75F40124Q00548 9-19-2024.pdf

75F40124Q00548

1. REQUEST NO.

5a. ISSUED BY

NAME

a. NAME

c. STREET ADDRESS

d. CITY

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON

OR BEFORE CLOSE OF BUSINESS (Date)

2. DATE ISSUED 3. REQUISITION/PURCHASE REQUEST NO. 4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG.1

RATING

6. DELIVERY BY (Date)

7. DELIVERY

9. DESTINATION

a. NAME OF CONSIGNEE

b. STREET ADDRESS

PAGE OF PAGES

5b. FOR INFORMATION CALL: (No collect calls)

TELEPHONE NUMBER

AREA CODE NUMBER

8. TO:

b. COMPANY

e. STATE f. ZIP CODE

c. CITY

d. STATE e. ZIP CODE

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it to the address in Block 5a. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

THIS RFQ

REQUEST FOR QUOTATION

(THIS IS NOT AN ORDER)

IS IS NOT A SMALL BUSINESS SET ASIDEX

09/19/2024

1 29

ATTN: Kimberly Pennix 10903 New Hampshire Ave.

WO2/3rd Floor

DHHS/FDA/OAGS/DAO

Silver Spring MD 20903

30 Days After Award

WO52

The Food and Drug Administration 10903 New Hampshire Avenue Building 52 Silver Spring MD 20993

Silver Spring

MD 20993

KIMBERLY PENNIX

09/26/2024 1700 ET

FOB DESTINATION

OTHER

(See Schedule)X

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

Period of Performance: 09/30/2024 to 09/29/2025

1 Project Title: DBPAP Amb a 1-Specific Aptamers

Delivery: 30 Days After Award

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS (%) b. 20 CALENDAR DAYS (%) c. 30 CALENDAR DAYS (%) d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations

13. NAME AND ADDRESS OF QUOTER

b. STREET ADDRESS

c. COUNTY

d. CITY e. STATE f. ZIP CODE

14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

16. SIGNER

a. NAME (Type or print)

c. TITLE (Type or print)

a. NAME OF QUOTER

AREA CODE

NUMBER

15. DATE OF QUOTATION

b. TELEPHONE are are not attached

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition not usable

STANDARD FORM 18 (REV. 6-95)

Prescribed by GSA - FAR (48 CFR) 53.215-1(a)

Request for Quotations (RFQ) No. 75F40124Q00548 DBPAP/ Amb a 1-Specific Aptamers

U.S. Food and Drug Administration (FDA)

Request for Quotations (RFQ) # 75F40124Q00548

Center for Biologics Evaluation and Research (CBER) DBPAP/ Amb a 1-Specific Aptamers

NAICS Code: 325414 - BIOLOGICAL PRODUCT (EXCEPT DIAGNOSTIC) MANUFACTURING

RFQ Issue Date: September 19, 2024

1. DESCRIPTION/ ITEM PROCUREMENT

This is Request for Quotation (RFQ) no. 75F40124Q00548 for services and products in accordance with the procedures of FAR Part 13- Simplified Acquisition Procedures. The associated North American Industry Classification System (NAICS) code is 325414 - BIOLOGICAL PRODUCT (EXCEPT DIAGNOSTIC) MANUFACTURING. The associated small business size standard is 1,250 employees.

This is a 100% small business set-aside solicitation in accordance with FAR Subpart 19.5 - Small Business Total Set-Asides, Partial Set-Asides, and Reserves.

2. NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2023-04, effective August 29, 2024.

The FAR provisions and clauses referenced in this solicitation can be found on the following website: www.acquisition.gov

The Department of Health and Human Services Acquisition Regulation (HHSAR) provisions and clauses referenced in this solicitation can be found on the following website: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

3. PURCHASE ORDER REQUIREMENTS

See Section 7, Statement of Work, for a full description of the services to be acquired.

4. ORDER TYPE

The Government anticipates awarding one (1) Firm-Fixed-Price (FFP) type Purchase Order.

5. PERIOD OF PERFORMANCE

The anticipated period of performance is date of award through twelve months.

6. PRICING

See Attachment A – Pricing Table http://www.acquisition.gov/ https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

7. STATEMENT OF WORK

Statement of Work (SOW)

Part I: General Information

A. Introduction Development of Amb a 1- Specific capture and biotin-labeled detection Aptamers for use in Enzyme Linked Immunosorbent Assay (ELISA)/ImmunoEnzymetric Assay (IEMA)

B. Background In the United States ragweed allergen extracts are standardized, which means that their potencies are determined in comparison to a US Reference Standard. Potency of the extract is determined by measuring Amb a 1 content. The Laboratory of Immunobiochemistry (LIB) needs to develop reference standard Amb a 1-specific capture and biotin-labeled detection monoclonal aptamers suitable for use in Enzyme Linked Immunosorbent Assay (ELISA)/ImmunoEnzymetric Assay (IEMA) to measure biological potencies of commercial ragweed pollen extracts marketed in the United States.

C. Scope Amb a 1-specific capture and biotin-labeled detection monoclonal antibodies suitable for use in Enzyme Linked Immunosorbent Assay (ELISA)/ImmunoEnzymetric Assay (IEMA).

Part II: Work Requirements

A. Technical Requirements Development of Amb a 1-Specific Optimer aptamer pair suitable for ELISA/IEMA following the workflow below:

• Phase 1:

Perform Preliminary screen to determine selection conditions and provide a Report.

If approved by LIB then proceed to Phase 2

• Phase 2:

Perform selection with Amb a 1 target and counter selection with p56 counter protein for evidence of full-length Optimer population showing specified binding properties to Amb a 1 by Biolayer Interferometry (BLI), relative to unselected library and compared to p56 counter selection target protein.

Provide a Report.

If approved by LIB then proceed to Phase 3

• Phase 3:

Perform screening and ranking of individual full-length Optmers based on selective binding to Amb a 1 compared to p56 Target protein Perform full-length pair-wise screening Prepare and screen Optimer fragment panel Perform Optimer fragment pairwise screening Perform Optimer kinetic studies characterizing up to six Optimers If Optimer pair is identified provide 100 micrograms each of up to two pairs (four Optimers) Provide Report

B. Deliverables

• Report (Phase 1): Preliminary Screen

• Report (Phase 2): In Vitro discovery or full length Optimer Population

Characterization

• Report (Phase 3): Isolation of individual Optimers, pair-wise screening and Kinetic studies

• If Optimer pair is identified provide 100 micrograms each of up to two pairs (four

Optimers)

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

Part III: Supporting Information

A. Security N/A

B. Place of Performance

Vendor location

C. Period of Performance Base Date of Award one year approximately.

D. Deliver to:

Ronald L. Rabin, MD Laboratory of Immunobiochemistry 10903 New Hampshire Avenue Building 72 Room 3346 Silver Spring, MD 20993

8. Contract Administration Data

Contracting Officer:

Nicholas Bisher

FDA/OO/OFBAP/OAGS/DAO/SCB

Nicholas.Bisher@fda.hhs.gov

Contract Specialist:

Kimberly Pennix

FDA/OO/OFBAP/OAGS/DAO/SCB

Kimberly.Pennix@fda.hhs.gov

Contracting Officer's Representative:

To be completed at time of award

Contracting Officer’s Authority

The Contracting Officer (CO) has responsibility for safeguarding the interests of the United States in its contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this purchase order and is the only person authorized to approve changes to any of the requirements under this order, and notwithstanding any provision contained elsewhere in this purchase order, this authority remains solely with the CO.

No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this purchase order. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the purchase order. The Government will not reimburse the Contractor for any work not authorized by the Contracting Officer, including work outside the scope of the purchase order.

Contracting Officer’s Representative (COR)

The Contracting Officer may designate other Government personnel, known as the Contracting Officer’s Representative (COR) to act as his or her authorized representative for contract administration functions which do not involve changes to the scope, price, schedule, or terms and conditions of the purchase order. The designation will be in writing, signed by the Contracting Officer, and will set forth the authorities and limitations of the representative(s) under the purchase order. Such designation will not contain authority to sign contractual documents, purchase order / contract changes, modify contract terms, or create any commitment or liability on the part of the Government different from that set forth in the purchase order.

The COR will provide the technical direction for the required work. The term “technical direction” is defined to include, without limitation, the following:

mailto:Nicholas.Bisher@fda.hhs.gov mailto:Kimberly.Pennix@fda.hhs.gov

• Directions to the Contractor which redirect the purchase order effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual statement of work.

• Provision of information to the Contractor which assists in the interpretation of drawings, specifications, or technical portions of the work descriptions.

• Review and, where required by the purchase order, approval of technical reports, drawings, specifications, and technical information to be delivered by the Contractor to the Government under the purchase order.

Technical direction must be within the general scope of work stated in this purchase order. The COR does not have the authority to and may not issue any technical direction which:

• Constitutes an assignment of additional work outside this purchase order.

• In any manner cause an increase or decrease in the total purchase order price or the time required for purchase order performance.

• Change any of the expressed terms, conditions, or specifications of the purchase order.

All technical direction shall be issued orally and/or in writing by the COR or shall be confirmed by him/her in writing within 5 working days after issuance.

The Contractor shall proceed promptly with the performance of technical direction duly issued by the COR in the manner prescribed by this article and within his/her authority under the provisions of this article.

If, in the opinion of the Contractor, any instructions or direction issued by the COR is within one of the categories described above, the Contractor shall not proceed but shall notify the Contracting Officer in writing within 5 working days after the receipt of any such instructions or direction and shall request the Contracting Officer issue a formal modification accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate formal remedy or advise the Contractor in writing that, in his/her opinion, the technical direction is within the scope of the purchase order.

The Contractor shall immediately contact the Contracting Officer if there is any question regarding the authority of an individual to act on behalf of the Contracting Officer under this purchase order.

The Government may unilaterally change its COR designation.

The following person has been appointed as the purchase order COR:

To be completed at time of award.

9. Offeror’s Certification – Organizational Conflicts of Interest

As a regulatory agency charged with protection of the public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has various policies and procedures that safeguard against both actual and apparent conflict of interest (COI) on the part of its employees. It is additionally critical that the FDA be assured that there is no actual or apparent COI on the part of either the Contractor's organization or its individual employees in performance of this contract.

Offerors submitting quotes to perform work under this contract must assure the protection of the information and data they receive in performance or under this contract from unauthorized use or disclosure, and must avoid actions that would cause a reasonable person to question the impartiality of the Contractor, its employees, or the Government in the performance of this immediate contract and potential participation in future contract actions. The Contractor will be held to the restrictions of the Organizational Conflict of Interest clause, unless an acceptable mitigation of risk plan is proposed, found to be acceptable by the Government, and enforced.

POTENTIAL CONFLICTS OF INTEREST SPECIFIC TO THIS PURCHASE ORDER – Offerors shall review the Statement of Work in detail to identify any particular aspects that may present organizational or individual COI, either actual or apparent.

DEFINITION OF CONFLICT OF INTEREST - Conflict of interest means that because of other activities or relationships with other persons or organizations, a person or organization is unable or potentially unable to render impartial assistance or advice to the Government, that the person's or organization's objectivity in performing the contract is or might be otherwise impaired, or that the person or organization has or might acquire an unfair competitive advantage (See FAR 9.501).

10. Conflicts of Interest (COI)

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract/blanket purchase agreement/order/call (hereafter referred to as contract), and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. This clause applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co-sponsor, joint venture, consultant, or in any similar capacity.

(c) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to a conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflicts. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d) Remedies. The Contracting Officer may terminate this contract, in whole or in part, or take any other lawful action deemed necessary to avoid, neutralize or mitigate an actual, apparent, or potential conflict of interest. If the contractor fails to disclose facts pertaining to the existence of actual, apparent, or potential conflicts of interest, or otherwise misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default or cause; suspend or debar the contractor from Government contracting; or, pursue such other remedies as may be permitted at law or equity.

(e) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(f) Prime Contractor Responsibilities. The Contractor shall determine in writing whether any relevant information disclosed by a subcontractor comprises an actual, apparent, or potential conflict of interest.

The prime contractor shall identify and avoid, neutralize, or mitigate any subcontractor conflict of interest prior to award of the subcontract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the prime contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's actual, apparent, or potential conflict of interest after award, the prime contractor agrees that the prime contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk.

(g) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

(End of Clause)

11. Government Closures and Federal Holidays

Recognized Federal Holidays— The Contractor is not required to provide services on the following Federal holidays or on days designated as Federal holidays for the Washington D.C. area:

New Year’s Day Inauguration Day Martin Luther King’s Birthday President’s Day Memorial Day Juneteenth National Independence Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

Note: January 20th, 2025 and January 20th, 2029 will be additional Federal Holidays for Inauguration Day.

The Contractor shall not schedule training during federal holidays or Government closure. As necessary, training scheduled during unexpected Government closures may be rescheduled following coordination with the COR. The contractor shall not bill the Government for any training that the Contractor did not perform due to any Government closures.

Emergency or other specified closings: the Contractor is not required to provide service on days when the Federal Government is closed to non-essential personnel, i.e., storm emergency days and other specified emergencies as approved by the COR or designee.

Early closings will be at the discretion of the COR and will follow the policies of CBER.

Inclement Weather – The Contractor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather.

In the event the Federal Government is closed by order of the President of the United States or the U.S.

Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

12. Non-Personal Services

The Government and the Contractor understand and agree that the services delivered by the Contractor to the Government are non-personal services. The parties also recognize and agree that no employer-employee relationship will exist between the Government and the Contractor. The Contractor and the Contractor’s employees are not employees of the Federal Government and are not eligible for entitlement and benefits given Federal employees.

Contractor personnel under this order shall not:

• Be placed in a position where there is an appearance that they are employed by a Federal Officer, or are under the supervision, direction, or evaluation of a Federal Officer.

• Be placed in a position of command, supervision, administration or control over personnel or personnel of other Government contractors, or become a part of the Government organization.

• Be used in administration or supervision of procurement activities.

13. NOTICE TO THE GOVERNMENT OF DELAYS

In the event the Contractor encounters difficulty in meeting performance requirements, or when the Contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any actual or potential situation is delaying or threatens to delay the timely performance of this contract, the Contractor shall immediately notify the Contracting Officer and COR in writing, giving pertinent details. This data shall be informational only in character and this provision shall not be construed as a waiver by the Government of any delivery schedule or date, or any rights or remedies provided by law or under this contract.

14. FAR 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): http://www.acquisition.gov/comp/far/index.html.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) PROVISIONS:

NUMBER TITLE DATE

52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT JAN 2017

REQUIRE CERTAIN INTERNAL CONFIDENTIALITY

AGREEMENTS OR STATEMENTS - REPRESENTATION

52.204-7 SYSTEM FOR AWARD MANAGEMENT OCT 2018

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE AUG 2020

REPORTING

52.204-17 OWNERSHIP OR CONTROL OF OFFEROR AUG 2020

52.204-24 REPRESENTATION REGARDING CERTAIN NOV 2021

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE

SERVICES OR EQUIPMENT

52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OCT 2020

OR SERVICES-REPRESENTATION

52.209-2 PROHIBITION ON CONTRACTING WITH INVERTED NOV 2015

DOMESTIC CORPORATIONS-REPRESENTATION

15. FAR PROVISIONS INCORPORATED BY FULL TEXT:

FAR 52.216-1 TYPE OF CONTRACT (APR 1984)

The Government contemplates award of a Firm-Fixed-Price (FFP) type Purchase Order resulting from this solicitation.

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address:

https://www.acquisition.gov/browse/index/far.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSES:

NUMBER TITLE DATE

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2019

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE AUG 2020

MAINTENANCE

http://www.acquisition.gov/comp/far/index.html.

52.219-6 NOTICE OF TOTAL SMALL BUSINESS SET-ASIDE NOV 2020

52.226-7 DRUG-FREE WORKPLACE MAY 2024

52.226-8 ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT MAY 2024

MESSAGING WHILE DRIVING

52.232-23 ASSIGNMENT OF CLAIMS MAY 2014

52.242-15 STOP-WORK ORDER AUG 1989

ALTERNATE I (APR 1984)

52.242-17 GOVERNMENT DELAY OF WORK APR 1984

52.243-1 CHANGES-FIXED-PRICE AUG 1987

52.243-1 CHANGES-FIXED-PRICE, ALT I APR 1984

52.246-25 LIMITATION OF LIABILITY-SERVICES FEB 1997

16. FAR CLAUSES IN FULL TEXT:

FAR 52.213-4 Terms and Conditions—Simplified Acquisitions (Other Than Commercial Products and Commercial Services) (AUG 2024)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses that are incorporated by reference:

(1) The clauses listed below implement provisions of law or Executive order:

(i) 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)).

(ii) 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).

(iii) 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).

(iv) 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117-328), unless the agency grants an exception - see paragraph (b) of 52.204-27.

(v) 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (DEC 2023) (Pub. L. 115–390, title II).

(vi) 52.222-3, Convict Labor (JUN 2003) (E.O.11755).

(vii) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(viii) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

(ix) 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).

(x) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801).

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

(xii) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) ( Pub. L. 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(2) Listed below are additional clauses that apply:

https://www.acquisition.gov/far/part-52#FAR_52_203_19 https://www.acquisition.gov/far/part-52#FAR_52_204_23 https://www.acquisition.gov/far/part-52#FAR_52_204_25 https://www.acquisition.gov/far/part-52#FAR_52_204_27 https://www.acquisition.gov/far/part-52#FAR_52_204_30 https://www.acquisition.gov/far/part-52#FAR_52_222_3 https://www.acquisition.gov/far/part-52#FAR_52_222_21 https://www.acquisition.gov/far/part-52#FAR_52_222_26 https://www.acquisition.gov/far/part-52#FAR_52_225_13 https://www.acquisition.gov/far/part-52#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/part-52#FAR_52_233_3 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3553&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_233_4 https://www.govinfo.gov/link/plaw/108/public/77 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section3805&num=0&edition=prelim

(i) 52.232-1, Payments (APR 1984).

(ii) 52.232-8, Discounts for Prompt Payment (FEB 2002).

(iii) 52.232-11, Extras (APR 1984).

(iv) 52.232-25, Prompt Payment (JAN 2017).

(v) 52.232-39, Unenforceability of Unauthorized Obligations (JUN 2013).

(vi) 52.233-1, Disputes (MAY 2014).

(vii) 52.244-6, Subcontracts for Commercial Products and Commercial Services (FEB 2024).

(viii) 52.253-1, Computer Generated Forms (JAN 1991).

(b) The Contractor shall comply with the following FAR clauses, incorporated by reference, unless the circumstances do not apply:

(1) The clauses listed below implement provisions of law or Executive order:

(i) 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).

(ii) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020)(Pub. L. 109-282) ( 31 U.S.C. 6101 note) (Applies to contracts valued at or above the threshold specified in FAR 4.1403(a) on the date of award of this contract).

(iii) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (FEB 2024) (E.O.

13126) (Applies to contracts for supplies exceeding the micro-purchase threshold, as defined in 2.101 on the date of award of this contract).

(iv) 52.222-20, Contracts for Materials, Supplies, Articles, and Equipment., Contracts for Materials, Supplies, Articles, and Equipment (JUN 2020) ( 41 U.S.C. chapter 65) (Applies to supply contracts over the threshold specified in FAR 22.602 on the date of award of this contract, in the United States, Puerto Rico, or the U.S. Virgin Islands).

(v) 52.222-35, Equal Opportunity for Veterans (JUN 2020) ( 38 U.S.C. 4212) (Applies to contracts valued at or above the threshold specified in FAR 22.1303(a) on the date of award of this contract).

(vi) 52.222-36, Equal Employment for Workers with Disabilities (JUN 2020) ( 29 U.S.C. 793) (Applies to contracts over the threshold specified in FAR 22.1408(a) on the date of award of this contract, unless the work is to be performed outside the United States by employees recruited outside the United States). (For purposes of this clause, "United States" includes the 50 States, the District of https://www.acquisition.gov/far/part-52#FAR_52_232_1 https://www.acquisition.gov/far/part-52#FAR_52_232_8 https://www.acquisition.gov/far/part-52#FAR_52_232_11 https://www.acquisition.gov/far/part-52#FAR_52_232_25 https://www.acquisition.gov/far/part-52#FAR_52_232_39 https://www.acquisition.gov/far/part-52#FAR_52_233_1 https://www.acquisition.gov/far/part-52#FAR_52_244_6 https://www.acquisition.gov/far/part-52#FAR_52_253_1 https://www.acquisition.gov/far/part-52#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/part-3#FAR_3_900 https://www.acquisition.gov/far/part-52#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/part-4#FAR_4_1403 https://www.acquisition.gov/far/part-52#FAR_52_222_19 https://www.acquisition.gov/far/part-2#FAR_2_101 https://www.acquisition.gov/far/part-52#FAR_52_222_20 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter65&saved=%7CZ3JhbnVsZWlkOlVTQy1wcmVsaW0tdGl0bGU0MC1jaGFwdGVyMzctZnJvbnQ%3D%7C%7C%7C0%7Cfalse%7Cprelim&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_222_35 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/part-22#FAR_22_1303 https://www.acquisition.gov/far/part-52#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/part-22#FAR_22_1408

Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, and Wake Island.)

(vii) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212) (Applies to contracts valued at or above the threshold specified in FAR 22.1303(a) on the date of award of this contract).

(viii) 52.222-41, Service Contract Labor Standards (AUG 2018) ( 41 U.S.C. chapter 67) (Applies to service contracts over $2,500 that are subject to the Service Contract Labor Standards statute and will be performed in the United States, District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, Johnston Island, Wake Island, or the outer Continental Shelf).

(ix)

(A) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627) (Applies to all solicitations and contracts).

(B) Alternate I (MAR 2015) (Applies if the Contracting Officer has filled in the following information with regard to applicable directives or notices: Document title(s), source for obtaining document(s), and contract performance location outside the United States to which the document applies).

(x) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022) (Applies when 52.222-6 or 52.222-41 are in the contract and performance in whole or in part is in the United States (the 50 States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, Johnston Island, Wake Island, and the outer Continental Shelf as defined in the Outer Continental Shelf Lands Act ( 43 U.S.C. 1331, et seq.))).

(xi) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706) (Applies when 52.222-6 or 52.222-41 are in the contract and performance in whole or in part is in the United States (the 50 States and the District of Columbia.))

(xii) 52.223-5, Pollution Prevention and Right-to-Know Information (MAY 2024) ( 42 U.S.C.

11001-11050 and 13101-13109) (Applies to services performed on Federal facilities).

(xiii) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (MAY 2024) ( 42 U.S.C. 7671, et seq.) (Applies to contracts for products as prescribed at FAR 23.110(d)(1)).

(xiv) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (MAY 2024) ( 42 U.S.C. 7671, et seq.) (Applies to maintenance, service, repair, or disposal of refrigeration equipment and air conditioners).

https://www.acquisition.gov/far/part-52#FAR_52_222_37 https://www.acquisition.gov/far/part-22#FAR_22_1303 https://www.acquisition.gov/far/part-52#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/part-52#FAR_52_222_50 https://www.acquisition.gov/far/part-52#FAR_52_222_55 https://www.acquisition.gov/far/part-52#FAR_52_222_6 https://www.acquisition.gov/far/part-52#FAR_52_222_41 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title43-section1331&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_222_62 https://www.acquisition.gov/far/part-52#FAR_52_222_6 https://www.acquisition.gov/far/part-52#FAR_52_222_41 https://www.acquisition.gov/far/part-52#FAR_52_223_5 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section11001&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section11001&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section13101&num=0&edition=prelim https://www.acquisition.gov/far/part-52#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/part-23#FAR_23_109 https://www.acquisition.gov/far/part-52#FAR_52_223_12 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section7671&num=0&edition=prelim

(xv) 52.223-20, Aerosols (MAY 2024) ( 42 U.S.C. 7671, et seq.) (Applies to contracts for products that may contain high global warming potential hydrofluorocarbons as a propellant or as a solvent; or contracts for maintenance or repair of electronic or mechanical devices).

(xvi) 52.223-21, Foams (MAY 2024) ( 42 U.S.C. 7671, et seq.) (Applies to contracts for products that may contain high global warming potential hydrofluorocarbons or refrigerant blends containing hydrofluorocarbons as a foam blowing agent; or contracts for construction of buildings or facilities.

(xvii) 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) (Applies to contracts when the agency identifies in the statement of work, or elsewhere in the contract, the sustainable products and services that apply to the acquisition).

(xviii)

(A) 52.225-1, Buy American-Supplies (OCT 2022) (41 U.S.C. chapter 67) (Applies to contracts for supplies, and to contracts for services involving the furnishing of supplies, for use in the United States or its outlying areas, if the value of the supply contract or supply portion of a service contract exceeds the micro-purchase threshold, as defined in 2.101 on the date of award of this contract, and the acquisition-

(1) Is set aside for small business concerns; or

(2) Cannot be set aside for small business concerns (see 19.502-2), and does not exceed $50,000).

(B) Alternate I (OCT 2022) (Applies if the Contracting Officer has filled in the domestic content threshold below, which will apply to the entire contract period of performance. Substitute the following sentence for the first sentence of paragraph (1)(ii)(A) of the definition of domestic end product in paragraph (a) of 52.225-1: (A) The cost of its components mined, produced, or manufactured in the United States exceeds ____ percent of the cost of all its components. [ Contracting officer to insert the percentage per instructions at 13.302-5(d)(4). ])

(xix) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations., Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792) (Applies to contracts greater than the threshold specified in FAR 26.404 on the date of award of this contract, that provide for the provision, the service, or the sale of food in the United States).

(xx) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (OCT 2013)(Applies when the payment will be made by electronic funds transfer (EFT) and the payment office uses the System for Award Management (SAM) as its source of EFT information).

(xxi) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (JUL 2013) (Applies when the payment will be made by EFT and the payment office does not use the SAM database as its source of EFT information).

https://www.acquisition.gov/far/part-52#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/part-52#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/part-52#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/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-2#FAR_2_101 https://www.acquisition.gov/far/part-19#FAR_19_502_2 https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-13#FAR_13_302_5 https://www.acquisition.gov/far/part-52#FAR_52_226_6 https://www.acquisition.gov/far/part-26#FAR_26_404 https://www.acquisition.gov/far/part-52#FAR_52_232_33 https://www.acquisition.gov/far/part-52#FAR_52_232_34

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) ( 46 U.S.C. 55305)(Applies to supplies transported by ocean vessels (except for the types of subcontracts listed at 47.504(d)).

(2) Listed below are additional clauses that may apply:

(i) 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (NOV 2021) (Applies to contracts when the contractor or a subcontractor at any tier may have Federal contract information residing in or transiting through its information system.)

(ii) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (NOV 2021) (Applies to contracts over the threshold specified in FAR 9.405-2(b) on the date of award of this contract).

(iii) 52.211-17, Delivery of Excess Quantities (SEPT 1989) (Applies to fixed-price supplies).

(iv) 52.247-29, F.o.b. Origin (FEB 2006) (Applies to supplies if delivery is f.o.b. origin).

(v) 52.247-34, F.o.b. Destination (JAN 1991) (Applies to supplies if delivery is f.o.b.

destination).

(c) FAR 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):

http://www.acquisition.gov/comp/far/index.html

(d) Inspection/Acceptance. The Contractor shall tender for acceptance only those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. The Government must exercise its postacceptance rights-

(1) Within a reasonable period of time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(e) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence, such as acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in https://www.acquisition.gov/far/part-52#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/part-47#FAR_47_504 https://www.acquisition.gov/far/part-52#FAR_52_204_21 https://www.acquisition.gov/far/part-52#FAR_52_209_6 https://www.acquisition.gov/far/part-9#FAR_9_405_2 https://www.acquisition.gov/far/part-52#FAR_52_211_17 https://www.acquisition.gov/far/part-52#FAR_52_247_29 https://www.acquisition.gov/far/part-52#FAR_52_247_34 http://www.acquisition.gov/comp/far/index.html connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(f) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges that the Contractor can demonstrate to the satisfaction of the Government, using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for any work performed or costs incurred that reasonably could have been avoided.

(g) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(h) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(End of clause)

17. Health and Human Services Acquisition Regulation (HHSAR) Provisions and Clauses

DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR

CHAPTER 3) PROVISIONS AND CLAUSES IN FULL TEXT:

HHSAR Clauses can be viewed in full text at: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

HHSAR Clauses incorporated by reference:

HHSAR 352.203-70 Anti-Lobbying (December 18, 2015) HHSAR 352.208-70 Printing and Duplication (December 18, 2015) HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) HHSAR 352.223-70 Safety and Health (December 18, 2015) HHSAR 352.224-71 Confidential Information (December 18, 2015) HHSAR 352.227-70 Publications and Publicity (December 18, 2015) HHSAR 352.231-70 Salary Rate Limitation (December 18, 2015) https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

HHSAR 352.233-71 Litigation and Claims (December 18, 2015)

HHSAR Provisions Incorporated in Full Text:

HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. 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.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

HHSAR 352.239-73 Electronic and Information Technology Accessibility Notice (December 18, 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

https://www.hhs.gov/web/508 http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.239-74

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues.