The Food and Drug Administration is offering this grant to fund research that enhances understanding of complex products and improves risk-based quality assessment of new and generic drugs, including biological products like monoclonal antibodies and therapeutic proteins. The grant aims to support activities related to formulation development, analysis, and manufacturing control. Applications for this grant must be submitted by April 22, 2019, with a focus on advancing regulatory science for CDER-relevant products.
Opportunity ID: 312912
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-19-011 |
| Funding 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: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Feb 13, 2019 |
| Last Updated Date: | Feb 13, 2019 |
| Original Closing Date for Applications: | Apr 22, 2019 |
| Current Closing Date for Applications: | Apr 22, 2019 |
| Archive Date: | May 22, 2019 |
| Estimated Total Program Funding: | $6,000,000 |
| Award Ceiling: | $3,000,000 |
| Award Floor: | $1,000,000 |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities State governments Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) 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 |
Additional Information
| Agency Name: | Food and Drug Administration |
| 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. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Shashi Malhotra Grants Management Specialist Phone 2404027592 Email: shashi.malhotra@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | RFA-FD-19-011 | FORM E | PKG00248342 | Feb 13, 2019 | Apr 22, 2019 | View |
Package 1
Mandatory forms
312912 RR_SF424_2_0-2.0.pdf
312912 PHS398_CoverPageSupplement_4_0-4.0.pdf
312912 RR_OtherProjectInfo_1_4-1.4.pdf
312912 PerformanceSite_2_0-2.0.pdf
312912 RR_KeyPersonExpanded_2_0-2.0.pdf
312912 RR_Budget_1_4-1.4.pdf
312912 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
312912 RR_SubawardBudget30_1_4-1.4.pdf
312912 PHS_AssignmentRequestForm_2_0-2.0.pdf
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