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

The summary for the 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 grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.

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: 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.

Federal Grant Title:	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 Agency Name:	Food and Drug Administration (HHS-FDA)
Grant Categories:	Consumer Protection Health Science and Technology
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-21-014
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Information not provided
Current Application Deadline:	March 25th, 2021
Original Application Deadline:	March 25th, 2021
Posted Date:	December 10th, 2020
Creation Date:	December 10th, 2020
Archive Date:	April 24th, 2021
Total Program Funding:
Maximum Federal Grant Award:	$500,000
Minimum Federal Grant Award:	$200,000
Expected Number of Awards:	3
Cost Sharing or Matching:	No
Last Updated:	February 10th, 2021

Applicants Eligible for this Grant: State governments - County governments - City or township governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - Native American tribal organizations (other than Federally recognized tribal governments) - Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education - Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education - Private institutions of higher education - For-profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on Eligibility: Higher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession OtherIndependent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Link to Full Grant Announcement: Full Announcement
Grant Announcement Contact: Shashi Malhotra
Grants Management Specialist
Phone 2404027592
[email protected]
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