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

Posted Feb 13 Closes Apr 22

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.

View on Grants.gov

Agency Contact

Shashi Malhotra Grants Management Specialist Phone 2404027592

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.

Data sourced from the SAM.gov Assistance Listings and Grants.gov. See our methodology for details. Retrieved and formatted by PlainGrants