36C25624Q0120_RFQ.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* RFQ: Radioactive Tracer: F-18 Positron Emission Tomography (PET)

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 77056-5643

SOLICITATION NUMBER* 36C25624Q0120

PUBLISH DATE/TIME/ZONE 01-18-2024 11:00am CENTRAL TIME, CHICAGO, USA QUESTIONS DATE/TIME/ZONE 02-05-2024 4:00pm CENTRAL TIME, CHICAGO, USA RESPONSE DATE/TIME/ZONE 02-16-2024 4:00pm CENTRAL TIME, CHICAGO, USA

ARCHIVE 7 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE N - Unrestricted

PRODUCT SERVICE CODE* 6505

NAICS CODE* 325412

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 16 Galleria Financial Center 5075 Westheimer Road, Suite 750 Houston TX 77056-5643

POINT OF CONTACT*

Contract Specialist Shasta Britt shasta.britt@va.gov

PLACE OF PERFORMANCE

ADDRESS Department of Veterans Affairs Michael E. DeBakey VA Medical Center

(MEDVAMC)

2002 Holcombe Blvd.

Houston Texas

POSTAL CODE 77030-4211

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov URL DESCRIPTION Department of Veterans Affairs AGENCY CONTACT’S EMAIL ADDRESS shasta.britt@va.gov EMAIL DESCRIPTION 36C25624Q0120 - RFQ Response mailto:shasta.britt@va.gov https://www.va.gov/

DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and

Solicitation for Commercial Items,” in conjunction with FAR Part 13.5 for Certain Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; a quote is being requested, and a written solicitation document will be issued.

This solicitation is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2023-

06 (eff. 12/04/2023), VAAR Update 2008-37 (eff. 07/28/2023), and Acquisition Policy Flash 23-15 (eff.

07/28/2023).

Contractor is required to be actively registered in the System for Award Management (SAM). Vendor quote may be considered non-compliant and rejected if the Contracting Officer is unable to verify registration and certification status.

The Michael E. DeBakey VA Medical Center (MEDVAMC) Nuclear Medicine, 2002 Holcombe Blvd, Houston, Texas 77030 is seeking to purchase F-18 Positron Emission Tomography (PET) Radioactive

Tracer imaging isotopes. This solicitation is a Brand Name or Equal Unrestricted IAW FAR 13.5 and is open to all concerns capable of approved FDA F-18 PET Tracer isotopes IAW terms and condition of this solicitation, Statement of Work (SOW), and delivery lead time for a Firm-Fixed Priced (FFP) Single-Award

Indefinite Delivery, Indefinite Quantity (IDIQ) Contract.

See attached document below: 36C25624Q0120_RFQ.

36C25624Q0120

Table of Contents

SECTION B - CONTINUATION CONTRACT OPPORTUNITIES COMBINED SYNOPSIS

SOLICITATION

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK (SOW)

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION [Completed by Quoter]

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

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

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.5 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.6 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (JAN 2023) (DEVIATION)

C.7 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.8 VAAR 852.219-70 VA SMALL BUSINESS SUBCONTRACTING PLAN MINIMUM

REQUIREMENTS (JAN 2023) (DEVIATION)

C.9 VAAR 852.223-71 SAFETY AND HEALTH (SEP 2019)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ..20

C.12 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.13 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

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) [Completed by

Quoter]

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

[Completed by Quoter]

E.4 52.214-21 DESCRIPTIVE LITERATURE (APR 2002)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.9 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023) [Completed by Quoter]

SECTION B - CONTINUATION CONTRACT OPPORTUNITIES

COMBINED SYNOPSIS SOLICITATION

B.1 CONTRACT ADMINISTRATION DATA

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

[Completed by Quoter]

a. CONTRACTOR: Company Name:

ATTN/POC Name:

Address:

Phone:

Email:

UEI:

Tax ID:

GSA/FSS, NAC, SEWP Contract# (if applicable):

b. GOVERNMENT: Contracting Officer 36C256

Department of Veterans Affairs Network Contracting Office 16 (NCO16) Galleria Financial Center

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

a. 52.232-33 Payment by Electronic Funds Transfer - System for Award Management through TUNGSTEN

3. INVOICES: Invoices shall be submitted in arrears:

a. Other: Upon receipt and acceptance by the Government

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.

5. Offeror shall complete the following located in Sections B thru E of this solicitation to be deemed eligible:

a. Section B- CONTRACT ADMINISTRATION DATA, CONTRACTOR contact information.

b. Section B- PRICE/COST SCHEDULE, unit price, amount, and grand total

c. Section E- 52.204-24 REPRESENTATION REGARDING CERTAIN

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT

d. Section E- 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT

2018)

e. Section E- 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS

f. Submission of manufacturer’s authorized distributor letter, cut-sheets, and specifications.

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK (SOW)

RADIOACTIVE ISOTOPES TRACER – POSITRON EMISSION TOMOGRAPHY (PET)

PART I: GENERAL INFORMATION

A. Introduction: The Michael E. DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Blvd, Houston, Tx 77030 has a requirement for radioactive PET imaging isotopes, specifically unit dose Fluorine-18 (F-18) Fluorodeoxyglucose (FDG), bulk F-18 FDG, and F-18 Florbetaben Injection (NeuraCeq). The overall purpose is needed to sustain patient care.

B. Background: The Nuclear Medicine (NUC MED) PET service is seeking to purchase multiple PET TRACER radioactive isotope or equal injections for diagnostic imaging. These PET isotopes are unit dose F-18 FDG, bulk F-18 FDG, F-18 Florbetaben Injection (NeuraCeq).

The F-18 isotopes are used for diagnosis, staging, and monitory treatment of cancers. F-18 also has been approved for diagnosing infection and Alzheimer’s disease.

C. Scope: Contractor shall provide all single unit and bulk dose of isotopes for use in NUC MED PET diagnostic imaging at MEDVAMC in Houston, Texas.

D. Applicable Documents:

• 10 Code of Federal Regulations Part 35: United States Nuclear Regulatory Commission

- Medical Use of Byproduct Material at https://www.ecfr.gov/current/title-10/chapter- I/part-35,

• 49 Code of Federal Regulations Part 173 Subpart I: Class 7 (Radioactive) Materials at https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C/part-173/subpart-I,

• Department of Veteran Affairs Materials Permit No. 03-01082-01 Amendment No. 76.,

• Department of Transportation at https://www.txdot.gov/,

• U.S. Food & Drug Administration (FDA) at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1,

• OSHA at https://www.osha.gov/ionizing-radiation/standards, and

• All other agency rules and regulations (Federal and State).

PART II: REQUIREMENTS

E. Ordering Requirements:

1. The Contractor shall provide personnel for orders to be placed by MEDVAMC employees for unit dose F-18 FDG, bulk F-18 FDG, and F-18 Florbetaben Injection (NeuraCeq) during standard hours of care Monday through Friday from 0700 (7:00 AM CST) until 1700 hours (5:00 PM CST), not including Federal holidays.

2. Salient physical, functional, or performance characteristics: F-18 is a fluorine radioisotope which is an important source of positrons. It has a mass of 18.0009380(6) u and its half-life is 109.771(20) minutes. It decays by positron emission 96% of the time and electron capture 4% of the time. Both modes of decay yield stable oxygen-18. The Contractor shall receive orders for unit dose F-18 FDG, bulk F-18 FDG, and F-18 Florbetaben Injection (NeuraCeq) from Staff Nuc Med Technologists assigned to the NUC MED Department at MEDVAMC. The Contractor shall ensure the Staff Nuc Med Technologist name and contact information that placed the order is included with the Contractor’s internal order processing system so that the Contractor can immediately verify who placed the order at the VA’s request.

https://www.ecfr.gov/current/title-10/chapter-I/part-35 https://www.ecfr.gov/current/title-10/chapter-I/part-35 https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C/part-173/subpart-I https://www.txdot.gov/ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1

3. The Contractor shall calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/- 20 percent of the specified ordered dose per specific requirements provided by the NUC MED department based on guidelines outlined in 10 CFR Part 35.

4. Orders may be placed orally, in writing, or by electronic means. Specific personnel authorized to place orders under this contract will be designated in writing upon award of the contract.

5. The Contractor shall notify MEDVAMC NUC MED department should the inability arise to provide Radiopharmaceutical doses by the required date and time. Notification shall be made within a Delivery Lead Time of two (2) hours of the Contractor becoming aware of the inability to provide the required doses.

F. Delivery Requirements:

1. The Contractor shall deliver ordered Radiopharmaceutical doses to:

Department of Veterans Affairs Michael E. DeBakey VA Medical Center

2002 Holcombe Blvd.

Nuclear Medicine PET Department, Room 1A-822A Houston, Texas 77030

2. Access to MEDVAMC during non-business hours shall be obtained by locating the VA Police located in the Emergency Department. The VA Police will accompany the delivery Person to the

NUC MED PET department and supervise the delivery.

3. The Contractor shall ensure all orders are delivered at least 30 minutes of the calibration time specified on the order.

4. The Contractor shall provide a packing slip accompanying all Radiopharmaceutical shipments to the NUC MED PET department for all orders placed that is compatible to be scanned into the BioDose system.

5. The Contractor shall ensure that all Radiopharmaceutical doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Pharmacist Contractor.

6. The Contractor shall provide courier service licensed to transport radioactive material in accordance with Department of Transportation, Nuclear Regulatory Commission and other applicable regulating authorities enabling the delivery of radioactive isotopes. Delivery will be made, for the times indicated in this contract to PET 1A-822A. Contractor shall provide routine delivery and pick-up as many times as required. The contractor shall be required, as deemed necessary by the MEDVAMC, to furnish such services as specified.

(a) Delivery date and time specified may be adjusted by the Contracting Officer (CO). The Contractor will be notified of this change at least seven (7) days prior to the original or adjusted delivery date.

G. Additional Requirements:

1. The Contractor shall provide any training or education required to meet commercial standards related to use of the radiopharmaceuticals to qualified Staff Nuc Med Physicians/Technologist stationed at the MEDVAMC no later than 60 days after commercial standards changes.

2. The Contractor shall obtain, maintain, and provide evidence of at the request of the Government, U.S. FDA approval of the radiopharmaceuticals prior to shipment.

3. Contractor will establish monthly invoice to the NUC MED Supervisor in addition to quarterly and annual usage reports that coincide with the VA fiscal year.

H. Government Responsibilities: The Government shall ensure all orders for radiopharmaceuticals doses be placed by the MEDVAMC to the Contractor in accordance with currently accepted Contractor guidelines.

PART III: SUPPORTING INFORMATION

I. Place of Performance: Same as paragraph F.1. above.

J. Period of Performance: Firm-Fixed Priced (FFP) Single-Award Indefinite Delivery, Indefinite Quantity (IDIQ) Contract is awarded as a one-year ordering base with four additional ordering years to fund the contract one year (annually) at a time, for a total ordering period of five years.

Ordering Period Year (PY) 1: 12 months (from date of award) Ordering Period Year (PY) 2: 12 months Ordering Period Year (PY) 3: 12 months Ordering Period Year (PY) 4: 12 months Ordering Period Year (PY) 5: 12 months

K. Obligation of Funds:

If there is still a requirement, obligatory funds will be awarded and made accessible every year for each purchasing ordering period year under a brand-new Delivery Order (DO) with new obligated funds Purchase Order (PO) number.

L. Hours of Work: Normal business hours for the NUC MED PET Department at the MEDVAMC are 7:00 a.m. to 5:00 p.m., Monday through Friday excluding the following federal holidays: New Year's Day, Martin Luther King Day, President's Day, Memorial Day, Juneteenth Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas, and any other day specifically declared by the President of the United States to be a national holiday.

M. Changes to Statement of Work: The CO is the only person authorized to approve changes or modify any of the requirements under this contract and such changes will be executed bilaterally in accordance with FAR 52.212-4(c). The Contractor shall communicate with the CO on all matters pertaining to contract administration. Only the CO is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the CO, the change shall 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.

(End of Statement of Work)

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION [Completed by Quoter]

ITEM

DESCRIPTION

OF SUPPLIES QUANTITY UNIT UNIT PRICE AMOUNT

1,000.00 EA __________________ __________________

F-18 FDG TRACER, 1-15 mCi (DOSE) UNIT DOSE

Contract Period: Ordering Period Year (PY) 1 POP Begin: 03-01-2024 POP End: 02-28-2025 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals MANUFACTURER PART NUMBER (MPN): FDG Tracer

6.00 VI __________________ __________________

F-18 FDG TRACER, 30mCi, LINEARITY VIAL

Contract Period: Ordering PY1 POP Begin: 03-01-2024 POP End: 02-28-2025 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

MANUFACTURER PART NUMBER (MPN): LINEARITY

200.00 VI __________________ __________________

F-18 FDG Tracer, 600 mCi, Bulk Dose Vial

Contract Period: Ordering PY1 POP Begin: 03-01-2024 POP End: 02-28-2025 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

MANUFACTURER PART NUMBER (MPN): Bulk Dose

20.00 EA __________________ __________________

F-18 Florbetaben Injection (NeuraCeq) unit dose

Contract Period: Ordering PY1 POP Begin: 03-01-2024 POP End: 02-28-2025 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

MANUFACTURER PART NUMBER (MPN): NEURACEQ

1.00 YR __________________ __________________

Ordering PY1 Total:

POP Begin: 03-01-2024 POP End: 02-28-2025

Contract Period: Ordering PY2 POP Begin: 03-01-2025 POP End: 02-28-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

Contract Period: Ordering PY2 POP Begin: 03-01-2025 POP End: 02-28-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

F-18 FDG Tracer, 600 mCi, Bulk Dose vial

Contract Period: Ordering PY2 POP Begin: 03-01-2025 POP End: 02-28-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

Contract Period: Ordering PY2 POP Begin: 03-01-2025 POP End: 02-28-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

Ordering PY2 Total:

POP Begin: 03-01-2025 POP End: 02-28-2026

Contract Period: Ordering PY3 POP Begin: 03-01-2026 POP End: 02-28-2027 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

Contract Period: Ordering PY3 POP Begin: 03-01-2026 POP End: 02-28-2027 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

F-18 FDG Tracer, 600 mCi, Bulk Dose vial Contract Period: Ordering PY3 POP Begin: 03-01-2026 POP End: 02-28-2027 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

Contract Period: Ordering PY3 POP Begin: 03-01-2026 POP End: 02-28-2027 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

Ordering PY3 Total:

POP Begin: 03-01-2026 POP End: 02-28-2027

Contract Period: Ordering PY4 POP Begin: 03-01-2027 POP End: 02-29-2028 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

Contract Period: Ordering PY4 POP Begin: 03-01-2027 POP End: 02-29-2028 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

Contract Period: Ordering PY4 POP Begin: 03-01-2027 POP End: 02-29-2028 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

Contract Period: Ordering PY4 POP Begin: 03-01-2027 POP End: 02-29-2028

PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

MANUFACTURER PART NUMBER (MPN): NEURACEQ

1.00 YR __________________ __________________

Ordering PY4 Total:

POP Begin: 03-01-2027

Contract Period: Ordering PY5 POP Begin: 03-01-2028 POP End: 02-28-2029 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

Contract Period: Ordering PY5 POP Begin: 03-01-2028 POP End: 02-28-2029 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

Contract Period: Ordering PY5 POP Begin: 03-01-2028 POP End: 02-28-2029 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

Contract Period: Ordering PY5 POP Begin: 03-01-2028 POP End: 02-28-2029 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing

Ordering PY5 Total:

POP Begin: 03-01-2028 POP End: 02-28-2029

GRAND TOTAL

VALUE

B.4 DELIVERY SCHEDULE

ITEM # SHIPPING INFORMATION QUANTITY DELIVERY DATE

0001 PY1 C.13 VAAR 852.247-71

DELIVERY LOCATION

1,000.00 POP Begin: 03-01-2024 POP End: 02-28-2025

Same as Above – C.13 6.00 Same as Above

Same as Above – C.13 200.00 Same as Above

Same as Above – C.13 20.00 Same as Above

1001 PY2 Same as Above – C.13 1,000.00 POP Begin: 03-01-2025 POP End: 02-28-2026

2001 PY3 Same as Above – C.13 1,000.00 POP Begin: 03-01-2026 POP End: 02-28-2027

3001 PY4 Same as Above – C.13 1,000.00 POP Begin: 03-01-2027

4001 PY5 Same as Above – C.13 1,000.00 POP Begin: 03-01-2028 POP End: 02-28-2029

[End of Section B]

SECTION C - CONTRACT CLAUSES

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/

FAR

Number

Title Date

52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST JUN 2020

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS

AND REQUIREMENT TO INFORM EMPLOYEES OF

WHISTLEBLOWER RIGHTS

JUN 2020

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON

POSTCONSUMER FIBER CONTENT PAPER

MAY 2011

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

DEC 2022

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—

COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES

SEP 2023

52.216-20 DEFINITE QUANTITY OCT 1995

52.217-6 OPTION FOR INCREASED QUANTITY MAR 1989

52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY

PRICED LINE ITEM

MAR 1989

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

MAR 2023

(End of Clause)

C.2 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from award date on SF1449 block 31 through five (5) years later from award date on SF1449 block 31.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the

Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor’s fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of Clause)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $100.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $340,150.00,

(2) Any order for a combination of items in excess of $1,700,750.00; or

(3) A series of orders from the same ordering office within 15 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection

52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 30 days after issuance, with written notice stating the

Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.4 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of

Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.5 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

(a) The Contractor shall conform to the standards established by: 10 Code of Federal

Regulations Part 35: United States Nuclear Regulatory Commission - Medical Use of Byproduct

Material at https://www.ecfr.gov/current/title-10/chapter-I/part-35, 49 Code of Federal

Regulations Part 173 Subpart I: Class 7 (Radioactive) Materials at https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C/part-173/subpart-I, Department of Veteran Affairs Materials Permit No. 03-01082-01 Amendment No. 76., Department of Transportation at https://www.txdot.gov/, F.D.A. at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1, OSHA at https://www.osha.gov/ionizing-radiation/standards, and all other agency rules and regulations

(Federal and State).

(b) The Contractor shall submit proof of conformance to the standard. This proof may be a label or seal affixed to the equipment or supplies, warranting that the item(s) have been tested in accordance with the standards and meet the contract requirement. Proof may also be furnished by the organization listed above certifying that the item(s) furnished have been tested in accordance with and conform to the specified standards.

(c) Quoters may obtain the standards cited in this clause by submitting a request, including the solicitation number, title and number of the publication to: Christie.Rufus@va.gov

(d) The quoter shall contact the Contracting Officer if response is not received within two weeks of the request.

(End of Clause)

C.6 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND

VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (JAN 2023)

(DEVIATION)

(a) In an effort to achieve socioeconomic small business goals, VA shall evaluate quoters based on their service-disabled veteran-owned or veteran-owned small business certification status and their proposed use of eligible certified service-disabled veteran-owned small businesses (SDVOSBs) and certified veteran-owned small businesses (VOSBs) as subcontractors.

(b) Eligible and certified service-disabled veteran-owned small businesses quoters will receive full credit, and quoters qualifying as veteran-owned small businesses will receive partial credit for the certified Service-Disabled Veteran-Owned and Veteran-Owned Small Business Status evaluation factor. To receive credit, an quoter must be listed at the time of submission of quotes https://www.ecfr.gov/current/title-10/chapter-I/part-35 https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C/part-173/subpart-I https://www.txdot.gov/ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1 https://www.osha.gov/ionizing-radiation/standards mailto:Christie.Rufus@va.gov and at time of award, as a certified SDVOSB/VOSB in the SBA certification database on the

SBA Veteran Small Business Certification Program portal at https://veterans.certify.sba.gov/

(see 13 CFR 128) and be otherwise eligible in accordance with SBA size standards for the acquisition and limitations on subcontracting requirements set forth in SBA regulations (see 13

CFR 121, 125 and 128.).

(c) Non-Veteran quoters proposing to use certified SDVOSBs or VOSBs as subcontractors will receive some consideration under this evaluation factor. Quoters must state in their proposals the names of the certified SDVOSBs and VOSBs with whom they intend to subcontract and provide a brief description of the proposed subcontracts and the approximate dollar values of the proposed subcontracts. In addition, the proposed subcontractors must be listed at the time of submission of quotes and at time of award, as a certified SDVOSB/VOSB in the SBA certification database.

(d) Pursuant to 38 U.S.C. 8127(g), any business concern that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB/VOSB status is subject to debarment for a period of not less than five years. This includes the debarment of all principals in the business.

(End of Clause)

C.7 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

(a) The quoter agrees, if awarded a contract, to use the service-disabled veteran-owned small businesses (SDVOSBs) or veteran-owned small businesses (VOSBs) proposed as subcontractors in accordance with 852.215–70, Service-Disabled Veteran-Owned and Veteran-

Owned Small Business Evaluation Factors, or to substitute one or more SDVOSBs or VOSBs for subcontract work of the same or similar value.

(b) Pursuant to 38 U.S.C. 8127(g), any business concern that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB/VOSB status is subject to debarment for a period of not less than five years. This includes the debarment of all principals in the business.

(End of Clause)

C.8 VAAR 852.219-70 VA SMALL BUSINESS SUBCONTRACTING PLAN

MINIMUM REQUIREMENTS (JAN 2023) (DEVIATION)

(a) This clause does not apply to small business concerns.

(b) If the quoter is required to submit an individual subcontracting plan, the minimum goals for award of subcontracts to certified service-disabled veteran-owned small business and certified veteran-owned small business SDVOSB/VOSB shall be at least commensurate with the

Department’s annual SDVOSB/VOSB subcontracting goals.

(c) For a commercial plan, the minimum goals for award of subcontracts to SDVOSB/ VOSB shall be at least commensurate with the Department’s annual service-disabled veteran-owned small business and veteran owned small business subcontracting goals for the total value of projected subcontracts to support the sales for the commercial plan.

https://veterans.certify.sba.gov/

(d) To be credited toward goal achievements, SDVOSB/VOSBs must be certified and listed in the SBA certification database at https://veterans.certify.sba.gov/ (see 13 CFR 128) and be otherwise eligible in accordance with SBA size standards for the acquisition and limitations on subcontracting requirements set forth in SBA regulations (see 13 CFR 121, 125 and 128).A contractor may reasonably rely on a subcontractor’s status as shown in the SBA certification database as of the date of subcontract award, provided the contractor retains records of the results of the SBA certification database query.

(e) The Contractor shall annually submit a listing of SDVOSB/VOSB (for which credit toward goal achievement is to be applied) for review by personnel in the Office of Small and

Disadvantaged Business Utilization. Use VA Form 0896A, Report of Subcontracts to Small and

Veteran-Owned Business.

(f) Pursuant to 38 U.S.C. 8127(g), any business concern that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB/VOSB status is subject to debarment for a period of not less than five years. This includes the debarment of all principals in the business.

(End of Clause)

C.9 VAAR 852.223-71 SAFETY AND HEALTH (SEP 2019)

(a) To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under this contract. These laws are implemented or enforced by the Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA) and other regulatory/enforcement agencies at the Federal, State, and local levels.

(1) Additionally, the Contractor shall comply with the following regulations when developing and implementing health and safety operating procedures and practices for both personnel and facilities involving the use or handling of hazardous materials and the conduct of research, development, or test projects:

(i) 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories. These regulations are available at https://www.osha.gov/.

(ii) Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy

Reorganization Act of 1974 (42 U.S.C. 5801 et seq.) Copies are available from the U.S. Nuclear

Regulatory Commission, Washington, DC 20555-0001.

(2) The following Government guidelines are recommended for developing and implementing health and safety operating procedures and practices for both personnel and facilities:

(i) Biosafety in Microbiological and Biomedical Laboratories, Centers for Disease Control and Prevention (CDC), available at http://www.cdc.gov/biosafety/publications/index.htm.

(ii) Prudent Practices in the Laboratory, National Research Council, National Academy

Press, Washington, DC 20001, available at http://www.nap.edu.

https://veterans.certify.sba.gov/ https://www.osha.gov/ http://www.cdc.gov/biosafety/publications/index.htm http://www.nap.edu/

(b)(1) The Contractor shall maintain an accurate record of, and promptly report to the

Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials; the injury or death of any person; or damage to property incidental to work performed under the contract resulting from toxic or hazardous materials and resulting in any or all violations for which the Contractor has been cited by any Federal, State or local regulatory/enforcement agency.

(2) The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State, or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.

(c) If the Contractor fails or refuses to comply with the Federal, State or local regulatory/enforcement agency's directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State, or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer.

No part of the time lost due to any such stop work order shall form the basis for a request for extension or costs or damages by the Contractor.

(d) The Contractor shall insert this clause in each subcontract involving toxic substances or hazardous materials. The Contractor is responsible for the compliance of its subcontractors with the provisions of this clause.

(End of Clause)

C.10 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.11 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.12 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

(a) Supplies and equipment. Rejected goods will be held subject to Contractor’s order for not more than 15 days, after which the rejected merchandise will be returned to the Contractor’s address at the Contractor’s risk and expense. Expenses incident to the examination and testing of materials or supplies that have been rejected will be charged to the Contractor.

(b) Perishable supplies. The Contractor shall remove rejected perishable supplies within 48 hours after notice of rejection. Supplies determined to be unfit for human consumption will not be removed without permission of the local health authorities. Supplies not removed within the allowed time may be destroyed. The Department of Veterans Affairs will not be responsible for, nor pay for, products rejected. The Contractor will be liable for costs incident to examination of rejected products.

(End of Clause)

C.13 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

Shipment of deliverable items, other than reports, shall be to:

Department of Veterans Affairs Michael E. DeBakey VA Medical Center Nuclear Medicine PET Dept. Rm. 1A-822A 2002 Holcombe BLVD Houston TX 77030-4298

(End of Clause)

(End of Addendum to 52.212-4)

[End of Section C]

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR

ATTACHMENTS

Intentionally Left Blank

[End of Section D]

SECTION E - SOLICITATION PROVISIONS

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

This combined synopsis/solicitation is issued under Federal Acquisition Regulation 12 and 13.5, Simplified Procedures for Certain Commercial Items.

QUOTE PREPARATION INSTRUCTIONS:

1. Quote Preparation

a. These instructions are designed to ensure the proper submission of information necessary to provide for comprehensive evaluation of quotes. Quoters shall carefully review this section prior to commencing preparation of quotes and take the necessary measures to ensure that the information submitted is factual, accurate, and complete.

2. Submission Instructions

a. One electronic copy (email) of all sections of the quote (Technical and Price) shall be submitted to the Contracting Specialist via email at shasta.britt@va.gov the publisher of this solicitation on or before the due date and time listed in this solicitation. The contractor’s email shall include in the subject line “RFQ 36C25624Q0120 – Vendor Name”

b. Faxed quotes are NOT permitted under any circumstances.

3. Quote Format

a. Electronic Copy: Provide one (1) electronic copy of the complete quote. Electronic copies must be in Microsoft Word or Adobe Acrobat format, and virus checked prior to submission.

b. The quoters shall be held responsible for the validity of all information supplied in their quote.

c. Please complete and submit, with completed price quote (volume 2) and all “Completed by

Quoter” Sections of RFQ IAW B.1. para. 5. In addition, all prior solicitation amendments must be acknowledged.

3.1. Volume 1 contains one section, Technical.

A summary of the Technical Volume 1 requirement is listed below. The detailed requirement for the technical volume is listed in section 4 below.

a. Technical

i. Quoter’s Technical Capability

ii. Quoter’s Qualifications

iii. Personnel Certifications

3.1.1 Past Performance - The contractor does not need to turn in any information for past performance. CPARS will be reviewed.

3.2. Volume 2 contains one section, Pricing Information.

A summary of the Price Volume 2 requirement is listed below.

a. Completed Section B.3 Price Schedule. Contractor shall complete all pricing in the B.3 price schedule. CLINS (Contract Line Items) without pricing will be found unacceptable. (The

Government seeks discounts. Identify any discounts offered and the amount within the line-item description).

4. Quote Volume Requirements

a. Volume 1 – TECHNICAL

i. Quoter's Technical Capability

1. Quoter shall demonstrate that it has experience delivering radiopharmaceuticals per this solicitation/SOW. Quoter shall submit with quote the capability to provide radiopharmaceuticals/isotopes as related to nuclear medicine and PET studies demonstrating their ability to provide scheduled products as listed in statement of work.

2. Quoter shall submit with quote its illustration/evidence the capability to meet the delivery requirements per the Solicitation/SOW to deliver orders within 120 minutes (2 hours) upon receipt of telephone order for each facility. Quotes that take exception to or cannot confirm capability to meet the 120 minutes (2 hours) delivery requirement will be considered technically unacceptable. For example, a quote that states the contractor “will try” to meet the requirement or will “do our best” to meet the requirement will be found unacceptable.

ii. Quoter’s Qualifications

1. Quoter shall demonstrate it is a nuclear pharmacy possessing a radioactive materials license issued by the NRC or Agreement state that allows shipping of radioactive materials to nuclear medicine providers in required locations. Quoter shall submit copies of recent inspection results and responses to deficiencies are available if requested. Quoter shall submit its all-current documentation and license/licenses with quote.

2. Quoter shall demonstrate its nuclear pharmacy possessing an active pharmacy registration for its resident state (and, if applicable, a non-resident pharmacy registration for my state) that is in good standing with the Board of Pharmacy. Quoter shall submit its documentation and registrations with quote.

3. Quoter shall submit all documentation/evidence that radiopharmaceutical preparations of doses, tagging of blood products and testing are performed at a facility that is USP <795> and/or <797> compliant and has in-house quality control testing standards for compounded radiopharmaceuticals.

4. Quoters shall submit with quote its authorized distributor memo/letter from the manufacturers. Quoter shall provide proof that its firm is an authorized distributor of the product.

The VA does not accept grey market items. Grey/gray market also known as a parallel market, is the trade of a commodity through distribution channels which, while legal, are unofficial, unauthorized, or unintended by the original manufacturer.

iii. Personnel Certifications

1. Nuclear Pharmacists: Quoter shall submit with quote all current certifications/licenses/ credentials for applicable states for its nuclear pharmacists preparing/dispensing radiopharmaceuticals for human administration.

2. Couriers: Quoter shall submit with quote all current training/certificates for couriers to ship/transport radiopharmaceuticals.

3. The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2 (b) (3), where quotations will be compared to one another to determine which provides the best benefit to the Government. All factors are equal in the comparative evaluation. Under Factor 1 Technical, the quotation will be evaluated to the extent to which it can meet and/or exceed the Government’s requirements as outlined in the solicitation and based on the information requested in the instructions to Quoters section of this solicitation.

Provisions 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 provisions are incorporated into 52.212-1 as an addendum to this solicitation:

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY

REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

FAR

Number

Title Date

52.204-7 SYSTEM FOR AWARD MANAGEMENT OCT 2018

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE

REPORTING

AUG 2020

52.211-6 BRAND NAME OR EQUAL AUG 1999

52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

SEP 2023

52.229-11 TAX ON CERTAIN FOREIGN PROCUREMENTS—NOTICE

AND REPRESENTATION

JUN 2020

(End of Provision)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR

EQUIPMENT (NOV 2021) [Completed by Quoter]

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the

Offeror has represented that it ‘‘does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument’’ in paragraph (c)(1) in the provision at

52.204–26, Covered Telecommunications Equipment or Services—Representation, or in paragraph (v)(2)(i) of the provision at 52.212–3, Offeror Representations and Certifications–

Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it ‘‘does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services’’ in paragraph (c)(2) of the provision at 52.204–26, or in paragraph (v)(2)(ii) of the provision at 52.212–3.

(a) Definitions. As used in this provision—

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204–25, Prohibition on Contracting for

Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition. (1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization

Act for Fiscal Year 2019 (Pub. L. 115–232) prohibits the head of an executive agency on or after

August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal

Year 2019 (Pub. L. 115–232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment,…