6505--Radiopharmaceutical - Pylarify

Description

{"description":"THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. \nTHE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e).\nDISCLAIMER: This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI 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 RFI.\nSOURCES SOUGHT DESCRIPTION\nThis is NOT a solicitation announcement. This is a sources sought/RFI only. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 325412. Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement.\nThe Department of Veterans Affairs (VA), VISN 5 Network Contracting Office, is seeking sources that can provide delivery for a radiopharmaceutical used to diagnose prostate cancer metastatic disease for the DC Veterans Affairs Medical Center (DC VAMC), Nuclear Medicine Section, 50 Irving Street N.W., Washington, D.C. 20422.\nPERFORMANCE LOCATION:\nDC Veterans Affairs Medical Center (DC VAMC)\nNuclear Medicine Section, Radiology Service\nGD-122\n50 Irving Street N.W.,\nWashington, D.C. 20422\n\nPERIOD OF PERFORMANCE:\n01/01/2026-12/31/2026 plus four 12-month option periods\n\nCONTRACT TYPE:\nFirm Fixed Price Contract\n\nREQUIREMENTS:\n\nRadiopharmaceutical must diagnose prostate cancer metastatic disease.\n\nPylarify (Piflufolastat F-18 Injection) PSMA - Normal Dose 10 mCi or equal brand. Pylarify (Piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer, with suspected metastasis who are candidates for initial definitive therapy and in male veterans with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Piflufolastat F 18 binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Fluorine-18 (F 18) is a + emitting radionuclide that enables PET scanning.\n\nThe radiopharmaceutical must be F-18 based with a half-life of 109 minutes or longer, to allow a timeline for scheduling, ordering, and injecting the patient population for ideal scanning.\n\nThe Contractor shall provide and deliver the radiopharmaceutical to the Nuclear Medicine Section, Radiology Service at the DC Veterans Affairs Medical Center (DC VAMC), 50 Irving Street N.W., GD-122, Washington, D.C. 20422 Monday to Friday.\nThe contractor shall deliver the Radiopharmaceuticals within two hours in the event of emergency studies.\n\nDelivery shall be destination.\n\nThe contractor shall provide capability for online/web ordering for the contract line items. \n\nA daily packing slip should accompany all 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 Nuclear Pharmacy Management System (NMIS) for tracking purposes. \n\nThe delivery order shall specify: contract item (s) and quantity, time (s) of delivery.\n\nThe contractor will calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/-10 percent of the specified ordered dose based on specific requirements provided by the Nuclear Medicine Department based on guidelines outlined in 10 CFR Part 35. \n\nThe Contractor will ensure that all radiopharmaceuticals doses provided are compound and calibrated by or under the supervision of a certified pharmacist.\n\nThe contractor shall provide courier service that is accordance with Department of Transportation, Nuclear Regulatory Commission and other applicable regulating enabling the delivery of all Radiopharmaceuticals. \n\nAll couriers shall be licensed and shall submit all required paperwork in order to be granted access to DCVAMC.\n\nThe contractor shall provide any training or education required to meet commercial standards related to use of radiopharmaceuticals to all staff Nuclear Medicine Technologists/Physicians stationed at DCVAMC.\n\nThe contractor shall be able to work with NMIS, the current Nuclear Medicine Management program at DCVAMC. This shall allow for the receipt, inventory and proper documentation of Radiopharmaceutical doses dispensed.\n\nAccess to the Nuclear Department location during non-business hours shall be obtained by contacting the VA Police to accompany the delivery person to the nuclear medicine department and supervise the delivery.\n\nTime 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 DCVAMC Nuclear Medicine Department immediately should the inability arise to provide Radiopharmaceutical doses.\nThe contractor shall perform the required work at the DC VAMC on the specified delivery schedule.\n\nContractor must show evidence that they are an authorized distributor of the supply.\n\nPERIOD OF PERFORMANCE:\nBASE: 01-1-26 TO 12-31-26\nOPTION PERIOD 1: 01-01-27 TO 12-31-27\nOPTION PERIOD 2: 01-01-28 TO 12-31-28\nOPTION PERIOD 3: 01-01-29 TO 12-31-29\nOPTION PERIOD 4: 01-01-30 TO 12-31-30\nSUBMISSION: \nThe 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. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions:\n(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.\n(2) Is your company considered small under the NAICS code identified under this RFI?\n(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?\n(4) If you re 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?\n(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.\n(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?\n(7) Please provide general pricing for your products/solutions for market research purposes.\n(8) Please submit your capabilities in regards to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes?\n*** Submissions addressing Section (8) should show clear, compelling and convincing*** evidence that all equal to items\" meet all required salient characteristics.\nResponses to this notice shall be submitted via email to Ryan.Singletary@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Friday, October 21, 2025 at 10:00 AM EST. 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.\n\n"} Solicitation Number: 36C24526Q0074 Type: Special Notice Base Type: Special Notice NAICS: 325412 Classification Code: 6505 Response Deadline: 2025-10-24T10:00:00-04:00 Office Address: LINTHICUM, MD POC: RYAN SINGLETARY, RYAN.SINGLETARY@VA.GOV, 202-745-8000 {"description":"THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. \nTHE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e).\nDISCLAIMER: This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI 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 RFI.\nSOURCES SOUGHT DESCRIPTION\nThis is NOT a solicitation announcement. This is a sources sought/RFI only. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 325412. Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement.\nThe Department of Veterans Affairs (VA), VISN 5 Network Contracting Office, is seeking sources that can provide delivery for a radiopharmaceutical used to diagnose prostate cancer metastatic disease for the DC Veterans Affairs Medical Center (DC VAMC), Nuclear Medicine Section, 50 Irving Street N.W., Washington, D.C. 20422.\nPERFORMANCE LOCATION:\nDC Veterans Affairs Medical Center (DC VAMC)\nNuclear Medicine Section, Radiology Service\nGD-122\n50 Irving Street N.W.,\nWashington, D.C. 20422\n\nPERIOD OF PERFORMANCE:\n01/01/2026-12/31/2026 plus four 12-month option periods\n\nCONTRACT TYPE:\nFirm Fixed Price Contract\n\nREQUIREMENTS:\n\nRadiopharmaceutical must diagnose prostate cancer metastatic disease.\n\nPylarify (Piflufolastat F-18 Injection) PSMA - Normal Dose 10 mCi or equal brand. Pylarify (Piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer, with suspected metastasis who are candidates for initial definitive therapy and in male veterans with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Piflufolastat F 18 binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Fluorine-18 (F 18) is a + emitting radionuclide that enables PET scanning.\n\nThe radiopharmaceutical must be F-18 based with a half-life of 109 minutes or longer, to allow a timeline for scheduling, ordering, and injecting the patient population for ideal scanning.\n\nThe Contractor shall provide and deliver the radiopharmaceutical to the Nuclear Medicine Section, Radiology Service at the DC Veterans Affairs Medical Center (DC VAMC), 50 Irving Street N.W., GD-122, Washington, D.C. 20422 Monday to Friday.\nThe contractor shall deliver the Radiopharmaceuticals within two hours in the event of emergency studies.\n\nDelivery shall be destination.\n\nThe contractor shall provide capability for online/web ordering for the contract line items. \n\nA daily packing slip should accompany all 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 Nuclear Pharmacy Management System (NMIS) for tracking purposes. \n\nThe delivery order shall specify: contract item (s) and quantity, time (s) of delivery.\n\nThe contractor will calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/-10 percent of the specified ordered dose based on specific requirements provided by the Nuclear Medicine Department based on guidelines outlined in 10 CFR Part 35. \n\nThe Contractor will ensure that all radiopharmaceuticals doses provided are compound and calibrated by or under the supervision of a certified pharmacist.\n\nThe contractor shall provide courier service that is accordance with Department of Transportation, Nuclear Regulatory Commission and other applicable regulating enabling the delivery of all Radiopharmaceuticals. \n\nAll couriers shall be licensed and shall submit all required paperwork in order to be granted access to DCVAMC.\n\nThe contractor shall provide any training or education required to meet commercial standards related to use of radiopharmaceuticals to all staff Nuclear Medicine Technologists/Physicians stationed at DCVAMC.\n\nThe contractor shall be able to work with NMIS, the current Nuclear Medicine Management program at DCVAMC. This shall allow for the receipt, inventory and proper documentation of Radiopharmaceutical doses dispensed.\n\nAccess to the Nuclear Department location during non-business hours shall be obtained by contacting the VA Police to accompany the delivery person to the nuclear medicine department and supervise the delivery.\n\nTime 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 DCVAMC Nuclear Medicine Department immediately should the inability arise to provide Radiopharmaceutical doses.\nThe contractor shall perform the required work at the DC VAMC on the specified delivery schedule.\n\nContractor must show evidence that they are an authorized distributor of the supply.\n\nPERIOD OF PERFORMANCE:\nBASE: 01-1-26 TO 12-31-26\nOPTION PERIOD 1: 01-01-27 TO 12-31-27\nOPTION PERIOD 2: 01-01-28 TO 12-31-28\nOPTION PERIOD 3: 01-01-29 TO 12-31-29\nOPTION PERIOD 4: 01-01-30 TO 12-31-30\nSUBMISSION: \nThe 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. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions:\n(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.\n(2) Is your company considered small under the NAICS code identified under this RFI?\n(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?\n(4) If you re 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?\n(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.\n(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?\n(7) Please provide general pricing for your products/solutions for market research purposes.\n(8) Please submit your capabilities in regards to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes?\n*** Submissions addressing Section (8) should show clear, compelling and convincing*** evidence that all equal to items\" meet all required salient characteristics.\nResponses to this notice shall be submitted via email to Ryan.Singletary@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Friday, October 21, 2025 at 10:00 AM EST. 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.\n\n"}