Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) – Clinical Trials Optional

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Funding Opportunity ID: 312912
Opportunity Number: RFA-FD-19-011
Opportunity Title: Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) – Clinical Trials Optional
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Agriculture
Consumer Protection
Food and Nutrition
Category Explanation:
CFDA Number(s): 93.103
Eligible Applicants: State governments
Special district governments
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
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 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 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 Non-domestic (non-U.S.) Entities (Foreign Institutions) Regional Organizations
Agency Code: HHS-FDA
Agency Name: Department of Health and Human Services
Food and Drug Administration
Posted Date: Feb 13, 2019
Close Date: Apr 22, 2019
Last Updated Date: Feb 13, 2019
Award Ceiling: $3,000,000
Award Floor: $1,000,000
Estimated Total Program Funding: $6,000,000
Expected Number of Awards: 2
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.
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