Solicitation 36C25724Q1028 for PET Radiopharmaceuticals.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

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

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

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

549-25-1-068-0002

36C25724Q1028 09-25-2024

Astrid McKinney 254-654-9608 09-30-2024 10:00am CDT

Department of Veterans Affairs Network Contracting Office 17 5441 Babcock Road Ste. 302 San Antonio TX 78240

X 100

X

325412

1300 Employees

N/A

X

VA North Texas HCS (Dallas) Nuclear Medicine Service (115) 4500 S. Lancaster Road Dallas TX 75216

Same as block 9.

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

Positron Emission Tomography (PET) Radiopharmaceuticals.

Contractor shall provide all products identified in the Statement of Work (SOW) - See B.4.

12-month Base plus (4) four 12-month Option Periods (OYs)

X X

X 1

Astrid McKinney Contracting Officer

36C25724Q1028

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

B.4 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...20

C.5 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.7 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)

C.8 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.6 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

E.8 52.216-1 TYPE OF CONTRACT (APR 1984)

E.9 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.10 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE

RESOLUTION (OCT 2018)

E.11 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.12 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE (FEB 2023)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C257 Astrid McKinney

Network Contracting Office 17

5441 Babcock Road

Ste. 302

San Antonio TX 78240

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVI

CES

QUANTI

TY

UNI

T UNIT PRICE AMOUNT

150.00 EA _______________

F-18 NaF UNIT DOSE Contract Period: Base POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals LOCAL STOCK NUMBER: NaF

1,900.00 EA _______________

FDG UNIT DOSE 0-15 MCI

Contract Period: Base POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

LOCAL STOCK NUMBER: FDG

300.00 EA _______________

F-18 FDG ADDITIOANL MCI (GREATER THAN 15MCI)

Contract Period: Base POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

F-18 NaF UNIT DOSE Contract Period: Option 1 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical

FDG UNIT DOSE 0-15 MCI

Contract Period: Option 1 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

F-18 FDG ADDITIOANL MCI (GREATER THAN 15MCI)

Contract Period: Option 1 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical

F-18 NaF UNIT DOSE Contract Period: Option 2 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

FDG UNIT DOSE 0-15 MCI

Contract Period: Option 2 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

F-18 FDG ADDITIOANL MCI (GREATER THAN 15MCI)

Contract Period: Option 2 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical

F-18 NaF UNIT DOSE Contract Period: Option 3 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

FDG UNIT DOSE 0-15 MCI

Contract Period: Option 3 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

F-18 FDG ADDITIOANL MCI (GREATER THAN 15MCI)

Contract Period: Option 3 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical

F-18 NaF UNIT DOSE Contract Period: Option 4 POP Begin: 10-01-2028 POP End: 09-30-2029 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

FDG UNIT DOSE 0-15 MCI

Contract Period: Option 4 POP Begin: 10-01-2028 POP End: 09-30-2029 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical

F-18 FDG ADDITIOANL MCI (GREATER THAN 15MCI)

Contract Period: Option 4 POP Begin: 10-01-2028 POP End: 09-30-2029 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical

GRAND TOTAL _______________

B.3 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001 SHIP TO: VA North Texas HCS (Dallas) Attn: Nuclear Medicine Service (115) PET 3rd Floor, Room 3B-672E 4500 S. Lancaster Road Dallas, TX 75216

USA

150.00 10-01-2024 to 09-30-2025

MARK FOR: Sussie DeMello 214-857-0132 sussie.demello@va.gov

FOB: DESTINATION

0002 SHIP TO: VA North Texas HCS (Dallas) Attn: Nuclear Medicine Service (115) PET 3rd Floor, Room 3B-672E 4500 S. Lancaster Road

1,900.00 10-01-2024 to

MARK FOR: Sussie DeMello

0003 SHIP TO: VA North Texas HCS (Dallas)

Service (115) PET

300.00 10-01-2024 to

3rd Floor, Room 3B-672E 4500 S. Lancaster Road

MARK FOR: Sussie DeMello

1001 SHIP TO: VA North Texas HCS (Dallas)

Service (115) PET 3rd Floor, Room 3B-672E 4500 S. Lancaster Road

150.00 10-01-2025 to 09-30-2026

MARK FOR: Sussie DeMello

1002 SHIP TO: VA North Texas HCS (Dallas)

Service (115) PET 3rd Floor, Room 3B-672E 4500 S. Lancaster Road

1,900.00 10-01-2025 to

MARK FOR: Sussie DeMello

1003 SHIP TO: VA North Texas HCS (Dallas)

Service (115) PET 3rd Floor, Room 3B-672E 4500 S. Lancaster Road

300.00 10-01-2025 to

MARK FOR: Sussie DeMello

2001 SHIP TO: VA North Texas HCS (Dallas)

Service (115) PET

150.00 10-01-2026 to 09-30-2027

3rd Floor, Room 3B-672E 4500 S. Lancaster Road

2002 SHIP TO: VA North Texas HCS (Dallas)

Service (115) PET 3rd Floor, Room 3B-672E 4500 S. Lancaster Road

1,900.00 10-01-2026 to

MARK FOR: Sussie DeMello

2003 SHIP TO: VA North Texas HCS (Dallas)

Service (115) PET 3rd Floor, Room 3B-672E 4500 S. Lancaster Road

300.00 10-01-2026 to

MARK FOR: Sussie DeMello

3001 SHIP TO: VA North Texas HCS (Dallas)

Service (115) PET 3rd Floor, Room 3B-672E 4500 S. Lancaster Road

150.00 10-01-2027 to 09-30-2028

MARK FOR: Sussie DeMello

3002 SHIP TO: VA North Texas HCS (Dallas)

Service (115) PET

1,900.00 10-01-2027 to

3rd Floor, Room 3B-672E 4500 S. Lancaster Road

3003 SHIP TO: VA North Texas HCS (Dallas)

Service (115) PET 3rd Floor, Room 3B-672E 4500 S. Lancaster Road

300.00 10-01-2027 to

MARK FOR: Sussie DeMello

4001 SHIP TO: VA North Texas HCS (Dallas)

Service (115) PET 3rd Floor, Room 3B-672E 4500 S. Lancaster Road

150.00 10-01-2028 to 09-30-2029

MARK FOR: Sussie DeMello

4002 SHIP TO: VA North Texas HCS (Dallas)

Service (115) PET 3rd Floor, Room 3B-672E 4500 S. Lancaster Road

1,900.00 10-01-2028 to

MARK FOR: Sussie DeMello

4003 SHIP TO: VA North Texas HCS (Dallas)

Service (115) PET

300.00 10-01-2028 to

3rd Floor, Room 3B-672E 4500 S. Lancaster Road

B.4 STATEMENT OF WORK

STATEMENT OF WORK (SOW)

Nuclear Medicine Service (NMS)

Positron Emission Tomography (PET) Radiopharmaceutical

1. Qualifications:

1. Quotes will only be considered from those who are regularly involved in the business called for, and who in the judgment of the Contracting Officer are financially responsible and able to show evidence of the reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service. VA North TX (VANTHCS) requires the manufacture of PET radiopharmaceuticals for the diagnostic imaging of Veterans with various clinical indications including but not limited to oncology and infection imaging.

1.2 The Contractor must hold a current unrevoked license by the US Nuclear Regulatory Commission (USNRC), or a State with a formal Agreement with the USNRC that allows the State to regulate radioactive materials (Licensee) and be regularly established in the business of providing radiopharmaceuticals at the scale and frequency necessary to meet this requirement. The Radiopharmaceuticals must be shipped from the Licensee directly to VANTHCS Nuclear Medicine Service. Non-manufacturing waiver does not apply to this solicitation.

1.3 Contractor/licensee shall meet all applicable Nuclear Regulatory Commission, VA/National Health Physics Program (NHPP), Department of Transportation, FDA, Joint Commission, OSHA, State, and Federal requirements, rules, and/or regulations related to the supply of Radiopharmaceuticals.

*Please note that the Offeror must provide copies of all relevant licenses, certifications, and/or partnering agreement(s), along with their quote/proposal to the Contracting Officer.

2. Requested Services:

2. Contractor/licensee must be able to provide PET radiopharmaceuticals to the VANTHCS Nuclear Medicine Service PET Imaging Facility at the Dallas VA Medical Center; Additional delivery locations include VA Fort Worth Outpatient Clinic, Sam Rayburn Memorial Veterans Center, Tyler VA Clinic, Plano CBOC, as needed for mobile PET Services, and any other future additional leased or owned VANTHCS locations.

2.1 Period of Performance: 12-month Base plus 4(four) 12-month option periods.

Base: 10/1/24-9/30/25

OY1: 10/1/25-9/30/26

OY2: 10/1/26-9/30/27

OY3: 10/1/27-9/30/28

OY4: 10/1/28-9/30/294

2.2 Contractor/licensee shall have available an adequate supply of contracted products to meet the requirements of the VA North Texas Healthcare System with proof of contingency supply chain to prevent disruption of clinical care. Should the vendor’s ability to supply product from the applicable pharmacy be limited for any reason the vendor shall notify the Customer of any limitations on the delivery times and dates that may affect its ability to supply Product when requested.

2.3 In the event local radio-pharmacies are unable to provide delivery of PET radiopharmaceuticals, the Contractor shall provide NMS a contingency plan for other locations to deliver doses with the least impact on patient care**

3. Deliverables and Acceptance Criteria.

3. The Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the performance of work, as set forth below.

3.1 All PET isotopes will be delivered directly to the following address:

VA North Texas HCS (Dallas) Nuclear Medicine Service (115) PET Imaging Center Building 2J, 3rd Floor, Room 3B-672E 4500 S. Lancaster Road Dallas, TX 75216

3.2 A Nuclear Medicine Technologist or appropriate staff will be at each location to receive the materials requested.

4. Delivery of Radiopharmaceuticals.

4. The Contractor/licensee shall deliver radioisotope in an amount greater than or equal to the activity ordered with calibration for the specified appointment time so that the patient-administered quantity is within regulatory limits of the prescribed dose. Failure to meet this requirement will result in dose compensation for VANTHCS Nuclear Medicine Service which is separate from any returned dose quantities. Greater than 10 such instances within a year duration of the contract may result in penalties and/or contract termination.

4.1 The Contractor/licensee shall provide at least one (1) scheduled delivery of PET radiopharmaceutical per day. Note that the VANTHCS PET Facility in Dallas provides both inpatient and outpatient care and is the tertiary VA Medical Center for the North Texas area.

Additional PET radiopharmaceutical delivery may be required based on clinical schedule, including emergency/STAT deliveries, at no additional cost. STAT delivery times during routine business hours should not exceed 60 minutes from the time the order is placed, and 90 minutes after-hours and holidays.

4.2 All routine PET radiopharmaceutical dose deliveries must occur >30 minutes before the calibration time. If the Nuclear Medicine Service is unable to perform a patient scan due to a PET dose arriving in an unusable form (e.g., too low activity and below the recommended range for diagnostic imaging radiopharmaceuticals, typically 10% to 20%), the vendor shall not invoice for the dose. The Vendor shall also offer a discount price for any unused radiopharmaceutical resulting from patient no-shows, reschedules, or other similar reasons for non-usage.

4.3 Calibration time for each requested radiopharmaceutical will be specified with each order or will be spelled out in the requirements provided by the VANTHCS Nuclear Medicine service.

4.4 Contractor will utilize only FDA approved products and sources for those products, unless otherwise mutually agreed upon in the context of compassionate care or IRB approved research.

4.5 All packages containing radioactive material shall be labeled and shipped IAW Title 49, Code of Federal Regulations Part 172 and 173.

4.6 The label shall include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label. Contractor/licensee shall label all unit doses of delivered radiopharmaceutical with the following details:

• Amount of radiopharmaceutical at calibration/preparation date and time

• Radiopharmaceutical expiration date and time

• Radiopharmaceutical volume

• Label must be affixed to each unit dose o The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport of radiation shield label.

4.7 Contractor/supplier shall abide by Title 10, Code of Federal Regulation, which states: A Licensee may use for medical purposes only:

(a) By-product material or cyclotron produced materials manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 35 and/or the equivalent regulations of an Agreement State.

(b) Reagent kit that has been manufactured, labeled, packed, and distributed in accordance with approval by the Commission pursuant to Title 10 CFR 32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

4.8

4.9 All orders shall be placed by authorized VA personnel during VA normal business hours throughout the workday. The Contractor will be furnished the name(s) of VA personnel that are authorized to place orders against the Contract and will provide appropriate personnel and contact information for staff receiving orders, able to offer technical or administrative support, as well as staff involved in radiopharmaceutical delivery in accordance with VA Radiation Safety Office requirements. Orders shall only be placed by authorized VANTHCS Nuclear Medicine Service personnel via telephone, fax, e-mail, or via an approved, secure, online ordering system. For electronic ordering systems, a closed-loop communication process such as confirmation e-mails is preferred.

4.10 The Contractor shall understand the limitations of the Nuclear Medicine Service at VANTHCS due to Radiation Safety with regards to storage and making radioactive kits for multiple use: Deliveries shall only contain unit dose or specific isotope bulk orders placed by authorized VA personnel.

4.11 The Contractor shall provide compatible software to allow for scanning by a Barcode reader using existing “Nuclear Management Information System” software at VANTHCS. A letter confirming this requirement must be submitted with the quote. If the Contractor's/licensee’s system varies or is incompatible from the VANTHCS facility NMIS, the a.

Common Nomenclature (commercial description):

PET Radiopharmaceuticals (Isotopes vary) b.

Kind of material (i.e., type, grade, alternatives, etc.):

Radioactive injection c.

Electrical Data (i.e., 110 v, 60 Hz, 3 Ph, etc.):

N/A

d. Dimensions, size, capacity:

Recommended dose 10 mCi per patient for routine studies, however, ranges can vary per isotope

e. Principles of operation: Radioactive isotope f.

Restrictive environmental conditions:

Must be stored in a secured hot lab in Nuclear Medicine

g. Intended use:

For PET diagnostic imaging of patients with cancer and/or infections h.

Equipment with which the item is used with (N/A if not applicable):

Imaged patients are scanned with PET/CT scanner

i. End item application: Clinical patient use j.

Original equipment manufacturer part number:

N/A k.

Other pertinent information that describes the item, material or service required:

Radioactive, handle using radiation safety measures

Contractor shall provide means for compatibility or an alternative system with any needed data migration, technical support, and training for staff on its use at no additional cost to the Government. Any additional tracking system(s) provided must comply with all VA and associated IT, as well as information security, requirements [see above]. Any provided system must adequately, and securely, link different sites of Nuclear Medicine Service operations.

5. Lead Shielding. Deliveries for VANTHCS- Nuclear Medicine Service will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards and regulations relating to the shipment of radioactive materials. Shipping containers shall comply with all federal and state regulations. This shall include the Department of Transportation (DOT), Department of Energy (DOE), and Nuclear Regulatory Commission (NRC), and/or agreement state licensure. The level of non-fixed contamination on the external surfaces of each package shall be following 49 CFR 173.443 and shall not exceed the limits outlined in Table 9 of that standard.

6. Material Safety Data Sheets. The Contractor shall provide current material safety data sheets (MSDS) and updates as necessary on all delivered products or the contractor must provide their website link where MSDS and package inserts for all radiopharmaceuticals can be accessed.

7. Quality Control (QC). The objective of QC is to ensure that the radiopharmaceutical passes all required testing to ensure that it is a quality product and safe for patient use. The Contractor shall perform all QC’s IAW the manufacturer/governing body specifications, the approved QC instructions, and the schedule.

8. QC Instructions. Using applicable manufacturer’s specifications, standard industry practices and this PWS, the Contractor shall test all products for Quality Control and only those products that pass quality control may be sent to the VANTHCS. This testing shall be performed at no cost to the VA. The contractor shall provide a detailed description of the test upon request. If a quality control or material defect is suspected and/or detected by any VANTHCS staff Nuclear Medicine Technologist or staff Nuclear Medicine Physician, or qualified personnel from the VANTHCS Radiation Safety Office, the Contracting Officer Representative (COR) for this contract will notify the Contractor and request the Contractor to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

• Provide technical expertise in calibration.

• Provide professional examination of product; submit results and recommendations to the Contracting Officer.

• Make expedient replacement of any product suspected of being deficient.

9. Instrument Calibrations. The Contractor shall provide instrument calibration/testing for dose calibrators, wipe counters, and probe/well. Testing must include Accuracy, Geometry, Linearity, and annual or as-needed calibrations.

10. Hours of Operation. Same-day add-on Delivery of routine non-emergent radiopharmaceuticals can be received at VANTHCS facilities up to 90 minutes after the order is placed during normal business hours if approved by VANTHCS authorized personnel. Nuclear

Medicine Service's normal business hours are considered Monday through Friday: 7:00 am – 4:30 pm, except Federal Holidays, and Saturdays from 7:00 am – 11:00 am.

10.1 These dates and hours exclude Federal Holidays, facility closures due to inclement weather and Furlough Days, and any other days designated a holiday by the President of the United States.

The following are Federal Holidays:

New Year’s Day Birthday of Martin Luther King, Jr. (day of observance) Washington’s Birthday Memorial Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day (Any other day designated as a National Holiday by the President of the United States.)

10.2 Although infrequent, emergency orders for this requirement will include all hours and days outside of normal operating hours.

11. Contractor Billing/Invoicing. The Contractor shall follow all CO guidelines for billing/invoicing through Tungsten and must include current PO on all invoices. The contractor shall provide billing/invoicing monthly, from the 1st of the month through the last day of the month. All billing/invoice statements must also include an itemized listing of all items delivered per day. All billing/invoices shall also be sent to the COR for approval.

SCHEDULE OF SUPPLIES AND SERVICES

12. The Department of Veterans Affairs North Texas Health Care System, Nuclear Medicine Service Center for PET Imaging requires the contractor/licensee to provide radiopharmaceuticals, and any needed check/QC/etc. sources to be used with PET and PET/CT imaging systems within VANTHCS. Items will be unit dose or bulk delivery, daily, and on an as-needed basis, following patient requirements for the period of one Base Year with four Option Years that may be exercised at the Agency’s discretion.

12.1 Note: All annual quantities are estimates, contractor will only be paid for items and quantities ordered and delivered.

12.2 The following line items are mandatory for this requirement:

Item # Description/Part Number

Month

Qty Est

1 F18 FDG Unit Dose up to 15 mCi per dose 1900

2 F18 NaF Unit Dose up to 10 mCi per dose 150

3 F-18 FDG additional mCi >15 mCi 300

13. Vendors are encouraged to list any additional line items they can provide, including new-to-market products, specialty radiotracers, and radiotracers that may provide a contingency source for other Nuclear Medicine Service modalities. Specialty radiotracers include:

Item # Description/Part Number

1 F18 Fluciclovine Unit Dose @ 10 mCi per dose

2 Ga-68 DOTATATE Unit Dose @ 5.4 mCi per dose

3 F-18 Florbetapir Unit Dose @ 10 mCi per dose

4 F-18 Florbetaben Unit Dose @ 8.1 mCi per dose

5 F-18 Flutemetamol Unit Dose @ 10 mCi per dose

6 N13 Ammonia Unit Dose @ 10 – 20 mCi per dose

7 Ga68 PSMA-11 Unit Dose 3.33 – 4.1 mCi per dose

*C&A requirements do not apply and a Security Accreditation Package is not required.

/ / / / / END OF SOW / / / / /

SECTION C - CONTRACT CLAUSES

FAR

Number

Title Date

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

NOV 2023

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 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 https://www.va.gov/oal/library/vaar/

(End of Clause)

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

852.203-70 COMMERCIAL ADVERTISING MAY 2018

852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS

(DEVIATION)

JAN 2023

852.215-71 EVALUATION FACTOR COMMITMENTS OCT 2019

852.246-71 REJECTED GOODS OCT 2018

(End of Addendum to 52.212-4)

C.2 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within 15 days of contract expiration. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

(End of Clause)

C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 15 days of contract expiration.

(End of Clause)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 15 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

C.5 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT

REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a

Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office.

Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT

2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract.

Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

C.7 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)

(a) The contract number shall be placed on or adjacent to all exterior mailing or shipping labels of deliverable items called for by the contract.

(b) Mark deliverables, except reports, for:

C.8 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

Material shall be packed for shipment in such a manner that will insure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with regulations of carriers as applicable to the mode of transportation.

(End of Clause)

C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

(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 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:

[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).

[] (2) 52.203–13, Contractor Code of Business Ethics and Conduct (NOV 2021) (41 U.S.C.

3509).

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

[] (4) 52.203–17, Contractor Employee Whistleblower Rights (NOV 2023) (41 U.S.C. 4712);

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

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

[] (6) [Reserved]

[] (7) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

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

[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).

[X] (11)(i) 52.204–30, Federal Acquisition Supply Chain Security Act Orders— Prohibition.

(DEC 2023) (Pub. L. 115–390, title II).

[] (ii) Alternate I (DEC 2023) of 52.204–30.

[X] (12) 52.209–6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) (31 U.S.C. 6101 note).

[X] (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.

[X] (20) 52.219-8, Utilization of Small Business Concerns (FEB 2024) (15 U.S.C. 637(d)(2) and (3)).

[] (21)(i) 52.219–9, Small Business Subcontracting Plan (SEP 2023) (15 U.S.C. 637(d)(4)).

[] (ii) Alternate I (NOV 2016) of 52.219-9.

[] (iii) Alternate II (NOV 2016) of 52.219-9.

[] (iv) Alternate III (JUN 2020) of 52.219–9.

[] (v) Alternate IV (SEP 2023) of 52.219–9.

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

[] (ii) Alternate I (MAR 2020) of 52.219-13.

[X] (23) 52.219–14, Limitations on Subcontracting (OCT 2022) (15 U.S.C. 657s).

[] (24) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) (15 U.S.C.

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

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

[X] (26) (i) 52.219–28, Post-Award Small Business Program Representation (FEB 2024) (15 U.S.C. 632(a)(2)).

[] (ii) Alternate I (MAR 2020) of 52.219–28.

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

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

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

[X] (30) 52.219–33, Nonmanufacturer Rule (SEP 2021) (15 U.S.C. 657s).

[] (31) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).

[X] (32) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (FEB 2024) (E.O. 13126).

[X] (33) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (34)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[] (ii) Alternate I (FEB 1999) of 52.222-26.

[X] (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.

[X] (37) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

[X] (38) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act

(DEC 2010) (E.O. 13496).

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

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

[] (40) 52.222-54, Employment Eligibility Verification (MAY 2022). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

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

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

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

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

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

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

[X] (46) 52.223-23, Sustainable Products and Services (MAY 2024) (E.O. 14057, 7 U.S.C.

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

[] (47)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

[] (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 (DEC 2022) of 52.225-3.

[] (iv) Alternate III (FEB 2024) of 52.225-3.

[] (v) Alternate IV (OCT 2022) of 52.225-3.

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

[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)

[X] (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

(OCT 2018) (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).

[] (63) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C.

637(d)(13)).

[] (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:

[] (1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

[] (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) (29 U.S.C 206 and 41 U.S.C. chapter 67).

[] (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

[] (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

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

(JAN 2022).

[] (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706).

[] (9) 52.226–6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792).

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

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

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

(i) 52.203–13, Contractor Code of Business Ethics and Conduct (NOV 2021) (41 U.S.C.

3509).

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

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

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

(v) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115–232).

(vi) 52.204–27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117–328).

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

(DEC 2023) (Pub. L. 115–390, title II).

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

(viii) 52.219–8, Utilization of Small Business Concerns (FEB 2024) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR

19.702(a) on the date of subcontract award, the subcontractor must include 52.219–8 in lower tier subcontracts that…