Inactive

36C246-22-AP-7062 VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT Effective Date: 02/01/2022 Page 1 of 4 LIMITED SOURCES JUSTIFICATION ORDER >... 36C246-22-AP-7062 VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT Effective Date: 02/01/2022 Page 1 of 4 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C246-22-AP-7062 (1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 6, 100 Emancipation Drive, Hampton VA 23667 in support of the Durham VA Medical Center at 508 Fulton Street Durham, NC 27705. Purchase request 558-23-2-241-0003. (2) Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). This acquisition is for a new delivery order against the FSS contract number listed below. Order against: FSS Contract Number: 36F79719D0170 Name of Proposed Contractor: Progenics Pharamaceuticals, Inc. Street Address: 331 Treble Cove Rd. City, State, Zip: N. Billerica, MA, 01862 Phone: 1-800-362-2668 (3) Description of Supplies or Services: Pylarify® Piflufolastat F 18 injection is used with a PET scan (positron emission tomography) of prostate-specific membrane antigen (PSMA) to identify suspected metastasis or recurrence of prostate cancer. Injections will be ordered on an as needed basis from February 18, 2023 through December 31, 2023. Estimated usage is 520 doses. (4) Identify the Authority and Supporting Rationale FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays: FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; Progenics Pharmaceuticals is the only pharmaceutical company to carry and distribute this product. A proprietary confirmation letter has been received stating they are the sole manufacturer and authorized supplier and is documented in the contract file. FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. FAR 8.405-6(b): Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: These are direct replacements parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. (5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: Pricing on the VA NAC contract has been negotiated by the VA and represent fair and reasonable pricing. The CO will request an additional discount from the vendor. (6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Progenics corporation is the only manufacturer and provider of Pylarify. There are currently three FDA approved PSMA imaging agents. Pylarify is the only acceptable choice for the Durham VA, as it is the only F 18 based, FDA approved, PSMA imaging agent. The other two approved agents use Gallium 68 (Ga 68). There are differences between F-18 and Ga-68. One of the most important differences between F 18 and Ga 68 is the half-life of the isotope. Half-life governs the amount of time the PSMA agent is useful for, with a 68 minute half-life for Ga 68, the dose becomes unusable in a very short time after the calibration. Pylarify has an additional 40 minutes of half-life which allows more flexibility for patients that arrive late, cannot find parking, or are difficult to gain intravenous access. The opportunity to waste/lose a dose due to these issues must be avoided. Pylarify has been demonstrated to provide better spatial resolution than Ga 68 based on the different characteristics of each isotope. Vendor Information Pages (VIP) database was searched using the applicable NAICS, however no two or more service-disabled veteran-owned businesses (SDVOSBs) or veteran-owned small businesses (VOSBs) were found capable of fulfilling this requirement. The VIP query has been documented in the solicitation file. (7) Any Other Facts Supporting the Justification: None (8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions of this type to be competed.