Broad Agency Announcement Notice

FDABAA-27-00123

Overview Information

Agency Name: Department of Health and Human Services (HHS), Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, Maryland 20993

Issuing Office: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions & Grants Service, 4041 Powder Mill Rd. Beltsville, MD 20705

Research Opportunity Title: Food and Drug Administration Broad Agency Announcement for the Advanced Research and Development of Regulatory Science

Announcement Type: Broad Agency Announcement (BAA)

Eligible Applicants: This BAA is open to ALL responsible sources and Small Businesses are strongly encouraged to respond. Offerors may include single entities or teams from private sector organizations, Federally Funded Research and Development Centers (FFRDCs) (see page 5 for FFRDC eligibility requirements) and academic institutions.

Research Opportunity Description: The FDA solicits advanced research and development proposals to support regulatory science and innovation. The FDA anticipates that research and development activities awarded under this BAA will serve to advance scientific knowledge to accomplish its mission to protect and promote the health of our nation.

Types of instruments that may be awarded: Procurement Contracts Only [Not Grants]

Notes: Regarding Funding

To ensure sufficient time to conduct the two-tiered evaluation described in Section I and still be considered for an award within the current fiscal year, prospective Offerors are required to submit Stage One Submittal Packages with: Checklist following required template (See attachment 3) Freestanding Concept Paper following required template (See attachment 4) Freestanding Full Proposal following required template (see attachment 5)

Freestanding Concept Paper and Full Proposal shall be submitted no later than 5:00 pm, Eastern Standard Time, Friday, January 22, 2027*, and earlier if possible. Early applications are highly encouraged. A submission will be considered incomplete if any of these critical elements are missing. Stage One Submittal Packages (Checklist, Freestanding Concept Paper, and Freestanding Full Proposal) received after that date will still be accepted, but due to lack of lead time, will not be considered for award in FY27. Notice and Disclosure Regarding Incomplete/Nonconforming Stage One Submittal Packages: All Stage One Submittal Packages received in response to this announcement must be complete and comply with all instructions provided herein (Note: Part III: Proposal Preparation and Submission must be considered; it lays out the details of what is included in Stage I and Stage II Package). The FDA reserves the right to reject (or otherwise give no further consideration to) any Packages that are found to be (1) missing any pertinent information, (2) submitted in a nonconforming format, or (3) otherwise require exchanges with offerors for the FDA to complete its evaluation due to patent or latent ambiguities contained within the submittal.