Cooperative Agreement to Support Regulatory Research Related to the 2023 Prescription Drug User Fee Act

The primary objective of this effort is to provide supporting research, identify key issues, and convene appropriate subject matter experts to help inform major regulatory science initiatives related to FDA commitments under the 2022 reauthorization of the Prescription Drug User Fee Act (PDUFA VII) and


Biosimilars User Fee Act (BsUFA III).
Related Programs

Food and Drug Administration_Research

Department of Health and Human Services


Agency: Department of Health and Human Services

Office: Food and Drug Administration

Estimated Funding: $4,500,000


Relevant Nonprofit Program Categories



Obtain Full Opportunity Text:
FULL ANNOUNCEMENT

Additional Information of Eligibility:
Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs)Alaska Native and Native Hawaiian Serving InstitutionsAsian 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 BusinessesFor-Profit Organizations (Other than Small Businesses)Local GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U. S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional Organizations

Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-023.html

Contact:


Agency Email Description:
shashi.malhotra@fda.hhs.gov

Agency Email:


Date Posted:
2022-12-01

Application Due Date:


Archive Date:
2023-04-12



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