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VHAPG Part 808.405-6 Limiting Sources VHAPG Part 808.405-6 Limiting Sources Effective Date: 02/01/2022 Page 1 of 5 Effective Date: 02/01/2022 Page 1 of 5 VHAPG Part 808.405-6 Limiting Sources Effectiv... VHAPG Part 808.405-6 Limiting Sources VHAPG Part 808.405-6 Limiting Sources Effective Date: 02/01/2022 Page 1 of 5 Effective Date: 02/01/2022 Page 1 of 5 VHAPG Part 808.405-6 Limiting Sources Effective Date: 02/01/2022 Page 1 of 5 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C261-24-AP-5157 JOFOC Tracker 25: FY25-NCO 21-16 Contracting Activity: Department of Veterans Affairs (VA), Regional Procurement Office West (RPOW), Network Contracting Office (NCO) 21, on behalf of the Veterans Integrated Service Networks (VISN) 21 VA Palo Alto Health Care System (VAPAHCS). 2237# 640-25-1-550-0005 Description of Action: This acquisition is conducted under the authority of the MultipleAward Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). The action being reviewed and approved is a new requirement for a sole source delivery order for PLUVICTO (lutetium Lu 177 vipivotide tetraxetan). Advanced Accelerator Applications USA, Inc. (AAA) is a large business. Order against: FSS Contract Number: 36F79719D0169 FSS Group 65 Name of Proposed Contractor: Advanced Accelerator Applications USA, Inc. Street Address: 57 East Willow Street City, State, Zip: Millburn, NY 07041 Phone: 646-634-6614 Description of Supplies or Services: The estimated value of the proposed action is $3,973,090.80. Pluvicto (lutetium Lu 177 vipivotide tetraxetan), with National Drug Code (NDC): 69488-0010- 61, is a radiopharmaceutical targeted therapy that was approved by the Food and Drug Administration (FDA) on March 23, 2022, for the treatment of adult veterans with prostate specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer(mCRPC). Each veteran requires 6 cycles of treatment that is provided every 6 weeks to complete treatment. This is a requirement for 120 doses for twenty (20) veterans. The Period of Performance is October 01, 2024, to September 30, 2025. 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. AAA is the sole FDA approved source of this highly specialized therapeutic radiopharmaceutical, PLUVICTO (lutetium Lu 177 vipivotide tetraxetan). There is no other radiopharmaceutical that can treat the same cancer. 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: The anticipated cost will be considered fair and reasonable utilizing the information on the price schedule under 36F79719D0169, which is active until August 31, 2025. Supplies offered on the schedule is listed at fixed prices. The VA has already determined the prices of supplies under schedule contracts to be fair and reasonable. The final contract price will be fair and reasonable as a comparison will be made with contract 36F79719D0169. (6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. The VAPAHCS has a need for the highly specialized therapeutic radiopharmaceutical, PLUVICTO (lutetium Lu 177 vipivotide tetraxetan). The North American Industry Classification System (NAICS) code is 325412 (Pharmaceutical Preparation Manufacturing)/ 1,300 employees; Product Service Code (PSC) is 6505 (Drugs and Biologicals). A Veteran Small Business Certification (VetCert) search utilizing NAICS code 325412 yielded 129 service-disabled veteran-owned small business (SDVOSB)/ veteran-owned small business (VOSB) matches. A query on the Department of Veterans Affairs (VA) National Acquisition Center (NAC) pharmaceutical catalog, using keyword Pluvicto , brought up one result from AAA that matches the radiopharmaceutical that is required. A search on the Supply Chain Master Catalog (SCMC) found a Blanket Purchase Agreement (BPA) 36C25023A0020 awarded off VA NAC 36F79719D0169. This decentralized BPA was awarded to AAA on a sole source basis. Only the local Radiation Safety Officers are authorized to place calls off the BPA. A query using keyword Pluvicto on Federal Procurement Data System (FPDS) resulted in a recent record that NCO 21 completed. The procurement history shows that this most recent contract for the VAPAHCS for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) was awarded on October 01, 2023, to AAA under 36C26124N0090, a large business, in the procurement value of $6,817,085.10 for a period of performance of one year. The procurement method was sole source against the VA Federal Supply Schedule (FSS) contract 36F79719D0169. Since Pluvicto is the first FDA approved targeted radioligand therapy (RLT) for eligible veterans with mCRPC that combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle) and was only approved on March 23, 2022, there is no reason to believe that there are any other products that can provide this type of treatment for prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). No additional market research was done. There are other drugs approved by FDA, but Pluvicto drug is used at the VAPAHCS and VA Northern California Health Care System (VANCHCS). Contract Opportunities indicated Intent to Sole Source Notice posted on SAM.gov for Pluvicto drug by other NCOs. Any Other Facts Supporting the Justification: The Contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. AAA is licensed and has provided satisfactory performance on previous orders for the VAPAHCS. 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: In the future, if another vendor supplies a suitable alternative, their qualifications will be evaluated. The market will be continually assessed to determine if other vendors can provide the required supplies. 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. HIGHER LEVEL APPROVAL (Required for orders over $750,000): VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.