6505--Request for Infromation - U.S. Produced Pharmaceuticals

REQUEST FOR INFORMATION Page 4 of 4 U.S. Department of Veterans Affairs U.S. Produced Pharmaceuticals Request for Information Company Name: _________________________ Pursuant to Executive Order (EO) 13944, the Department of Veterans Affairs (VA) is conducting market research to identify sources of U.S. Produced Pharmaceuticals. At this time, VA is seeking to collect information. There is no guarantee that a solicitation will be issued or that any future solicitation would include all of the products attached to this questionnaire. VA understands that many pharmaceuticals rely on ingredients from all over the world. While worldwide supply chains create cost efficiencies, they create potential vulnerabilities and disruptions for the U.S. supply chain, which can put patient safety at risk. This market research seeks information necessary to assess whether procurement opportunities for U.S. produced pharmaceuticals exist that can mitigate these risks. VA s highest priority is identifying pharmaceuticals that fully qualify as U.S.-Produced under EO 13944; however, VA also places significant value on products that incorporate any U.S. manufacturing activity, including domestic production of critical inputs, intermediate steps, or final processing. Specifically, VA is seeking to identify pharmaceuticals that are produced in the U.S., as defined in EO 13944 (August 6, 2020) An Essential Medicine or Medical Countermeasure is produced in the United States if the Critical Inputs used to produce the Essential Medicine or Medical Countermeasures are produced in the United States and if the Finished Drug Product or Finished Device, are manufactured, prepared, propagated, compounded, or processed, as those terms are defined in section 360(a)(1) of title 21, United States Code, in the United States. Exec. Order No. 13944, 85 FR 49929, 49933 (August 6, 2020) Pharmaceuticals of particular interest are listed on Attachment 1. Please complete all columns in yellow. For the columns requesting the origin of various ingredients and components, please indicate the origin country. This information will allow VA to verify whether the pharmaceutical is wholly U.S.-produced, consistent with EO 13944 and the definition provided above. Please provide any additional information about your company s product or your company s understanding of the market conditions/availability of the product in general in the comments column. See the definitions tab of the spreadsheet for further information about each category. Please also provide a response to the following: Is your Company able to meet the following minimum requirements: National Drug Code (NDC): Offerors shall provide a separate and distinct eleven-digit NDC number unique to the offeror (e.g., 00012-3456-78) for each product proposed. The first five numbers of the eleven-digit NDC number (known as the labeler code) for each product proposed shall identify the offeror. Additionally, the successful offeror/contractor s label with its unique NDC shall be the only label on the product. Contractors shall not affix their label over another label on the product. Does your company have a unique NDC (Labeler Code)? _____________ If the offeror is not the manufacturer of the offered items, the offeror shall submit a letter of commitment from the manufacturer to the offeror which will assure the offeror a source of supply sufficient to satisfy the Government's requirements for the contract period. As noted, this may include that each offeror will maintain at least six months of stock for each awarded pharmaceutical. Name of Manufacturer: _________________ Would you be able to provide a letter of commitment from the manufacturer for all pharmaceuticals that your company is interested in offering? _____________ Pharmaceutical Prime Vendor: All Ordering Activities under the Department of Veterans Affairs and Department of Defense acquire their pharmaceutical requirements through their Pharmaceutical Prime Vendor Program (PPV). The contractor shall ensure that chargeback agreements with the PPVs have been executed with sufficient time to permit the PPVs to begin timely distribution of Government orders, if an award is made. Does your company currently have a business-to-business agreement with the PPVs?_________ Under NAICS code 325412, is your company size (check one): Large Business ______ Small Business ______ If a small business, does your company manufacture (measure, weigh, mix, and compound) at least 50% of any or all of the products?_________ Please explain below what length of contract your company would be interested in. VA s goal is to establish a contract with a one-year base period plus four one-year option periods, which provide our customers with continuity and consistency of product by allowing long-term purchases of your product. _____________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ If an award were to be made based on the above requirements, would your company be able to begin supplying the product in the estimated quantities within 60 days of the contract award date? If not, please provide an estimated timeframe to prepare, providing any relevant details. ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ If your company is uninterested or incapable in/of participating, please respond and provide as much background information possible. This aids our market research for future procurements. ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________ Please provide your responses and completed spreadsheet to [email protected], [email protected], and [email protected]. If you could provide your responses to by next Thursday, June 24, 2026, it would be greatly appreciated. Please address all questions to the names noted above. DISCLAIMER 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. 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 RFI.