Attachment VI - Buy American Certificate .docx

Attachment VII — Buy American Act Compliance Certification Solicitation Number: 75F40126Q00231 Solicitation Title: Semiautomatic Aerosol Propellant Filler for pMDI Two-Stage Formulation

Purpose This certification is required in accordance with FAR 52.225-1 and FAR Subpart 25.1. The offeror shall complete and submit this certification with their quotation. The Buy American Act (41 U.S.C. §§ 8301–8305) restricts the Government from acquiring supplies that are not domestic end products, unless an exception applies. By completing this certification, the offeror certifies that each end product offered is a domestic end product as defined under FAR 25.003, or that an applicable exception has been identified.

Section 1 — Offeror Information

Company Name

Unique Entity Identifier (UEI)

Point of Contact Name

Title

Phone Number

Email Address

Date of Certification

Section 2 — End Product Information The offeror shall identify each product being offered and its country of origin. For each product, the offeror shall indicate whether it qualifies as a domestic end product under the Buy American Act.

☐ Yes ☐ No

☐ Yes ☐ No

☐ Yes ☐ No

☐ Yes ☐ No

☐ Yes ☐ No

☐ Yes ☐ No

☐ Yes ☐ No

Section 3 — Certification Statement In accordance with FAR 52.225-1, Buy American — Supplies, the offeror hereby certifies as follows:

(a) Each end product, except those listed in paragraph (b) of this certification, is a domestic end product as defined in FAR 25.003, meaning:

- The end product is manufactured in the United States; and

- The cost of domestic components exceeds 60 percent of the cost of all components (or 65 percent for iron and steel end products, and 75 percent for certain critical items, per current FAR thresholds).

(b) The following end products are NOT U.S.-made end products (if none, write "NONE"):

(c) The offeror understands that:

· The Government will not accept delivery of a non-designated country end product unless the Contracting Officer has authorized an exception in accordance with FAR 25.103.

· Submission of a false certification may subject the offeror to civil and criminal penalties under applicable Federal law.

· The Government reserves the right to verify the domestic origin and component content of any end product offered under this solicitation.

Section 4 — Buy American Act Exceptions Reference For reference, exceptions to the Buy American Act domestic end product requirement may apply under FAR 25.103 in the following circumstances:

Nonavailability: The domestic end product is not available in sufficient commercial quantities or satisfactory quality.

Unreasonable Cost: The cost of the domestic end product would be unreasonable (i.e., the price of the domestic offer exceeds the price of the foreign offer by the applicable evaluation factor).

Public Interest: The agency head has determined that domestic preference is inconsistent with the public interest.

Resale: The end product is for use outside the United States.

Section 5 — Signature Block By signing below, the offeror certifies that the information provided in this certification is accurate, complete, and made in good faith in accordance with FAR 52.225-1.

Authorized Signature: _____________________________________________ Printed Name: _____________________________________________________ Title: _____________________________________________________________ Company Name: ___________________________________________________ Date: _____________________________________________________________

Section 6 — Submission Instructions The completed and signed Attachment VII shall be:

· Submitted electronically as part of the offeror's quotation package to: Michele.Jackson@fda.hhs.gov

· Submitted no later than: June 22, 2026, at 11:00 AM Eastern Time

· Included in the quotation email with the subject line: [Company Name] – 75F40126Q00231/CDER-2026-133243 Quote

· Failure to submit a completed and signed Buy American Act Compliance Certification may render the quotation technically unacceptable and ineligible for award.

2 | Page