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This request for proposal solicits development of a validated analytical method and screen for detecting diethylene glycol and ethylene glycol in over-the-counter children's cough syrup. The Food and Drug Administration seeks to procure and test approximately 160 unique samples from a list of drug products. Offerors must propose performing analyses within 12 months and submitting a final report no later than 30 days before the end of the period of performance. Proposals are due by September 1, 2023 and should contain technical and pricing volumes not exceeding 10 and 5 pages respectively. The firm fixed price order will be awarded based on evaluation of an offeror's technical approach, ability to complete analyses, time frame, and fair and reasonable price to satisfy the statement of work.

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SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

DAO

Beltsville MD 20705 4041 Powder Mill Road ATTN: Sheila Brown

DHHS/FDA/OAGS/DAO

CODE 16. ADMINISTERED BYCODE

X

X

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDAO

REQUEST FOR

PROPOSAL

(RFP)

INVITATION

FOR BID (IFB)

10. THIS ACQUISITION ISCODE

REQUEST FOR

QUOTE (RFQ)

14. METHOD OF SOLICITATION

13b. RATING

NORTH AMERICAN INDUSTRY

CLASSIFICATION STANDARD

(NAICS):

SMALL BUSINESS

09/01/2023 1530 ET

08/23/2023

IAN WEISS

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40123R00139

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 38 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

Beltsville MD 20705 4041 Powder Mill Road ATTN: Ian Weiss

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FREE ON BOARD

(FOB) DESTINATION UNLESS

BLOCK IS MARKED

11.

SEE SCHEDULEX

12. DISCOUNT TERMS THIS CONTRACT IS A RATED

ORDER UNDER THE DEFENSE

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS/DAO

WOMEN-OWNED SMALL

BUSINESS (WOSB)

ECONOMICALLY DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

This is a Request for Proposal (RFP) for Development of a Validated Analytical Method and Screen for DEG/EG in OTC Childrens Cough Syrup.

Offers in response to this solicitation shall be due no later than Friday, September 1, 2023, 3:30PM Eastern Time.

Questions are due no later than Monday, August 28, 2023, by 3:00 PM Eastern Time Period of Performance: 09/30/2023 to 09/29/2024

1 Children's Cough Syrup Samples Continued ...

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

X

XX

DATED

IAN S. WEISS

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Government Use Only)

OFFER

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT: REFERENCE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 11/2021) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

38 2 of

Development of a Validated Analytical Method and Screen for

DEG/EG in OTC Children’s Cough Syrup

PART 1- Description

Solicitation number FDA-RFP - 75F40123R00139 is issued as a Request for Proposal (RFP).

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information from FAR Part 13 and included in this notice. The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2023-03. The North American Industrial Classification System (NAICS) code for this procurement is 541380, Testing Laboratories.

Type of Contract

The Government intends to award a Firm-Fixed-Price order for a base period of twelve (12) months.

PART 2- SUPPLIES OR SERVICES AND PRICES/COSTS

Description of Services and Supplies

The Food and Drug Administration’s Center for Drug Evaluation and Research has a need for access to DEG EG Screening of Children's Cough Syrup Drug.

BASE YEAR

CLI

N

Description of Supplies/Service

Qty. Unit Total Price

0001 Children's Cough Syrup Samples

160 items

BASE YEAR: Total Firm Fixed Price

TOTAL CONTRACT VALUE

BASE PERIOD TOTAL PRICE

TOTAL FIRM FIXED PRICE

PART 3 - DESCRIPTIONS/SPECIFICATIONS/STATEMENT OF WORK

BACKGROUND

To help ensure safe and effective drugs are marketed in the United States, the Food and Drug Administration (FDA) tests selected drug products in FDA laboratories. This includes active pharmaceutical ingredients (API) used to make the product and the finished drug product sold to consumers. The FDA Laboratories use the same standards that are part of the drug approval process for identity, strength, purity, and bioavailability, which is also used to establish bioequivalence.

The FDA is committed to protecting patients from potentially unsafe, non-effective or poor-quality drugs. Post market surveillance testing is one way that FDA works to help ensure patients have access to safe, effective, quality drugs.

The FDA has become aware of a large number of adverse events in Gambia occurring in 2022.

The events were acute kidney injury cases affecting children and the associated fatality rates were greater than 80%. The implicated syrup-based pediatric medications that had been administered to patients were imported from a single Indian manufacturer. This is one of the first documented DEG outbreaks in which contaminated medications were imported rather than being domestically manufactured. DEG mass poisonings continue to occur worldwide, especially in low-resource settings. Strengthened international pharmaceutical regulatory structures and event-based surveillance systems can help prevent DEG-associated large-scale poisoning events.

OBJECTIVES

Fund an ISO 17025 accredited contract laboratory (or equivalent) to help the agency procure and screen various marketed over the counter (OTC) children’s cough syrup drug products to determine levels of DEG/EG. The contract laboratory must be an FDA registered firm with FDA inspection history, and in good compliance standing with the agency. The contract lab will be responsible for developing analytical methods that are accurate and precise, able to achieve a limit of detection of ≤0.1% DEG/EG and must be validated using multiple sample matrices to rule out any potential matrix effects. The preferred method is a single method that can test all drug products neat, without the need for sample preparations or dilutions. In addition, the contract laboratory must be equipped to handle significant throughput (~ 160 unique samples within a 12-month period of performance).

SCOPE

The overall scope of the project is to have an accredited contract laboratory procure (Optional Preference) and test ~ 160 children’s cough syrup drug product samples for DEG and EG contamination, using a validated test method(s). The contract laboratory must be an FDA registered firm, with FDA inspection history, and in good compliance standing with the agency.

The preferred analytical test method would be a universal method that would directly analyze the neat product. Drug product samples to test will be procured (preferred option) by the contractor based on a list, provided by FDA, of approximately 160 OTC children’s cough syrup drug products.

PART 4 -TASK

The FDA is seeking support in procuring samples (preferred option), development and validation of a test method capable of achieving a ≤0.1% DEG/EG limit, and analysis of approximately160 OTC children’s cough syrup drug products.

1.1 (preferred option) The contracting laboratory shall have an established process to procure samples based on the list, provided by FDA, of OTC children’s cough syrup drug products. The list of drug products will include the following information:

• Proprietary Name of the OTC Drug Product

• NDC Number – Unique Product Identifier

• Manufacturer Information – FEI Number

• Labeler Information

If the contractor cannot readily obtain the samples, the contractor will contact the Manufacturer and/or Labeler directly to purchase the sample(s) and/or determine where the product can be purchased.

1.2 The contracting laboratory shall have an established process for reliable receipt and management/traceability of all drug product samples provided for testing, including:

1.2.1 Chain of custody

1.2.2 Acceptable storage conditions

1.2.3 Lot information

1.2.4 Expiry information

1.3 The contracting lab should ensure testing is performed within the sample’s expiration date.

1.4 The contracting lab should ensure appropriate analytical test method development.

The preferred method developed will be applicable for all formulations and have a limit of detection of ≤0.1% DEG/EG.

1.4.1 The contractor shall validate methods under an appropriate quality management system and determined to be fit for purpose which includes the method characteristics given below. The contractor shall provide FDA with method validation reports along with detailed analytical methodologies which shall include:

1.4.1.1 System Suitability

1.4.1.2 Specificity

1.4.1.3 Accuracy

1.4.1.4 Precision

1.4.1.5 Robustness

1.4.1.6 Limit of detection (LOD)

1.4.1.7 Limit of quantitation (LOQ)

1.4.1.8 Quality Control

1.4.1.9 Range

1.4.1.10 Linearity

1.4.1.11 Recoveries

1.4.1.12 Analytical testing may utilize compendial methods (e.g., FDA

Guidance, USP Chapter <1225>). Any modifications to these methods should be justified.

1.5 DEG/EG testing requirements

1.5.1 Method(s) to quantitate DEG/EG in children’s cough syrup drug products shall be developed by the Contractor, based on technical expertise and laboratory capabilities. The FDA published a method for the analysis of DEG/EG contamination in glycerin that can be used as a reference. A publication by Dr. Randy Self on a “Direct analysis in real time mass spectrometry for rapid qualitative screening of toxic glycols in glycerin containing products” 1may also be used as a method reference for developing and validating a universal method capable of analyzing the neat product. The contract laboratory is responsible for conducting full method development and validation of a test method for the analysis of DEG/EG in

1 R.L. Self. Direct analysis in real time-mass spectrometry (DART-MS) for rapid quantitative screening of toxic glycols in glycerin-containing products. Journal of Pharmaceutical and Biomedical Analysis. (2013) 155-158.

all cough syrup drug products. Contractors with existing methods for ≤0.1% DEG/EG detection should demonstrate existing methods and provide comparable results to the methods developed by the FDA and those referenced in literature.

1.5.2 Laboratory methods must be provided to the agency for review and shall include a description of procedures used to determine the level of ≤0.1% DEG/EG in the selected drug products. Additionally, the methods shall include a thorough description of how the sample will be prepared and how the DEG/EG concentration in each sample will be verified. Quality control data acquired during the testing of samples must be provided to ensure reliability of the method.

1.5.3 The contractor shall procure samples (preferred option) and conduct tests to determine DEG/EG content in commercial children’s cough syrup drug products (~160) based on a list, provided by FDA, of OTC drug products.

Upon receiving the samples, the contractor shall record the following product information: full product name, image or product packaging, manufacturer, lot/batch number (#), product identification number (ID) if any (e.g., UPC code), number of samples, receiving date, manufacturing date (if any), sell-by date (if any), and storage conditions by the laboratory before analysis. The contractor shall keep a copy or photo of the front and back of the product package/label for record.

1.5.4 If matrix effects are observed for a sample under investigation, the contractor shall provide a report on the recovery/efficiency studies performed. The Contractor shall provide this report no later than 30 days from day of discovery.

1.6 Provide Final Report to FDA, to include:

1.6.1 Raw data and tabulated results (means, averages, coefficient of variation and standard deviations) of all analyses of drug products specifically identified by FDA and for quality control samples.

1.6.2 The number of documents provided should include representative data, results, and chromatograms with a brief explanation in the appropriate report(s) (e.g., collate chromatograms and insert them into the appropriate sections of the report instead of sending in numerous individual, unidentified data files; label chromatograms/data).

1.6.3 Validation reports

1.6.3.1 Must be for the method used to complete the analyses.

1.6.3.2 Include full descriptions of analytical test methods used

1.6.3.3 Include a summary of the quality management system under which the test methods were used and validated to complete the analysis

1.6.3.4 Include Standard Operating Procedures that were used for the sample management and analysis

1.6.3.5 Include Running control charts

1.6.3.6 Include Descriptions of any laboratory issues encountered along with their solutions, and any other issues relevant to the study.

1.7 All internal documents that are referenced by the report. These documents can be provided in an appendix or in the report (e.g., if you refer to an internal method/SOP, provide the method/SOP). The Contractor shall provide a draft Report to FDA for review before issuing the Final Report.

1.8 The Final report is due to FDA no later than 30 days after completion of testing, or no later than 30 days before the end of the period of performance (whichever is sooner).

PART 5 – DELIVERABLES

Deliverables Due Date

Monthly progress reports – documented activities and accomplishments, overall performance compared with goal, and overall summary. These progress reports should include any problems identified along with recommended solutions.

5th working day of each month

Kick-off meeting One calendar week after award date

Established procedures for procurement, receipt, storing, and traceability of samples for testing while in the contractor’s possession

Two calendar weeks after award date

Established procedure(s) to ensure testing is performed on samples within expiry (this may include some prioritization schema)

Two calendar weeks after award date

Preferred Option – Contractor will procure all samples to test based on the FDA list of specific drug products. If the contractor is not able to procure samples, FDA will provide samples within approximately 8 weeks after award date.

Eight calendar weeks after award date

Deliverables Due Date

Validated test method with a limit of detection ≤0.1% DEG/EG in all cough syrup formulations – documented, submitted to FDA. Preferred Option: The Agency prefers the development of a universal, validated test method to test the neat product.

12 weeks after award date

Test Results/Analytical Worksheets submitted to FDA as part of monthly progress reports

Monthly, starting in January 2024

Draft Report submitted to FDA for approval Nine months after award date

Final Report, tabulating all relevant activities and results No later than 11 months after award date

PART 6 - PERIOD OF PERFORMANCE

The anticipated period of performance shall be as follows:

Base Period: September 30, 2023, to September 29, 2024. The contractor is expected to complete all testing within 12 months from the date of the award, including submission of the Final Report mentioned in the Part 4 -Task Section.

PART 7 - CONTRACT ADMINISTRATION:

DELIVERY LOCATION

The Contractor shall deliver all reports and relevant documentation to:

Conchetta Newton – COR

Conchetta.Newton@fda.hhs.gov

GOVERNMENT ISSUED PROPERTY

Not applicable.

mailto:Conchetta.Newton@fda.hhs.gov

CONTRACT TYPE

Firm fixed price

Contracting Officer Representative

The following COR will represent the Government for the purpose of this contract:

(COR To be determined at the time of contract award)

Contracting Officer’s Authority: The Contracting Officer is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract. 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 contract. In the event the Contractor effects any changes to this contract or contracts at the direction of any person other than the CO, the changes will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. The CO will be the only individual authorized to accept nonconforming work, waive any requirement of the contract/task order and modify any term or condition of the contract/task order. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including The surveillance and assessment of performance and recommending changes in requirements to the Contracting Officer; (2) interpreting the Statement of Work and any and all other technical performance requirements; (3) performing technical evaluations as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance of the contract. The Government may unilaterally change its COR designation.

The contact information for the Contracting Specialist is:

Sheila Brown

OFBA/OO/OAGS

4041 Powder Mill Road

Calverton, MD 20705

E-Mail: Sheila.Brown1@fda.hhs.gov

Phone: (301) 796-0827 mailto:Sheila.Brown1@fda.hhs.gov

The contact information for the Contracting Officer is:

Ian Weiss -OFBA/OO/OAGS

4041 Powder Mill Road

Calverton, MD 20705

Phone: (301) 796-5782

Email: Ian.Weiss@fda.hhs.gov

INVOICE SUBMISSION

1. The following clauses are incorporated into the contract:

a. 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)

mailto:Ian.Weiss@fda.hhs.gov

b. 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 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 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.

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• 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;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

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

• 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;

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

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

• 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:

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

(c) 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 task 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.

(END OF CLAUSE)

PART 8- CONTRACT CLAUSES

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services.

As prescribed in 12.301(b)(4), insert the following clause:

Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Products and Commercial Services (Jun 2023)

(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 https://www.acquisition.gov/far/12.301#FAR_12_301 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 and Other Covered Entities (Nov 2021) (Section 1634 of Pub. L. 115-91).

(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.]

X (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).

https://www.acquisition.gov/far/52.203-19#FAR_52_203_19 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/52.209-10#FAR_52_209_10 https://www.acquisition.gov/far/52.232-40#FAR_52_232_40 https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/10/3801 https://www.acquisition.gov/far/52.233-3#FAR_52_233_3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.233-4#FAR_52_233_4 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-6#FAR_52_203_6 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.govinfo.gov/link/uscode/10/4655

(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.)

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

(5) [Reserved].

(6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111- 117, section 743 of Div. C).

(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

X (8) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

X(9) 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).

X (10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

(11) [Reserved].

https://www.acquisition.gov/far/52.203-13#FAR_52_203_13 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-15#FAR_52_203_15 https://www.acquisition.gov/far/52.204-10#FAR_52_204_10 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-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 https://www.acquisition.gov/far/52.204-27#FAR_52_204_27 https://www.acquisition.gov/far/52.209-6#FAR_52_209_6 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-section6101&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-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%3AUSC-prelim-title41-section2313&num=0&edition=prelim

(12) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) (15 U.S.C. 657a).

X (13) 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).

(14) [Reserved]

(15)(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.

(16)(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.

X (17) 52.219-8, Utilization of Small Business Concerns (Oct 2022) (15 U.S.C.

637(d)(2) and (3)).

(18)(i) 52.219-9, Small Business Subcontracting Plan (Oct 2022) (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/52.219-3#FAR_52_219_3 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title15-section637a&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/far/52.219-4#FAR_52_219_4 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-6#FAR_52_219_6 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-6#FAR_52_219_6 https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 https://www.acquisition.gov/far/52.219-8#FAR_52_219_8 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 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 2021) of 52.219-9.

(19)(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.

(20) 52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 637s).

(21) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) (15 U.S.C.

637(d)(4)(F)(i)).

(22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set- Aside (Oct 2022) (15 U.S.C. 657f).

X (23)(i) 52.219-28, Post Award Small Business Program Rerepresentation (Mar 2023)(15 U.S.C. 632(a)(2)).

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

(24) 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)).

(25) 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)).

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 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-13#FAR_52_219_13 https://www.acquisition.gov/far/52.219-14#FAR_52_219_14 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-16#FAR_52_219_16 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-27#FAR_52_219_27 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-28#FAR_52_219_28 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-28#FAR_52_219_28 https://www.acquisition.gov/far/52.219-29#FAR_52_219_29 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-30#FAR_52_219_30

X (26) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

X (27) 52.219-33, Nonmanufacturer Rule (Sep 2021) (15U.S.C. 637(a)(17)).

X (28) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

X (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Dec 2022) (E.O.13126).

X (30) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

X (31)(i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

(ii) Alternate I (Feb 1999) of 52.222-26.

X (32)(i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

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

X (33)(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.

X (34) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

https://www.acquisition.gov/far/52.219-32#FAR_52_219_32 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec644.htm https://www.acquisition.gov/far/52.219-33#FAR_52_219_33 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec637.htm 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/52.222-21#FAR_52_222_21 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title38-section4212&num=0&edition=prelim 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%3AUSC-prelim-title29-section793&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-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%3AUSC-prelim-title38-section4212&num=0&edition=prelim

(35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

(36)(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).

(37) 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.)

(38)(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.)

(39) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

(40) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

(41)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

https://www.acquisition.gov/far/52.222-40#FAR_52_222_40 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 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 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.223-11#FAR_52_223_11 https://www.acquisition.gov/far/52.223-12#FAR_52_223_12 https://www.acquisition.gov/far/52.223-13#FAR_52_223_13

(ii) Alternate I (Oct 2015) of 52.223-13.

(42)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun2014) of 52.223-14.

(43) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) (42 U.S.C. 8259b).

(44)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-16.

X (45) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

(46) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

(47) 52.223-21, Foams (Jun2016) (E.O. 13693).

X (48)(i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

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

https://www.acquisition.gov/far/52.223-13#FAR_52_223_13 https://www.acquisition.gov/far/52.223-14#FAR_52_223_14 https://www.acquisition.gov/far/52.223-14#FAR_52_223_14 https://www.acquisition.gov/far/52.223-15#FAR_52_223_15 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.223-16#FAR_52_223_16 https://www.acquisition.gov/far/52.223-16#FAR_52_223_16 https://www.acquisition.gov/far/52.223-18#FAR_52_223_18 https://www.acquisition.gov/far/52.223-20#FAR_52_223_20 https://www.acquisition.gov/far/52.223-21#FAR_52_223_21 https://www.acquisition.gov/far/52.224-3#FAR_52_224_3

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

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

(50)(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Dec 2022) (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 (Jan 2021) of 52.225-3.

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

(51) 52.225-5, Trade Agreements (Dec 2022) (19 U.S.C. 2501, et seq., 19 U.S.C.

3301 note).

X (52) 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).

(53) 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).

https://www.acquisition.gov/far/52.225-1#FAR_52_225_1 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 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://www.govinfo.gov/link/uscode/19/3301 https://www.govinfo.gov/link/uscode/19/3301 https://www.govinfo.gov/link/uscode/19/2112 https://www.govinfo.gov/link/uscode/19/3805 https://www.govinfo.gov/link/uscode/19/4001 https://www.govinfo.gov/link/uscode/19/4001 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%3AUSC-prelim-title19-section2501&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title19-section3301&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-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

(54) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

(55) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) (42 U.S.C. 5150).

(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).

(59) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) (31 U.S.C. 3332).

(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).

X (63) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C.

637(d)(13)).

https://www.acquisition.gov/far/52.226-4#FAR_52_226_4 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.226-5#FAR_52_226_5 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.229-12#FAR_52_229_12 https://www.acquisition.gov/far/52.232-29#FAR_52_232_29 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.govinfo.gov/link/uscode/10/3805 https://www.acquisition.gov/far/52.232-30#FAR_52_232_30 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.govinfo.gov/link/uscode/10/3805 https://www.acquisition.gov/far/52.232-33#FAR_52_232_33 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-section3332&num=0&edition=prelim https://www.acquisition.gov/far/52.232-34#FAR_52_232_34 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.232-36#FAR_52_232_36 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.239-1#FAR_52_239_1 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title5-section552a&num=0&edition=prelim https://www.acquisition.gov/far/52.242-5#FAR_52_242_5

(64)(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) https://www.acquisition.gov/far/52.247-64#FAR_52_247_64 https://www.govinfo.gov/content/pkg/USCODE-2019-title46/html/USCODE-2019-title46-subtitleV-partD-chap553-subchapI-sec55305.htm https://www.govinfo.gov/content/pkg/USCODE-2019-title46/html/USCODE-2019-title46-subtitleV-partD-chap553-subchapI-sec55305.htm http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 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 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-42#FAR_52_222_42 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-43#FAR_52_222_43 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-44#FAR_52_222_44 http://uscode.house.gov/browse.xhtml%3Bjsessionid%3D114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-51#FAR_52_222_51

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

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

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