75F40126R00049_RFP_IRV Exhaust_Vacuum Pump.pdf

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IRV Exhaust and Vacuum Pump Replacement
Solicitation number
75F40126R00049
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Request for Proposal Summary

This is a Request for Proposal (RFP) issued by the U.S. Food and Drug Administration (FDA) Office of Facilities Engineering and Mission Support Services for commercial construction services to remove, replace, install, and commission exhaust and vacuum pump systems at the FDA Laboratory building in Irvine, California (19701 Fairchild Road, Irvine, CA 92612-2506). The solicitation number is 75F40126R00049, with a requisition number of OC-2026-133488.

Scope and Requirements: The project requires replacement of the existing laboratory vacuum system with implementation of N+1 redundancy and installation of a Room 2309 exhaust system. Work must be performed within an occupied, operational laboratory facility while maintaining continuity of operations. The contractor must coordinate utility outages, integrate new equipment with the existing Building Automation System (BAS), perform testing, adjusting, and balancing (TAB), and complete full commissioning. Substantial completion is required within 222 calendar days after Notice to Proceed, followed by a 12-month workmanship warranty. A mandatory site visit is scheduled for Wednesday, July 22, 2026 at 8:30 AM PT, with registration required by Monday, July 20, 2026 at 12:00 PM PT. Attendance is mandatory; proposals from non-attendees will be rejected.

Competition and Requirements: This is a full and open construction competition with NAICS Code 236220 (Commercial and Institutional Building Construction) and a small business size standard of $45.0 million. The offeror must be registered in SAM.gov at time of submission, evaluation, and prior to award. Construction Wage Rate Davis-Bacon (DBA) Decision No. 20260024 dated 05/18/2026 applies. Performance and Payment Bonds are required within 15 calendar days of contract award. The Buy American-Construction Materials clause applies. Offers must be submitted by the deadline listed in SAM.gov (specifically referenced as email submission), with questions due by Monday, July 27, 2026.

Evaluation and Pricing: Award will be made on a best-value tradeoff basis considering price and non-price factors. Non-price factors (Technical Approach, Project Team and Experience, and Past Performance) when combined are significantly more important than price. The Government anticipates award without discussions. Offerors must submit four separate volumes: Volume I (Technical Proposal, 30-page limit covering construction approach, schedule, quality control, and project team experience), Volume II (Past Performance, 20-page limit with 3-5 projects), Volume III (Price with no page limit), and completed certifications and representations. Pricing must include all labor, materials, equipment, supervision, overhead, G&A, bonds, permits, mobilization, and profit. No advance payments or upfront project funding will be provided; payment will be made only for completed, Government-accepted work according to contract milestone schedules and inspection/acceptance requirements.

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SOLICITATION, OFFER,

AND AWARD

2. TYPE OF SOLICITATION

6. PROJECT NO. 4. CONTRACT NO. 5. REQUISITION/PURCHASE REQUEST NO.

PAGE OF PAGES

7. ISSUED BY CODE 8. ADDRESS OFFER TO

SOLICITATION

(Construction, Alteration, or Repair)

1. SOLICITATION NO. 3. DATE ISSUED

IMPORTANT -- The "offer" section on the reverse must be fully completed by offeror.

9.

INFORMATION CALL

a. NAME b. TELEPHONE NO. (Include area code) (NO COLLECT CALLS)

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder."

FOR

SEALED BID (IFB)

NEGOTIATED (RFP)

DHHS/FDA/OAGS/DAP

11601 Landsdown St.

13th Floor Attn: Sheneil Green

DAP

North Bethesda MD 20852

SHENEIL GREEN 301-796-0675

OC-2026-133488

x 07/07/2026

75F40126R00049

INVITATION FOR BID

REQUEST FOR PROPOSAL

10. THE GOVERNMENT REQUIRES PERFORMANCE OF THE WORK DESCRIBED IN THESE DOCUMENTS (Title, identifying no., date)

Project Titles: IRV Lab Exhaust & Vacuum Pump Replacement at FDA Pacific Southwest

Laboratory

Project Location: 19701 Fairchild Rd, Irvine, CA 92612-2506

The U.S. Food and Drug Administration (FDA) Office of Facilities Engineering and

Mission Support Services (OFEMS) has a requirement to remove, replace, install, and commission exhaust and vacuum pump systems at the FDA Laboratory building located in

Irvine, CA. This requirement is a full and open construction competition. NAICS

Code: 236220 – Commercial and Institutional Building Construction, with a small business size standard of $45.0M applies. Offeror must be registered in SAM.gov at time of submission of offer, during evaluation and prior to award.

A site visit is mandatory, see Section B: Instructions to Offerors for specifics.

An Offer guarantee is not required. However, Performance and Payment Bonds will be required by the successful offeror.

Construction Wage Rate Davis Bacon (DBA) Decision No. 20260024, dated 05/18/2026 applies and is attached.

11. The Contractor shall begin performance within

12a. THE CONTRACTOR MUST FURNISH ANY REQUIRED PERFORMANCE AND PAYMENT BONDS?

award, notice to proceed. The performance period is mandatory negotiable. (See ________________________________________________.)

13. ADDITIONAL SOLICITATION REQUIREMENTS:

a. Sealed offers in original and is not required.is, b. An offer guarantee

c. All offers are subject to the (1) work requirements, and (2) other provisions and clauses incorporated in the solicitation in full text or by reference.

(date). If this is a sealed bid solicitation, offers will be publicly opened at that time. Sealed envelopes containing offers shall be marked to show the offeror's name and address, the solicitation number, and the date and time offers are due.

d. Offers providing less than

12b. CALENDAR DAYSYES NO

(If "YES", indicate within how many calendar days after award in Item 12b.)

0 222 calendar days and complete it within ________________ ________________ calendar days after receiving

IRV Exhaust_Vacuum Pump SOW

08/14/2026

NSN 7540-01-155-3212

x x x x copies to perform the work required are due at the place specified in Item 8 by _____________ ___________________ (hour) local time calendar days for Government acceptance after the date offers are due will not be considered and will be rejected . _________________

STANDARD FORM 1442 (Rev. 12/2022)

Prescribed by GSA

FAR(48 CFR) 53.236-1(d)

17. The offeror agrees to perform the work required at the prices specified below in strict accordance with the terms of this solicitation, if this offer is accepted by the Government in writing within ____________________ calendar days after the date offers are due. (Insert any number equal to or greater than the minimum requirement stated in item 13d. Failure to insert any number means the offeror accepts the minimum in item 13d.)

14. NAME AND ADDRESS OF OFFEROR (Include ZIP Code) 15. TELEPHONE NO. (Include area code)

16. REMITTANCE ADDRESS (Include only if different than item 14.)

CODE FACILITY CODE

AMOUNTS

18. The offeror agrees to furnish any required performance and payment bonds.

19. ACKNOWLEDGEMENT OF AMENDMENTS

OFFER (Must be fully completed by offeror)

(The offeror acknowledges receipt of amendments to the solicitation -- give number and date of each)

AMENDMENT NO.

DATE.

20a. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER (Type or print) 20b. SIGNATURE 20c. OFFER DATE

AWARD (To be completed by Government)

21. ITEMS ACCEPTED:

22. AMOUNT 23. ACCOUNTING AND APPROPRIATION DATA

24. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM 25. OTHER THAN FULL AND OPEN COMPETITION PURSUANT TO THE UNITED STATES CODE AT

26. ADMINISTERED BY CODE 27. PAYMENT WILL BE MADE BY

CONTRACTING OFFICER WILL COMPLETE ITEM 28 OR 29 AS APPLICABLE

(Contractor is required to sign this document solicitation is hereby accepted as to the items listed. This award consummates the contract, which consists of (a) the Government solicitation and your offer, and (b) this contract award. No further contractual document is necessary.

30a. NAME AND TITLE OF CONTRACTOR OR PERSON AUTHORIZED TO SIGN (Type or print) 31a. NAME OF CONTRACTING OFFICER (Type or print)

30b. SIGNATURE 30c. DATE 31b. UNITED STATES OF AMERICA 31c. DATE

BY

2PAGE OF

DHHS/FDA/OAGS/DAP

11601 Landsdown St.

13th Floor North Bethesda MD 20862

DAP

LINDA M. FINAN

28. NEGOTIATED AGREEMENT 29. AWARD

and deliver all items or perform all work requirements identified on this form and any continuation sheets for the consideration stated in this contract. The rights and obligations of the parties to this contract shall be governed by (a) this contract award, (b) the solicitation, and (c) the clauses, representations,certifications, and specifications incorporated by reference in or attached to this contract.

copies to issuing office.) Contractor agrees to furnish

10 U.S.C. 3204(a) 41 U.S.C. 3304(a)

STANDARD FORM 1442 (REV. 12/2022) BACK

Continued...

and return

(Contractor is not required to sign this document.) Your offer on this

ITEM NO.

(A)

SUPPLIES/SERVICES

(B)

QUANTITY

(C)

UNIT

(D)

UNIT PRICE

(E)

AMOUNT

(F)

NAME OF OFFEROR OR CONTRACTOR

3 49

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

75F40126R00049

Delivery: 180 Days After Notice to Proceed

Delivery Location Code: 906

FDA

19701 FAIRCHILD

IRVINE CA 92612

100 Mobilization and pre-construction submittals 1 LS

200 Vacuum Pump Replacement 1 LS

(Not Separately Priced)

201 Existing Conditions Verification, Shutdown 1 LS

Planning and Demolition

202 Vacuum Pump Equipment Furnishing and Delivery 1 LS

203 Vacuum Pump Installation, Piping, Controls and 1 LS

Electrical Connections

204 Startup, Testing and Commissioning 1 LS

300 Rm 2309 Exhaust System 1 LS

(Not Separately Priced)

301 Demolition, Roof Penetrations and Preparatory Work 1 LS

302 Exhaust Fans, Ductwork, Supports and Material 1 LS

Furnishing

303 Exhaust System Installation and Associated 1 LS

Construction

304 BAS Integration, Startup and Functional Testing 1 LS

400 TAB and Commissioning 1 LS

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

ITEM NO.

(A)

SUPPLIES/SERVICES

(B)

QUANTITY

(C)

UNIT

(D)

UNIT PRICE

(E)

AMOUNT

(F)

NAME OF OFFEROR OR CONTRACTOR

4 49

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

75F40126R00049

(Not Separately Priced)

401 TAB Planning and Pre-Functional Activities 1 LS

402 TAB Services and System Verification 1 LS

403 Commissioning Reports and Acceptance Documentation 1 LS

500 Final Inspection, Punch List Completion, Closeout 1 LS

Documentation, Training, O&M Manuals, As-Builts and Warranties

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

ALP: OC-2026-133488

75F40126R00049 IRV Lab Exhaust & Vacuum Pump

REQUEST FOR PROPOSAL

SECTION 1: GENERAL INFORMATION & SUMMARY OF REQUIREMENT

This is a Request for Proposal (RFP) for commercial construction prepared in accordance with RFO Part 12 (Acquisition of Commercial Products and Commercial Services), RFO Part 36 (Construction and Architect-Engineer Contracts), and the labor standards of RFO Part 22.

The Solicitation number is 75F40126R00049.

The NAICS Code for this requirement is 236220 – Commercial and Institutional Building Construction.

The small business size standard for this NAICS code is $45.0M. The full table of size standards is available at: https://www.sba.gov/document/support-table-size-standards

Description of Requirement: The U.S. Food and Drug Administration (FDA) Office of Facilities Engineering and Mission Support Services (OFEMS) has a requirement to remove, replace, install, and commission exhaust and vacuum pump systems at the FDA Laboratory building located in Irvine, CA as outlined in the Section C: Scope of Work (SOW).

Construction Wage Determination CA20260024 dated 05/18/2026 applies to this requirement.

SECTION 2: PERIOD OF PERFORMANCE

The Contractor shall achieve substantial completion within 222 calendar days after the Notice to Proceed (NTP), followed by a workmanship warranty of 12 months from the date of final acceptance (see 52.246-21, Warranty of Construction).

SECTION 3: CONTRACT LINE ITEMS (CLINs)

CLIN Sub CLIN Description Qty Unit of

Issue Unit Price Extended Price

0001 — Mobilization and pre-construction submittals 1 LS $ $

0002 — Vacuum Pump Replacement

0002 000201 Existing Conditions Verification, Shutdown Planning and Demolition 1 LS $ $

0002 000202 Vacuum Pump Equipment Furnishing and Delivery 1 LS $ $

0002 000203 Vacuum Pump Installation, Piping, Controls and Electrical Connections 1 LS $ $

0002 000204 Startup, Testing and Commissioning 1 LS $ $ 0003 — Rm 2309 Exhaust System

0003 000301 Demolition, Roof Penetrations and Preparatory Work 1 LS $ $ https://www.sba.gov/document/support-table-size-standards

IRV Lab Exhaust & Vacuum Pump

CLIN Sub CLIN Description Qty Unit of

Issue Unit Price Extended Price

0003 000302 Exhaust Fans, Ductwork, Supports and Material Furnishing 1 LS $ $

0003 000303 Exhaust System Installation and Associated Construction 1 LS $ $

0003 000304 BAS Integration, Startup and Functional Testing 1 LS $ $

0004 — TAB and Commissioning

0004 000401 TAB Planning and Pre-Functional Activities 1 LS $ $

0004 000402 TAB Services and System Verification 1 LS $ $

0004 000403 Commissioning Reports and Acceptance Documentation 1 LS $ $

0005 —

Final Inspection, Punch List Completion, Closeout Documentation, Training, O&M Manuals, As-Builts and Warranties

1 LS $ $

TOTAL $

The Offeror shall complete and submit the pricing schedule provided as Attachment 4, Pricing Schedule. Do not price on this page; pricing submitted on this page will not be evaluated.

Pricing shall be inclusive of all labor, materials, equipment, supervision, overhead, G&A, bonds, permits, mobilization, and profit. The Offeror shall complete and sign the SF 1442 and complete the pricing schedule. Separate any travel and other direct costs into a dedicated CLIN if required.

*Do not price on this page; pricing submitted on this page will not be evaluated. *

**Performance and Payment Bonds will be required for this project within 15 calendar days of contract award.**

Contract Financing and Payment Disclaimer This acquisition does not provide for advance payments or upfront project funding. The Government will not prepay for mobilization, materials, equipment, or project startup costs except as specifically authorized under the contract. Payment will be made only for work completed, properly invoiced, and accepted by the Government in accordance with the contract’s milestone schedule, progress payment provisions, and inspection/acceptance requirements.

Offerors are responsible for ensuring they possess adequate financial capacity, cash flow, bonding capability, labor resources, and supplier arrangements necessary to perform the work pending Government payment. Submission of an offer constitutes acknowledgment and acceptance of these payment terms.

IRV Lab Exhaust & Vacuum Pump

SECTION 4: POINTS OF CONTACT

4.1 Contracting Officer

The Contracting Officer for this contract is:

L. Maria Finan U.S. Food and Drug Administration Email: Linda.Finan@fda.hhs.gov Phone: 240-402-5712

The Contracting Officer is the only person authorized to: - Modify contract terms, scope, or pricing.

4.2 Contract Specialist

The Contract Specialist for this contract is:

Sheneil Green U.S. Food and Drug Administration Email: Sheneil.Green@fda.hhs.gov Phone: 301-796-0675

The Contract Specialist assists with contract administration but does not have authority to modify contract terms or obligate Government funds.

4.3 Contracting Officer’s Representative

The Contracting Officer’s Representative (COR) for this contract is:

Darrel Wilmoth U.S. Food and Drug Administration Email: Darrel.Wilmoth@fda.hhs.gov Phone: 240-402-1093

The Contracting Officer’s Representative will oversee and monitor the technical requirements of the contract. The COR will be responsible for handling the Government’s inspection of the work and determining acceptability. The COR does not have the authority to modify the contract’s terms or obligate Government funds.

4.4 Contractor Points of Contact

The Contractor designated Project Manager / Contracts Manager for this contract is:

Project Manager Name:

Email:

Phone:

Contracts Manager Name:

Email:

Phone:

IRV Lab Exhaust & Vacuum Pump

SECTION 5: CONTRACT CLAUSES

5.1 Clauses Incorporated by Reference

52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://acquisition.gov https://acquisition.gov/far-overhaul https://acquisition.gov/hhsar

52.252-6 Authorized Deviations in Clauses (Nov 2020)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter

1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any Department of Health and Human Services Acquisition Regulations or (48 CFR Chapter 3) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

Clause No. Title Date

52.212-4 Terms and Conditions—Commercial Products and Commercial Services (see Addendum to RFO 52.212-4 (Construction) in this section for construction tailoring)

Nov 2025

52.203-6 w/Alt I

Restrictions on Subcontractor Sales to the Government June 2020; Nov

52.203-17 Contractor Employee Whistleblower Rights Nov 2025

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

Jan 2017

52.204-9 Personal Identity Verification of Contractor Personnel Jan 2011

52.204-10 Reporting Executive Compensation and First Tier Subcontract Awards

Nov 2025

52.204-13 System for Award Management—Maintenance Nov 2025

52.204-19 Incorporation by Reference of Representations and Certifications

Dec 2014

52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment

Nov 2025

52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters

Nov 2025

IRV Lab Exhaust & Vacuum Pump

Clause No. Title Date

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations

Nov 2025

52.219-8 Utilization of Small Business Concerns Nov 2025

52.222-3 Convict Labor Apr 2026 (RFO

DEV)

52.222-35 Equal Opportunity for Veterans Apr 2026 (DEV)

52.222-36 Equal Opportunity for Workers with Disabilities Apr 2026 (DEV)

52.222-37 Employment Reports on Veterans Apr 2026 (DEV)

52.222-40 Notification of Employee Rights Under the National Labor Relations Act

Apr 2026

52.222-50 Combating Trafficking in Persons Apr 2026

52.222-54 Employment Eligibility Verification Apr 2026 (DEV)

52.222-90 Addressing DEI Discrimination by Federal Contractors Apr 2026 (RFO

DEV)

52.223-11 Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons

Nov 2025

52.223-23 Sustainable Products and Services Nov 2025

52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving

May 2024

52.229-12 Tax on Certain Foreign Procurements Nov 2025

52.232-33 Payment by Electronic Funds Transfer—System for Award Management

Oct 2018

52.232-40 Providing Accelerated Payments to Small Business Subcontractors

Mar 2023

52.233-1 Disputes Nov 2025

52.233-3 Protest After Award Nov 2025

52.233-4 Applicable Law for Breach of Contract Claim Nov 2025

52.240-91 Security Prohibitions and Exclusions Nov 2025

52.242-13 Bankruptcy July 1995

52.242-14 Suspension of Work Apr 1984

52.243-4 Changes Jul 2025

52.244-6 Subcontracts for Commercial Products and Commercial Services

Nov 2025

52.222-4 Contract Work Hours and Safety Standards—Overtime Compensation

Nov 2025

52.222-6 Construction Wage Rate Requirements Apr 2026 (DEV)

52.222-7 Withholding of Funds Apr 2026 (RFO

DEV)

IRV Lab Exhaust & Vacuum Pump

Clause No. Title Date

52.222-8 Payrolls and Basic Records Apr 2026 (RFO

DEV)

52.222-9 Apprentices and Trainees Apr 2026 (RFO

DEV)

52.222-10 Compliance with Copeland Act Requirements Apr 2026 (RFO

DEV)

52.222-11 Subcontracts (Labor Standards) Apr 2026 (DEV)

52.222-12 Contract Termination—Debarment May 2014

52.222-13 Compliance with Construction Wage Rate Requirements and Related Regulations

May 2014

52.222-14 Disputes Concerning Labor Standards Nov 2025

52.222-15 Certification of Eligibility May 2014

52.236-2 Differing Site Conditions Aug 2025 (RFO

DEV)

52.236-3 Site Investigation and Conditions Affecting the Work Aug 2025 (RFO

DEV)

52.236-5 Material and Workmanship Aug 2025 (RFO

DEV)

52.236-6 Superintendence by the Contractor Aug 2025 (RFO

DEV)

52.236-7 Permits and Responsibilities Aug 2025 (RFO

DEV)

52.236-8 Other Contracts (if other contractors will work on site) Aug 2025 (RFO

DEV)

52.236-9 Protection of Existing Vegetation, Structures, Equipment, Utilities, and Improvements

Aug 2025 (RFO

DEV)

52.236-10 Operations and Storage Areas Aug 2025 (RFO

DEV)

52.236-11 Use and Possession Prior to Completion Aug 2025 (RFO

DEV)

52.236-12 Cleaning Up Aug 2025 (RFO

DEV)

52.236-13 Accident Prevention Aug 2025 (RFO

DEV)

52.236-13 w/Alt I

Accident Prevention, with Alternate I (high-hazard or long-duration work)

Aug 2025 (RFO

DEV)

52.236-15 Schedules for Construction Contracts Aug 2025 (RFO

DEV)

52.236-21 Specifications and Drawings for Construction Aug 2025 (RFO

DEV)

IRV Lab Exhaust & Vacuum Pump

Clause No. Title Date

52.228-5 Insurance—Work on a Government Installation Jan 1997

52.228-15 Performance and Payment Bonds—Construction Jun 2020

52.232-5 Payments under Fixed-Price Construction Contracts May 2014

52.232-27 Prompt Payment for Construction Contracts Jan 2017

52.246-12 Inspection of Construction Aug 1996

52.246-21 Warranty of Construction Mar 1994

52.249-2 w/Alt I

Termination for Convenience of the Government (Fixed- Price), with Alternate I

Apr 2012; Sept

52.249-10 Default (Fixed-Price Construction) Apr 1984

HHSAR

352.237-75

Key Personnel Dec 2015

5.2 Clauses Incorporated by Full Text:

Addendum to RFO 52.212-4 (Construction) This is a commercial construction acquisition under RFO Part 12 and RFO Part 36. RFO 52.212-4 applies as the primary terms and conditions clause. For the construction work, the following clauses govern in lieu of the corresponding paragraphs of 52.212-4:

(a) Inspection and acceptance. 52.246-12, Inspection of Construction, governs in lieu of paragraph (b) of 52.212-4.

(b) Payment. 52.232-5, Payments under Fixed-Price Construction Contracts, and 52.232-27, Prompt Payment for Construction Contracts, govern in lieu of paragraph (i) of 52.212-4.

(c) Changes. 52.243-4, Changes, governs changes to the work in lieu of paragraph (d) of 52.212-4.

(d) Disputes. 52.233-1, Disputes, applies in addition to paragraph (e) of 52.212-4.

(e) Warranty. 52.246-21, Warranty of Construction, governs in lieu of the warranty provided at paragraph (o) of 52.212-4.

(f) Termination. 52.249-2, Termination for Convenience of the Government (Fixed-Price), with Alternate I, governs in lieu of paragraph (l) of 52.212-4, and 52.249-10, Default (Fixed-Price Construction), governs in lieu of paragraph (m) of 52.212-4.

All other paragraphs of RFO 52.212-4 remain in effect. Order of precedence is governed by paragraph (r) of 52.212-4.

(End of addendum)

52.225-9 Buy American-Construction Materials (Nov 2025) (DEV)

(a) Definitions. As used in this clause— Commercially available off-the-shelf (COTS) item—

IRV Lab Exhaust & Vacuum Pump

(1) Means any item of supply (including construction material) that is–

(i) A commercial product (as defined in paragraph (1) of the definition of “commercial product” at Federal Acquisition Regulation (FAR) 2.101);

(ii) Sold in substantial quantities in the commercial marketplace; and

(iii) Offered to the Government, under a contract or subcontract at any tier, without modification, in the same form in which it is sold in the commercial marketplace; and

(2) Does not include bulk cargo, as defined in 46 U.S.C. 40102(4), such as agricultural products and petroleum products.

"Construction material" means an article, material, or supply brought to the construction site by the Contractor or a subcontractor for incorporation into the building or work. The term also includes an item brought to the site preassembled from articles, materials, or supplies.

However, emergency life safety systems, such as emergency lighting, fire alarm, and audio evacuation systems, that are discrete systems incorporated into a public building or work and that are produced as complete systems, are evaluated as a single and distinct construction material regardless of when or how the individual parts or components of those systems are delivered to the construction site. Materials purchased directly by the Government are supplies, not construction material.

Cost of components means—

(1) For components purchased by the Contractor, the acquisition cost, including transportation costs to the place of incorporation into the construction material (whether or not such costs are paid to a domestic firm), and any applicable duty (whether or not a duty-free entry certificate is issued); or

(2) For components manufactured by the Contractor, all costs associated with the manufacture of the component, including transportation costs as described in paragraph (1) of this definition, plus allocable overhead costs, but excluding profit. Cost of components does not include any costs associated with the manufacture of the construction material.

Critical component means a component that is mined, produced, or manufactured in the United States and deemed critical to the U.S. supply chain. The list of critical components is at FAR 25.105.

Critical item means a domestic construction material or domestic end product that is deemed critical to U.S. supply chain resiliency. The list of critical items is at FAR 25.105.

Domestic construction material means—

(1) For construction material that does not consist wholly or predominantly of iron or steel or a combination of both-

(i) An unmanufactured construction material mined or produced in the United States; or

(ii) A construction material manufactured in the United States, if–

(A) The cost of its components mined, produced, or manufactured in the United States exceeds 60 percent of the cost of all its components, except that the percentage will be 65 percent for items delivered in calendar years 2024 through 2028 and 75 percent for items delivered starting in calendar year 2029. Components of foreign origin of the same class or kind for which nonavailability determinations have been made are treated as domestic. Components of unknown origin are treated as foreign; or

(B) The construction material is a COTS item; or http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title46-section40102(4)&num=0&edition=prelim

IRV Lab Exhaust & Vacuum Pump

(2) For construction material that consists wholly or predominantly of iron or steel or a combination of both, a construction material manufactured in the United States if the cost of foreign iron and steel constitutes less than 5 percent of the cost of all components used in such construction material. The cost of foreign iron and steel includes but is not limited to the cost of foreign iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the construction material and a good faith estimate of the cost of all foreign iron or steel components excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the construction material contains multiple components, the cost of all the materials used in such construction material is calculated in accordance with the definition of "cost of components".

Fastener means a hardware device that mechanically joins or affixes two or more objects together. Examples of fasteners are nuts, bolts, pins, rivets, nails, clips, and screws.

Foreign construction material means a construction material other than a domestic construction material.

Foreign iron and steel means iron or steel products not produced in the United States. Produced in the United States means that all manufacturing processes of the iron or steel must take place in the United States, from the initial melting stage through the application of coatings, except metallurgical processes involving refinement of steel additives. The origin of the elements of the iron or steel is not relevant to the determination of whether it is domestic or foreign.

Predominantly of iron or steel or a combination of both means that the cost of the iron and steel content exceeds 50 percent of the total cost of all its components. The cost of iron and steel is the cost of the iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the product and a good faith estimate of the cost of iron or steel components excluding COTS fasteners.

Steel means an alloy that includes at least 50 percent iron, between 0.02 and 2 percent carbon, and may include other elements.

"United States" means the 50 States, the District of Columbia, and outlying areas.

(b) Domestic preference.

(1) This clause implements 41 U.S.C. chapter 83, Buy American, by providing a preference for domestic construction material. In accordance with 41 U.S.C. 1907, the domestic content test of the Buy American statute is waived for construction material that is a COTS item, except that for construction material that consists wholly or predominantly of iron or steel or a combination of both, the domestic content test is applied only to the iron and steel content of the construction materials, excluding COTS fasteners. The Contractor shall use only domestic construction material in performing this contract, except as provided in paragraphs (b)(2) and (b)(3) of this clause.

(2) This requirement does not apply to information technology that is a commercial product or to the construction materials or components listed by the Government as follows: None

(3) The Contracting Officer may add other foreign construction material to the list in paragraph (b)(2) of this clause if the Government determines that-

(i) The cost of domestic construction material would be unreasonable.

(A) For domestic construction material that is not a critical item or does not contain critical components.

http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter83&saved=%7CZ3JhbnVsZWlkOlVTQy1wcmVsaW0tdGl0bGU0MC1jaGFwdGVyMzctZnJvbnQ%3D%7C%7C%7C0%7Cfalse%7Cprelim&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section1907&num=0&edition=prelim

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(1) The cost of a particular domestic construction material subject to the requirements of the Buy American statute is unreasonable when the cost of such material exceeds the cost of foreign material by more than 20 percent;

(2) For construction material that is not a COTS item and does not consist wholly or predominantly of iron or steel or a combination of both, if the cost of a particular domestic construction material is determined to be unreasonable or there is no domestic offer received, and the low offer is for foreign construction material that is manufactured in the United States and does not exceed 55 percent domestic content, the Contracting Officer will treat the lowest offer of foreign construction material that exceeds 55 percent domestic content as a domestic offer and determine whether the cost of that offer is unreasonable by applying the evaluation factor listed in paragraph (b)(3)(i)(A)(1) of this clause.

(3) The procedures in paragraph (b)(3)(i)(A)(2) of this clause will no longer apply as of January 1, 2030.

(B) For domestic construction material that is a critical item or contains critical components.

(1) The cost of a particular domestic construction material that is a critical item or contains critical components, subject to the requirements of the Buy American statute, is unreasonable when the cost of such material exceeds the cost of foreign material by more than 20 percent plus the additional preference factor identified for the critical item or construction material containing critical components listed at FAR 25.105.

(2) For construction material that does not consist wholly or predominantly of iron or steel or a combination of both, if the cost of a particular domestic construction material is determined to be unreasonable or there is no domestic offer received, and the low offer is for foreign construction material that does not exceed 55 percent domestic content, the Contracting Officer will treat the lowest foreign offer of construction material that is manufactured in the United States and exceeds 55 percent domestic content as a domestic offer, and determine whether the cost of that offer is unreasonable by applying the evaluation factor listed in paragraph (b)(3)(i)(B)(1) of this clause.

(3) The procedures in paragraph (b)(3)(i)(B)(2) of this clause will no longer apply as of January 1, 2030.

(ii) The application of the restriction of the Buy American statute to a particular construction material would be impracticable or inconsistent with the public interest; or

(iii) The construction material is not mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities of a satisfactory quality.

(c) Request for determination of inapplicability of the Buy American statute.

(1)

(i) Any Contractor request to use foreign construction material in accordance with paragraph (b)(3) of this clause shall include adequate information for Government evaluation of the request, including-

(A) A description of the foreign and domestic construction materials;

(B) Unit of measure;

(C) Quantity;

(D) Price;

(E) Time of delivery or availability;

(F) Location of the construction project;

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(G) Name and address of the proposed supplier; and

(H) A detailed justification of the reason for use of foreign construction materials cited in accordance with paragraph (b)(3) of this clause.

(ii) A request based on unreasonable cost shall include a reasonable survey of the market and a completed price comparison table in the format in paragraph (d) of this clause.

(iii) The price of construction material shall include all delivery costs to the construction site and any applicable duty (whether or not a duty-free certificate may be issued).

(iv) Any Contractor request for a determination submitted after contract award shall explain why the Contractor could not reasonably foresee the need for such determination and could not have requested the determination before contract award. If the Contractor does not submit a satisfactory explanation, the Contracting Officer need not make a determination.

(2) If the Government determines after contract award that an exception to the Buy American statute applies and the Contracting Officer and the Contractor negotiate adequate consideration, the Contracting Officer will modify the contract to allow use of the foreign construction material. However, when the basis for the exception is the unreasonable price of a domestic construction material, adequate consideration is not less than the differential established in paragraph (b)(3)(i) of this clause.

(3) Unless the Government determines that an exception to the Buy American statute applies, use of foreign construction material is noncompliant with the Buy American statute or Balance of Payments Program.

(d) Data. To permit evaluation of requests under paragraph (c) of this clause based on unreasonable cost, the Contractor shall include the following information and any applicable supporting data based on the survey of suppliers:

Foreign and Domestic Construction Materials Price Comparison

Construction material description Unit of measure Quantity Price (dollars)*

Item 1:

Foreign construction material. _______ _______ _______

Domestic construction material. _______ _______ _______

Item 2:

Foreign construction material. _______ _______ _______

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Domestic construction material. _______ _______ _______

[* Include all delivery costs to the construction site and any applicable duty (whether or not a duty-free entry certificate is issued)].

[List name, address, telephone number, and contact for suppliers surveyed. Attach copy of response; if oral, attach summary.] [Include other applicable supporting information.]

HHSAR 352.203-70 Anti-Lobbying (JUN 2026) (RFO DEVIATION)

Pursuant to the HHS annual appropriations acts, except for normal and recognized executive-legislative relationships, the Contractor must not use any HHS contract funds for:

(a) Publicity or propaganda purposes;

(b) The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any state or local legislature itself; or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any state or local government, except in presentation to the executive branch of any state or local government itself; or

(c) Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any state government, state legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a state, local, or tribal government in policymaking and administrative processes within the executive branch of that government.

(d) The prohibitions in paragraphs (a), (b), and (c) of this clause include any activity to advocate or promote any proposed, pending, or future federal, state, or local tax increase, or any proposed, pending, or future requirement for, or restriction on, any legal consumer product, including its sale or marketing, including, but not limited to, the advocacy or promotion of gun control.

HHSAR 352.204-73 Contractor Personnel Security and Agency Access (Feb 2024) (DEV)

(a) Definitions. As used in this clause—

Agency access means access to HHS facilities, sensitive information, information systems or other HHS resources.

Applicant means a contractor employee for whom the Contractor applies for an HHS

IRV Lab Exhaust & Vacuum Pump identification card.

Contractor employee means a prime contractor and subcontractor employee who requires agency access to perform work under an HHS contract.

Identification card (or "ID card") means a government issued or accepted identification card such as a Personal Identity Verification (PIV) card, a PIV-Interoperable (PIV-I) card from an authorized PIV-1 issuer, or a non-PIV card issued by HHS, or a nonPIV card issued by another Federal agency and approved by HHS. PIV and PIV-1 cards have physical and electronic attributes that other (non-PIV) ID cards do not have.

Issuing office means the HHS entity that issues identification cards to contractor employees.

Local security servicing organization means the HHS entity that provides security services to the HHS organization sponsoring the contract.

(b) Risk and sensitivity level designations. For contracts requiring access to HHS facilities, sensitive information, information systems or other HHS resources, contractor employees will be required to complete background investigations, identity proofing, and government identification card application procedures to determine suitability for access. HHS will assign a risk and sensitivity level designation to the overall contract and/or to contractor employee positions by category, group or individual. The risk and sensitivity level designations will be the basis for determining the level of personnel security processing required for contractor employees. The position sensitivity designation levels that apply will be identified in the contract. The following risk and sensitivity level designations and associated level of processing are required, and each level includes the prior levels—

1. Low risk level: National Agency Check with Written Inquiries (NACI);

2. Moderate risk level: Minimum Background Investigation (MBI); and

3. High risk level: Background Investigation.

(c) Security clearances. Contractor employees may also be required to obtain security clearances (i.e., Confidential, Secret, or Top Secret). National Security work designated "special sensitive," "critical sensitive," or "non-critical sensitive," will determine the level of clearance required for contractor employees. Personnel security clearances for national security contracts in HHS will be processed according to the HHS Personnel Security and Suitability Program, HHS Instruction 731-1, and the Department of Defense National Industrial Security Program Operating Manual (NISPOM).

(d) Pre-screening of contractor employees. The Contractor must pre-screen individuals designated for employment under any HHS contract by verifying minimal suitability requirements to ensure that only candidates that appear to meet such requirements are

IRV Lab Exhaust & Vacuum Pump considered for contract employment, and to mitigate the burden on the Government of conducting background investigations on objectionable applicants. The Contractor must exercise due diligence in pre-screening all employees prior to submission to HHS for agency access. HHS may decline to grant agency access to a contractor employee for reasons including, but not limited to—

(1) Conviction of a felony, a crime of violence, or a misdemeanor involving moral turpitude;

(2) Falsification of information entered on forms or of other documents submitted;

(3) Improper conduct including criminal, infamous, dishonest, immoral, or notoriously disgraceful conduct or other conduct adverse to the Government regardless of whether the conduct is directly related to the contract; and

(4) Any behavior judged to pose a potential threat to HHS facilities, sensitive information, information systems or other resources.

(e) Citizenship status. The Contractor must monitor a non-citizen’s continued authorization for employment in the United States. The Contractor must provide documentation to the Contracting Officer or the Contracting Officer's Representative (COR) during the background investigation process that validates that the E-Verify requirement has been met for each contractor employee.

(f) Background investigation and adjudication. A contractor employee must have a favorable adjudication of background investigation before HHS will issue an ID card to the contractor employee granting access to HHS facilities, sensitive information, information systems or other HHS resources. HHS may accept favorable adjudications of background investigations from other Federal agencies when applicants have held PIV cards issued by those agencies with no break in service. HHS may also accept PIV-I (Interoperable) cards issued by an authorized PIV- 1 issuer as evidence of identity. A favorable adjudication does not preclude HHS from initiating a new investigation when deemed necessary. At a minimum, the FBI National Criminal History Check (fingerprint check) must be favorably completed before an HHS identification card can be issued. Each Contractor must use the Office of Personnel Management's (OPM) e-QIP system, or successor system identified by HHS, to complete any required investigative forms.

Instructions for obtaining fingerprints will be provided by the COR or Contracting Officer. The HHS Assistant Secretary for Administration, Program Support Center (PSC), or authorized HHS designee, is responsible for adjudicating the suitability of contractor employees.

(g) Agency access denied. Upon contract award, HHS will initiate the agency access procedure for all contractor employees requiring access to HHS facilities, sensitive information, controlled unclassified information, information systems, and other HHS resources for contract performance. HHS may deny agency access to any individual about whom an adverse suitability determination is made. Failure to submit the required security information or to truthfully answer all questions shall constitute grounds for denial of access. The Contractor must

IRV Lab Exhaust & Vacuum Pump not provide agency access to contractor employees until the COR or Contracting Officer provides notice of approval, which is authorized only by the PSC, or authorized HHS designee.

Where a proposed contractor employee is denied agency access by the Government or, if for any reason a proposed application is withdrawn by the Contractor during the agency access process, the additional costs and administrative burden for conducting additional background investigations caused by a lack of effective prescreening or planning on the part of the Contractor may be considered as part of the Contractor's overall performance evaluation.

(h) Identification card application process. The COR will be the HHS ID card Sponsor and point of contact for the Contractor's application for an HHS ID card. The COR shall review and approve the HHS ID card application before an ID card is issued to the applicant. An applicant may be issued either a Personal Identity Verification (PIV) card that meets the standards of Homeland Presidential Security Directive (HSPD-12), or an applicant may be issued a non-PIV card. Generally, a non-PIV card will be issued for contracts that expire in six months or less, including option periods. The COR may request the issuing office to waive the six-month eligibility requirement when it is in HHS interest for contract performance. The following applies—

(1) PIV card. The applicant must complete an HHS on-line application for a PIV card;

(2) Non-PIV card. The applicant must complete and submit a hard copy of the necessary form(s) to be provided to Contractor by COR/Sponsor) to the COR/Sponsor; and

(3) Regardless of the type of card to be issued (PIV or non-PIV), the applicant must appear in person to provide two forms of identity source documents in original form to HHS. The identity source documents must come from the list of acceptable documents included in Form F-9, OMB No. 1115-0136, Employment Eligibility Verification. At least one document must be a valid State or Federal government-issued picture identification. For a PIV card, the applicant may be required to appear in-person a second time for enrollment and activation.

(i) Identification card custody and control. The Contractor is responsible for the custody and control of all forms of government identification issued by HHS to contractor employees for access to HHS facilities, sensitive information, information systems and other HHS resources.

The Contractor shall:

(1) Provide a listing of personnel for whom an identification (ID) card is requested to the COR who will provide a copy of the listing to the card issuing office. This may include Contractor and subcontractor personnel. Follow issuing office directions for submittal of an application package(s).

(2) While visiting or performing work on an HHS facility, as specified by the issuing office or COR, ensure that contractor employees prominently display their ID card.

(3) Immediately notify the COR or, if the COR is unavailable, the Contracting Officer when a

IRV Lab Exhaust & Vacuum Pump contractor employee’s status changes and no longer requires agency access (e.g., employee’s transfer, completion of a project, retirement, removal from work on the contract, or termination of employment) that may affect the employee’s eligibility for access to the facility, sensitive information, or resources.

(4) Promptly deliver to the issuing office: (a) all ID cards assigned to an employee who no longer requires access to the facility; and (b) all expired ID cards within five (5) days of their expiration or all cards at time of contract termination, whichever occurs first.

(5) Immediately report any lost or stolen ID cards to the issuing office and follow its instructions.

(i) The Contractor is responsible for maintaining and safeguarding the HHS ID card upon issuance to the contractor employee. The Contractor must ensure that contractor employees comply with HHS requirements concerning the renewal, loss, theft, or damage of an ID card.

The Contractor must immediately notify the COR or, if the COR is unavailable, the Contracting Officer when an ID card is lost, stolen or damaged.

(ii) Failure to comply with the requirements for custody and control of HHS ID cards may result in withholding final payment or contract termination based on the potential for serious harm caused by inappropriate access to HHS facilities, sensitive information, information systems or other HHS resources.

(iii) Specific actions and activities are required in certain events—

(A) Renewal. A contractor employee's HHS issued ID card is valid for a maximum of three years or until the contract expiration date (including option periods), whichever occurs first. The renewal process should begin six weeks before the PIV card expiration date. If a PIV card is not renewed before it expires, the contractor employee will be required to sign-in daily for facility access and may have limited access to information systems and other resources.

(B) Lost/stolen. Immediately upon detection, the Contractor or contractor employee must report a lost or stolen HHS ID card to the COR, or if the COR is unavailable, the Contracting Officer, the issuing office, or the local servicing security organization. The Contractor must submit an incident report within 48 hours, through the COR or, if the COR is unavailable, the Contracting Officer, the issuing office, or the local security servicing organization describing the circumstances of the loss or theft. The Contractor must also report a lost or stolen PIV card through the HHS on-line registration system. If the loss or theft is reported by the Contractor to the local police, a copy of the police report must be provided to the COR or Contracting Officer.

From the date of notification to HHS, the Contractor must wait three days before getting a replacement ID card. During the 3-day wait period, the contractor employee must sign in daily for facility access.

(C) Replacement. An ID card will be replaced if it is damaged, contains incorrect data, or is lost or stolen for more than 3 days, provided there is a continuing need for agency access to

IRV Lab Exhaust & Vacuum Pump perform work under the contract.

(D) Surrender of ID cards. Upon notification that routine access to HHS facilities, sensitive information, information systems or other HHS resources is no longer required, the Contractor must surrender the HHS issued ID card to the COR, or if the COR is unavailable, the Contracting Officer, the issuing office, or the local security servicing organization in accordance with agency procedures.

(j) Flow down of clause. The Contractor is required to include this clause in any subcontracts at any tier that require the subcontractor or subcontractor's employees to have access to HHS facilities, sensitive information, information systems or other resources.

HHSAR 352.208-70 Printing and Duplication (Feb 2026) (RFO DEV)

(a) Unless otherwise specified in this contract, no printing by the Contractor or any subcontractor is authorized under this contract. All printing required must be performed by the Government Printing Office except as authorized by the Contracting Officer. The Contractor must submit camera-ready copies to the Contracting Officer's Representative (COR). The terms “printing” and “duplicating/copying” are defined in the Government Printing and Binding Regulations of the Joint Committee on Printing.

(b) If necessary for performance of the contract, the Contractor may duplicate or copy less than 5,000 production units of only one page, or less than 25,000 production units in aggregate of multiple pages for the use of a department or agency. A production unit is defined as one sheet, size 8.5 x 11 inches, one side only, and one color. The pages may not exceed a maximum image size of 10 3⁄4 by 14 1⁄4 inches. This page limit applies to each printing requirement and not for all printing requirements under the entire contract.

(c) Approval for all printing, as well as duplicating/copying in excess of the stated limits, must be obtained from the COR who will consult with the designated publishing services office and provide direction to the contractor. The cost of any unauthorized printing or duplicating/copying under this contract will be considered an unallowable cost for which the Contractor will not be reimbursed.

HHSAR 352.223-70 Safety and Health (Dec 2015)

(a) To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under…

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