Opportunity ID: 331582
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-21-019 |
| Funding Opportunity Title: | Dermal Physiologically-based Pharmacokinetic (PBPK) Models Accounting for the Absorption and Evaporation of Vehicle/Co-solvent following the Application of Generic Dermatological Products (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Science and Technology and other Research and Development |
| 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 17, 2021 |
| Last Updated Date: | Feb 17, 2021 |
| Original Closing Date for Applications: | Apr 22, 2021 |
| Current Closing Date for Applications: | Apr 22, 2021 |
| Archive Date: | May 22, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $500,000 |
| Award Floor: | $250,000 |
Eligibility
| Eligible Applicants: | City or township governments Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Private institutions of higher education Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments County governments Public and State controlled institutions of higher education Special district governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses |
| Additional Information on Eligibility: | Higher Education Institutions
Public/State Controlled Institutions of Higher Education o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Small Businesses State Governments Independent School Districts |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The overall objective of this funding opportunity is to develop an enhanced mechanistic PBPK model for generic dermatological drug products by taking account the absorption and evaporation of vehicle/co-solvent simultaneously and implementing the effect of these two dynamic processes on the permeation of drug molecule through skin. The developed model will be utilized to inform decisions on generic dermatological product development, to enhance the understanding of the effect of metamorphosis of dermatological drug products on skin absorption, and to predict the local and systemic exposure of drug molecule following topical application of dermatological drug products. |
| Link to Additional Information: | RFA-FD-21-019 – 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
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-21-019 | FORMS F | PKG00265470 | Feb 17, 2021 | Apr 22, 2021 | View |
Package 1
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