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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... 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: 36C250-22-AP-6933 (1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10, located at 24 Frank Lloyd Wright Drive, Ann Arbor, MI 48105 in support of VISN 10 VA Ann Arbor Healthcare System at 2215 Fuller Road, Ann Arbor, MI 48105. 2237: 506-23-1-020-0004. (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). New requirement for the purchase of radioactive drug Lutetium Lu177 Vipivotide Tetra (PLUVICTO). Order against: FSS Contract Number: 36F79719D0169 Name of Proposed Contractor: Advance Accelerator Applications USA, Inc. Street Address: 57 East Willow Street City, State, Zip: Millburn, NY, 07041 Phone: 201-314-3345 (3) Description of Supplies or Services: Nuclear Medicine is requesting procurement of radioactive drug Lutetium Lu177 Vipivotide Tetraxetan (PLUVICTO) used for therapy treatment of metastatic castrate resistant prostate cancer from FDA approved sole source vendor Advance Accelerator Applications USA, Inc. This radioactive therapy drug is to be ordered and received by trained Nuclear Medicine staff only. Estimated period of performance: 12/1/2022 11/30/2025. (4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor s unique qualifications to provide the required supply or service. 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; This is currently the only product that is FDA approved. The radioactive drug Lutetium Lu177 Vipivotide Tetraxetan (PLUVICTO) is manufactured and distributed by a sole vendor due to guidelines in FDA approval. All Nuclear Medicine radioactive drug agents are unique and highly specialized. Advance Accelerator Applications USA, Inc. has been contacted and they have confirmed they are the only source and they do not have distributors. 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: Advance Accelerator Applications USA, Inc. is the first and only FDA approved commercial manufacture of Lutetium Lu177 Vipivotide Tetraxetan (PLUVICTO) for metastatic castrate resistant prostate cancer binding to PSMA11 receptor cells for radioactive therapy. There is no generic form or other manufacturer. Products are on a NAC contract and therefore the pricing has already been deemed fair and reasonable. (6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. VIP was queried with NAICS 325412 and 91 concerns were found. A keyword pluvicto was added and there were 0 concerns found. The VA Rule of Two cannot be met. Advanced Accelerator Applications USA, Inc. is the manufacturer and the only vendor with these items on their NAC contract 36F79719D0169. They have confirmed that they have no distributors. A Sources Sought 36C25023Q0043 was posted to Contract Opportunities from 10/3/2022 10/11/2022 with no responses. Items are manufactured in Italy (a TAA/WTO country). Because this is a national contract, any BAA/TAA issues regarding the items on contract and use of the contract were addressed at time of award and any subsequent delivery orders would thereby be covered as a result. Therefore, the Contracting Officer believes that placing an order against this contract would be in line with any BAA requirements and does not require any further action. Recommend FSS Sole Source to Advanced Accelerator. (7) Any Other Facts Supporting the Justification: There are no other facts supporting the justification. (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: Should a requisition of this nature recur, the market will be surveyed.