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This is a Solicitation/Contract for Commercial Items issued by the Department of Health and Human Services Food and Drug Administration (FDA) to acquire scientific laboratory equipment. The FDA's Division of Applied Regulatory Science (DARS) is seeking to purchase two AB Sciex brand (or equal) liquid chromatograph-tandem mass spectrometers: a ZenoTOF 7600+ and a 4500 QTrap, along with associated accessories and installation. The procurement is a small business set-aside with NAICS code 334516 and a size standard of 1,000 employees, with a total contract period from 09/01/2025 to 08/30/2026. The solicitation is structured as a lowest-priced technically acceptable award, with proposals due by 3:00 p.m. Eastern Time on July 7, 2025, and a contract value to be determined based on submitted quotes.

The equipment will replace existing outdated mass spectrometers and expand DARS's analytical capabilities for bioanalytical research, including pharmacokinetic studies, drug metabolism analysis, and investigations involving biologics and biosimilars. The solicitation requires vendors to provide comprehensive documentation demonstrating how proposed equipment meets technical specifications, include a trade-in value for an existing Waters Xevo TQ-XS instrument, and submit pricing inclusive of shipping, handling, installation, and training. The contract includes provisions for one-year limited warranties, StatusScope Remote Monitoring Service, and preventative maintenance. Proposals must be submitted via email to the Contract Specialist Hilda M. Aryeh in native MS Word, Excel, or PDF format, with strict requirements against using macros in submitted documents.

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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

13 Floor 11601 Landsdown Street ATTN: Hilda M. Aryeh

DHHS/FDA/OAGS/DAO

CODE 16. ADMINISTERED BYCODE

X

X

X

541714

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDAO

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

07/07/2025 1700 ET

06/15/2025

HILDA ARYEH

(No collect calls)

INFORMATION CALL:

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

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40125Q00229

5. SOLICITATION NUMBER

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

1 46 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

ROCKVILLE MD 20852

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

ROCKVILLE MD 20852

13 Floor 11601 Landsdown Street ATTN: Hilda M. Aryeh

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

1,000

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

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS/DAO

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Period of Performance: 09/01/2025 to 08/30/2026

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

HEREIN, IS ACCEPTED AS TO ITEMS:

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 FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

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:

REF.

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. 2/2012) 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

46 2 of

75F40125Q00229 Page 3 of 46

1. BACKGROUND

Bioanalysis is the quantitative measurement of both small molecule drugs and large biomolecules in biological systems for the purpose of pharmacokinetics, toxicokinetics, bioequivalence, and/or pharmacodynamics studies. The Division of Applied Regulatory Science (DARS) executes a variety of internal and external studies including clinical and nonclinical pharmacokinetic-pharmacodynamic modeling, bioequivalence, drug metabolism and transport, in-vivo/in-vitro correlations, and drug-drug interaction studies bioanalytical analyses at both the clinical and pre-clinical levels.

To support these projects, DARS currently utilizes five liquid chromatograph-tandem mass spectrometers (LC-MS/MS) from AB Sciex brand name or equal. Often these projects are of high-visibility, and mission critical (Opioids drug interaction, In-vivo conversion of ranitidine to carcinogen, sunscreens dermal absorption, cannabinoids, etc.) for the FDA leading to stringent deadlines and necessity for high quality data. We are also seeing an increased workload of internal in vitro projects aimed at evaluating microphysiological systems as appropriate tools for regulatory submissions. We are also providing bioanalytical support for a cross-center collaboration between CDER and CTP. As the drug development space moves towards biologics and biosimilars, it is important for DARS to equipped with the latest instrumentation necessary to analyze those products. Our current high resolution mass spectrometer is over 12 years old. The technology is obsolete. We are looking to replace our outdated technology with the ZenoTOF 7600+ LC-MS/MS system from AB Sciex brand name or equal. With this instrument we look to expand our analytical repertoire into the biologics and biosimilar realm.

To successfully handle the workload and maintain data quality of both internal and external projects it is imperative that the instruments be compatible with the FDA network security. The DARS bioanalytical team utilizes Watson Laboratory Information Management System (LIMS) to track sample handling and data analysis. For security purposes, this system and our instruments need to be on the regulatory network. Sciex systems integrate very well with FDA network security and Watson. The 4500 QTrap is meant to replace a spectrometer from Waters that is not compatible with FDA network security.

Additionally, there is analyst familiarity with the Sciex systems because we already operate five such LC-MS/MS instruments. This will allow us to rapidly deploy and use the instrument with minimal training.

To that end, DARS is seeking to add both a 4500 QTrap and a ZenoTOF 7600+ LC-MS/MS system from AB Sciex brand name or equal to not only replace an outdated high resolution mass spectrometer system but also simultaneously expand our analytical capabilities allowing us to execute new types of projects while handling the increased workload.

1.1 NOTICE OF COMBINED SYNOPSIS/SOLICITATION

1.2 This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

1.2 NOTICE OF FAC

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2025-03, effective January 17, 2025.

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

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

75F40125Q00229 Page 4 of 46

1.3 NOTICE OF NAICS/SET ASIDE

This requirement is intended for a small business set aside. The associated North American Industry Classification System (NAICS) code is 334516 - Analytical Laboratory Instrument Manufacturing. It is advised that SAM be active when submitting the proposal. Offerors must have an active registration in SAM.gov (https://beta.sam.gov), with completed representations and certifications, by the close date of the solicitation. Proposals submitted by offerors not registered in SAM.gov will not be considered.

1.4 CONTRACT TYPE

This is a Firm-Fixed Price Contract.

1.5 CONSIDERATION AND PAYMENT

The Contractor shall provide the necessary personnel, equipment, supplies, and support services to perform as described in Section 3 of this document. In consideration for successful performance of these services, the Contractor shall be paid upon the presentation of a proper invoice in accordance with the applicable invoice clause with the Firm Fixed Price contract type specified.

2. PRICING SCHEDULE

Description Part/Product # Quantity Unit Cost Total Cost

“Brand name or equal” Sciex QTrap 4500

(includes one-year limited warranty with StatusScope Remote Monitoring Service and one no-charge Preventative Maintenance during the one-year warranty period)

5062218

“Brand name or equal” FG, Synergi 4U Fusion

RP80A 50 X 2

4376878 1

“Brand name or equal” Triazine Standard Mixture

4376887 1

“Brand name or equal” PPGs Chemical Standards Kit (Low-High Concentration)

4406127 1

“Brand name or equal” ZenoTOF 7600+ LC- MS/MS System

(includes one-year limited warranty with StatusScope Remote Monitoring Service and one no-charge Preventative Maintenance during the one-year warranty period)

5309722

“Brand name or equal” SOUNDPROOF BOX

FOR VACUUM PUMP SV65

5014334 1

“Brand name or equal” UPS POWERVAR

SECURITY PLUS II 8000VA

5076232 1 https://beta.sam.gov/

75F40125Q00229 Page 5 of 46

“Brand name or equal” SCIEX OS Acq QT Starter Kit - OS-Q E-License

5307946 2

“Brand name or equal” SCIEX GAS

GENERATOR N26A26

5303450 1

“Brand name or equal” SCIEX GAS

GENERATOR N19A26 KIT

5303449 1

“Brand name or equal” MS Bench, 60W X 31D X 30H

5073675 2

“Brand name or equal” LC Bench, 36W X 31D X 30H

5073676 2

“Brand name or equal” MS Office 2021 Professional Plus LTSC ISV Global K

5300238 2

“Brand name or equal” Success Master Platform training

TRNLP003 1

“Brand name or equal” OEM LC Installation SV000025 2

“Brand name or equal” 1290 INFINITY II HIGH

SPEED PUMP 1300 BAR

5039523 2

“Brand name or equal” 1290 INFINITY II

MULTISAMPLER W/THERMOSTAT

5068205 2

“Brand name or equal” G7116B 1290 INFINITY

II MULTICOLUMN

THERMOSTAT WIT

5039525

“Brand name or equal” 1290 INFINITY II

DIODE ARRAY DETECTOR WITH 10 MM F

5039531

Trade-in (Waters Xevo TQ-XS s/n WBA0396 and accompanying LCs)

*trade-in credit on purchase of 7600+ system (see section 3.7)

S202-DHR

Shipping and Handling

Training

Total:

75F40125Q128406 Page 6 of 47

3. TECHNICAL REQUIREMENTS

3.1 “Brand name or equal” ZenoTOF 7600+ Mass Spectrometer

• TwinSpray TurboV Source, compatible with both ESI or APCI probes for automated calibration and allowing flow rates from 5 to 3000 ul/min (ESI) and flow rates from 200 to 3000 ul/min (APCI).

• One standard roughing pump.

• System ships with Data Acquisition Computer running Windows 10 64 bit.

• Standard Monitor.

• OEM installation.

3.2 “Brand name or equal” 4500 Triple Quadrupole Mass Spectrometer

• Turbo V Source that accepts either the Turbo IonSpray Probe or APCI Probe.

• Turbo IonSpray Probe: Heated IonSpray probe for use in the Turbo V Source.

• Accepts flow rates from 5 to 3000 ul/min without splitting.

• APCI Probe: Atmospheric Pressure Chemical Ionization probe for use in the Turbo V Source.

•Accepts flow rates from 200 to 3000 ul/min.

• System includes integrated syringe pump and 6 port, 2 position switching valve.

• One standard wet pump kit (roughing pump).

• System ships with Data Acquisition Computer running Windows 10 64 bit.

• Standard Monitor.

• OEM installation.

3.3 “Brand name or equal” Liquid Chromatograph(s) 1290 Infinity II High Speed Pump

• Operating range up to 130 MPa (1300 bar) up to 2 ml/min, 80 MPa (800 bar) at 5 ml/min.

• Includes Active Seal Wash, Tool Kit, Solvent Cabinet, bottles and ISET. High speed UCT, Safe cap, Poroshell 120 EC-C18,2.1x50mm column.

• Delivers a flow rate of up to 5mL/min.,

• A pH range 1.0 -12.5

• Low gradient delay volume of the pump (10 μL)

• Flow Precision: ≤0.07% RSD or ≤0.005 min SD, whatever is greater.

• Composition precision: ≤0.15% RSD or ≤0.01 min SD, whatever is greater.

• OEM installation.

75F40125Q128406 Page 7 of 47

3.4 “Brand name or equal” 1290 Infinity Multisampler

• Up to 1300 bar for well plates and individual sample containers.

• 1 sample drawer, 2x 54-vial containers, a needle flush port, 40 uL metering device, 20 uL loop. (For

Dual-needle instruments metering is 100 ul and loop size is 20 ul), InfLab sample thermostat included, multi-wash option, with 3 Dual-height drawer kit. Sample Loop- Flex 40 uL right.

• Capacity: Various and scalable drawer types from 2-16 well plates all within the LC-stack footprint

• Carryover: 9 ppm using multi-wash option

• Cycle Time: 10 seconds Injection cycle time for Single needle instrument.

• Dual needle option: Two flow paths and delay volumes. Large and small sample loop volumes without HW change.

• Injection Volume Range: 0.1 to 500μL or 1500 μL by seat loop extension

• Linearity: By Dual-needle option from 0.1 to 500 μL R2 = 0.9999

• OEM installation.

3.5 “Brand name or equal” 1290 Infinity II Multicolumn Thermostat

• Capacity up to eight columns with 10 cm length and a temperature range from 20°C below ambient to 110°C At least two independent temperature zones required.

• 1.6uL Quick-Connect Heat Exchanger, Quick-Connect fitting and two Quick-Turn fittings.

•Temperature range at high flow rate: 10°C below ambient to 100°C at up to 2.5 ml/min flow of pure Water and 10°C below ambient to 80°C at up to 5 ml/min flow of pure Water •Temperature accuracy must be ± 0.8 °C or ± 0.5 °C with calibration.

3.6 Compatibility with existing Mass Spectrometer (MS) System

• Shall be able to interface with Mass Spectrometer System (AB Sciex 4500 QTRAP)

• Mass Spectrometer software (Analyst Software) shall be cable of controlling all LC components including pumps, autosampler, multicolumn thermostat, 2position/6 port valve and diode array detector.

3.7 Instrument Trade-in

• Trade-in of instrument Waters Xevo TQ-XS s/n WBA0396 and accompanying LCs with purchase of a ZenoTOF 7600+ system.

• Packing, shipping, and credit towards purchase of new instruments shall be included.

3.8 Training

Onsite instructor-led training will be within 120 days of installation.

• Success Master learning program: Now Learning Hub

• 0.5 Day (5 Hours) of instructor led training at the customer site by an experienced

Service Professional.

• 3 Days of instructor led training at the customer site by an experienced Applications

Support Scientist.

• 7-11 hours of guided eLearning covering topics such as theory, system operation, software, workflow and maintenance.

• Consumables required to complete the training.

75F40125Q128406 Page 8 of 47

• Hands-on training focused on 1 Primary Learner. 2 additional learners can join for observation and content.

• Online workflow certificate upon successful completion of final exam (Two levels available depending on the workflow:

Basic Operator and Method Developer).

• P.A.C.E.® Continuing Education Credits: 18 credits upon completion of entire training session and a brief evaluation survey.

• Enrollment in related self-paced eLearning courses, lectures, reference material and lab exercises on the Learning Hub.

• Permanent access to all course materials for reference.

• Access to > 100 Now Learning Hub Self-paced eLearning, lectures, demonstrations as well as Now online Support tools available for up to 3 Learners.

• Complimentary follow-up virtual session with an Applications Support Scientist to ensure your success.

• Valid for 12 months from date of purchase.

4. DELIVERY or PERIOD of PERFORMANCE

4.1. Period of Performance/Basis.

Delivery within 30 days of award. Installation within 30 days of delivery.

4.2. Reporting Requirements and Deliverables.

Instruments will be delivered and installed as described in Section 3. Staff will be trained on the new instruments by vendor as described in Section 3.

DELIVER TO:

Ryan De Palma Us Food And Drug Administration 10903 New Hampshire AVE

WO BLDG 64 RM 2019

Silver Spring MD 20993 Phone No: 301-796-3383

Email: Ryan.DePalma@fda.hhs.gov

Freight should be delivered to WO Bldg 62 Loading Dock Vendor will contact the Project Officer: Ryan De Palma (Ryan.DePalma@fda.hhs.gov) / (301-796- 3383) by phone or email to schedule delivery within 30 days of the award date.

Deliveries must be coordinated with the Project Officer prior to shipment. No deliveries will be accepted without prior authorization from the Project Officer.

Vendor must notify recipient via email with tracking information when it is shipped.

5. INSPECTION AND ACCEPTANCE

The Contracting Officer’s Representative (COR) will, in accordance with FAR 52.212 perform inspection and acceptance of all service maintenance and reports required.

5.1. Service Performance & Location Performance:

Satisfactory performance of this contract shall be deemed to occur upon performance of the work described in PART 3 of this solicitation and upon acceptance by the Contracting Officer, or the COR, of all services required.

Services required by the contractor shall be F.O.B. destination to the address/addresses listed below:

mailto:Ryan.DePalma@fda.hhs.gov mailto:(Ryan.DePalma@fda.hhs.gov

75F40125Q128406 Page 9 of 47

5.2 Service Location:

The U.S. Food and Drug Administration White Oak Campus; Building#64, Rm 2011/2019 Attn: Ryan De Palma 10903 New Hampshire Avenue Silver Spring, MD 20993

Deliveries shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year’s Day Labor Day Martin Luther King, Jr.’s Birthday Columbus Day Washington’s Birthday Veterans Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day

6. CONTRACT ADMINISTRATION

6.1 Contracting Officers Representative (COR)

The Contracting Officer (CO) 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 contract. 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 contract. Such designation will not contain authority to sign contractual documents, 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 contract.

CORs do not have authority to act as agent of the Government under the contract or task order. The Government may unilaterally change its COR designation.

6.2 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.

Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer:

Ian Weiss U.S. Food and Drug

75F40125Q128406 Page 10 of 47

Administration Office of Acquisitions and Grants Services Rockville MD 20852 11601 Landsdown Street Email: Ian.Weiss@fda.hhs.gov

The Contract Specialist for this task order is:

Hilda M. Aryeh

U.S. Food and Drug Administration Office of Acquisitions and Grants Services Rockville MD 20852 11601 Landsdown Street Email: Hilda.Aryeh@fda.hhs.gov

The contact information for the Contracting Officer Representative:

Name: Katherine Shea U.S. Food and Drug Administration

WO64 RM 2080

FRC Building 64 LAB – 10903 New Hampshire AVE Silver Spring MD 20993-0002 Email: katherine.shea@fda.hhs.gov Phone: 301-796-4979

The contact information for the Contractor Point-of-Contact:

Name: Ryan De Palma U.S. Food and Drug Administration

WO64 RM 2064

FRC Building 64 LAB - 10903 New Hampshire AVE Silver Spring MD 20993-0002 Email: Ryan.DePalma@fda.hhs.gov Phone: 301-796-3383

Contract Type: Commercial Product - Firm fixed price

7. CONTRACT CLAUSES

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

https://www.acquisition.gov/browse/index/far and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2023), applies to this acquisition. The following addenda apply:

FAR Clauses 52.204-13 System for Award Management and Maintenance (Oct 2018) 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020) mailto:Ian.Weiss@fda.hhs.gov mailto:Hilda.Aryeh@fda.hhs.gov mailto:katherine.shea@fda.hhs.gov mailto:Ryan.DePalma@fda.hhs.gov

75F40125Q128406 Page 11 of 47

7.1 HHSAR Clauses

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)

352.239-74[9] Electronic and Information [and Communication] Technology Accessibility.

[(Deviation)] [(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/.

Information about Section 508 is available at https://www.hhs.gov/web/section- 508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order may be identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibilitychecklists/ index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

http://www.ipp.gov/ http://www.access-board.gov/ict/ http://www.hhs.gov/web/section-http://www.hhs.gov/web/section-508/accessibilitychecklists/ http://www.itic.org/policy/accessibility/vpat)

75F40125Q128406 Page 12 of 47

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements.

(End of clause)]

Payment Terms: Net 30 days after government acceptance of proper invoice. No advance payments will be made.

Invoice Submission: FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions -

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

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

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

3. The Contractor POC will receive two emails from IPP Customer Support, the first email http://www.hhs.gov/web/section-508/accessibility-checklists/index.html) http://www.itic.org/policy/accessibility/vpat) http://www.ipp.gov/vendors/index.htm http://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

75F40125Q128406 Page 13 of 47 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. 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.

75F40125Q128406 Page 14 of 47

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.

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.

7.2 FAR Clauses in full Text

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (Jan 2025) [(Deviation Feb 2025)]

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1)52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2)52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(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 mailto:ERIC@fda.hhs.gov 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_209_10 https://www.acquisition.gov/far/part-52#FAR_52_232_40

75F40125Q128406 Page 15 of 47

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

(2) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

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

[Contracting Officer check as appropriate.] (1)52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

(2)52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C. 3509)).

(3)52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

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

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

(5)52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

(6)[Reserved].

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

(8)52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (9)52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

(10)52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (Dec 2023) ( Pub. L. 115–390, title II).

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

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

(12)52.209-6, Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded. (Jan 2025) ( 31 U.S.C. 6101 note).

(13)52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) ( 41 U.S.C. 2313).

(14)[Reserved].

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

(16)52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

(17)[Reserved] _X_ (18) (i)52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

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

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

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

https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-section3903&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title10-section3801&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_233_3 https://www.acquisition.gov/far/part-52#FAR_52_233_4 https://www.acquisition.gov/far/part-52#FAR_52_203_6 https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title10-section4655&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_203_13 https://www.acquisition.gov/far/part-52#FAR_52_203_15 https://www.acquisition.gov/far/part-52#FAR_52_203_17 https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-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%3AUSC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_204_14 https://www.acquisition.gov/far/part-52#FAR_52_204_15 https://www.acquisition.gov/far/part-52#FAR_52_204_27 https://www.acquisition.gov/far/part-52#FAR_52_204_28 https://www.govinfo.gov/link/plaw/115/public/390 https://www.acquisition.gov/far/part-52#FAR_52_204_30 https://www.govinfo.gov/link/plaw/115/public/390 https://www.acquisition.gov/far/part-52#FAR_52_204_30 https://www.acquisition.gov/far/part-52#FAR_52_209_6 https://www.govinfo.gov/link/uscode/31/6101 https://www.acquisition.gov/far/part-52#FAR_52_209_9 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_219_3 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_219_4 https://www.acquisition.gov/far/part-52#FAR_52_219_6 https://www.acquisition.gov/far/part-52#FAR_52_219_6 https://www.acquisition.gov/far/part-52#FAR_52_219_7 https://www.acquisition.gov/far/part-52#FAR_52_219_7

75F40125Q128406 Page 16 of 47

(20)52.219-8, Utilization of Small Business Concerns (Jan 2025)( 15 U.S.C. 637(d)(2) and (3)).

(21) (i)52.219-9, Small Business Subcontracting Plan (Jan 2025) ( 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.

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

(v)Alternate IV (Jan 2025) of 52.219-9.

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

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

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

(24)52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) (15 U.S.C. 637(d)(4)(F)(i)).

(25)52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran- Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (Feb 2024) (15 U.S.C. 657f).

_X_ (26) (i)52.219-28, Postaward Small Business Program Rerepresentation (Jan 2025) (15 U.S.C. 632(a)(2)).

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

(27)52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) (15 U.S.C. 637(m)).

(28)52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Oct 2022) (15 U.S.C. 637(m)).

(29)52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) ( 15 U.S.C. 644(r)).

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

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

_X_ (32)52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2025)( E.O.

13126).

(33) [Reserved] 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(34) [Reserved] (i)52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

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

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

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

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

(38)52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

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

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

(40)52.222-54, Employment Eligibility Verification (Jan 2025) ( Executive Order 12989).

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

(41) (i)52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

https://www.acquisition.gov/far/part-52#FAR_52_219_8 https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title15-section637&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title15-section637&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_13 https://www.acquisition.gov/far/part-52#FAR_52_219_13 https://www.acquisition.gov/far/part-52#FAR_52_219_14 https://www.acquisition.gov/far/part-52#FAR_52_219_16 https://www.acquisition.gov/far/part-52#FAR_52_219_27 https://www.acquisition.gov/far/part-52#FAR_52_219_28 https://www.acquisition.gov/far/part-52#FAR_52_219_28 https://www.acquisition.gov/far/part-52#FAR_52_219_29 https://www.acquisition.gov/far/part-52#FAR_52_219_30 https://www.acquisition.gov/far/part-52#FAR_52_219_32 https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title15-section644&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_219_33 https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title15-section637&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_222_3 https://www.acquisition.gov/far/part-52#FAR_52_222_19 https://www.federalregister.gov/executive-order/13126 https://www.federalregister.gov/executive-order/13126 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_222_26 https://www.acquisition.gov/far/part-52#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/part-52#FAR_52_222_35 https://www.acquisition.gov/far/part-52#FAR_52_222_36 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title29-section793&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_222_36 https://www.acquisition.gov/far/part-52#FAR_52_222_37 http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_222_40 https://www.acquisition.gov/far/part-52#FAR_52_222_50 https://www.acquisition.gov/far/part-52#FAR_52_222_50 https://www.acquisition.gov/far/part-52#FAR_52_222_54 https://www.federalregister.gov/executive-order/12989 https://www.acquisition.gov/far/part-22#FAR_22_1803 https://www.acquisition.gov/far/part-52#FAR_52_223_9

75F40125Q128406 Page 17 of 47

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

(42)52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (May 2024) ( 42 U.S.C. 7671, et seq.).

(43)52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (May 2024) ( 42 U.S.C. 7671, et seq.).

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

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

(46)52.223-23, Sustainable Products and Services (May 2024) [(Deviation Feb 20250] ( E.O.

14057, 7 U.S.C. 8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, and 42 U.S.C. 7671l).

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

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

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

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

(49) (i)52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023) ( 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C.

chapter 29 (sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109- 53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

(ii)Alternate I [Reserved].

(iii)Alternate II (Jan 2025) of 52.225-3.

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

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

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

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

(52)52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

(53)52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

(54)52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

_X_ (55)52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) ( E.O. 13513).

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

(57)52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

(58)52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

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

(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)52.240-1, Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by American Security Drone Act-Covered Foreign Entities (Nov 2024) (Sections 1821-1826, Pub.

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

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

https://www.acquisition.gov/far/part-52#FAR_52_223_9 https://www.acquisition.gov/far/part-52#FAR_52_223_11…

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