Federal Register / Vol. 89, No. 190 / Tuesday, October 1, 2024 / Proposed Rules 79851 

1See 41 U.S.C. 8301–8305. 

2See e.g., 41 U.S.C. 8302. 

3 Infrastructure Investment and Jobs Act, Public 

Law 117–58, 135 Stat. 429 (2021). 

4Make 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. 

5Public Law 117–58, 135 Stat. 1312. 

6Public Law 117–58, 135 Stat. 1313. 

7Public Law. 117–58, 135 Stat. 1313–14. 

8Public Law 117–58, 135 Stat. 1314. 

9 Id. 

10 Id. 11 Id. 12 Id. 13See HSAR Deviations, available at: https://

www.dhs.gov/publication/current-hsar-deviations. 14See 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. 

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) 

AGENCY: Office of the Chief Procurement 

Officer (OCPO), Department of 

Homeland Security (DHS). 

ACTION: Proposed rule. 

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: 

• Regulations.gov: https://

www.regulations.gov. 

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. 

• 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 HSAR@hq.dhs.gov. 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

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 


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15See proposed 48 CFR 3025.7101. 

16See proposed 48 CFR 3025.7102–3. 

17See proposed 48 CFR 3025.7102–3. 

18Made 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. 

19See proposed 48 CFR 3025.7103. 

20Congressional 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). 

21Public 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). 

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

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. 

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. 


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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 https://sam.gov/opp/ 

45a5c9581d864342a983dc9184c2c77d/view). 

24The 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). 

26See 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. 

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. 

TABLE 1—DHS PROCUREMENT OF PPE AWARD AMOUNTS

[$2023] 1

Fiscal year 

(FY) 

Total annual 

DHS PPE 

award amount 

Total annual 

DHS PPE 

award amount 

domestic 

Total annual 

DHS PPE 

award amount 

foreign 

Total annual 

DHS PPE award 

percentage 

domestic 

Total annual 

DHS PPE award 

percentage 

foreign 

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 

1Bureau 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 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 foreignassembled 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 


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29Public Law 117–58, 135 Stat. 1313. 

30The 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. 

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. 

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-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 

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. 

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 


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

■ 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). 

■ 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 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 

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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79856 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. 

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: 

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). 

■ 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) 

■ 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 

lllllll lllllll 

lllllll 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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