Inactive

The Minneapolis VA Medical Center requires the purchase of the following Radiopharmaceuticals: Axumin (Fluciclovine F 18) 10 mCi Amyvid (Florbetapir F 18) 10 mCi Tauvid (Flortaucipir F 18) 10 mCi Ceri... The Minneapolis VA Medical Center requires the purchase of the following Radiopharmaceuticals: Axumin (Fluciclovine F 18) 10 mCi Amyvid (Florbetapir F 18) 10 mCi Tauvid (Flortaucipir F 18) 10 mCi Cerianna (Fluoroestradiol F 18) 6 mCi Posluma (Flotufolastat F 18) 8 mCi. This will be a Brand Name or Equal procurement. This is a SOURCES SOUGHT NOTICE only looking for businesses to provide the supplies listed in the Preliminary Statement of Work below for market research purposes. No proposals are being requested or accepted with this notice. THIS IS NOT A SOLICITATION FOR PROPOSALS OR PRICING AND NO CONTRACT SHALL BE AWARDED FROM THIS NOTICE. This notice shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. Responses to this notice will be treated only as information for the Government to consider as part of their market research efforts. The information provided will be used by the Government in developing its acquisition strategy regarding possible set aside for Veteran Owned and other socio-economic categories of small business. Interested parties are responsible for adequately marking proprietary, restricted or competition sensitive information contained in their response. The Government does not intend to pay for the information submitted in response to this notice and parties responding will not be entitled to payment for direct or indirect costs incurred in responding to this notice. The North American Industry Classification System (NAICS) code for this requirement is 325412, Pharmaceutical Preparation Manufacturing, with an SBA Small Business Size Standard of 1,300 employees. If you are a vendor capable of providing the requested information and required supplies described below with competitive pricing, send your information with a description of proof of capability and answers to ALL quesitons to: Alisha.Milander@va.gov on or before Monday, July 28, 2025 at 12:00 PM Central Time. Please provide answers as appropriate to the following questions in the table below with your response to this Sources Sought. Failure to respond accurately to the following questions may affect the acquisition strategy.  Failure to respond to the questions at all will result in your response being determined as non-responsive. 1. Please provide all socio-economic categories of your firm (e.g., SDVOSB, VOSB, WOSB, Large Business, 8a, etc.) as well as your firm s SAM Unique Entity ID number (replaces DUNS number) and Government Contract POC. 2. Identify if your organization is the manufacturer of the requested supplies. If you are not the manufacturer, identify the manufacturer of the supplies that you will provide and their socio-economic category.  3. Identify whether any foreign-end products, as defined in FAR Provision 52.225-2, would be provided to meet this requirement. Fill out the certificate under FAR Provision 52.225-2(b), identifying the item and its country of origin. ( https://www.acquisition.gov/far/part-52#FAR_52_225_2__d3401e52). If the product is a US domestic end product, write in USA for the item's country of origin. 4. State whether any of the requested supplies may be ordered against a government contract awarded to your organization (e.g Federal Supply Schedule (FSS), General Services Administration (GSA), etc.). 5. Address whether your organization meets the requirements of 13 CFR 121.406 (b)(1)(i), (b)(1)(ii) and (b)(1)(iii) (https://www.ecfr.gov/current/title-13/chapter-I/part-121/subpart-A/subject-group-ECFR0fca5207262de47/section-121.406#p-121.406(b)). 6. Provide estimated shipping and delivery information for the requested supplies (e.g. Expected lead time on delivery). *If applicable, FAR Provision 52.219-14 Limitations on Subcontracting, will apply to the potential solicitation if set-aside for Small-Businesses.* *If applicable, VAAR 852.219-76 VA Notice of Limitations on Subcontracting Certificate of Compliance for Supplies and Products, will apply to the potential solicitation if set-aside for Veteran Owned Small-Businesses.* *If applicable, VAAR 852.212-71 Gray Market Items, will apply to the potential solicitation.* DISCLAIMER This Sources Sought is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Sources Sought that is marked as proprietary will be handled accordingly. In accordance with 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. The deadline for this information is 12:00 PM Central Time on, Monday, July 28, 2025. PRELIMINARY STATEMENT OF WORK General: The purpose of this contract is to provide the Minneapolis Veteran Affairs Health Care System with Brand Name or Equal Radiopharmaceutical agents and provide the delivery of those agents to the Nuclear Medicine Department, Minneapolis Veterans Affairs Health Care System, One Veterans Drive, Minneapolis, MN 55472, here in referred to as MVAHCS. Period of Performance: This shall be a five-year IDIQ with ordering periods as follows: Ordering Period 1: 10/01/2025 to 09/30/2026 Ordering Period 2: 10/01/2026 to 09/30/2027 Ordering Period 3: 10/01/2027 to 09/30/2028 Ordering Period 4: 10/01/2028 to 09/30/2029 Ordering Period 5: 10/01/2029 to 09/30/2030 Estimated Quantities: The quantities listed in the Price/Cost Schedule are estimated requirements based on historical usage. The MVAHCS attempts to be as accurate as possible when providing estimated quantities; however, actual quantities required may vary from quantities as listed. MVAHCS does not guarantee to order the quantities listed. The unit prices supplied that are quoted to the NCO 23 Contracting Officer shall apply to the quantities actually ordered by Authorized Ordering Individuals. All products will be requested on an on demand, as needed basis order via phone or email by MVAHCS authorized personnel only. Authorized Ordering Individuals are MVAHCS Nuclear Medicine Technologists and the COR (Contracting Officer s Representative). The quantities listed in the schedule of items are estimates. Schedule of Items Ordering Period 1: 10/01/2025 to 09/30/2026 CLIN Product # Description Estimated Annual Qtys 0001  Axumin (Fluciclovine F 18) 3 0002  Amyvid (Florbetapir F 18) 2 0003  Tauvid (Flortaucipir F 18) 1 0004  Cerianna (Fluoroestradiol F 18) 2 0005 Posluma (Flotufolastat F 18) 150 0006 Delivery charges per shipment 1 Ordering Period 2: 10/01/2026 to 09/30/2027 CLIN Product # Description Estimated Annual Qtys 1001  Axumin (Fluciclovine F 18) 3 1002  Amyvid (Florbetapir F 18) 2 1003  Tauvid (Flortaucipir F 18) 1 1004  Cerianna (Fluoroestradiol F 18) 2 1005 Posluma (Flotufolastat F 18) 150 1006 Delivery charges per shipment 1 Ordering Period 3: 10/01/2027 to 09/30/2028 CLIN Product # Description Estimated Annual Qtys 2001  Axumin (Fluciclovine F 18) 3 2002  Amyvid (Florbetapir F 18) 2 2003  Tauvid (Flortaucipir F 18) 1 2004  Cerianna (Fluoroestradiol F 18) 2 2005 Posluma (Flotufolastat F 18) 150 2006 Delivery charges per shipment 1 Ordering Period 4: 10/01/2028 to 09/30/2029 CLIN Product # Description Estimated Annual Qtys 3001  Axumin (Fluciclovine F 18) 3 3002  Amyvid (Florbetapir F 18) 2 3003  Tauvid (Flortaucipir F 18) 1 3004  Cerianna (Fluoroestradiol F 18) 2 3005 Posluma (Flotufolastat F 18) 150 3006 Delivery charges per shipment 1 Ordering Period 5: 10-01-2029 to 09-30-2030 CLIN Product # Description Estimated Annual Qtys 4001  Axumin (Fluciclovine F 18) 3 4002  Amyvid (Florbetapir F 18) 2 4003  Tauvid (Flortaucipir F 18) 1 4004  Cerianna (Fluoroestradiol F 18) 2 4005 Posluma (Flotufolastat F 18) 150 4006 Delivery charges per shipment 1 Deliveries: Deliveries shall be made to one of MVAHCS hot rooms, to be specified at the time of ordering by MVAHCS: Location 1: VA Medical Center, Bldg 70, Room BW101D Warehouse (90D), PO #: ________ One Veterans Drive Minneapolis, MN 55417 Location 2: VA Medical Center, Bldg 70, Room BV113 Warehouse (90D), PO #: ________ One Veterans Drive Minneapolis, MN 55417 Between 8:00am and 3:30pm, Monday-Friday except Federal Holidays. The Federal Holidays (actual days observed by the Federal Government) are: New Year s Day Martin Luther King s Birthday Washington s Birthday Memorial Day Juneteenth National Independence Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day And any day specifically declared by the President of the United States to be a national holiday. Note: If the federal holiday falls on a Saturday it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday. All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain the vendor s name, purchase order number, date of order, date of delivery, itemized list of products furnished (including product description), and quantity shipped. All products are purchased subject to acceptance by the MVAHCS, Nuclear Medicine Service. Products will be rejected and may be discarded if found unsatisfactory when they are received, or later if deterioration of the product occurs before the outdate. The MVAHCS shall not be financially liable for unacceptable radiopharmaceutical agents. At no time shall delivery driver leave radioactive material unattended in facility. All deliveries shall be delivered directly to the nuclear medicine department in one of their hot rooms . Requirements: Contractor must be licensed by the State of Minnesota. Additionally, Contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Contractor must provide copies of these licenses and certifications upon request of the Contracting Officer. All products provided under this contract shall meet all requirements of the Nuclear Regulatory Commission. All products provided under this contract shall be packaged and shipped in accordance with the requirements of the Nuclear Regulatory Commission (NRC) and Department of Transportation (DOT). All products returned will also be packaged in accordance with the requirements of the NRC and the DOT. All products provided under this contract shall be in compliance with all OSHA manufacturing, packaging and shipping regulations. All labeled products shall be LEU-derived radiopharmaceuticals where applicable and available. Contractor shall guarantee the quality of all radiopharmaceuticals. Contractor shall provide quality control on each agent dispensed. Contractor shall provide complete documentation on quality Control results upon request. Contractor shall provide documentation of inventory, disposal and patient dose records, which documents compliance with Nuclear Regulatory Commission (NRC) requirements and MVAHCS Radioactive Material License (RAM). Contractor shall be capable of providing the radiopharmaceuticals and estimated quantities necessary to provide operation levels. Types and quantities of product may change throughout the course of the contract. Contractor/supplier shall abide by (CFR 10) Title 10 Code of Federal Regulations, which states: Title 10 Code of Federal Regulations is available at: http://www.nrc.gov/reading-rm/doc-collections/cfr/. A licensee may use for medical use only: Byproduct material manufactured, labeled, packaged, and distributed in accordance with a license issue pursuant to the regulations in Title 10, Code of Federal Regulations, part 30 and SS32.72, or 32.74 of this chapter or the equivalent regulations of an Agreement State: Reagent kits that have been manufactured, labeled, packed, and distributed in accordance with the approval by the Commission pursuant to S32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all federal and state regulations. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE on the outside of the carton in which it is shipped. Contractor must provide a copy of their laboratory s current quality control manual and must be willing to discuss any discrepancies in lab results, which do not fit the clinical picture. Contractor must test all products for Quality Control periodically and only those products that pass quality control may be sent to the VA. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request. Contractor must assign to this medical center an individual sales representative to aide in facilitation in the smooth coordination between the medical center and laboratory pharmacy. Contractor must provide current material safety data sheets in a in a binder and updates as necessary on all delivered products for each medical center or the contractor must provide their website link where MSDS and package inserts for all radiopharmaceuticals can be read and printed. Contractor may provide patient orientation education video presentations and other appropriate material as deemed necessary by the medical center. Contractor may provide appropriate signs and posters alerting patients, employees, and the public of safety precautions in handling of radioactive materials. Contractor must replace any items delivered in error at no cost to the government. Contractor must label all products as to the amount of radiopharmaceutical, preparation time, expiration time and date, etc. Contractor must follow all USP 797 guidelines and provide verification of compliance upon Contracting Officer request. No Employee status: The contractor shall be responsible for protecting the Contractor s staff furnishing services. To carry out this responsibility, the Contractor shall provide or certify that the following are provided for all their staff providing services under the resultant contract: Workers compensation Professional liability insurance Health examinations Income tax withholding, and FICA and Medicare tax withholding TRANSPORTATION: Contractor personnel, drivers and alternates, shall be able to read, write, speak, and understand the English language. Personnel shall present a neat appearance and be easily recognized as a Contractor employee by wearing an identification badge that includes the company s name/logo and employee name and photograph. Vehicles used during this service shall prominently display the company s name/logo. Contractor must ensure that courier service/drivers maintain their Motor Carrier Permit, hazardous material license number, certificate of training of couriers (employees), valid state-issued drivers licenses, vehicle insurance and registration. Contractor shall be required to maintain a record log of courier deliveries, indicating time and date, number, and description of items for each location, along with signatures. Contractor will be responsible for all reimbursement of the original and/or repeat items because of mishandling or loss. All vehicles are to be insured in accordance with the regulations of the State of Minnesota at the expense of the contractor. Billing/Invoices: Contractor must submit a weekly invoice to the COR, in arrears, showing period covered, billing date, name of preparation, quantity, and amount. The invoices shall contain the following information at a minimum: Purchase Order Number Name of Radiopharmaceutical agent The quantity provided The unit/unit cost Total price Contractor shall add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the cost of the Contractor. Replacements must be received within 48 hours of notification by the VA. Contractor shall provide upon request a detailed description of the test to be performed, as provided by the manufacturer. Billings rendered by the Contractor to the MVAHCS for services furnished under the terms of this contract shall be billed in full. Neither beneficiary, his/her insurer, nor any other third party shall be billed. Payments for services will be at the rates specified in the Price/Cost Schedule. Payment shall only be made for actual services rendered and items that are received and found acceptable.