Federal Acquisition Supply Chain Security Act, 54263-54271 [2020-18939]
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Federal Register / Vol. 85, No. 170 / Tuesday, September 1, 2020 / Rules and Regulations
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 26, 2020.
Jean Overstreet,
Acting Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Revise § 180.1337 to read as
follows:
■
§ 180.1337 Citrus tristeza virus expressing
spinach defensin proteins 2, 7, and 8;
exemption from the requirement of a
tolerance.
A temporary exemption from the
requirement of a tolerance is established
for residues of the microbial pesticide
Citrus tristeza virus expressing spinach
defensin proteins 2, 7, and 8 (either
alone or in combinations with each
other) in or on the commodities listed
in fruit, citrus group 10–10, when used
in accordance with the terms of
Experimental Use Permit No. 88232–
EUP–2. This temporary exemption from
the requirement of a tolerance expires
on August 31, 2023.
[FR Doc. 2020–19351 Filed 8–28–20; 4:15 pm]
BILLING CODE 6560–50–P
OFFICE OF MANAGEMENT AND
BUDGET
41 CFR Part 201
Federal Acquisition Supply Chain
Security Act
Office of Management and
Budget, OMB.
ACTION: Interim final rule with request
for comments.
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AGENCY:
SUMMARY: As authorized by the Federal
Acquisition Supply Chain Security Act
of 2018 (FASCSA), the Federal
Acquisition Security Council (FASC) is
issuing this interim final rule to
implement the requirements of the laws
that govern the operation of the FASC,
the sharing of supply chain risk
information, and the exercise of its
authorities to recommend issuance of
removal and exclusion orders to address
supply chain security risks.
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Effective September 1, 2020.
Written comments must be received on
or before November 2, 2020.
ADDRESSES: Interested parties should
provide comments via electronic mail to
the following inbox: OFCIO@
omb.eop.gov. The Office of Management
and Budget is located at 725 17th Street
NW, Washington, DC 20503. No
physical copies will be accepted.
Instructions: Comments sent by any
other method, to any other address or
individual, or received after the end of
the comment period, may not be
considered. Comments submitted in
response to this notice may be made
publically available and are subject to
disclosure under the Freedom of
Information Act. For this reason, please
do not include in your comments
information of a confidential nature,
such as sensitive personal information
or proprietary information, or any
information that you would not want
publicly disclosed. Summary
information of the public comments
received, including any specific
comments, may be posted on
regulations.gov.
FOR FURTHER INFORMATION CONTACT: Lisa
N. Barr, 202–395–3015, Lisa.N.Barr@
omb.eop.gov.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
Information and communications
technology and services (ICTS) are
essential to the proper functioning of
U.S. government information systems.
The U. S. government’s efforts to
evaluate threats to and vulnerabilities in
ICTS supply chains have historically
been undertaken by individual or small
groups of agencies to address specific
supply chain security risks. Because of
the scale of supply chain risks faced by
government agencies, and the need for
better coordination among a broader
group of agencies, there was an
organized effort within the executive
branch to support Congressional efforts
in 2018 to pass new legislation to
improve executive branch coordination,
supply chain information sharing, and
actions to address supply chain risks.
The Federal Acquisition Supply
Chain Security Act of 2018 (FASCSA or
Act) (Title II of Pub. L. 115–390), signed
into law on December 21, 2018,
established the Federal Acquisition
Security Council (FASC). The FASC is
an executive branch interagency
council, chaired by a senior-level
official from the Office of Management
and Budget (OMB), and includes
representatives from the General
Services Administration (GSA);
Department of Homeland Security
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(DHS); Office of the Director of National
Intelligence (ODNI); Department of
Justice; Department of Defense (DoD);
and Department of Commerce
(Commerce).
Pursuant to subsection 202(d) of the
FASCSA, the FASC is required to
prescribe this IFR to implement
subchapter III of chapter 13 of title 41,
U.S. Code. This IFR is organized in
three subparts. Subpart A explains the
scope of this IFR, provides definitions
for relevant terms, and establishes the
membership of the FASC. Subpart B
establishes the role of the FASC’s
Information Sharing Agency (ISA). DHS,
acting primarily through the
Cybersecurity and Infrastructure
Security Agency, will serve as the ISA.
The ISA will standardize processes and
procedures for submission and
dissemination of supply chain
information, and will facilitate the
operations of a Supply Chain Risk
Management (SCRM) Task Force under
the FASC. This FASC Task Force
(hereafter referred to as ‘‘Task Force’’)
will be comprised of designated
technical experts that will assist the
FASC in implementing its information
sharing, risk analysis, and risk
assessment functions. Subpart B also
prescribes mandatory and voluntary
information sharing criteria and
associated information protection
requirements. Subpart C provides the
criteria and procedures by which the
FASC will evaluate supply chain risk
from sources and covered articles and
recommend issuance of orders requiring
removal of covered articles from
executive agency information systems
(removal orders) and orders excluding
sources or covered articles from future
procurements (exclusion orders).
Subpart C also provides the process for
issuance of removal orders and
exclusion orders and agency requests for
waivers from such orders.
II. Analysis of Part 201
Subpart A—General
Subpart A establishes regulations
generally applicable to the operations of
the FASC. Subpart A, § 201.101(a)
summarizes the scope of subparts A, B,
and C, which generally govern the
activities of federal agencies, and not
non-federal entities. § 201.101(b)
clarifies that nothing in these
regulations require non-federal entities
to share supply chain risk information
with the federal government. In
addition, because subpart C provides for
the issuance of exclusion orders and
removal orders, which affect the supply
and use of products and services
supplied by non-federal entities,
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§ 201.101(b)(2) explains that subpart C
does not require the removal or a
covered article from a non-federal
information system or the exclusion of
a covered article from procurement by a
non-federal entity except to the extent
that an exclusion order or a removal
order applies to a prime contractor or
subcontractor of a federal agency. This
applicability to non-federal entities is
addressed in § 201.303(e).
Subpart A, § 201.102 provides
definitions applicable to the part.
Subpart A, § 201.103 describes the
membership of the FASC, the authority
of the FASC to request information from
executive agencies, and the authority of
the FASC to establish a program office,
committees, working groups, or other
constituent bodies. These bodies are
authorized to perform any function
lawfully delegated to them by the FASC.
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Subpart B—Supply Chain Risk
Information Sharing
Subpart B identifies DHS as the
executive agency for information
sharing (or the ISA) and provides for the
creation and establishment of a supply
chain risk management and information
sharing Task Force under the FASC. The
ISA will facilitate and provide the
administrative support to the FASC
Task Force and serve as the liaison to
the FASC. The Task Force will develop
processes and procedures to be
approved by the FASC that describe: (1)
How the ISA and Task Force will
operate and support the FASC; (2) how
federal and non-federal entities submit
supply chain risk information to the
FASC, including any necessary
requirements for information handling,
protection and classification; (3) how to
share information to support supply
chain risk analyses under § 1326 of the
Act, recommendations issued by the
FASC, and covered procurement actions
under § 4713 of the Act; (4) how to
provide information to the FASC and to
executive agencies regarding removal
orders and covered procurement
actions; and (5) any other processes and
procedures describing the operations of
the FASC as determined by the FASC
Chairperson. Subpart B, § 201.202
describes additional details of the
mechanics of submitting information to
the FASC (including mandatory and
voluntary submissions) and
dissemination of information by the
FASC.
Subpart C—Removal Orders and
Exclusion Orders
Subpart C describes the process by
which the FASC will evaluate one or
more sources and/or one or more
covered articles to determine whether to
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recommend that the Secretary of
Homeland Security, Secretary of
Defense, and/or Director of National
Intelligence issue a removal order and/
or an exclusion order. Initiation of the
process can begin either by referral of
the FASC or any member of the FASC;
upon the written request of any U.S.
Government body; or based on
information submitted to the FASC by
any individual or non-federal entity that
the FASC determines to be credible.
The FASC will evaluate sources and
covered articles pursuant to a common
set of non-exclusive factors that are
listed in this IFR. Allowing for the
evaluation of additional information
provides the FASC with the needed
flexibility to evaluate additional
considerations and information on a
case-by-case basis.
As part of the analysis of sources and/
or covered articles, the FASC will
conduct appropriate due diligence
regarding the information that it is
considering. This due diligence may
include reviewing any information
made available to the FASC; ensuring,
to the extent possible, that the
information is credible or that the level
of confidence in the information is
appropriately taken into consideration;
and examining other relevant publiclyavailable information as necessary and
appropriate. In addition, the FASC will
consult with the National Institute of
Standards and Technology (NIST),
before recommending issuance of an
exclusion or removal order, to ensure
that recommended orders do not
conflict with existing federal standards
and guidelines.
If the FASC does not find that
recommending a removal or exclusion
order is warranted, risk information
received and analyzed by the FASC may
be shared, as appropriate, pursuant to
the procedures in Subpart B.
If the FASC decides to issue a
recommendation, that recommendation
will include the information necessary
for the Secretary of Homeland Security,
the Secretary of Defense, or the Director
of National Intelligence, as appropriate,
to determine whether to issue an
exclusion order and/or a removal order.
The recommendation must include the
risk information and summaries
specified in Subpart B, § 201.202(e). The
recommendation will be directed to the
Secretary of Homeland Security,
Secretary of Defense, and/or Director of
National Intelligence based on the scope
of federal systems, identified in 41
U.S.C. 1323(c)(5), for which the FASC is
recommending removal or exclusion
from future procurements. The FASC or
its designee will provide notice of the
recommendation, along with the
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contents specified in Subpart C,
§ 201.302(b), to any source named in the
recommendation. This due process
procedure is intended to provide the
named source(s) with the information
needed for the source(s) to respond to
the recommendation. If named source(s)
wishes to respond to the notice, the
source(s) should prepare a thorough and
complete written response, submitting
the response as directed in the notice.
The FASC encourages source(s) to
provide any information that it believes
relevant in responding to the
recommendation, including additional
technical information about the covered
article(s), details about the relationship
between the source(s) and any foreign
government, and a detailed mitigation
proposal that the source(s) believes
would satisfy the concerns identified in
the notice. The source(s) should submit
such information and materials in
writing before any request for a meeting
to enable the FASC and the Secretary of
Homeland Security, Secretary of
Defense, and Director of National
Intelligence, as applicable, to fully
consider the source’s written
submission. The FASC may choose to
rescind the recommendation based on
the information provided by the
source(s). The FASC does not intend to
publicly disclose communications with
the source(s) except to the extent
required by law. The FASC welcomes
comment on the adequacy or specific
improvements to these procedures.
The Secretary of Homeland Security,
the Secretary of Defense, or the Director
of National Intelligence, as applicable,
will review the recommendation and
accompanying risk information and
materials provided by the FASC, and
any information and response submitted
by a source, and determine whether to
issue a removal order, an exclusion
order, or both, for the agencies and
systems within the scope of the
authority of 41 U.S.C. 1323(c)(5)(A)(i)–
(iii). If one of these officials or an
authorized designee issues an exclusion
order or removal order, the named
source(s) will be notified, among other
required and discretionary notifications.
Once a removal or exclusion order is
issued, all agencies to which the order
applies would be required to comply
with the order pursuant to 41 U.S.C.
1323(c)(7) and 44 U.S.C.
3554(a)(1)(B)(vi). If orders applying to
the same source(s) or covered articles
were issued by the Secretaries of
Homeland Security and Defense and the
Director of National Intelligence (i.e.,
effectively an executive branch-wide
removal and/or exclusion order), the
Administrator of General Services and
officials at other executive agencies
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responsible for management of the
Federal Supply Schedules, governmentwide acquisition contracts, and multiagency contracts would facilitate
implementation of such orders by
removing the covered articles or sources
identified in the orders from such
contracts.
The regulation provides procedures
for agencies to submit requests to the
issuing official for an exception to an
issued order. An agency may request an
exception to an issued order for various
reasons, such as need for additional
time to comply with the order, or for a
complete waiver based on issues of
national security. The FASC will
establish procedures for requesting
waivers and criteria for approving or
disapproving such requests, as
appropriate.
All issued exclusion and removal
orders must be reviewed at least
annually pursuant to procedures which
will be established by the FASC.
Furthermore, an authorized official of
the issuing agency may modify or
rescind an issued exclusion or removal
order, so long as a modified order does
not apply more broadly than the order
before modification.
III. Request for Comment
The FASC invites comments on all
aspects of this IFR. Any non-public (oral
and written) communications with
FASC officials regarding the substance
of this rule would be considered an exparte presentation, and a summary of
the substance of the ex-parte
presentation will be placed on the
public record and become part of this
docket. Not later than two (2) business
days after an oral communication or
meeting, the party which engaged in
such communication or meeting must
submit a memorandum to OMB
summarizing the substance of the
communication. OMB reserves the right
to supplement the memorandum with
additional information as necessary, or
to request that the party making the
filing do so, if a FASC official believes
that important information was omitted
or characterized incorrectly. Any
written presentation provided in
support of the oral communication or
meeting will also be placed on the
public record and become part of this
docket. Such ex-parte communications
must be submitted to this docket as
provided in the ADDRESSES section
above and clearly labeled as an ex-parte
presentation. Federal entities are not
subject to these procedures.
IV. Classification
Executive Orders 12866 and 13563:
Executive Orders (E.O.s) 12866 and
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13563 direct agencies to assess all costs
and benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). E.O. 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. This rule has been
designated a significant regulatory
action under E.O. 12866. Accordingly,
the Office of Information and Regulatory
Affairs has reviewed this rule.
Executive Order 13771: This rule is
not subject to the requirements of E.O.
13771, because the rule is issued with
respect to a national security function of
the United States. As highlighted by
sections I and II of this preamble,
national security is a primary direct
benefit of this rule. Application of the
national security exemption under E.O.
13771 requires assessing the application
of the ‘‘good cause’’ exception under 5
U.S.C. 533. This rule meets the ‘‘good
cause’’ exception, as FASCSA requires
publication of an interim final rule to
effectuate the authorities of the FASC in
a timely manner, and the one-year
deadline Congress established for
publication of such rule would not
provide sufficient time for notice and
comment in light of the complex nature
of the rule and interagency process.
Regulatory Flexibility Act: Because
the FASC is not required to publish a
notice of proposed rulemaking for this
interim final rule under 5 U.S.C. 553, no
Regulatory Flexibility Analysis is
required. See 5 U.S.C. 603(a), 604(a).
Paperwork Reduction Act: The
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.) (PRA) provides that
an agency generally cannot conduct or
sponsor a collection of information, and
no person is required to respond to nor
be subject to a penalty for failure to
comply with a collection of information,
unless that collection has obtained OMB
approval and displays a currently valid
OMB Control Number. This rule does
not contain a collection of information
and is therefore not subject to the PRA.
Congressional Review Act: The FASC
has determined that this rule will take
effect upon publication pursuant to 5
U.S.C. 808(2). The FASC finds that
notice and public procedure before this
rule takes effect is unnecessary and
contrary to the public interest under 5
U.S.C. 808(2) in light of Congress’s
direction to issue an interim final rule
to address the critical supply chain
security issues covered by this rule and
to respond to public comments when
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issuing a final rule. See 41 U.S.C. 1321
note.
Unfunded Mandates Reform Act of
1995: This rule does not contain any
unfunded mandate or significantly or
uniquely affect small governments, as
described in the Unfunded Mandates
Reform Act of 1995.
Executive Order 13132 (Federalism):
This rule does not have Federalism
implications as specified in Executive
Order 13132.
Executive Order 12630 (Governmental
Actions and Interference with
Constitutionally Protected Property
Rights): This rule does not implement
policies that have takings implications
as identified in Executive Order 12630.
Executive Order 13175 (Consultation
and Coordination with Indian Tribes):
The rule does not have tribal
implications and will not impose
substantial direct costs on tribal
governments or preempt tribal law as
specified by Executive Order 13175.
National Environmental Policy Act:
This IFR does not require a detailed
environmental analysis as the
establishment and operation of FASC
will not ‘‘individually or cumulatively
have a significant effect on the human
environment’’ (40 CFR 1508.4).
List of Subjects in 41 CFR Part 201
Cybersecurity, Federal acquisition,
Government procurement, Information
sharing, Information technology,
National security, Removal and
exclusion orders, Security measures,
Supply chain, Supply chain risk
information, Technology.
Grant Schneider,
Federal Chief Information Security Officer.
For the reasons set out in the
preamble, 41 CFR part 201 is added to
read as follows:
■
PART 201—FEDERAL ACQUISITION
SUPPLY CHAIN SECURITY
Subpart A—General
Sec.
201.101 Scope.
201.102 Definitions.
201.103 Federal Acquisition Security
Council (FASC).
Subpart B—Supply Chain Risk Information
Sharing
201.201 Information Sharing Agency (ISA).
201.202 Submitting information to the
FASC.
Subpart C—Removal orders and exclusion
orders
201.301 Recommending removal orders and
exclusion orders.
201.302 Notice of recommendation to
source and opportunity to respond.
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201.303 Issuing removal orders and
exclusion orders and other related
activities.
201.304 Executive agency compliance with
exclusion and removal orders.
Authority: 41 U.S.C. 1321–1328, 4713.
Subpart A—General
§ 201.101
Scope.
(a) Except as provided in paragraph
(b) of this section, this part applies to
the following:
(1) The membership and operations of
the FASC, including all U.S. and
contractor personnel supporting the
FASC’s operations;
(2) Submission and dissemination of
supply chain risk information; and
(3) Recommendations for, issuance of,
and associated procedures related to
removal orders and exclusion orders.
(b) This part does not require the
following:
(1) Mandatory submission of supply
chain risk information by non-federal
entities.
(2) The removal or exclusion of any
covered article by non-federal entities,
except to the extent that an exclusion or
removal order issued pursuant to
subpart C of this Part applies to prime
contractors and subcontractors to
federal agencies.
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§ 201.102
Definitions.
For purposes of this part:
(a) Appropriate congressional
committees and leadership means:
(1) The Committee on Homeland
Security and Governmental Affairs, the
Committee on the Judiciary, the
Committee on Appropriations, the
Committee on Armed Services, the
Committee on Commerce, Science, and
Transportation, the Select Committee on
Intelligence, and the majority and
minority leader of the Senate; and
(2) The Committee on Oversight and
Government Reform, the Committee on
the Judiciary, the Committee on
Appropriations, the Committee on
Homeland Security, the Committee on
Armed Services, the Committee on
Energy and Commerce, the Permanent
Select Committee on Intelligence, and
the Speaker and minority leader of the
House of Representatives.
(b) Council or FASC means the
Federal Acquisition Security Council.
(c) Covered article means any of the
following:
(1) Information technology, as defined
in 40 U.S.C. 11101, including cloud
computing services of all types;
(2) Telecommunications equipment or
telecommunications service, as those
terms are defined in section 3 of the
Communications Act of 1934 (47 U.S.C.
153);
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(3) The processing of information on
a Federal or non-Federal information
system, subject to the requirements of
the Controlled Unclassified Information
program or subsequent U.S. government
program for controlling sensitive
unclassified information; or
(4) Hardware, systems, devices,
software, or services that include
embedded or incidental information
technology.
(d) Covered procurement means:
(1) A source selection for a covered
article involving either a performance
specification, as provided in subsection
(a)(3)(B) of title 41 U.S.C. 3306, or an
evaluation factor, as provided in
subsection (b)(1)(A) of title 41 U.S.C.
3306, relating to a supply chain risk, or
where supply chain risk considerations
are included in the agency’s
determination of whether a source is a
responsible source;
(2) The consideration of proposals for
and issuance of a task or delivery order
for a covered article, as provided in title
41 U.S.C. 4106(d)(3), where the task or
delivery order contract includes a
contract clause establishing a
requirement relating to a supply chain
risk;
(3) Any contract action involving a
contract for a covered article where the
contract includes a clause establishing
requirements relating to a supply chain
risk; or
(4) Any other procurement in a
category of procurements determined
appropriate by the Federal Acquisition
Regulatory Council, with the advice of
the Federal Acquisition Security
Council.
(e) Covered procurement action
means any of the following actions, if
the action takes place in the course of
conducting a covered procurement:
(1) The exclusion of a source that fails
to meet qualification requirements
established under 41 U.S.C. 3311, for
the purpose of reducing supply chain
risk in the acquisition or use of covered
articles;
(2) The exclusion of a source that fails
to achieve an acceptable rating with
regard to an evaluation factor providing
for the consideration of supply chain
risk in the evaluation of proposals for
the award of a contract or the issuance
of a task or delivery order;
(3) The determination that a source is
not a responsible source, based on
considerations of supply chain risk; and
(4) The decision to withhold consent
for a contractor to subcontract with a
particular source or to direct a
contractor to exclude a particular source
from consideration for a subcontract
under the contract.
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(f) Exclusion order means any of the
following orders requiring the exclusion
of sources or covered articles from
executive agency procurement actions:
(1) An order issued by Secretary of
Homeland Security applicable to federal
executive branch civilian agencies;
(2) An order issued by the Secretary
of Defense applicable to Department of
Defense and national security systems
other than sensitive compartmented
information systems; or
(3) An order issued by the Director of
National Intelligence applicable to the
Intelligence Community and sensitive
compartmented information systems.
(g) Executive agency means:
(1) An executive department specified
in 5 U.S.C. 101;
(2) A military department specified in
5 U.S.C. 102;
(3) An independent establishment as
defined in 5 U.S.C. 104(1); and
(4) A wholly owned Government
corporation fully subject to chapter 91
of title 3 U.S.C.
(h) Information and communications
technology means:
(1) Information technology as defined
in 40 U.S.C. 11101;
(2) Information systems, as defined in
44 U.S.C. 3502; and
(3) Telecommunications equipment
and telecommunications services, as
those terms are defined in section 3 of
the Communications Act of 1934 (47
U.S.C. 153).
(i) Information technology has the
definition provided in 40 U.S.C. 11101.
(j) Intelligence Community includes
the following:
(1) The Office of the Director of
National Intelligence;
(2) The Central Intelligence Agency;
(3) The National Security Agency;
(4) The Defense Intelligence Agency;
(5) The National GeospatialIntelligence Agency;
(6) The National Reconnaissance
Office;
(7) Other offices within the
Department of Defense for the collection
of specialized national intelligence
through reconnaissance programs;
(8) The intelligence elements of the
Army, the Navy, the Air Force, the
Marine Corps, the Coast Guard, the
Federal Bureau of Investigation, the
Drug Enforcement Administration, and
the Department of Energy;
(9) The Bureau of Intelligence and
Research of the Department of State;
(10) The Office of Intelligence and
Analysis of the Department of the
Treasury;
(11) The Office of Intelligence and
Analysis of the Department of
Homeland Security;
(12) Such other elements of any
department or agency as may be
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designated by the President, or
designated jointly by the Director of
National Intelligence and the head of
the department or agency concerned, as
an element of the intelligence
community.
(k) National security system has the
definition given to it in 44 U.S.C. 3552
and means any information system
(including any telecommunications
system) used or operated by an agency
or by a contractor of an agency, or other
organization on behalf of an agency—
(1) The function, operation, or use of
which involves intelligence activities;
involves cryptologic activities related to
national security; involves command
and control of military forces; involves
equipment that is an integral part of a
weapon or weapons system; or subject
to paragraph (j)(1)(3) of this section, is
critical to the direct fulfillment of
military or intelligence missions, but
does not include a system that is to be
used for routine administrative and
business applications (including
payroll, finance, logistics, and personnel
management applications); or
(2) Is protected at all times by
procedures established for information
that have been specifically authorized
under criteria established by an
Executive order or an Act of Congress to
be kept classified in the interest of
national defense or foreign policy.
(3) Does not include a system that is
to be used for routine administrative
and business applications (including
payroll, finance, logistics, and personnel
management applications).
(l) Removal order means any of the
following orders, issued pursuant to 41
U.S.C. 1323(c)(5), requiring the removal
of covered articles from executive
agency information systems:
(m) An order issued by Secretary of
Homeland Security applicable to federal
executive branch civilian agencies;
(2) An order issued by the Secretary
of Defense applicable to Department of
Defense and national security systems
other than sensitive compartmented
information systems; or
(3) An order issued by the Director of
National Intelligence applicable to the
intelligence community and sensitive
compartmented information systems.
(n) Responsible source means a
responsible prospective contractor and
subcontractors, at any tier, as defined in
part 9 of the Federal Acquisition
Regulation.
(o) Source means a non-federal
supplier, or potential supplier, of
products or services, at any tier.
(p) Supply chain risk means the risk
that any person may sabotage,
maliciously introduce unwanted
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manipulate the design, integrity,
manufacturing, production, distribution,
installation, operation, maintenance,
disposition, or retirement of covered
articles so as to surveil, deny, disrupt,
or otherwise manipulate the function,
use, or operation of the covered articles
or information stored or transmitted by
or through covered articles.
(q) Supply chain risk information
includes, but is not limited to,
information that describes or identifies:
(1) Functionality of covered articles,
including access to data and
information system privileges;
(2) Information on the user
environment where a covered article is
used or installed;
(3) The ability of the source to
produce and deliver covered articles as
expected (i.e., supply chain assurance);
(4) Foreign control of, or influence
over, the source (e.g., foreign ownership,
personal and professional ties between
the source and any foreign entity, legal
regime of any foreign country in which
the source is headquartered or conducts
operations);
(5) Implications to national security,
homeland security, and/or national
critical functions associated with use of
the covered source;
(6) Vulnerability of federal systems,
programs, or facilities;
(7) Market alternatives to the covered
source;
(8) Potential impact or harm caused
by the possible loss, damage, or
compromise of a product, material, or
service to an organization’s operations
or mission;
(9) Likelihood of a potential impact or
harm, or the exploitability of a system;
(10) Security, authenticity, and
integrity of covered articles and their
supply and compilation chain;
(11) Capacity to mitigate risks
identified;
(12) Credibility of and confidence in
other supply chain risk information;
(13) Any other information that would
factor into an analysis of the security,
integrity, resilience, quality,
trustworthiness, or authenticity of
covered articles or sources;
(14) A summary of the above
information, including: Summary of the
threat level on 1 (low) to 5 (high) scale;
and summary of the vulnerability level
on 1 (low) to 5 (high) scale; and, any
other information determined to be
relevant to the determination of supply
chain risk.
§ 201.103 Federal Acquisition Security
Council (FASC).
(a) The following agencies and agency
components shall be represented on the
FASC:
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(1) Office of Management and Budget;
(2) General Services Administration;
(3) Department of Homeland Security;
(4) Cybersecurity and Infrastructure
Security Agency;
(5) Office of the Director of National
Intelligence;
(6) National Counterintelligence and
Security Center;
(7) Department of Justice;
(8) Federal Bureau of Investigation;
(9) Department of Defense;
(10) National Security Agency;
(11) Department of Commerce;
(12) National Institute of Standards
and Technology; and
(13) Any other executive agency, or
agency component, as determined by
the Chairperson of the FASC.
(b) The FASC may request such
information from executive agencies as
is necessary for the FASC to carry out
its functions, including evaluation of
sources and covered articles for
purposes of determining whether to
recommend the issuance of removal or
exclusion orders, and the receiving
executive agency shall provide the
requested information to the fullest
extent possible.
(c) Consultation and Coordination
with Other Councils. The FASC will
consult and coordinate, as appropriate,
with the Chief Information Officers
Council, the Chief Acquisition Officers
Council, the Federal Acquisition
Regulatory Council, the Committee on
Foreign Investment in the United States,
and other relevant councils and
interagency committees with respect to
supply chain risks posed by the
acquisition and use of covered articles.
(d) Program Office and Committees.
The FASC may establish a program
office and any committees, working
groups, or other constituent bodies the
FASC deems appropriate, in its sole and
unreviewable discretion, to carry out its
functions. Such a committee, working
group, or other constituent body is
authorized to perform any function
lawfully delegated to it by the FASC.
Subpart B—Supply Chain Risk
Information Sharing
§ 201.201
(ISA).
Information Sharing Agency
The Act requires the FASC to identify
an appropriate executive agency—the
FASC’s Information Sharing Agency
(ISA)—to perform the administrative
information sharing functions on behalf
of the FASC, as enumerated in the law
at 41 U.S.C. 1323(a)(3). The ISA will
facilitate and provide the administrative
support to a FASC supply chain and
risk management Task Force; and serve
as the liaison to the FASC to
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communicate the Task Force efforts, as
the Task Force develops the processes
under which the functions in 41 U.S.C.
1323(a)(3) will be implemented on
behalf of the FASC. The Department of
Homeland Security (DHS), acting
primarily through the Cybersecurity and
Infrastructure Security Agency, is
named the appropriate executive agency
to serve as the FASC’s ISA. The ISA’s
administrative functions are not
construed to limit or impair the
authority or responsibilities of any other
federal agency with respect to
information sharing.
(a) All references in this part to the
‘‘submission of information to the
FASC’’ mean the submission of
information to the ISA and the Task
Force, on behalf of the FASC, pursuant
to the FASC-approved processes and
procedures described in this Section.
(b) The ISA and the Task Force will
carry out administrative information
dissemination functions on behalf of the
FASC, and any references to the
‘‘dissemination of information by the
FASC’’ mean dissemination of
information by the ISA, on behalf of the
FASC, pursuant to the FASC-approved
processes and procedures described in
this Section.
(c) Interagency Supply Chain Risk
Management Task Force. The FASC will
identify members for an interagency
supply chain risk management (SCRM)
task force (the Task Force) to assist the
FASC with implementing its
information sharing, risk analysis, and
risk assessment functions as described
in 41 U.S.C. 1323(a)(3). The purpose of
the Task Force is to allow the FASC to
capitalize on the various supply chain
risk management and information
sharing efforts across the federal
enterprise. This Task Force will include
technical experts in SCRM and related
interdisciplinary experts from agencies
identified in § 201.103 and any other
agency, or agency component, the FASC
Chairperson identifies. The ISA will
facilitate the efforts of and provide
administrative support to the Task Force
and periodically report to the FASC on
the Task Force efforts. The ISA will
convene the Task Force, including
providing a physical location/facility to
host the Task Force.
(d) The ISA, in consultation with the
Task Force, will submit to the FASC for
approval:
(1) Processes and procedures
describing how the ISA and the Task
Force will operate and support the
FASC;
(2) Processes and procedures
describing how federal and non-federal
entities must submit supply chain risk
information (both mandatory and
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voluntary submissions of information)
to the FASC, including any necessary
requirements for information handling,
protection and classification;
(3) Processes and procedures for the
ISA to notify the federal entity that
provided classified information to the
ISA, prior to disseminating that
classified information;
(4) Processes and procedures
describing how the ISA and the Task
Force will facilitate the sharing of
information to support supply chain
risk analyses under 41 U.S.C. 1326,
recommendations issued by the FASC,
and covered procurement actions under
41 U.S.C. 4713;
(5) Process and procedures describing
how the ISA and Task Force will
provide information to the FASC and to
executive agencies regarding covered
procurement actions by agencies and
any issued removal orders and covered
procurement actions; and
(6) Any other processes and
procedures describing the operations of
the Task Force as determined by the
FASC Chairperson.
(e) The ISA will also identify to the
FASC any ISA resource gaps, including,
but not limited to, gaps in staffing,
budget, organization, training, materials,
and facility needs that may be necessary
to implement its duties pursuant to this
part.
§ 201.202
FASC.
Submitting Information to the
(a) Requirements for Submission of
Information. All submissions of
information to the FASC must be
accomplished through the processes and
procedures approved by the FASC in
§ 201.201. Any information submission
to the FASC must comply with
information sharing protections
described in § 201.202 and be consistent
with applicable law and regulations.
(b) Mandatory Information
Submission Requirements. Executive
agencies must expeditiously submit
supply chain risk information to the ISA
using procedures approved by the FASC
in § 201.201 when:
(1) The FASC requests information
relating to a particular source, covered
article or covered procurement; or
(2) An executive agency has
determined there is a reasonable basis to
conclude a substantial supply chain risk
associated with a source, covered
procurement, or covered article exists.
In such instances, the executive agency
shall provide the FASC with relevant
information concerning the source or
covered article, including:
(i) Supply chain risk information
identified through the course of the
agency’s activities in furtherance of
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mitigating, identifying or managing its
supply chain risk;
(ii) Supply chain risk information
regarding covered procurement actions
by the agency under 41 U.S.C. 4713; and
any orders issued by the agency under
41 U.S.C. 4713.
(c) Voluntary Information Submission
Requirements. All federal and nonfederal entities may submit information
relevant to SCRM, covered articles,
sources, or covered procurement actions
to the FASC not described in paragraph
(b) in this section, Mandatory
Information Submission Requirements.
(d) Information Protections. To the
extent that information submitted to the
FASC must be protected in accordance
with applicable law and regulation,
agencies providing such information
must ensure the information contains
proper marking, handling,
dissemination, or use restrictions,
including but not limited to the
following:
(1) For classified information, the
transmitting and receiving agencies
shall ensure that information is
provided to designated ISA personnel,
who have an appropriate security
clearance and a need to know the
information. The ISA, Task Force, and
the FASC will handle such information
consistent with the applicable
restrictions.
(2) Other protected information
submitted to the FASC must be marked
in accordance with any applicable
intellectual property, business
confidentiality, contractual, or other
applicable dissemination rules. The
FASC, the ISA, and the Task Force, will
handle such information in a manner
consistent with such markings.
(3) To the extent supply chain risk
information submitted to the FASC
includes information protected by the
Procurement Integrity Act, agencies
shall submit such information
consistent with the FASC approved
processes and procedures described in
§ 201.201. The FASC will handle such
information consistent with the
identified restrictions.
(d) Dissemination of Information by
the FASC. The FASC maintains the
responsibility, at its sole discretion to
disclose its recommendations and any
supply chain risk information relevant
to its recommendation with any federal
or non-federal entities when the FASC
determines that such sharing may
facilitate identification or mitigation of
supply chain risk to information
systems and to the extent consistent
with the following paragraphs:
(1) The FASC may maintain its
recommendations and any supply chain
risk information as nonpublic, to the
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extent permitted by law, or otherwise
release such information to impacted
entities and appropriate stakeholders if
circumstances warrant such an
approach including but not limited to
exercising its discretion regarding the
timing of any such release of
information, the scope of information to
be released, and the intended recipients
of such information.
(2) Any release by the FASC of
recommendations and supply chain risk
information will be in accordance title
41 U.S.C. 1323 and with § 201.202(d),
(e), (f) and (g).
(3) The FASC will not release a
recommendation to a non-federal entity,
unless a decision on whether or not to
issue an exclusion or removal order has
been made, and the affected source has
been notified.
(e) Reliance on Shared information.
Executive agencies and the officials
identified in § 201.103(a)(1) may
consider and rely upon supply chain
risk information and any other
information the FASC determines
appropriate, received pursuant to this
subpart and the criteria established
under § 201.201, to exercise the
authorities and responsibilities in 41
U.S.C. 1323, 1326, and 4713.
(f) Limitation on further
dissemination of the information. The
FASC (including the ISA, Task Force,
and any other FASC constituent bodies)
shall comply with applicable limitations
on dissemination of supply chain risk
information submitted pursuant to this
subpart, including but not limited to the
following restrictions:
(1) Controlled Unclassified
Information, such as Law Enforcement
Sensitive, Proprietary, Privileged, or
Personally Identifiable Information, may
only be disseminated in compliance
with the safeguarding and
dissemination controls applicable for
that category of information and
consistent with any additional
administrative markings applied to this
specific information as laid out in
Executive Order 13556, Controlled
Unclassified Information, 32 CFR part
2002.
(2) Classified Information may only be
disseminated consistent with the
restrictions applicable to the
information and in accordance with the
FASC’s processes and procedures for
disseminating classified information as
required by this part.
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Subpart C—Removal Orders and
Exclusion Orders
§ 201.301 Recommending removal orders
and exclusion orders.
(a) Referral Procedure. The FASC may
commence an evaluation of one or more
sources and one or more covered
articles, pursuant to the criteria in
paragraph (b) of this section and for the
purpose of determining whether to
recommend that the source(s) or
covered article(s) be subject to a removal
order or exclusion order, in any of the
following ways:
(1) Upon the referral of the FASC or
any member of the FASC;
(2) Upon the request, in writing, of the
head of an executive agency or designee,
accompanied by a submission of
relevant information; or
(3) Based on information submitted to
the FASC by any federal or non-federal
entity that the FASC deems, in its
discretion, to be credible.
(b) Criteria. The FASC will evaluate
sources and covered articles, including
by analyzing available information, and
considering the following, nonexclusive factors, as appropriate:
(1) Functionality of the covered
articles, including the source’s access to
data and information system privileges;
(2) Security, authenticity, and
integrity of covered articles and their
supply and compilation chains,
including for embedded, integrated, and
bundled software;
(3) The ability of the source to
produce and deliver the covered articles
as expected (i.e., supply chain
assurance);
(4) Ownership of, control of, or
influence over the source or covered
article(s) by a foreign government or
parties owned or controlled by a foreign
government, or other ties between the
source and a foreign government, which
may include the following
considerations:
(i) Whether the U.S. government has
identified the country as a foreign
adversary or country of special concern;
(ii) Whether the source or its
component suppliers have headquarters,
research, development, manufacturing,
test, distribution, or service facilities or
other operations in a foreign country,
including a country of special concern
or a foreign adversary;
(iii) Personal and professional ties
between the source—including its
officers, directors or similar officials,
employees, consultants, or contractors—
and any foreign government; and
(iv) Laws and regulations of any
foreign country in which the source has
headquarters, research development,
manufacturing, testing, packaging,
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distribution, or service facilities or other
operations.
(5) Implications to national, homeland
security, or critical functions associated
with use of the source(s) or covered
article(s);
(6) Vulnerabilities of federal systems,
programs, or facilities;
(7) Capacity of the source or the U.S.
Government to mitigate risks;
(8) Credibility of, and confidence in
available information used to formulate
assessment(s) of risk associated with
proceeding, with using alternatives,
and/or with adopting range of
mitigations;
(9) Any transmission of information
or data by a covered article to a country
outside of the U.S.; and
(10) Any other information that would
factor into an assessment of supply
chain risk, including any impact to
agency mission critical functions, and
other information as the FASC deems
appropriate.
(c) Due Diligence. As part of the
analysis conducted pursuant to
paragraph (b) of this section, the FASC
will conduct appropriate due diligence.
Such due diligence may include but
need not be limited to the following
actions:
(1) Review any information made
available by the executive agency
identified in § 202.201(a), and any other
information the FASC determines
appropriate;
(2) Ensure, to the extent possible, that
the level of confidence in the
information is appropriately taken into
consideration; and
(3) Examine other relevant public or
commercially available information as
necessary or appropriate.
(d) Consultation with NIST. NIST will
participate in FASC activities as a
member and will advise the FASC on
NIST standards and guidelines issued
under 40 U.S.C. 11331, including
ensuring that any recommended orders
do not conflict with such standards and
guidelines.
(e) Content of recommendation. (1)
The FASC shall include the following in
any recommendation to the Secretary of
Homeland Security, Secretary of
Defense, and/or Director of National
Intelligence:
(i) Information necessary to positively
identify any source(s) or covered
article(s) recommended for exclusion or
removal;
(ii) Information regarding the scope
and applicability of the recommended
exclusion order, removal order, or both,
including whether any such order
should apply to all executive agencies
or a subset of executive agencies;
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(iii) A summary of the supply chain
risk assessment reviewed or conducted
in support of the recommended
exclusion or removal order, including
material conflicting or contrary
information, if any;
(iv) A summary of the basis for the
recommendation, including a
discussion of less intrusive measures
that were considered and why such
measures were not reasonably available
to reduce supply chain risk;
(v) A description of the actions
necessary to implement the
recommended exclusion or removal
order; and,
(vi) Where practicable, in the FASC’s
sole and unreviewable discretion, a
description of the mitigation steps that
could be taken by the source that may
result in the FASC rescinding the
recommendation.
(2) Information sharing in absence of
recommendation: If the FASC decides
not to issue a recommendation,
information received and analyzed
pursuant to the procedures in this
section may be shared, as appropriate,
pursuant to the procedures in subpart B
of this chapter.
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§ 201.302 Notice of recommendation to
source and opportunity to respond.
(a) Notice to source. The FASC shall
provide a notice of the FASC’s
recommendation to any source named
in the recommendation.
(b) Content of notice. The notice
under paragraph (a) of this section shall
advise the source:
(1) That a recommendation has been
made;
(2) Of the criteria the FASC relied
upon and, to the extent consistent with
national security and law enforcement
interests, the information that forms the
basis for the recommendation;
(3) That, within 30 days after receipt
of the notice, the source may submit
information in response to the
recommendation;
(4) Of the procedures governing the
review and possible issuance of an
exclusion or removal order; and
(5) Where practicable, in the FASC’s
sole and unreviewable discretion, a
description of the mitigation steps that
could be taken by the source that may
result in the FASC rescinding the
recommendation.
(c) Confidentiality of notice issued to
source. U.S. government personnel
shall:
(1) Keep confidential and not make
available outside of the executive
branch, except to the extent required by
law, any notice issued to a source under
paragraph (b) of this section until an
exclusion order or removal order is
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issued and the source has been notified
pursuant to § 201.303(f)(1); and
(2) Keep confidential and not make
available outside of the executive
branch, except to the extent required by
law, any notice issued to a source under
paragraph (b) of this section if the FASC
rescinds a recommendation or the
Secretary of Homeland Security,
Secretary of Defense, and Director of
National Intelligence, as applicable,
decide not to issue the recommended
exclusion order and/or removal order.
(d) Confidentiality of information
submitted by source. The FASC and its
member agencies shall treat information
that the source marks as confidential,
private, or closely held, when marked
by the source as Confidential and Not to
be Publicly Shared. The FASC and its
member agencies will not disclose such
information to the public except to the
extent required by law.
§ 201.303 Issuing removal orders and
exclusion orders and other related
activities.
(a)(1) Consideration of and issuance
of exclusion and removal orders. The
Secretary of Homeland Security, the
Secretary of Defense, and the Director of
National Intelligence shall review the
FASC’s recommendations and
accompanying information and
materials provided by the FASC
pursuant to § 201.201, together with any
information submitted by a source
pursuant to § 201.202, and determine
whether to issue an order based upon
such recommendation.
(2) Administrative record. The
administrative record for judicial review
of an exclusion or removal order issued
pursuant to 41 U.S.C. 1323(c)(6) shall,
subject to the limitations set forth in 41
U.S.C. 1327(b)(4)(B)(ii)–(v), consist only
of:
(i) The recommendation issued
pursuant to 41 U.S.C. 1323(c)(2);
(ii) The notice of recommendation
and review issued pursuant to 41 U.S.C.
1323(c)(3);
(iii) Any information and argument in
opposition to the recommendation
submitted by the source pursuant to 41
U.S.C. 1323(c)(3)(C);
(iv) The exclusion or removal order
issued pursuant to 41 U.S.C. 1323(c)(5)
and any information or materials
directly relied upon by the official
identified in paragraphs (b) through (d)
of this section, as applicable, in issuing
the exclusion or removal order; and
(v) The notification to the source
issued pursuant to 41 U.S.C.
1323(c)(6)(A).
(3) Other information. Other
information or material collected by,
shared with, or created by the FASC or
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its member agencies shall not be
included in the administrative record
unless the official identified in
paragraphs (b) through (d) of this
section, as applicable, directly relied on
that information or material in issuing
the exclusion or removal order.
(b) Secretary of Homeland Security.
The Secretary of Homeland Security
shall issue removal or exclusion orders
applicable only to civilian agencies, to
the extent not covered by paragraph (c)
or (d) of this section.
(c) Secretary of Defense. The Secretary
of Defense shall issue removal or
exclusion orders applicable only to the
Department of Defense including
national security systems other than
sensitive compartmented information
systems.
(d) Director of National Intelligence.
The Director of National Intelligence
shall issue removal or exclusion orders
applicable only to the Intelligence
Community and sensitive
compartmented information systems, to
the extent not covered by paragraph (c)
in this section.
(e) Applicability of issued orders to
Non-Federal entities. An exclusion
order and a removal order may affect
non-federal entities, including as
follows:
(1) An exclusion order may require
the exclusion of sources or covered
articles from any executive agency
procurement action, including but not
limited to source selection and consent
for a contractor to subcontract. To the
extent required by the exclusion order,
agencies shall exclude the source or
covered articles, as applicable, from
being supplied by any prime contractor
and subcontractor at any tier.
(2) A removal order may require
removal of the covered article(s) from an
executive agency information system
owned and operated by an agency; from
an information system operated by a
contractor on behalf of an agency; and
from other contractor information
systems to the extent that the removal
order applies to contractor equipment or
systems within the scope of
‘‘information technology,’’ as defined at
herein.
(f) Notification of issued exclusion
and removal orders. The official who
issued the exclusion or removal order:
(1) Shall, upon issuance of an
exclusion or removal order pursuant to
paragraph (a) of this section:
(i) Notify any source named in the
order of the exclusion or removal order;
and to the extent consistent with
national security and law enforcement
interests, information that forms the
basis for the order;
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(ii) Provide classified or unclassified
notice of the exclusion or removal order
to the appropriate congressional
committees and leadership;
(iii) Provide the exclusion or removal
order to the ISA;
(iv) Notify the Interagency Suspension
and Debarment Committee about the
exclusion or removal order.
(2) May provide the exclusion order
or removal order to other persons,
including public disclosure, as the
official deems appropriate and to the
extent consistent with national security
and law enforcement interests.
(g) Delegation. The officials identified
in paragraph (a) of this section may not
delegate the authority to issue exclusion
and removal orders to an official below
the level one level below the Deputy
Secretary or Principal Deputy Director
level, except that the Secretary of
Defense may delegate authority for
removal orders to the Commander of
U.S. Cyber Command, who may not redelegate such authority to an official
below the level of the Deputy
Commander.
(h) Removal from Federal supply
contracts. If the officials identified in
paragraphs (b) through (d) of this
section, or their delegate, issue orders
collectively resulting in a governmentwide exclusion, the Administrator for
General Services and officials at other
executive agencies responsible for
management of the Federal Supply
Schedules, government-wide
acquisition contracts and multi-agency
contracts shall facilitate implementation
of such orders by removing the covered
articles or sources identified in the
orders from such contracts.
(i) Annual review of issued orders.
The officials identified in paragraphs (b)
through (d) of this section shall review
all issued exclusion and removal orders
not less frequently than annually
pursuant to procedures established by
the FASC.
(j) Modification or rescission of issued
orders. The officials identified in
paragraphs (b) through (d) of this
section may modify or rescind an issued
exclusion or removal order, provided
that a modified order shall not apply
more broadly than the order before the
modification.
jbell on DSKJLSW7X2PROD with RULES
§ 201.304 Executive agency compliance
with exclusion and removal orders.
(a) Agency compliance. Executive
agencies shall:
(1) Comply with exclusion and
removal orders issued pursuant to
§ 201.303 and applicable to their
agency, as required by 41 U.S.C. 1323(d)
and 44 U.S.C. 35554(a)(1)(B); and
VerDate Sep<11>2014
15:57 Aug 31, 2020
Jkt 250001
(2) Not make publicly-available any
exclusion order or removal order unless
otherwise approved by the FASC prior
to such release.
(b) Exceptions to issued exclusion and
removal orders. An executive agency
required to comply with an exclusion
order or a removal order may submit to
the official that issued the order a
request that an issued order not apply
to the agency, to specific actions of the
agency, to actions of the agency for a
period of time before compliance with
the order is practicable, and any other
request that the requesting agency seeks.
The request shall include all necessary
information for the issuing official to
review and evaluate the request,
including alternative mitigations to the
risks addressed by the order and the
ability of an agency to fulfill its mission
critical functions. Other circumstances
that may warrant an exception to an
issued order include other findings
related to the national interest,
including national security reviews,
national security investigations, or
national security agreements. The
request shall be submitted in writing.
The FASC may establish and update
additional procedures for requesting
waivers and criteria for approving or
disapproving such requests as
appropriate.
[FR Doc. 2020–18939 Filed 8–31–20; 8:45 am]
BILLING CODE 3110–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 9
[Docket Number NIH–2019–0001]
RIN: 0925–AA66
Standards of Care for Chimpanzees
Held in the Federally Supported
Sanctuary System
AGENCY:
National Institutes of Health,
HHS.
Final rule; technical
amendments.
ACTION:
SUMMARY: This document contains
technical amendments to the Health and
Human Services (HHS) regulation
regarding the Standards of Care for
Chimpanzees Held in the Federally
Supported Sanctuary System. The
regulatory content is being amended to
correct references that are made
throughout the regulation regarding
delegated authorities and activities of
the National Center for Research
Resources (NCRR) of the National
Institutes of Health (NIH). With the
abolishment of NCRR in 2011, the
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
54271
Director, NIH, delegated these
authorities to the Office of Research
Infrastructure Programs (ORIP) within
the Division of Program Coordination,
Planning, and Strategic Initiatives
(DPCPSI), NIH. The ORIP/DPCPSI now
has the lead responsibility for
coordinating all efforts on behalf of HHS
concerning the sanctuary system for
surplus chimpanzees from both federal
and non-federal sources. The references
to NCRR throughout the regulation are
corrected to reflect ORIP/DPCPSI, the
definition of National Primate Research
Center is corrected to reflect the correct
number of currently existing centers,
and the office address provided for
ORIP/DPCPSI in the regulation is
corrected.
DATES: Effective on September 1, 2020.
FOR FURTHER INFORMATION CONTACT:
Daniel Hernandez, Acting NIH
Regulations Officer, Office of
Management Assessment, Division of
Management Support, 6011 Executive
Boulevard, Suite 601, Rockville,
Maryland 20852–7669, telephone 301–
435–3343, email dhernandez@
od.nih.gov.
SUPPLEMENTARY INFORMATION: On
December 20, 2000, the United States
Congress enacted the Chimpanzee
Health Improvement, Maintenance, and
Protection Act of 2000 (Pub. L. 106–551,
‘‘CHIMP Act’’). Section 1 of this law
amended the Public Health Service Act
by adding section 481C (42 U.S.C. 287a–
3a). Section 481C requires the Secretary,
HHS, to provide for the establishment
and operation of a sanctuary system to
provide for the lifetime care of
chimpanzees that have been used, or
were bred or purchased for use, in
research conducted or supported by
NIH, the Food and Drug Administration
(FDA), or other agencies of the Federal
Government, and with respect to which
it has been determined by the Secretary,
HHS, that the chimpanzees are not
needed for such research (i.e., surplus
chimpanzees).
Section 481C(d) directs the Secretary,
HHS, to establish, by regulation,
standards of care for operating the
sanctuary system to provide for the
permanent retirement of surplus
chimpanzees. On April 5, 2001, the
Secretary, HHS, delegated to the
Director, NIH, authorities to establish
and operate the sanctuary system.
Subsequently, the Director, NIH,
delegated the authorities to NCRR. On
October 10, 2008, HHS issued a final
rule that established the regulation at 42
CFR part 9 which sets forth the
standards of care for chimpanzees held
in the federally supported chimpanzee
sanctuary system. References are made
E:\FR\FM\01SER1.SGM
01SER1
Agencies
[Federal Register Volume 85, Number 170 (Tuesday, September 1, 2020)]
[Rules and Regulations]
[Pages 54263-54271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18939]
=======================================================================
-----------------------------------------------------------------------
OFFICE OF MANAGEMENT AND BUDGET
41 CFR Part 201
Federal Acquisition Supply Chain Security Act
AGENCY: Office of Management and Budget, OMB.
ACTION: Interim final rule with request for comments.
-----------------------------------------------------------------------
SUMMARY: As authorized by the Federal Acquisition Supply Chain Security
Act of 2018 (FASCSA), the Federal Acquisition Security Council (FASC)
is issuing this interim final rule to implement the requirements of the
laws that govern the operation of the FASC, the sharing of supply chain
risk information, and the exercise of its authorities to recommend
issuance of removal and exclusion orders to address supply chain
security risks.
DATES: Effective September 1, 2020. Written comments must be received
on or before November 2, 2020.
ADDRESSES: Interested parties should provide comments via electronic
mail to the following inbox: [email protected]. The Office of
Management and Budget is located at 725 17th Street NW, Washington, DC
20503. No physical copies will be accepted.
Instructions: Comments sent by any other method, to any other
address or individual, or received after the end of the comment period,
may not be considered. Comments submitted in response to this notice
may be made publically available and are subject to disclosure under
the Freedom of Information Act. For this reason, please do not include
in your comments information of a confidential nature, such as
sensitive personal information or proprietary information, or any
information that you would not want publicly disclosed. Summary
information of the public comments received, including any specific
comments, may be posted on regulations.gov.
FOR FURTHER INFORMATION CONTACT: Lisa N. Barr, 202-395-3015,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Information and communications technology and services (ICTS) are
essential to the proper functioning of U.S. government information
systems. The U. S. government's efforts to evaluate threats to and
vulnerabilities in ICTS supply chains have historically been undertaken
by individual or small groups of agencies to address specific supply
chain security risks. Because of the scale of supply chain risks faced
by government agencies, and the need for better coordination among a
broader group of agencies, there was an organized effort within the
executive branch to support Congressional efforts in 2018 to pass new
legislation to improve executive branch coordination, supply chain
information sharing, and actions to address supply chain risks.
The Federal Acquisition Supply Chain Security Act of 2018 (FASCSA
or Act) (Title II of Pub. L. 115-390), signed into law on December 21,
2018, established the Federal Acquisition Security Council (FASC). The
FASC is an executive branch interagency council, chaired by a senior-
level official from the Office of Management and Budget (OMB), and
includes representatives from the General Services Administration
(GSA); Department of Homeland Security (DHS); Office of the Director of
National Intelligence (ODNI); Department of Justice; Department of
Defense (DoD); and Department of Commerce (Commerce).
Pursuant to subsection 202(d) of the FASCSA, the FASC is required
to prescribe this IFR to implement subchapter III of chapter 13 of
title 41, U.S. Code. This IFR is organized in three subparts. Subpart A
explains the scope of this IFR, provides definitions for relevant
terms, and establishes the membership of the FASC. Subpart B
establishes the role of the FASC's Information Sharing Agency (ISA).
DHS, acting primarily through the Cybersecurity and Infrastructure
Security Agency, will serve as the ISA. The ISA will standardize
processes and procedures for submission and dissemination of supply
chain information, and will facilitate the operations of a Supply Chain
Risk Management (SCRM) Task Force under the FASC. This FASC Task Force
(hereafter referred to as ``Task Force'') will be comprised of
designated technical experts that will assist the FASC in implementing
its information sharing, risk analysis, and risk assessment functions.
Subpart B also prescribes mandatory and voluntary information sharing
criteria and associated information protection requirements. Subpart C
provides the criteria and procedures by which the FASC will evaluate
supply chain risk from sources and covered articles and recommend
issuance of orders requiring removal of covered articles from executive
agency information systems (removal orders) and orders excluding
sources or covered articles from future procurements (exclusion
orders). Subpart C also provides the process for issuance of removal
orders and exclusion orders and agency requests for waivers from such
orders.
II. Analysis of Part 201
Subpart A--General
Subpart A establishes regulations generally applicable to the
operations of the FASC. Subpart A, Sec. 201.101(a) summarizes the
scope of subparts A, B, and C, which generally govern the activities of
federal agencies, and not non-federal entities. Sec. 201.101(b)
clarifies that nothing in these regulations require non-federal
entities to share supply chain risk information with the federal
government. In addition, because subpart C provides for the issuance of
exclusion orders and removal orders, which affect the supply and use of
products and services supplied by non-federal entities,
[[Page 54264]]
Sec. 201.101(b)(2) explains that subpart C does not require the
removal or a covered article from a non-federal information system or
the exclusion of a covered article from procurement by a non-federal
entity except to the extent that an exclusion order or a removal order
applies to a prime contractor or subcontractor of a federal agency.
This applicability to non-federal entities is addressed in Sec.
201.303(e).
Subpart A, Sec. 201.102 provides definitions applicable to the
part. Subpart A, Sec. 201.103 describes the membership of the FASC,
the authority of the FASC to request information from executive
agencies, and the authority of the FASC to establish a program office,
committees, working groups, or other constituent bodies. These bodies
are authorized to perform any function lawfully delegated to them by
the FASC.
Subpart B--Supply Chain Risk Information Sharing
Subpart B identifies DHS as the executive agency for information
sharing (or the ISA) and provides for the creation and establishment of
a supply chain risk management and information sharing Task Force under
the FASC. The ISA will facilitate and provide the administrative
support to the FASC Task Force and serve as the liaison to the FASC.
The Task Force will develop processes and procedures to be approved by
the FASC that describe: (1) How the ISA and Task Force will operate and
support the FASC; (2) how federal and non-federal entities submit
supply chain risk information to the FASC, including any necessary
requirements for information handling, protection and classification;
(3) how to share information to support supply chain risk analyses
under Sec. 1326 of the Act, recommendations issued by the FASC, and
covered procurement actions under Sec. 4713 of the Act; (4) how to
provide information to the FASC and to executive agencies regarding
removal orders and covered procurement actions; and (5) any other
processes and procedures describing the operations of the FASC as
determined by the FASC Chairperson. Subpart B, Sec. 201.202 describes
additional details of the mechanics of submitting information to the
FASC (including mandatory and voluntary submissions) and dissemination
of information by the FASC.
Subpart C--Removal Orders and Exclusion Orders
Subpart C describes the process by which the FASC will evaluate one
or more sources and/or one or more covered articles to determine
whether to recommend that the Secretary of Homeland Security, Secretary
of Defense, and/or Director of National Intelligence issue a removal
order and/or an exclusion order. Initiation of the process can begin
either by referral of the FASC or any member of the FASC; upon the
written request of any U.S. Government body; or based on information
submitted to the FASC by any individual or non-federal entity that the
FASC determines to be credible.
The FASC will evaluate sources and covered articles pursuant to a
common set of non-exclusive factors that are listed in this IFR.
Allowing for the evaluation of additional information provides the FASC
with the needed flexibility to evaluate additional considerations and
information on a case-by-case basis.
As part of the analysis of sources and/or covered articles, the
FASC will conduct appropriate due diligence regarding the information
that it is considering. This due diligence may include reviewing any
information made available to the FASC; ensuring, to the extent
possible, that the information is credible or that the level of
confidence in the information is appropriately taken into
consideration; and examining other relevant publicly-available
information as necessary and appropriate. In addition, the FASC will
consult with the National Institute of Standards and Technology (NIST),
before recommending issuance of an exclusion or removal order, to
ensure that recommended orders do not conflict with existing federal
standards and guidelines.
If the FASC does not find that recommending a removal or exclusion
order is warranted, risk information received and analyzed by the FASC
may be shared, as appropriate, pursuant to the procedures in Subpart B.
If the FASC decides to issue a recommendation, that recommendation
will include the information necessary for the Secretary of Homeland
Security, the Secretary of Defense, or the Director of National
Intelligence, as appropriate, to determine whether to issue an
exclusion order and/or a removal order. The recommendation must include
the risk information and summaries specified in Subpart B, Sec.
201.202(e). The recommendation will be directed to the Secretary of
Homeland Security, Secretary of Defense, and/or Director of National
Intelligence based on the scope of federal systems, identified in 41
U.S.C. 1323(c)(5), for which the FASC is recommending removal or
exclusion from future procurements. The FASC or its designee will
provide notice of the recommendation, along with the contents specified
in Subpart C, Sec. 201.302(b), to any source named in the
recommendation. This due process procedure is intended to provide the
named source(s) with the information needed for the source(s) to
respond to the recommendation. If named source(s) wishes to respond to
the notice, the source(s) should prepare a thorough and complete
written response, submitting the response as directed in the notice.
The FASC encourages source(s) to provide any information that it
believes relevant in responding to the recommendation, including
additional technical information about the covered article(s), details
about the relationship between the source(s) and any foreign
government, and a detailed mitigation proposal that the source(s)
believes would satisfy the concerns identified in the notice. The
source(s) should submit such information and materials in writing
before any request for a meeting to enable the FASC and the Secretary
of Homeland Security, Secretary of Defense, and Director of National
Intelligence, as applicable, to fully consider the source's written
submission. The FASC may choose to rescind the recommendation based on
the information provided by the source(s). The FASC does not intend to
publicly disclose communications with the source(s) except to the
extent required by law. The FASC welcomes comment on the adequacy or
specific improvements to these procedures.
The Secretary of Homeland Security, the Secretary of Defense, or
the Director of National Intelligence, as applicable, will review the
recommendation and accompanying risk information and materials provided
by the FASC, and any information and response submitted by a source,
and determine whether to issue a removal order, an exclusion order, or
both, for the agencies and systems within the scope of the authority of
41 U.S.C. 1323(c)(5)(A)(i)-(iii). If one of these officials or an
authorized designee issues an exclusion order or removal order, the
named source(s) will be notified, among other required and
discretionary notifications.
Once a removal or exclusion order is issued, all agencies to which
the order applies would be required to comply with the order pursuant
to 41 U.S.C. 1323(c)(7) and 44 U.S.C. 3554(a)(1)(B)(vi). If orders
applying to the same source(s) or covered articles were issued by the
Secretaries of Homeland Security and Defense and the Director of
National Intelligence (i.e., effectively an executive branch-wide
removal and/or exclusion order), the Administrator of General Services
and officials at other executive agencies
[[Page 54265]]
responsible for management of the Federal Supply Schedules, government-
wide acquisition contracts, and multi-agency contracts would facilitate
implementation of such orders by removing the covered articles or
sources identified in the orders from such contracts.
The regulation provides procedures for agencies to submit requests
to the issuing official for an exception to an issued order. An agency
may request an exception to an issued order for various reasons, such
as need for additional time to comply with the order, or for a complete
waiver based on issues of national security. The FASC will establish
procedures for requesting waivers and criteria for approving or
disapproving such requests, as appropriate.
All issued exclusion and removal orders must be reviewed at least
annually pursuant to procedures which will be established by the FASC.
Furthermore, an authorized official of the issuing agency may modify or
rescind an issued exclusion or removal order, so long as a modified
order does not apply more broadly than the order before modification.
III. Request for Comment
The FASC invites comments on all aspects of this IFR. Any non-
public (oral and written) communications with FASC officials regarding
the substance of this rule would be considered an ex-parte
presentation, and a summary of the substance of the ex-parte
presentation will be placed on the public record and become part of
this docket. Not later than two (2) business days after an oral
communication or meeting, the party which engaged in such communication
or meeting must submit a memorandum to OMB summarizing the substance of
the communication. OMB reserves the right to supplement the memorandum
with additional information as necessary, or to request that the party
making the filing do so, if a FASC official believes that important
information was omitted or characterized incorrectly. Any written
presentation provided in support of the oral communication or meeting
will also be placed on the public record and become part of this
docket. Such ex-parte communications must be submitted to this docket
as provided in the ADDRESSES section above and clearly labeled as an
ex-parte presentation. Federal entities are not subject to these
procedures.
IV. Classification
Executive Orders 12866 and 13563: Executive Orders (E.O.s) 12866
and 13563 direct agencies to assess all costs and benefits of available
regulatory alternatives and, if regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety effects, distributive
impacts, and equity). E.O. 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This rule has been designated a
significant regulatory action under E.O. 12866. Accordingly, the Office
of Information and Regulatory Affairs has reviewed this rule.
Executive Order 13771: This rule is not subject to the requirements
of E.O. 13771, because the rule is issued with respect to a national
security function of the United States. As highlighted by sections I
and II of this preamble, national security is a primary direct benefit
of this rule. Application of the national security exemption under E.O.
13771 requires assessing the application of the ``good cause''
exception under 5 U.S.C. 533. This rule meets the ``good cause''
exception, as FASCSA requires publication of an interim final rule to
effectuate the authorities of the FASC in a timely manner, and the one-
year deadline Congress established for publication of such rule would
not provide sufficient time for notice and comment in light of the
complex nature of the rule and interagency process.
Regulatory Flexibility Act: Because the FASC is not required to
publish a notice of proposed rulemaking for this interim final rule
under 5 U.S.C. 553, no Regulatory Flexibility Analysis is required. See
5 U.S.C. 603(a), 604(a).
Paperwork Reduction Act: The Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.) (PRA) provides that an agency generally cannot
conduct or sponsor a collection of information, and no person is
required to respond to nor be subject to a penalty for failure to
comply with a collection of information, unless that collection has
obtained OMB approval and displays a currently valid OMB Control
Number. This rule does not contain a collection of information and is
therefore not subject to the PRA.
Congressional Review Act: The FASC has determined that this rule
will take effect upon publication pursuant to 5 U.S.C. 808(2). The FASC
finds that notice and public procedure before this rule takes effect is
unnecessary and contrary to the public interest under 5 U.S.C. 808(2)
in light of Congress's direction to issue an interim final rule to
address the critical supply chain security issues covered by this rule
and to respond to public comments when issuing a final rule. See 41
U.S.C. 1321 note.
Unfunded Mandates Reform Act of 1995: This rule does not contain
any unfunded mandate or significantly or uniquely affect small
governments, as described in the Unfunded Mandates Reform Act of 1995.
Executive Order 13132 (Federalism): This rule does not have
Federalism implications as specified in Executive Order 13132.
Executive Order 12630 (Governmental Actions and Interference with
Constitutionally Protected Property Rights): This rule does not
implement policies that have takings implications as identified in
Executive Order 12630.
Executive Order 13175 (Consultation and Coordination with Indian
Tribes): The rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175.
National Environmental Policy Act: This IFR does not require a
detailed environmental analysis as the establishment and operation of
FASC will not ``individually or cumulatively have a significant effect
on the human environment'' (40 CFR 1508.4).
List of Subjects in 41 CFR Part 201
Cybersecurity, Federal acquisition, Government procurement,
Information sharing, Information technology, National security, Removal
and exclusion orders, Security measures, Supply chain, Supply chain
risk information, Technology.
Grant Schneider,
Federal Chief Information Security Officer.
0
For the reasons set out in the preamble, 41 CFR part 201 is added to
read as follows:
PART 201--FEDERAL ACQUISITION SUPPLY CHAIN SECURITY
Subpart A--General
Sec.
201.101 Scope.
201.102 Definitions.
201.103 Federal Acquisition Security Council (FASC).
Subpart B--Supply Chain Risk Information Sharing
201.201 Information Sharing Agency (ISA).
201.202 Submitting information to the FASC.
Subpart C--Removal orders and exclusion orders
201.301 Recommending removal orders and exclusion orders.
201.302 Notice of recommendation to source and opportunity to
respond.
[[Page 54266]]
201.303 Issuing removal orders and exclusion orders and other
related activities.
201.304 Executive agency compliance with exclusion and removal
orders.
Authority: 41 U.S.C. 1321-1328, 4713.
Subpart A--General
Sec. 201.101 Scope.
(a) Except as provided in paragraph (b) of this section, this part
applies to the following:
(1) The membership and operations of the FASC, including all U.S.
and contractor personnel supporting the FASC's operations;
(2) Submission and dissemination of supply chain risk information;
and
(3) Recommendations for, issuance of, and associated procedures
related to removal orders and exclusion orders.
(b) This part does not require the following:
(1) Mandatory submission of supply chain risk information by non-
federal entities.
(2) The removal or exclusion of any covered article by non-federal
entities, except to the extent that an exclusion or removal order
issued pursuant to subpart C of this Part applies to prime contractors
and subcontractors to federal agencies.
Sec. 201.102 Definitions.
For purposes of this part:
(a) Appropriate congressional committees and leadership means:
(1) The Committee on Homeland Security and Governmental Affairs,
the Committee on the Judiciary, the Committee on Appropriations, the
Committee on Armed Services, the Committee on Commerce, Science, and
Transportation, the Select Committee on Intelligence, and the majority
and minority leader of the Senate; and
(2) The Committee on Oversight and Government Reform, the Committee
on the Judiciary, the Committee on Appropriations, the Committee on
Homeland Security, the Committee on Armed Services, the Committee on
Energy and Commerce, the Permanent Select Committee on Intelligence,
and the Speaker and minority leader of the House of Representatives.
(b) Council or FASC means the Federal Acquisition Security Council.
(c) Covered article means any of the following:
(1) Information technology, as defined in 40 U.S.C. 11101,
including cloud computing services of all types;
(2) Telecommunications equipment or telecommunications service, as
those terms are defined in section 3 of the Communications Act of 1934
(47 U.S.C. 153);
(3) The processing of information on a Federal or non-Federal
information system, subject to the requirements of the Controlled
Unclassified Information program or subsequent U.S. government program
for controlling sensitive unclassified information; or
(4) Hardware, systems, devices, software, or services that include
embedded or incidental information technology.
(d) Covered procurement means:
(1) A source selection for a covered article involving either a
performance specification, as provided in subsection (a)(3)(B) of title
41 U.S.C. 3306, or an evaluation factor, as provided in subsection
(b)(1)(A) of title 41 U.S.C. 3306, relating to a supply chain risk, or
where supply chain risk considerations are included in the agency's
determination of whether a source is a responsible source;
(2) The consideration of proposals for and issuance of a task or
delivery order for a covered article, as provided in title 41 U.S.C.
4106(d)(3), where the task or delivery order contract includes a
contract clause establishing a requirement relating to a supply chain
risk;
(3) Any contract action involving a contract for a covered article
where the contract includes a clause establishing requirements relating
to a supply chain risk; or
(4) Any other procurement in a category of procurements determined
appropriate by the Federal Acquisition Regulatory Council, with the
advice of the Federal Acquisition Security Council.
(e) Covered procurement action means any of the following actions,
if the action takes place in the course of conducting a covered
procurement:
(1) The exclusion of a source that fails to meet qualification
requirements established under 41 U.S.C. 3311, for the purpose of
reducing supply chain risk in the acquisition or use of covered
articles;
(2) The exclusion of a source that fails to achieve an acceptable
rating with regard to an evaluation factor providing for the
consideration of supply chain risk in the evaluation of proposals for
the award of a contract or the issuance of a task or delivery order;
(3) The determination that a source is not a responsible source,
based on considerations of supply chain risk; and
(4) The decision to withhold consent for a contractor to
subcontract with a particular source or to direct a contractor to
exclude a particular source from consideration for a subcontract under
the contract.
(f) Exclusion order means any of the following orders requiring the
exclusion of sources or covered articles from executive agency
procurement actions:
(1) An order issued by Secretary of Homeland Security applicable to
federal executive branch civilian agencies;
(2) An order issued by the Secretary of Defense applicable to
Department of Defense and national security systems other than
sensitive compartmented information systems; or
(3) An order issued by the Director of National Intelligence
applicable to the Intelligence Community and sensitive compartmented
information systems.
(g) Executive agency means:
(1) An executive department specified in 5 U.S.C. 101;
(2) A military department specified in 5 U.S.C. 102;
(3) An independent establishment as defined in 5 U.S.C. 104(1); and
(4) A wholly owned Government corporation fully subject to chapter
91 of title 3 U.S.C.
(h) Information and communications technology means:
(1) Information technology as defined in 40 U.S.C. 11101;
(2) Information systems, as defined in 44 U.S.C. 3502; and
(3) Telecommunications equipment and telecommunications services,
as those terms are defined in section 3 of the Communications Act of
1934 (47 U.S.C. 153).
(i) Information technology has the definition provided in 40 U.S.C.
11101.
(j) Intelligence Community includes the following:
(1) The Office of the Director of National Intelligence;
(2) The Central Intelligence Agency;
(3) The National Security Agency;
(4) The Defense Intelligence Agency;
(5) The National Geospatial-Intelligence Agency;
(6) The National Reconnaissance Office;
(7) Other offices within the Department of Defense for the
collection of specialized national intelligence through reconnaissance
programs;
(8) The intelligence elements of the Army, the Navy, the Air Force,
the Marine Corps, the Coast Guard, the Federal Bureau of Investigation,
the Drug Enforcement Administration, and the Department of Energy;
(9) The Bureau of Intelligence and Research of the Department of
State;
(10) The Office of Intelligence and Analysis of the Department of
the Treasury;
(11) The Office of Intelligence and Analysis of the Department of
Homeland Security;
(12) Such other elements of any department or agency as may be
[[Page 54267]]
designated by the President, or designated jointly by the Director of
National Intelligence and the head of the department or agency
concerned, as an element of the intelligence community.
(k) National security system has the definition given to it in 44
U.S.C. 3552 and means any information system (including any
telecommunications system) used or operated by an agency or by a
contractor of an agency, or other organization on behalf of an agency--
(1) The function, operation, or use of which involves intelligence
activities; involves cryptologic activities related to national
security; involves command and control of military forces; involves
equipment that is an integral part of a weapon or weapons system; or
subject to paragraph (j)(1)(3) of this section, is critical to the
direct fulfillment of military or intelligence missions, but does not
include a system that is to be used for routine administrative and
business applications (including payroll, finance, logistics, and
personnel management applications); or
(2) Is protected at all times by procedures established for
information that have been specifically authorized under criteria
established by an Executive order or an Act of Congress to be kept
classified in the interest of national defense or foreign policy.
(3) Does not include a system that is to be used for routine
administrative and business applications (including payroll, finance,
logistics, and personnel management applications).
(l) Removal order means any of the following orders, issued
pursuant to 41 U.S.C. 1323(c)(5), requiring the removal of covered
articles from executive agency information systems:
(m) An order issued by Secretary of Homeland Security applicable to
federal executive branch civilian agencies;
(2) An order issued by the Secretary of Defense applicable to
Department of Defense and national security systems other than
sensitive compartmented information systems; or
(3) An order issued by the Director of National Intelligence
applicable to the intelligence community and sensitive compartmented
information systems.
(n) Responsible source means a responsible prospective contractor
and subcontractors, at any tier, as defined in part 9 of the Federal
Acquisition Regulation.
(o) Source means a non-federal supplier, or potential supplier, of
products or services, at any tier.
(p) Supply chain risk means the risk that any person may sabotage,
maliciously introduce unwanted functionality, extract data, or
otherwise manipulate the design, integrity, manufacturing, production,
distribution, installation, operation, maintenance, disposition, or
retirement of covered articles so as to surveil, deny, disrupt, or
otherwise manipulate the function, use, or operation of the covered
articles or information stored or transmitted by or through covered
articles.
(q) Supply chain risk information includes, but is not limited to,
information that describes or identifies:
(1) Functionality of covered articles, including access to data and
information system privileges;
(2) Information on the user environment where a covered article is
used or installed;
(3) The ability of the source to produce and deliver covered
articles as expected (i.e., supply chain assurance);
(4) Foreign control of, or influence over, the source (e.g.,
foreign ownership, personal and professional ties between the source
and any foreign entity, legal regime of any foreign country in which
the source is headquartered or conducts operations);
(5) Implications to national security, homeland security, and/or
national critical functions associated with use of the covered source;
(6) Vulnerability of federal systems, programs, or facilities;
(7) Market alternatives to the covered source;
(8) Potential impact or harm caused by the possible loss, damage,
or compromise of a product, material, or service to an organization's
operations or mission;
(9) Likelihood of a potential impact or harm, or the exploitability
of a system;
(10) Security, authenticity, and integrity of covered articles and
their supply and compilation chain;
(11) Capacity to mitigate risks identified;
(12) Credibility of and confidence in other supply chain risk
information;
(13) Any other information that would factor into an analysis of
the security, integrity, resilience, quality, trustworthiness, or
authenticity of covered articles or sources;
(14) A summary of the above information, including: Summary of the
threat level on 1 (low) to 5 (high) scale; and summary of the
vulnerability level on 1 (low) to 5 (high) scale; and, any other
information determined to be relevant to the determination of supply
chain risk.
Sec. 201.103 Federal Acquisition Security Council (FASC).
(a) The following agencies and agency components shall be
represented on the FASC:
(1) Office of Management and Budget;
(2) General Services Administration;
(3) Department of Homeland Security;
(4) Cybersecurity and Infrastructure Security Agency;
(5) Office of the Director of National Intelligence;
(6) National Counterintelligence and Security Center;
(7) Department of Justice;
(8) Federal Bureau of Investigation;
(9) Department of Defense;
(10) National Security Agency;
(11) Department of Commerce;
(12) National Institute of Standards and Technology; and
(13) Any other executive agency, or agency component, as determined
by the Chairperson of the FASC.
(b) The FASC may request such information from executive agencies
as is necessary for the FASC to carry out its functions, including
evaluation of sources and covered articles for purposes of determining
whether to recommend the issuance of removal or exclusion orders, and
the receiving executive agency shall provide the requested information
to the fullest extent possible.
(c) Consultation and Coordination with Other Councils. The FASC
will consult and coordinate, as appropriate, with the Chief Information
Officers Council, the Chief Acquisition Officers Council, the Federal
Acquisition Regulatory Council, the Committee on Foreign Investment in
the United States, and other relevant councils and interagency
committees with respect to supply chain risks posed by the acquisition
and use of covered articles.
(d) Program Office and Committees. The FASC may establish a program
office and any committees, working groups, or other constituent bodies
the FASC deems appropriate, in its sole and unreviewable discretion, to
carry out its functions. Such a committee, working group, or other
constituent body is authorized to perform any function lawfully
delegated to it by the FASC.
Subpart B--Supply Chain Risk Information Sharing
Sec. 201.201 Information Sharing Agency (ISA).
The Act requires the FASC to identify an appropriate executive
agency--the FASC's Information Sharing Agency (ISA)--to perform the
administrative information sharing functions on behalf of the FASC, as
enumerated in the law at 41 U.S.C. 1323(a)(3). The ISA will facilitate
and provide the administrative support to a FASC supply chain and risk
management Task Force; and serve as the liaison to the FASC to
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communicate the Task Force efforts, as the Task Force develops the
processes under which the functions in 41 U.S.C. 1323(a)(3) will be
implemented on behalf of the FASC. The Department of Homeland Security
(DHS), acting primarily through the Cybersecurity and Infrastructure
Security Agency, is named the appropriate executive agency to serve as
the FASC's ISA. The ISA's administrative functions are not construed to
limit or impair the authority or responsibilities of any other federal
agency with respect to information sharing.
(a) All references in this part to the ``submission of information
to the FASC'' mean the submission of information to the ISA and the
Task Force, on behalf of the FASC, pursuant to the FASC-approved
processes and procedures described in this Section.
(b) The ISA and the Task Force will carry out administrative
information dissemination functions on behalf of the FASC, and any
references to the ``dissemination of information by the FASC'' mean
dissemination of information by the ISA, on behalf of the FASC,
pursuant to the FASC-approved processes and procedures described in
this Section.
(c) Interagency Supply Chain Risk Management Task Force. The FASC
will identify members for an interagency supply chain risk management
(SCRM) task force (the Task Force) to assist the FASC with implementing
its information sharing, risk analysis, and risk assessment functions
as described in 41 U.S.C. 1323(a)(3). The purpose of the Task Force is
to allow the FASC to capitalize on the various supply chain risk
management and information sharing efforts across the federal
enterprise. This Task Force will include technical experts in SCRM and
related interdisciplinary experts from agencies identified in Sec.
201.103 and any other agency, or agency component, the FASC Chairperson
identifies. The ISA will facilitate the efforts of and provide
administrative support to the Task Force and periodically report to the
FASC on the Task Force efforts. The ISA will convene the Task Force,
including providing a physical location/facility to host the Task
Force.
(d) The ISA, in consultation with the Task Force, will submit to
the FASC for approval:
(1) Processes and procedures describing how the ISA and the Task
Force will operate and support the FASC;
(2) Processes and procedures describing how federal and non-federal
entities must submit supply chain risk information (both mandatory and
voluntary submissions of information) to the FASC, including any
necessary requirements for information handling, protection and
classification;
(3) Processes and procedures for the ISA to notify the federal
entity that provided classified information to the ISA, prior to
disseminating that classified information;
(4) Processes and procedures describing how the ISA and the Task
Force will facilitate the sharing of information to support supply
chain risk analyses under 41 U.S.C. 1326, recommendations issued by the
FASC, and covered procurement actions under 41 U.S.C. 4713;
(5) Process and procedures describing how the ISA and Task Force
will provide information to the FASC and to executive agencies
regarding covered procurement actions by agencies and any issued
removal orders and covered procurement actions; and
(6) Any other processes and procedures describing the operations of
the Task Force as determined by the FASC Chairperson.
(e) The ISA will also identify to the FASC any ISA resource gaps,
including, but not limited to, gaps in staffing, budget, organization,
training, materials, and facility needs that may be necessary to
implement its duties pursuant to this part.
Sec. 201.202 Submitting Information to the FASC.
(a) Requirements for Submission of Information. All submissions of
information to the FASC must be accomplished through the processes and
procedures approved by the FASC in Sec. 201.201. Any information
submission to the FASC must comply with information sharing protections
described in Sec. 201.202 and be consistent with applicable law and
regulations.
(b) Mandatory Information Submission Requirements. Executive
agencies must expeditiously submit supply chain risk information to the
ISA using procedures approved by the FASC in Sec. 201.201 when:
(1) The FASC requests information relating to a particular source,
covered article or covered procurement; or
(2) An executive agency has determined there is a reasonable basis
to conclude a substantial supply chain risk associated with a source,
covered procurement, or covered article exists. In such instances, the
executive agency shall provide the FASC with relevant information
concerning the source or covered article, including:
(i) Supply chain risk information identified through the course of
the agency's activities in furtherance of mitigating, identifying or
managing its supply chain risk;
(ii) Supply chain risk information regarding covered procurement
actions by the agency under 41 U.S.C. 4713; and any orders issued by
the agency under 41 U.S.C. 4713.
(c) Voluntary Information Submission Requirements. All federal and
non-federal entities may submit information relevant to SCRM, covered
articles, sources, or covered procurement actions to the FASC not
described in paragraph (b) in this section, Mandatory Information
Submission Requirements.
(d) Information Protections. To the extent that information
submitted to the FASC must be protected in accordance with applicable
law and regulation, agencies providing such information must ensure the
information contains proper marking, handling, dissemination, or use
restrictions, including but not limited to the following:
(1) For classified information, the transmitting and receiving
agencies shall ensure that information is provided to designated ISA
personnel, who have an appropriate security clearance and a need to
know the information. The ISA, Task Force, and the FASC will handle
such information consistent with the applicable restrictions.
(2) Other protected information submitted to the FASC must be
marked in accordance with any applicable intellectual property,
business confidentiality, contractual, or other applicable
dissemination rules. The FASC, the ISA, and the Task Force, will handle
such information in a manner consistent with such markings.
(3) To the extent supply chain risk information submitted to the
FASC includes information protected by the Procurement Integrity Act,
agencies shall submit such information consistent with the FASC
approved processes and procedures described in Sec. 201.201. The FASC
will handle such information consistent with the identified
restrictions.
(d) Dissemination of Information by the FASC. The FASC maintains
the responsibility, at its sole discretion to disclose its
recommendations and any supply chain risk information relevant to its
recommendation with any federal or non-federal entities when the FASC
determines that such sharing may facilitate identification or
mitigation of supply chain risk to information systems and to the
extent consistent with the following paragraphs:
(1) The FASC may maintain its recommendations and any supply chain
risk information as nonpublic, to the
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extent permitted by law, or otherwise release such information to
impacted entities and appropriate stakeholders if circumstances warrant
such an approach including but not limited to exercising its discretion
regarding the timing of any such release of information, the scope of
information to be released, and the intended recipients of such
information.
(2) Any release by the FASC of recommendations and supply chain
risk information will be in accordance title 41 U.S.C. 1323 and with
Sec. 201.202(d), (e), (f) and (g).
(3) The FASC will not release a recommendation to a non-federal
entity, unless a decision on whether or not to issue an exclusion or
removal order has been made, and the affected source has been notified.
(e) Reliance on Shared information. Executive agencies and the
officials identified in Sec. 201.103(a)(1) may consider and rely upon
supply chain risk information and any other information the FASC
determines appropriate, received pursuant to this subpart and the
criteria established under Sec. 201.201, to exercise the authorities
and responsibilities in 41 U.S.C. 1323, 1326, and 4713.
(f) Limitation on further dissemination of the information. The
FASC (including the ISA, Task Force, and any other FASC constituent
bodies) shall comply with applicable limitations on dissemination of
supply chain risk information submitted pursuant to this subpart,
including but not limited to the following restrictions:
(1) Controlled Unclassified Information, such as Law Enforcement
Sensitive, Proprietary, Privileged, or Personally Identifiable
Information, may only be disseminated in compliance with the
safeguarding and dissemination controls applicable for that category of
information and consistent with any additional administrative markings
applied to this specific information as laid out in Executive Order
13556, Controlled Unclassified Information, 32 CFR part 2002.
(2) Classified Information may only be disseminated consistent with
the restrictions applicable to the information and in accordance with
the FASC's processes and procedures for disseminating classified
information as required by this part.
Subpart C--Removal Orders and Exclusion Orders
Sec. 201.301 Recommending removal orders and exclusion orders.
(a) Referral Procedure. The FASC may commence an evaluation of one
or more sources and one or more covered articles, pursuant to the
criteria in paragraph (b) of this section and for the purpose of
determining whether to recommend that the source(s) or covered
article(s) be subject to a removal order or exclusion order, in any of
the following ways:
(1) Upon the referral of the FASC or any member of the FASC;
(2) Upon the request, in writing, of the head of an executive
agency or designee, accompanied by a submission of relevant
information; or
(3) Based on information submitted to the FASC by any federal or
non-federal entity that the FASC deems, in its discretion, to be
credible.
(b) Criteria. The FASC will evaluate sources and covered articles,
including by analyzing available information, and considering the
following, non-exclusive factors, as appropriate:
(1) Functionality of the covered articles, including the source's
access to data and information system privileges;
(2) Security, authenticity, and integrity of covered articles and
their supply and compilation chains, including for embedded,
integrated, and bundled software;
(3) The ability of the source to produce and deliver the covered
articles as expected (i.e., supply chain assurance);
(4) Ownership of, control of, or influence over the source or
covered article(s) by a foreign government or parties owned or
controlled by a foreign government, or other ties between the source
and a foreign government, which may include the following
considerations:
(i) Whether the U.S. government has identified the country as a
foreign adversary or country of special concern;
(ii) Whether the source or its component suppliers have
headquarters, research, development, manufacturing, test, distribution,
or service facilities or other operations in a foreign country,
including a country of special concern or a foreign adversary;
(iii) Personal and professional ties between the source--including
its officers, directors or similar officials, employees, consultants,
or contractors-- and any foreign government; and
(iv) Laws and regulations of any foreign country in which the
source has headquarters, research development, manufacturing, testing,
packaging, distribution, or service facilities or other operations.
(5) Implications to national, homeland security, or critical
functions associated with use of the source(s) or covered article(s);
(6) Vulnerabilities of federal systems, programs, or facilities;
(7) Capacity of the source or the U.S. Government to mitigate
risks;
(8) Credibility of, and confidence in available information used to
formulate assessment(s) of risk associated with proceeding, with using
alternatives, and/or with adopting range of mitigations;
(9) Any transmission of information or data by a covered article to
a country outside of the U.S.; and
(10) Any other information that would factor into an assessment of
supply chain risk, including any impact to agency mission critical
functions, and other information as the FASC deems appropriate.
(c) Due Diligence. As part of the analysis conducted pursuant to
paragraph (b) of this section, the FASC will conduct appropriate due
diligence. Such due diligence may include but need not be limited to
the following actions:
(1) Review any information made available by the executive agency
identified in Sec. 202.201(a), and any other information the FASC
determines appropriate;
(2) Ensure, to the extent possible, that the level of confidence in
the information is appropriately taken into consideration; and
(3) Examine other relevant public or commercially available
information as necessary or appropriate.
(d) Consultation with NIST. NIST will participate in FASC
activities as a member and will advise the FASC on NIST standards and
guidelines issued under 40 U.S.C. 11331, including ensuring that any
recommended orders do not conflict with such standards and guidelines.
(e) Content of recommendation. (1) The FASC shall include the
following in any recommendation to the Secretary of Homeland Security,
Secretary of Defense, and/or Director of National Intelligence:
(i) Information necessary to positively identify any source(s) or
covered article(s) recommended for exclusion or removal;
(ii) Information regarding the scope and applicability of the
recommended exclusion order, removal order, or both, including whether
any such order should apply to all executive agencies or a subset of
executive agencies;
[[Page 54270]]
(iii) A summary of the supply chain risk assessment reviewed or
conducted in support of the recommended exclusion or removal order,
including material conflicting or contrary information, if any;
(iv) A summary of the basis for the recommendation, including a
discussion of less intrusive measures that were considered and why such
measures were not reasonably available to reduce supply chain risk;
(v) A description of the actions necessary to implement the
recommended exclusion or removal order; and,
(vi) Where practicable, in the FASC's sole and unreviewable
discretion, a description of the mitigation steps that could be taken
by the source that may result in the FASC rescinding the
recommendation.
(2) Information sharing in absence of recommendation: If the FASC
decides not to issue a recommendation, information received and
analyzed pursuant to the procedures in this section may be shared, as
appropriate, pursuant to the procedures in subpart B of this chapter.
Sec. 201.302 Notice of recommendation to source and opportunity to
respond.
(a) Notice to source. The FASC shall provide a notice of the FASC's
recommendation to any source named in the recommendation.
(b) Content of notice. The notice under paragraph (a) of this
section shall advise the source:
(1) That a recommendation has been made;
(2) Of the criteria the FASC relied upon and, to the extent
consistent with national security and law enforcement interests, the
information that forms the basis for the recommendation;
(3) That, within 30 days after receipt of the notice, the source
may submit information in response to the recommendation;
(4) Of the procedures governing the review and possible issuance of
an exclusion or removal order; and
(5) Where practicable, in the FASC's sole and unreviewable
discretion, a description of the mitigation steps that could be taken
by the source that may result in the FASC rescinding the
recommendation.
(c) Confidentiality of notice issued to source. U.S. government
personnel shall:
(1) Keep confidential and not make available outside of the
executive branch, except to the extent required by law, any notice
issued to a source under paragraph (b) of this section until an
exclusion order or removal order is issued and the source has been
notified pursuant to Sec. 201.303(f)(1); and
(2) Keep confidential and not make available outside of the
executive branch, except to the extent required by law, any notice
issued to a source under paragraph (b) of this section if the FASC
rescinds a recommendation or the Secretary of Homeland Security,
Secretary of Defense, and Director of National Intelligence, as
applicable, decide not to issue the recommended exclusion order and/or
removal order.
(d) Confidentiality of information submitted by source. The FASC
and its member agencies shall treat information that the source marks
as confidential, private, or closely held, when marked by the source as
Confidential and Not to be Publicly Shared. The FASC and its member
agencies will not disclose such information to the public except to the
extent required by law.
Sec. 201.303 Issuing removal orders and exclusion orders and other
related activities.
(a)(1) Consideration of and issuance of exclusion and removal
orders. The Secretary of Homeland Security, the Secretary of Defense,
and the Director of National Intelligence shall review the FASC's
recommendations and accompanying information and materials provided by
the FASC pursuant to Sec. 201.201, together with any information
submitted by a source pursuant to Sec. 201.202, and determine whether
to issue an order based upon such recommendation.
(2) Administrative record. The administrative record for judicial
review of an exclusion or removal order issued pursuant to 41 U.S.C.
1323(c)(6) shall, subject to the limitations set forth in 41 U.S.C.
1327(b)(4)(B)(ii)-(v), consist only of:
(i) The recommendation issued pursuant to 41 U.S.C. 1323(c)(2);
(ii) The notice of recommendation and review issued pursuant to 41
U.S.C. 1323(c)(3);
(iii) Any information and argument in opposition to the
recommendation submitted by the source pursuant to 41 U.S.C.
1323(c)(3)(C);
(iv) The exclusion or removal order issued pursuant to 41 U.S.C.
1323(c)(5) and any information or materials directly relied upon by the
official identified in paragraphs (b) through (d) of this section, as
applicable, in issuing the exclusion or removal order; and
(v) The notification to the source issued pursuant to 41 U.S.C.
1323(c)(6)(A).
(3) Other information. Other information or material collected by,
shared with, or created by the FASC or its member agencies shall not be
included in the administrative record unless the official identified in
paragraphs (b) through (d) of this section, as applicable, directly
relied on that information or material in issuing the exclusion or
removal order.
(b) Secretary of Homeland Security. The Secretary of Homeland
Security shall issue removal or exclusion orders applicable only to
civilian agencies, to the extent not covered by paragraph (c) or (d) of
this section.
(c) Secretary of Defense. The Secretary of Defense shall issue
removal or exclusion orders applicable only to the Department of
Defense including national security systems other than sensitive
compartmented information systems.
(d) Director of National Intelligence. The Director of National
Intelligence shall issue removal or exclusion orders applicable only to
the Intelligence Community and sensitive compartmented information
systems, to the extent not covered by paragraph (c) in this section.
(e) Applicability of issued orders to Non-Federal entities. An
exclusion order and a removal order may affect non-federal entities,
including as follows:
(1) An exclusion order may require the exclusion of sources or
covered articles from any executive agency procurement action,
including but not limited to source selection and consent for a
contractor to subcontract. To the extent required by the exclusion
order, agencies shall exclude the source or covered articles, as
applicable, from being supplied by any prime contractor and
subcontractor at any tier.
(2) A removal order may require removal of the covered article(s)
from an executive agency information system owned and operated by an
agency; from an information system operated by a contractor on behalf
of an agency; and from other contractor information systems to the
extent that the removal order applies to contractor equipment or
systems within the scope of ``information technology,'' as defined at
herein.
(f) Notification of issued exclusion and removal orders. The
official who issued the exclusion or removal order:
(1) Shall, upon issuance of an exclusion or removal order pursuant
to paragraph (a) of this section:
(i) Notify any source named in the order of the exclusion or
removal order; and to the extent consistent with national security and
law enforcement interests, information that forms the basis for the
order;
[[Page 54271]]
(ii) Provide classified or unclassified notice of the exclusion or
removal order to the appropriate congressional committees and
leadership;
(iii) Provide the exclusion or removal order to the ISA;
(iv) Notify the Interagency Suspension and Debarment Committee
about the exclusion or removal order.
(2) May provide the exclusion order or removal order to other
persons, including public disclosure, as the official deems appropriate
and to the extent consistent with national security and law enforcement
interests.
(g) Delegation. The officials identified in paragraph (a) of this
section may not delegate the authority to issue exclusion and removal
orders to an official below the level one level below the Deputy
Secretary or Principal Deputy Director level, except that the Secretary
of Defense may delegate authority for removal orders to the Commander
of U.S. Cyber Command, who may not re-delegate such authority to an
official below the level of the Deputy Commander.
(h) Removal from Federal supply contracts. If the officials
identified in paragraphs (b) through (d) of this section, or their
delegate, issue orders collectively resulting in a government-wide
exclusion, the Administrator for General Services and officials at
other executive agencies responsible for management of the Federal
Supply Schedules, government-wide acquisition contracts and multi-
agency contracts shall facilitate implementation of such orders by
removing the covered articles or sources identified in the orders from
such contracts.
(i) Annual review of issued orders. The officials identified in
paragraphs (b) through (d) of this section shall review all issued
exclusion and removal orders not less frequently than annually pursuant
to procedures established by the FASC.
(j) Modification or rescission of issued orders. The officials
identified in paragraphs (b) through (d) of this section may modify or
rescind an issued exclusion or removal order, provided that a modified
order shall not apply more broadly than the order before the
modification.
Sec. 201.304 Executive agency compliance with exclusion and removal
orders.
(a) Agency compliance. Executive agencies shall:
(1) Comply with exclusion and removal orders issued pursuant to
Sec. 201.303 and applicable to their agency, as required by 41 U.S.C.
1323(d) and 44 U.S.C. 35554(a)(1)(B); and
(2) Not make publicly-available any exclusion order or removal
order unless otherwise approved by the FASC prior to such release.
(b) Exceptions to issued exclusion and removal orders. An executive
agency required to comply with an exclusion order or a removal order
may submit to the official that issued the order a request that an
issued order not apply to the agency, to specific actions of the
agency, to actions of the agency for a period of time before compliance
with the order is practicable, and any other request that the
requesting agency seeks. The request shall include all necessary
information for the issuing official to review and evaluate the
request, including alternative mitigations to the risks addressed by
the order and the ability of an agency to fulfill its mission critical
functions. Other circumstances that may warrant an exception to an
issued order include other findings related to the national interest,
including national security reviews, national security investigations,
or national security agreements. The request shall be submitted in
writing. The FASC may establish and update additional procedures for
requesting waivers and criteria for approving or disapproving such
requests as appropriate.
[FR Doc. 2020-18939 Filed 8-31-20; 8:45 am]
BILLING CODE 3110-05-P