Food and Drug Administration Broad Agency Announcement for the Advanced Research and Development of Regulatory Science
Award Notice Posted
- Solicitation number
- FDABAA-19-00123
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Awarded
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- Multiple
- NAICS code
- Not on record
- PSC
- Not on record
Notice details come from SAM.gov. Updated .
About this opportunity
This Broad Agency Announcement from the Food and Drug Administration awards multiple contracts totaling over $55 million to support regulatory science research initiatives. Contracts were awarded to academic and private organizations to advance projects in drug evaluation modernization, real-world evidence generation, medical product quality improvement, and clinical research methodology. Award values ranged from under $100,000 to over $5.5 million for research durations depending on proposal details and available funding to the agency.
Notice text
5 versions
Update #5 · Latest ·
Notice of Award
Please see attached document for a list of the contract numbers, award values and contractors receiving an award in FY19 in response to the FDABAA-19-00123 Broad Agency Announcement and its subsequent amendments.. Awarded Vendors: Multiple - See attachment. Contract Award Dollar Amount: Multiple contracts totaling $69,839,526.94 - See attachment. Contract Award Date: 2019-09-30.
Update #4 ·
Amendment 3: This amendment adds additional information to Section 4: Stage 2 Full Proposal Preparation (B) Volume I - Appendices regarding proposals for studies involving research on Human Subjects.
Additionally, HHSAR Clauses 352.270-4b Protection of Human Subjects (DEC 2015) and 352.211-3 Paperwork Reduction Act (DEC 2015) are added to Section 4: Stage 2 Full Proposal Preparation (F) Studies that Involve Human Subjects..
Update #3 ·
Amendment 2: Updates research areas of interest to include revisions to prior language as well as new areas of interest. Also includes updated information on proposal instructions; clauses pertaining to studies involving human subjects; and clarifies evaluation criteria. Finally, this amendment includes a Small Business Subcontracting Plan Template (required for proposals exceeding $700,000.00 and submitted by "Other than Small Business" entities). See Attachments for full announcement including Amendment 2 language and the Small Business Subcontracting Plan Template..
Update #2 ·
Amendment 1 adds an additional research area of interest (2.6 - Facilitate Development of Drug Therapies for Youth Tobacco Cessation). See attached for full announcement with amendment 1 language added..
Update #1 ·
The Food and Drug Administration (FDA) solicits for 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.
This announcement will remain open until further notice and is renewed on an annual basis..
Files
| File | Type | Posted |
|---|---|---|
| FY19_FBO_Award_Announcement.pdf | ||
| FDABAA-19-00123_-A3.pdf | ||
| HHS_Small_Business_SubK_Plan.doc | DOC document | |
| HHS_Small_Business_SubK_Plan.doc | DOC document | |
| FDABAA-19-00123_-A2.pdf | ||
| FDABAA-19-00123_-A1.pdf | ||
| FDABAA-19-00123.pdf |
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