This grant is for the purpose of supporting research to develop innovative in vitro test methods specifically for Transdermal and Topical Delivery Systems (TDS). The primary goal is to create methodologies that accurately correlate with, and are predictive of, TDS adhesion performance in vivo. Such methods are crucial because variations in product design, formulation, or quality attributes between a generic TDS and its reference can impact adhesion quality. The expected in vitro tests will enable the industry to identify potential adhesion-related failure modes during the development of prospective generic TDS. Furthermore, these methods will assist the FDA in robustly assessing differences in adhesion quality and performance between prospective generic TDS and their reference products, ultimately enhancing product safety and efficacy evaluation.
Opportunity ID: 336296
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-22-015 |
| Funding Opportunity Title: | In Vitro Approaches to Evaluate and Compare the Adhesion Performance of Transdermal and Topical Delivery Systems (TDS) (U01) Clinical Trial Required |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | 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: | Jan 12, 2022 |
| Last Updated Date: | Jan 12, 2022 |
| Original Closing Date for Applications: | Mar 31, 2022 |
| Current Closing Date for Applications: | Mar 31, 2022 |
| Archive Date: | Apr 30, 2022 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $1,250,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | City or township governments Private institutions of higher education County governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities State governments Native American tribal governments (Federally recognized) Small businesses Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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:o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs)o Alaska Native and Native Hawaiian Serving Institutionso 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 BusinessesFor-Profit Organizations (Other than Small Businesses)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)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. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity is to support the research to develop in vitro test methods for Transdermal and Topical delivery systems (collectively, TDS) that can correlate with and be predictive of TDS adhesion performance in vivo. Differences in product design, formulation, or quality attributes between a prospective generic TDS and it reference TDS may have the potential to alter the adhesion quality or performance of the test TDS, compared to the reference TDS. The in vitro test methods to be developed are expected to be useful for the industry to evaluate potential failure modes related to TDS adhesion during the development of prospective generic TDS, and useful in FDA’s assessment of potential differences in the adhesion quality and performance of prospective generic TDS relative to their reference TDS. |
| 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-22-015 | FORM G | PKG00271303 | Jan 14, 2022 | Mar 31, 2022 | View |
Package 1
Mandatory forms
336296 RR_SF424_5_0-5.0.pdf
336296 PHS398_CoverPageSupplement_5_0-5.0.pdf
336296 RR_OtherProjectInfo_1_4-1.4.pdf
336296 PerformanceSite_4_0-4.0.pdf
336296 RR_KeyPersonExpanded_4_0-4.0.pdf
336296 RR_Budget_3_0-3.0.pdf
336296 PHS398_ResearchPlan_4_0-4.0.pdf
336296 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
336296 RR_SubawardBudget30_3_0-3.0.pdf
336296 PHS_AssignmentRequestForm_3_0-3.0.pdf
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