SPECIAL NOTICE
65 -- Radiopharmaceutical Pylarify Injection Nuclear Med, CLE Supply
- Notice Date
- 2/1/2024 2:11:54 PM
- Notice Type
- Special Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- 250-NETWORK CONTRACT OFFICE 10 (36C250) DAYTON OH 45428 USA
- ZIP Code
- 45428
- Solicitation Number
- 36C25024Q0261
- Response Due
- 2/7/2024 2:00:00 PM
- Archive Date
- 05/07/2024
- Point of Contact
- Gina P. Crank, Contracting Officer, Phone: 614 625 1236, Fax: NA
- E-Mail Address
-
gina.crank@va.gov
(gina.crank@va.gov)
- Awardee
- null
- Description
- Page 1 of 1 36C25024Q0261 SPECIAL NOTICE NOTICE OF INTENT TO SOLE SOURCE Radiopharmaceutical Pylarify Injection The Department of Veterans Affairs, The Louis Stokes Cleveland Department of Veteran Affairs Medical Center, 10701 East Boulevard, Cleveland, Ohio 44106 intends to solicit and negotiate with only one source under the authority of FAR 6.302-1(a)(2), Only one responsible source and no other supplies or services will satisfy agency requirements. The VA intends to solicit and negotiate with Progenics Pharmaceuticals, Inc., a Lantheus company, 331 Treble Cove Road, N. Billerica, MA 01862 the sole manufacturer and authorized supplier of Pylarify. The Louis Stokes Cleveland VAMC, Nuclear Medicine Service, requires Pylarify, the only Prostate-specific membrane antigen (PSMA) radiotracer for PET/CT imaging used for detecting and staging of prostate cancer. Currently used for detection is Axumin, which only offers low sensitivity, also low specificity in low -value prostate-specific antigen (PSA) cohort (testing in which the harms outweigh the benefits). Pylarify agents offer more sensitive specific results. Pylarify will be replacing the current prostate radiotracer used in PET/CT; with this the Veterans get increased specificity and sensitivity. The Government believes that only this business can satisfy the agency requirements and intends to negotiate with only one source under the authority of FAR 6.302-1(a)(2), Only one responsible source and no other supplies or services will satisfy agency requirements. Other persons may identify their interest and capability by responding to this requirement by Wednesday, February 7, 2024 by 5PM EST. Such capabilities information will be used solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. All information shall be furnished at no cost or obligation to the Government. A determination by the Government not to open the requirement to competition based upon responses to this notice is solely within the discretion of the Government. No solicitation is available at this time. All inquiries must be submitted by email to Gina P. Crank at gina.crank@va.gov Enter RFQ 36C25024Q0261 Radiopharmaceutical Pylarify Injection in the email subject line. LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C250-24-AP-1143 (1) Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 10, located 2780 Airport Drive, Suite 340, Columbus, OH 43219, in support of VISN 10, Louis Stokes Cleveland VA Medical Center, 10701 East Blvd, Cleveland, OH 44106 using transaction # 541-24-2-778-0044. (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). Purchase of Pylarify (piflufolastat F-18), a radiopharmaceutical, on a limited source basis, from Progenics Pharmaceuticals, Inc., a Lantheus company. Progenics Pharmaceuticals, Inc. is the sole manufacturer and authorized supplier of Pylarify. This will be awarded as a new Firm Fixed Price delivery order. Order against: FSS Contract Number: 36F79719D0170 (ends August 31, 2024) Name of Proposed Contractor: Progenics Pharmaceuticals, Inc. Street Address: 331 Treble Cove Road City, State, Zip: N. Billerica, MA 01862 Phone: 414-336-9169 (3) Description of Supplies or Services:- Required Delivery Date March 15, 2024 August 31, 2024. The Louis Stokes Cleveland VAMC, Nuclear Medicine Service, requires Pylarify, the only Prostate-specific membrane antigen (PSMA) radiotracer for PET/CT imaging used for detecting and staging of prostate cancer. Currently used for detection is Axumin, which only offers low sensitivity, also low specificity in low -value prostate-specific antigen (PSA) cohort (testing in which the harms outweigh the benefits). Pylarify agents offer more sensitive specific results. Pylarify will be replacing the current prostate radiotracer used in PET/CT; with this the Veterans get increased specificity and sensitivity. An estimated 450 doses are needed. (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: Progenics Pharmaceuticals, Inc. a Lantheus company is the sole manufacturer and authorized supplier of Pylarify. There is no other like item(s) or product(s) available for purchase that would serve the same purpose or function and there is only one price for the above mentioned requirement because of exclusive distribution or marketing rights. 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: There is no like product available on the market. The GSA Contracting Officer has already determined the prices under this federal schedule to be fair and reasonable. In accordance with FAR 8.405-4, the contracting officer shall seek a price reduction. (6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. A VetCert search using NAICS 325412 provided one hundred and twenty-eight (128) SDVOSB and nine (9) VOSB. A search also conducted on the SBA s DSBS at https://web.sba.gov/pro-net/search/dsp_dsbs.cfm in an attempt to locate SDVOSB and VOSB concerns using the same NAICS. The search provided one thousand, two hundred and sixty one (1,261) SD/VOSB. A search using key word Pylarify resulted zero (0) SD/VOSB. The VA Rule of Two is unattainable. Progenics Pharmaceuticals, Inc., a Lantheus company and a small business is the sole manufacturer and authorized supplier of Pylarify. (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: Market research will be conducted to determine if there are more clinically effective products available to meet mission requirements. (9) 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. (This signature is the requestor s supervisor, fund control point official, chief of service or someone with responsibility and accountability.) Jaymie Claytor Supervisory Nuclear Medicine Cleveland VAMC (10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: a. Contracting Officer s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Gina P. Crank Contracting Officer NCO 10 Contracting b. 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. Adam P. Weber Branch Chief - Supply Team #1 NCO 10 Contracting Thomas P. Moore Division Chief Supply/Prosthetics NCO 10 Contracting Marie L. Smith Director of Contracting NCO 10 Contracting HIGHER LEVEL APPROVAL (Required for orders over $750,000): c. VHA RPO HCA Review and Approval: 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. _____________________________ Gerald F. Jacobs Acting Executive Director Regional Procurement Office Central (VHA)
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