Opportunity ID: 330299
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-21-013 |
| Funding Opportunity Title: | Physiologically-based pharmacokinetic (PBPK) models to aid the development of generic dermatological products (U01) Clinical Trials Optional |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 3 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 10, 2020 |
| Last Updated Date: | Feb 16, 2021 |
| Original Closing Date for Applications: | Feb 15, 2021 |
| Current Closing Date for Applications: | Feb 18, 2021 |
| Archive Date: | Mar 17, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $500,000 |
| Award Floor: | $250,000 |
Eligibility
| Eligible Applicants: | Special district governments Small businesses 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 City or township governments County governments For profit organizations other than small businesses Private institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public housing authorities/Indian housing authorities |
| Additional Information on Eligibility: | Higher Education Institutions· Public/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 Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions 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) · Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations· Small Businesses · For-Profit Organizations (Other than Small Businesses) Governments· State 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 Other· Independent School Districts · Public Housing Authorities/Indian Housing Authorities · Native American Tribal Organizations (other than Federally recognized tribal governments) · Faith-based or Community-based Organizations · Regional Organizations · Non-domestic (non-U.S.) Entities (Foreign Institutions) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this project is to develop enhanced mechanistic physiologically-based pharmacokinetic (PBPK) models that allow the description of absorption through the skin of active ingredients applied as dermatological drug products. The developed models will be utilized to inform decisions on generic dermatological product development and to perform virtual bioequivalence assessments in support of regulatory decisions. |
| 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 |
|---|---|---|
| extend due date | Feb 16, 2021 | |
| Dec 10, 2020 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-21-013 |
| Funding Opportunity Title: | Physiologically-based pharmacokinetic (PBPK) models to aid the development of generic dermatological products (U01) Clinical Trials Optional |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 3 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 10, 2020 |
| Last Updated Date: | Feb 16, 2021 |
| Original Closing Date for Applications: | Feb 15, 2021 |
| Current Closing Date for Applications: | Feb 18, 2021 |
| Archive Date: | Mar 17, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $500,000 |
| Award Floor: | $250,000 |
Eligibility
| Eligible Applicants: | Special district governments Small businesses 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 City or township governments County governments For profit organizations other than small businesses Private institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public housing authorities/Indian housing authorities |
| Additional Information on Eligibility: | Higher Education Institutions· Public/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 Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions 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) · Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations· Small Businesses · For-Profit Organizations (Other than Small Businesses) Governments· State 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 Other· Independent School Districts · Public Housing Authorities/Indian Housing Authorities · Native American Tribal Organizations (other than Federally recognized tribal governments) · Faith-based or Community-based Organizations · Regional Organizations · Non-domestic (non-U.S.) Entities (Foreign Institutions) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this project is to develop enhanced mechanistic physiologically-based pharmacokinetic (PBPK) models that allow the description of absorption through the skin of active ingredients applied as dermatological drug products. The developed models will be utilized to inform decisions on generic dermatological product development and to perform virtual bioequivalence assessments in support of regulatory decisions. |
| 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 |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-21-013 |
| Funding Opportunity Title: | Physiologically-based pharmacokinetic (PBPK) models to aid the development of generic dermatological products (U01) Clinical Trials Optional |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 3 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 10, 2020 |
| Last Updated Date: | Dec 10, 2020 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Feb 15, 2021 |
| Archive Date: | Mar 17, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $500,000 |
| Award Floor: | $250,000 |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) County governments Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) City or township governments Small businesses State governments Nonprofits having a 501(c)(3) status with the IRS, other than 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 Private institutions of higher education For profit organizations other than small businesses |
| Additional Information on Eligibility: | Higher Education Institutions
· Public/State Controlled Institutions of Higher Education Hispanic-serving Institutions · 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 purpose of this project is to develop enhanced mechanistic physiologically-based pharmacokinetic (PBPK) models that allow the description of absorption through the skin of active ingredients applied as dermatological drug products. The developed models will be utilized to inform decisions on generic dermatological product development and to perform virtual bioequivalence assessments in support of regulatory decisions. |
| 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 |
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-21013 | FORMS F | PKG00264419 | Dec 10, 2020 | Feb 18, 2021 | View |
Package 1
Mandatory forms
Optional forms
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