Buy_America_TAA Supplies-Checklist.docx

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Electrosurgical unit (ESU)
Solicitation number
75F40126Q00277
Issued by

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This is a Buy American Act (BAA) and Trade Agreements Act (TAA) compliance checklist for supplies completed by the Department of Health and Human Services in support of a federal contract opportunity. The checklist documents the contracting officer's determination that the Buy American statute applies to this acquisition, while the Trade Agreements Act does not apply. The document serves as a mandatory compliance tool to be included in the contract file and guides the contracting officer through a series of decision points to ensure adherence to domestic preference requirements and trade agreement obligations under the Federal Acquisition Regulation (FAR).

The specific acquisition pertains to solicitation 75F40126Q00277 for the purchase of one commercial Electrosurgical Unit (ESU) and related accessories for the FDA's Center for Devices and Radiological Health (CDRH). The equipment will be used to generate electromagnetic disturbance signals for laboratory experiments and test method development. The ESU must include a touchscreen user interface, real-time tissue impedance monitoring, output frequency between 400 kHz and 500 kHz, monopolar and bipolar operating modes, vessel-sealing capability, accessories, user and technical documentation, a minimum one-year manufacturer's warranty, and delivery within 30 calendar days after contract award. The checklist confirms that the product is used in the United States and exceeds the micro-purchase threshold, triggering Buy American compliance requirements. No exceptions to the Buy American statute apply, and the acquisition is not set aside for small business, making domestic end products the requirement unless cost is determined unreasonable or specific exceptions are documented.

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Supplies_CSS__V2_2_260620.docx DOCX document
Attachment 1 Requirements_Document_ESU_CDRH-2026-134011_jwg.docx DOCX document

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

The Buy American (BA)[footnoteRef:2] Statute [2: Historically known as Buy American Act (BAA), now referred to as “Buy American.” See FAR 1.110, Positive law codification and as now currently referenced in the FAR and in title 41, U.S. Code, Public Contracts.] and the Trade Agreements Act (TAA) Checklist

Supplies

This Checklist must be completed and included in the contract file. For exceptions and additional guidance on the Buy American statute and the Trade Agreements Act, please refer to FAR Part 25, HHS FAR Class Deviation (2022-01), to FAR Part 25, and HHSAM Part 325. If a Determinations and Findings (D&F) is required, use appropriate template and include in contract file after approval.

Question
Answer

Buy American (FAR subpart 25.1)

1) Is this product used in the United States? (FAR 25.100(b) If yes, proceed to question 2. If no, the Buy American statute does not apply. Proceed to question 8.
Yes
2) Does the supply contract (including all options) exceed the micro- purchase threshold? (FAR 25.100(b)) If yes, proceed to question 3. If no, Buy American does not apply, (Note that even when Buy American and the Trade Agreements Act are both inapplicable, end products from Cuba, Iran, Sudan, Burma, or North Korea may never be supplied under United States government contracts. In addition, lists of entities and individuals subject to economic sanctions are included in the Office of Foreign Assets Control’s (OFAC) List of Specially Designated Nationals and Blocked Persons at https://ofac.treasury.gov/ http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3. More information about these restrictions, as well as updates, is available in OFAC’s regulations at 31 CFR Chapter V and/or on OFAC’s website at https://ofac.treasury.gov/ http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3. (FAR subpart 25.7))
Yes

Revision – June 2025

Question
Answer
3) Has the head of the agency determined domestic preference would be inconsistent with the public interest (This exception applies when an agency has an agreement with a foreign government that provides a blanket exception to the Buy American.)? (FAR 25.103(a)) If yes, Buy American does not apply; complete D&F. If no, proceed to question 4. Refer to FAR subpart 25.11, Solicitation Provisions and Contract Clauses, including FAR 25.1101, Acquisition of supplies, and FAR 25.1103, Other provisions and clauses, for provisions and clauses applicable to the acquisition of supplies and services involving the furnishing of supplies.
No
4) Is the item on the nonavailable articles list (FAR 25.104) (This determination does not necessarily mean that there is no domestic source for the listed items, but that domestic sources can only meet 50 percent or less of total United States Government and nongovernment demand.)? (FAR 25.103(b)(1)) If yes, proceed to a. If no, proceed to question 5.
No

a. Conduct market research to determine if the article on the list is available domestically in sufficient and reasonably available commercial quantities of a satisfactory quality to meet the requirements of the solicitation. (FAR 25.103(b)(1)(ii)) (HHSAM 325.103 (b)

b. If yes, the agency must confirm through market research that domestic sources can meet 50% or more of the total U.S. Government and nongovernment demand. If the product meets 50% or less, the agency will require a class determination. If the product meets 50% or more, the agency should procure the product through the domestic source. Proceed to d.

c. If no, the head of the contracting activity can make an individual determination that an article, material, or supply is not mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities of satisfactory quality. (FAR 25.103(b)(2)(i)). Proceed to d.

d. Did the contracting officer post a proposed individual nonavailability waiver determination to MadeinAmerica.gov? (unless an exception applies per (FAR 25.103(b)(2)(iii); HHSAM 325.103(b) All waivers must be approved by the Head of Contracting (HCA) prior to submission to the Made In America Office (MIAO). The contracting officer shall include the required information in the Made in America digital waiver portal. The contracting officer shall not make an award until confirmation is received that the MIAO has completed its review of the proposed nonavailability waiver determination; MIAO has waived the requirement for a review; or an exception to posting the proposed nonavailability waiver determination applies. The agency shall make the final determination on whether to grant a waiver. Refer to FAR 25.103(b)(2)(iii)(A)(B) for digital waiver requirements and posting information using the digital waiver. Refer to FAR 25.103(b)(2)(iii)(D) for posting exceptions. If yes, proceed to question 5, if no, comply with FAR 25.103(b) and proceed to question 5.

5) Is the cost of a domestic end product unreasonable in accordance with FAR 25.106 and FAR subpart 25.5? (FAR 25.103(c)) *Note: This determination can only be made at the evaluation of proposals.

If yes, the agency must prepare a determination for concurrence by the HCA and approval by the SAO. A copy of the determination must be included in the contract file.

If no, proceed to question 6.

No

6) Is the foreign end item for commissary resale? (FAR 25.103(d)) If yes, the agency must prepare a determination for concurrence by the HCA and approval by the (SAO). A copy of the determination must be included in the contract file.

If no, proceed to question 7.

No

7) Is the item information technology that is a commercial product? (FAR 25.103(e)) If yes, the agency must prepare a determination for approval by the HCA. A copy of the determination must be included in the contract file.

If no, proceed to question 8.

No

Trade Agreements Act (FAR subpart 25.4)

8) Determine the value of the acquisition and country of origin (FAR 25.403(b), Thresholds). Refer to Trade Agreement threshold table at FAR 25.402(b) for applicable designated countries and dollar thresholds. Is the country of origin a "Designated Country"? If yes, proceed to question 9. If no, the Trade Agreement Act does not apply; no further action needed.
No

9) Determine the value of the acquisition and country of origin (FAR 25.403(b) Thresholds). Refer to Trade Agreement threshold table at FAR 25.402(b) for applicable designated countries and dollar thresholds. (In determining the estimated value of an acquisition, consider the value of all options. (FAR 25.403(b)(2)) Is the acquisition at or above the dollar threshold? If yes, proceed to question 10. If no, the Trade Agreement Act does not apply; no further action needed.

10) Is this acquisition set aside for small business? (FAR 25.401(a)(1)) If yes, the Trade Agreement Act does not apply; no further action needed. If no, proceed to question 11.

11) Is this an acquisition of arms, ammunition, or war materials, or purchases indispensable for national security or national defense? (FAR 25.401(a)(2)) If yes, the Trade Agreement Act does not apply; no further action needed. If no, proceed to question 12.

12) Is the end product for resale? (FAR 25.401(a)(3)) If yes, the Trade Agreement Act does not apply; no further action needed. If no, proceed to question 13.

13) Is this acquisition from Federal Prison Industries, Inc. (FAR subpart 8.6)? (FAR 25.401(a)(4)) If yes, the Trade Agreement Act does not apply; no further action needed. If no, proceed to question 14.

14) Is this acquisition from nonprofit agencies employing people who are blind or severely disabled (FAR subpart 8.7)? (FAR 25.401(a)(4)) If yes, the Trade Agreement Act does not apply; no further action needed. If no, proceed to question 15.

15) Is this acquisition exempt from full and open competition as authorized by FAR subparts 6.2 or 6.3? (FAR 25.401(a)(5)) If yes, the Trade Agreement Act does not apply; no further action needed. If no, proceed to question 16.

16) Is this acquisition a sole source justified in accordance with FAR 13.501(a)? (FAR 25.401(a)(5)) If yes, the Trade Agreement Act does not apply; no further action needed. If no, proceed to question 17.

17) Is the country of origin of product or service Cuba, Iran, Sudan, Burma, or North Korea? (FAR 25.701(b)) If yes, refer to FAR subpart 25.7. For waivers for Sudan, refer to FAR 25.702-4 and HHSAM 325.702-4. For waivers for Iran, refer to FAR 25.703-4 and HHSAM 325.703-4. If no, proceed to question 18.

18) Is the acquisition covered by the World Trade Organization Government Procurement Agreement (WTO GPA)? (FAR 25.403(c)(1)) If yes, acquire only United States-made or designated country end products or services unless offers are not received or are insufficient to fulfill the requirement. (Note: This purchase restriction does not apply below the WTO GPA threshold even if the acquisition is covered by a FTA (https://www.wto.org/english/tratop_e/gproc_e/thresh_e.htm ).) If no, proceed to question 19.

19) Is the acquisition covered by the least developed country provision? (FAR 25.404) If yes, for acquisitions covered by the WTO GPA, least developed country end products, construction material, and services must be treated as eligible products. If no, proceed to question 20.

20) Is the acquisition covered by the Caribbean Basin Trade Initiative? (FAR 25.405) If yes, under the Caribbean Basin Trade Initiative, the United States Trade Representative has determined that, for acquisitions covered by the WTO GPA, Caribbean Basin country end products, construction material, and services must be treated as eligible products. If no, proceed to question 21.

21)"HHS acquisitions of supplies that are Israeli End Products (see definition in FAR 25.003) are covered by the Israeli Trade Act if the estimated value of the acquisition is at or above the threshold indicated in FAR 25.406 but does not exceed the WTO GPA threshold for supplies (see FAR 25.402(b) Table 1). If no, proceed to question 22."

22) Does acquisition contain civil aircraft and related articles that meet the substantial transformational test of the Trade Agreements Act? (FAR 25.407) If yes, under the authority of Section 303 of the Trade Agreements statute, the United States Trade Representative has waived the Buy American statute. Countries include: Albania, Austria, Belgium, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Macao China, Malta, Montenegro, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan (Chinese Taipei), and the United Kingdom. If no, proceed to question 23.

23) "Is the WTO GPA or an FTA applicable? (Refer to FAR 25.402(b) Table 1 and FAR 25.403 for thresholds and procedures, and FAR 25.401(b) for exceptions for services). If the WTO GPA or an FTA is applicable, refer to FAR 25.408 for specific acquisition procedures that must be followed. Refer to FAR subpart 25.5 for specific evaluation procedures related to foreign offers

This is to certify that the undersigned has provided responses to all the questions to the best of their ability and that the information/data provided to support the rationale and determination(s) is accurate and complete. The offeror’s awardee’s Representations and Certifications in the System for Award Management (SAM), pertaining to the Buy American Act (BAA) and the Trade Agreement Act (TAA will be reviewed. Applicable Federal Acquisition Regulation (FAR) provisions and clauses will be incorporated into the solicitation and award. In addition, FPDS-NG reporting will be completed accurately and appropriately.

Based on the information above, the undersigned has determined:

BAA Applicable: Yes

TAA Applicable: No

Solicitation Number: 75F40126Q00277

Requisition Number: 1291273

Project Title: Electrosurgical unit (ESU)

Title: Contract Specialist: Reagan Davis

Contract Specialist Signature: Date:

Title: Contracting Officer

Contracting Officer Signature: Date

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