Closed · RFA-FD-21-014 · CFDA 93.103 · Discretionary

Development of Methods to Evaluate the Impact of Design Differences to the User Interface of Generic Drug-Device Combination Products in Comparison to their Reference Listed Drugs (U01) Clinical Trials Optional

Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.

$200K-$500K
Award range
Closed
Status
March 25, 2021
Close date
3
Expected awards

The verdict

Development of Methods to Evaluate the Impact of Design Differences to the User Interface of Generic Drug-Device Combination Products in Comparison to their Reference Listed Drugs (U01) Clinical Trials Optional is a closed discretionary listing from Food and Drug Administration that offered $200,000 -- $500,000 across 3 expected awards. Future funding cycles may be published under the same CFDA number. PlainGrants indexes 481 other opportunities from Food and Drug Administration.

$200K-$500K
award range
Closed
application status
3
expected awards
93.103
CFDA program

Archived opportunity record

Development of Methods to Evaluate the Impact… is closed (last close March 25, 2021). 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 March 25, 2021

Posted Dec 10 Closes Mar 25

Expected Awards

3

Instrument

Cooperative Agreement

Description

The goal of this project is to develop methods for evaluating the impact of differences in the design of the user interface of generic drug-device combination products in comparison to the reference listed drug (RLD). Specifically, the project should (i) investigate methods that have the potential to support the categorization of differences in the design of the user interface (minor design differences or other design differences), and (ii) explore different approaches (using in vivo and/or in vitro methods) to assess other design differences as potential alternatives to comparative use human factors (CUHF) studies. The developed methods for evaluating the impact of differences in the design of the user interface will be used by all stakeholders engaged in the development of generic drug-device combination products including regulatory agencies, the pharmaceutical industry and academia. The outcomes of this project will help improve the understanding of the factors related to design differences of the user interface that may impact substitutability between generic and RLD drug-device combination products for intended end-user groups and, thereby, support the development of generic versions of these products that can enhance and stabilize patient access to medicines they need.

Wide-open applicant board · 15 Grants.gov doors

Development of Methods to Evaluate the Impact… prints 15 distinct Grants.gov eligibility doors (State governments; County governments; City or township governments; Special district governments; +11 more). Filter fit before reading award size as demand — most applicant classes appear on the row. The extract does not mark applicant cost-sharing as required. Instrument: Cooperative Agreement. Funding-activity codes span Consumer Protection · Health · Science and Technology / R&D (CP;HL;ST). 120 other Food and Drug Administration listings share this eligibility-code string (25% of 482).

Code 00
State governments
Code 01
County governments
Code 02
City or township governments
Code 04
Special district governments
Code 05
Independent school districts
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 22
For-profit organizations other than small businesses
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

Development of Methods to Evaluate the Impact… 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