This grant, aligning with FDA guidance, aims to advance the approval of additional strengths for oral modified release drug products. Specifically, this grant is for determining the critical quality attributes of various release-controlling platform technologies. The project will also identify appropriate factors to scale formulations for new strengths, ensuring consistent drug release mechanisms and dissolution profiles. This research will address recommendations outlined in the FDA’s ‘Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (Aug 2021)’ guidance. The expected outcomes will significantly support generic drug development processes and inform regulatory decision-making regarding modified release drug products.
Opportunity ID: 344256
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-23-013 |
| Funding Opportunity Title: | Evaluation of oral modified release drug tablet to support the approval of additional strengths |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 01, 2022 |
| Last Updated Date: | Dec 01, 2022 |
| Original Closing Date for Applications: | Mar 15, 2023 |
| Current Closing Date for Applications: | Mar 15, 2023 |
| Archive Date: | Apr 14, 2023 |
| Estimated Total Program Funding: | $450,000 |
| Award Ceiling: | $450,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities Private institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) State governments Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Special district governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) City or township governments |
| Additional Information on 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 OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The FDA guidance, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (Aug 2021), provides recommendations for demonstrating the bioequivalence of additional strengths of a proposed modified release drug product. The recommendations involve evidence to demonstrate the same drug release mechanism and similar dissolution profiles across strengths, as well as ratios of drug excipients across strengths that are appropriate for the drug release mechanism. The purpose of this project is to determine the critical quality attributes for different release controlling platform technologies and to determine the appropriate factors to scale the formulation for additional strengths. The outcomes of this research are intended to support generic drug development and regulatory decision making. |
| 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
Folder 344256 Full Announcement-FULL ANNOUNCEMENT -> FINAL – RFA-FD-23-013.pdf
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-23-013 | FORMS H | PKG00278745 | Dec 01, 2022 | Mar 15, 2023 | View |
Package 1
Mandatory forms
344256 RR_SF424_5_0-5.0.pdf
344256 PHS398_CoverPageSupplement_5_0-5.0.pdf
344256 RR_OtherProjectInfo_1_4-1.4.pdf
344256 PerformanceSite_4_0-4.0.pdf
344256 RR_KeyPersonExpanded_4_0-4.0.pdf
344256 RR_Budget_3_0-3.0.pdf
344256 PHS398_ResearchPlan_5_0-5.0.pdf
344256 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
344256 RR_SubawardBudget30_3_0-3.0.pdf
344256 PHS_AssignmentRequestForm_3_0-3.0.pdf
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