Effective Date: 10/01/2026
HHSAR Text Baseline is 48 CFR Chapter 3 as of March 25, 2026.
Changes to baseline shown as [bolded, bracketed additions] and strikethrough deletions.
For HHSAR part 352, only the provisions and clauses associated with part 325 are shown.
HHSAR PART 325 – FOREIGN ACQUISITION [(RFO DEVIATION)]
[Subpart 325.70 – Restrictions on Foreign Acquisition of Covered PPE
325.7000 Scope of subpart.
325.7001 Definitions.
325.7002 Policy.
325.7003 Exceptions.
325.7004 Solicitation provision and contract clause.]
[Subpart 325.70 – Restrictions on Foreign Acquisition of Covered PPE
325.7000 Scope of subpart.
This subpart—
(a) Implements section 70953 of the Make PPE in America Act (Pub. L. 117-58, Div. G, Title IX, Subtitle C (Nov. 15, 2021)) requirements that limit buying covered personal protective equipment (PPE) from foreign sources.
(b) Applies to solicitations, contracts, and Government Purchase Card (GPC) transactions at any dollar value.
325.7001 Definitions.
As used in this subpart—
Component means as defined in FAR 25.003.
Covered personal protective equipment (PPE) means surgical masks, respirators, powered air purifying respirators (and required filters), face shields, protective eyewear, gloves, gowns (disposable or reusable), head and foot coverings, and other gear that protects people from disease.
Domestic PPE end product means a covered PPE, including the materials and components thereof, that is grown, reprocessed, reused, or produced in the United States.
Foreign-assembled domestic PPE end product means a covered PPE that is assembled outside the United States containing only materials and components that are grown, reprocessed, reused, or produced in the United States.
Foreign PPE end product means a covered PPE that is other than a domestic PPE end product or foreign-assembled domestic PPE end product.
Wholly foreign PPE end product means a foreign PPE end product that is assembled outside the United States containing only materials and components that are grown, reprocessed, reused, or produced outside the United States.
325.7002 Policy.
Unless an exception at 325.7003 applies—
(a) HHS acquisition officials, contracting officers, and authorized GPC cardholders must buy only domestic PPE end products.
(b) Any contract for covered PPE must have a base period of performance of at least two years, plus any option periods.
(c) The GPC can only be used to purchase covered PPE if the covered PPE is part of a contract, or other authorized acquisition instrument that complies with this subpart. Standalone purchases of covered PPE on the GPC are not allowed.
325.7003 Exceptions.
When one of the following exceptions applies, the contracting officer may acquire covered PPE without regard to the restrictions in 325.7002(a) and (b):
(a) Emergency needs. When the HHS Secretary—
(1) Maximizes sources for foreign-assembled domestic PPE end products; and
(2) Certifies every 120 days that alternative procedures are needed to meet urgent public health needs.
(b) Nonavailability or unreasonable cost. When—
(1) A covered PPE item or part includes a material on the FAR 25.104 list with a nonavailability determination; or
(2) The HHS Secretary determines that domestic PPE end products in sufficient quantity and quality cannot be obtained at U.S. market prices, and certifies every 120 days that alternative procurement is needed to respond to a public health emergency.
325.7004 Solicitation provision and contract clause.
(a) Insert the clause at 352.225-70, Made in America – Covered Personal Protective Equipment, in solicitations, orders, and contracts, regardless of dollar value, when procuring covered PPE.
(b) Insert the provision at 352.225-71, Made in America Certificate – Covered Personal Protective Equipment, in solicitations containing the clause at 352.225-70.]
HHSAR PART 352 – SOLICITATION PROVISIONS AND CONTRACT CLAUSES [(RFO DEVIATION)]
Subpart 352.2 – Texts of Provisions and Clauses
[352.225-70 Made in America – Covered Personal Protective Equipment.
352.225-71 Made in America Certificate – Covered Personal Protective Equipment.]
Subpart 352.2 – Texts of Provisions and Clauses
[352.225-70 Made in America – Covered Personal Protective Equipment.
As prescribed in 325.7004(a), insert the following clause:
Made in America – COVERED Personal Protective Equipment (OCT 2026) (RFO DEVIATION)
(a) Definitions. As used in this clause—
Component means as defined in FAR 25.003.
Covered personal protective equipment (PPE) means surgical masks, respirators, powered air purifying respirators (and required filters), face shields, protective eyewear, gloves, gowns (disposable or reusable), head and foot coverings, and other gear that protects people from disease.
Domestic PPE end product means a covered PPE, including the materials and components thereof, that is grown, reprocessed, reused, or produced in the United States.
Foreign-assembled domestic PPE end product means a covered PPE that is assembled outside the United States containing only materials and components that are grown, reprocessed, reused, or produced in the United States.
Foreign PPE end product means a covered PPE that is other than a domestic PPE end product or foreign-assembled domestic PPE end product.
Wholly foreign PPE end product means a foreign PPE end product that is assembled outside the United States containing only materials and components that are grown, reprocessed, reused, or produced outside the United States.
(b) Requirement. The Contractor must deliver only domestic PPE end products unless the Contractor identified the item, during the solicitation stage and as part of its proposal submission, in the provision at 352.225-71, Made in America Certificate – Covered Personal Protective Requirement.
(c) Postaward reporting. During performance of this contract, if the Contractor determines that any other item of covered PPE to be delivered under this contract is other than domestic PPE, and the item was not previously listed in the provision at 352.227-71, the Contractor must—
(1) Immediately update the list and submit it to the Contracting Officer; and
(2) Not deliver the items of covered PPE until approved by the Contracting Officer .
(d) Subcontracts. The Contractor must include the substance of this clause, including this paragraph (d), in all subcontracts.
(End of clause)
352.225-71 Made in America Certificate – Covered Personal Protective Equipment.
As prescribed in 325.7004(b), insert the following provision:
Made In America Certificate – COVERED Personal Protective Equipment (OCT 2026) (RFO DEVIATION)
(a) The terms “component,” “covered personal protective equipment (PPE),” “domestic PPE end product,” “foreign-assembled domestic PPE end product,” “foreign PPE end product,” and “wholly foreign PPE end product” are defined in the clause at 352.225-70, Made in America – Covered Personal Protective Equipment, in this solicitation.
(b) The Offeror/Vendor certifies that each item of covered PPE proposed to be delivered on any contract resulting from this solicitation, including under any proposed subcontractors, except those listed in paragraph (c) of this provision, is a domestic PPE end product.
(c) Covered PPE not a Domestic PPE End Products: (The Offeror/Vendor to list any PPE that is not fully domestic, whether the item is to be delivered by Offeror or through a proposed subcontractor. If the covered PPE doesn't qualify as domestic end item, list it in the table below.)
Line Item No. | Product Description | Supplier Name | Country of Assembly | Components and Materials – Country(ies) of Origin |
(d) This certificate is valid for 30 days for the same products listed in paragraph (c) of this provision.
(End of provision)]