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Proposed Rule2024-17095

HHS Acquisition Regulation: Regulatory Review

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Published

October 3, 2024

Issuing agencies

Health and Human Services Department

Abstract

The Department of Health and Human Services (HHS) is proposing to amend and update its Health and Human Services Acquisition Regulation (HHSAR) to update and streamline the HHSAR. Under this initiative, all parts of the regulation were reviewed to streamline the regulation, to revise or remove policy superseded by changes in the Federal Acquisition Regulation (FAR), to remove any procedural guidance that is internal to HHS into a new HHS Acquisition Manual (HHSAM) as internal policies, guidance, and instructions. The rule would add new coverage to implement agency unique requirements. The HHSAR would also be updated to reflect organizational changes in the Department, incorporate recent statutory changes and government mandates, and to accomplish editorial revisions for clarification.

Full Text

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<title>Federal Register, Volume 89 Issue 192 (Thursday, October 3, 2024)</title>
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[Federal Register Volume 89, Number 192 (Thursday, October 3, 2024)]
[Proposed Rules]
[Pages 80634-80714]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17095]

[[Page 80633]]

Vol. 89

Thursday,

No. 192

October 3, 2024

Part II

Department of Health and Human Services

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48 CFR Parts 301, 302, 303, et al.

HHS Acquisition Regulation: Regulatory Review; Proposed Rule

Federal Register / Vol. 89 , No. 192 / Thursday, October 3, 2024 /
Proposed Rules

[[Page 80634]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

48 CFR Parts 301, 302, 303, 304, 305, 306, 308, 309, 311, 312, 313,
314, 315, 316, 318, 319, 322, 323, 324, 325, 326, 327, 330, 331,
332, 333, 334, 335, 336, 337, 341, 342, 343, 344, 345, 347, 352,
and 370

RIN 0991-AC36

HHS Acquisition Regulation: Regulatory Review

AGENCY: Department of Health and Human Services.

ACTION: Proposed rule.

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SUMMARY: The Department of Health and Human Services (HHS) is proposing
to amend and update its Health and Human Services Acquisition
Regulation (HHSAR) to update and streamline the HHSAR. Under this
initiative, all parts of the regulation were reviewed to streamline the
regulation, to revise or remove policy superseded by changes in the
Federal Acquisition Regulation (FAR), to remove any procedural guidance
that is internal to HHS into a new HHS Acquisition Manual (HHSAM) as
internal policies, guidance, and instructions. The rule would add new
coverage to implement agency unique requirements. The HHSAR would also
be updated to reflect organizational changes in the Department,
incorporate recent statutory changes and government mandates, and to
accomplish editorial revisions for clarification.

DATES: Comments must be received on or before December 2, 2024, to be
considered in the formulation of the final rule.

ADDRESSES: Submit written comments in response to HHSAR Case 2023-002
through the Federal eRulemaking Portal at: <a href="https://www.regulations.gov">https://www.regulations.gov</a>
by searching for ``HHSAR Case 2023-002''. Select the link ``Comment
Now'' and follow the ``Submit a comment'' instructions. Please include
your name, company name (if any), and indicate they are submitted in
response to ``RIN 0991-AC36--HHS Acquisition Regulation: Regulatory
Review (HHSAR Case 2023-002).''
Warning: Do not include any personally identifiable information
(such as name, address, or other contact information) or confidential
business information that you do not want publicly disclosed. All
comments may be posted on the internet and can be retrieved by most
internet search engines. No deletions, modifications, or redactions
will be made to comments received.
Inspection of Public Comments: All comments received before the
close of the comment period will be available for viewing by the
public, including personally identifiable or confidential business
information that is included in a comment. You may wish to consider
limiting the amount of personal information that you provide in any
voluntary public comment submission you make. HHS may withhold
information provided in comments from public viewing that it determines
may impact the privacy of an individual or is offensive. For additional
information, please read the Privacy Act notice that is available via
the link in the footer of <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the
search instructions on that website to view the public comments.

FOR FURTHER INFORMATION CONTACT: Mr. Jarreau Vieira, Chief, Acquisition
Rule-Making Branch, U.S. Department of Health and Human Services,
Office of the Assistant Secretary for Financial Resources, Office of
Acquisition Policy, 200 Independence Avenue SW, Washington, DC 20201.
Email: <a href="/cdn-cgi/l/email-protection#53323022263a203a273a3c3d0c233c3f3a302a133b3b207d343c25"><span class="__cf_email__" data-cfemail="88e9ebf9fde1fbe1fce1e7e6d7f8e7e4e1ebf1c8e0e0fba6efe7fe">[email&#160;protected]</span></a>, Telephone: (202) 731-4625. This is
not a toll-free telephone number.

SUPPLEMENTARY INFORMATION:

I. Background

This rulemaking is being taken under the authority of the Office of
Federal Procurement Policy (OFPP) Act which provides the authority for
an agency head to authorize the issuance of agency acquisition
regulations that implement or supplement the FAR. The OFPP Act, as
codified in 41 U.S.C. 1702, provides the authority for the FAR and for
the issuance of agency acquisition regulations consistent with the FAR.
This authority ensures that Government procurements are handled fairly
and consistently, that the Government receives overall best value, and
that the Government and contractors both operate under a known set of
rules. The statute at 41 U.S.C. 1121(b) provides authority for the FAR,
while 41 U.S.C. 1121(e), 1702(b)(3)(e), and 1702(c)(2), when read
together, provide authority for the issuance of agency acquisition
regulations consistent with the FAR. HHS issues the HHSAR under these
authorities.
HHS has determined that changes to the HHSAR are necessary to align
it to the FAR. As a result, the HHS Acquisition Policy Division
Integrated Project Team (IPT) under the direction of the Senior
Procurement Executive and composed of representatives from HHS's
operating divisions (OPDIVs) and staff divisions (STAFFDIVs) and other
agency stakeholders, have participated in reviews of the regulation,
resulting in a complete revision of the HHSAR. HHS conducted a
comprehensive review of the HHSAR with the goal of updating obsolete
coverage, streamlining policies and procedures where applicable
consistent with current guidance, and moving internal policies
applicable to the HHS acquisition workforce to a new HHS Acquisition
Manual (HHSAM). The HHSAM will incorporate portions of the internal
procedural guidance removed from the HHSAR, as well as other internal
agency acquisition policy.
This proposed rule reflects changes that need to be made to the
HHSAR to implement and/or supplement the FAR. HHS is proposing to
substantially revise and streamline the HHSAR to update or remove
references to superseded or obsolete policies, procedures, and
organizations and to incorporate electronic links to FAR provisions and
other matters referenced in the HHSAR. Other revisions include
incorporating additional policies, solicitation provisions, and/or
contract clauses into the HHSAR to implement and supplement the FAR and
satisfy HHS unique mission needs and responsibilities. This includes
incorporating changes in dollar and approval thresholds, definitions,
and HHS position titles and offices. The reissued HHSAR proposed in
this notice would correct inconsistencies, remove redundant and
duplicate material already covered by the FAR, delete outdated material
or information, and appropriately renumber HHSAR text, clauses, and
provisions where required to comport with FAR format, numbering, and
arrangement. All amendments, revisions, and removals have been reviewed
and concurred with by a HHSAR revision team from each of the OPDIVs/
STAFFDIVs and key agency stakeholders. This effort will create a 2024
edition of the HHSAR.
Currently, HHS is tracking a number of new FAR case proposed and
final rules, as well as Executive orders (E.O.s) and directives that
the Civilian Agency Acquisition Council and the Defense Acquisition
Regulations Council (the Councils) are reviewing for potential impact
to the FAR system. The Executive orders include E.O. 13985, ``Advancing
Racial Equity and Support for Underserved Communities Through the
Federal Government'' (86 FR 7009; Jan. 25, 2021), E.O. 14005,
``Ensuring the Future is Made in All of America by All of America's
Workers'' (86 FR 7475; Jan. 28, 2021), and E.O. 14008, ``Tackling the
Climate Crisis at Home and Abroad'' (86 FR 7619; Feb. 1, 2021). If and
when FAR cases and proposed

[[Page 80635]]

rules are drafted and FAR final rules are published, HHS intends to
examine each of these for impact to the HHSAR and any updates that may
be required to maintain the HHSAR. HHS is institutionalizing an
ongoing, sustained HHSAR refreshment process, so that as FAR proposed
and final rules, E.O.s, and other directives are issued, HHS will
initiate new HHSAR cases to bring the regulation in alignment and to
avoid duplication, as necessary. HHS will examine any FAR final rules
that become effective and will take into consideration such FAR
changes, as appropriate, in subsequent rulemakings. When needed, HHS
will also consider use of an advanced notice of proposed rulemaking
(ANPRM) to obtain public input as the agency implements rulemaking to
address new and emerging issues that may be identified by the Councils
or by HHS as a result of E.O.s and other directives. HHS will use this
public input to inform how HHS implements such guidance in the HHSAR.
The HHSAR uses the regulatory structure and arrangement of the FAR,
and headings and subject areas are broken up consistent with the FAR
content. The HHSAR is divided into subchapters, parts (each of which
covers a separate aspect of acquisition), subparts, sections, and
subsections.
When Federal agencies acquire supplies and services using
appropriated funds, the purchase is governed by the FAR, set forth at
title 48 Code of Federal Regulations (CFR), chapter 1, parts 1 through
53, and the agency regulations that implement and supplement the FAR.
The HHSAR is set forth at 48 CFR, chapter 3, parts 301 through 370.
HHS is proposing to revise the HHSAR to add new policy or
regulatory requirements and to remove any guidance that is applicable
only to HHS's internal operating processes or procedures. Codified
acquisition regulations may be amended and revised only through
rulemaking.

Discussion and Analysis

HHS proposes to make the following changes to the HHSAR as a part
of its updating and streamlining initiative. For procedural guidance
cited below that is proposed to be deleted from the HHSAR, each section
cited for removal has been considered for inclusion in HHS's internal
agency operating procedures in accordance with FAR 1.301(a)(2).
Similarly, delegations of authorities that are removed from the HHSAR
will be included in the HHSAM as internal agency guidance.
We propose to revise the following parts of the HHSAR, 48 CFR
chapter 3: Parts 301, 302, 303, 304, 305, 306, 308, 309, 311, 312, 313,
314, 315, 316, 319, 322, 323, 324, 326, 327, 330, 331, 332, 333, 334,
335, 336, 337, 342, 352, and 370.
We propose to add seven (7) parts to the HHSAR: Parts 318
(Emergency Acquisitions); 325 (Foreign Acquisition); 341 (Acquisition
of Utility Services); 343 (Contract Modifications); 344 (Subcontracting
Policies and Procedures); 345 (Government Property); and 347
(Transportation).
And, to streamline the HHSAR and improve its use and benefit to the
public, small businesses, and the HHS acquisition workforce, we propose
to remove the following three (3) parts from the HHSAR: Parts 307
(Acquisition Planning); 310 (Market Research); and 317 (Special
Contracting Methods). This would also move internal procedural guidance
still applicable from these parts to the HHSAM, and/or remove outdated
and unnecessary text or policy redundant to the FAR.
We propose to revise the authority citations cited in each HHSAR
part to reflect as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C.
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304. Where
additional authorities for a specific part are applicable, we identify
them under that discussion of each HHSAR part later in this preamble.
We propose to retain the authority of 5 U.S.C. 301. This authority
provides that the head of an Executive department or military
department may prescribe regulations for the government of his
department, the conduct of its employees, the distribution and
performance of its business, and the custody, use, and preservation of
its records, papers, and property.
We propose to retain the authority of 40 U.S.C. 121(c) and slightly
revise the reference. This authorizes the head of each executive agency
to issue orders and directives that the agency head considers necessary
to carry out the FAR.
We propose to include a reference to 41 U.S.C. 1121(c)(3). This
provision states that the authority of an executive agency under
another law to prescribe policies, regulations, procedures, and forms
for procurement is subject to the authority conferred in section 1121,
as well as other sections of title 41.
We propose to add an authority citation for 41 U.S.C. 1702 which
addresses the acquisition planning and management responsibilities of
HHS' Senior Procurement Executive.
And we propose to add the citation of ``48 CFR 1.301 through
1.304'' to reflect the authority and responsibility set forth in the
FAR and delegated to Federal agencies to issue agency regulations that
supplement and implement the FAR.
Any other proposed changes to authorities are shown under the
individual parts below.
Throughout the proposed rule (including in the discussion of each
proposed revised or new HHSAR part), whenever HHS indicates that it
proposes to revise and update the citation(s) to the FAR and HHSAR, it
is for the purpose of comporting with FAR Drafting Guidelines
convention and style, and in accordance with FAR 1.105-2, Arrangement
of regulations, that specifies how the FAR and by extension the HHSAR
is to be referenced within the body of the regulation. References to
revising and updating citations are to either correct the current
citations, correct any FAR or HHSAR references to a more suitable
citation, or add appropriate FAR or HHSAR citations where necessary.

HHSAR Subchapter Headings

Under the authority of 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C.
1121(c)(3); 41 U.S.C. 1702, and 48 CFR 1.301 through 1.304 we propose
to update the following HHSAR subchapter heading to align with the
Federal Acquisition Regulation, title 48, chapter 1:
<bullet> SUBCHAPTER B--COMPETITION AND ACQUISITION PLANNING is
revised to read: SUBCHAPTER B--ACQUISITION PLANNING
We propose to update the following HHSAR subchapter numbering and
heading to provide a similar numbering and heading construct as other
agency supplemental regulations:
<bullet> SUBCHAPTER M--HHS SUPPLEMENTATIONS is revised to read:
SUBCHAPTER I--DEPARTMENT SUPPLEMENTARY REGULATIONS

HHSAR Part 301--HHS Acquisition Regulation System

We propose to revise the authority citations for part 301, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(b), (c)(3); 41
U.S.C. 1303(a)(2); 41 U.S.C. 1702, 1707; and 48 CFR 1.301 through
1.304.
In addition to the authorities described in the Discussion and
Analysis above, we propose to add the authority of the statute at 41
U.S.C. 1121(b) which provides authority for the FAR, while 41 U.S.C.
1121(e), 41 U.S.C. 1702(b)(3)(e), and 41 U.S.C. 1702(c)(2), when read
together, provide authority for the issuance of agency acquisition
regulations consistent with the FAR.

[[Page 80636]]

We also propose to add the authority of 41 U.S.C. 1303(a)(2) to
HHSAR part 301. This authority provides that other regulations relating
to procurement issued by an executive agency shall be limited to
regulation essential to implement Government-wide policies and
procedures within the agency, and additional policies and procedures
required to satisfy the specific and unique needs of the agency. HHS
follows these limitations on the policy and procedures promulgated in
the HHSAR.
We also propose to add the authority of 41 U.S.C. 1707 to HHSAR
part 301. This authority prescribes the required publication of
proposed rules that HHS follows to ensure transparency and the ability
of the public to comment on the unique policies and procedures HHS has
identified to implement specific agency requirements to fulfill its
mission and issue and administer contracts and acquisitions in
accordance with the FAR.
We propose to add section 301.000, Scope of part, to prescribe
general Department of Health and Human Services Acquisition Regulation
(HHSAR) policies, including information regarding the maintenance and
administration of the HHSAR, acquisition policies, and procedures for
deviation from the HHSAR and the Federal Acquisition Regulation (FAR).
In subpart 301.1, Purpose, Authority, Issuance, we propose to
revise section 301.101, Purpose, to remove scope of part language now
covered in section 301.000, as well as moving the remaining language to
the more appropriately placed new subpart 301.3, Agency Acquisition
Regulations, section 301.301, Policy. We propose to add language that
the subpart establishes uniform acquisition policies and procedures to
implement and supplement the FAR, and the authorities under which the
HHSAR is issued.
We propose to revise section 301.103, Authority, to prescribe the
delegated authority by the Secretary of HHS to the Senior Procurement
Executive (SPE) for clarity and explain the authority under which the
HHSAR is issued, move the 48 CFR chapter 3 reference to new section
301.501-1, as well as other administrative edits.
We propose to add section 301.104, Applicability, to prescribe that
the FAR and the HHSAR apply to all HHS acquisitions, except where
expressly excluded.
We propose to add sections 301.105, Issuance, and 301.105-1,
Publication and code arrangement, to identify the HHSAR issuance as 48
CFR chapter 3, which was moved from section 301.103. We propose to add
section 301.105-2 Arrangement of regulations, to prescribe the HHSAR
arrangement, numbering system, and references and citations, to conform
with FAR 1.105-2. We propose to add section 301.105-3, Copies,
regarding access to and HHSAR availability.
We propose to revise section 301.106, OMB Approval under the
Paperwork Reduction Act, to revise the title to comport with FAR 1.106,
and to identify that the list of the information collection and
recordkeeping requirements contained in the HHSAR, approved by the
Office of Management and Budget (OMB), are revised to reflect current
approved information collections. This list would be otherwise publicly
available on <a href="http://reginfo.gov">reginfo.gov</a> after a final rule pertaining to this proposed
rule is published and effective.
We propose to add section 301.107, Certifications, to prescribe
when a new requirement for a certification by a contractor or offeror
may be included in the HHSAR, per 41 U.S.C. 1304(a)(b)(3).
We propose to remove the reserved subpart 301.2, as unnecessarily
needed.
We propose to add subpart 301.3, Agency Acquisition Regulations,
and section 301.301, Policy, where we propose to move the language from
section 301.101 to be more appropriately placed here to describe that
the HHSAR contains HHS policies governing implementation and
supplementation of the FAR, including minor administrative edits.
We propose to add section 301.301-70, Amendment of the HHSAR, as an
HHS supplemental section to the FAR prescribing the processes for
requesting a change to the HHSAR and maintenance of HHSAR and HHSAM
content and publication.
We propose to add section 301.303-70, Publication and
codification--HHSAR, to prescribe that the HHSAR and HHSAM shall
parallel the FAR in format, arrangement, and numbering systems. The
section also establishes that HHSAR titles and numbering sequencing
shall conform with the FAR to the maximum extent practicable, describes
the policy, guidance and/or procedures regarding HHSAR numbering
sequence when supplementing the FAR, and provides unique HHS Operating
Division guidance on supplementary material numbering sequencing.
We propose to add section 301.304, Agency control and compliance
procedures, which provides that the SPE is responsible for amending the
HHSAR for compliance with FAR 1.304.
In subpart 301.470, Deviations from the FAR and HHSAR, we propose
to remove section 301.401, Deviations, and revise the section number
and title to section 301.402, Policy, and propose additional references
to new sections 301.403 and 301.404, as well as administrative edits
for clarification. We propose to add section 301.403, Individual
deviations, to prescribe the delegated authority to the SPE. We propose
to add section 301.404, Class deviations, to prescribe the delegated
authority to the SPE.
In subpart 301.6, Career Development, Contracting Authority, and
Responsibilities, we propose to add section 301.601, General, to
prescribe the delegated authority to the Chief Acquisition Officer and
the SPE, to manage the HHS contracting functions. We propose to add the
authorities delegated to the SPE in paragraph (a), and the authorities
the SPE may further delegate to other HHS officials, such as the heads
of the contracting activities (HCAs), and that HCA's may authorize the
use of ordering officers, in paragraph (b).
We propose to revise section 301.602-3, Ratification of
unauthorized commitments, in paragraph (a) with administrative edits
and to move agency procedural language to be appropriately placed in
the HHSAM. We propose to remove paragraph (b)(2) as repetitive to the
FAR and moving paragraph (c)(5) to the HHSAM as procedural language.
We propose to revise section 301.603, Selection, appointment, and
termination of appointment of contracting officers, and 301.603-1,
General, to establish SPE and re-delegable authority.
We propose to add section 301.603-3, Appointment, to prescribe
agency policy regarding contracting officer appointments and
delegations of authority, and that HCAs may delegate micro-purchase
authority to HHS employees under the HHS Governmentwide Purchase Card
Program.
We propose to add section 301.604, Contracting Officer's
Representative (COR), and 301.604-70, Contract clause, which provides
the prescription for contracting officers to insert the new clause at
352.201-70, Contracting Officer's Representative, in solicitations and
contracts, when the contracting officer intends to designate a COR.
We propose to add section 301.707, Signatory authority, to state
that the signature authorities for determinations and findings, when
delegable in the FAR, are prescribed in the applicable HHSAR parts or
corresponding HHSAM part.

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HHSAR Part 302--Definitions of Words and Terms

We propose to revise the authority citations for part 302, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
In subpart 302.1, Definitions, and section 302.101, Definitions, we
propose to add one new definition, remove one definition, and revise
two existing definitions. We propose to add the definition for ordering
officer, and to remove the definition for Contracting Officer's
Representative as it is duplicative of the FAR. We also propose to
revise the definition for agency head or head of the agency to add
delegation designation clarifications, and to revise the definition for
head of the contracting activity (HCA) to make minor edits and to add
the HHSAR citation for HCA delegated authorities.

HHSAR Part 303--Improper Business Practices and Personal Conflicts of
Interest

We propose to revise the authority citations for part 303, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
In subpart 303.1, Safeguards, we propose to revise the text at
303.101-3, Agency regulations, to specify employee applicability of the
HHS Standards of Conduct, as found in 45 CFR part 73. We propose to
remove 303.104-7, Violations or possible violations of the Procurement
Integrity Act, to appropriately move the content to the HHSAM as agency
procedures.
In subpart 303.2, Contractor Gratuities to Government Personnel, we
propose no revisions to section 303.203, Reporting suspected violations
of the Gratuities clause. We propose to add section 303.204, Treatment
of violations, to provide guidance required by FAR 3.203, and to
provide notice and hearing information required by FAR 3.204. The
section identifies the Suspending and Debarring Official (SDO) as the
official designated to make the determination whether a violation of
the Gratuities clause at FAR 52.203-3 has occurred and what action will
be taken under FAR 3.204(c). We also propose adding the cross reference
to 309.406-3, Procedures, when the SDO determines that a violation has
occurred, and that debarment is being considered.
In subpart 303.6, Contracts with Government Employees or
Organizations Owned or Controlled by Them, we propose to revise section
303.603, Exceptions, with minor administrative edits for clarification.
In subpart 303.7, Voiding and Rescinding Contracts, we propose to
revise section 303.704, Policy, with a minor administrative edit.
We propose to remove subpart 303.10, Contractor Code of Business
Ethics and Conduct, and section 303.1003, Requirements, to
appropriately move the content to the HHSAM as agency procedures.

HHSAR Part 304--Administrative and Information Matters

We propose to revise the authority citations for part 304, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to revise the title of part 304 to ``Administrative and
Information Matters,'' to comport with FAR part 4.
We propose to remove subpart 304.6, Contract Reporting, and section
304.6, General, and propose the content be moved to the HHSAM as agency
procedures.
We propose to remove subpart 304.16, Unique Procurement Instrument
Identifiers, and section 304.1600, Scope of subpart, and we propose the
content be moved to the HHSAM as agency procedures.
In subpart 304.71, Review and Approval of Proposed Contract
Actions, we propose to remove the underlying sections, and reserve the
subpart. We propose to remove section 304.7100, Policy, and propose the
content be moved to the HHSAM as agency procedures.
In subpart 304.72, Affordable Care Act Prevention and Public Health
Fund--Reporting Requirements, section 304.7200, Scope of subpart, we
propose to move some of the language to the retitled section 304.7201,
Policy, due to the nature of the implementing language.
We propose to retitle section 304.7201 as ``Policy,'' and move
paragraphs (a) through (c) to the HHSAM as agency procedures. We
propose minor administrative edits to the remaining content and
restructuring the section to accommodate the relocated from section
304.7200.
We propose to revise section 304.7202, Contract clause, to add the
applicable solicitations and contract actions value of $25,000 or more
threshold, and to provide minor administrative edits.

HHSAR Part 305--Publicizing Contract Actions

We propose to revise the authority citations for part 305, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to remove subpart 305.3, Synopses of Contract Awards,
and section 305.303, Announcement of contract awards, and propose the
content be moved to the HHSAM as agency procedures.
We propose to add subpart 305.4, Release of Information, and
section 305.402, General public, to state that requests from the public
for specific records pertaining to contract actions shall be processed
according to the Freedom of Information Act. We propose to add sections
305.470, Contractor award announcements, advertisements, and releases,
and 305.470-1, Policy, to provide policy that restricts contractors
from referring to its HHS contract(s) in commercial advertising in a
manner that states or implies the Government approves or endorses the
contractor's products or services, or considers them superior to other
products and services. This section also states that HHS contractors
share responsibility for protecting sensitive and classified
information, and approval requirements by the contracting officer prior
to the release of any contract award information by the contractor.
We propose to add section 305.470-2, Contract clause, which would
also prescribe clause 352.205-70, Advertisements, Publicizing Awards,
and Releases, in solicitations and contracts that exceed the simplified
acquisition threshold and includes an Alternate I for contracts
involving sensitive or classified information.
We propose removing subpart 305.5, Paid Advertisements, and section
305.502, Authority, and propose to move the content to the HHSAM as
agency procedures.
In subpart 305.70, Publicizing Requirements Funded From the
Affordable Care Act Prevention and Public Health Fund, we propose minor
administrative edits for clarification to sections 305.7003,
Publicizing preaward, and 305.7004, Publicizing postaward.

HHSAR Part 306--Competition Requirements

We propose to revise the authority citations for part 306, for the
reasons set forth in the discussion and analysis

[[Page 80638]]

section, to read as follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C.
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.
In subpart 306.2, Full and Open Competition After Exclusion of
Sources, we propose to revise section 306.202, Establishing or
maintaining alternative sources, by redesignating paragraph (a) as
paragraph (b)(1) to comport with FAR and HHSAR numbering policy, move
the existing content at paragraph (b)(1) to the HHSAM as agency
procedures, and provide administrative edits for clarification.
In subpart 306.3, Other Than Full and Open Competition, in section
306.302-1, Only one responsible source and no other supplies or
services will satisfy agency requirements, we propose to remove the
reference to FAR 6.302-1 in the title, assign paragraph designation
(a)(2) to the first paragraph to comport with FAR and HHSAR numbering
policy, and to add descriptive implementing language. We propose to add
section 306.302-2, Unusual and compelling urgency, to prescribe
delegated authority to the SPE regarding making the determination that
exceptional circumstances apply when seeking a total period of
performance exceeding one year, including all options, for a contract
awarded or modified using the authority at FAR 6.302-2(d)(1)(ii).
In subpart 306.5, Competition Advocates, we propose to revise the
title to ``Advocates for Competition,'' to comport with the FAR subpart
title. We propose to revise section 306.501, Requirement, to prescribe
the designation of the Advocate for Competition as the Director,
Acquisition Policy Division, Office of Acquisitions (ASFR/APD). We also
propose to add that the Director, ASFR/APD may further delegate this
authority to appoint an alternate agency advocate for competition, and
that the HHS Advocate for Competition shall designate procuring
activity advocates for competition in accordance with FAR 6.501. We
also propose to add the uniform resource locator for the location of
the list of HHS procuring activity advocates for competition.

HHSAR Part 307--Acquisition Planning

We propose to remove and reserve HHSAR part 307 in its entirety
including underlying section 307.105, Contents of written acquisition
plans, as the language is duplicative of the FAR, and to move other
content to the HHSAM as needed as agency internal procedures.

HHSAR Part 308--Required Sources of Supplies and Services

We propose to revise the authority citations for part 308, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to remove subpart 308.4, Federal Supply Schedules, and
section 308.405-6, Limited source justification and approval, as
duplicative to the FAR, and to move some content to the HHSAM as agency
procedures.
In subpart 308.8, Acquisition of Printing and Related Supplies, we
recommend removing sections 308.800, Scope of subpart, and 308.801,
Definitions, as the sections contain content duplicative of the FAR,
and procedural in nature. We propose to move the applicable content to
the HHSAM as agency procedures. In section 308.802, Policy, we propose
to revise the existing content to explicitly state that unless
specifically authorized in HHS contracts, no printing by a contractor
or subcontractor is authorized under an HHS contract. And we propose to
add language that permits contracting officers to authorize limited
printing pursuant to the clause prescribed at section 308.870. We also
propose to remove the information about HHS' designated central
printing authority to the HHSAM as internal agency guidance.
We propose to revise section 308.803 by renumbering and retitling
it to 308.870, Contract clause, which prescribes clause 352.208-70,
Printing and Duplication, to be inserted in all solicitations,
contracts, and orders for supplies or services over the simplified
acquisition threshold, unless printing or increased duplication is
authorized by statute.

HHSAR Part 309--Contractor Qualifications

We propose to revise the authority citations for part 309, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to add subpart 309.1, Responsible Prospective Contracts,
and sections 309.104, Standards, and 309.104-1, General standards, to
establish that for cost-reimbursement or incentive type contracts, or
contracts with progress payments, the prospective contractor's
accounting system must provide reasonable stated assurances.
In subpart 309.4, Debarment, Suspension, and Ineligibility, we
propose adding section 309.400, Scope of subpart, to establish that the
subpart implements FAR subpart 9.4 and prescribes HHS procedures and
related actions for the suspension and debarment of contractors.
We propose to revise section 309.403, Definitions, by adding the
definition for the Suspension and Debarment (S&D) Committee introduced
in revised section 309.406-3. We also propose revising the existing
definition to the Suspending and Debarring Official (SDO) to comport
with the FAR 9.403, as well as revising the title of the appointed HHS
SDO to Deputy Assistant Secretary for Acquisitions, to reflect the
current title.
We propose to remove section 309.404, System for Award Management
(SAM) exclusions, as much of the content is duplicative of the FAR, and
the remaining content be moved to the HHSAM as agency procedures.
We propose to revise section 309.405, Effect of listing, by
removing from the section title ``(compelling reason determinations),''
to comport with the title at FAR 9.405, and to move the existing
content in paragraph (a) to the HHSAM as agency procedures and replace
the content with language to prescribe the delegation of authority to
the SDO and permit further redelegation to the HCA.
We propose to add section 309.405-1, Continuation of current
contracts, which authorizes the continuation of contracts for
contractors debarred (or proposed to be debarred) or suspended. It also
requires a written determination before the award of orders or options
on existing contracts with these contractors (see FAR 9.405-1(a)(2))
and delegates authority to the SDO with further redelegation to the
HCA. We also propose to add section 309.405-2, Restrictions on
subcontracting, which prescribes the delegated authority to the SDO,
who further redelegates the authority to the HCA to consent to a
contractor's use of a subcontractor who is suspended, proposed for
debarment, or is debarred.
We propose to add section 309.406-1, General, to provide additional
SDO debarment consideration and determination factors and examples.
We propose to revise section 309.406-3, Procedures, to include
minor administrative edits to the existing content, and to introduce a
formal Suspending and Debarring Committee (S&D Committee) to assist the
SDO in the final determination for debarment. This section also
provides additional public-facing debarment referral procedures and S&D
Committee procedures for transparency.

[[Page 80639]]

We propose to add sections 309.407, Suspension, and 309.407-1,
General, to prescribe the delegated authority to the SDO to determine
whether to continue business dealings with a suspended contractor, and
to establish the SDO as the suspending official under the Federal
Management Regulation at 41 CFR 102-117.295.
We propose to revise section 309.407-3, Procedures, to include
minor administrative edits to the existing content, and to introduce a
formal Suspending and Debarring Committee (S&D Committee) to assist the
SDO in the final determination for suspension. This section also
provides additional public-facing suspension referral procedures and
S&D Committee procedures for transparency.
We propose to revise section 309.470-1, Situations where reports
are required, to make administrative edits in stating that the
contracting officer shall report to the HCA and SDO regarding the
situations listed thereafter.
We propose to add section 309.471, Fact-finding procedures, to
establish procedures to resolve genuine disputes of material fact
involving debarment or suspension determinations. The section provides
details to include the Office of General Council, witnesses, and other
factors needed to assist the SDO in a final suspension or debarment
determination.
We propose to add subpart 309.5, Organizational and Consultant
Conflicts of Interest, and section 309.503, Waiver, to provide that the
SPE is the designee at FAR 9.403 to waive general rules or procedures
of the subpart. We also propose to add section 309.507-1, Solicitation
provision, which prescribes the new provision at 352.209-70,
Organizational Conflicts of Interest, to be included in any
solicitation for the services addressed at FAR 9.502.

HHSAR Part 310--Market Research

We propose to remove HHSAR part 310, Market Research, and reserve
the part as we propose to remove the coverage currently contained at
section 310.001 as duplicative of the FAR.

HHSAR Part 311--Describing Agency Needs

We propose to revise the authority citations for part 311, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to add subpart 311.1, Selecting and Developing
Requirement Documents, and section 311.103, Market acceptance, to
prescribe that the authority is delegated to the HCA.
We propose to add subpart 311.5, Liquidated Damages, and section
311.501, Policy, to establish that the HCA may reduce or waive the
amount of liquidated damages assessed under a contracts, if the
Commissioner, Financial Management Service, or designee, approves.
We propose to add subpart 311.6, Priorities and Allocations, to
provide information on the HHS Health Resources Priorities and
Allocation System (HRPAS) that is part of the Federal Priorities and
Allocations System. This subpart references guidance and procedures for
use of the Defense Production Act (DPA) priorities and allocations
authority with respect to health resources necessary or appropriate to
promote the national defense as delegated to the Secretary of HHS.
We propose to add section 311.600, Scope of subpart, to establish
that the subpart details information on the HHS HRPAS that is part of
the Federal Priorities and Allocations System. This subpart references
guidance and procedures for use of the DPA priorities and allocations
authority with respect to health resources necessary or appropriate to
promote the national defense as delegated to the Secretary.
We propose to add section 311.601, Definitions, to establish two
definitions, national defense and rated order, as the definitions
differ slightly from the FAR and are derived from 45 CFR part 101.
We propose to add section 311.602-70, The Health Resources
Priorities and Allocation System, to reference Executive Order (E.O.)
13603, National Defense Resources Preparedness, dated March 16, 2012.
This E.O. provides the Secretary the authority to require acceptance
and priority performance of contracts or orders (other than contracts
of employment) to promote the national defense over performance of any
other contracts or orders, and to allocate materials, services, and
facilities as deemed necessary or appropriate to promote the national
defense, with respect to health resources is delegated to the
Secretary.
We propose to add section 311.603, Procedures, and section 311.603-
70, Agency program, to reference specific HHS agency procedures as set
forth in the HRPAS regulations at 45 CFR part 101, which provides
guidance and procedures for use of the DPA priorities and allocations
authority with respect to health resources, including the use of
priority rated orders, necessary or appropriate to promote the national
defense.
In subpart 311.70, Section 508 Accessibility Standards, we propose
to reserve the subpart, as we propose to move the content at section
311.7000, Defining electronic information technology requirements, to
the HHSAM as agency procedures.
In subpart 311.71, Public Accommodations and Commercial Facilities,
we propose to revise section 311.7102, Contract clause, which
prescribes clause 352.211-1, Public Accommodations and Commercial
Facilities, be inserted in solicitations, contracts, and orders
requiring the contractor to conduct events in accordance with
311.7100(b). We propose to revise clause number to 352.211-70, to
comport with FAR numbering convention of supplemental clauses.
In subpart 311.72, Conference Funding and Sponsorship, we propose
minor administrative edits to section 311.7201, Funding and
sponsorship. We also propose to revise section 311.7202, Contract
clause, which prescribes clause 352.211-2, Conference Sponsorship
Request and Conference Materials Disclaimer, be inserted in
solicitations, contracts, and orders providing funding which partially
or fully supports a conference. We propose to revise clause number to
352.211-71, to comport with FAR numbering convention of supplemental
clauses.
In subpart 311.73, Contractor Collection of Information, we propose
minor administrative edits to section 311.7300, Policy. We also propose
to revise section 311.7301, Contract clause, which prescribes clause
352.211-3, Paperwork Reduction Act, be inserted in solicitations,
contracts, and orders that require a contractor to collect the same
information from 10 or more persons. We propose to revise the clause
number to 352.211-72, to comport with FAR numbering convention of
supplemental clauses.

HHSAR Part 312--Acquisition of Commercial Products and Commercial
Services

We propose to revise the authority citations for part 312, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to revise the title of part 312 to ``Acquisition of
Commercial Products and Commercial Services,'' to comport with the FAR
part 12 title.
We propose to remove subpart 312.1, Acquisition of Commercial
Items--General, and section 312.101, Policy,

[[Page 80640]]

moving the content to the HHSAM as agency procedures.
We propose to remove subpart 312.2, Special Requirements for the
Acquisition of Commercial Items, and section 312.202, Market research
and description of agency need, as the content is duplicative to the
FAR.
We propose adding subpart 312.3, Solicitation Provisions and
Contract Clauses for the Acquisition of Commercial Products and
Commercial Services, consisting of section 312.301, which prescribes
clause 352.212-70, Gray Market and Counterfeit Items, which requires
the contracting officer to insert in solicitations and contracts for
new medical supplies, new medical equipment, new information technology
equipment, and maintenance of medical or information technology
equipment that includes replacement parts, if used, refurbished, or
remanufactured parts are unacceptable, when the associated solicitation
includes FAR provisions 52.212-1, Instructions to Offerors--Commercial
Products and Commercial Services, and 52.212-2, Evaluation--Commercial
Products and Commercial Services.

HHSAR Part 313--Simplified Acquisition Procedures

We propose to revise the authority citations for part 313, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to revise part 313, Simplified Acquisition Procedures,
to remove one section and substantively revise subpart 313.3 to enact
legislative requirements. We propose to remove section 313.003, Policy,
which provides section 508 of the Rehabilitation Act of 1973 guidance
for Information and Communication Technology acquisition. This guidance
is also found at 339.203(a) and will be addressed in the HHSAM in part
339.
We also propose to revise subpart 313.3, Simplified Acquisition
Methods, and section 313.301, Governmentwide commercial purchase card.
The existing content at 313.301 is removed and placed in the HHSAM as
it is more appropriate for internal agency operating procedures. We
propose to redesignate the section as 313.301-70, revise the heading to
read ``Governmentwide commercial purchase card--purchases of PPE'', and
state that the Infrastructure Investment and Jobs Act (IIJA), Public
Law 117-58, Subtitle C, Make Personal Protective Equipment (PPE) in
America (MPPEIA), applies to all purchases of PPE including those
transactions made using the Governmentwide commercial purchase card
under the micro-purchase threshold. We are including a cross reference
to subpart 325.71 for definitions, restrictions, and exceptions, when
procuring PPE.

HHSAR Part 314--Sealed Bidding

We propose to revise the authority citations for part 314, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to remove subpart 314.1, Use of Sealed Bidding, and
section 314.103, Policy, which states that electronic and information
technology supplies and service shall comply with section 508 of the
Rehabilitation Act of 1973, as the content is appropriately covered in
part 339, Acquisition of Information Technology.
We propose to retain subpart 314.4, Opening of Bids and Award of
Contract, and section 314.404-1, Cancellation of invitations after
opening, with no change to the content. We propose to revise section
314.407-3, Other mistakes disclosed before award, to add delegation,
without redelegation, language to the HCA's authority. We also propose
to revise section 314.407-4, Mistakes after award, to add delegation,
without redelegation, language to the HCA's authority.
We propose to add sections 314.408, Award, and 314.408-70, Award
when only one bid is received, to provide when only one bid is received
in response to an invitation for bids, such bid may be considered and
accepted if the contracting officer makes a written determination,
approved one level above the contracting officer, documenting the
stated issues in the section, and that the determination shall be
placed in the contract file.

HHSAR Part 315--Contracting by Negotiation

We propose to revise the authority citations for part 315, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
In subpart 315.2, Solicitation and Receipt of Proposals and
Information, we propose to remove section 315.204-5, Part IV--
Representations and instructions, as the content is repetitive to the
FAR, and moving some content to the HHSAM as agency procedure.
We recommend retaining section 315.208, Submission, modification,
revision, and withdrawal of proposals, as a title with no content, and
moving the current content to new section 315.208-70, Submission,
modification, revision, and withdrawal of proposals--R&D acquisitions,
to clarify that the content applies in the case of biomedical or
behavioral research and development acquisitions only. We also propose
to restructure the content into redesignated paragraph numbers.
Paragraph (a) contains the original 315.208(b) text, revised for
clarity. Paragraph (b) is a new proposed paragraph that sets forth the
policy permitting the contracting officer to consider a proposal
received concerning biomedical or behavioral research and development
(R&D) acquisitions after the date specified for receipt, under certain
conditions. It is based on the existing provision at 352.215-70, Late
Proposals and Revisions, that pertains only to biomedical or behavioral
R&D solicitations using competitive proposals. While the provision
itself was previously codified, there was no corresponding policy in
the HHSAR, which is now provided. Paragraph (c) contains the original
315.208(b)(2) content. We propose redesignating the paragraph as
paragraph (c), removing the acronym ``HCA'', and substituting it with
``contracting officer'' to reflect that the contracting officer will
exercise this authority rather than the HCA.
We propose to add section 315.209-70, Solicitation provision, which
prescribes the provision 352.215-70, Late Proposals and Revisions--R&D
Solicitations, in biomedical or behavioral R&D competitive acquisition
solicitations subject to the requirements of 315.208-70(a) and the
authorization of the HCA.
In subpart 315.3, Source Selection, we propose to revise section
315.303-70 by incorporating administrative edits and formatting
revisions to the section for clarification.
We propose to revise section 315.304, Evaluation factors and
significant subfactors, by removing the term ``electronic and
information technology (EIT)'' and replacing it with ``information and
communication technology (ICT)'' to comport with FAR subpart 315.3
terminology. We propose to revise the section to provide clarity that
the requirement is that contracting officers shall include a separate
technical evaluation factor pertaining to compliance with section 508
requirements, rather than the language as now shown that appears to
just require contracting officers to comply with the general tenets of
section 508. We also propose to add a reference to 339.203.

[[Page 80641]]

We propose to revise section 315.305, Proposal evaluation, by
removing the content and leaving the header with no text. We propose
adding section 315.305-70, Proposal evaluation--use of non-Federal
evaluators, and revising and updating the content now at 315.305(c)(1)
through (2) and move it to 315.305-70. Accordingly, we propose to
reformat and redesignate the text in section 315.305 from paragraphs
(c)(1) and (2) to paragraphs (a) and (b) to comport with FAR numbering
requirements, and to include paragraphs (b)(1) through (4), and to add
a new paragraph (c) to outline HHS's policy with respect to use of non-
Federal evaluators. We also propose administrative edits in the section
for clarification.
In paragraph (a), we propose to add language that add the
requirement that the Source Selection Authority or the contracting
officer, as applicable, make the decision to disclose proposals to non-
Federal evaluators and to add a reference to FAR 15.305(c) at the end
of the paragraph.
In paragraph (b), redesignated from paragraph (c)(1), we propose to
add content that when an offeror's or contractor's proposal will be
disclosed outside the Government, the provision prescribed at 315.305-
71 requires that the contractor and its employees, as well as any
subcontractors and their employees, agree that when performing work as
an evaluator under a Government contract that they will use the data
(trade secrets, business data, and technical data) contained in the
proposal for evaluation purposes only. Proposed paragraphs (b)(1)
through (4) provides other conditions and restrictions on use of non-
Federal evaluators. In paragraph (c), it requires that the agreement
shall be signed by the contractor and the assigned contractor employee,
subcontractor, or consultant (i.e., the non-Federal evaluator) and
filed in the contract file of an offeror's proposal.
We propose to add section 315.305-71, Solicitation provision, to
prescribe the provision at 352.215-71, Use of Non-Federal Evaluators--
Conditions for Evaluating Proposals, in solicitations when the
Government may use non-Federal evaluators to evaluate an offeror's or
contractor's proposals and offers.
In subpart 315.4, Contract Pricing, at section 314.404-2, Data to
support proposal analysis, we propose to revise the section title to
comport with the FAR section title, provide administrative edits within
the section for clarification, and move some of the content to the
HHSAM as agency procedures.
In subpart 315.6, Unsolicited Proposals, we propose to add section
315.604, Agency points of contact, to establish minimum information
that HHS operating divisions/staff divisions must make available to
potential offerors of unsolicited proposals in accordance with FAR
15.604(a) and assigning this responsibility to the HCAs. Additionally,
we propose adding a uniform resource locator to the HHS internet web
page to provide the HHS point of contact information.
We propose to revise section 315.605-70, Content of unsolicited
proposals--warranty by offeror, by revising the title and number of the
section to redesignate it as a supplement to the FAR, and to add ``--
warranty by offeror,'' to reflect the focus of the content,
distinguishable from the FAR. We also propose minor administrative
edits to comport with FAR formatting requirements.
We propose to retain section 315.606, Agency procedures, with no
changes.
We propose to revise section 315.606-1, Receipt and initial review,
to redesignate the paragraph number to comport with the appropriate FAR
paragraph being implemented.

HHSAR Part 316--Types of Contracts

We propose to revise the authority citations for part 316, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
In subpart 316.3, Cost-Reimbursement Contracts, section 316.307,
Contract clauses, we propose to revise paragraph (a)(1), which
prescribes clause 352.216-70, Allowable Cost and Payment for Hospitals,
and requires contracting officer to insert the clause in solicitations
and contracts when a cost-reimbursement contract with a hospital
(profit or non-profit) is contemplated and when the clause 52.216-7 is
inserted in the contract. We propose to revise the content with
administrative edits for clarification. We also propose to revise the
clause content with administrative edits to remove the reference to 45
CFR part 75. We also propose to remove paragraph (a)(2), which
prescribes clause 352.216-70, Additional Cost Principles for Hospitals
(Profit and Non-Profit), and requires contracting officer to insert the
clause when a cost-reimbursement contract with a hospital (profit or
non-profit) is contemplated. We propose to appropriately move this
clause to part 331, Contract Cost Principles and Procedures.
In subpart 316.5, Indefinite-Delivery Contracts, section 316.505,
Ordering, we propose to revise paragraph (b)(8) to update the title of
the HHS Advocate for Competition to comport with FAR usage and to
designate the HHS Advocate for Competition as the task-order and
delivery-order ombudsman. The section is also updated to require each
HHS HCA to designate, in writing, a task-order and delivery-order
ombudsman and to provide the website on the HHS internet where this is
listed.
We propose to remove subpart 316.6, Time-and-Materials, Labor-Hour,
and Letter Contracts, and sections 316.603, Letter contracts, and
316.303-3, Limitations, as internal operational procedures or
delegations that will be moved to the HHS Acquisition Manual (HHSAM).

HHSAR Part 317--Special Contracting Methods

We propose to remove part 317, Special Contracting Methods, and
reserve the part as we propose to remove the current part content.
We propose to remove subpart 317.1, Multi-Year Contracting, and
section 317.104, General, moving the content to the HHSAM as agency
procedure.
We propose to remove sections 317.105, Policy, and 317.105-1, Uses,
moving the content to the HHSAM as agency procedure.
We propose to remove section 317.107, Options, moving the content
to the HHSAM as agency procedure.
We propose to remove section 317.108, Congressional notification,
moving the content to the HHSAM as agency procedures.
We propose to remove subpart 317.2, Options, and section 317.204,
Contracts, removing most of the content as duplicative to the FAR, and
moving the remaining content to the HHSAM as agency procedures.

HHSAR Part 318--Emergency Acquisitions

We propose to add the authority citations for part 318, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to add section 318.000 to identify that part 318 will
set forth additional emergency acquisition flexibilities. We also
propose to add section 318.001, Definition, and section 318.001-71,
Agency delegation of determination, to prescribe the delegated
authority to the HCA to utilize emergency acquisition flexibilities and
make the agency head determinations as

[[Page 80642]]

set forth in FAR part 18 and as defined in subpart 318.2.
We propose to add subpart 318.1, Available Acquisition
Flexibilities, section 318.109, Priorities and allocations, and section
318.109-70, The Health Resources Priorities and Allocation System, to
provide description and reference to subpart 311.6 to comport with FAR
formatting.
We propose to add subpart 318.2, Emergency Acquisition
Flexibilities, and section 318.202-70, Specific HHS flexibilities, to
provide four specific definitions to reflect the delegated emergency
authorities for: the Micro-purchase threshold; the Simplified
acquisition threshold; Commercial product or commercial service
treatment; and Simplified procedures for certain commercial products
and commercial services.
We propose to add 318.270, Head of the agency delegations, to
prescribe the delegated authority to the HCA to make the determinations
in the listed FAR references, which include FAR 2.101, definitions of
``Simplified acquisition threshold'' and ``Micro-purchase threshold,
12.102(f), 13.201(g), and 13.500(c)(1).

HHSAR Part 319--Small Business Programs

We propose to revise the authority citations for part 319, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 15 U.S.C. 631, et seq.; 40 U.S.C. 121(c); 41
U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to add the authority of 15 U.S.C. 631, et seq. (the
Small Business Act), as an authority pertaining to small business
programs.
We propose to clarify subpart 319.2, Policies, by making minor
administrative updates in citations, references, and titles of
individuals.
We propose redesignating paragraph (d) of 319.201as paragraph (c)
to align with FAR 19.201, as the topical coverage more appropriately
falls under paragraph (c). We also add ``Executive'' to the title for
the OSDBU Director.
We propose redesignating paragraph (e) of 319.201 as paragraph (d)
to align with FAR 19.201, as the topical coverage more appropriately
falls under paragraph (d). We are removing the language that dealt with
SBS review of all acquisitions that are not set-aside. The matter is
more appropriately addressed in internal procedural policy in the HHS
Acquisition Manual (HHSAM).
In subpart 319.2, we are adding section 319.202 to provide the
requirement that contracting officers document set-aside actions and
recommendation on HHS Form 653, Small Business Program Review.
We propose to remove the coverage concerning unique mentor-
prot[eacute]g[eacute] clauses as the HHS Mentor Prot[eacute]g[eacute]
(MP) program is no longer in effect. Therefore, references to the
program and related clauses have been deleted from the HHSAR. HHS
follows the SBA Federal-wide guidance.
We propose adding subpart 319.8, Contracting With the Small
Business Administration (the 8(a) Program), to provide coverage for the
SBA partnership agreement. Under this subpart we are adding coverage at
sections 319.800, General, 319.811, Preparing the contracts, and
319.811-370, SBA Partnership Agreement and contract clauses. This
subpart prescribes two new clauses to be used when an 8(a) acquisition
is processed pursuant to the Partnership Agreement: 352.219-72, HHS
Notification of Competition Limited to Eligible 8(a) Participants, and
for noncompetitive solicitations and awards, we propose adding the
clause at 352.219-73, Notification of Section 8(a) Direct Awards,
instead of the prescribed FAR clauses at 52.219-11, Special 8(a)
Contract Conditions; 52.219-12, Special 8(a) Subcontract Conditions;
and 52.219-17, Section 8(a) Award, as it governs HHS unique agency
requirements.

HHSAR Part 322--Application of Labor Laws to Government Acquisitions

We propose to revise the authority citations for part 322, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to revise HHSAR part 322 by adding a new subpart 322.1
and revising the existing subpart 322.8.
We propose to add subpart 322.1, Basic Labor Policies, to provide
the procedures for the admittance of union representatives to HHS
facilities. Under this subpart we propose to add section 322.101, Labor
relations, as a header with no underlying text. We propose to add
section 322.101-70, Admittance of union representatives to HHS
facilities, to provide necessary admittance policy and procedures, and
reporting requirements if entry is denied. In paragraph (a) it states
that it is HHS policy to admit labor union representatives of
contractor employees to HHS facilities to visit work sites and transact
labor union business with contractors, their employees, or union
stewards pursuant to existing union collective bargaining agreements.
Their presence shall not interfere with the contractor's work progress
under an HHS contract nor violate the safety or security regulations
that may be applicable to persons visiting the facility. The union
representatives will not be permitted to conduct meetings, collect
union dues, or make speeches concerning union matters while visiting a
work site. Paragraph (b) would require that whenever a union
representative is denied entry to a facility or work site, the person
denying entry shall make a written report to the HHS labor coordinator,
the Office of the General Counsel (OGC), or corresponding labor
advisor, with a copy to the cognizant contracting officer within two
working days after the request for entry is denied. The report shall
include the reason(s) for the denial, the name of the representative
denied entry, the union affiliation and number, and the name and title
of the person that denied the entry.
We propose to revise subpart 322.8, Equal Employment Opportunity,
to include a new section 322.808, Complaints. The new section would
require that contractors shall, in good faith, cooperate with HHS in
investigations of Equal Employment Opportunity (EEO) complaints
processed pursuant to 29 CFR part 1614 and in accordance with clause
352.222-70 as prescribed in this subpart.
We propose to revise section 322.810, Solicitation provisions and
contract clauses, to redesignate the paragraph from (h) to (e) to
properly align with the FAR, and to add ``and Anti-Harassment'' to the
title of the clause, 352.222-70, so the title of the clause would read
``Contractor Cooperation in Equal Employment Opportunity and Anti-
Harassment Investigations.'' The clause is prescribed to be included in
solicitations, contracts, and order that include the clause at FAR
52.222-26, Equal Opportunity.

HHSAR Part 323--Environment, Sustainable Acquisition, and Material
Safety

We propose to revise the authority citations for part 323, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to revise HHSAR part 323 by updating the header of the
part to ``Environment, Sustainable Acquisition, and Material Safety,''
to align with the title for FAR part 23 recently updated effective May
22, 2024, via FAR Case 2022-006 (RIN 2900-AO43) final rule (89 FR
30212). Additionally, we propose

[[Page 80643]]

moving text from existing sections to a new subpart 323.3 to properly
align with the FAR, and to redesignate existing subpart 323.71 to 323.1
as described below.
We propose to remove sections 323.7000, 323.7001, and 323.7002 and
move the coverage under a new subpart 323.3 where it will align with
the FAR coverage concerning hazardous material identification.
We propose to revise subpart 323.71, Sustainable Acquisition
Requirements, by renumbering and retitling the header for the subpart
as 323.1, Sustainable Products and Services. This aligns with the
updated FAR subpart title and numbering. We propose to remove sections
323.7101 and 323.7102 as internal agency procedures that will be
updated and moved to the HHSAM. The remaining sections, 323.7100 and
323.7103, would be renumbered as 323.103-70 and 323.109-70,
respectively to appropriately align with the FAR.
In proposed section 323.103-70, Policy--Sustainable Acquisition
Plan, the existing text is removed as unnecessary and redundant to the
FAR. A new paragraph (a) is added to provide that contracting officers
may, for new contracts and orders above the micro-purchase threshold,
insert an evaluation factor on the offeror's Sustainable Action Plan in
the solicitation. And a new paragraph (b) is added to require that
offerors, when the solicitation includes the provision prescribed at
323.109-70 (i.e., the newly numbered 352.223-70, Instructions to
Offerors--Sustainable Acquisition Plan), offerors shall include a
Sustainable Acquisition Plan in their technical proposal addressing
sustainable products for services for delivery under any resulting
contract, and that the contracting officer shall incorporate the final
Sustainable Acquisition Plan into the contract.
In proposed section 323.109-70, Solicitation provision, the
prescribed provision number is updated to reflect 352.223-70, and the
title is updated to reflect ``Instructions to Offerors--Sustainable
Acquisition Plan.''
We propose to add subpart 323.3, Hazardous Material Identification,
Material Safety Data, and Notice of Radioactive Materials, to reflect
the revised FAR header at FAR subpart 23.3, and we propose to add
underlying sections 323.300 and 323.304-70. The new subpart aligns with
the FAR and adds updated language moved from sections 323.7000,
323.7001, and 323.7002. Section 323.300, Scope of subpart, identifies
this subpart provides procedures for administering safety and health
requirements. In section 323.304-70, Contract clause, clause 352.223-
71, Safety and Health, is prescribed to be inserted in solicitations
and contracts that involve hazardous materials or hazardous operations
and details for which types of requirements.

HHSAR Part 324--Protection of Privacy and Freedom of Information

We propose to revise the authority citations for part 324, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to make only limited revisions at this time to HHSAR
part 324 as this part will be updated through future rulemaking. To
align with FAR numbering conventions in FAR subpart 24.1, we propose to
renumber 324.103 to 324.103-70 and renumber 324.104 to 324.103-71. We
propose to amend section 324.105, Contract clauses, by renumbering it
to 324.104 to align with the FAR and revising paragraph (b) to add at
the end of the sentence for the prescription of HHSAR clause 352.224-
71, Confidential Information, the phrase ``. . . and in solicitations,
contracts, and orders that include the clause at 352.227-71, Rights in
Data--Supplement--Exceptional Circumstances.'' We also propose in this
sentence to remove the word ``to'' in front of ``third party
information'' so it would read ``to Government or third party
confidential information.''

HHSAR Part 325--Foreign Acquisition

We propose to revise the authority citations for part 325, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to add HHSAR part 325 to provide agency policies and
procedures and the restrictions on Make Personal Protective Equipment
(PPE) in America. This rule would add subpart 325.71, Make PPE in
America Act Restrictions on Foreign Acquisition of Personal Protective
Equipment, and underlying sections 325.7100 through 325.7103 as
described below.
In section 325.7100, Scope of subpart, it indicates that the
subpart contains restrictions on the acquisition of certain personal
protective equipment as required by the Make PPE in America Act (Pub.
L. 117-58) for solicitations and contracts issued by HHS (among other
agencies not included under the purview of this regulation). This
subpart would codify the class deviation to the HHSAR issued by the HHS
Senior Procurement Executive on February 9, 2023, that implemented the
Make PPE in America Act, Division G, Title IX, Subtitle C, secs. 70951-
70953 of the Infrastructure Investment and Jobs Act (Pub. L. 117-58),
dated November 15, 2021. On November 15, 2021, the President signed,
the Infrastructure Investment and Jobs Act (IIJA). As part of the IIJA,
Congress enacted the Make PPE in America Act (the Act). In promulgating
the Act, Congress found, among other things, that the COVID-19 pandemic
exposed the vulnerability of the United States' supply chains with
respect to PPE and the lack of domestic production of PPE, including
the components and materials thereof. To meet the needs for a long-term
investment strategy for the domestic production of PPE items critical
to the U.S. national response to a public health emergency, including,
but not limited to, the COVID-19 pandemic, the Act requires action by
HHS, the Department of Homeland Security, and the Department of
Veterans Affairs (the covered agencies). To incentivize domestic
manufacturing of PPE, the Act imposes certain requirements for
contracts awarded by the covered agencies for the procurement of PPE.
The class deviation issued by the Senior Procurement Executive
implemented the tenets of the Act applicable to HHS in advance of
rulemaking. This rule seeks public comment on the proposed language to
be added to the HHSAR that HHS has been following and in effect at the
agency since February 9, 2023.
In section 325.7101, Definitions, we propose six definitions to
ensure common understanding and meaning as used in this part--
component, domestic personal protective equipment, foreign-made
domestic personal protective equipment, foreign personal protective
equipment, personal protective equipment, and United States.
We propose to add section 325.7102, Restrictions on certain
personal protective equipment, as a header with no text.
In section 325.7102-1, Restrictions, certain restrictions are
identified that implement section 70952 of the Make PPE in America Act,
and they apply to all contracts and orders for the purchase of personal
protective equipment. These restrictions include the requirement for
contracting officers to purchase domestic personal protective equipment
(PPE), except as provided in section 325.7102-2, Exceptions. And the
text provides that any contract for PPE shall have a base period of
performance of at least two years, plus any option periods, as required
by law.

[[Page 80644]]

In section 325.7102-2, Exceptions, paragraph (a) provides that
acquisitions of PPE in certain categories are not subject to the
restrictions in section 325.7102-1, to include PPE where the HHS
Secretary has maximized sources for foreign-made domestic PPE, and
where the HHS Secretary certifies every 120 days that it is necessary
to procure PPE under alternative procedures to respond to the immediate
needs of a public health emergency. Other exceptions set forth in
paragraph (b) include an item of PPE or component thereof, including
those described in paragraph (a), that is, or includes, a material
listed in FAR 25.104 as one for which a nonavailability determination
has been made; or to which the HHS Secretary--
<bullet> Determines that a sufficient quantity of a satisfactory
quality that is grown, reprocessed, reused, or produced in the United
States cannot be procured as, and when, needed at United States market
prices; and
<bullet> Certifies every 120 days that it is necessary to procure
PPE to respond to the immediate needs of a public health emergency.

Under paragraph (c), the HHS Secretary is authorized to make the
certification in paragraphs (a) and (b) or the nonavailability or
unreasonable cost determination; supporting documentation requirements
and approval levels are further outlined for the public.
In section 325.7103, Solicitation provisions and contract clauses,
paragraph (a), clause 352.225-70, Made in America--Personal Protective
Equipment, is prescribed to be inserted in solicitations and contracts,
regardless of dollar value, when procuring any item covered under
325.7102-1(a). And in paragraph (b), provision 352.225-71, Made in
America Certificate--Personal Protective Equipment, would be required
to be inserted in solicitations containing the clause at 352.225-70.

HHSAR Part 326--Other Socioeconomic Programs

We propose to revise the authority citations for part 326, for the
reasons set forth in the discussion and analysis section and as
described below, to read as follows: 5 U.S.C. 301; 25 U.S.C. 47; 25
U.S.C. 1633; 25 U.S.C. 5301 et seq.; 40 U.S.C. 121(c); 41 U.S.C.
1121(c)(3); 41 U.S.C. 1702; 42 U.S.C. 2003 and 48 CFR 1.301 through
1.304. We propose to retain the existing authorities of 5 U.S.C. 301;
25 U.S.C. 47; 25 U.S.C. 1633; and 42 U.S.C. 2003 as applicable to the
subject matter and requirements set forth in the part. We removed the
authority citation for 41 U.S.C. 253(c)(5) as it no longer exists.
Additionally, we propose to add the authority citations for 40 U.S.C.
121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through
1.304 as set forth in the discussion and analysis section above, to
align part 326 with the other parts set forth in 48 U.S.C. chapter 3.
We propose to add one additional authority under which Public Law 93-
638 was recodified: 25 U.S.C. 5301 et seq., as it sets forth
requirements that impact acquisitions under 25 U.S.C. chapter 46,
Indian Self-Determination and Education Assistance.
We propose to make minor administrative and non-substantive
technical changes to the part to update numbering conventions to FAR
drafting standards, to spell out words, correct capitalization, and
update references, including revising the table of contents and
numbering of current subparts to properly align with the FAR and
conform to FAR drafting conventions as follows:
<bullet> Revise the current subpart numbering for subpart 326.5,
Indian Preference in Employment, Training, and Subcontracting
Opportunities, to subpart 326.70. The underlying sections and
subsections would be renumbered accordingly. Other numbering and minor
administrative edits are made to comport with FAR drafting guidelines.
<bullet> Revise the current subpart numbering for subpart 326.6,
Acquisitions Under the Buy Indian Act, to subpart 326.71. The
underlying sections and subsections would be renumbered accordingly.
Other numbering and minor administrative edits are made to comport with
FAR drafting guidelines.
<bullet> Revise the current subpart numbering for subpart 326.7,
Acquisitions Requiring the Native American Graves Protection and
Repatriation Act, to subpart 326.72. The underlying sections and
subsections would be renumbered accordingly.
We also propose to make certain limited revisions to update the
part:
<bullet> In section 326.501 (proposed to be renumbered to 326.7001,
we updated to the current citations.
<bullet> In section 326.502 (proposed to be renumbered and retitled
to 326.7002, Additional Definitions), we propose the following changes:
(1) delete section 326.502(c) and (d) as duplicative of FAR 26.101; (2)
add definitions to reflect those at 25 U.S.C. 3504; (3) revised
paragraph (b); (4) redesignate paragraphs (a), (b), (e), and (f), and;
(4) revise this section by renumbering 326.502 as shown to comport with
the FAR drafting guidelines. We propose to add the following
definitions: construction contract, construction programs, contract
funding, direct program costs, indirect costs, indirect cost rate,
mature contract, Secretary, self-determination contract, state
education agency, Tribal organization or as relevant to the part and
the usage from the cited authorities.
<bullet> In 326.505 (proposed to be renumbered to 326.7005), we
propose to revise the header title to read ``Contract clauses'' in lieu
of ``Applicability'' as the section prescribes two clauses: 352.226-70,
Indian Preference, and 352.226-71, Indian Preference Program, and the
naming convention for the header comports with the FAR.
<bullet> In subpart 326.6, Acquisitions Under the Buy Indian Act,
we have made minimal revisions. Note: An update to subpart 326.6,
Acquisitions Under the Buy Indian Act, took place recently. The update
was published in the Federal Register on 1/13/2022, with an effective
date of March 14, 2022. The rule is intended to establish Buy Indian
Act acquisition policies and procedures for HHS that are consistent
with rules proposed and/or adopted by the Department of the Interior
(DOI). Due to the recent HHSAR changes and the tremendous collaborative
effort to implement time sensitive legislative mandates, we are not
proposing any substantive changes to this subpart. However, there are
minor technical changes that are necessary to integrate this
collaborative effort into the HHSAR update project to be FAR compliant.
These changes include the following:
[cir] We propose to revise this subpart by renumbering 326.6 as
shown to comport with the FAR drafting guidelines. Specifically, we
recommend this subpart be referenced as 326.71 since it is unique to
HHS and has no correlation to the programs under the FAR part. Headings
and references within the subpart have been updated to reflect the new
numbering scheme. The underlying sections and subsections would be
renumbered accordingly. Other numbering and minor administrative edits
are made to comport with FAR drafting guidelines.
[cir] In section 326.602 (proposed to be renumbered to 326.7102),
we propose to revise the header title to ``Applicability'' and to add
the text that will be moved from 326.602-1.
[cir] We propose to remove 326.602-1, Scope of part. The placement
and text for this material more properly falls under the proposed
section 326.7102, Applicability.
[cir] In section 326.604-2, Procedures for Acquisitions under the
Buy Indian Act (proposed to be renumbered to 326.7104-2), we propose to
remove

[[Page 80645]]

paragraph (e) in its entirety and move the prescriptions for clauses
under a new proposed section 326.7104-5, Solicitation provisions and
contract clauses, to comport with FAR drafting convention and style.
[cir] We propose to add section 326.7104-4, Performance and payment
bonds. This text is moved from a section proposed to be removed,
326.605-2, Performance and payment bonds, to reflect the requirements
of 25 U.S.C. 47a and to permit contracting officers to accept
alternative forms of security in lieu of performance and payment bonds
if a determination is made that such forms of security provide the
Government with adequate security for performance and payment.
[cir] We propose to renumber and retitle section 326.605, Contract
Requirements, to 326.7105, Solicitation provisions and contract
clauses, and move the prescriptions for the existing provisions and
clauses in 326.604-2(c) to this section and renumber the provisions and
clauses accordingly: 352.226-73, Notice of Indian Small Business
Economic Enterprise Set-Aside; 352.226-74, Notice of Indian Economic
Enterprise Set-Aside; 352.226-75, Indian Economic Enterprise
Subcontracting Limitations; and 352.226-76, Indian Economic Enterprise
Representation; and 352.226-75, Indian Economic Enterprise
Subcontracting Limitations.
[cir] We propose to remove section 326.605-2, Performance and
payment bonds. Updated text concerning the requirements under this
paragraph is proposed to move to section 326.7104-4, Performance and
payment bonds, as the placement earlier in the subpart is more
appropriate with the last section of the subpart reflecting any
prescribed provisions or clauses to comport with FAR drafting
conventions.
[cir] In section 326.606-2, Representation provision, we propose to
renumber it to 326.7106-2 based on the renumbering of all sections
within the subpart, and adding one requirement in paragraph (c) for the
contracting officer to include the documentation in the file, when the
head of the contracting activity is informed in writing of all
suspected Indian Economic Enterprise (IEE) misrepresentations by an
offeror or failure to provide written notification of a change in IEE
eligibility.
<bullet> In subpart 326.7, Acquisitions Requiring the Native
American Graves Protection and Repatriation Act, we propose to revise
this subpart by renumbering it as subpart 326.72 to comport with the
FAR drafting guidelines and reflect as a unique HHS supplement. The
underlying sections and subsections would be renumbered accordingly.
Other numbering and minor administrative edits are made to comport with
FAR drafting guidelines.

HHSAR Part 327--Patents, Data, and Copyrights

We propose to revise the authority citations for part 327, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
In subpart 327.3, Patent Rights Under Government Contracts, we
propose to revise section 327.303 by renumbering it to 327.303-70 and
changing the header to read ``Contract clause'' in lieu of
``Solicitation provision and contract clause'' since it prescribes only
one clause. We also propose to update the text to reflect the revised
numbering and title of clause 352.227-11, Patent Rights--Exceptional
Circumstances, to now read, ``352.227-70, Patent Rights--Supplement--
Exceptional Circumstances,'' and to prescribe its use in solicitations,
contracts, and orders that include the FAR clause at 52.227-11, Patent
Rights--Ownership by the Contractor. Instructions to the contracting
officer that are internal operating procedures are removed and will be
revised and moved to the HHSAM.
In subpart 327.4, Rights in Data and Copyrights, we propose to
remove section 327.404-70, Solicitation provision and contract clause,
as the prescription is being moved to section 327.409 where all the
subpart's prescriptions will be located.
We propose to revise section 327.409, Solicitation provision and
contract clauses, by renumbering it to 327.409-70 and revising the
header title to ``Contract clauses'' to reflect that only contract
clauses are prescribed in the subpart. In paragraph (a) we propose to
update the citation to the prescribed clause 352.227-14 and renumber it
to ``352.227-71'' to comport with FAR drafting guidelines, and to
retitle the clause to ``Rights in Data--Supplement--Exceptional
Circumstances.'' We also propose to prescribe its use in solicitations,
contracts, and others that include the FAR clause at 52.227-14, Rights
in Data--General, and have updated the grammar and structure of the
sentence to provide clarity.
We propose to add paragraph (b) to set forth the prescription for
the clause moved from the removed section 327.404-70, and renumber the
clause from ``352.227-70, Publications and Publicity'' to ``352.227-72,
Publications and Publicity.''

HHSAR Part 330--Cost Accounting Standards

We propose to revise the authority citations for part 330, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
In subpart 330.2, CAS Program Requirements, in section 330.201-5,
Waiver, we propose to revise his section to restructure and clarify the
sentence that states the Senior Procurement Executive is authorized to
exercise the waiver authority under FAR 30.201-5(a)(1) when the
conditions at FAR 30.201-5(a)(1) are met. We propose to remove the
coverage concerning the Operating and Staff Divisions and forwarding
the waiver requests to the Senior Procurement Executive as it is
internal operating procedures more appropriate to the HHS Acquisition
Manual (HHSAM).

HHSAR Part 331--Contract Cost Principles and Procedures

We propose to revise the authority citations for part 331, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
In subpart 331.1, Applicability, we propose to revise section
331.101-70, Salary rate limitation, to renumber it to section 331.170,
to align with FAR drafting convention numbering as there is no existing
FAR section to intelligibly implement the required HHS policy and
numbering as ``331.170'' places it appropriately as a supplement to
subpart 331. We also propose to remove the paragraph (a) designation as
there is no paragraph (b), and to remove the reference to a fiscal year
as not necessary to the policy requirement. We also propose to revise
the paragraph to update and provide the name of the Rates of Basic Pay
for the Executive Schedule (EX) Level II, that is found on the Office
of Personnel Management website.
We also propose to remove the designation of paragraph (b) as the
text will be contained in a new proposed section. We propose to add
section 331.101-70, Contract clause, to contain the prescription for
clause 352.231-70, Salary Rate Limitation, that was previously
contained in paragraph (b) under the prior existing section 331.101-70,
and to fix sentence

[[Page 80646]]

construction and punctuation to provide clarity.

HHSAR Part 332--Contract Funding

We propose to revise the authority citations for part 332, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to revise HHSAR part 332, Contract Financing, by adding
introductory sections 332.006, 332.006-1, and 332.006-4 to align with
the FAR.
We propose to add section 332.006, Reduction or suspension of
contract payments upon finding of fraud, as a section header with no
text to align with the FAR.
We propose to add section 332.006-1, General, paragraph (b), to
provide that the Senior Procurement Executive (SPE) is authorized to
make the determination there is substantial evidence that a
contractor's request for advance, partial, or progress payments is
based on fraud, and may direct further payments to the contractor be
reduced or suspended, in accordance with FAR 32.006 and that the
authority may not be redelegated.
And we propose to also add section 332.006-4, Procedures, paragraph
(b), to align with the FAR and to designate the Remedy Coordination
Official (RCO) for HHS as the SPE, who shall carry out the
responsibilities in FAR 32.006-4(b). We add paragraph (e) under this
section to implement the FAR and stipulate that the RCO is authorized
to carry out the responsibilities of the agency head in FAR 32.006-4(e)
to notify the contractor of the reasons for the recommended action and
of its right to submit information within a reasonable period of time
in response to the proposed action under FAR 32.006. In paragraph
(e)(1), HHS sets forth the procedures to be followed for the notice of
proposed action and the requirement to send it to the last known
address of the contractor, the contractor's counsel, or agent for
service of process, by certified mail, return receipt requested, or any
other method that provides signed evidence of receipt. In the case of a
business, the notice of proposed action may be sent to any partner,
principal, officer, director, owner or co-owner, or joint venture. We
also propose to set forth the due process rights for contractors to be
afforded an opportunity to appear before the RCO to present information
or argument in person or through a representative and to supplement the
oral presentation with written information and argument. In paragraph
(e)(2), additional processes and procedures for due process rights are
established including that the proceedings will be conducted in an
informal manner without the requirement for a transcript. It also would
state that if the RCO does not receive a reply from the contractor
within 30 calendar days, the RCO will base his or her recommendations
on the information available. The RCO is required to make a
determination whether or not substantial evidence of fraud exists.
And, in paragraph (g) under section 332.006-4, we propose to
require that the SPE shall provide a copy of each final determination
and the supporting documentation to the contractor, the RCO, the
contracting officer, and the HHS Office of the Inspector General (OIG).
We propose to add subpart 332.2, Commercial Product and Commercial
Service Purchase Financing, and the underlying section 332.202,
General, to provide that the SPE is authorized to approve actions for
commercial item purchase financing pursuant to FAR 32.202.
In subpart 332.4, we propose to revise the subpart header title
from ``Advance Payments for Non-Commercial Items'' to ``Advance
Payments for Other Than Commercial Acquisitions'' to align with the
updated title in the FAR. In section 332.402, General, we propose to
revise the sentence for clarity that the head of the contracting
activity (HCA) is authorized to make determinations related to advance
payments and that the authority may not be redelegated. We propose to
remove section 332.407, Interest, as this delegation by the agency head
to the HCA to make the determination required by FAR 32.407(d) is being
moved to the HHSAM.
In subpart 332.5, Progress Payments Based on Costs, we propose to
correct the header title listed in the HHSAR to match the FAR by adding
an ``s'' to the existing word ``Cost.'' In section 332.501-2, Unusual
progress payments, we propose to revise the sentence to comport with
FAR drafting guidelines and style, and rephrased the same delegation
that authorizes the HCA to approve unusual progress payments and to
stipulate that the authority may not be relegated.
In subpart 332.7, Contract Funding, we propose to remove section
332.702, Policy, and move it to the HHSAM as internal operational
policy.
We propose to retain the underlying sections 332.703-1, General,
and 332.703-71, Incrementally funded cost-reimbursement contracts, as
important policy and procedures contracting officers shall follow when
administering incremental funding under an HHS contract and the
considerations contracting officers must examine when approving the use
of incrementally funded cost-reimbursement contracts. We also propose
to redesignate 332.703-71 to 332.703-70.
We propose to revise the numbering of section 332.703-72,
Incremental Funding Table, to ``332.703-71'' based on the redesignation
of 332.703-71 to 332.703-70.
We propose to revise the header title of section 332.706,
Solicitation provision and contract clauses, to ``Contract clauses'' to
align with the FAR.
In subpart 332.70, Electronic Submission and Processing of Payment
Requests, and the underlying sections 332.7001, 332.7002, and 332.7003,
we make minor editorial formatting and capitalization corrections. In
section 332.7003, Contract clause, we add language that states the
clause at 352.232-71, Electronic Submission of Payment Requests, is to
be used in all solicitations and contracts, unless an exception at
HHSAR 332.7002(a) or (b) applies.

HHSAR Part 333--Protests, Disputes, and Appeals

We propose to revise the authority citations for part 333, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to revise HHSAR part 333 to revise text and add sections
as described below.
In subpart 333.1, Protests, we propose to revise section 333.102,
General, to make minor typographical and editorial updates and remove
the paragraph designation of (g)(1).
In section 333.103, Protests to the agency, we propose to
substantially revise the content to provide clarity by identifying that
the contracting officer prepares the determination pursuant to FAR
33.103(f)(1) and to state that the contracting activity's designated
protest official control officer, in consultation with the cognizant
HHS legal office, may approve the determination subject to the
procedures in 333.103-70.
We propose to add section 333.103-70, Procedures--protests to HHS,
paragraphs (a) through (d), to provide agency procedures on how HHS
will handle protests submitted to the agency. This includes providing
information on protests to the contracting officer, and a higher-level
independent review or appeal of a contracting officer decision for
protests files directly with the

[[Page 80647]]

agency. We also propose to add language at paragraph (d) that if
protests are pending with the contracting officer and have not been
decided yet, an independent review of a protest filed pursuant to
paragraph (a)(2) will not be considered.
We propose to add section 333.103-71, Agency actions on specific
protests, to provide that the following types of protests may be
dismissed without consideration of the merits or may be forwarded to
another agency for appropriate action:
<bullet> Contract administration. Disputes between a contractor and
HHS are resolved under the disputes clause (see the Dispute statute, 41
U.S.C. chapter 71).
<bullet> Small business size standards and standard industrial
classification. These are handled by the Small Business Administration.
<bullet> Small business certificate of competency program. A
protest made under section 8(b)(7) of the Small Business Act, or in
regard to any issuance of a certificate of competency or refusal to
issue a certificate under that section, is not reviewed in accordance
with bid protest procedures unless there is a showing of possible fraud
or bad faith on the part of Government officials.
<bullet> Decision not to set-aside under section 8(a) of the Small
Business Act. The decision to place or not to place a procurement under
the 8(a) program is not subject to review unless there is a showing of
possible fraud or bad faith on the part of Government officials or that
regulations may have been violated (see 15 U.S.C. 637(a)).
<bullet> Affirmative determination of responsibility by the
contracting officer. An affirmative determination of responsibility
will not be reviewed unless there is a showing that such determination
was made fraudulently or in bad faith or that definitive responsibility
criteria in the solicitation were not met.
<bullet> Contracts subject to FAR subpart 22.6--Contracts for
Materials, Supplies, Articles, and Equipment. Challenges concerning the
legal status of a firm as a regular dealer or manufacturer within the
meaning of 41 U.S.C. chapter 65 are determined solely by the procuring
agency, the SBA (if a small business is involved), and the Secretary of
Labor (see FAR subpart 22.6).
<bullet> Subcontractor protests. The contracting agency will not
consider subcontractor protests except where HHS determines it is in
the interest of the Government.
<bullet> Judicial proceedings. The contracting agency will not
consider protests where the matter involved is the subject of
litigation before a court of competent jurisdiction.
<bullet> Alternative dispute resolution. Bidders/offerors and HHS
contracting officers are encouraged to use alternative dispute
resolution (ADR) procedures to resolve protests at any stage in the
protest process. If ADR is used, HHS will not furnish any documentation
in an ADR proceeding beyond what is required by FAR 33.103.
In subpart 333.2, Disputes and Appeals, we propose to add section
333.201, Definitions, to provide the definition for Agency board of
contract appeals for HHS means the Civilian Board of Contract Appeals
(CBCA).
We propose to revise section 333.203, Applicability, to make minor
editorial corrections, to use the acronym CBCA, and to provide an
updated address for each method of filing--e-file, U.S. Postal Service,
or Overnight or Courier Delivery.
In section 333.209, Suspected fraudulent claims, we propose to add
to the end of the existing sentence that the contracting officer may
submit any instance of a contractor's suspected fraudulent claim for
potential referral to the Department of Justice through the head of the
contracting activity (HCA).
We propose to add section 333.214, Alternative dispute resolution
(ADR), to state that contracting officers and contractors are
encouraged to use alternative dispute resolution (ADR) procedures, and
that guidance on ADR may be obtained at the U.S. Civilian Board of
Contract Appeals website at <a href="https://www.cbca.gsa.gov">https://www.cbca.gsa.gov</a>.
And in section 333.215-70, Contract clauses, we propose to revise
paragraph (b) to revise the phrase, ``commercial item'' to ``commercial
product or commercial service'' to comport with the updated usage of
the terms in the FAR.

HHSAR Part 334--Major System Acquisition

We propose to revise the authority citations for part 334, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to revise HHSAR part 334 to make minor editorial changes
to provide clarity to the sentence structure and to add needed
references.
In section 334.201, Policy, introductory sentence, we are adding
the acronym ``(EVMS)'' after earned value management system to permit
usage of the acronym later in the section. In paragraph (b), we remove
the fully spelled out term and use the EVMS acronym.
In section 334.202, Integrated Baseline Reviews (IBRs), we remove
the acronym usage in the header. In paragraph (a), we reconstructed the
sentence for clarity by adding the term ``Integrated Baseline Review
(IBR)'' and a reference to FAR 34.201(a), and we remove the phrase
``normally should read'' and replace it with ``is usually''.

HHSAR Part 335--Research and Development Contracting

We propose to revise the authority citations for part 335, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to revise HHSAR part 335 to make minor editorial changes
to provide clarity, to remove material more appropriate to internal
agency procedures in the HHSAM, to add needed FAR references, and to
remove two sections that are unnecessary.
In section 335.070-1, Policy, paragraph (a), we propose to remove
the last sentence as it contains a general statement concerning the
Government's interest that is unnecessary and vague. We propose to
remove paragraph (c) as more appropriate to internal agency procedures
that may be revised and moved to the HHSAM.
In section 335.070-2, Amount of cost-sharing, paragraph (a), we
propose to add the phrase ``appropriate (see FAR 16.303 and FAR
42.707)'' to provide key FAR references.
We propose to remove sections 335.071, which is reserved, and
335.072, Key personnel. Section 335.071 was reserved during a previous
rulemaking and is no longer required to be reserved. Section 335.072,
Key personnel, is removed as internal agency guidance more appropriate
to be revised and moved to the HHSAM.

HHSAR Part 336--Construction and Architect-Engineer Contracts

We propose to revise the authority citations for part 336, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to revise HHSAR part 336 to remove one subpart and add a
new subpart and make other necessary editorial changes.
We propose to remove subpart 336.1, General, and the underlying
section 336.104, Policy, as the information repeats the FAR and also
contains a

[[Page 80648]]

general reference to internal agency Facilities Management guidance
that is vague and more appropriate to place in the HHSAM as internal
operational procedures.
We propose to add subpart 336.2, Special Aspects of Contracting for
Construction, and sections 336.203 and 336.204, to provide policy on
the use of Government estimates of construction costs and other policy
and procedures on the disclosure of the magnitude of construction
projects.
In section 336.203, Government estimate of construction costs,
paragraph (a), we propose to require that the Government estimate must
be designated ``CUI Controlled by: HHS, [OPDIV/STAFFDIV designation''
unless the nature of the information therein requires a security
classification or other classification, in which event it shall be
handled in accordance with applicable security regulations. The
designation would only be removed when the estimate is made public in
accordance with the procedures outlined in the section. In paragraph
(b), if the acquisition is by sealed bidding, a sealed copy of the
detailed Government estimate must be filed with the bids until bid
opening. After the bids are read and recorded, the ``CUI'' designation,
or other classification, must be removed and the estimate read and
recorded in the same detail as the bids. In paragraph (c), we propose
procedures governing the use of the marking if the acquisition is by
negotiation.
In section 336.204, Disclosure of the magnitude of construction
projects, we propose policy that requires the contracting officer to
utilize the estimated price ranges defined in FAR 36.204(a) through (e)
as further supplemented in paragraphs (f) through (h) in this section
when identifying the magnitude of an HHS project in advance notices and
solicitations. In paragraph (f), we propose that for estimated price
ranges between $1,000,000 and $5,000,000, the contracting officer shall
identify the magnitude of an HHS project in advance notices and
solicitations in terms of the following price ranges:
<bullet> Between $1,000,000 and $2,000,000.
<bullet> Between $2,000,000 and $5,000,000.
In paragraph (g), the estimated price ranges are between $5,000,000
and $10,000,000. And in paragraph (h), for estimated price ranges
greater than $10,000,000, the contracting officer shall identify the
magnitude of an HHS project in advance notices and solicitations in
terms of one of the following price ranges:
<bullet> Between $10,000,000 and $20,000,000.
<bullet> Between $20,000,000 and $50,000,000.
<bullet> Between $50,000,000 and $100,000,000.
<bullet> Between $100,000,000 and $150,000,000.
<bullet> Between $150,000,000 and $200,000,000.
<bullet> Between $200,000,000 and $250,000,000.
<bullet> More than $250,000,000.
In subpart 336.5, Contract Clause, we propose to make minor
editorial revisions and to revise the header title of the subpart to
``Contract Clauses'' to align with the FAR.
In section 336.570, Contract clause, paragraph (a), we remove the
word ``all'' before ``design-build requirements'' as it is unnecessary.
In paragraph (b), we make minor capitalization corrections. We propose
to remove paragraph (c) in its entirety as internal agency guidance
that will be considered for the HHSAM and is unnecessary in the HHSAR.

HHSAR Part 337--Service Contracting

We propose to revise the authority citations for part 337, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to revise HHSAR part 337 to provide updated agency
policy and procedures to implement specific requirements concerning
performance on HHS service contracts, and to add a new subpart 337.70
that provides the policy for the clauses prescribed by this part.
We propose to revise the header title of HHSAR part 337 from
``Service Contracting--General'' to ``Service Contracting'' to align
with the FAR title.
We propose to remove subpart 337.1, Service Contracting--General,
which currently contains prescriptions of key clauses required to be
inserted into certain HHS solicitations and contracts. This coverage is
proposed to be revised and moved to another new section specifically
pertaining to prescriptions for contract clauses, 337.3306, as
described below, to comport with FAR drafting standards and guidance.
We propose to add subpart 337.70, Services--Special Contract
Requirements, to provide the policy and procedures applicable to the
clauses prescribed under this part. We propose to add sections
337.7000, 337.7001, 337.7002, 337.7003, 337.7004, 337.7005, and
337.7006 as discussed below.
We propose to add section 337.7000, Prohibition on smoking in
facilities during delivery of services to children, to detail the
policy prohibition on smoking in certain facilities where certain
federally funded children's services are provided pursuant to 20 U.S.C.
7181 (Pub. L. 107-110, the Pro-Children Act of 2001 (the Act)).
Contractors are required to represent to the contracting officer and
agree that by submission of its bid or offer and if awarded a contract
for this requirement, the contractor agrees to comply with the
requirements of the Act and the prohibition of smoking in facilities as
specified in paragraph (a). The contractor shall enforce the provisions
of the clause prescribed in 337.7006(a), and ensure that each of its
employees, subcontractors, and any subcontractor staff, is made aware
of, understands, and complies with the provisions of the Act. This
section also outlines the penalties for failure to comply with the Act.
We propose to add section 337.7001, Reporting of child abuse by
covered professionals and key definitions, to implement the
requirements of Public Law 101-647, known as the Crime Control Act of
1990 (the Act) (34 U.S.C. 20341), which imposes responsibilities on
certain individuals who, while engaged in a professional capacity or
activity as a covered professional, as defined in the Act, on Federal
land or in a federally-operated (or contracted) facility, learn of
facts that give the individual reason to suspect that a child has
suffered an incident of child abuse. Paragraph (c) details the
reporting requirements, and paragraph (d) contains the requirement that
the offeror shall represent that it understands that by submission of
its bid or offer and if awarded a contract for a requirement, the
Contractor agrees to comply with the requirements of the Act.
Contracting officers shall ensure the requirements of clause 352.237-71
are flowed down to subcontractors at any tier.
We propose to add section 337.7002, Requirement for background
checks--childcare services, to set forth the agency policy and
requirement for background checks pursuant to Public Law 101-647, known
as the Crime Control Act of 1990 (the Act) (34 U.S.C. 20351), requires
that all individuals involved with the provision of childcare services
to children under the age of 18 undergo a criminal background check.
Any conviction for a sex crime, an offense involving a child victim, or
a drug felony, may be grounds for denying employment or for dismissal
of an employee providing any childcare services. This would require the
contracting officer to provide the necessary information to the
contractor

[[Page 80649]]

regarding the process for obtaining the background check. And it
contains the representation requirement that the offeror shall
represent that it understands that by submission of its bid or offer
and if awarded a contract for a requirement, the contractor agrees to
comply with the requirements of the Act. Contracting officers shall
ensure the requirements of clause 352.237-72 are flowed down to
subcontractors at any tier.
We propose to add section 337.7003, Indian Child Protection and
Family Violence Act-background investigations, to ensure protection of
Indian children, and to implement requirements of the Indian Child
Protection and Family Violence Act, Public Law 101-630 (25 U.S.C. 3201,
et seq.), which prohibits employment, including personal service
contracts, with anyone who has been convicted of any crime of violence
when performance under a contract may require duties and
responsibilities of a contractor, its employees, subcontractors, or
third parties providing service under the contract that involve regular
contact with or control over Indian children. The Act requires that a
contractor and its employees and subcontractors, at any tier, be
subject to a character and background investigation. This investigation
is conducted by the Indian Health Service, Office of Human Resources.
This section would require that as a prerequisite to providing services
under a contract involving access to Indian children, contractors
shall--
<bullet> Complete and sign a declaration concerning the background
of employees or subcontractors providing such services as required by
the terms and conditions of the contract;
<bullet> Provide information as required by the contracting officer
to ascertain such information about its employees, subcontractors, and
third parties providing services under the contract;
<bullet> Report convictions of any crime of violence immediately to
the contracting officer that involve such employees, subcontractors, or
third parties, who may be employed or are currently employed under the
contract; and
<bullet> Flow down clause the clause prescribed at 337.7006(d),
352.337-73, Indian Child Protection and Family Violence Act--Background
Investigations, into all subcontracts, at any tier.
We propose to add section 337.7004, Non-discrimination in service
delivery, to implement HHS policy that no person otherwise eligible
will be excluded from participation in, denied the benefits of, or
subjected to discrimination in the administration of HHS programs and
services based on non-merit factors such as race, color, national
origin, religion, sex, gender identity, sexual orientation, or
disability (physical or mental). It would include a representation
requirement that the offeror shall represent that it understands that
by submission of its bid or offer and if awarded a contract for a
requirement, the contractor agrees to comply with the requirements of
the policy. Contracting officers shall ensure the requirements of
clause 352.237-74 are flowed down to subcontractors at any tier.
We propose to add section 337.7005, Key personnel, to implement HHS
policy on identification and use of key personnel when considered
essential to work performance under an HHS contract. We propose to
require contractors to provide notice if they divert proposed personnel
deemed key personnel. At least 30 days prior to the contractor
voluntarily diverting any of the specified individuals in a contract to
other programs or contracts, the contractor shall notify the
contracting officer and submit a justification for the diversion or
replacement, and request to replace the individual. It would also
outline notification, justification, and replacement requirements.
We propose to add section 337.7006, Contract clauses, to provide
the prescription for the use of the following clauses in both
solicitations and contracts as required by each prescription:

<bullet> 352.237-70, Nonsmoking Policy--Delivery of Services to
Children
<bullet> 352.237-71, Reporting of Child Abuse
<bullet> 352.237-72, Requirement for Background Checks
<bullet> 352.237-73, Indian Child Protection and Family Violence Act--
Background Investigations
<bullet> 352.237-74, Non-Discrimination in Service Delivery
<bullet> 352.237-75, Key Personnel

HHSAR Part 341--Acquisition of Utility Services

We propose to add authority citations for part 341, for the reasons
set forth in the discussion and analysis section, to read as follows: 5
U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and
48 CFR 1.301 through 1.304.
We propose to add HHSAR part 341, Acquisition of Utility Services,
and subparts 341.1, General, and 341.5, Solicitation Provision and
Contract Clauses, to provide policy on purchases of utility services
from nonregulated and regulated utility suppliers, and the acquisition
of energy when purchased as a commodity in accordance with FAR part 41.
We propose to add subpart 341.1, General, and section 341.102,
Applicability, paragraph (a), to implement FAR 41.102(a) and to state
that this part applies to purchases of utility services from
nonregulated and regulated utility suppliers when a delegation of
authority from GSA for those services is requested and obtained. In
paragraph (b)(4), we provide the explanation that the acquisition of
energy, such as electricity, and natural or manufactured gas, when
purchased as a commodity is considered to be acquisitions of supplies
rather than utility services as described in FAR part 41.
We propose to add subpart 341.5, Solicitation Provision and
Contract Clauses, and sections 341.501 and 341.501-70. In section
341.501, Solicitation provision and contract clauses, we propose to add
the section header with no text for alignment with the FAR where HHS
supplements coverage in an underlying section. In section 341.501-70,
Disputes--utility contracts, we propose to require contracting officers
to insert the clause at 352.241-70, Disputes--Utility Contracts, in
solicitations and contracts for utility services subject to the
jurisdiction and regulation of a utility rate commission, to provide
the notice to the contractor on specific disputes requirements
concerning utilities. In the clause, it provides that the requirements
of the Disputes clause at FAR 52.233-1 are supplemented to provide that
matters involving the interpretation of tariffed retail rates, tariff
rate schedules, and tariffed terms provided under this contract are
subject to any determinations by the independent regulatory body having
jurisdiction (i.e., the Federal Energy Regulatory Commission, a state-
wide agency, or an agency with less than state-wide jurisdiction when
operating pursuant to state authority. The body has the power to fix,
establish, or control the rates and services of utility suppliers.).

HHSAR Part 342--Contract Administration and Audit Services

We propose to revise the authority citations for part 342, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to revise HHSAR part 342 to update its header title, and
to add subpart 342.2.
We propose to revise and update the header title of part 342 from
``Contract Administration'' to ``Contract

[[Page 80650]]

Administration and Audit Service'' to align with the FAR part title.
We propose to add subpart 342.2, Contract Administration, and
sections 342.270, 342.271, and 342.272, to set forth policy and
procedures with respect to the use of Contracting Officer's
Representatives (CORs) in contract administration, the Administrative
Contracting Officer's (ACO) role in contract administration and
delegated functions, and prescribed agency contract clauses.
We propose to add section 342.270, Contracting Officer's
Representatives role in contract administration, to establish that a
contracting officer may designate a qualified person to be the
Contracting Officer's Representative (COR) for the purpose of
performing certain technical functions in administering a contract.
Paragraph (b) would provide that the COR may act solely as a technical
representative of the contracting officer and is not authorized to
perform any function that results in a change in the scope, price,
terms, or conditions of the contract, and that the designation must be
in writing and a copy of the designation must be furnished to the
contractor and the ACO.
We propose to add section 342.271, Administrative Contracting
Officer's role in contract administration and delegated functions, to
provide the department's use of an Administrative Contracting Officer
Letter of Delegation, which means a delegation of functions as set
forth in FAR 42.202 and 42.302 and this section, that is issued by a
contracting officer to delegate certain contract administration or
specialized support services. This section would limit the ACO's
authority to the actions detailed in the delegation, state that they
shall be set forth in a written ACO Letter of Delegation issued by the
contracting officer to the accepting contract administration office and
designated administrative contracting officer. This section would
require that the ACO Letter of Delegation shall contain the information
required in FAR 42.202(a) through (c) and identify the responsibilities
and limitations of the ACO. A copy of the delegation will be furnished
to the contractor and the ACO.
And we propose to add section 342.272, Contract clauses, to
prescribe two clauses to be used: The clause at 352.242-70,
Administrative Contracting Officer, to be inserted in solicitations and
contracts expected to exceed the micro-purchase threshold, when
contract administration is delegated, and the clause at 352.242-71,
Government Construction Contract Administration, to be inserted in
solicitations and contracts for construction expected to exceed the
micro-purchase threshold, when contract administration is delegated

HHSAR Part 343--Contract Modifications

We propose to add authority citations for part 343, for the reasons
set forth in the discussion and analysis section, to read as follows: 5
U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and
48 CFR 1.301 through 1.304.
We propose to add HHSAR part 343, Contract Modifications, and
subpart 343.2, Change Orders, to provide agency policy on the
definitization of unpriced change orders with an estimated value
exceeding $5 million.
We propose to add subpart 342.2, Change Orders, and sections
343.204, Administration; 343.204-70, Definitization; and 343.205,
Contract clauses.
We propose to add section 343.204, Administration, as a section
header with no text, and the underlying section 343.204-70,
Definitization, to establish policy with respect to the definitization
of unpriced change orders with an estimated value exceeding $5 million.
This section would require that unpriced change orders, when authorized
by the contracting officer, shall contain a not-to-exceed price and
requires a definitization schedules that provide for definitization
by--
<bullet> The date after issuance of the change order may not exceed
180 days after the contractor submits a qualifying proposal); or
<bullet> The date on which the amount of funds paid to the
contractor under the contract action is equal to more than 50 percent
of the not-to-exceed price.
This section would also provide that if the contractor does not
submit a timely qualifying proposal, the contracting officer may
suspend or reduce progress payments under FAR 32.503-6 or take other
appropriate action. The section would also provide a limitations on
obligations in paragraph (b) that the Government shall not obligate
more than 50 percent of the not-to-exceed price before definitization.
However, if a contractor submits a qualifying proposal before 50
percent of the not-to-exceed price has been obligated by the
Government, the limitation on obligations before definitization may be
increased to no more than 75 percent. Exceptions are provided as
authorized by the head of the contracting activity (HCA). The HCA may
waive the limitations for unpriced change orders if the HCA determines
that the waiver is necessary to support an emergency acquisition
operation.
We propose to add section 343.205, Contract clauses, to provide
agency policy that as authorized in the introductory text of clauses
FAR 52.243-1, Changes--Fixed-Price; 52.243-2, Changes--Cost-
Reimbursement; and 52.243-4, Changes, and in the prescription at FAR
43.205(c) for FAR 52.243-3, Changes--Time-and-Materials or Labor-Hours,
the contracting officer may vary the period within which a contractor
must assert its right to an equitable adjustment, but the extended
period shall not exceed 60 calendar days, unless approval is one level
above the contracting officer.

HHSAR Part 344--Subcontracting Policies and Procedures

We propose to add authority citations for part 344, for the reasons
set forth in the discussion and analysis section, to read as follows: 5
U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and
48 CFR 1.301 through 1.304.
We propose to add HHSAR part 344, Subcontracting Policies and
Procedures, and underlying subparts 344.2, Consent to Subcontracts, and
344.3, Contractors' Purchasing Systems Reviews.
We propose to add subpart 344.2, Consent to Subcontracts, and
section 344.202-2, Considerations, paragraph (a), to require, in
addition to the considerations outlined in FAR 44.202-2(a), that the
contracting officer responsible for consent must review the request and
supporting data submitted by the contractor and document whether the
contractor adequately substantiated the selection as being fair,
reasonable, and representing the best value to the Government where
other than the lowest price is the basis for subcontractor selection.
We propose to add subpart 344.3, Contractors' Purchasing Systems
Reviews, and section 344.303-70, Additional contractors' purchasing
systems reviews, to identify that special attention shall also be paid
to reviewing documentation of commercial products and commercial
services determinations. Additionally, the section states that if the
contractor has an approved purchasing system as defined in FAR 44.101,
the contracting officer shall not withhold consent to subcontract
without written coordination of the program manager or comparable
requiring activity official. This ensures that a decision to withhold
consent is made in concert with the full awareness of program officials
who have overall programmatic, budget and schedule responsibilities for

[[Page 80651]]

acquisitions that may be impacted by a decision to withhold consent.

HHSAR Part 345--Government Property

We propose to add authority citations for part 345, for the reasons
set forth in the discussion and analysis section, to read as follows: 5
U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and
48 CFR 1.301 through 1.304.
We propose to add HHSAR part 345, Government Property, and subpart
345.1, General, to provide agency policy and procedures on contractors'
property management system compliance.
In subpart 345.1, General, we propose to add sections 345.105-70
and 345.107, Contract clauses. We propose to add section 345.105-70,
Contractors' property management system compliance--policy and
procedures, to provide definitions for acceptable property management
system, property management system, and significant deficiency when
complying with agency policies and procedures. In paragraph (a), policy
is provided that the cognizant contracting officer, in consultation
with the property administrator, shall determine the acceptability of
the system and approve or disapprove the system, and pursue correction
of any deficiencies. Paragraph (c) would provide that in evaluating the
acceptability of a contractor's property management system, the
contracting officer, in consultation with the property administrator,
shall determine whether the contractor's property management system
complies with the system criteria for an acceptable property management
system as prescribed in the clause at 352.245-70, Contractor Property
Management System Administration. The section also outlines in
paragraph (d) the procedures for disposition of findings, including
notification to the contractor, in writing, whether the contractor's
property management system is acceptable and approved. If the
contracting officer finds that there are one or more significant
deficiencies (as defined in the clause at 352.245-70, Contractor
Property Management System Administration) due to the contractor's
failure to meet one or more of the property management system criteria
in the clause at 352.245-70, the contracting officer shall--
<bullet> Promptly make an initial written determination on any
significant deficiencies and notify the contractor, in writing,
providing a description of each significant deficiency in sufficient
detail to allow the contractor to understand the deficiency;
<bullet> Request the contractor to respond, in writing, to the
initial determination within 30 days and;
<bullet> Evaluate the contractor's response to the initial
determination, in consultation with the property administrator, and
make a final determination.
Paragraph (d)(3) of this section also provides the procedures for
final determination and notification to the contractor in writing
whether acceptable and approved, whether significant deficiencies
remain and the requested corrective actions, disapproval, and
monitoring of the system. Paragraphs (e) and (f) provide policy and
procedures on system approval, and other contracting officer
notifications.
We propose to add section 345.107, Contract clauses, to prescribe
the HHSAR clause at 352.245-70, Contractor Property Management System
Administration, be inserted in solicitations and contracts containing
the clause at FAR 52.245-1, Government Property.

HHSAR Part 347--Transportation

We propose to add authority citations for part 347, for the reasons
set forth in the discussion and analysis section, to read as follows: 5
U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 1702; and
48 CFR 1.301 through 1.304.
We propose to add part 347, Transportation, to provide unique HHS
delivery information and marking requirements. Proposed underlying
sections 347.303-6, F.o.b. destination; 347.303-670, Place of delivery,
prescribe clause 352.247-70, Delivery Location, or a clause
substantially the same as the clause at 352.247-70 in supply contracts
when it is necessary to specify delivery locations.
Section 347.305, Solicitation provisions, contract clauses, and
transportation factors, and its underlying section 347.305-10, Packing,
marking, and consignment instructions, prescribes two clauses:
<bullet> Paragraph (a) prescribes the clause 352.247-71, Marking
Deliverables, or a clause substantially the same as 352.247-71 in
solicitations and contracts if special marking on deliverables is
required.
<bullet> Paragraph (b) prescribes the clause at 352.247-72, Packing
for Domestic Shipment, in contracts when item(s) will be delivered for
immediate use to a destination in the continental United States; when
the material specification or purchase description does not provide
preservation, packaging, packing, and/or marking requirements; and/or
when the requiring activity has not cited a specific specification for
packaging.

HHSAR Part 352--Solicitation Provisions and Contract Clauses

We propose to revise the authority citations for part 352, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to revise subpart 352.1, Instructions for Using
Provisions and Clauses, to update the underlying sections 352.100,
Scope of subpart, and 351.101-70, Application of provisions and
clauses, as follows:
We propose to revise 352.100, Scope of subpart, to make a minor
grammatical revision by adding the word ``supplemental'' before the
words ``provisions and clauses'' in the text to provide clarity.
We propose to add a section header with no text, 352.102,
Incorporating provisions and clauses, to align the supplemental HHSAR
section that follows it.
And we propose to renumber section 352.101-70 to 352.102-70 as the
topical coverage in the text more appropriately aligns under FAR
52.102. We propose to add the phrase ``unless fill-ins are required''
at the end of paragraph (a) to add a caveat to the policy that it is
not necessary to also include clauses in a task order or delivery order
if it is included in the overarching master instrument.
We propose to add clause 352.201-70, Contracting Officer's
Representative, as prescribed in section 301.602-70, to provide that if
the contracting officer designates a COR, the contractor will receive a
copy of the written designation. It will specify the extent of the
COR's authority to act on behalf of the contracting officer. The COR is
not authorized to make any commitments or changes that will affect
price, quality, quantity, delivery, or any other term or condition of
the contract.
We propose to revise clause 352.203-70, Anti-Lobbying, as
prescribed in section 303.808-70, to make minor administrative and
grammatical updates, including to the prescription. This clause
provides that the contractor shall not use any HHS contract funds for:
<bullet> Publicity or propaganda purposes;
<bullet> The preparation, distribution, or use of any kit,
pamphlet, booklet, publication, electronic communication, radio,
television, or video presentation designed to support or defeat the
enactment of legislation before the Congress or any State or local
legislature

[[Page 80652]]

or legislative body, except in presentation to the Congress or any
state or local legislature itself; or designed to support or defeat any
proposed or pending regulation, administrative action, or order issued
by the executive branch of any state or local government, except in
presentation to the executive branch of any state or local government
itself;
<bullet> Payment of salary or expenses of the Contractor, or any
agent acting for the Contractor, related to any activity designed to
influence the enactment of legislation, appropriations, regulation,
administrative action, or Executive order proposed or pending before
the Congress or any state government, state legislature or local
legislature or legislative body, other than for normal and recognized
executive-legislative relationships or participation by an agency or
officer of a State, local, or Tribal government in policymaking and
administrative processes within the executive branch of that
government.
We propose to revise clause 352.204-70, Prevention and Public
Health Fund--Reporting Requirements, to update the prescription, and
make minor administrative updates. In paragraph (a), we provide an
updated citation to Public Law 112-74, section 220(b)(5). In paragraph
(c), we correct grammar to move the word ``electronic'' after the words
``508 compliant.'' And in paragraphs (c)(2) and (5), we are removing
the words ``funds'' and ``funding'' respectively for clarity since the
acronym ``PPHF'' contains the word ``fund'' in its name.
We propose to add clause 352.205-70, Advertisements, Publicizing
Awards, and Releases, to state that for HHS contracts and orders, the
contractor shall not refer to the contract in commercial advertising or
similar promotions in such a manner as to state or imply that the
product or service provided is endorsed or preferred by the Federal
Government or is considered by the Government to be superior to other
products or services. An Alternate I version of the clause is proposed
for use when a contract involves sensitive or classified information.
We propose to revise clause 352.208-70, Printing and Duplication,
to update the prescription to a FAR compliant format, to move all
definitions under paragraph (a), to provide context to the clause, to
add headers to each paragraph to comport with FAR style and convention,
to rephrase paragraphs (b) through (d) for clarity, and to add
paragraph (e) to require the clause is flowed down in subcontracts.
We propose to add provision 352.209-70, Organizational Conflicts of
Interest, to include the requirement that offerors shall provide a
statement with its offer which describes, in a concise manner, all
relevant facts concerning any past, present, or currently planned
interest (financial, contractual, organizational, or otherwise) or
actual or potential organizational conflicts of interest relating to
the services to be provided under this solicitation.
We propose to revise clause 352.211-1, Public Accommodations and
Commercial Facilities, to renumber it to 352.211-70 to comport with FAR
drafting standards, and to revise the prescription to comport with FAR
style conventions.
We propose to revise clause 352.211-2, Conference Sponsorship
Requests and Conference Materials Disclaimer, to renumber it to
352.211-71 to comport with FAR drafting standards, to update the
prescription to comport with FAR style conventions, and to make minor
grammatical updates to paragraphs (a) and (b) for clarity.
We propose to revise clause 352.211-3, Paperwork Reduction Act, to
renumber it to 352.211-72, update the title so it would read:
``Paperwork Reduction Act Requirements,'' and update the prescription
to comport with FAR style conventions.
We propose to add clause 352.212-70, Gray Market and Counterfeit
Items, to provide important protection for supplies or equipment
offered to the Government to prevent unauthorized items from entering
the HHS supply chain. HHS' critical mission is to enhance the health
and well-being of all Americans, by providing for effective health and
human services and by fostering sound, sustained advances in the
sciences underlying medicine, public health, and social services. It is
imperative that HHS have a high degree of fidelity in the supplies and
equipment delivered to support the critical programs under its purview.
This clause would importantly require that no used, refurbished, or
remanufactured supplies or equipment/parts shall be provided, and that
the procurement is for new Original Equipment Manufacturer (OEM) items
only. As stated in paragraph (a), this clause would prohibit gray
market items under the contract which are OEM goods intentionally or
unintentionally sold outside an authorized sales territory or sold by
non-authorized dealers in an authorized sales territory. Paragraph (b)
provides that no counterfeit supplies or equipment/parts shall be
provided. Counterfeit items include unlawful or unauthorized
reproductions, substitutions, or alterations that have been mismarked,
misidentified, or otherwise misrepresented to be an authentic,
unmodified item from the original manufacturer, or a source with the
express written authority of the original manufacturer or current
design activity, including an authorized aftermarket manufacturer.
Unlawful or unauthorized substitutions include used items represented
as new, or the false identification of grade, serial number, lot
number, date code, or performance characteristics. The clause would
also state in paragraph (c) that the vendor is required to be an OEM,
authorized dealer, authorized distributor, or authorized reseller for
the proposed equipment, verified by an authorization letter or other
documents from the OEM. All software licensing, warranty and service
associated with the equipment shall be in accordance with the OEM terms
and conditions.
We propose to revise provision 352.215-70, Late Proposals and
Revisions, by updating the title to add ``- R&D Solicitations'' to make
clear the types of solicitations this clause involves. And we propose
to update the prescription to comport with FAR style conventions, and
to substantively revise the provision for clarity and standard FAR
clause and provision construction that uses lists for ease of reading.
This would include revising the introductory text so that it clarifies
that notwithstanding the procedures contained in the provision at FAR
52.215-1, Instructions to Offerors--Competitive Acquisition, paragraph
(c)(3), the contracting officer may consider a proposal received for
biomedical or behavioral research and development (R&D) solicitations
after the date specified for receipt if the three conditions set forth
in the clause are met.
We propose to add provision 352.215-71, Use of Non-Federal
Evaluators--Conditions for Evaluating Proposals, as prescribed in
315.305-71, to provide terms and conditions pertaining to the use of
non-Federal evaluators when evaluating proposals and offers. We propose
to require that to participate in such role as a non-Federal evaluator,
the Contractor shall agree that it and its employees, as well as any
subcontractors and their employees as non-Federal evaluators will use
the data (trade secrets, business data, and technical data) contained
in any proposals under review for evaluation purposes only. Further,
the Contractor, its employees, and subcontractors and their employees
may not release, in whole or in part, any material received from the
Government to evaluate and must protect and secure the data against

[[Page 80653]]

unauthorized disclosure. The provision requires each non-Federal
evaluator to insert their name, title, company, signature, and date and
provide to the HHS office providing the material and the contracting
officer.
We propose to remove clause 352.216-70, Additional Cost Principles
for Hospitals (Profit and Non-Profit), as the requirement is being
removed as a clause and placed in another part of the HHSAR--part 331.
The clause number will be repurposed for a HHSAR part 316 related
clause.
We propose to add clause 352.216-70, Allowable Cost and Payment for
Hospitals (Profit and Non-Profit), to stipulate that payment amounts
requested by the Contractor and included in invoices submitted for
payment in accordance with FAR clause 52.216-7, paragraph (a)(1), must
be determined allowable by the Contracting Officer in accordance with
the FAR clause at 52.216-7, 45 CFR part 75, appendix IX, and FAR
subpart 31.2.
We propose to remove two outdated clauses as they are no longer
relevant to the HHS small business programs: 352.219-70, Mentor-
Prot[eacute]g[eacute] Program, and 352.219-71, Mentor-
Prot[eacute]g[eacute] Program Reporting Requirements. HHS does not
currently have a mentor prot[eacute]g[eacute] program and the clauses
are obsolete.
We propose to add two clauses related to the 8(a) partnership
program under HHSAR part 319: the clause at 352.219-70, Notification of
Competition Limited to Eligible 8(a) Participants, and the clause at
352.219-71, Notification of Section 8(a) Direct Award.
We propose to add clause 352.219-70, Notification of Competition
Limited to Eligible 8(a) Participants, as prescribed in 319.811-370.
This clause provides that when FAR 52.219-18, Notification of
Competition Limited to Eligible 8(a) Participants, is utilized in
conjunction with the FAR clause at 52.219-18, any award resulting from
a solicitation will be made directly by the contracting officer to the
successful 8(a) offeror. The contractor shall comply with the
limitations on subcontracting requirements as provided in 13 CFR 125.6
and all other 8(a) program requirements, as set forth in 13 CFR part
124.
We propose to add clause 352.219-71, Notification of Section 8(a)
Direct Award, as prescribed in 319.811-370. The clause alerts 8(a)
firms of the direct contract authority and provides that by submission
of its offer, the Offeror represents that it is in good standing and
that it meets all the criteria for participation in the program in
accordance with 13 CFR part 124, including compliance with the
limitations on subcontracting, and the other 8(a) program principles
and administrative requirement that are still under the SBA purview.
We propose to revise clause 352.222-70, Contractor Cooperation in
Equal Employment Opportunity Investigations, by revising the title to
read ``Contractor Cooperation in Equal Employment and Anti-Harassment
Opportunity Investigations'' to convey the additional important new
content added to the clause. We propose to update the prescription to
comport with FAR style conventions, and to substantively revise the
provision for clarity and standard FAR clause and provision
construction. We propose to substantively revise the flow and content
of the paragraphs to provide clarity and add headers to each paragraph.
We propose to retain the three definitions from the existing paragraph
(a), include the header ``Definitions,'' and revise the definitions to
comport with standard FAR drafting style and convention. We propose to
redesignate the existing paragraph (a) as paragraph (b) and add the
header ``Cooperation with investigations.'' In paragraph (b), we also
add the requirement for contractors to cooperate in HHS internal Anti-
Harassment investigations. We also propose to redesignate paragraph (b)
as paragraph (d) and add a header of ``Subcontract flowdown.'' We
propose to update paragraph (c) and add the header ``Compliance.''
We propose to revise clause 352.223-71, Instructions to Offerors--
Sustainable Acquisition, to renumber it as 352.223-70 to comport with
FAR and agency supplement numbering conventions. We propose to revise
the title to read: ``Instructions to Offerors--Sustainable Acquisition
Plan,'' to identify the content of the provision more clearly. We
propose to make minor updates to revise the prescription, correct a FAR
citations, and make minor grammatical revisions.
We propose to revise clause 352.223-70, Safety and Health, to
renumber it as 352.223-71 to comport with FAR and agency supplement
numbering conventions and to make other minor updates in the
prescription.
We propose to add clause 352.225-70, Made in America--Personal
Protective Equipment, that provides new legislative requirements from
the Make PPE in America Act (Pub. L. 117-58, sec. 70951, dated November
15, 2021). This codifies a class deviation issued by HHS, Department of
Health and Human Services (HHS) Class Deviation from the Health and
Human Services Acquisition Regulation (HHSAR)--Implementation of the
Make Personal Protective Equipment (PPE) in America Act Requirements,
issued on February 9. 2023. The clause requires contractors to deliver
only domestic personal protective equipment, unless the solicitation
specifies delivery of foreign-made domestic personal protective
equipment in the provision of the solicitation entitled ``Made in
America Certificate--Personal Protective Equipment.'' The clause is to
be inserted in solicitations and contracts for PPE as prescribed in
325.7103(a), above the micro-purchase threshold, when the clause at FAR
52.212-5, Contract Terms and Conditions Required To Implement Statutes
or Executive Orders--Commercial Products and Commercial Services, is
included in a solicitation or contract for PPE. Contracting officers
shall include the full text of the clause at 352.225-70.
We propose to add provision 352.225-71, Made in America
Certificate--Personal Protective Equipment, in solicitations containing
the clause at 352.225-70. The provision requires the offeror to certify
that each item of personal protective equipment, except those listed in
paragraph (b) of this provision, is domestic personal protective
equipment. The clause also requires the offeror to list offered
foreign-made domestic personal protective equipment items in paragraph
(b). The provision is to be inserted in solicitations as prescribed in
325.7103(b), above the micro-purchase threshold, when the provision at
FAR 52.212-3, Offeror Representations and Certifications--Commercial
Products and Commercial Services is included in a solicitation for PPE.
Contracting officers shall include the full text of the provision at
352.225-71.
We propose to revise clause 352.226-1, Indian Preference, to
renumber the clause to 352.226-70 to comport with FAR drafting
standards and to make minor updates to the clause prescription and
citation.
We propose to revise clause 352.226-2, Indian Preference Program,
to renumber the clause to 352.226-71 to comport with FAR drafting
standards and to make minor updates to the clause prescription and
citation.
We propose to revise clause 352.226-3, Native American Graves
Protection and Repatriation Act, to renumber the clause to 352.226-72
to comport with FAR drafting standards and to make minor updates to the
clause prescription and citation.
We propose to revise clause 352.226-4, Notice of Indian Small
Business Economic Enterprise set-aside, to

[[Page 80654]]

renumber the clause to 352.226-73, and to capitalize ``Set-Aside'' in
the title to comport with FAR drafting standards and to make minor
updates to the clause prescription and citation. We also propose to
update an HHSAR citation in the second sentence.
We propose to revise clause 352.226-5, Notice of Indian Economic
Enterprise set-aside, to renumber the clause to 352.226-74, and to
capitalize ``Set-Aside'' in the title to comport with FAR drafting
standards and to make minor updates to the clause prescription and
citation. We also propose to align the Public Law citation in paragraph
(a), in the definition for ``Alaska Native Claims Settlement Act
(ANCSA)'' to reflect the ``Pub. L.'' abbreviation and to update the
HHSAR reference from the ``subpart'' to the ``section'' to standardize
with FAR drafting standards. We also propose to spell out ``contracting
officer'' in lieu of ``CO'' throughout the clause, as well as update
any HHSAR section citations as these have been renumbered to comport
with FAR standard numbering conventions.
We propose to revise clause 352.226-6, Indian Economic Enterprise
Subcontracting Limitations, to renumber the clause to 352.226-75, to
comport with FAR drafting standards and to make minor updates to the
clause prescription and citation. We also propose to spell out
``contracting officer'' in lieu of ``CO'' throughout the clause and
other minor administrative abbreviation update.
We propose to revise clause 352.226-7, Indian Economic Enterprise
Representation, to renumber the clause to 352.226-76, to comport with
FAR drafting standards and to make minor updates to the clause
prescription and citation.
We propose to revise clause 352.227-11, Patent Rights--Exceptional
Circumstances, to renumber the clause to 352.227-70, and to add the
word ``Supplement'' in the title so it now reads: ``Patent Rights--
Supplement--Exceptional Circumstances,'' to comport with FAR drafting
standards and to make minor updates to the clause prescription and
citation. We propose to remove the first introductory sentence in the
clause and move it to a new paragraph (b). We propose to update the
definition of ``Agency'' in paragraph (a) to make reference to HHS
operating division or agency, and provide examples (i.e., Centers for
Disease Control and Prevention, Food and Drug Administration, etc.). We
propose to renumber the existing paragraph (b) to (c) and update the
FAR clause 52.227-11 title in paragraph (c)(2)(ii) to read ``Patent
Rights-Ownership by the Contractor'' to reflect the correct FAR title.
We also propose to make minor grammatical and FAR citation reference
updates in paragraphs (c)(2)(ii) and (c)(3), and add paragraphs
(c)(3)(i) and (ii) to the existing text to appropriately break up the
text for ease of reading and reference. And we propose to make other
minor citation reference numbering updates in the clause to reflect the
correct paragraph numbers and to correct the FAR clause referenced in
paragraph (e)(2) to read ``FAR 52.227-11'' versus ``52.227-13.'' And we
propose to make other minor non-substantive administrative updates, and
to update HHSAR clause reference cited in the prescription for
Alternate I of the clause.
We propose to revise clause 352.227-14, Rights in Data--Exceptional
Circumstances, to renumber the clause to 352.227-71, and to add the
word ``Supplement'' in the title so it now reads: ``Rights in Data--
Supplement--Exceptional Circumstances,'' to comport with FAR drafting
standards and to make minor updates to the clause prescription and
citation. We propose to revise clause 352.227-14, Rights in Data--
Exceptional Circumstances, as a supplemental HHSAR clause to FAR clause
at 52.227-14, Rights in Data. The current clause, 352.227-14,
duplicates the FAR clause at 52.227-14 except for paragraphs (d)(4)
through (6). These paragraphs were added to provide HHS-specific
direction when a Decision of Exceptional Circumstances was issued
(paragraphs (d)(4) and (5)), and to provide additional policy at
paragraph (d)(6) regarding confidential information. We propose to
remove paragraphs (a) through (d)(3) as redundant to the FAR clause and
unnecessary in the proposed revision to the HHS supplemental clause. We
propose to retain the existing paragraphs (d)(4) and (5), with minor
administrative updates to citations referenced in the text.
Additionally, we propose to remove paragraphs (d)(6), (e), (f), (g),
(h), and (i) and the Alternate I through V paragraphs of the existing
clause.
We propose to revise clause 352.227-70, Publications and Publicity,
to renumber the clause to 352.227-72, to comport with FAR drafting
standards and to make minor updates to the clause prescription and
citation. We propose to revise paragraph (a) to reformat the paragraph
to use a list of items the contractor shall send to the contracting
officer's representative. And we propose to make minor administrative
and editorial revisions in paragraphs (b) through (d) for clarity.
We propose to revise clause 352.231-70, Salary Rate Limitation, to
comport with FAR drafting standards and to make minor updates to the
clause prescription and citation and to include a subcontract flowdown
requirements in a new paragraph (f).
We propose to revise provision 352.232-70, Incremental Funding, to
comport with FAR drafting standards and to make minor updates to the
provision prescription and citation.
We propose to revise clause 352.232-71, Electronic submission of
payment requests, to capitalize the major words in the title and make
minor updates to the clause prescription and citation to comport with
FAR drafting standards.
We propose to revise clause 352.233-70, Choice of Law (Overseas),
to make minor updates to the clause prescription and citation to
comport with FAR drafting standards.
We propose to revise clause 352.233-71, Litigation and Claims, to
make minor updates to the clause prescription and citation to comport
with FAR drafting standards.
We propose to revise clause 352.236-70, Design-Build Contracts, to
make minor updates to the clause prescription and citation to comport
with FAR drafting standards.
We propose to revise clause 352.237-70, Pro-Children Act, to revise
the title of the clause to read: Nonsmoking Policy--Delivery of
Services to Children, to make substantive updates to add needed content
and bring reference citations up to date, and to make minor updates to
the clause prescription and citation to comport with FAR drafting
standards. We propose to revise each paragraph in the clause to add
headers. In paragraph (a), the paragraph is revised to make clear that
smoking is prohibited in facilities where certain federally funded
children's services are provided pursuant to the Pro-Children Act, 20
U.S.C. 7181, Public Law 107-100, sec. 4301 (the Act). Other edits for
grammatical clarity are made. In paragraph (b), the text is updated to
make clear that the offeror represents and understands that by
submission of its bid or offer and if awarded a contract for this
requirement the contractor agrees to comply with the requirements of
the Act and the prohibition of smoking in facilities as specified in
paragraph (a) of the clause. Paragraph (c) is updated to provide
information concerning penalties for each violation. And a
subcontractor flowdown clause is added as paragraph (d).
We propose to revise 352.237-71, Crime Control Act--Reporting of
Child Abuse, to revise the title of the clause

[[Page 80655]]

to read: Reporting of Child Abuse, to make substantive updates to add
needed content and bring reference citations up to date, and to make
minor updates to the clause prescription and citation to comport with
FAR drafting standards. We propose to redesignate the existing
paragraph (a) as paragraph (b) and move two existing definitions for
``child abuse'' and ``covered professionals'' from paragraph (b) into a
new paragraph (a), and to add a header titled ``Definitions.'' We
propose to add a header to the redesignated paragraph (b),
Responsibility to report child abuse, and to update the statute
citation. We propose to remove the existing paragraph (b) in its
entirety as the definitions previously in this paragraph have been
moved to paragraph (a), Definitions, to align such definition placement
at the beginning of the clause to comport with FAR drafting
conventions. We propose to add headers to paragraphs (c) and (d), and
we propose to add a new paragraph (e) to provide subcontract flow down
requirements.
We propose to revise clause 352.237-72, Crime Control Act--
Requirement for Background Checks, to revise the title of the clause to
read: Requirement for Background Checks, to make substantive updates to
add needed content and bring reference citations up to date, and to
make minor updates to the clause prescription and citation to comport
with FAR drafting standards. We propose to redesignate the existing
paragraph (a) as paragraph (b) and move an existing definition for
``child care'' from paragraph (b) into a new paragraph (a), and to add
a header titled ``Definition.'' We propose to add a header to the
redesignated paragraph (b), Requirement for background checks, and to
update the statute citation. We propose to add headers to redesignated
paragraphs (c) and (d), and we propose to add a new paragraph (e) to
provide subcontract flow down requirements.
We propose to revise clause 352.237-73, Indian Child Protection and
Family Violence Act, to revise the title of the clause to read: Indian
Child Protection and Family Violence Act--Background Investigation, to
make substantive updates to add needed content and bring reference
citations up to date, and to make minor updates to the clause
prescription and citation to comport with FAR drafting standards. We
propose to redesignate the paragraphs by adding a designation for
paragraph (b) to break up the existing paragraph (a), and to
redesignate paragraph (b) as paragraph (c), and add a paragraph (d) to
provide subcontract flow down requirements.
We propose to revise clause 352.237-74, Non-Discrimination in
Service Delivery, to make substantive updates to add needed content and
bring reference citations up to date, and to make minor updates to the
clause prescription and citation to comport with FAR drafting
standards. We propose to add paragraph designations and headers to the
clause, which will now contain paragraphs (a) through (c). We propose
paragraph (a), Policy, to provide the policy of HHS that no person
otherwise eligible will be excluded from participation in, denied the
benefits of, or subjected to discrimination in the administration of
HHS programs and services based on non-merit factors such as race,
color, national origin, religion, sex, gender identity, sexual
orientation, or disability (physical or mental). We propose to add
paragraphs (b) and (c) to provide that the offeror represents and
understands that by submission of its bid or offer and if awarded a
contract for this requirement the contractor agrees to comply with this
policy in supporting the program and in performing the services called
for under this contract in a non-discriminatory manner. And in
paragraph (c) we propose to add a subcontract flow down requirement.
We propose to revise clause 352.237-75, Key Personnel, to make
minor administrative and grammatical updates, and to update the clause
prescription and citation to comport with FAR drafting standards.
We propose to add clause 352.241-70, Disputes--Utility Contracts,
to provide that the requirements of the Disputes clause at FAR 52.233-1
are supplemented to provide that matters involving the interpretation
of tariffed retail rates, tariff rate schedules, and tariffed terms
provided under this contract are subject to any determinations by the
independent regulatory body having jurisdiction.
We propose to add clause 352.242-70, Administrative Contracting
Officer, to stipulate that the contracting officer reserves the right
to designate an Administrative Contracting Officer (ACO) for the
purpose of performing certain tasks/duties in the administration of the
contract. It also states that such designation will be in writing
through an ACO Letter of Delegation and will identify the
responsibilities and limitations of the ACO, with a copy to be
furnished to the contractor.
We propose to add clause 352.242-71, Government Construction
Contract Administration, to detail certain delegated contract
administration functions, for construction contracts, set forth in FAR
42.302 that are delegated, if any, and to stipulate express functions
that are not delegated.
We propose to add clause 352.245-70, Contractor Property Management
System Administration, that would be inserted in solicitations and
contracts containing the clause at FAR 52.245-1, Government Property,
to require the contractor to establish and maintain an acceptable
property management system and that failure to maintain an acceptable
property management system, as defined in this clause, may result in
disapproval of the system by the contracting officer and/or withholding
of payments. The clause provides three definitions, and details what
criteria will be utilized by the Government in its review of the
contractor's property management system how system deficiencies will be
handled, and how the contracting officer will evaluate the contractor's
response, and the contracting officer's notification on resolution or
disapproval. The clause provides for a contracting officer's final
determination and requires the contractor to, within 45 days of receipt
of final determination, either correct the significant deficiencies or
submit an acceptable corrective action plan showing milestones and
actions to eliminate the significant deficiencies.
We propose to add clause 352.247-70, Delivery Location, to be used
in supply contracts when it is necessary to specify delivery locations
and provides an insert in the clause for the address and identifying
data for shipment of deliverable items other than reports.
We propose to add clause 352.247-71, Marking Deliverables, as
prescribed at 347.305-10(a), Packing, marking, and consignment
instructions, or a clause substantially the same as the proposed clause
at 352.247-71, in solicitations and contracts if special marking on
deliverables is required.
We propose to add clause 352.247-72, Packing for Domestic Shipment,
as prescribed at 347.205-10(b), in contracts when item(s) will be
delivered for immediate use to a destination in the continental United
States; when the material specification or purchase description does
not provide preservation, packaging, packing, and/or marking
requirements; and/or when the requiring activity has not cited a
specific specification for packaging. This clause requires that
material shall be packed for shipment in such a manner that will ensure
acceptance by common carriers and safe delivery at destination.
Containers and closures shall comply with regulations of carriers as
applicable to the mode of transportation.

[[Page 80656]]

We propose to revise the provisions and clauses related to HHSAR
part 370, as follows, in the order currently reflected in the Code of
Federal Regulations:
We propose to revise provision 352.270-4a, Notice to Offerors,
Protection of Human Subjects, to make minor administrative corrections
to renumber the provision to 352.270-70, revise the HHSAR citation
referencing the prescription, provide the current electronic Code of
Federal Regulations website address for 45 CFR part 46, update other 45
CFR part 46 citations where included in the provision, and add
paragraph (h) to provide the registration processes.
We propose to revise clause 352.270-4b, Protection of Human
Subjects, to make minor administrative corrections to renumber to
352.270-72 and to revise the HHSAR citation referencing the
prescription.
We propose to revise 352.270-5a, Notice to Offerors of Requirement
for Compliance with Public Health Service Policy on Humane Care and the
Use of Laboratory Animals, to make administrative corrections. This
includes revising the provision to a clause, renumbering the clause to
352.270-77, revising the title to ``Compliance with the Public Health
Service Policy on Humane Care and Use of Laboratory Animals,'' and
revising the HHSAR citation referencing the prescription. These
revisions would add paragraph (a), Definitions, and three definitions,
as well as additional content to paragraph (b) that the contract will
not be awarded without the approval of the Office of Laboratory Animal
Welfare, National Institutes of Health upon receipt of the contractor's
assurance. We propose to revise paragraphs (b) and (c) to combine the
current content into paragraph (b), and revise paragraph (c) to permit
the contracting officer to immediately suspend, in whole or in part,
work performance and further payments if the contractor is not in
compliance with any of the requirements and standards in the clause.
We propose to revise clause 352.270-5b, Care of Live Vertebrate
Animals, to make minor administrative corrections to renumber the
clause to 352.270-78, revise the HHSAR citation referencing the
prescription, remove duplicative content in paragraph (c), change the
``Note'' to new paragraph (e), and other minor edits for clarification.
We propose to revise clause 352.270-6, Restriction on Use of Human
Subjects, to make minor administrative corrections to renumber the
clause to 352.270-73, revise the HHSAR citation referencing the
prescription, and other minor edits for clarification.
We propose to remove the ``352.270-7--352.270-8 [Reserved]''
annotation as it is no longer needed with the revision, renumbering,
and retitling of the clauses and provisions under this part.
We propose to revise provision 352.270-9, Non-Discrimination for
Conscience, to make minor administrative corrections to renumber the
clause to 352.270-79, revise the HHSAR citation referencing the
prescription, and to add ``The PEPFAR Stewardship Act of 2013, and The
PEPFAR Extension Act of 2018,'' to paragraph (a).
We propose to revise provision 352.270-10, Notice to Offerors--
Protection of Human Subjects, Research Involving Human Subjects
Committee (RIHSC) Approval of Research Protocols Required, to make
minor administrative corrections to renumber the clause to 352.270-71,
slightly revise the title and the HHSAR citation referencing the
prescription, update the citation of the HHSAR provision number in
paragraph (a), and other minor punctuation edits.
We propose to revise clause 352.270-11, Protection of Human
Subjects--Research Involving Human Subjects Committee (RIHSC) Approval
of Research Protocols Required, to make minor administrative
corrections to renumber the clause to 352.270-74, revise the HHSAR
citation referencing the prescription, update the citation of the HHSAR
provision number in paragraph (a), and other minor punctuation edits.
We propose to revise clause 352.270-12, Needle Exchange, to make
minor administrative corrections to renumber the clause to 352.270-75
and revise the HHSAR citation referencing the prescription.
We propose to revise clause 352.270-13, Continued Ban on Funding
Abortion and Continued Ban on Funding of Human Embryo Research, to make
minor administrative corrections to renumber the clause to 352.270-76
and revise the HHSAR citation referencing the prescription.
This table reflects the above proposed revisions and renumbering of
the HHSAR part 370 prescribed clauses and provisions:

----------------------------------------------------------------------------------------------------------------
Proposed revised prescription
Existing subpart prescription (in order of for each solicitation provision
sequence) Existing No. Proposed No. and contract clause Note:
(P)=Provision, (C)=Clause
----------------------------------------------------------------------------------------------------------------
370.303(a).................................... 352.270-4a 352.270-70 370.304(a): 352.270-70, Notice
to Offerors, Protection of
Human Subjects (P).
370.303(d).................................... 352.270-10 352.270-71 370.304(b): 352.270-71, Notice
to Offerors--Protection of
Human Subjects, Research
Involving Human Subjects
Committee (RIHSC) Approval of
Research Protocols Required
(P).
370.304(b).................................... 352.270-6 352.270-73 370.304(d): 352.270-73,
Restriction on Use of Human
Subjects (C).
370.304(a).................................... 352.270-4b 352.270-72 370.304(c): 352.270-72,
Protection of Human Subjects
(C).
370.304(c).................................... 352.270-11 352.270-74 370.304(e): 352.270-74,
Protection of Human Subjects--
Research Involving Human
Subjects Committee (RIHSC)
Approval of Research Protocols
Required (C).
370.304(d).................................... 352.270-12 352.270-75 370.304(f): 352.270-75, Needle
Exchange (C).
370.304(e).................................... 352.270-13 352.270-76 370.304(g): 352.270-76,
Continued Ban on Funding
Abortion and Continued Ban on
Funding of Human Embryo
Research (C).
370.403(a).................................... 352.270-5a 352.270-77 370.403(a): 352.270-77,
Requirement for Compliance with
the Public Health Service
Policy on Humane Care and Use
of Laboratory Animals (C).
370.404....................................... 352.270-5b 352.270-78 370.403(b): 352.270-78, Care of
Live Vertebrate Animals (C).
370.701....................................... 352.270-9 352.270-79 370.701: 352.270-79, Non-
Discrimination for Conscience
(P).
----------------------------------------------------------------------------------------------------------------

We propose to add subpart 352.3, Provision and Clause Matrix, and
section 352.301, Solicitation provisions and contract clauses (Matrix).
Section 352.301 identifies that the HHSAR matrix is not published in
the Code of Federal Regulations and will be available on the
<a href="http://Acquisition.gov">Acquisition.gov</a> website.

[[Page 80657]]

Subchapter M--HHS Supplementations

We propose to redesignate and retitle subchapter M, HHS
Supplementations, title 48, chapter 3, to subchapter I, Department
Supplementary Regulations, to better align with other FAR system
regulatory subchapter placements under similar agency supplements to
title 48.

HHSAR Part 370--Special Programs Affecting Acquisition

We propose to revise the authority citations for part 370, for the
reasons set forth in the discussion and analysis section, to read as
follows: 5 U.S.C. 301; 40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41
U.S.C. 1702; and 48 CFR 1.301 through 1.304.
We propose to revise the title of part 370 to ``Special Programs
Affecting Acquisitions,'' to comport with the plural usage of
``Acquisitions'' in the subpart titles.
In subpart 370.3, Acquisitions Involving Human Subjects, we propose
in section 370.300, Scope of subpart, to add a reference to 45 CFR part
46 policy scope and update the references to the 2018 Requirements
revisions. Specifically, we are adding a reference to 45 CFR 46.102,
which defines the applicability of the HHS policy in general. We are
also removing the reference to the old Sec. 46.102(d) and (f), which
defined ``Human Subject'' and ``Research'' respectively and replacing
them with the new 2018 paragraphs (e) and (l). In section 370.301,
Policy, we propose to add a reference to the 2018 exemption for certain
research as set forth in 45 CFR 46.104. We also propose administrative
edits in the second sentence for further clarification.
We propose in section 370.302, Federal-wide Assurance (FWA), to
revise the title to ``Federal-wide assurance'' and make other minor
edits for clarification.
In section 370.303, Notice to offerors/Provisions, we propose to
revise the section title to ``Notice to offerors,'' moving the two
provisions prescribed in paragraphs (a) and (d) to revised section
370.304, Solicitation provisions and contract clause, paragraphs (a)
and (b). We also propose in section 370.303 to add a statement at
paragraph (a) to reinforce the 2018 Requirements that unless exempt, no
contract can start without the required certifications.
We propose in section 370.304, Contract clauses, to revise the
title to ``Solicitation provisions and contract clause.'' The following
revisions to the text under this section are proposed:
<bullet> Move provision 352.270-4a, Notice to Offerors--Protection
of Human Subjects, from section 370.303, paragraph (a), to be
renumbered as 352.270-70, to comport with FAR numbering conventions.
The provision is prescribed to be inserted in solicitations that
involve human subjects.
<bullet> Move propose provision 352.270-10, Notice to Offerors--
Protection of Human Subjects, Research Involving Human Subjects
Committee (RIHSC) Approval of Research Protocols Required, from section
370.303, paragraph (d), to be renumbered as 352.270-71, to comport with
FAR numbering conventions. The provision is prescribed to be inserted
in solicitations that involve human subjects when the research is
subject to RIHSC review and approval.
<bullet> Redesignate the existing paragraph (a) to paragraph (c),
and renumber the clause 352.270-4b, Protection of Human Subjects, to
352.270-72, to comport with FAR numbering conventions. The clause is
prescribed to be inserted in solicitations, contracts, and orders
involving human subjects.
<bullet> Redesignate the existing paragraph (b) to paragraph (d),
and renumber the clause 352.270-6, Restriction of Use of Human
Subjects, to 352.270-73, to comport with FAR numbering conventions. The
clause is prescribed to be inserted in solicitations, contracts, and
orders involving human subjects. In contracts and orders if the
contractor has an approved FWA of compliance in place but cannot
certify prior to award that an IRB registered with OHRP reviewed and
approved the research, because definite plans for involvement of human
subjects are not set forth in the proposal (e.g., projects in which
human subjects' involvement will depend upon completion of instruments,
prior animal studies, or purification of compounds). Under these
conditions, the contracting officer may make the award without the
requisite certification, as long as the contracting officer includes
appropriate conditions in the contract or order.
<bullet> Redesignate the existing paragraph (c) to paragraph (e),
and renumber the clause 352.270-11, Protection of Human Subjects--
Research Involving Human Subjects Committee (RIHSC) Approval of
Research Protocols Required, to 352.270-74, to comport with FAR
numbering conventions. The clause is prescribed to be inserted in
solicitations, contracts, and orders that involve human subjects when
the research is subject to RIHSC review and approval.
<bullet> Redesignate the existing paragraph (e) to paragraph (f),
and renumber the clause 352.270-12, Needle Exchange, to 352.270-75, to
comport with FAR numbering conventions. The clause is prescribed to be
inserted in solicitations, contracts, and orders that involve human
subjects.
<bullet> Redesignate the existing paragraph (e) to paragraph (e),
and renumber the clause 352.270-13, Continued Ban on Funding Abortion
and Continued Ban on Funding of Human Embryo Research, to 352.270-76,
to comport with FAR numbering conventions. The clause is prescribed to
be inserted in solicitations, contracts, and orders that involve human
subjects.
In subpart 370.4, Acquisitions Involving the Use of Laboratory
Animals, we propose minor edits for clarification, and to move the
citation regarding the Public Health Service (PHS) Policy on Humane
Care and Use of Laboratory Animals (PHS Policy) to new section 370.402,
Policy. We propose in new section 370.401, Definitions, to define three
definitions used in this subpart, ``Animal,'' ``Animal Welfare
Assurance or assurance,'' and ``Institutional Animal Care and Use
Committee.''
We propose to redesignate section 370.401 as section 370.402 to
comport with FAR conventions and have made conforming revisions in the
section to comport with the revised Public Health Service (PHS) Policy
on Humane Care and Use of Laboratory Animals, which implements Public
Law 99-158. We also propose to redesignate paragraph (b) to paragraph
(c), and remove content to the HHSAM as internal procedures, as well as
submission requirements that have more appropriately been moved to
clause 352.270.77, Compliance with the Public Health Policy on Humane
Care and Use of Laboratory Animals, which is prescribed at section
370.403(a).
We propose to remove section 370.402 and move the details of the
assurance and approval requirements to clause 352.270.77, Compliance
with the Public Health Policy on Humane Care and Use of Laboratory
Animals, which is prescribed at section 370.403(a).
We propose to rename section 370.403 as ``Contract clauses,'' to
reflect that only clauses are prescribed in the section. The following
revisions are proposed:
<bullet> In paragraph (a), change the prescription to renumbered
clause 352.270-77, Compliance with the Public Health Policy on Humane
Care and Use of Laboratory Animals, which comports with FAR numbering
convention. The clause is prescribed to be inserted in solicitations,
contracts, and orders that involve live vertebrate animals.
<bullet> Move the prescription currently at section 370.304 for
clause 352.270-5b, Care of Live Vertebrate Animals, to

[[Page 80658]]

paragraph (b) of section 370.403, Contract clauses, and renumber the
clause to 352.270-76, which comports with FAR numbering convention. The
clause is prescribed to be inserted in solicitations and contracts that
involve live vertebrate animals.
<bullet> Remove the remaining content in section 370.403 as the
language is duplicative of the prescribed clauses.
We propose to remove section 370.404, Contract clause, as the
content has been moved to section 370.403.
In subpart 370.7, Acquisitions Under the Leadership Act, we propose
to revise the title of the subpart to ``Acquisitions Under the
President's Emergency Plan for AIDS Relief,'' as this is the more
commonly used title of Public Law 108-25, in addition to the fact the
short title, ``Leadership Act,'' is no longer widely used.
In section 370.700, Scope of subpart, we propose to add the
``PEPFAR'' (``President's Emergency Plan for AIDS Relief'') acronym and
update the amended public law references to include Public Law 115-305,
the PEPFAR Extension Act.
In section 370.701, Solicitation provision, we propose to number
provision 352.270-9, Non-Discrimination for Conscience, to 352.270-79,
to comport with FAR numbering convention. We also propose to revise the
prescription language at paragraphs (a) to update with the enacted
PEPFAR Stewardship and Oversight Act of 2013 (Pub. L. 113-56) in lieu
of the PEPFAR Extension Act of 2018 (Pub. L. 115-305). We also propose
to move the content of paragraph (b) to the HHSAM as agency procedures.

Regulatory Reviews

Executive Order 12866 and 13563

Executive Orders (E.O.) 12866 and 13563 direct agencies to assess
all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). Executive Order 13563 (Improving Regulation and Regulatory
Review) emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
The Office of Information and Regulatory Affairs has examined the
economic, interagency, budgetary, legal, and policy implications of
this regulatory action, and has determined that this rule is not a
significant regulatory action under E.O. 12866.
HHS's impact analysis can be found as a supporting document at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>, usually within 48 hours after the
rulemaking document is published.

Paperwork Reduction Act

This proposed rule includes provisions constituting collections of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521) that require approval by the Office of Management and Budget
(OMB). Accordingly, under 44 U.S.C. 3507(d), HHS has submitted a copy
of this rulemaking action to OMB for its review.
OMB assigns control numbers to collections of information it
approves. HHS may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. HHS is revising 12 currently
approved collections of information proposed in this rule under the
HHSAR, 48 CFR part 352, Solicitation Provisions and Contract Clauses,
that are prescribed under and related to the following HHSAR parts:
<bullet> 48 CFR part 370, Special Programs Affecting Acquisition;
<bullet> 48 CFR part 327, Patents, Data, and Copyrights;
<bullet> 48 CFR part 337, Service Contracting--General; and
<bullet> 48 CFR part 311, Describing Agency Needs.
The 12 existing approved information collections followed by their
currently designated numbers and titles are reflected below. (Note: The
following existing section (clause or provision) numbers may be updated
by number or title as reflected later in this section via a table
describing the updated burden information.)
<bullet> 48 CFR 352.270-4a, Notice to Offerors, Protection of Human
Subjects.
<bullet> 48 CFR 352.270-10, Notice to Offerors--Protection of Human
Subjects, Research Involving Human Subjects Committee (RIHSC) Approval
of Research Protocols Required.
<bullet> 48 CFR 352.270-4b, Protection of Human Subjects.
<bullet> 48 CFR 352.270-11, Protection of Human Subjects--Research
Involving Human Subjects Committee (RIHSC) Approval of Research
Protocols Required.
<bullet> 48 CFR 352.237-73, Indian Child Protection and Family
Violence Act.
<bullet> 48 CFR 352.270-5a, Notice to Offerors of Requirement for
Compliance with Public Health Service Policy on Humane Care and the Use
of Laboratory Animals.
<bullet> 48 CFR 352.270-5b, Care of Live Vertebrate Animals.
<bullet> 48 CFR 352.211-1, Public Accommodations and Commercial
Facilities.
<bullet> 48 CFR 352.211-2, Conference Sponsorship Request and
Conference Materials Disclaimer.
<bullet> 48 CFR 352.227-11, Patent Rights--Exceptional
Circumstances.
<bullet> 48 CFR 52.227-14, Rights in Data--Exceptional
Circumstances.
<bullet> 48 CFR 352.237-72, Crime Control Act--Requirement for
Background Checks.
Additionally, HHS is proposing to add six (6) new collections of
information in this proposed rule under the HHSAR, 48 CFR part 352,
Solicitation Provisions and Contract Clauses, that are prescribed under
and related to the following HHSAR parts:
<bullet> 48 CFR part 304, Administrative Matters (proposed to be
revised to a new header to comport with the FAR: Administrative and
Information Matters);
<bullet> 48 CFR part 308, Required Sources of Supplies and
Services;
<bullet> 48 CFR part 309, Contractor Qualifications;
<bullet> 48 CFR part 323, Environment, Energy and Water Efficiency,
Renewable Energy Technologies, Occupational Safety, and Drug-Free
Workplace (proposed to be revised to a new header to comport with the
FAR: Environment, Sustainable Acquisition, and Material Safety);
<bullet> 48 CFR part 333, Protests, Disputes, and Appeals; and
<bullet> 48 CFR part 345, Government Property.
The six new proposed approved information collections are as
follows (Note: Based on the number of respondents for two of the
associated information collections falling under 10 that do not require
OMB approval due to exception, HHS is requesting four (4) new approved
OMB control numbers for items 1 through 4 as follows out of the six new
identified collections of information.):
1. 48 CFR 352.204-70, Prevention and Public Health Fund--Reporting
Requirements.
2. 48 CFR 352.209-70, Organizational Conflicts of Interest.
3. 48 CFR 352.208-70, Printing and Duplication.
4. 48 CFR 352.245-70, Contractor Property Management System
Administration.
5. 48 CFR 352.223-70, Instructions to Offerors--Sustainable
Acquisition Plan. (OMB approval not required at this time.)

[[Page 80659]]

6. 48 CFR 352.233-71, Litigation and Claims. (OMB approval not
required at this time.)
If OMB does not approve the collections of information as
requested, HHS will immediately remove the provisions containing a
collection of information or take such other action as is directed by
OMB.
Comments on the collections of information contained in this
proposed rule should be submitted to the Office of Management and
Budget, Attention: Desk Officer for the Department of Health and Human
Services, Office of Information and Regulatory Affairs, Washington, DC
20503, with copies sent by mail or hand delivery to the U.S. Department
of Health and Human Services, Office of the Chief Information Officer,
Attn: Sherrette Funn, 200 Independence Ave. SW, Room 336E, Washington,
DC 20201; or email to <a href="/cdn-cgi/l/email-protection#b9cad1dccbcbdccdcddc97dfccd7d7f9d1d1ca97ded6cf"><span class="__cf_email__" data-cfemail="502338352222352424357e36253e3e103838237e373f26">[email&#160;protected]</span></a>; and email to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Comments should indicate that they are submitted
in response to ``RIN 0991-AC36--HHS Acquisition Regulation: Regulatory
Review (HHSAR Case 2023-002).''
OMB is required to make a decision concerning the collections of
information contained in this proposed rule between 30 and 60 days
after publication of this document in the Federal Register. Therefore,
a comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of publication. This does not affect the
deadline for the public to comment on the proposed rule.
The Department considers comments by the public on proposed
collections of information in--
<bullet> Evaluating whether the proposed collections of information
are necessary for the proper performance of the functions of the
Department, including whether the information will have practical
utility;
<bullet> Evaluating the accuracy of the Department's estimate of
the burden of the proposed collections of information, including the
validity of the methodology and assumptions used;
<bullet> Enhancing the quality, usefulness, and clarity of the
information to be collected; and
<bullet> Minimizing the burden of the collections of information on
those who are to respond, including through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses.
The collection of information on currently approved OMB control
numbers can be accessed on <a href="http://reginfo.gov">reginfo.gov</a>. The following table provides a
summary of the proposed revisions of the 12 currently approved
collections of information. The proposed revisions do not change
information collection requirements and the estimated burden hours. But
the proposed revision made changes in the Information Collection
Instruments/Instructions. HHS has submitted them to OMB for review and
approval.

----------------------------------------------------------------------------------------------------------------
Proposed clause/
Existing clause/provision number Approved OMB provision number and Proposed other Burden hours
and header title control number header title changes
----------------------------------------------------------------------------------------------------------------
352.270-4a, Notice to Offerors, 0990-0431 352.270-70, Notice to Revise the HHSAR 450
Protection of Human Subjects. Offerors--Protection citation referencing
of Human Subjects. the prescription.
352.270-10 Notice to Offerors-- 0990-0431 352.270-71, Notice to N/A.................. 450
Protection of Human Subjects, Offerors--Protection
Research Involving Human Subjects of Human Subjects,
Committee (RIHSC) Approval of Research Involving
Research Protocols Required. Human Subjects
Committee (RIHSC)
Approval of Research
Protocols Required.
352.270-4b, Protection of Human 0990-0431 352.270-72, Revise the HHSAR 450
Subjects. Protection of Human citation referencing
Subjects. the prescription.
352.270-11 Protection of Human 0990-0431 352.270-74 Protection Revise the HHSAR 450
Subjects--Research Involving of Human Subjects-- citation referencing
Human Subjects Committee (RIHSC) Research Involving the prescription.
Approval of Research Protocols Human Subjects
Required. Committee (RIHSC)
Approval of Research
Protocols Required.
352.237-72, Crime Control Act-- 0990-0430 352.237-72, Update the 160
Requirement for Background Checks. Requirement for prescription and the
Background Checks. title.
352.270-5a, Notice to Offerors of 0990-0432 352.270-77, Revise the title and 54
Requirement for Compliance with Compliance with the HHSAR citation
Public Health Service Policy on Public Health referencing the
Humane Care and the Use of Service Policy on prescription. Adding
Laboratory Animals. Humane Care and Use new content.
of Laboratory
Animals.
352.270-5b, Care of Live 0990-0432 352.270-78, Care of Revise the HHSAR 54
Vertebrate Animals. Live Vertebrate citation referencing
Animals. the prescription and
remove duplicative
content.
352.211-1, Public Accommodations 0990-0434 352.211-70, Public Revise the 533.5
and Commercial Facilities. Accommodations and prescription to
Commercial comport with FAR
Facilities. style conventions.
352.211-2, Conference Sponsorship 0990-0434 352.211-71, Update the 533.5
Request and Conference Materials Conference prescription to
Disclaimer. Sponsorship Requests comport with FAR
and Conference style conventions.
Materials Disclaimer.
352.227-11, Patent Rights-- 0990-0419 352.227-70, Patent Make minor updates to 5,449.5
Exceptional Circumstances. Rights--Supplement-- the clause
Exceptional prescription and
Circumstances. citation.
352.227-14, Rights in Data-- 0990-0419 352.227-71, Rights in Make minor updates to 5,449.5
Exceptional Circumstances. Data--Supplement--Ex the clause
ceptional prescription and
Circumstances. citation and remove
duplicate content.

[[Page 80660]]

352.237-73, Indian Child 0990-0433 352.237-73, Indian Revise title of the 67
Protection and Family Violence Child Protection and clause. Add needed
Act. Family Violence Act-- content and bring
Background reference citations
Investigations. up to date. Updates
to the clause
prescription and
citation.
----------------------------------------------------------------------------------------------------------------

HHSAR parts 308, 309, 304, 323, 333, and 345 related new
collections of information: Individual summaries of collection of
information, description of need for information and proposed use of
information, along with supporting estimated data are described below.
The following table summarizes HHS request for four (4) new OMB
control numbers for the four proposed clauses/provisions containing
collections of information with burdens on the public.

----------------------------------------------------------------------------------------------------------------
HHSAR clause BLS hourly Estimated cost
OMB control # requesting provision Estimated hour wage rate to the public
----------------------------------------------------------------------------------------------------------------
1............................................... 352.208-70 500 $42.89 $21,445
1............................................... 352.209-70 150 42.89 6,434
N/A *........................................... 352.233-71 N/A 42.89 N/A
N/A *........................................... 352.223-70 N/A 42.89 N/A
1............................................... 352.204-70 260 42.89 11,151
1............................................... 352.245-70 66 42.89 2,831
--------------------------------------------------------------------------------------

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