Inactive

Objective: This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No... Objective: This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) and the Joint Program Executive Office for Chemical, biological, Radiological, and Nuclear Defense (JPEO-CBRND) is seeking information on the available capabilities and willingness of private entities (academic, non-profit, and commercial) to collaborate with the Government in the areas listed below. Background: JPM CBRN Medical, is conducting market research seeking capabilities from more than one potential source for procurement of an anthrax vaccine. Anthrax Vaccine Adsorbed (AVA) will no longer be available to the Department of Defense (DoD) from the Administration for Strategic Preparedness and Response (ASPR) Strategic National Stockpile (SNS) beginning 2024. Requirements: Candidate vaccine should have a minimum shelf life and storage of 4 years at 2-8oC (i.e., refrigerated) and have a Pre-Exposure Prophylaxis (PrEP) indication. Performance: The vaccine must be FDA approved, or able to obtain FDA approval within 6 months. Regulatory Objectives: The vaccine shall meet or exceed the quality standards established by the current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and FDA and/or International Conference on Harmonization (ICH) and International Organization for Standardization (ISO) Standards, for safety and efficacy of the product. RFI: The Respondents shall provide the following in reply to the RFI, not to exceed 11 pages in total: Company Description (2 page maximum). Provide a brief description of company history, alliances and funding emphasizing experience in vaccine development. FDA Approved Anthrax Vaccine Candidate Questions (9 page maximum) Detail your company’s FDA approved Anthrax vaccine. Provide your high-level Regulatory Strategy. What do you anticipate the cost per dose to be of your FDA approved Anthrax vaccine? What is the minimum production amount required for an Anthrax vaccine to keep your manufacturing line open? What is the maximum number (# of doses) of FDA approved Anthrax vaccine you can produce annually? Does your facility have cGMP storage capability of vaccine products? If so, what is your capacity to store vialed Anthrax vaccine? Administration: The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government security classification markings. All written responses must be received by COB on 20 October 2022. Responses should be sent by e-mail to usarmy.detrick.mcs.mbx.baa@mail.mil, with Subject Line of Responding Organization and RFI Title. Material that is advertisement only in nature is not desired. JPM Medical also manages a Broad Agency Announcement (BAA), which may be viewed on SAM.gov, keywords W911SR-22-R-CBRND at https://sam.gov/opp/66870bda25274773b3e5fa7cfd3c0e11/view. For questions related to this RFI, please email usarmy.detrick.mcs.mbx.baa@mail.mil. The Point of Contact for this RFI is Susan Ruzicka, at susan.e.ruzicka2.civ@army.mil.