SAM #FDABAA-27-00123

FDA FY27 Broad Agency Announcement for Regulatory Science Research and Development

The FDA is seeking research and development proposals to advance regulatory science under its FY 2027 Broad Agency Announcement (BAA). - Agency: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Office of Acquisitions & Grants Service. - Opportunity: A continuously open BAA for basic and applied research with potential regulatory application. This is a procurement for contracts, not a grant program. - Who may respond: Responsible sources, including businesses, academic institutions, and eligible research organizations. - Research priorities: Proposals should address one or more FDA priority areas, including regulatory review, nonclinical research and clinical trials, domestic manufacturing, antimicrobial resistance, medical countermeasures, medical-product cybersecurity, shortages and supply chains, post-market surveillance, aging and longevity, animal health, digital health, generic drugs, mental health, neurological disorders, oncology, pediatric health, rare diseases, regenerative medicine, women's health, substance use disorders, and tobacco and nicotine. - Submission timing: Stage One packages for FY27 consideration are due January 22, 2027, at 5:00 p.m. Eastern. The October 30, 2026 amendment moved the deadline earlier from February 1, 2027. The open submission period runs through September 21, 2027; later submissions may be considered for FY28. If FDA requests a revised proposal, it is due within 14 days. - Awards and duration: FDA anticipates multiple awards, depending on proposal merit and available funds. Offerors may propose a base period and options, with a maximum total period of five years. No specific funding amount or contract value is stated. - Procurement scope: Offerors define the specific research scope, approach, methods, deliverables, and proposed costs. No particular products, manufacturers, part numbers, or quantities are identified. - Current attachments: The attachment list is unchanged and includes the BAA notice, a statement-of-work template, and a cost appendix/proposal template. The notice archive date is September 30, 2027.

Description

Amendment 001 - 10/30/26 - Updated the proposal due date from 2/1/27 at 5:00 pm to 1/22/27 at 5:00 pm. Updated the Special Notice Archive date from 15 days after response date to 09/30/27.

In accordance with FAR 6.102(d)(2) and 35.016, the US Food and Drug Administration (FDA) solicits for the acquisition of basic and applied research and development proposals to support regulatory science and innovation through this Broad Agency Announcement (BAA). Research and development activities acquired under this BAA are intended to advance scientific knowledge in specific research areas as well as sub areas of interest defined within the BAA that serve the FDA in accomplishing its mission to protect and promote the health of our nation. Proposals submitted under this announcement are not limited solely to the PSC code "AJ11" specified in this announcement. 

FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. 

View original listing