RFQ 75F40125Q00332.pdf

CDER-2025-130449

RFQ No.: 75F40125Q00332

Purchase of laboratory supplies and consumable

Section 1 – General Information

A. Summary of Requirement

This is a Purchase Order Request for Quotation (RFQ) for commercial products and services prepared in accordance with the procedures outlined in Federal Acquisition Regulation (FAR)

13.106. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A

SEPARATE SOLICITATION WILL NOT BE ISSUED.

This is a brand name or equal requirement.

The Request for Quotation (RFQ) number is 75F40125Q00332.

This requirement is being solicited as unrestricted.

a. The NAICS for this requirement is: 334516 - Analytical Laboratory Instrument

Manufacturing

b. The SB size standard for the NAICS code is: 1000 employees. The full table of size standards can be found at: https://www.sba.gov/document/support-table-size-standards

Description of Requirement: The U.S. Food and Drug Administration (FDA) Division of

Applied Regulatory Science (DARS), within OCP/OTS/CDER, is conducting a research program focused on evaluating complex in vitro models for regulatory science.

These supplies include reagents, media, consumables, and specialized tools required for maintaining and characterizing advanced cell-based models, such as those derived from human induced pluripotent stem cells (hiPSCs). These resources enable the development of physiologically relevant microenvironments that more accurately replicate in vivo conditions compared to traditional cell culture systems. The materials are used across multiple research areas and directly support projects evaluating drug safety and efficacy.

Period of Performance:

• Delivery shall occur within 14 calendar days from the date of award.

• Vendor must coordinate delivery within 7 days of award with the Project Officer:

o Bhavya Bhardwaj o Email: Bhavya.Bhardwaj@fda.hhs.gov o Phone: TBD

Note: No deliveries will be accepted without prior coordination and approval.

Delivery Address:

U.S. Food and Drug Administration https://www.sba.gov/document/support-table-size-standards

WO 64, Room 2014 10903 New Hampshire Avenue Silver Spring, MD 20993 Attn: Bhavya Bhardwaj (Bhavya.Bhardwaj@fda.hhs.gov)

Freight Address:

WO Building 62 Loading Dock, then deliver to WO64-2014

B. Points of Contact

Contracting Officer (CO):

Maria Finan

Email: Linda.Finan@fda.hhs.gov

Contract Specialist (CS):

Erika Crawford

Email: Erika.Crawford@fda.hhs.gov

Contracting Officer Representative (COR)

TBD

mailto:Linda.Finan@fda.hhs.gov mailto:Erika.Crawford@fda.hhs.gov

Section 2 - Contract Clauses

Clauses Incorporated by Reference

All applicable terms and conditions from the Contractor’s parent Indefinite Delivery Vehicle

(IDV) flows down to the associated and awarded order.

Clause Number Clause Title

52.212-4 Contract Terms and Conditions-Commercial Products and Commercial

Services (Nov 2023)

52.212-5 Contract Terms and Conditions

Required To Implement Statutes or Executive Orders—Commercial

Products and Commercial Services (JAN 2025)

HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity

Investigations (DEC 2015)

HHSAR 352.232-71 Electronic Submission of Payment Requests

Clauses by Full Text

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://www.acquisition.gov/far/part-52 https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses

(End of clause)

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive

Orders—Commercial Products and Commercial Services (JAN 2025)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or

Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or

Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and

Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services

Developed or Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of

Pub. L. 115-91).

https://www.acquisition.gov/far/part-52 https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses https://www.acquisition.gov/far/52.203-19#FAR_52_203_19 https://www.acquisition.gov/far/52.204-23#FAR_52_204_23

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video

Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-

232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov

2015).

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar

2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws

108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting

Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.]

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun

2020), with Alternate I (Nov 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov

2021) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment

Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the

American Recovery and Reinvestment Act of 2009.)

__ (4) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) ( 41 U.S.C. 4712);

this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

_X_ (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun

2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (6) [Reserved].

__ (7) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (8) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery

Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.209-10#FAR_52_209_10 https://www.acquisition.gov/far/52.232-40#FAR_52_232_40 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3903&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section3801&num=0&edition=prelim https://www.acquisition.gov/far/52.233-3#FAR_52_233_3 https://www.acquisition.gov/far/52.233-4#FAR_52_233_4 https://www.acquisition.gov/far/52.203-6#FAR_52_203_6 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section4655&num=0&edition=prelim https://www.acquisition.gov/far/52.203-13#FAR_52_203_13 https://www.acquisition.gov/far/52.203-15#FAR_52_203_15 https://www.acquisition.gov/far/52.203-17#FAR_52_203_17 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section4712&num=0&edition=prelim https://www.acquisition.gov/far/3.900#FAR_3_900 https://www.acquisition.gov/far/52.204-10#FAR_52_204_10 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/52.204-14#FAR_52_204_14 https://www.acquisition.gov/far/52.204-15#FAR_52_204_15

_X_ (9) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of

Division R of Pub. L. 117-328).

__ (10) 52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply

Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (Dec

2023) ( Pub. L. 115–390, title II).

__ (11) (i) 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec

2023) ( Pub. L. 115–390, title II).

__ (ii) Alternate I (Dec 2023) of 52.204-30.

_X_ (12) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors

Debarred, Suspended, or Proposed for Debarment. (Nov 2021) ( 31 U.S.C. 6101 note).

__ (13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility

Matters (Oct 2018) ( 41 U.S.C. 2313).

__ (14) [Reserved].

__ (15) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022)

( 15 U.S.C. 657a).

__ (16) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns

(Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer)

(15 U.S.C. 657a).

__ (17) [Reserved]

_ X _ (18) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-6.

__ (19) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-7.

__ (20) 52.219-8, Utilization of Small Business Concerns (Feb 2024) (15 U.S.C. 637(d)(2) and

(3)).

__ (21) (i) 52.219-9, Small Business Subcontracting Plan (Sep 2023) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

https://www.acquisition.gov/far/52.204-27#FAR_52_204_27 https://www.acquisition.gov/far/52.204-28#FAR_52_204_28 https://www.govinfo.gov/link/plaw/115/public/390 https://www.acquisition.gov/far/52.204-30#FAR_52_204_30 https://www.govinfo.gov/link/plaw/115/public/390 https://www.acquisition.gov/far/52.204-30#FAR_52_204_30 https://www.acquisition.gov/far/52.209-6#FAR_52_209_6 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/52.209-9#FAR_52_209_9 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/far/52.219-3#FAR_52_219_3 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/far/52.219-4#FAR_52_219_4 https://www.acquisition.gov/far/52.219-6#FAR_52_219_6 https://www.acquisition.gov/far/52.219-6#FAR_52_219_6 https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 https://www.acquisition.gov/far/52.219-8#FAR_52_219_8 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9

__ (iv) Alternate III (Jun 2020) of 52.219-9.

__ (v) Alternate IV (Sep 2023) of 52.219-9.

__ (22) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

__ (ii) Alternate I (Mar 2020) of 52.219-13.

_ X _ (23) 52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 657s).

__ (24) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep

2021) (15 U.S.C. 637(d)(4)(F)(i)).

__ (25) 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-

Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (Feb 2024)

(15 U.S.C. 657f).

_ X _ (26) (i) 52.219-28, Post Award Small Business Program Rerepresentation (Feb 2024)

(15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (Mar 2020) of 52.219-28.

__ (27) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically

Disadvantaged Women-Owned Small Business Concerns (Oct 2022) (15 U.S.C. 637(m)).

__ (28) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small

Business Concerns Eligible Under the Women-Owned Small Business Program (Oct 2022)

(15 U.S.C. 637(m)).

__ (29) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar

2020) ( 15 U.S.C. 644(r)).

__ (30) 52.219-33, Nonmanufacturer Rule (Sep 2021) ( 15 U.S.C. 637(a)(17)).

_ X _ (31) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_ X _ (32) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2024).

_ X _ (33) [RESERVED]

_ X _ (34) [RESERVED]

__ (ii) [RESERVED]

__ (35) (i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) ( 38 U.S.C. 4212).

https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-13#FAR_52_219_13 https://www.acquisition.gov/far/52.219-13#FAR_52_219_13 https://www.acquisition.gov/far/52.219-14#FAR_52_219_14 https://www.acquisition.gov/far/52.219-16#FAR_52_219_16 https://www.acquisition.gov/far/52.219-27#FAR_52_219_27 https://www.acquisition.gov/far/52.219-28#FAR_52_219_28 https://www.acquisition.gov/far/52.219-28#FAR_52_219_28 https://www.acquisition.gov/far/52.219-29#FAR_52_219_29 https://www.acquisition.gov/far/52.219-30#FAR_52_219_30 https://www.acquisition.gov/far/52.219-32#FAR_52_219_32 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section644&num=0&edition=prelim https://www.acquisition.gov/far/52.219-33#FAR_52_219_33 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637&num=0&edition=prelim https://www.acquisition.gov/far/52.222-3#FAR_52_222_3 https://www.acquisition.gov/far/52.222-19#FAR_52_222_19 https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim

__ (ii) Alternate I (Jul 2014) of 52.222-35.

_ X _ (36) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun

2020) ( 29 U.S.C. 793).

__ (ii) Alternate I (Jul 2014) of 52.222-36.

__ (37) 52.222-37, Employment Reports on Veterans (Jun 2020) ( 38 U.S.C. 4212).

__ (38) 52.222-40, Notification of Employee Rights Under the National Labor Relations

Act (Dec 2010) (E.O. 13496).

_ X _ (39) (i) 52.222-50, Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ (40) 52.222-54, Employment Eligibility Verification (May 2022) (Executive Order 12989).

(Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

__ (41) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated

Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (42) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential

Hydrofluorocarbons (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (43) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and

Air Conditioners (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (44) 52.223-20, Aerosols (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (45) 52.223-21, Foams (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (46) 52.223-23, Sustainable Products and Services (May 2024) ( E.O. 14057, 7 U.S.C.

8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, and 42 U.S.C. 7671l).

__ (47) (i) 52.224-3 Privacy Training (Jan 2017) ( 5 U.S.C. 552 a).

__ (ii) Alternate I (Jan 2017) of 52.224-3.

__ (48) (i) 52.225-1, Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83).

https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section793&num=0&edition=prelim https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 https://www.acquisition.gov/far/52.222-37#FAR_52_222_37 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/52.222-40#FAR_52_222_40 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 https://www.acquisition.gov/far/52.222-54#FAR_52_222_54 https://www.acquisition.gov/far/22.1803#FAR_22_1803 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 https://www.acquisition.gov/far/52.223-11#FAR_52_223_11 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section7671&num=0&edition=prelim https://www.acquisition.gov/far/52.223-12#FAR_52_223_12 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section7671&num=0&edition=prelim https://www.acquisition.gov/far/52.223-20#FAR_52_223_20 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section7671&num=0&edition=prelim https://www.acquisition.gov/far/52.223-21#FAR_52_223_21 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section7671&num=0&edition=prelim https://www.acquisition.gov/far/52.223-23#FAR_52_223_23 https://www.federalregister.gov/executive-order/14057 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section8102&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section8102&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section6962&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section8259&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section7671&num=0&edition=prelim https://www.acquisition.gov/far/52.224-3#FAR_52_224_3 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim https://www.acquisition.gov/far/52.224-3#FAR_52_224_3 https://www.acquisition.gov/far/52.225-1#FAR_52_225_1

__ (ii) Alternate I (Oct 2022) of 52.225-1.

__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023) ( 19

U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C.

chapter 29 (sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109-

53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I [Reserved].

__ (iii) Alternate II (Dec 2022) of 52.225-3.

__ (iv) Alternate III (Feb 2024) of 52.225-3.

__ (v) Alternate IV (Oct 2022) of 52.225-3.

__ (50) 52.225-5, Trade Agreements (NOV 2023) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the

Treasury).

__ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United

States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for

Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007)

(42 U.S.C. 5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov

2007) (42 U.S.C. 5150).

_X_ (55) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While

Driving (May 2024) ( E.O. 13513).

__ (56) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

__ (57) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial

Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

__ (58) 52.232-30, Installment Payments for Commercial Products and Commercial

Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

_ X _ (59) 52.232-33, Payment by Electronic Funds Transfer-System for Award

Management (Oct2018) ( 31 U.S.C. 3332).

https://www.acquisition.gov/far/52.225-1#FAR_52_225_1 https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section3301&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section3301&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section2112&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section3805&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section4001&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title19-chapter29&saved=%7CZ3JhbnVsZWlkOlVTQy1wcmVsaW0tdGl0bGU0MC1jaGFwdGVyMzctZnJvbnQ%3D%7C%7C%7C0%7Cfalse%7Cprelim&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title19-chapter29&saved=%7CZ3JhbnVsZWlkOlVTQy1wcmVsaW0tdGl0bGU0MC1jaGFwdGVyMzctZnJvbnQ%3D%7C%7C%7C0%7Cfalse%7Cprelim&edition=prelim https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.acquisition.gov/far/52.225-5#FAR_52_225_5 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section2501&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section3301&num=0&edition=prelim https://www.acquisition.gov/far/52.225-13#FAR_52_225_13 https://www.acquisition.gov/far/52.225-26#FAR_52_225_26 https://www.acquisition.gov/far/52.226-4#FAR_52_226_4 https://www.acquisition.gov/far/52.226-5#FAR_52_226_5 https://www.acquisition.gov/far/52.226-8#FAR_52_226_8 https://www.federalregister.gov/executive-order/13513 https://www.acquisition.gov/far/52.229-12#FAR_52_229_12 https://www.acquisition.gov/far/52.232-29#FAR_52_232_29 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section3805&num=0&edition=prelim https://www.acquisition.gov/far/52.232-30#FAR_52_232_30 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section3805&num=0&edition=prelim https://www.acquisition.gov/far/52.232-33#FAR_52_232_33 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3332&num=0&edition=prelim

__ (60) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award

Management (Jul 2013) (31 U.S.C. 3332).

__ (61) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ (62) 52.239-1, Privacy or Security Safeguards (Aug 1996) ( 5 U.S.C. 552a).

__ (63) 52.240-1, Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by

American Security Drone Act-Covered Foreign Entities (Nov 2024) (Sections 1821-1826, Pub.

L. 118-31, 41 U.S.C. 3901 note prec.).

__ (64) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

__ (65) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov

2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631).

__ (ii) Alternate I (Apr 2003) of 52.247-64.

__ (iii) Alternate II (Nov 2021) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.]

__ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price

Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and

41 U.S.C. chapter 67).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price

Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).

__ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to

Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements

(May 2014) (41 U.S.C. chapter 67).

__ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to

Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

https://www.acquisition.gov/far/52.232-34#FAR_52_232_34 https://www.acquisition.gov/far/52.232-36#FAR_52_232_36 https://www.acquisition.gov/far/52.239-1#FAR_52_239_1 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552a&num=0&edition=prelim https://www.acquisition.gov/far/52.240-1#FAR_52_240_1 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section3901&num=0&edition=prelim https://www.acquisition.gov/far/52.242-5#FAR_52_242_5 https://www.acquisition.gov/far/52.247-64#FAR_52_247_64 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title46-section55305&num=0&edition=prelim https://www.acquisition.gov/far/52.247-64#FAR_52_247_64 https://www.acquisition.gov/far/52.247-64#FAR_52_247_64 https://www.acquisition.gov/far/52.222-41#FAR_52_222_41 https://www.acquisition.gov/far/52.222-42#FAR_52_222_42 https://www.acquisition.gov/far/52.222-43#FAR_52_222_43 https://www.acquisition.gov/far/52.222-44#FAR_52_222_44 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section206&num=0&edition=prelim https://www.acquisition.gov/far/52.222-51#FAR_52_222_51 https://www.acquisition.gov/far/52.222-53#FAR_52_222_53

__ (7) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan

2022).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020)

(42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the

Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor

Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the

Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1), in a subcontract for commercial products or commercial services. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C. 3509).

(ii) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) ( 41 U.S.C. 4712).

(iii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or

Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further

Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

https://www.acquisition.gov/far/52.222-55#FAR_52_222_55 https://www.acquisition.gov/far/52.222-62#FAR_52_222_62 https://www.acquisition.gov/far/52.226-6#FAR_52_226_6 https://www.acquisition.gov/far/2.101#FAR_2_101 https://www.acquisition.gov/far/52.215-2#FAR_52_215_2 https://www.acquisition.gov/far/subpart-4.7#FAR_Subpart_4_7 https://www.acquisition.gov/far/52.203-13#FAR_52_203_13 https://www.acquisition.gov/far/52.203-17#FAR_52_203_17 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section4712&num=0&edition=prelim https://www.acquisition.gov/far/52.203-19#FAR_52_203_19

(iv) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or

Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(v) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video

Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(vi) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of

Division R of Pub. L. 117-328).

(vii)

(A) 52.204–30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec

2023) ( Pub. L. 115–390, title II).

(B) Alternate I (Dec 2023) of 52.204–30.

(viii) 52.219-8, Utilization of Small Business Concerns (Feb 2024) ( 15 U.S.C. 637(d)(2) and

(3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in

FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(ix) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(x) 52.222-26, Equal Opportunity (Sep 2015) (E.O.11246).

(xi) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

(xii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

(xiii) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

(xiv) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec

2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xv) 52.222-41, Service Contract Labor Standards (Aug 2018) ( 41 U.S.C. chapter 67).

(xvi)

(A) 52.222-50, Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and E.O

13627).

(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

https://www.acquisition.gov/far/52.204-23#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.204-27#FAR_52_204_27 https://www.govinfo.gov/link/plaw/115/public/390 https://www.acquisition.gov/far/52.219-8#FAR_52_219_8 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637&num=0&edition=prelim https://www.acquisition.gov/far/19.702#FAR_19_702 https://www.acquisition.gov/far/52.219-8#FAR_52_219_8 https://www.acquisition.gov/far/52.222-21#FAR_52_222_21 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 https://www.acquisition.gov/far/52.222-37#FAR_52_222_37 https://www.acquisition.gov/far/52.222-40#FAR_52_222_40 https://www.acquisition.gov/far/52.222-40#FAR_52_222_40 https://www.acquisition.gov/far/52.222-41#FAR_52_222_41 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-chapter67-front&num=0&edition=prelim https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50

(xvii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to

Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements

(May 2014) (41 U.S.C. chapter 67).

(xviii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to

Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

(xix) 52.222-54, Employment Eligibility Verification (May 2022) (E.O. 12989).

(xx) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan

2022).

(xxi) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

(xxii)

(A) 52.224-3, Privacy Training (Jan 2017) ( 5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

(xxiii) 52.225-26, Contractors Performing Private Security Functions Outside the United

States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for

Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

(xxiv) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun

2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxv) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023)

( 31 U.S.C. 3903 and 10 U.S.C. 3801). Flow down required in accordance with paragraph (c) of 52.232-40.

(xxvi) 52.240-1, Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by

American Security Drone Act-Covered Foreign Entities (Nov 2024) (Sections 1821-1826, Pub.

L. 118-31, 41 U.S.C. 3901 note prec.).

(xxvii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov

2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631). Flow down required in accordance with paragraph

(d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause) https://www.acquisition.gov/far/52.222-51#FAR_52_222_51 https://www.acquisition.gov/far/52.222-53#FAR_52_222_53 https://www.acquisition.gov/far/52.222-54#FAR_52_222_54 https://www.acquisition.gov/far/52.222-55#FAR_52_222_55 https://www.acquisition.gov/far/52.222-62#FAR_52_222_62 https://www.acquisition.gov/far/52.224-3#FAR_52_224_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.224-3#FAR_52_224_3 https://www.acquisition.gov/far/52.225-26#FAR_52_225_26 https://www.acquisition.gov/far/52.226-6#FAR_52_226_6 https://www.acquisition.gov/far/52.226-6#FAR_52_226_6 https://www.acquisition.gov/far/52.232-40#FAR_52_232_40 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3903&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section3801&num=0&edition=prelim https://www.acquisition.gov/far/52.232-40#FAR_52_232_40 https://www.acquisition.gov/far/52.240-1#FAR_52_240_1 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section3901&num=0&edition=prelim https://www.acquisition.gov/far/52.247-64#FAR_52_247_64 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title46-section55305&num=0&edition=prelim https://www.acquisition.gov/far/52.247-64#FAR_52_247_64

Addendum to FAR 52.212-4

52.217-8 Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The

Contracting Officer may exercise the option by written notice to the Contractor at any time before contract completion.

(End of clause)

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP)

(JAN 2022)

a. All Invoice submissions for goods and or services must be made electronically through the

U.S. Department of Treasury's Invoice Processing Platform System

(IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable

Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions -

Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis

(FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other

Indirects)- show rate, base and total amount;

3. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

(i.) invoice number, amount, & date submitted

(ii.) corresponding payment amount & date received

(2) total amount of all payments received to date under the subject contract or order

(3) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the Delivery

Order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which

Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-

ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the

Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

Section 3 – Attachments

Attachment 1 – Statement of Work (SOW)

Section 4 – Solicitation Provisions

Provisions Incorporated by Reference

Provision Number Provision Title

52.212-1 Instructions to Offerors-Commercial Products and Commercial

Services (Sep 2023)

52.212-2 Evaluation-Commercial Products and Commercial Services (Nov

2021)

Provisions by Full Text

52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

(End of provision)

Addendum to FAR 52.212-1

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 90 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

QUESTION DEADLINE: Questions related to this procurement shall be submitted directly by email to the Contracting Officer and Contract Specialist points of contacted listed in Section 1

All questions must be submitted in writing. Questions not received by the question submission deadline of: Monday, September 8, 2025, at 12:00 PM Eastern Time (ET) may not be considered.

QUOTATION DEADLINE: The deadline for receipt of quotations for this requirement is as showing in the SAM.gov posting.

The Contractor shall submit a firm-fixed-price quote, including details of all costs supporting the price for the required deliverables. Quotes shall be for all the deliverables requested.

The Contractor shall include and complete the attached pricing schedule/pricing chart below.

Pricing shall include all applicable fees; any charges presented after contract award shall not be considered/acceptable.

Submit two separate volumes: Volume I (Technical) and Volume II (Price). Each volume must be submitted as separate volumes. Volume I must exclude pricing. Volume I shall include equipment specifications and delivery timeline, and is limited to 10 pages.

Quotes shall clearly reference the RFQ number and include:

1. Date of quotation

2. Company Name

3. Company Point of Contact name, email address and phone number

4. System for Award Management Unique Entity ID (UEI)

5. Quotation validity of at least 90 days after RFQ due date and time

The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition., 52.212-2 Evaluation-Commercial Products and Commercial Services (Nov 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer is the Lowest Price Technically Acceptable (LPTA) along with other factors considered. The following factors shall be used to evaluate offers:

1. Technical

2. Price

All non-price factors are approximately equal.

All non-price factors when combined are approximately equal to price.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the

Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

Addendum to FAR 52.212-2

Factor 1 - Technical, will be evaluated to determine if the quoter complied with the statement of work and proposed the correct items.

Factor 2 - Price, will be evaluated to ensure it contains an itemized breakdown of price and that it is complete, fair, and reasonable given the items or scope of work. The total evaluated price will be the sum of the base period, any option periods, any optional quantities, and any pro-rated amount for the option under FAR 52.217-8.

The Government anticipates selecting the best-suited quoter from initial responses, without engaging in exchanges with quoters. Quoters are strongly encouraged to submit their best technical solutions and price in response to this RFQ.

Once the Government determines the quoter that is the best-suited (i.e., the apparent successful quoter), the Government reserves the right to communicate with only that quoter to address any remaining issues, if necessary, and finalize a task order with that quoter. These issues may include technical and price. If the parties cannot successfully address any remaining issues, as determined pertinent at the sole discretion of the Government, the Government reserves the right to communicate with the next best-suited quoter based on the original analysis and address any remaining issues. Once the Government has begun communications with the next best-suited quoter, no further communications with the previous quoter will be entertained until after the task order has been awarded. This process shall continue until an agreement is successfully reached and a task order is awarded.

(End of provision)

1. Background

The Division of Applied Regulatory Science (DARS), within OCP/OTS/CDER, is conducting a research program focused on evaluating complex in vitro models for regulatory science.

These supplies include reagents, media, consumables, and specialized tools required for maintaining and characterizing advanced cell-based models, such as those derived from human induced pluripotent stem cells (hiPSCs). These resources enable the development of physiologically relevant microenvironments that more accurately replicate in vivo conditions compared to traditional cell culture systems. The materials are used across multiple research areas and directly support projects evaluating drug safety and efficacy.

2. Objectives

The objective of this acquisition is to procure laboratory supplies to support complex in vitro studies utilizing hiPSCs. These items will enable FDA scientists to perform experiments in alignment with CDER’s regulatory research priorities, thereby enhancing the agency’s scientific capabilities.

3. Scope

This procurement covers the purchase of specified laboratory supplies. These items are required to perform high-priority scientific investigations under the CDER regulatory science framework.

4. Requirements

The Contractor shall provide the exact items listed below. Substitutions will not be accepted. All materials must be new and unused.

Deliverables

Description Part/Product # Quantity

48-Well Plates 152640 4

Fluo4 F14201 1

FluoroBrite DMEM A1896702 4

Goat anti-Rabbit IgG (H+L), Alexa Fluor™ 488 A-11008 4

Goat anti-Rabbit IgG (H+L), Alexa Fluor™ 546 A-11035 4

Goat anti-Mouse IgG (H+L), Alexa Fluor™ 488 A-11001 4

Description Part/Product # Quantity

Goat anti-Mouse IgG (H+L), Alexa Fluor™ 594 A-11005 4

PBS, pH 7.4 10010049 4

UltraPure™ DNase/RNase-Free Distilled Water 10977023 4

Gentamicin 10 mg/mL 15710072 2

DMSO J66650.AD 2

25 mL Reservoirs 8093-11 4

10L…