NPRM Make Personal Protective in America Act Restrictions on Foreign Acquisition

Federal Register / Vol. 89, No. 190 / Tuesday, October 1, 2024 / Proposed Rules
List of Subjects in 40 CFR Parts 281 and
282
Environmental protection,
Administrative practice and procedure,
Hazardous substances, Incorporation by
reference, Indian country, Petroleum,
Reporting and recordkeeping
requirements, State program approval,
Underground storage tanks.
Authority: This document is issued under
the authority of sections 2002(a), 9004, and
7004(b) of the Solid Waste Disposal Act, as
amended, 42 U.S.C. 6912, 6991c, 6991d, and
6991e.
Dated: September 25, 2024.
Jeaneanne M. Gettle,
Acting Regional Administrator, Region 4.
[FR Doc. 2024–22540 Filed 9–30–24; 8:45 am]
BILLING CODE 6560–50–P

DEPARTMENT OF HOMELAND
SECURITY
48 CFR Parts 3025 and 3052
[Docket No. DHS–2024–0020]
RIN 1601–AB15

Homeland Security Acquisition
Regulation, Make Personal Protective
Equipment in America Act Restrictions
on Foreign Acquisition (HSAR Case
2024–003)
Office of the Chief Procurement
Officer (OCPO), Department of
Homeland Security (DHS).
ACTION: Proposed rule.
AGENCY:

DHS is proposing to amend
the Homeland Security Acquisition
Regulation (HSAR) to add a new
subpart, clause, and provision that
would codify how DHS complies with
the requirements of the Make Personal
Protective Equipment (PPE) in America
Act. DHS believes these proposed
changes would help to ensure the
sustainment and expansion of domestic
manufacturing for certain types of PPE
critical to the United States’ national
response to a public health crisis, such
as the COVID–19 pandemic.
DATES: Comments on the proposed rule
should be submitted in writing to one of
the addresses shown below on or before
December 2, 2024, to be considered in
the formation of the final rule.
ADDRESSES: Submit comments
identified by HSAR Case 2024–003,
Make PPE in America Act Restrictions
on Foreign Acquisition, using any of the
following methods:
• Regulations.gov: https://
www.regulations.gov.
Submit comments via the Federal
eRulemaking portal by entering ‘‘HSAR

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Case 2024–003’’ under the heading
‘‘Enter Keyword or ID’’ and select
‘‘Search.’’ Select the link ‘‘Submit a
Comment’’ that corresponds with
‘‘HSAR Case 2024–003.’’ Follow the
instructions provided at the ‘‘Submit a
Comment’’ screen. Please include your
name, company name (if any), and
‘‘HSAR Case 2024–003’’ on your
attached document.
• Fax: (202) 447–0520.
• Mail: Department of Homeland
Security, Office of the Chief
Procurement Officer, Acquisition Policy
and Legislation, ATTN: Ms. Shaundra
Ford, 245 Murray Drive, Bldg. 410
(RDS), Washington, DC 20528.
Comments received generally will be
posted without change to https://
www.regulations.gov, including any
personal information provided. To
confirm receipt of your comment(s),
please check www.regulations.gov,
approximately two to three days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
FOR FURTHER INFORMATION CONTACT:
Shaundra Ford, Department of
Homeland Security, Office of the Chief
Procurement Officer, Acquisition Policy
and Legislation, at (202) 282–8000 or
email at [email protected]. Include
HSAR Case 2024–003 in the subject
line.
SUPPLEMENTARY INFORMATION:
I. Background
The Buy American Act of 1933, as
amended (BAA), addresses preferences
in Federal procurement.1 The BAA
provides a preference for the purchase
of domestic supplies.2
On November 15, 2021, the
Infrastructure Investment and Jobs Act
was signed into law.3 Subtitle C of title
IX of Division G of the Infrastructure
Investment and Jobs Act is the Make
PPE in America Act (‘‘the Act’’).4 The
Act requires the Department of
Homeland Security (DHS), Department
of Veterans Affairs (VA), and the U.S.
Department of Health and Human
Services (HHS) to take certain actions to
ensure the sustainment and expansion
of domestic manufacturing for certain
types of PPE critical to the United
States’ national response to a public
health crisis, such as the COVID–19
pandemic.5
1 See

41 U.S.C. 8301–8305.
e.g., 41 U.S.C. 8302.
3 Infrastructure Investment and Jobs Act, Public
Law 117–58, 135 Stat. 429 (2021).
4 Make PPE in America Act, Public Law 117–58,
div. G, title IX, subtitle C, sections 70951–70953,
135 Stat. 1312–1316. The Make PPE in America Act
is codified in 41 U.S.C. 8301 note.
5 Public Law 117–58, 135 Stat. 1312.
2 See

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The Act defines PPE as surgical
masks, respirator masks and powered
air purifying respirators and required
filters, face shields and protective
eyewear, gloves, disposable and
reusable surgical and isolation gowns,
head and foot coverings, and other gear
or clothing used to protect an individual
from the transmission of disease.6 The
Act requires that any contracts for the
procurement of PPE entered into by
DHS, VA, and HHS be for PPE,
including the materials and components
thereof, that is domestically grown,
reprocessed, reused, or produced.7 The
Act also requires that these contracts
with DHS, HHS, or VA for PPE last at
least two years in duration plus all
option periods necessary, to incentivize
investment in the domestic production
of PPE and the materials and
components thereof.8 The Act allows for
alternatives to domestic production
under certain conditions (i.e., where
PPE assembled outside of the United
States contains only materials and
components grown, reprocessed, reused
or produced in the United States).9
When using alternatives to domestic
production, DHS, HHS, or VA, as
applicable, must certify every 120 days
that alternatives to domestic production
are necessary to procure PPE due to the
immediate needs of a public health
emergency.10 The Act further recognizes
certain exceptions to the domestic
production of PPE, such as due to
nonavailability, or where the PPE
cannot be procured at U.S. market
prices.11 Where DHS, HHS, or VA
respectively grants an exception, that
Secretary would also need to certify that
implementing these exceptions are
necessary to meet the immediate needs
of a public health emergency.12
The DHS Chief Procurement Officer
can issue HSAR deviations when
necessary to allow Components to
deviate from the HSAR.13 On October
17, 2022, DHS issued a deviation
regarding how DHS would comply with
the Make PPE in America Act
requirements (Deviation 23–01). 14
DHS proposes to amend the HSAR at
48 CFR part 3025, Foreign Acquisition,
and at 48 CFR part 3052, Solicitation
6 Public

Law 117–58, 135 Stat. 1313.
Law. 117–58, 135 Stat. 1313–14.
8 Public Law 117–58, 135 Stat. 1314.
9 Id.
10 Id.
11 Id.
12 Id.
13 See HSAR Deviations, available at: https://
www.dhs.gov/publication/current-hsar-deviations.
14 See HSAR Class Deviation 23–01
Implementation of the Make PPE in America Act at
https://www.dhs.gov/sites/default/files/2022-10/
HSARClassDeviation23-01Implementation
ofMakePPEinAmericaAct-508Final.pdf.
7 Public

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Provisions and Contract Clauses, to
reflect the requirements of the Act.
II. Discussion
DHS is proposing to add a new HSAR
subpart, add an HSAR clause, and add
an HSAR provision to codify how DHS
complies with the Act. These proposed
changes would also be consistent with
Deviation 23–01. Each of these proposed
changes is described in detail in the
following paragraphs.
DHS is proposing to add new subpart
3025.71, Make PPE in America Act
Restrictions on Foreign Acquisition, to
the HSAR. This would codify the
restrictions in Deviation 23–01
applicable to the acquisition of certain
PPE consistent with the Act. These
restrictions include minimum time
periods for contract duration, content
requirements for certain PPE,
alternatives to domestic production
when conforming PPE is not available,
and exceptions when conforming PPE is
either nonavailable or cannot be
procured at U.S. market prices (or in
other words, only available at an
unreasonable cost). This rule also
proposes to codify the definitions of
terms used in Deviation 23–01.15 These
terms are ‘‘component,’’ ‘‘domestic
personal protective equipment,’’
‘‘foreign-assembled domestic personal
protective equipment,’’ ‘‘foreign
personal protective equipment,’’
‘‘personal protective equipment,’’ and
‘‘United States.’’
HSAR 3025.7102–1 would apply to all
types of actions, orders, option
exercises, and contracts awarded and
administered by DHS. It would require
contracting officers to purchase
domestic PPE except for certain
exceptions specified in HSAR
3025.7102–2 and would require that any
contract for PPE have a base period of
performance of at least two years, plus
option periods.
HSAR 3025.7102–2 proposes to codify
the conditions under which acquisitions
of PPE, or component thereof, would be
excepted from the requirements of
HSAR 3025.7102–1 (i.e., alternatives to
domestic production, nonavailability,
and unreasonable cost) consistent with
Deviation 23–01.
Deviation 23–01 lists the clauses and
provisions that apply when an
exception due to nonavailability or
unreasonable cost is used, clarifying
that contracting officers still need to
comply with applicable laws and
regulations.16 This rule proposes to
codify these clauses and provisions.17
15 See

proposed 48 CFR 3025.7101.
proposed 48 CFR 3025.7102–3.
17 See proposed 48 CFR 3025.7102–3.
16 See

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DHS believes this approach maximizes
the use of Made in America laws 18 by
defaulting to a Buy American-compliant
or Trade Agreements Act-compliant
item, depending on the dollar value of
the procurement, when both domestic
PPE and foreign-assembled domestic
PPE cannot be acquired.
HSAR 3025.7103 proposes one
provision and one contract clause. DHS
is proposing to add HSAR clause
3052.225–7X, Make PPE in America,
and HSAR provision HSAR 3052.225–
7Y, Make PPE in America Certificate.
The clause codifies Deviation 23–01
which requires contractors to deliver
only domestic PPE, identify in the
provision if foreign-assembled domestic
PPE is being provided, and identifies
the order of precedence for the Buy
American statute and the Trade
Agreements Act when neither domestic
PPE nor foreign-assembled domestic
PPE are available due to nonavailability
or unreasonable cost. Regarding the
provision, Deviation 23–01 also requires
contractors to identify any foreignassembled domestic PPE being offered
to the Department and the country
where it was assembled. This proposed
rule would codify this clause and
provision.19
III. Regulatory Analyses
A. Executive Orders 12866, 13563, and
14094
Executive Order 12866 (Regulatory
Planning and Review), as amended by
Executive Order 14094 (Modernizing
Regulatory Review) and Executive Order
13563 (Improving Regulation and
Regulatory Review) direct agencies to
assess the costs and benefits of available
regulatory alternatives and, if regulation
is necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility.
18 Made in America Laws means all statutes,
regulations, rules, and Executive orders relating to
Federal financial assistance awards or Federal
procurement, including those that refer to ‘‘Buy
America’’ or ‘‘Buy American,’’ that require, or
provide a preference for, the purchase or
acquisition of goods, products, or materials
produced in the United States, including iron, steel,
and manufactured goods offered in the United
States. Made in America Laws include laws
requiring domestic preference for maritime
transport, including the Merchant Marine Act of
1920 (Pub. L. 66–261), also known as the Jones Act.
(See sec. 2, paragraph (b) of Executive Order 14005,
Ensuring the Future Is Made in All of America by
All of America’s Workers.
19 See proposed 48 CFR 3025.7103.

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The Office of Management and Budget
(OMB) has not designated this proposed
rule a significant regulatory action
under section 3(f) of Executive Order
12866, as amended by Executive Order
14094. Accordingly, OMB has not
reviewed this regulatory action.
Background
During the COVID–19 pandemic, the
United States encountered challenges
obtaining PPE in adequate amounts to
address the urgent public health and
safety need. This was in part due to an
unprecedented increase in demand for
PPE and challenges in the supply chain.
Before the COVID–19 pandemic,
domestic production of PPE was limited
and most PPE used in the United States
was predominantly imported.20 The
COVID–19 pandemic exposed the
vulnerability of the United States PPE
supply chains and lack of domestic PPE
production.21 To help address the need
for domestically produced PPE, between
March 2020 to September 2021, the U.S.
Government invested approximately
$957.5 million into expansion of
domestic PPE production.22 These
federally-funded projects expanded an
existing domestic industrial base to
meet surging demand during the
pandemic.
On November 15, 2021, the
Infrastructure Investment and Jobs Act
(Pub. L. 117–58), was signed into law
and included the Act. Congress enacted
this legislation to sustain domestic
demand in PPE manufacturing, support
the continuity of domestic PPE material
sourcing and manufacturing, and reduce
the U.S.’s dependence on foreignproduced PPE. Congress took this action
to reduce the vulnerabilities from future
pandemic supply chain challenges and
to address national security concerns on
foreign dependence of critical supplies.
On October 17, 2022, DHS issued
Deviation 23–01 to comply with the
Act’s requirements. Under Deviation
23–01, solicitations for PPE released on
or after February 14, 2022, or contracts
awarded on or after February 14, 2022,
were subject to the Act’s requirements.
Since issuance of Deviation 23–01, DHS
Components have incorporated the
domestic sourcing and production
requirements for PPE in solicitations
and contracts, as required by the Act.
20 Congressional Research Service (CRS), COVID–
19 and Domestic PPE Production and Distribution:
Issues and Policy Options. 5–6. (Dec. 7, 2020)
(accessible at https://crsreports.congress.gov/
product/pdf/R/R46628).
21 Public Law 117–58, 135 Stat. 1312.
22 Government Accountability Office (GAO),
Agencies Are Taking Steps to Improve Future Use
of Defense Production Act Authorities (GAO–22–
105380), 1, 10 (Dec.16, 2021) (accessible at https://
www.gao.gov/products/gao-22-105380).

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DHS has largely transitioned to
wholly domestically sourced and
manufactured PPE items except for
nitrile gloves. The challenges with
acquiring nitrile gloves that comply
with the Act are two-fold: (1) the
domestic nonavailability of nitrile
butadiene rubber (NBR) at the required
quality and quantity to meet demand
and (2) specific to DHS, insufficient
domestic manufacturing capacity of

nitrile gloves that can successfully pass
Departmental testing requirements for
interference with explosives detection
equipment.23 Therefore, prior to
publication of this proposed rule, DHS
procurements and subsequent contracts
for PPE already complied with the Act’s
requirement through the issuance of
Deviation 23–01. In the following table,
DHS estimated the total awarded
amount for PPE procurement in Fiscal

79853

Years (FY) 2017 through 2023. DHS
used data from Federal Procurement
Data System 24 and filtered for specific
product codes that were most likely to
include covered PPE.25 Table 1 displays
the total award amount DHS spent,
adjusted to 2023 dollars, on PPE and
distribution of awards spent on
domestic versus foreign manufacturers.

TABLE 1—DHS PROCUREMENT OF PPE AWARD AMOUNTS
[$2023] 1

2017
2018
2019
2020
2021
2022
2023

Total annual
DHS PPE
award amount
domestic

Total annual
DHS PPE
award amount

Fiscal year
(FY)
.................................................................
.................................................................
.................................................................
.................................................................
.................................................................
.................................................................
.................................................................

$11,586,965
7,130,580
6,247,764
1,534,234,102
128,945,552
132,875
6,549,382

Total annual
DHS PPE
award amount
foreign

$11,542,312
7,071,960
6,247,764
506,314,364
25,025,686
132,875
6,549,382

Total annual
DHS PPE award
percentage
domestic

Total annual
DHS PPE award
percentage
foreign

99.61
99.18
100.00
33.00
19.41
100.00
100.00

0.39
0.82
0.00
67.00
80.59
0.00
0.00

$44,654
58,620
0
1,027,919,738
103,919,866
0
0

1 Bureau of Economic Analysis, Table 1.1.9. Implicit Price Deflators for Nondurable Goods, [Index numbers, 2017 = 100], Annual data from
1929 to 2023; data published March 28, 2024.

The benefits and costs of a regulation
are generally measured against a noaction baseline, which is a reasonable
forecast of the way the world would
look absent the regulatory action being
assessed.26 As the proposed rule would
align the regulations with DHS current
practice, it would not result in
additional costs for the Federal
Government. The proposed rule would
codify the requirement for contactors to
submit a Make PPE in America
Certificate, only in the situation when
the contractor is proposing foreign-

assembled domestic PPE. DHS already
included this contractor requirement to
certify compliance in Deviation 23–01.
Because DHS contractors already
comply with Deviation 23–01, they
would not incur new costs due to this
proposed rule.
However, Deviation 23–01, which is
how DHS complies with the
requirements of the Act, may cause DHS
to incur additional costs in the form of
higher prices for domestically produced
PPE compared to foreign-produced PPE.
Future DHS procurement price
differences between domestic and
foreign-sourced PPE are difficult to
accurately estimate. External factors
(outside of the Act’s requirement) may
influence prices. For example, U.S.
Government investments in domestic
PPE production could factor into
domestic production costs and prices.
There is uncertainty on foreign
governments investment in foreign PPE
production which would impact foreign
prices. An analysis of PPE would have

to be conducted by type of PPE, such as
the domestic and foreign prices of
masks, protective eyewear, or gloves.
Further, DHS has specific requirements
in certain procurements such as gloves
(i.e., testing for interference with
explosive equipment and protection
against Fentanyl exposure) that would
need to be considered in any price
comparisons.27 Another factor that
would be difficult to address in direct
price comparisons is product
differences. There are no internationally
agreed upon guidelines or standards of
what specific products make up PPE
categories, complicating product
comparisons.28
Consequently, due to the lack of
specific data, complexity of various
factors, and uncertainty of external price
influences, DHS is not able to estimate
the long-run additional DHS cost of an
increased shift to domestic PPE
procurements due to the requirements
of the Act. Importantly, DHS has already
complied with the requirements of the

23 DHS, Special Notice to Industry on
Developments per the Make PPE in America Act, 1,
1 (Dec. 16, 2023) (accessible at https://sam.gov/opp/
45a5c9581d864342a983dc9184c2c77d/view).
24 The Federal Procurement Data System (FPDS)
is a centralized site for U.S. Government-wide
procurement data. FPDS is managed by the U.S.
General Services Administration, and it contains
detailed information on Federal procurements over
the micro-purchase threshold of $10,000 (this
threshold has increased over time). DHS retrieved
FPDS Report via the SAM.gov Data Bank. SAM.gov
reports support analysis of the Federal award
lifecycle.

25 DHS filtered for product codes 6516 (Medical
and Surgical Instruments, Equipment, and
Supplies), 6532 (Hospital and Surgical Clothing and
Related Special Purpose Items), 6545
(Replenishable Field Medical Sets, Kits, and
Outfits), and 8415 (Clothing, Special Purpose).
26 See OMB Circular A–4, p, 11 (Nov. 9, 2023)
(accessible at https://www.whitehouse.gov/wpcontent/uploads/2023/11/CircularA-4.pdf).
27 DHS, White Paper: Current State of Personal
Protective Equipment Procurement by Make PPE in
America Act Covered Agencies. 3–4 (March 13,
2024).

28 ‘‘For example, KN95 respirator masks- China
made analogues to domestically regulated N–95
respirators- are generally not authorized as medical
PPE in the United States. KN95 are authorized in
many countries abroad, and received temporary
(and limited) Emergency Use Authorization from
the [U.S. Food and Drug Administration] FDA.’’
FDA, Certain Filtering Facepiece Respirators from
China May Not Provide Adequate Respiratory
Protection—Letter to Health Care Providers,
October 15, 2020, at https://www.fda.gov/medicaldevices/letters-health-care-providers/certainfiltering-facepiece-respirators-china-may-notprovide-adequate-respiratory-protection-letter.

Need for the Proposed Rule
This proposed rule would codify the
requirements as set forth in the Act and
Deviation 23–01. DHS proposes this
update to the Homeland Security
Acquisition Regulation (HSAR) to align
with current DHS practice in Deviation
23–01. This proposed rule would
provide for consistency between the Act
and the HSAR.

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Act through Deviation 23–01 and
subsequent contract changes.
Congress recognized the need for the
United States to have a robust, secure,
and wholly domestic PPE supply chain
to safeguard public health and national
security.29 This proposed rule codifies
the statutory requirements that support
the sustainment of the U.S. PPE supply
chain. This proposed rule would
provide the clarification benefit of
consistency and transparency for
contractors and DHS contracting
officers.

certificate would be $14.49 (15 minutes
× $57.95).
Based on the estimated cost of $14.49
per certificate, DHS assumes this cost
would not be a significant economic
impact on a small entity affected by the
proposed rule. DHS also believes that
contractors generally pass along the cost
of complying with DHS contracting
requirements to DHS. Therefore, DHS
certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a
significant economic impact on a
substantial number of small entities.

B. Regulatory Flexibility Act

C. Paperwork Reduction Act
The Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501 et seq.) requires
that DHS consider the impact of
paperwork and other information
collection burdens imposed on the
public and, under the provisions of 44
U.S.C. 3507(d), obtain approval from the
OMB for each collection of information
it conducts, sponsors, or requires
through regulations. This proposed rule
contains information collection
requirements. Accordingly, DHS is
updating OMB No. 1600–0005,
Solicitation of Proposal Information for
Award of Public Contracts.
The collection requirements for this
proposed rule are nominal and based on
the new provision, 3052.225–7Y, Make
PPE in America Certificate.
Overview of Information Collection:
(1) Type of Information Collection:
Modification to Existing Collection.
(2) Title of the Form/Collection:
Solicitation of Proposal Information for
Award of Public Contracts.
(3) Agency form number, if any, and
the applicable component of DHS
sponsoring the collection: No form;
OCPO.
(4) Affected public who will be asked
or required to respond; as well as a brief
abstract: The affected public is business
or other for-profit institutions. DHS
needs the information required by
provision 3052.225–7Y to assess
contractor compliance with the Make
PPE in America Act. Responses are
required for respondents to obtain or
retain benefits.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: The estimated number of
respondents for reporting is 0.08. This
number is nominal because a response
to this provision is required only if the
offeror is proposing foreign-assembled
domestic PPE. Such response should be
rare, because the offeror of such
products is unlikely to receive an
award, unless no offers for domestic
PPE are received. In Fiscal Year (FY)
2022, DHS awarded 8 contracts for

The Regulatory Flexibility Act of
1980, 5 U.S.C. 601 et seq., as amended
by the Small Business Regulatory
Enforcement Fairness Act of 1996,
Public Law 104–121 (Mar. 29, 1996),
hereafter jointly referred to as the
‘‘RFA,’’ requires Federal agencies
engaged in rulemaking to consider the
economic impacts of their rules on
small entities. A small entity may be a
small business (defined as any
independently owned and operated
business not dominant in its field that
qualifies as a small business per the
Small Business Act); a small not-forprofit organization; or a small
governmental jurisdiction (locality with
fewer than 50,000 people). This
proposed rule would codify direct
requirements for DHS, which DHS has
already implemented through Deviation
23–01. Federal agencies are not
included in the definition of small
entity set forth in 5 U.S.C. 601. The
proposed rule only codifies an existing
requirement for contractors to submit
the Make PPE in America Certificate
with the PPE. Contractors currently
provide the Make PPE in America
Certificate in compliance with Deviation
23–01. The Make PPE in America
Certificate is required only if the offeror
is proposing foreign-assembled
domestic PPE. DHS estimates the
contractor burden based on experience
from subject matter experts familiar
with Deviation 23–01. DHS estimates it
will take a contractor 15 minutes to
identify any foreign-assembled domestic
PPE items it is offering and complete the
Make PPE in America Certificate. DHS
assumes an estimated hourly
compensation rate of $57.95 for the time
burden.30 The time burden cost per
29 Public

Law 117–58, 135 Stat. 1313.
average hourly earnings are based upon the
U.S. Department of Labor, Bureau of Labor
Statistics’ website (www.bls.gov). The wage rate
category selected is for Business and Financial
Operations Occupations, May 2022. The rate is
estimated to be $57.95 ($41.39 × 1.4), which
includes the wage rate multiplier.
30 The

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domestic PPE. DHS estimates it will
receive ten offers per solicitation. Using
the number of contracts awarded in FY
2022, DHS estimates it received 80
offers. DHS estimates 0.2 percent of
offers, or 0.16 responses, will include
foreign-assembled domestic protective
equipment. The average number of
responses per respondent is two or 0.08
respondents. DHS estimates it will take
each respondent 15 minutes to complete
the certificate. These numbers are not
unusual given that DHS awarded a
mandatory for use, Departmentwide
contract for domestic PPE in March of
2022 and the requirements of provision
3052.225–7Y Make PPE in America
Certificate were satisfied at the contract
level. Standalone contracts are awarded
only when the domestic PPE needed is
not available under the Departmentwide
contract.
(6) An estimate of the total public
burden (in hours) associated with the
information collection: The total
estimated annual hour burden
associated with this collection is 0.033
hours or 2 minutes.
(7) An estimate of the total public
burden (in cost) associated with the
information collection: The estimated
total annual cost burden associated with
this collection of information is $2.32.
D. National Environmental Policy Act
Section 102 of the National
Environmental Policy Act of 1969
(NEPA), Public Law 91–190, 83 Stat.
852 (Jan. 1, 1970) (42 U.S.C. 4321 et
seq.), as amended, requires Federal
agencies to evaluate the impacts of a
proposed major Federal action that may
significantly affect the human
environment, consider alternatives to
the proposed action, provide public
notice and opportunity to comment, and
properly document its analysis. DHS
and its agency components analyze
proposed actions to determine whether
NEPA applies to them and, if so, what
level of documentation and analysis is
required.
DHS Directive 023–01, Rev. 01 and
DHS Instruction Manual 023–01–001–
01, Rev. 01 (Instruction Manual)
establish the policies and procedures
DHS and its component agencies use to
comply with NEPA and the Council on
Environmental Quality (CEQ)
regulations for implementing NEPA
codified in 40 CFR parts 1500 through
1508. The CEQ regulations allow
Federal agencies to establish, in their
implementing procedures, with CEQ
review and concurrence, categories of
actions (‘‘categorical exclusions’’) that
experience has shown do not,
individually or in the aggregate, have a
significant effect on the human

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environment and, therefore, do not
require preparation of an environmental
assessment or environmental impact
statement. 40 CFR 1501.4, 1507.3(c)(8).
Appendix A of the Instruction Manual
lists the DHS categorical exclusions.
Under DHS NEPA implementing
procedures, for an action to be
categorically excluded, it must satisfy
each of the following three conditions:
(1) the entire action clearly fits within
one or more categorical exclusions; (2)
the action is not a piece of a larger
action; and (3) no extraordinary
circumstances exist that create the
potential for a significant environmental
effect.
The proposed rule, if finalized, would
amend the HSAR to better clarify how
DHS complies with the Make PPE in
America Act. This would include
codifying Deviation 23–01 that is
currently in effect. DHS is not aware of
any significant impact on the
environment, or any change in
environmental effect that will result
from this proposed rule. DHS finds
promulgation of the rule clearly fits
within categorical exclusion A3,
established in the Department’s NEPA
implementing procedures.
This proposed rule is a standalone
rule and is not part of any larger action.
This proposed rule would not result in
any major Federal action that would
significantly affect the quality of the
human environment. Furthermore, DHS
has determined that no extraordinary
circumstances exist that would create
the potential for significant
environmental effects. Therefore, this
proposed rule is categorically excluded
from further NEPA review and
documentation.
List of Subjects in 48 CFR Parts 3025
and 3052
Government procurement.
Accordingly, for the reasons set forth
in the preamble, DHS proposes to
amend 48 CFR parts 3025 and 3052 as
follows:
PART 3025—FOREIGN ACQUISITION
1. The authority citation for part 3025
is revised to read as follows:

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■

Authority: 5 U.S.C. 301–302, 41 U.S.C.
1303, 41 U.S.C. 1707, 41 U.S.C. 1702, 41
U.S.C. 8301 note, 48 CFR part 1, subpart 1.3,
DHS Delegation No. 00701, Revision No.
03.2, paragraphs (III)(H), and DHS Delegation
No. 00702, Revision No. 01.2, paragraphs
(III)(M).

2. Add subpart 3025.71 to read as
follows:

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Subpart 3025.71—Make PPE in
America Act Restrictions on Foreign
Acquisition
Sec.
3025.7100 Scope of subpart.
3025.7101 Definitions.
3025.7102 Restrictions on certain personal
protective equipment.
3025.7102–1 Restrictions.
3025.7102–2 Exceptions.
3025.7102–3 Specific application of the
Buy American Act and Trade
Agreements Act.
3025.7103 Solicitation provisions and
contract clauses.
3025.7100

Scope of subpart.

This subpart contains restrictions on
the acquisition of certain personal
protective equipment (PPE) imposed by
the Make PPE in America Act (Pub. L.
117–58) and they apply to all types of
actions, orders, option exercises, and
contracts entered into on or after
February 14, 2022.
3025.7101

Definitions.

As used in this subpart—
(a) Component, as applied to an item
described in 3025.7102–1, means an
article, material, or supply incorporated
directly into an item of personal
protective equipment.
(b) Domestic personal protective
equipment, as applied to an item
described in 3025.7102–1, means
personal protective equipment,
including the materials and components
thereof, that is grown, reprocessed,
reused, or produced in the United
States.
(c) Foreign-assembled domestic
personal protective equipment, as
applied to an item described in
3025.7102–2, means personal protective
equipment that is assembled outside the
United States containing only materials
and components that are grown,
reprocessed, reused, or produced in the
United States.
(d) Foreign personal protective
equipment means personal protective
equipment other than domestic personal
protective equipment or foreignassembled domestic personal protective
equipment.
(e) Personal protective equipment, as
applied to an item described in
3025.7102–1, means surgical masks,
respirator masks and powered air
purifying respirators and required
filters, face shields and protective
eyewear, gloves, disposable and
reusable surgical and isolation gowns,
head and foot coverings, and other gear
or clothing used to protect an individual
from the transmission of disease.
(f) United States, as applied to an item
described in 3025.7102–1, means the 50

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79855

States, the District of Columbia, and the
possessions of the United States.
3025.7102 Restrictions on certain personal
protective equipment.
3025.7102–1

Restrictions.

The following restrictions implement
section 70953 of the Make PPE in
America Act, and they apply to all types
of actions, orders, option exercises, and
contracts.
(a) Except as provided in 3025.7102–
2, contracting officers shall purchase
domestic personal protective
equipment.
(b) Any contract for personal
protective equipment shall have a base
period of performance of at least 2 years,
plus all option periods.
3025.7102–2

Exceptions.

Acquisitions in the following
categories are not subject to the
restrictions in 3025.7102–1:
(a) Acquisitions of an item of personal
protective equipment, or component
thereof, otherwise covered by
3025.7102–1 when the DHS Chief
Procurement Officer:
(1) Maximizes sources for foreignassembled domestic personal protective
equipment; and
(2) Certifies every 120 days that it is
necessary to procure personal protective
equipment under alternative procedures
to respond to the immediate needs of a
public health emergency.
(b) Acquisitions of an item of personal
protective equipment, or component
thereof, including those described in
paragraph (a) of this section—
(1) That is, or that includes, a material
listed in FAR 25.104 as one for which
a nonavailability determination has
been made; or
(2) As to which the Chief Procurement
Officer 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
(3) The Chief Procurement Officer
certifies every 120 days that it is
necessary to procure personal protective
equipment to respond to the immediate
needs of a public health emergency.
(c) When either of the exceptions in
paragraph (a) or (b) of this section are
used:
(1) Only the DHS Chief Procurement
Officer is authorized to make the
certification in paragraphs (a)(2) and
(b)(3) of this section or the
nonavailability or unreasonable cost
determination in paragraph (b) of this
section.
(2) The supporting documentation for
the DHS Chief Procurement Officer shall

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Federal Register / Vol. 89, No. 190 / Tuesday, October 1, 2024 / Proposed Rules

be prepared by the DHS Component(s)
and:
(i) For the certification in paragraphs
(a)(2) and (b)(3) of this section:
(A) Include a written justification
documenting the immediate public
health emergency requiring use of
alternative procedures; and
(B) Be concurred on by the Head of
the Contracting Activity before
submission to the Chief Procurement
Officer.
(ii) For the nonavailability or
unreasonable cost determination in
paragraph (b) of this section:
(A) Include a written justification
documenting why a nonavailability or
unreasonable cost exception is required;
and
(B) Be concurred on by the Head of
the Contracting Activity before
submission to the Chief Procurement
Officer.
3025.7102–3 Specific application of the
Buy American Act and Trade Agreements
Act.

In the event the DHS Chief
Procurement Officer determines neither
domestic personal protective equipment
nor foreign-assembled domestic
personal protective equipment is
available due to nonavailability or
unreasonable cost, contracting officers
shall apply one of the following:
(a) The clause at FAR 52.225–1, Buy
American—Supplies, and the provision
at FAR 52.225–2, Buy American
Certificate;
(b) The clause at FAR 52.225–3, Buy
American—Free Trade Agreements—
Israeli Trade Act, and the provision at
FAR 52.225–4, Buy American—Free
Trade Agreements—Israeli Trade Act
Certificate; or
(c) The clause at FAR 52.225–5, Trade
Agreements, and the provision at FAR
52.225–6, Trade Agreements Certificate,
as applicable.

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3025.7103 Solicitation provisions and
contract clauses.

(a) Insert the clause at 3052.225–7X,
Make PPE in America, in solicitations
and contracts, regardless of dollar value,
when procuring any item covered under
3025.7102–1(a).
(b) Insert the provision at 3052.225–
7Y, Make PPE in America Certificate, in
solicitations containing the clause at
3052.225–7X.
PART 3052—SOLICITATION
PROVISIONS AND CONTRACT
CLAUSES
3. The authority citation for part 3052
is revised to read as follows:

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Authority: 5 U.S.C. 301–302, 41 U.S.C.
1303, 41 U.S.C. 1707, 41 U.S.C. 1702, 41
U.S.C. 8301 note, 48 CFR part 1, subpart 1.3,
DHS Delegation No. 00701, Revision No.
03.2, paragraphs (III)(H), and DHS Delegation
No. 00702, Revision No. 01.2, paragraphs
(III)(M).

2 Buy American Certificate or 52.225–4 Buy
American—Free Trade Agreements—Israeli
Trade Act Certificate or the clause at FAR
52.225–5 Trade Agreements and the
provision at FAR 52.225–6 Trade Agreements
Certificate, as applicable.

4. Add section 3052.225–7X to read as
follows:

(End of clause)

■

5. Add section 3052.225–7Y to read as
follows:

■

3052.225–7X

Make PPE in America.

As prescribed in 3025.7103(a), insert
the following clause:
Make PPE in America (DATE)
(a) Definitions. As used in this clause—
Component, as applied to an item
described in paragraph (b) of this clause,
means an article, material, or supply
incorporated directly into personal protective
equipment.
Domestic personal protective equipment,
as applied to an item described in paragraph
(b) of this clause, means personal protective
equipment, including the materials and
components thereof, that is grown,
reprocessed, reused, or produced in the
United States.
Foreign-assembled domestic personal
protective equipment, as applied to an item
described in paragraph (b) of this clause,
means personal protective equipment that is
assembled outside the United States
containing only materials and components
that are grown, reprocessed, reused, or
produced in the United States.
Foreign personal protective equipment
means personal protective equipment other
than domestic personal protective equipment
or foreign-assembled domestic personal
protective equipment.
Personal protective equipment, as applied
to an item described in paragraph (b) of this
clause, means surgical masks, respirator
masks and powered air purifying respirators
and required filters, face shields and
protective eyewear, gloves, disposable and
reusable surgical and isolation gowns, head
and foot coverings, and other gear or clothing
used to protect an individual from the
transmission of disease.
United States, as applied to an item
described in paragraph (b) of this clause,
means the 50 States, the District of Columbia,
and the possessions of the United States.
(b) The Contractor shall deliver only
domestic personal protective equipment
except to the extent that it specified delivery
of foreign-assembled domestic personal
protective equipment in the provision of the
solicitation entitled ‘‘Make PPE in America
Certificate.’’
(c) Order of Precedence. In the event the
Department of Homeland Security
determines neither domestic personal
protective equipment nor foreign-assembled
domestic personal protective equipment are
available due to nonavailability or
unreasonable cost, the Contractor shall
comply with the clauses at Federal
Acquisition Regulation (FAR) 52.225–1 Buy
American—Supplies or 52.225–3 Buy
American—Free Trade Agreements—Israeli
Trade Act and the provisions at FAR 52.225–

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3052.225–7Y
Certificate.

Make PPE in America

As prescribed in 3025.7103(b), insert
the following provision:
Make PPE in America Certificate (DATE)
(a)(1) The Offeror certifies that each item
of personal protective equipment, except
those listed in paragraph (b) of this provision,
is domestic personal protective equipment.
(2) The Offeror shall list foreign-assembled
domestic personal protective equipment
items.
(3) The terms ‘‘domestic personal
protective equipment,’’ ‘‘foreign-assembled
domestic personal protective equipment,’’
‘‘foreign personal protective equipment,’’ and
‘‘personal protective equipment,’’ are defined
in the clause of this solicitation entitled
‘‘Make PPE in America.’’
(b) Foreign-assembled Domestic Personal
Protective Equipment:
Line item No.
lllllll
lllllll
lllllll

Country of assembly
lllllll
lllllll
lllllll

[List as necessary]
(c) In the event the Department of
Homeland Security determines both
domestic personal protective equipment and
foreign-assembled domestic personal
protective equipment are not available due to
nonavailability or unreasonable cost, the
Contractor shall comply with the clauses at
Federal Acquisition Regulation (FAR)
52.225–1 Buy American—Supplies or
52.225–3 Buy American—Free Trade
Agreements—Israeli Trade Act and the
provisions at FAR 52.225–2 Buy American
Certificate or 52.225–4 Buy American—Free
Trade Agreements—Israeli Trade Act
Certificate or the clause at FAR 52.225–5
Trade Agreements and the provision at FAR
52.225–6 Trade Agreements Certificate, as
applicable. The contracting officer will notify
offerors if a nonavailability or unreasonable
cost determination is made.

(End of provision)
Paul Courtney,
Chief Procurement Officer, U.S. Department
of Homeland Security.
[FR Doc. 2024–22303 Filed 9–30–24; 8:45 am]
BILLING CODE 9112–FE–P

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