FAR 13.5 Sole Source Justification - Over SAT Netspot Ga68_Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C242-24-AP-2519

1. Contracting Activity: Department of Veterans Affairs, VISN 02, Network Contracting Office, Appletree Business Park, 2875 Union Road, Suite 3500 Cheektowaga, NY 14227.

Organizational Activity: New York Harbor Health Care System (NYHHCS) at Brooklyn, 800 Poly Place, Brooklyn, NY 11209. New Jersey Healthcare System (NJHCS) at East Orange, 385 Tremont Ave, East Orange, NJ 07018. James J. Peters VA Medical Center, 130 W. Kingsbridge Rd., Bronx, NY 10468.

2. Nature and/or Description of the Action Being Processed: This procurement is for the brand name purchase of Radiopharmaceutical drug Netspot (Ga68 dotatate) for patients as needed in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR

13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

This requirement will be a firm-fixed price requirements contract for the Radiopharmaceutical drug NETSPOT (Ga68 dotatate) via solicitation on the open market to ensure fair and reasonable pricing to the government. This is a follow-on procurement to purchase Netspot (Ga68 dotatate) Intravenous injections for the Bronx, NJHCS (East Orange), and NYH (Brooklyn) facilities. The facilities are currently using the Netspot (Ga68 dotatate) intravenous injections, and a continuation of Netspot (Ga68 dotatate) is required to continue supporting the mission to serve Veterans.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

New York Harbor Health Care System (Brooklyn), New Jersey Healthcare System (East Orange), and the James J. Peters VA Medical Center are requiring the brand name purchase of Radiopharmaceutical drug Netspot (Ga68 dotatate) for patients as needed. Netspot (G68 dotatate) is a radioactive drug that is manufactured in the United States by Advanced Accelerator Applications and distributed by Due to the nature of Netspot (Ga68 dotatate) as a radiopharmaceutical, it can only be administered on an as needed basis on the day needed. Price is determined by size, weight and height of the Veteran patients. The following will meet the agency’s need: Gallium-68 Dotatate IV.

Period of Performance:

Base Year: 7/30/2024-7/29/2025 Option 1: 7/30/2025-7/29/2026 Option 2: 7/30/2026-7/29/2027 Option 3: 7/30/2027-7/29/2028 Option 4: 7/30/2028-7/29/2029

4. Statutory Authority Permitting Restricted Competition:

Effective Date: 02/01/2022 Page 3 of 5

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

the OEM (Advanced Accelerator Applications) Holds an FSS contract, the proposed requirements contract will be open market to the distributor. Through competition, pricing is anticipated to be fair and reasonable to the government.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

A search on SBA DSBS yielded zero (0) small businesses. A search on VetCert using NAICS code 325412 yielded 129 SD/VOSBs.

A search on the SCMC produced zero (0) relevant results – RPO West results. A search on GSA showed zero (0) results.

The OEM is a large business and no longer sells direct to the VAMC. Advanced Accelerator Applications provided a list of authorized distributors to the CO on 6/4/2024.

Although the OEM Holds an FSS contract, the proposed requirements contract will be open market to the distributor.

Netspot (G68 dotatate) is a radioactive drug that is manufactured in the United States by Advanced Accelerator Applications and distributed by several companies. Due to the nature of Netspot (Ga68 dotatate) as a radiopharmaceutical it can only be administered on an as needed basis on the day needed. Price is determined by size, weight and height of the Veteran patients. The following will meet the agency’s need: Gallium-68 Dotatate IV.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. The Contracting Officer concluded from the results of the market research that there were insufficient SDVOSBs or VOSBs with both interest and capability to meet the VA Rule of Two, IAW VAAR 819.70. Therefore, a set aside for VOSB providers or SDVOSB providers is not a viable strategy for this procurement.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

All facts supporting the use of Other than Full and Open Competition have been provided.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Effective Date: 02/01/2022 Page 4 of 5 subsequent acquisitions for the supplies or services required:

No additional actions are required by the Agency at this time, as competition amongst authorized vendors will lead to fair and reasonable pricing for the government.

Through competition, pricing is anticipated to be fair and reasonable to the government.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Name Date Title Facility

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Janelle Bonafede Date Contracting Officer

NCO 2

Effective Date: 02/01/2022 Page 5 of 5

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Brad Mills Date Branch Chief, Supply Team 1

NCO 2