Closed · RFA-FD-19-011 · CFDA 93.103 · Discretionary
Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- $1M-$3M
- Award range
- Closed
- Status
- April 22, 2019
- Close date
- 2
- Expected awards
The verdict
Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional is a closed discretionary listing from Food and Drug Administration that offered $1,000,000 -- $3,000,000 across 2 expected awards. Future funding cycles may be published under the same CFDA number. PlainGrants indexes 481 other opportunities from Food and Drug Administration.
- $1M-$3M
- award range
- Closed
- application status
- 2
- expected awards
- 93.103
- CFDA program
Archived opportunity record
Enhancing Regulatory Science for the Risk Bas… is closed (last close April 22, 2019). The parent program page for CFDA 93.103 is the reliable place to catch re-announcements. Food and Drug Administration still indexes 481 other opportunities here.
According to Grants.gov (extract vintage 2026-08-10), this record reflects the officially published listing. See methodology.
Deadline tracker
Application window closed
Closed April 22, 2019
Est. Total Funding
$6,000,000
Expected Awards
2
Instrument
Cooperative Agreement
Description
The purpose of this program is to support research activities that expand the knowledge base related to complex products and formulation development, analysis, and manufacturing control to advance risk-based quality assessment of new and generic drug products. We will also consider biological products relevant to CDER (e.g., monoclonal antibodies and therapeutic proteins) for this announcement.
Market-open applicant set · includes for-profit door
The eligibility set for Enhancing Regulatory Science for the Risk Bas… includes a for-profit door among 11 printed types (State governments; Special district governments; Public / state-controlled institutions of higher education; Federally recognized tribal governments; +7 more). Competitive traffic can include commercial applicants alongside other listed classes. The extract does not mark applicant cost-sharing as required. Instrument: Cooperative Agreement. Funding-activity codes span Agriculture · Consumer Protection · Food and Nutrition (AG;CP;FN). Inside Food and Drug Administration's indexed book this exact eligibility-code string is unique to this listing.
- Code 00
- State governments
- Code 04
- Special district governments
- Code 06
- Public / state-controlled institutions of higher education
- Code 07
- Federally recognized tribal governments
- Code 08
- Public / Indian housing authorities
- Code 11
- Native American tribal organizations (other than Federally recognized tribal governments)
- Code 12
- Nonprofits with 501(c)(3) status (other than IHEs)
- Code 13
- Nonprofits without 501(c)(3) status (other than IHEs)
- Code 20
- Private institutions of higher education
- Code 23
- Small businesses
- Code 25
- Others (see official listing text)
Codes are Grants.gov eligibility category values from the extract vintage 2026-08-10. Confirm the full eligibility statement on the official listing or the Grants.gov eligibility reference.
Official Listing on Grants.gov
View full details, application forms, and submission instructions.
Parent Grant Program
Food and Drug Administration Research
U.S. Department of Health and Human Services
Agency Contact
Shashi Malhotra Grants Management Specialist Phone 2404027592
More from Food and Drug Administration
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Education and Outreach to Tribal Producers through the Tribal Food Safety Alliance
Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional
What to do next
Enhancing Regulatory Science for the Risk Bas… is closed; use the parent program and agency catalog for the next funding cycle.
- Parent CFDA 93.103 may publish future NOFOs under the same assistance listing. Open program
- Food and Drug Administration Research indexes 42 Grants.gov listings in this extract. Program profile
- Food and Drug Administration lists 481 other indexed opportunities on PlainGrants. Agency catalog
Opportunity deadlines and eligibility change on Grants.gov; PlainGrants mirrors the extract and is not the submission system.
Disclaimer: This information is sourced from Grants.gov and SAM.gov and is for informational purposes only. Opportunity details, deadlines, and eligibility requirements change frequently. Always verify current information directly on Grants.gov before applying. PlainGrants is not affiliated with any federal agency.
Read our methodology - how this data is sourced, computed, and verified.
| Publisher | PlainGrants |
| Sources | the SAM.gov Assistance Listings and Grants.gov |