FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science

ID: FDABAA-25-00123 • Type: Special Notice

Description

Posted: Feb. 26, 2025, 9:49 a.m. EST

Amendment 05 - The BAA Notice has been updated to version 6 with various changes throughout.

Amendment 04 - The BAA Notice has been updated to version 5 with various changes throughout. Table 1 and attachment 5 have also been updated and included seperately. The response date has been changed to March 04th at 1159 PM EST.

Amendment 03 - The BAA Notice has been updated to version 4 with various changes throughout, Table 1 and attachments 4 and 5 have also been updated and included seperately.

Amendment 02 - The BAA Notice has been updated to version 3 with various changes throughout.

Amendment 01 - The BAA Notice has been updated to version 2 with various changes throughout, and table 1 has been updated and included seperately.

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. Join us to learn more about the FY 2025 BAA, and how to apply.

Save the date for the 2024 FDA Broad Agency Announcement (BAA) Day! November 14th, 2024. BAA Day for FY25 2024 will be hosted on November 14th, 2024, as a virtual only event and will provide an opportunity to learn more about the application process and FDA's priorities for regulatory research.

https://www.fda.gov/science-research/advancing-regulatory-science/2024-fda-broad-agency-announcement-day-11142024

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Background
The US Food and Drug Administration (FDA), part of the Department of Health and Human Services (HHS), is soliciting proposals for basic and applied research and development to support regulatory science and innovation through this Broad Agency Announcement (BAA).

The goal is to advance scientific knowledge in specific research areas that align with the FDA's mission to protect and promote the health of the nation. This BAA is open to all responsible sources, with a strong encouragement for small businesses to participate.

Work Details
The Statement of Work (SOW) should include:

1.0 Scope: A general description of the work effort to be performed by the contractor.

2.0 Requirements: Detailed tasks that the contractor shall perform, written in complete sentences using active voice, arranged systematically and logically. Each task must be clearly explained, including adherence to any industry-specific standards.

3.0 Deliverables: Definition of deliverable products which may include monthly or quarterly progress reports (technical and financial), final reports, software (executable, source, or operational code), and hardware (contractor-acquired property, government-furnished property, prototypes).

Place of Performance
The geographic location for performance is not explicitly provided but is associated with the FDA's offices located in Silver Spring, Maryland.

Overview

Agency

FDA Office of Acquisition and Grant Services (OAGS) [HHS - FDA]

Response Deadline

March 4, 2025, 11:59 p.m. EST (original: Feb. 24, 2025, 11:59 p.m. EST) Past Due

Posted

Oct. 3, 2024, 11:24 a.m. EDT (updated: Feb. 26, 2025, 9:49 a.m. EST)

Set Aside

None

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

PSC

AJ11 - General Science And Technology R&D Services; General Science And Technology; Basic Research

Place of Performance

Silver Spring, MD 20993 United States

Source

SAM

Current SBA Size Standard

1000 Employees

Pricing

Multiple Types Common

On 10/3/24 FDA Office of Acquisition and Grant Services issued Special Notice FDABAA-25-00123 for FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science due 3/4/25.

Primary Contact

Name

Ian Weiss Profile

ian.weiss@fda.hhs.gov

Phone

(301) 796-5728

Question & Answer

Incumbent or Similar Awards

Contracts Similar to Special Notice FDABAA-25-00123

Potential Bidders and Partners

Awardees that have won contracts similar to Special Notice FDABAA-25-00123

Additional Details

Source Agency Hierarchy

HEALTH AND HUMAN SERVICES, DEPARTMENT OF > FOOD AND DRUG ADMINISTRATION > FDA Office of Acquisitions and Grants Services

FPDS Organization Code

7524-75FDA1

Source Organization Code

500035507

Last Updated

Feb. 26, 2025

Last Updated By

ian.weiss@fda.hhs.gov

Archive Date

Sept. 30, 2025