
VA’s policy regarding small businesses
and does not have a significant
economic impact to individual
businesses. The overall impact of the
proposed rule would be of benefit to
small businesses owned by Veterans or
service-disabled Veterans as the VAAR
is being updated to provide needed
guidance to ensure VA’s contractors
properly protect and safeguard VA
sensitive information, which includes
Veteran’s sensitive personal
information. This rulemaking adds a
new VAAR part concerning Acquisition
of Information Technology that codifies
information collection burdens. VA’s
requirement to collect the information is
the result of existing requirements to
ensure compliance across the Federal
government and specifically when VA
contractors, subcontractors, business
associates and their employees require
access to VA information (including VA
sensitive information) or information
systems. VA is merely adding existing
and current regulatory requirements to
the VAAR and placing guidance that is
applicable only to VA’s internal
operation processes or procedures into a
VA Acquisition Manual. VA estimates
no substantial cost impact to individual
VerDate Sep<11>2014
17:39 Feb 22, 2022
Jkt 256001
businesses will result from these rule
updates already required to be
considered by both large and small
businesses to receive an award from VA
or another Federal agency. There are
costs associated with this rulemaking
pertaining to the codification of an
information collection request in order
to comply with VA’s responsibilities
under the Federal Information Security
Modernization Act of 2014. Each agency
of the Federal Government must provide
security for the information and
information systems that support the
operations and assets of the agency,
including those provided or managed by
another agency, contractor, or other
source. By statute, VA is required to
ensure that its contractors,
subcontractors, business associates, and
their employees operating under
contracts at VA shall be subject to the
same Federal laws, regulations, policies
or procedures as VA and VA personnel.
While this requirement adds some
burden in annual costs and hours to
firms already awarded and performing
contracts at VA, the overall cost is
considered de minimis, for either large
or small contractors, in relation to the
potential impact and harm to Veterans
and VA information and information
systems should a contractor not comply.
Properly setting forth the requirements
will provide clarity to the public and
ensure appropriate safeguards are in
place to ensure protection of VA’s
information (in particular VA sensitive
personal information) and information
systems. In total, this rulemaking does
not change VA’s policy regarding small
businesses, does not have a substantial
economic impact to individual
businesses, and does not significantly
increase or decrease costs small
business were already required to bear
when performing contracts which
required the access, maintenance,
process, or utilization of VA sensitive
information or information systems.
Unfunded Mandates
The Unfunded Mandates Reform Act
of 1995 requires, at 2 U.S.C. 1532, that
agencies prepare an assessment of
anticipated costs and benefits before
issuing any rule that may result in the
expenditure by State, local, and tribal
Governments, in the aggregate, or by the
private sector, of $100 million or more
(adjusted annually for inflation) in any
one year. This proposed rule would
have no such effect on State, local, and
tribal Governments or on the private
sector.
PO 00000
Frm 00082
Fmt 4702
Sfmt 4702
List of Subjects
48 CFR Part 801
Administrative practice and
procedure, Government procurement,
Reporting and recordkeeping
requirements.
48 CFR Parts 802, 808, and 816
Government procurement.
48 CFR Part 835
Administrative practice and
procedure, Government procurement,
Reporting and recordkeeping
requirements.
48 CFR Part 852
Government procurement, Reporting
and recordkeeping requirements.
Signing Authority
Denis McDonough, Secretary of
Veterans Affairs, approved this
document on February 3, 2022, and
authorized the undersigned to sign and
submit the document to the Office of the
Federal Register for publication
electronically as an official document of
the Department of Veterans Affairs.
Consuela Benjamin,
Regulation Development Coordinator, Office
of Regulation Policy & Management, Office
of General Counsel, Department of Veterans
Affairs.
For the reasons set out in the
preamble, VA is proposing to amend 48
CFR parts 801, 802, 808, 816, 835, and
852 as follows:
■ 1. Part 801 is revised to read as
follows:
PART 801—DEPARTMENT OF
VETERANS AFFAIRS ACQUISITION
REGULATION SYSTEM
Sec.
801.000 Scope of part.
Subpart 801.1—Purpose, Authority, Issuance
801.101 Purpose.
801.103 Authority.
801.104 Applicability.
801.104–70 Exclusions.
801.106 OMB approval under the
Paperwork Reduction Act.
Subpart 801.3—Agency Acquisition
Regulations
801.301 Policy.
801.304 Agency control and compliance
procedures.
Subpart 801.4—Deviations from the FAR
801.403 Individual deviations.
801.404 Class deviations.
Subpart 801.6—Career Development,
Contracting Authority, and Responsibilities
801.601 General.
801.602–3 Ratification of unauthorized
commitments.
E:\FR\FM\23FEP1.SGM
23FEP1
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules
801.604 Contracting Officer’s
Representative (COR).
Authority: 38 U.S.C. 8123; 38 U.S.C. 8153;
38 U.S.C. 8303; 40 U.S.C. 121(c); 41 U.S.C.
1702; and 48 CFR 1.301 through 1.304.
801.000
Scope of part.
This part includes general Department
of Veterans Affairs (VA) Acquisition
Regulation (VAAR) policies, including
information regarding the maintenance
and administration of the VAAR,
acquisition policies and practices, and
procedures for deviation from the VAAR
and the Federal Acquisition Regulation
(FAR).
Subpart 801.1—Purpose, Authority,
Issuance
801.101
Purpose.
(a) VA established the VAAR to codify
and publish uniform policies and
procedures for VA’s acquisition of
supplies and services, including
construction.
(b) The VAAR implements and
supplements the FAR.
801.103
Authority.
The VA issues the VAAR under the
authority of 41 U.S.C. 1707 and 48 CFR
1.301 through 1.304, and other
authorities as cited.
801.104
Applicability.
The FAR and the VAAR apply to all
FAR-based VA actions using
appropriated funds unless otherwise
specified in this regulation. Supply
Fund monies (38 U.S.C. 8121) and
General Post Funds (38 U.S.C. 8302) are
appropriated funds.
khammond on DSKJM1Z7X2PROD with PROPOSALS
801.104–70
Exclusions.
(a) Restricted gifts. The FAR and
VAAR do not apply to purchases and
contracts that use General Post Funds if
using the FAR and the VAAR would
infringe upon a donor’s right to specify
the exact item to be purchased and/or
the source of supply (38 U.S.C. 8303).
(b) Procurement of prosthetic
appliances. The VA may procure
prosthetic appliances and necessary
services required in the fitting,
supplying, and training and use of
prosthetic appliances by purchase,
manufacture, contract, or in such other
manner as the VA may determine to be
proper, without regard to any other
provision of law (38 U.S.C. 8123).
(c) Sharing of health-care resources.
(1) To secure health-care resources
which otherwise might not be feasibly
available, or to effectively utilize certain
other health-care resources, the VA may,
when the VA determines it to be in the
best interest of the prevailing standards
of the Department medical care
VerDate Sep<11>2014
17:39 Feb 22, 2022
Jkt 256001
program, make arrangements, by
contract or other form of agreement for
the mutual use, or exchange of use, of
health-care resources between
Department health-care facilities and
any health-care provider, or other entity
or individual.
(2) The VA may enter into a contract
or other agreement under paragraph
(c)(1) of this section if such resources
are not, or would not be, used to their
maximum effective capacity.
(3)(i) If the health-care resource
required is a commercial service, the
use of medical equipment or space, or
research, and is to be acquired from an
institution affiliated with the
Department in accordance with 38
U.S.C. 7302, including medical practice
groups and other entities associated
with affiliated institutions, blood banks,
organ banks, or research centers, the VA
may make arrangements for acquisition
of the resource without regard to any
law or regulation (including any
Executive order, circular, or other
administrative policy) that would
otherwise require the use of competitive
procedures for acquiring the resource.
(ii) If the health-care resource
required is a commercial service or the
use of medical equipment or space, and
is not to be acquired from an entity
described in paragraph (c)(3)(i) of this
section, any procurement of the
resource may be conducted without
regard to any law or regulation that
would otherwise require the use of
competitive procedures for procuring
the resource, but only if the
procurement is conducted in
accordance with the simplified
procedures prescribed in part 873. (38
U.S.C. 8153).
801.106 OMB approval under the
Paperwork Reduction Act.
See VA Acquisition Manual (VAAM)
M801.106 for a list of the information
collection and recordkeeping
requirements contained in this part that
have been approved by the Office of
Management and Budget.
Subpart 801.3—Agency Acquisition
Regulations
801.301 Policy.
(a)(1) VA implementation and
supplementation of the FAR is issued in
the Veterans Affairs Acquisition
Regulation (VAAR) under authorization
and subject to the authority, direction,
and control of the Secretary of Veterans
Affairs. The VAAR contains—
(i) Requirements of law;
(ii) Agency policies;
(iii) Delegations of FAR authorities;
(iv) Deviations from FAR
requirements; and
PO 00000
Frm 00083
Fmt 4702
Sfmt 4702
10163
(v) Policies/procedures that have a
significant effect beyond the internal
operating procedures of VA or a
significant cost or administrative impact
on contractors or offerors.
(2) Relevant internal procedures,
guidance, and information (PGI) that do
not meet the criteria in paragraph (a)(1)
of this section are issued in the Veterans
Affairs Acquisition Manual (VAAM).
801.304 Agency control and compliance
procedures.
The Principal Executive Director of
VA’s Office of Acquisition, Logistics
and Construction is designated as the
Department’s Chief Acquisition Officer.
The Executive Director for the Office of
Acquisition and Logistics (OAL) is
designated as the Department’s Senior
Procurement Executive (SPE). The SPE
is responsible for amending the VAAR
for compliance with FAR 1.304.
Subpart 801.4—Deviations From the
FAR
801.403
Individual deviations.
The SPE may authorize individual
deviations from the FAR and VAAR in
accordance with FAR 1.403 when an
individual deviation is in the best
interest of the Government.
801.404
Class deviations.
The SPE may authorize class
deviations from the FAR and VAAR
when a class deviation is in the best
interest of the Government.
Subpart 801.6—Career Development,
Contracting Authority, and
Responsibilities
801.601
General.
(a) The Senior Procurement Executive
is granted the authority to appoint and
terminate contracting officers. This
authority is further delegated to the
heads of the contracting activities (HCA)
and others as appropriate. The SPE may
also delegate authority to execute,
award, and administer contracts,
purchase orders, and other agreements
to other VA officials, such as HCAs and
contracting officers. All delegations of
authority will be made in writing.
(b) HCAs may authorize the use of
ordering officers to order supplies and
services in accordance with the ordering
limits identified in the contract or
agreement or the specific ordering
guide. Ordering officers shall be
delegated in writing. The written
delegation must be specific to the
contract or agreement and articulate the
limitations of the delegated authority.
Ordering officers shall only place orders
against the contract or agreement if it is
awarded to a single awardee. Ordering
E:\FR\FM\23FEP1.SGM
23FEP1
10164
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules
officers may not negotiate contract terms
and conditions, determine price
reasonableness, or determine best value.
If the contracting officer determines
prior to award that ordering officers will
be authorized to place orders against a
contract or agreement, the contracting
officer will furnish the contractor with
the names of individuals delegated
ordering officer authority by separate
letter upon issuance of the contract.
801.602–3 Ratification of unauthorized
commitments.
(a) This section applies to
unauthorized commitments, including
any commitment made by a contracting
officer that exceeds that contracting
officer’s contracting authority and
unauthorized commitments made by a
Government representative who lacked
the authority to enter into that
agreement on behalf of the Government.
(b) The approving authority and
ratification official for any unauthorized
commitments is the HCA. The approval
authority may not be re-delegated.
801.604 Contracting Officer’s
Representative (COR).
When the contracting officer intends
to designate a Contracting Officer’s
Representative for a solicitation or
contract, the contracting officer must
include the clause in 852. 201–70,
Contracting Officer’s Representative, in
the solicitation and contract.
PART 802—DEFINITIONS OF WORDS
AND TERMS
2. The authority citation for part 802
continues to read as follows:
Authority: 38 U.S.C. 8127–8128; 40 U.S.C.
121(c); 41 U.S.C. 1702; and 48 CFR 1.301
through 1.304.
Subpart 808.4—Federal Supply
Schedules
5. Add section 808.470 to read as
follows:
■
808.470
Ordering Officers
In accordance with 801.601, when
authorized, ordering officers may place
orders for supplies and services against
agreements or task or delivery orders
established by a contracting officer
against Federal Supply Schedules
within the ordering limits identified in
the contract or agreement or the specific
ordering guide when funding is
available. Ordering officers shall only
place orders against the order or
agreement if it is awarded to a single
awardee. The contracting officer that
awarded the Blanket Purchase
Agreements (BPA) or order will provide
the contractor a list of authorized
ordering officers. Any modifications to
the agreement or order must be
performed by a contracting officer.
PART 816—TYPES OF CONTRACTS
6. The authority citation for part 816
continues to read as follows:
■
Authority: 40 U.S.C. 121(c); 41 U.S.C.
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301
through 1.304.
Subpart 816.5—Indefinite-Delivery
Contracts
■
7. Add section 816.570 to read as
follows:
■
Authority: 40 U.S.C. 121(c); 41 U.S.C.
1121(c)(3); 41 U.S.C. 1702; and 48 CFR
1.301–1.304.
816.570
Subpart 802.1—Definitions
3. Section 802.101 is amended by
adding the definition ‘‘Ordering officer’’
in alphabetical order to read as follows:
■
802.101
Definitions.
khammond on DSKJM1Z7X2PROD with PROPOSALS
*
*
*
*
*
Ordering officer means the VA official
authorized to order supplies and
services against a FAR-based contract or
agreement in accordance with the
ordering limits identified in the contract
or agreement or the specific ordering
guide in accordance with 801.601(b).
*
*
*
*
*
PART 808—REQUIRED SOURCES OF
SUPPLIES AND SERVICES
4. The authority citation for part 808
is revised to read as follows:
■
VerDate Sep<11>2014
17:39 Feb 22, 2022
Jkt 256001
Ordering officers.
In accordance with 801.601, when
authorized, ordering officers may place
orders for supplies and services against
established Indefinite-Delivery
Contracts within the ordering limits
identified in the contract or the specific
ordering guide when funding is
available. Ordering officers shall only
place orders against the contract if it is
awarded to a single awardee. When a
contracting officer appoints an ordering
officer in writing after award, the
contracting officer will furnish the
contractor with an updated list of
individual ordering officers authorized
to place orders against the contract.
Ordering officers may not negotiate
contract terms and conditions,
determine price reasonableness, or
determine best value.
■ 8. Part 835 is added to subchapter F
to read as follows:
PO 00000
Frm 00084
Fmt 4702
Sfmt 4702
PART 835—RESEARCH AND
DEVELOPMENT CONTRACTING
Sec.
835.001–70 Veterans Affairs (VA)
definitions.
835.003–70 VA policy.
835.003–71 Research misconduct.
835.003–72 Protection of human subjects.
835.003–73 Animal welfare.
835.003–74 Facilities.
835.003–75 Acknowledgement of support
and disclaimer.
835.010 Scientific and technical reports.
Authority: 38 U.S.C. 7303; 40 U.S.C.
121(c); 41 U.S.C. 1702 and 48 CFR 1.301
through 1.304.
835.001–70 Veterans Affairs (VA)
definitions.
Research means a systematic
investigation, including research
development, testing and evaluation,
designed to develop or contribute to
generalized knowledge.
Research impropriety refers to
noncompliance with the laws,
regulations, and policies regarding
human subject protections, laboratory
animal welfare, research safety, research
laboratory security, research
information security, and research
misconduct. It does not encompass
improper procedures or conduct in
areas outside of the mandate of the
Office of Research Oversight (ORO) (e.g.,
waste, fraud, abuse, or fiscal
mismanagement).
Research misconduct means
fabrication, falsification, or plagiarism
in proposing, performing, or reviewing
research, or in reporting research
results.
VA facility means a component of the
VA national health care system, such as
a VA Medical Center, VA Health Care
System, or VA Medical and Regional
Office Center.
835.003–70
VA policy.
(a) Pursuant to 38 U.S.C. 7303, VA is
authorized to carry out a program of
medical research in connection with the
provisions of medical care and
treatment to Veterans.
(b) The Office of Research Oversight
(ORO) serves as the primary Veterans
Health Administration (VHA) office that
advises the Under Secretary for Health
on all compliance matters related to—
(1) Human subject protections;
(2) Laboratory animal welfare;
(3) Research safety;
(4) Research laboratory security;
(5) Research information security;
(6) Research misconduct; and
(7) Other research improprieties.
835.003–71
Research misconduct.
The contracting officer shall insert the
clause at 852.235–70, Research
E:\FR\FM\23FEP1.SGM
23FEP1
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules
Misconduct, in all research and
development (R&D) solicitations and
contracts.
835.003–72
Protection of human subjects.
The contracting officer shall insert the
clause at 852.235–71, Protection of
Human Subjects, in all research and
development (R&D) solicitations and
contracts.
835.003–73
Animal welfare.
The contracting officer shall insert the
clause at 852.235–72, Animal Welfare,
in all research and development (R&D)
solicitations and contracts.
835.003–74
Facilities.
If the contracting officer determines
that the facilities to be assigned to
perform effort on a research and
development (R&D) contract are critical
to the success of the R&D effort, the
contracting officer shall insert the clause
at 852.235–73, Facilities, in the
solicitation and contract.
835.003–75 Acknowledgement of support
and disclaimer.
The contracting officer shall insert the
clause at 852.235–74,
Acknowledgement of Support and
Disclaimer, in all research and
development (R&D) solicitations and
contracts.
835.010
Scientific and technical reports.
The contracting officer shall insert the
clause at 852.235–75, Scientific and
Technical Reports, in all research and
development (R&D) solicitations and
contracts.
PART 852—SOLICITATION
PROVISIONS AND CONTRACT
CLAUSES
9. The authority citation for part 852
continues to read as follows:
■
Authority: 38 U.S.C. 8127–8128, and
8151–8153; 40 U.S.C. 121(c); 41 U.S.C.
1121(c)(3), 41 U.S.C. 1303; 41 U.S.C. 1702;
and 48 CFR 1.301 through 1.304.
10. Section 852.235–70 is added to
read as follows:
■
852.235–70
Research Misconduct.
As prescribed at 835.003–71, insert
the following clause:
khammond on DSKJM1Z7X2PROD with PROPOSALS
Research Misconduct (Date)
(a) The Contractor is responsible for
maintaining the integrity of research
performed pursuant to this contract award
including the prevention, detection and
remediation of research misconduct as
defined in 835.001–70.
(b) The Contractor shall notify the
Contracting Officer within 7 business days of
any research misconduct allegations received
by the facility concerning this contract
award.
VerDate Sep<11>2014
17:39 Feb 22, 2022
Jkt 256001
(c) The Contractor shall conduct an initial
inquiry into any allegation of research
misconduct. If the Contractor determines that
there is sufficient evidence to proceed to an
investigation, the Contractor shall notify the
Contracting Officer and, unless otherwise
instructed shall—
(1) Conduct an investigation to develop a
complete factual record and an examination
of such record leading to either a finding of
research misconduct and an identification of
appropriate remedies, or a recommendation
that no further action is warranted;
(2) When the investigation results in a
research misconduct finding, ensure the
matter is adjudicated by a responsible official
who was not involved in the inquiry or
investigation and is organizationally
separated from the element which conducted
the investigation. The adjudication shall
include a review of the investigation record
and a recommendation of appropriate
corrective actions and sanctions; and
(3) When an investigation is complete, the
Contractor shall forward to the Contracting
Officer a copy of the evidentiary record, the
investigative report, any recommendations
made to the Contractor’s adjudicating official,
the adjudicating official’s recommendation
and notification of any proposed corrective
action, and the subject’s written response, if
any. The Contracting Officer will review the
documentation to determine whether the
proposed corrective action can proceed.
(d) The VA may elect to act in lieu of the
Contractor in conducting an inquiry or
investigation into an allegation of research
misconduct if the Contracting Officer finds
that—
(1) The research organization is not
prepared to handle the allegation in a manner
consistent with this clause and it is believed
it cannot reasonably conduct the inquiry;
(2) VA involvement is necessary to ensure
the public health, safety, and security, or to
prevent harm to the public interest; or
(3) The allegation involves possible
criminal misconduct.
(e) The Contractor shall provide safeguards
for information received and protect
informants, witnesses and respondents of
allegations as follows:
(1) The Contractor shall provide safeguards
to ensure that individuals may bring
allegations of research misconduct made in
good faith to the attention of the Contractor
without suffering retribution. Safeguards
include: protection against retaliation; fair
and objective procedures for examining and
resolving allegations; and diligence in
protecting positions and reputations.
(2) The Contractor shall also assure the
respondent that their rights are protected and
that the mere filing of an allegation of
research misconduct will not result in an
adverse action. Safeguards include timely
written notice regarding substantive
allegations against them, a description of the
allegations and reasonable access to any
evidence submitted to support each
allegation. Respondents must be given the
opportunity to prepare a response to an
allegation and notice of any findings of
research misconduct.
(f) Objectivity and expertise. The
Contractor shall select individual(s) to
PO 00000
Frm 00085
Fmt 4702
Sfmt 4702
10165
inquire, investigate, and adjudicate
allegations of research misconduct who have
appropriate expertise and have no
unresolved conflict of interest. The
individual(s) who conducts the adjudication
must not be the same individual(s) who
conducted the inquiry or investigation and
must be separate organizationally from the
element that conducted the inquiry or
investigation.
(End of clause)
■ 11. Section 852.235–71 is added to
read as follows:
852.235–71
Protection of Human Subjects.
As prescribed at 835.003–72, insert
the following clause:
Protection of Human Subjects (Date)
(a) Research involving human subjects is
not permitted under this award unless
expressly authorized in writing by the
Contracting Officer. Such authorization will
specify the details of the approved research
involving human subjects and will be
incorporated by reference into this contract.
(b) The Federal Policy for the Protection of
Human Subjects (the ‘‘Common Rule’’),
adopted by VA (see 38 CFR part 16), requires
Contractors to maintain appropriate policies
and procedures for the protection of human
subjects in research. The Common Rule
defines a ‘‘human subject’’ as a living
individual about whom an investigator
conducting research obtains data through
intervention or interaction with the
individual, or identifiable private
information. The term ‘‘research’’ means a
systematic investigation, including research
development and/or testing and evaluation,
designed to develop or contribute to
generalized knowledge. The Common Rule
also sets forth categories of research that may
be considered exempt from 15 CFR part 27.
These categories may be found at 15 CFR
27.101.
(c) Should research involving human
subjects be included in the proposal, prior to
issuance of an award, the Contractor shall
submit the following documentation to the
Contracting Officer:
(1) Documentation to verify that the
Contractor has established a relationship
with an appropriate Institutional Review
Board (‘‘cognizant IRB’’). An appropriate IRB
is one that is located within the United States
and within the community in which the
research will be conducted;
(2) Documentation to verify that the
cognizant IRB possesses a valid registration
with the United States Department of Health
and Human Services’ Office for Human
Research Protections (‘‘OHRP’’);
(3) Documentation to verify that the
Contractor has a valid Federal-wide
Assurance (FWA) issued by OHRP.
(d) Prior to starting any research involving
human subjects, the Contractor shall submit
appropriate documentation to the
Contracting Officer for institutional review
and approval. This documentation may
include:
(1) Copies of the research protocol, all
questionnaires, surveys, advertisements, and
informed consent forms approved by the
cognizant IRB;
E:\FR\FM\23FEP1.SGM
23FEP1
khammond on DSKJM1Z7X2PROD with PROPOSALS
10166
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules
(2) Documentation of approval for the
research protocol, questionnaires, surveys,
advertisements, and informed consent forms
by the cognizant IRB;
(3) Documentation of continuing IRB
approval by the cognizant IRB at appropriate
intervals as designated by the IRB, but not
less than annually; and/or
(4) Documentation to support an
exemption for the project from the Common
Rule (Note: this option is not available for
activities that fall under 45 CFR part 46,
subpart C).
(e) Additionally, if the Contractor modifies
a research protocol, questionnaire, survey,
advertisement, or informed consent form
approved by the cognizant IRB, the
Contractor shall submit a copy of all
modified material along with documentation
of approval for said modification by the
cognizant IRB to the Contracting Officer for
institutional review and approval. The
Contractor shall not implement any IRB
approved modification without written
approval by the Contracting Officer.
(f) No work involving human subjects may
be undertaken, conducted, or costs incurred
and/or charged to the project, until the
Contracting Officer approves the required
appropriate documentation in writing.
(g) The Contractor shall bear full
responsibility for the performance of all work
and services involving the use of human
subjects under this contract 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 be deemed to
constitute the Contractor or any
subcontractor, agent or employee of the
Contractor, or any other person, organization,
institution, or group of any kind whatsoever,
as the agency or employee of the
Government. 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 judgement or
otherwise, as an independent Contractor
without imputing liability on the part of the
Government for the acts of the Contractor or
its employees.
(h) If at any time during performance of
this contract, the Contracting Officer
determines, in consultation with the Office
for Protection from Research Risks (OPRR),
National Institutes of Health (NIH), that the
Contractor is not in compliance with any of
the requirements, the Contracting Officer
may immediately suspend the research and
further payments under this contract until
the Contractor corrects such noncompliance.
Notice of the suspension may be
communicated by telephone and confirmed
in writing. If the Contractor fails to complete
the corrective action within the period of
time designated in the Contracting Officer’s
written notice of suspension, the Contracting
Officer may, in consultation with OPRR, NIH,
terminate this contract and the Contractor’s
name may be removed from the list of those
Contractors with approved Department of
Health and Human Services Human Subject
Assurances.
(End of clause)
VerDate Sep<11>2014
17:39 Feb 22, 2022
Jkt 256001
12. Section 852.235–72 is added to
read as follows:
852.235–74 Acknowledgement of Support
and Disclaimer.
852.235–72
As prescribed at 835.003–75, insert
the following clause:
■
Animal Welfare.
As prescribed in 835.003–73, insert
the following clause:
Animal Welfare (Date)
(a) The Contractor shall—
(1) Use the Veterans Affairs (VA), Office of
Research Oversight (ORO) Laboratory Animal
Welfare Checklist;
(2) Comply with the United States
Department of Agriculture (USDA) Animal
Welfare Act and Animal Welfare Regulations
at https://www.aphis.usda.gov/animal_
welfare, and the Animal Welfare Information
Center’s (AWIC) information for improved
animal care and use in research, testing, and
teaching provided at https://
www.nal.usda.gov/awic;
(3) Develop and provide to the Contracting
Officer a written plan of providing adequate
veterinary care to laboratory animals,
including—
(i) The frequency of visits; and
(ii) Provisions for after-hours, weekend and
holiday veterinary coverage.
(b) The Contracting Officer may
immediately suspend the work by issuance of
a stop work order and suspend further
payments under this contract for failure to
comply with the requirements of this clause.
(c) The suspension will stay in effect until
the Contractor complies with the
requirements. Failure to complete corrective
action within the time specified by the
Contracting Officer may result in termination
of this contract.
(d) The Contractor shall include the
substance of this clause, in all subcontracts
involving research and development, testing,
evaluation or training that use live vertebrate
animals.
(End of clause)
■ 13. Section 852.235–73 is added to
read as follows:
852.235–73
Acknowledgement of Support and
Disclaimer (Date)
(a) The Contractor shall include an
acknowledgment of the Government’s
support in the publication of any material
based on or developed under this contract,
stated in the following terms: This material
is based upon work supported by the (name
of contracting agency) under this VA
contract.
(b) All material, except scientific articles or
papers published in scientific journals, must,
in addition to any notices or disclaimers by
the Contractor, also contain the following
disclaimer:
Any opinions, findings, conclusions or
recommendations expressed in this material
are those of the author(s) and do not
necessarily reflect the views of the VA.
(End of clause)
■ 15. Section 852.235–75 is added to
read as follows:
852.235–75
Reports.
Scientific and Technical
As prescribed at 835.010, insert the
following clause:
Scientific and Technical Reports (Date)
The Contractor shall submit an electronic
copy of the approved scientific technical
reports, not a summary, delivered under this
contract to the National Technical
Information Service (NTIS) as delineated at
FAR 35.010.
(End of clause)
852.270–1 [Redesignated as Section
852.201–70]
16. Section 852.270–1 is redesignated
as section 852.201–70 and revised to
read as follows:
■
Facilities.
As prescribed at 835.003–74, insert
the following clause:
Facilities (Date)
852.201–70 Contracting Officer’s
Representative.
(a) The facilities specified in the contract
are considered essential to the work being
performed under this contract. Therefore,
prior to removing, replacing, or diverting any
of the listed or specified facilities, the
Contractor shall—
(1) Notify the Contracting Officer in
writing; and
(2) Submit justification (including
proposed substitutions) in sufficient detail to
permit evaluation of the potential impact on
this contract.
(b) The Contractor shall make no removal,
replacement or diversion of facilities without
the Contracting Officer’s written consent.
As prescribed in 801.604, insert the
following provision:
(End of clause)
■ 14. Section 852.235–74 is added to
read as follows:
(End of provision)
PO 00000
Frm 00086
Fmt 4702
Sfmt 9990
Contracting Officer’s Representative
(Date)
The Contracting Officer reserves the right
to designate representatives to act for him/
her in furnishing technical guidance and
advice or generally monitor the work to be
performed under this contract. Such
designation will be in writing and will define
the scope and limitation of the designee’s
authority. A copy of the designation letter
shall be furnished to the Contractor.
[FR Doc. 2022–02796 Filed 2–22–22; 8:45 am]
BILLING CODE 8320–01–P
E:\FR\FM\23FEP1.SGM
23FEP1
Agencies
[Federal Register Volume 87, Number 36 (Wednesday, February 23, 2022)]
[Proposed Rules]
[Pages 10158-10166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02796]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
48 CFR Parts 801, 802, 808, 816, 835, and 852
RIN 2900-AQ23
VA Acquisition Regulation: Department of Veterans Affairs
Acquisition Regulation System and Research and Development
AGENCY: Department of Veterans Affairs.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Veterans Affairs (VA) is proposing to amend
and update its VA Acquisition Regulation (VAAR) in phased increments to
revise or remove any policy superseded by changes in the Federal
Acquisition Regulation (FAR), to remove procedural guidance internal to
VA into the VA Acquisition Manual (VAAM), and to incorporate any new
agency specific regulations or policies. These changes seek to
streamline and align the VAAR with the FAR and remove outdated and
duplicative requirements and reduce burden on contractors. The VAAM
incorporates portions of the removed VAAR as well as other internal
agency acquisition policy. VA will rewrite certain parts of the VAAR
and VAAM, and as VAAR parts are rewritten, will publish them in the
Federal Register.
[[Page 10159]]
VA will combine related topics, as appropriate. This rulemaking revises
VAAR coverage concerning Department of Veterans Affairs Acquisition
Regulation System and Research and Development. It also revises
affected parts concerning Definitions of Words and Terms, Required
Sources of Supplies and Services, Types of Contracts and Solicitation
Provisions and Contract Clauses.
DATES: Comments must be received on or before April 25, 2022 to be
considered in the formulation of the final rule.
ADDRESSES: Comments may be submitted through www.Regulations.gov.
Comments received will be available at regulations.gov for public
viewing, inspection or copies.
FOR FURTHER INFORMATION CONTACT: Mr. Rafael Taylor, Senior Procurement
Analyst, Procurement Policy and Warrant Management Services, 003A2A,
810 Vermont Avenue NW, Washington, DC 20420, (202) 714-8560. (This is
not a toll-free number.)
SUPPLEMENTARY INFORMATION:
Background
This rulemaking is issued under the authority of the Office of
Federal Procurement Policy (OFPP) Act which provides the authority for
an agency head to issue agency acquisition regulations that implement
or supplement the FAR.
VA is proposing to revise the VAAR to add new policy or regulatory
requirements and to remove any redundant guidance and guidance that is
applicable only to VA's internal operating processes or procedures.
Codified acquisition regulations may be amended and revised only
through rulemaking. All amendments, revisions and removals have been
reviewed and concurred with VA's Integrated Product Team of agency
stakeholders.
The VAAR uses the regulatory structure and arrangement of the FAR
and headings and subject areas are consistent with FAR content. The
VAAR is divided into subchapters, parts (each of which covers a
separate aspect of acquisition), subparts and sections.
The Office of Federal Procurement Policy Act, as codified in 41
U.S.C. 1707, provides the authority for the Federal Acquisition
Regulation and for the issuance of agency acquisition regulations
consistent with the FAR.
When Federal agencies acquire supplies and services using
appropriated funds, the purchase is governed by the FAR, set forth at
title 48 Code of Federal Regulations (CFR), chapter 1, parts 1 through
53, and the agency regulations that implement and supplement the FAR.
The VAAR is set forth at 48 CFR, chapter 8, parts 801 to 873.
Discussion and Analysis
VA proposes to make the following changes to the VAAR in this phase
of its revision and streamlining initiative. For procedural guidance
cited below that is proposed to be deleted from the VAAR, each section
cited for removal has been considered for inclusion in VA's internal
agency operating procedures in accordance with FAR 1.301(a)(2).
Similarly, delegations of authority that are removed from the VAAR will
be included in the VAAM as internal agency guidance. The VAAM is being
created in parallel with these revisions to the VAAR and is not subject
to the rulemaking process as they are internal VA procedures and
guidance. The VAAM will not be finalized until corresponding VAAR parts
are finalized.
VAAR Part 801--Department of Veterans Affairs Acquisition Regulation
System
We propose to revise the authorities cited for this part. The
authorities cited for this part are 38 U.S.C. 8123; 38 U.S.C. 8153; 38
U.S.C. 8303; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; 41
U.S.C. 1707; and 48 CFR 1.301-1.304. The Title 38 authorities are cited
as they provide the statutory basis for the exclusions as outlined in
801.104-70. We have retained the authority from 48 CFR 1.301-1.304 as
this is the FAR subpart outlining the guidance for agency acquisition
regulations.
Under subpart 801.1, Purpose, Authority, Issuance, we propose to
revise 801.103, Authority, to add 41 U.S.C. 1707 (the OFFP Act) as an
authority to the publishing of this regulation. Under 801.104,
Applicability, we propose to revise the text for clarity and to remove
an unnecessary reference to the VA Canteen Service.
In 801.104-70, Exclusions, we propose to retain the first paragraph
and redesignate it as paragraph (a) which explains that the FAR and
VAAR do not apply to those purchases made using the General Post Fund
when a donor specifies the exact item to be purchased. Under 801.104-
70, we also propose to add paragraph (b) to address the statutory
exception at 38 U.S.C. 8123, Procurement of prosthetic appliances,
which states: ``The VA may procure prosthetic appliances and necessary
services required in the fitting, supplying, and training and use of
prosthetic appliances by purchase, manufacture, contract, or in such
other manner as the VA may determine to be proper, without regard to
any other provision of law.'' Finally, under this section, we propose
to add paragraph (c) to address the statutory exception at 38 U.S.C.
8153, Sharing of health-care resources, which allows the VA to secure
health-care resources which otherwise might not be feasibly available,
or to effectively utilize certain other health-care resources, by using
simplified procedures which were codified in VAAR part 873, Simplified
Acquisition Procedures For Health-Care Resources.
We propose to remove 801.105 (no text) and 801.105-2, Arrangement
of regulations, as the location of this guidance has been revised to
comport with the placement of the corresponding FAR guidance. The
information that was covered here has been moved to 801.301, Policy.
In 801.106, OMB approval under the Paperwork Reduction Act, we
propose to delete the chart that contains the OMB approval numbers. We
propose to revise this section to add language directing the reader to
the VAAM for the list of information collection and recordkeeping
requirements associated with the control numbers. Given the constant
updating of VA's information collection requirements and the OMB
control numbers, it is more prudent to place this information in the
VAAM which doesn't require rulemaking for updating.
VA proposes to remove subpart 801.2, Administration, as it explains
the role of the Defense Acquisition Regulations Council and the
Civilian Agency Acquisition Council, which is redundant to the FAR.
We propose to revise the name of subpart 801.3 from ``Department
Acquisition Regulations'' to ``Agency Acquisition Regulations'' so that
the title comports with the FAR heading. We propose to add 801.301,
Policy, which states that the VA implementation and supplementation of
the FAR is issued in the VAAR under authorization and subject to the
authority, direction, and control of the Secretary of Veterans Affairs.
This section also explains what the VAAR contains and introduces and
explains the VAAM.
For 801.304, we propose to revise this section to change the title
from ``Department control and compliance procedures'' to ``Agency
control and compliance procedures'' to comport with the FAR title of
this section. We also propose to revise the text to reflect
[[Page 10160]]
the roles and titles currently in use in VA.
We propose to revise the title of subpart 801.4 from ``Deviations
from the FAR and VAAR'' to ``Deviations from the FAR.'' This change was
made to conform to the FAR title.
We propose to revise 801.403, Individual deviations, by adding
language specifying that the Senior Procurement Executive (SPE) may
authorize individual deviations from the FAR and VAAR when an
individual deviation is in the best interest of the Government.
Under 801.404, Class deviations, we propose to revise the language
to clarify that the SPE is the VA authority designated to comply with
FAR 1.404.
Under subpart 801.6, Career Development, Contracting Authority and
Responsibilities, we propose to revise 801.601, General, to reflect
that that the SPE has authority to appoint contracting officers under
FAR 1.603 and this authority is further delegated to the heads of the
contracting activities (HCAs). This revision also removes the reference
to VA's Contracting Officer Certification Program (COCP) which no
longer exists. We also propose to revise the section to remove the
material pertaining to purchase card holders and to add coverage that
HCAs may authorize ordering officers to place orders against a contract
or agreement under certain circumstances.
Under 801.602, Contracting officers, we propose to remove this
section as the policy regarding bills of lading and the authorization
to sell personal property is outdated and the coverage including the
responsibilities delegated to contracting officers is not required in
the regulation.
We propose to remove 801.602-2, Responsibilities, and move this
internal guidance to the VA Acquisition Manual (VAAM).
We propose to revise 801.602-3, Ratification of unauthorized
commitments, to update the authorities within the VA designated to
ratify unauthorized commitments. This section incorporates the language
from Class Deviation--VAAR 801.602-3, Ratification of Unauthorized
Commitments, dated May 3, 2013. We propose to delete the procedural
guidance from this section and move it to the VAAM.
We propose to remove 801.602-70, General review requirements, and
add it to the VAAM as it contains VA's internal procedures.
We propose to remove 801.602-71, Basic review requirements, and add
it to the VAAM as it contains VA's internal procedures.
We propose to remove the following three sections: 801.602-72,
Exceptions and additional review requirements; 801.602-73, Review
requirements for scarce medical specialist contracts and contracts for
health care resources; and 801.602-74, Review requirements for an
interagency agreement. The three sections contain policy requiring
reviews at the Departmental level, inconsistent with current VA policy
in this area.
We propose to remove 801.602-75, Review requirements--OGC, and the
corresponding table and add it to the VAAM as it contains VA's internal
procedures and review thresholds. A class deviation to update this
policy was signed April 12, 2017.
We propose to delete the sections listed below as they contain
policy requiring reviews at the Departmental level, inconsistent with
current VA policy in this area. Various sections are also specific to
only one administration/organization which is inconsistent with the
objective to establish policies and procedures at the departmental
level. The sections slated for removal as described above are as
follows:
801.602-76 Business clearance review.
801.602-77 Processing solicitations and contract documents for legal
or technical review--general.
801.602-78 Processing solicitations and contract documents for legal
or technical review--Veterans Health Administration field
facilities, Central Office (except Office of Construction and
Facilities Management), the National Acquisition Center, and the
Denver Acquisition and Logistics Center.
801.602-79 Processing solicitations and contract documents for legal
or technical review--Veterans Benefits Administration.
801.602-80 Legal and technical review--Office of Construction and
Facilities Management and National Cemetery Administration.
801.602-81 Documents required for business clearance reviews.
801.602-82 Documents to submit for legal or technical review--
general.
801.602-83 Documents to submit for legal or technical review--
contract modifications.
801.602-84 Documents to submit for business clearance reviews.
801.602-85 Results of review.
We also propose to remove section 801.603, Selection, appointment,
and termination of appointment, as this information includes internal
VA procedures and this information is more suitable for inclusion in
the VAAM. The sections slated for removal under this section are as
follows:
801.603-1 General.
801.603-70 Representatives of contracting officers.
801.603-71 Representatives of contracting officers; receipt of
equipment, supplies, and nonpersonal services.
We propose to renumber and retitle the proposed for removal
801.603-70, to 801.604, and from ``Representatives of contracting
officers'' to ``Contracting Officer's Representatives (COR),'' to
comport with the FAR heading and location. We propose to revise the
section to remove the text stating that contracting officers can name a
Government employee as a representative as it is redundant to guidance
at FAR 1.602-2(d). We have also removed obsolete guidance allowing
contracting officers to delegate their authority to other Government
contracting officers under centralized indefinite delivery type
contracts. We also removed outdated guidance pertaining to centralized
contracts for blood and other contract practices that are managed at
the contracting office level. We propose to revise the text prescribing
the clause to match the revised section heading. The clause has been
renumbered from 852.270-1 to 852.201-70 to be consistent with the
numbering convention for VA's clauses.
We propose to remove 801.670, Special and limited delegation, for
not adding value to the regulation. It restates guidance that is
provided elsewhere regarding the delegation of authority to award
contracts.
We propose to remove 801.670-1, Issuing bills of lading, which
rescinds the authority to issue bills of lading. This is redundant as
the authority to issue bills of lading was removed from the VAAR at
801.602. We propose to remove section 801.670-3, as this policy is now
obsolete.
We propose to remove 801.670-4, National Cemetery Administration,
as it does not fit the criteria of being departmental level policy and
it also includes information that is no longer current.
We propose to remove 801.670-5, Letters of agreement, as it states
that the authority to utilize letters of agreement has been rescinded.
This guidance is no longer relevant at this time.
We propose to remove 801.680, Contracting authority of the
Inspector General, as this information is more appropriate for the
VAAM.
We propose to remove 801.690, VA's COCP and the following sections:
801.690-1, Definitions; 801.690-2, General; 801.690-3, Responsibilities
under the COCP; 801.690-4, Selection; 801.690-5, Requirements for
contracting authority; 801.690-6, Appointment; 801.690-7, Termination;
801.690-8, Interim appointment provisions; and 801.690-9, Distribution
of Certificates of
[[Page 10161]]
Appointment. We propose to delete the sections listed above as they all
describe a program, the Contracting Officer's Certification Program
(COCP) that no longer exists. The guidance previously located in
801.690-9, Distribution of Certificates of Appointment, has been moved
to 801.603-3.
We propose to remove 801.695, VA's Appointment of HCA's Program,
and the supporting sections: 801.695-1, Policy; 801.695-2, Procedures
for appointment of HCAs; and 801.695-3, Authority of the HCA. We
propose to remove the sections listed above and move them to the VAAM
as they include information that is internal to the VA.
VAAR Part 802--Definitions of Words and Terms
VA proposes adding the definition of Ordering Officer to reflect
the introduction and usage of the term in multiple parts of the VAAR.
The authorities cited for this part are: 40 U.S.C. 121(c); 41 U.S.C.
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301-1.304.
VAAR Part 808--Required Sources of Supplies and Services
We propose adding a new section, 808.470, Ordering officers, under
subpart 808.4, Federal Supply Schedules, to convey that ordering
officers may be authorized to place orders under established orders and
Blanket Purchase Agreements under a Federal Supply Schedule award with
a single awardee. The authorities cited for this part are: 38 U.S.C.
8127-8128; 40 U.S.C. 121(c); 41 U.S.C. 1702; and 48 CFR 1.301 through
1.304.
VAAR Part 816--Types of Contracts
VA proposes to add a new section, 816.570, Ordering officers, under
subpart 816.5, Indefinite-Delivery Contracts, to convey that ordering
officers may be authorized to place orders under established
Indefinite-Delivery Contracts with a single awardee. The authorities
cited for this part are: 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301-1.304.
VAAR Part 835--Research and Development
We propose to add a new part 835, Research and Development. The
authorities cited for this part are 38 U.S.C. 7303, 40 U.S.C. 121(c),
41 U.S.C. 1702 and 48 CFR 1.301-1.304. We propose to add 835.001-70, VA
definitions, to provide four R&D definitions crafted for the VA. We
propose to add 835.003-70, Policy, in which paragraph (a) cites the
U.S. Code that authorizes VA to execute a medical research program to
improve the medical treatment of our Veterans and paragraph (b) states
that the Office of Research Oversight (ORO) serves as the primary VHA
office that advises the Under Secretary for Health on all compliance
matters related to: Human subject protections; laboratory animal
welfare, research safety, research laboratory security, research
information security, research misconduct, and other research
improprieties. Also under part 835, we propose to add 835.003-71,
Research misconduct, which requires the contracting officer to insert
the research misconduct clause into all R&D solicitations and contracts
and 835.003-72, Protection of human subjects, which requires the
contracting officer to insert the ``Protection of Human Subject''
clause in all R&D solicitations and contracts.
In 835.003-73, Animal welfare, we propose to add a prescription
requiring the contracting officer to insert the Animal Welfare clause,
852.235-72, in all R&D solicitations and contracts. Under 835.003-74,
Facilities, we propose to add a prescription requiring contracting
officers to insert clause 852.235-73, Facilities, into R&D
solicitations and contracts when the facilities to be assigned to
perform effort on an R&D contract are critical to the success of the
R&D effort or are a critical factor in the award of the contract. Under
835.003-75, Acknowledgement of support and disclaimer, we propose to
add a prescription requiring contracting officers to insert clause
852.235-74, Acknowledgement of Support and Disclaimer, into R&D
solicitations and contracts. We propose to add 835.010, Scientific and
technical reports, which includes a prescription requiring contracting
officers to insert clause 852.235-75, Scientific and Technical Reports,
into R&D solicitations and contracts.
VAAR Part 852--Solicitation Provisions and Contract Clauses
In subpart 852.2, Text of Provisions and Clauses, we propose to add
clause 852.201-70, Contracting Officer's Representative (COR). This
clause replaces a clause previously numbered as 852.270-1 and entitled
``Representatives of contracting officers.''
We propose to add clause 852.235-70, Research Misconduct. This
clause requires contractors to notify the contracting officer if there
are any allegations of research misconduct. The clause also provides
procedures for contractors to follow if their initial inquiry into the
allegations requires a full investigation. We propose to add clause
852.235-71, Protection of Human Subjects, which makes clear that
research involving human subjects is not permitted under the award
unless expressly authorized in writing by the contracting officer.
We propose to add clause 852.235-72, Animal Welfare, which should
be used in all R&D solicitation and contracts and directs VA's
contractors to comply with the United States Department of Agriculture
(USDA) Animal Welfare Act and Animal Welfare Regulations at https://www.aphis.usda.gov/animal_welfare, and the Animal Welfare Information
Center's (AWIC) information for improved animal care and use in
research, testing, and teaching. This clause also directs the
contractor to provide to the contracting officer a written plan of
providing adequate veterinary care to laboratory animals, including the
frequency of visits and provisions for after hours, weekend and holiday
veterinary coverage. We propose to add clause 852.235-73, Facilities,
which stipulates that the facilities specified in the contract proposal
are considered essential to the work being performed under the contract
and that prior to changing the facilities, the contractor must notify
the contracting officer in writing of the intent to remove, replace, or
divert any of the specified facilities and the contractor cannot make a
change in facilities without the contracting officer's written consent.
Under subpart 852.2, we propose to add 852.235-74, Acknowledgement
of Support and Disclaimer. This clause requires the contractor to
acknowledge the Government's support in the publication of any material
based on research developed under the contract and it also requires
contractors to add a disclaimer (for all material published outside of
scientific journals and papers), that ``any opinions, findings, and
conclusions or recommendations expressed in this material are those of
the author(s) and do not necessarily reflect the views of the VA.'' We
also propose to add clause 852.235-75, Scientific and Technical
Reports, which requires contractors to submit an electronic copy of the
approved scientific technical reports delivered under the contract to
the National Technical Information Service (NTIS).
Executive Orders 12866 and 13563
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess
the costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits
[[Page 10162]]
(including potential economic, environmental, public health and safety
effects, and other advantages; distributive impacts; and equity). E.O.
13563 (Improving Regulation and Regulatory Review) emphasizes the
importance of quantifying both costs and benefits, reducing costs,
harmonizing rules, and promoting flexibility. The Office of Information
and Regulatory Affairs has determined that this proposed rule is not a
significant regulatory action under Executive Order 12866.
The Regulatory Impact Analysis associated with this rulemaking can
be found as a supporting document at www.regulations.gov.
Paperwork Reduction Act
This proposed rule contains no provisions constituting a collection
of information under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3521).
Regulatory Flexibility Act
The Secretary hereby certifies that this proposed rule would not
have a significant economic impact on a substantial number of small
entities as they are defined in the Regulatory Flexibility Act (5
U.S.C. 601-612). Therefore, pursuant to 5 U.S.C. 605(b), the initial
and final regulatory flexibility analysis requirements of 5 U.S.C. 603
and 604 do not apply.
This rulemaking does not change VA's policy regarding small
businesses and does not have a significant economic impact to
individual businesses. The overall impact of the proposed rule would be
of benefit to small businesses owned by Veterans or service-disabled
Veterans as the VAAR is being updated to provide needed guidance to
ensure VA's contractors properly protect and safeguard VA sensitive
information, which includes Veteran's sensitive personal information.
This rulemaking adds a new VAAR part concerning Acquisition of
Information Technology that codifies information collection burdens.
VA's requirement to collect the information is the result of existing
requirements to ensure compliance across the Federal government and
specifically when VA contractors, subcontractors, business associates
and their employees require access to VA information (including VA
sensitive information) or information systems. VA is merely adding
existing and current regulatory requirements to the VAAR and placing
guidance that is applicable only to VA's internal operation processes
or procedures into a VA Acquisition Manual. VA estimates no substantial
cost impact to individual businesses will result from these rule
updates already required to be considered by both large and small
businesses to receive an award from VA or another Federal agency. There
are costs associated with this rulemaking pertaining to the
codification of an information collection request in order to comply
with VA's responsibilities under the Federal Information Security
Modernization Act of 2014. Each agency of the Federal Government must
provide security for the information and information systems that
support the operations and assets of the agency, including those
provided or managed by another agency, contractor, or other source. By
statute, VA is required to ensure that its contractors, subcontractors,
business associates, and their employees operating under contracts at
VA shall be subject to the same Federal laws, regulations, policies or
procedures as VA and VA personnel. While this requirement adds some
burden in annual costs and hours to firms already awarded and
performing contracts at VA, the overall cost is considered de minimis,
for either large or small contractors, in relation to the potential
impact and harm to Veterans and VA information and information systems
should a contractor not comply. Properly setting forth the requirements
will provide clarity to the public and ensure appropriate safeguards
are in place to ensure protection of VA's information (in particular VA
sensitive personal information) and information systems. In total, this
rulemaking does not change VA's policy regarding small businesses, does
not have a substantial economic impact to individual businesses, and
does not significantly increase or decrease costs small business were
already required to bear when performing contracts which required the
access, maintenance, process, or utilization of VA sensitive
information or information systems.
Unfunded Mandates
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C.
1532, that agencies prepare an assessment of anticipated costs and
benefits before issuing any rule that may result in the expenditure by
State, local, and tribal Governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation) in any one year. This proposed rule would have no such
effect on State, local, and tribal Governments or on the private
sector.
List of Subjects
48 CFR Part 801
Administrative practice and procedure, Government procurement,
Reporting and recordkeeping requirements.
48 CFR Parts 802, 808, and 816
Government procurement.
48 CFR Part 835
Administrative practice and procedure, Government procurement,
Reporting and recordkeeping requirements.
48 CFR Part 852
Government procurement, Reporting and recordkeeping requirements.
Signing Authority
Denis McDonough, Secretary of Veterans Affairs, approved this
document on February 3, 2022, and authorized the undersigned to sign
and submit the document to the Office of the Federal Register for
publication electronically as an official document of the Department of
Veterans Affairs.
Consuela Benjamin,
Regulation Development Coordinator, Office of Regulation Policy &
Management, Office of General Counsel, Department of Veterans Affairs.
For the reasons set out in the preamble, VA is proposing to amend
48 CFR parts 801, 802, 808, 816, 835, and 852 as follows:
0
1. Part 801 is revised to read as follows:
PART 801--DEPARTMENT OF VETERANS AFFAIRS ACQUISITION REGULATION
SYSTEM
Sec.
801.000 Scope of part.
Subpart 801.1--Purpose, Authority, Issuance
801.101 Purpose.
801.103 Authority.
801.104 Applicability.
801.104-70 Exclusions.
801.106 OMB approval under the Paperwork Reduction Act.
Subpart 801.3--Agency Acquisition Regulations
801.301 Policy.
801.304 Agency control and compliance procedures.
Subpart 801.4--Deviations from the FAR
801.403 Individual deviations.
801.404 Class deviations.
Subpart 801.6--Career Development, Contracting Authority, and
Responsibilities
801.601 General.
801.602-3 Ratification of unauthorized commitments.
[[Page 10163]]
801.604 Contracting Officer's Representative (COR).
Authority: 38 U.S.C. 8123; 38 U.S.C. 8153; 38 U.S.C. 8303; 40
U.S.C. 121(c); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.
801.000 Scope of part.
This part includes general Department of Veterans Affairs (VA)
Acquisition Regulation (VAAR) policies, including information regarding
the maintenance and administration of the VAAR, acquisition policies
and practices, and procedures for deviation from the VAAR and the
Federal Acquisition Regulation (FAR).
Subpart 801.1--Purpose, Authority, Issuance
801.101 Purpose.
(a) VA established the VAAR to codify and publish uniform policies
and procedures for VA's acquisition of supplies and services, including
construction.
(b) The VAAR implements and supplements the FAR.
801.103 Authority.
The VA issues the VAAR under the authority of 41 U.S.C. 1707 and 48
CFR 1.301 through 1.304, and other authorities as cited.
801.104 Applicability.
The FAR and the VAAR apply to all FAR-based VA actions using
appropriated funds unless otherwise specified in this regulation.
Supply Fund monies (38 U.S.C. 8121) and General Post Funds (38 U.S.C.
8302) are appropriated funds.
801.104-70 Exclusions.
(a) Restricted gifts. The FAR and VAAR do not apply to purchases
and contracts that use General Post Funds if using the FAR and the VAAR
would infringe upon a donor's right to specify the exact item to be
purchased and/or the source of supply (38 U.S.C. 8303).
(b) Procurement of prosthetic appliances. The VA may procure
prosthetic appliances and necessary services required in the fitting,
supplying, and training and use of prosthetic appliances by purchase,
manufacture, contract, or in such other manner as the VA may determine
to be proper, without regard to any other provision of law (38 U.S.C.
8123).
(c) Sharing of health-care resources. (1) To secure health-care
resources which otherwise might not be feasibly available, or to
effectively utilize certain other health-care resources, the VA may,
when the VA determines it to be in the best interest of the prevailing
standards of the Department medical care program, make arrangements, by
contract or other form of agreement for the mutual use, or exchange of
use, of health-care resources between Department health-care facilities
and any health-care provider, or other entity or individual.
(2) The VA may enter into a contract or other agreement under
paragraph (c)(1) of this section if such resources are not, or would
not be, used to their maximum effective capacity.
(3)(i) If the health-care resource required is a commercial
service, the use of medical equipment or space, or research, and is to
be acquired from an institution affiliated with the Department in
accordance with 38 U.S.C. 7302, including medical practice groups and
other entities associated with affiliated institutions, blood banks,
organ banks, or research centers, the VA may make arrangements for
acquisition of the resource without regard to any law or regulation
(including any Executive order, circular, or other administrative
policy) that would otherwise require the use of competitive procedures
for acquiring the resource.
(ii) If the health-care resource required is a commercial service
or the use of medical equipment or space, and is not to be acquired
from an entity described in paragraph (c)(3)(i) of this section, any
procurement of the resource may be conducted without regard to any law
or regulation that would otherwise require the use of competitive
procedures for procuring the resource, but only if the procurement is
conducted in accordance with the simplified procedures prescribed in
part 873. (38 U.S.C. 8153).
801.106 OMB approval under the Paperwork Reduction Act.
See VA Acquisition Manual (VAAM) M801.106 for a list of the
information collection and recordkeeping requirements contained in this
part that have been approved by the Office of Management and Budget.
Subpart 801.3--Agency Acquisition Regulations
801.301 Policy.
(a)(1) VA implementation and supplementation of the FAR is issued
in the Veterans Affairs Acquisition Regulation (VAAR) under
authorization and subject to the authority, direction, and control of
the Secretary of Veterans Affairs. The VAAR contains--
(i) Requirements of law;
(ii) Agency policies;
(iii) Delegations of FAR authorities;
(iv) Deviations from FAR requirements; and
(v) Policies/procedures that have a significant effect beyond the
internal operating procedures of VA or a significant cost or
administrative impact on contractors or offerors.
(2) Relevant internal procedures, guidance, and information (PGI)
that do not meet the criteria in paragraph (a)(1) of this section are
issued in the Veterans Affairs Acquisition Manual (VAAM).
801.304 Agency control and compliance procedures.
The Principal Executive Director of VA's Office of Acquisition,
Logistics and Construction is designated as the Department's Chief
Acquisition Officer. The Executive Director for the Office of
Acquisition and Logistics (OAL) is designated as the Department's
Senior Procurement Executive (SPE). The SPE is responsible for amending
the VAAR for compliance with FAR 1.304.
Subpart 801.4--Deviations From the FAR
801.403 Individual deviations.
The SPE may authorize individual deviations from the FAR and VAAR
in accordance with FAR 1.403 when an individual deviation is in the
best interest of the Government.
801.404 Class deviations.
The SPE may authorize class deviations from the FAR and VAAR when a
class deviation is in the best interest of the Government.
Subpart 801.6--Career Development, Contracting Authority, and
Responsibilities
801.601 General.
(a) The Senior Procurement Executive is granted the authority to
appoint and terminate contracting officers. This authority is further
delegated to the heads of the contracting activities (HCA) and others
as appropriate. The SPE may also delegate authority to execute, award,
and administer contracts, purchase orders, and other agreements to
other VA officials, such as HCAs and contracting officers. All
delegations of authority will be made in writing.
(b) HCAs may authorize the use of ordering officers to order
supplies and services in accordance with the ordering limits identified
in the contract or agreement or the specific ordering guide. Ordering
officers shall be delegated in writing. The written delegation must be
specific to the contract or agreement and articulate the limitations of
the delegated authority. Ordering officers shall only place orders
against the contract or agreement if it is awarded to a single awardee.
Ordering
[[Page 10164]]
officers may not negotiate contract terms and conditions, determine
price reasonableness, or determine best value. If the contracting
officer determines prior to award that ordering officers will be
authorized to place orders against a contract or agreement, the
contracting officer will furnish the contractor with the names of
individuals delegated ordering officer authority by separate letter
upon issuance of the contract.
801.602-3 Ratification of unauthorized commitments.
(a) This section applies to unauthorized commitments, including any
commitment made by a contracting officer that exceeds that contracting
officer's contracting authority and unauthorized commitments made by a
Government representative who lacked the authority to enter into that
agreement on behalf of the Government.
(b) The approving authority and ratification official for any
unauthorized commitments is the HCA. The approval authority may not be
re-delegated.
801.604 Contracting Officer's Representative (COR).
When the contracting officer intends to designate a Contracting
Officer's Representative for a solicitation or contract, the
contracting officer must include the clause in 852. 201-70, Contracting
Officer's Representative, in the solicitation and contract.
PART 802--DEFINITIONS OF WORDS AND TERMS
0
2. The authority citation for part 802 continues to read as follows:
Authority: 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C.
1702; and 48 CFR 1.301-1.304.
Subpart 802.1--Definitions
0
3. Section 802.101 is amended by adding the definition ``Ordering
officer'' in alphabetical order to read as follows:
802.101 Definitions.
* * * * *
Ordering officer means the VA official authorized to order supplies
and services against a FAR-based contract or agreement in accordance
with the ordering limits identified in the contract or agreement or the
specific ordering guide in accordance with 801.601(b).
* * * * *
PART 808--REQUIRED SOURCES OF SUPPLIES AND SERVICES
0
4. The authority citation for part 808 is revised to read as follows:
Authority: 38 U.S.C. 8127-8128; 40 U.S.C. 121(c); 41 U.S.C.
1702; and 48 CFR 1.301 through 1.304.
Subpart 808.4--Federal Supply Schedules
0
5. Add section 808.470 to read as follows:
808.470 Ordering Officers
In accordance with 801.601, when authorized, ordering officers may
place orders for supplies and services against agreements or task or
delivery orders established by a contracting officer against Federal
Supply Schedules within the ordering limits identified in the contract
or agreement or the specific ordering guide when funding is available.
Ordering officers shall only place orders against the order or
agreement if it is awarded to a single awardee. The contracting officer
that awarded the Blanket Purchase Agreements (BPA) or order will
provide the contractor a list of authorized ordering officers. Any
modifications to the agreement or order must be performed by a
contracting officer.
PART 816--TYPES OF CONTRACTS
0
6. The authority citation for part 816 continues to read as follows:
Authority: 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C.
1702; and 48 CFR 1.301 through 1.304.
Subpart 816.5--Indefinite-Delivery Contracts
0
7. Add section 816.570 to read as follows:
816.570 Ordering officers.
In accordance with 801.601, when authorized, ordering officers may
place orders for supplies and services against established Indefinite-
Delivery Contracts within the ordering limits identified in the
contract or the specific ordering guide when funding is available.
Ordering officers shall only place orders against the contract if it is
awarded to a single awardee. When a contracting officer appoints an
ordering officer in writing after award, the contracting officer will
furnish the contractor with an updated list of individual ordering
officers authorized to place orders against the contract. Ordering
officers may not negotiate contract terms and conditions, determine
price reasonableness, or determine best value.
0
8. Part 835 is added to subchapter F to read as follows:
PART 835--RESEARCH AND DEVELOPMENT CONTRACTING
Sec.
835.001-70 Veterans Affairs (VA) definitions.
835.003-70 VA policy.
835.003-71 Research misconduct.
835.003-72 Protection of human subjects.
835.003-73 Animal welfare.
835.003-74 Facilities.
835.003-75 Acknowledgement of support and disclaimer.
835.010 Scientific and technical reports.
Authority: 38 U.S.C. 7303; 40 U.S.C. 121(c); 41 U.S.C. 1702 and
48 CFR 1.301 through 1.304.
835.001-70 Veterans Affairs (VA) definitions.
Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute
to generalized knowledge.
Research impropriety refers to noncompliance with the laws,
regulations, and policies regarding human subject protections,
laboratory animal welfare, research safety, research laboratory
security, research information security, and research misconduct. It
does not encompass improper procedures or conduct in areas outside of
the mandate of the Office of Research Oversight (ORO) (e.g., waste,
fraud, abuse, or fiscal mismanagement).
Research misconduct means fabrication, falsification, or plagiarism
in proposing, performing, or reviewing research, or in reporting
research results.
VA facility means a component of the VA national health care
system, such as a VA Medical Center, VA Health Care System, or VA
Medical and Regional Office Center.
835.003-70 VA policy.
(a) Pursuant to 38 U.S.C. 7303, VA is authorized to carry out a
program of medical research in connection with the provisions of
medical care and treatment to Veterans.
(b) The Office of Research Oversight (ORO) serves as the primary
Veterans Health Administration (VHA) office that advises the Under
Secretary for Health on all compliance matters related to--
(1) Human subject protections;
(2) Laboratory animal welfare;
(3) Research safety;
(4) Research laboratory security;
(5) Research information security;
(6) Research misconduct; and
(7) Other research improprieties.
835.003-71 Research misconduct.
The contracting officer shall insert the clause at 852.235-70,
Research
[[Page 10165]]
Misconduct, in all research and development (R&D) solicitations and
contracts.
835.003-72 Protection of human subjects.
The contracting officer shall insert the clause at 852.235-71,
Protection of Human Subjects, in all research and development (R&D)
solicitations and contracts.
835.003-73 Animal welfare.
The contracting officer shall insert the clause at 852.235-72,
Animal Welfare, in all research and development (R&D) solicitations and
contracts.
835.003-74 Facilities.
If the contracting officer determines that the facilities to be
assigned to perform effort on a research and development (R&D) contract
are critical to the success of the R&D effort, the contracting officer
shall insert the clause at 852.235-73, Facilities, in the solicitation
and contract.
835.003-75 Acknowledgement of support and disclaimer.
The contracting officer shall insert the clause at 852.235-74,
Acknowledgement of Support and Disclaimer, in all research and
development (R&D) solicitations and contracts.
835.010 Scientific and technical reports.
The contracting officer shall insert the clause at 852.235-75,
Scientific and Technical Reports, in all research and development (R&D)
solicitations and contracts.
PART 852--SOLICITATION PROVISIONS AND CONTRACT CLAUSES
0
9. The authority citation for part 852 continues to read as follows:
Authority: 38 U.S.C. 8127-8128, and 8151-8153; 40 U.S.C.
121(c); 41 U.S.C. 1121(c)(3), 41 U.S.C. 1303; 41 U.S.C. 1702; and 48
CFR 1.301 through 1.304.
0
10. Section 852.235-70 is added to read as follows:
852.235-70 Research Misconduct.
As prescribed at 835.003-71, insert the following clause:
Research Misconduct (Date)
(a) The Contractor is responsible for maintaining the integrity
of research performed pursuant to this contract award including the
prevention, detection and remediation of research misconduct as
defined in 835.001-70.
(b) The Contractor shall notify the Contracting Officer within 7
business days of any research misconduct allegations received by the
facility concerning this contract award.
(c) The Contractor shall conduct an initial inquiry into any
allegation of research misconduct. If the Contractor determines that
there is sufficient evidence to proceed to an investigation, the
Contractor shall notify the Contracting Officer and, unless
otherwise instructed shall--
(1) Conduct an investigation to develop a complete factual
record and an examination of such record leading to either a finding
of research misconduct and an identification of appropriate
remedies, or a recommendation that no further action is warranted;
(2) When the investigation results in a research misconduct
finding, ensure the matter is adjudicated by a responsible official
who was not involved in the inquiry or investigation and is
organizationally separated from the element which conducted the
investigation. The adjudication shall include a review of the
investigation record and a recommendation of appropriate corrective
actions and sanctions; and
(3) When an investigation is complete, the Contractor shall
forward to the Contracting Officer a copy of the evidentiary record,
the investigative report, any recommendations made to the
Contractor's adjudicating official, the adjudicating official's
recommendation and notification of any proposed corrective action,
and the subject's written response, if any. The Contracting Officer
will review the documentation to determine whether the proposed
corrective action can proceed.
(d) The VA may elect to act in lieu of the Contractor in
conducting an inquiry or investigation into an allegation of
research misconduct if the Contracting Officer finds that--
(1) The research organization is not prepared to handle the
allegation in a manner consistent with this clause and it is
believed it cannot reasonably conduct the inquiry;
(2) VA involvement is necessary to ensure the public health,
safety, and security, or to prevent harm to the public interest; or
(3) The allegation involves possible criminal misconduct.
(e) The Contractor shall provide safeguards for information
received and protect informants, witnesses and respondents of
allegations as follows:
(1) The Contractor shall provide safeguards to ensure that
individuals may bring allegations of research misconduct made in
good faith to the attention of the Contractor without suffering
retribution. Safeguards include: protection against retaliation;
fair and objective procedures for examining and resolving
allegations; and diligence in protecting positions and reputations.
(2) The Contractor shall also assure the respondent that their
rights are protected and that the mere filing of an allegation of
research misconduct will not result in an adverse action. Safeguards
include timely written notice regarding substantive allegations
against them, a description of the allegations and reasonable access
to any evidence submitted to support each allegation. Respondents
must be given the opportunity to prepare a response to an allegation
and notice of any findings of research misconduct.
(f) Objectivity and expertise. The Contractor shall select
individual(s) to inquire, investigate, and adjudicate allegations of
research misconduct who have appropriate expertise and have no
unresolved conflict of interest. The individual(s) who conducts the
adjudication must not be the same individual(s) who conducted the
inquiry or investigation and must be separate organizationally from
the element that conducted the inquiry or investigation.
(End of clause)
0
11. Section 852.235-71 is added to read as follows:
852.235-71 Protection of Human Subjects.
As prescribed at 835.003-72, insert the following clause:
Protection of Human Subjects (Date)
(a) Research involving human subjects is not permitted under
this award unless expressly authorized in writing by the Contracting
Officer. Such authorization will specify the details of the approved
research involving human subjects and will be incorporated by
reference into this contract.
(b) The Federal Policy for the Protection of Human Subjects (the
``Common Rule''), adopted by VA (see 38 CFR part 16), requires
Contractors to maintain appropriate policies and procedures for the
protection of human subjects in research. The Common Rule defines a
``human subject'' as a living individual about whom an investigator
conducting research obtains data through intervention or interaction
with the individual, or identifiable private information. The term
``research'' means a systematic investigation, including research
development and/or testing and evaluation, designed to develop or
contribute to generalized knowledge. The Common Rule also sets forth
categories of research that may be considered exempt from 15 CFR
part 27. These categories may be found at 15 CFR 27.101.
(c) Should research involving human subjects be included in the
proposal, prior to issuance of an award, the Contractor shall submit
the following documentation to the Contracting Officer:
(1) Documentation to verify that the Contractor has established
a relationship with an appropriate Institutional Review Board
(``cognizant IRB''). An appropriate IRB is one that is located
within the United States and within the community in which the
research will be conducted;
(2) Documentation to verify that the cognizant IRB possesses a
valid registration with the United States Department of Health and
Human Services' Office for Human Research Protections (``OHRP'');
(3) Documentation to verify that the Contractor has a valid
Federal-wide Assurance (FWA) issued by OHRP.
(d) Prior to starting any research involving human subjects, the
Contractor shall submit appropriate documentation to the Contracting
Officer for institutional review and approval. This documentation
may include:
(1) Copies of the research protocol, all questionnaires,
surveys, advertisements, and informed consent forms approved by the
cognizant IRB;
[[Page 10166]]
(2) Documentation of approval for the research protocol,
questionnaires, surveys, advertisements, and informed consent forms
by the cognizant IRB;
(3) Documentation of continuing IRB approval by the cognizant
IRB at appropriate intervals as designated by the IRB, but not less
than annually; and/or
(4) Documentation to support an exemption for the project from
the Common Rule (Note: this option is not available for activities
that fall under 45 CFR part 46, subpart C).
(e) Additionally, if the Contractor modifies a research
protocol, questionnaire, survey, advertisement, or informed consent
form approved by the cognizant IRB, the Contractor shall submit a
copy of all modified material along with documentation of approval
for said modification by the cognizant IRB to the Contracting
Officer for institutional review and approval. The Contractor shall
not implement any IRB approved modification without written approval
by the Contracting Officer.
(f) No work involving human subjects may be undertaken,
conducted, or costs incurred and/or charged to the project, until
the Contracting Officer approves the required appropriate
documentation in writing.
(g) The Contractor shall bear full responsibility for the
performance of all work and services involving the use of human
subjects under this contract 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 be deemed to constitute the
Contractor or any subcontractor, agent or employee of the
Contractor, or any other person, organization, institution, or group
of any kind whatsoever, as the agency or employee of the Government.
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 judgement or
otherwise, as an independent Contractor without imputing liability
on the part of the Government for the acts of the Contractor or its
employees.
(h) If at any time during performance of this contract, the
Contracting Officer determines, in consultation with the Office for
Protection from Research Risks (OPRR), National Institutes of Health
(NIH), that the Contractor is not in compliance with any of the
requirements, the Contracting Officer may immediately suspend the
research and further payments under this contract until the
Contractor corrects such noncompliance. Notice of the suspension may
be communicated by telephone and confirmed in writing. If the
Contractor fails to complete the corrective action within the period
of time designated in the Contracting Officer's written notice of
suspension, the Contracting Officer may, in consultation with OPRR,
NIH, terminate this contract and the Contractor's name may be
removed from the list of those Contractors with approved Department
of Health and Human Services Human Subject Assurances.
(End of clause)
0
12. Section 852.235-72 is added to read as follows:
852.235-72 Animal Welfare.
As prescribed in 835.003-73, insert the following clause:
Animal Welfare (Date)
(a) The Contractor shall--
(1) Use the Veterans Affairs (VA), Office of Research Oversight
(ORO) Laboratory Animal Welfare Checklist;
(2) Comply with the United States Department of Agriculture
(USDA) Animal Welfare Act and Animal Welfare Regulations at https://www.aphis.usda.gov/animal_welfare, and the Animal Welfare
Information Center's (AWIC) information for improved animal care and
use in research, testing, and teaching provided at https://www.nal.usda.gov/awic;
(3) Develop and provide to the Contracting Officer a written
plan of providing adequate veterinary care to laboratory animals,
including--
(i) The frequency of visits; and
(ii) Provisions for after-hours, weekend and holiday veterinary
coverage.
(b) The Contracting Officer may immediately suspend the work by
issuance of a stop work order and suspend further payments under
this contract for failure to comply with the requirements of this
clause.
(c) The suspension will stay in effect until the Contractor
complies with the requirements. Failure to complete corrective
action within the time specified by the Contracting Officer may
result in termination of this contract.
(d) The Contractor shall include the substance of this clause,
in all subcontracts involving research and development, testing,
evaluation or training that use live vertebrate animals.
(End of clause)
0
13. Section 852.235-73 is added to read as follows:
852.235-73 Facilities.
As prescribed at 835.003-74, insert the following clause:
Facilities (Date)
(a) The facilities specified in the contract are considered
essential to the work being performed under this contract.
Therefore, prior to removing, replacing, or diverting any of the
listed or specified facilities, the Contractor shall--
(1) Notify the Contracting Officer in writing; and
(2) Submit justification (including proposed substitutions) in
sufficient detail to permit evaluation of the potential impact on
this contract.
(b) The Contractor shall make no removal, replacement or
diversion of facilities without the Contracting Officer's written
consent.
(End of clause)
0
14. Section 852.235-74 is added to read as follows:
852.235-74 Acknowledgement of Support and Disclaimer.
As prescribed at 835.003-75, insert the following clause:
Acknowledgement of Support and Disclaimer (Date)
(a) The Contractor shall include an acknowledgment of the
Government's support in the publication of any material based on or
developed under this contract, stated in the following terms: This
material is based upon work supported by the (name of contracting
agency) under this VA contract.
(b) All material, except scientific articles or papers published
in scientific journals, must, in addition to any notices or
disclaimers by the Contractor, also contain the following
disclaimer:
Any opinions, findings, conclusions or recommendations expressed
in this material are those of the author(s) and do not necessarily
reflect the views of the VA.
(End of clause)
0
15. Section 852.235-75 is added to read as follows:
852.235-75 Scientific and Technical Reports.
As prescribed at 835.010, insert the following clause:
Scientific and Technical Reports (Date)
The Contractor shall submit an electronic copy of the approved
scientific technical reports, not a summary, delivered under this
contract to the National Technical Information Service (NTIS) as
delineated at FAR 35.010.
(End of clause)
852.270-1 [Redesignated as Section 852.201-70]
0
16. Section 852.270-1 is redesignated as section 852.201-70 and revised
to read as follows:
852.201-70 Contracting Officer's Representative.
As prescribed in 801.604, insert the following provision:
Contracting Officer's Representative (Date)
The Contracting Officer reserves the right to designate
representatives to act for him/her in furnishing technical guidance
and advice or generally monitor the work to be performed under this
contract. Such designation will be in writing and will define the
scope and limitation of the designee's authority. A copy of the
designation letter shall be furnished to the Contractor.
(End of provision)
[FR Doc. 2022-02796 Filed 2-22-22; 8:45 am]
BILLING CODE 8320-01-P