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Proposed Rule2024-22303

Homeland Security Acquisition Regulation, Make Personal Protective Equipment in America Act Restrictions on Foreign Acquisition (HSAR Case 2024-003)

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Published

October 1, 2024

Issuing agencies

Homeland Security Department

Abstract

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.

Full Text

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<title>Federal Register, Volume 89 Issue 190 (Tuesday, October 1, 2024)</title>
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[Federal Register Volume 89, Number 190 (Tuesday, October 1, 2024)]
[Proposed Rules]
[Pages 79851-79856]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-22303]

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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)

AGENCY: Office of the Chief Procurement Officer (OCPO), Department of
Homeland Security (DHS).

ACTION: Proposed rule.

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SUMMARY: 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:
<bullet> <a href="http://Regulations.gov">Regulations.gov</a>: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit comments via the Federal eRulemaking portal by entering
``HSAR 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.
<bullet> Fax: (202) 447-0520.
<bullet> 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
<a href="https://www.regulations.gov">https://www.regulations.gov</a>, including any personal information
provided. To confirm receipt of your comment(s), please check
<a href="http://www.regulations.gov">www.regulations.gov</a>, 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 <a href="/cdn-cgi/l/email-protection#f0b8a3b1a2b09881de949883de979f86"><span class="__cf_email__" data-cfemail="ca82998b988aa2bbe4aea2b9e4ada5bc">[email&#160;protected]</span></a>. 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\
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\1\ See 41 U.S.C. 8301-8305.
\2\ See e.g., 41 U.S.C. 8302.
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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\
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\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.
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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\
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\6\ Public Law 117-58, 135 Stat. 1313.
\7\ Public Law. 117-58, 135 Stat. 1313-14.
\8\ Public Law 117-58, 135 Stat. 1314.
\9\ Id.
\10\ Id.
\11\ Id.
\12\ Id.
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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\
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\13\ See HSAR Deviations, available at: <a href="https://www.dhs.gov/publication/current-hsar-deviations">https://www.dhs.gov/publication/current-hsar-deviations</a>.
\14\ See HSAR Class Deviation 23-01 Implementation of the Make
PPE in America Act at <a href="https://www.dhs.gov/sites/default/files/2022-10/HSARClassDeviation23-01ImplementationofMakePPEinAmericaAct-508Final.pdf">https://www.dhs.gov/sites/default/files/2022-10/HSARClassDeviation23-01ImplementationofMakePPEinAmericaAct-508Final.pdf</a>.
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DHS proposes to amend the HSAR at 48 CFR part 3025, Foreign
Acquisition, and at 48 CFR part 3052, Solicitation

[[Page 79852]]

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.''
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\15\ See proposed 48 CFR 3025.7101.
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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\ 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.
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\16\ See proposed 48 CFR 3025.7102-3.
\17\ See proposed 48 CFR 3025.7102-3.
\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.
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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 foreign-
assembled domestic PPE being offered to the Department and the country
where it was assembled. This proposed rule would codify this clause and
provision.\19\
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\19\ See proposed 48 CFR 3025.7103.
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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.
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.
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\20\ Congressional Research Service (CRS), COVID-19 and Domestic
PPE Production and Distribution: Issues and Policy Options. 5-6.
(Dec. 7, 2020) (accessible at <a href="https://crsreports.congress.gov/product/pdf/R/R46628">https://crsreports.congress.gov/product/pdf/R/R46628</a>).
\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 <a href="https://www.gao.gov/products/gao-22-105380">https://www.gao.gov/products/gao-22-105380</a>).
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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 foreign-produced
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.

[[Page 79853]]

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 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.
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\23\ DHS, Special Notice to Industry on Developments per the
Make PPE in America Act, 1, 1 (Dec. 16, 2023) (accessible at <a href="https://sam.gov/opp/45a5c9581d864342a983dc9184c2c77d/view">https://sam.gov/opp/45a5c9581d864342a983dc9184c2c77d/view</a>).
\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 <a href="http://SAM.gov">SAM.gov</a> Data Bank. <a href="http://SAM.gov">SAM.gov</a> 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).

Table 1--DHS Procurement of PPE Award Amounts
[$2023] \1\
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Total annual DHS Total annual DHS
Total annual DHS Total annual DHS Total annual DHS PPE award PPE award
Fiscal year (FY) PPE award amount PPE award amount PPE award amount percentage percentage
domestic foreign domestic foreign
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2017.......................................................... $11,586,965 $11,542,312 $44,654 99.61 0.39
2018.......................................................... 7,130,580 7,071,960 58,620 99.18 0.82
2019.......................................................... 6,247,764 6,247,764 0 100.00 0.00
2020.......................................................... 1,534,234,102 506,314,364 1,027,919,738 33.00 67.00
2021.......................................................... 128,945,552 25,025,686 103,919,866 19.41 80.59
2022.......................................................... 132,875 132,875 0 100.00 0.00
2023.......................................................... 6,549,382 6,549,382 0 100.00 0.00
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\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.

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.
Benefits and Costs of the Proposed Rule
The benefits and costs of a regulation are generally measured
against a no-action 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.
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\26\ See OMB Circular A-4, p, 11 (Nov. 9, 2023) (accessible at
<a href="https://www.whitehouse.gov/wp-content/uploads/2023/11/CircularA-4.pdf">https://www.whitehouse.gov/wp-content/uploads/2023/11/CircularA-4.pdf</a>).
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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\
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\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 <a href="https://www.fda.gov/medical-devices/letters-health-care-providers/certain-filtering-facepiece-respirators-china-may-not-provide-adequate-respiratory-protection-letter">https://www.fda.gov/medical-devices/letters-health-care-providers/certain-filtering-facepiece-respirators-china-may-not-provide-adequate-respiratory-protection-letter</a>.
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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

[[Page 79854]]

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.
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\29\ Public Law 117-58, 135 Stat. 1313.
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B. Regulatory Flexibility Act

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-for-profit
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 certificate would be $14.49 (15 minutes x $57.95).
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\30\ The average hourly earnings are based upon the U.S.
Department of Labor, Bureau of Labor Statistics' website
(<a href="http://www.bls.gov">www.bls.gov</a>). The wage rate category selected is for Business and
Financial Operations Occupations, May 2022. The rate is estimated to
be $57.95 ($41.39 x 1.4), which includes the wage rate multiplier.
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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.

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 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

[[Page 79855]]

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

0
1. The authority citation for part 3025 is revised to read as follows:

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).

0
2. Add subpart 3025.71 to read as follows:

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 foreign-
assembled 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 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 foreign-assembled 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

[[Page 79856]]

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.

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

0
3. The authority citation for part 3052 is revised to read as follows:

0
4. Add section 3052.225-7X 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 52.225-2 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.

(End of clause)

0
5. Add section 3052.225-7Y to read as follows:

3052.225-7Y Make PPE in America Certificate.

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. Country of assembly
------------------------------------------------------------------------
_______ _______
_______ _______
_______ _______
------------------------------------------------------------------------
[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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