Responses must be received no later than Wednesday, December 17, 2025, at 10:00AM EST. THIS SOURCES SOUGHT NOTICE IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS SOURCES SOUGHT NOTICE IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER: This Sources Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Sources Sought Notice that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Sources Sought Notice. SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a sources sought notice only. The purpose of this sources sought notice is to gain knowledge of potential qualified sources and their size classification relative to NAICS 325412. Responses to this sources sought notice will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought notice, a solicitation announcement may be published. Responses to this sources sought notice are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 5 Network Contracting Office, is seeking sources that can provide F18 PSMA PYLARIFY for the Baltimore VA Medical Center. ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 166.00 EA __________________ __________________ LIN 0001 Pylarify F-18 GRAND TOTAL __________________ STATEMENT OF WORK RADIOPHARMACEUTICAL SUPPLIES & SERVICES Objectives: The contractor will provide the resources necessary to provide F18 PSMA (PYLARIFYtm) to VA Baltimore Medical Center. Salient Characteristics: F-18 Pylarify (Piflufolastat F-18): Pylarify is a radiopharmaceutical indicated for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. It is a radioactive diagnostic agent used to identify suspected metastasis or recurrence based on elevated serum PSA levels. Pylarify is labeled with Fluorine-18 (F-18), a positron-emitting isotope with a physical half-life of approximately 110 minutes. Qualifications of Contractor: The contractor must be licensed to manufacture, preparation, or transport for commercial distribution of radiopharmaceuticals containing byproduct material for medical use under USNRC 10 CFR Part 35 Subpart C 32.72. A copy of the license must be provided to Baltimore VA Medical Center. The contractor must employ licensed Nuclear Pharmacists to oversee daily operations. A license for each pharmacist must be provided to VAMHCS. The contractor shall provide the most recent regulatory inspection report. This shall include any Notices of Violation and the corrective actions taken by the contractor. The contractor shall prepare and transport doses according to (including all updates to) manufacturer s insert instructions, DOT requirements, FDA requirements and US Pharmacopeia including USP 797 and 825. Ordering Product: The contractor shall provide capability for online/web ordering for the radiopharmaceutical. A daily packing slip should accompany all Radiopharmaceutical shipments to the Nuclear Medicine Department for all orders placed. The packing slip shall include a bar code that s compatible and also be able to be scanned into the NMIS radio-pharmaceutical system for tracking purposes. The delivery order shall specify: contract item (s) and quantity, time (s) of delivery. Radiopharmaceuticals shall be within +/- 10% of the ordered activity for the time it is calibrated. Orders from VAMHCS can be made during normal work hours 0730-1530 during workdays Monday through Friday. This excludes weekends or holidays. Delivery of Product: All packages containing radioactive material shall be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173. Compliance with all applicable regulatory bodies, including FDA and US DOT is required. All deliveries shall be made directly to the Hot Lab within the nuclear medicine department. Access to the Nuclear Department location during non-business hours shall be obtained by contacting the Baltimore VA Police to accompany the delivery person to the nuclear medicine department and supervise the delivery. The contractor radiopharmaceutical unit doses will be delivered 30 minutes prior to the calibration time. Time of delivery specified or mutually agreed to at the time of receipt of web ordering during normal duty hours and telephone orders after normal duty hours shall become mandatory upon the Contractor. Failure to perform in accordance with the delivery commitment may be grounds for termination of the contract in accordance with the provisions for default. The contractor shall notify VAMHCS Nuclear Medicine Department immediately should the inability arise to provide Radiopharmaceutical doses. Product Description: Radiopharmaceuticals shall be delivered as unit doses in shielded containers. Each unit dose shall be labeled contain, a minimum the following information Contractor s name and address Prescription/lot number Customer identification Ordering physician name Radiopharmaceutical name Calibration date/time Calibration date/time Total volume Concentration (mCi/ml) Expiration Date/time An additional label shall be affixed to the dose syringe or other container being utilized. It shall contain, at minimum, the following information: The radiopharmaceutical name The exam to be performed Date and time calibrated Prescription number Each unit dose must contain a bar code insert with above dose information so it can be scanned into the NMIS system. Quality Control: The Contractor shall perform all necessary quality control procedures in accordance with Title 10 CFR Part 35 and any other Federal/State regulations that are applicable to the radio-pharmacy industry. Each radiopharmaceutical dose shall pass quality control before dispensed to VAMHCS. Quality Control results will be furnished to VAMHCS upon request. Packaging and Packing: In accordance with accepted commercial practice and nuclear regulatory requirements. All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173. Compliance with all applicable regulatory bodies, including FDA and US DOT is requisite. An additional label shall be affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label. Place of Performance: Department of Veterans Affairs Baltimore VA Medical Center 10 N. Greene St. Baltimore MD 21201 ------------------------------------------------------------------------------------------------------------------------------ The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications. If you are interested and are capable of providing the sought-out supplies/services, please provide the requested information as well as the information indicated below. If you are interested and are capable of providing the sought-out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc. (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer or distributor of the items being referenced above (or equivalent product/solution)? What is the manufacturing country of origin of these items? (4) If you are a small business and you are an authorized distributor/reseller for the items identified above (or equivalent product/solution), do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (5) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract type and number. (6) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the referenced items/solutions available on your schedule/contract? (7) Please provide general pricing for your products/solutions for market research purposes. (8) Please submit your capabilities in regard to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? *** Submissions addressing Section (8) should show clear, compelling, and convincing*** evidence that all equal to items" meet all required salient characteristics. Responses to this notice shall be submitted via email to
[email protected]. Telephone responses shall not be accepted. Responses must be received no later than Wednesday, December 17, 2025, at 10:00AM Eastern TimeT. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this request for information. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.