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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 w…
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