Opportunity ID: 351806

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-24-008
Funding Opportunity Title: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
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: 1
Assistance Listings: 93.103 — Food and Drug Administration Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 4
Posted Date: Jan 15, 2024
Last Updated Date: Apr 02, 2024
Original Closing Date for Applications: Mar 31, 2024
Current Closing Date for Applications: Apr 08, 2024
Archive Date: Apr 30, 2024
Estimated Total Program Funding: $250,000
Award Ceiling: $250,000
Award Floor:

Eligibility

Eligible Applicants: Private institutions of higher education
For profit organizations other than small businesses
City or township governments
Native American tribal governments (Federally recognized)
Public and State controlled 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
State governments
County governments
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Public housing authorities/Indian housing authorities
Independent school districts
Special district governments
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Information on Eligibility:

Additional Information

Agency Name: Food and Drug Administration
Description:

The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products. 

Link to Additional Information: RFA-FD-24-008 Funding Opportunity Announcement
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Terrin Brown

Grantor
Email:terrin.brown@fda.hhs.gov

Version History

Version Modification Description Updated Date
The deadline has been extended to April 8, 2024. Apr 02, 2024
The closing date was incorrect on grants.gov. Jan 15, 2024
The link to the full announcement has been added. Jan 15, 2024
Jan 15, 2024

DISPLAYING: Synopsis 4

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-24-008
Funding Opportunity Title: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
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: 1
Assistance Listings: 93.103 — Food and Drug Administration Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 4
Posted Date: Jan 15, 2024
Last Updated Date: Apr 02, 2024
Original Closing Date for Applications: Mar 31, 2024
Current Closing Date for Applications: Apr 08, 2024
Archive Date: Apr 30, 2024
Estimated Total Program Funding: $250,000
Award Ceiling: $250,000
Award Floor:

Eligibility

Eligible Applicants: Private institutions of higher education
For profit organizations other than small businesses
City or township governments
Native American tribal governments (Federally recognized)
Public and State controlled 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
State governments
County governments
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Public housing authorities/Indian housing authorities
Independent school districts
Special district governments
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Information on Eligibility:

Additional Information

Agency Name: Food and Drug Administration
Description:

The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products. 

Link to Additional Information: RFA-FD-24-008 Funding Opportunity Announcement
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Terrin Brown

Grantor
Email:terrin.brown@fda.hhs.gov

DISPLAYING: Synopsis 3

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-24-008
Funding Opportunity Title: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
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: 1
Assistance Listings: 93.103 — Food and Drug Administration Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 3
Posted Date: Jan 15, 2024
Last Updated Date: Apr 01, 2024
Original Closing Date for Applications:
Current Closing Date for Applications: Apr 01, 2024
Archive Date: Apr 30, 2024
Estimated Total Program Funding: $250,000
Award Ceiling: $250,000
Award Floor:

Eligibility

Eligible Applicants: Public and State controlled institutions of higher education
County governments
Public housing authorities/Indian housing authorities
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Native American tribal organizations (other than Federally recognized tribal governments)
Independent school districts
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Private institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Special district governments
For profit organizations other than small businesses
State governments
Small businesses
Additional Information on Eligibility:

Additional Information

Agency Name: Food and Drug Administration
Description:

The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products. 

Link to Additional Information: RFA-FD-24-008 Funding Opportunity Announcement
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Terrin Brown

Grantor
Email:terrin.brown@fda.hhs.gov

DISPLAYING: Synopsis 2

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-24-008
Funding Opportunity Title: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
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: 1
Assistance Listings: 93.103 — Food and Drug Administration Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 2
Posted Date: Jan 15, 2024
Last Updated Date: Mar 14, 2024
Original Closing Date for Applications:
Current Closing Date for Applications: Mar 31, 2024
Archive Date: Apr 30, 2024
Estimated Total Program Funding: $250,000
Award Ceiling: $250,000
Award Floor:

Eligibility

Eligible Applicants: Public and State controlled institutions of higher education
County governments
Public housing authorities/Indian housing authorities
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Native American tribal organizations (other than Federally recognized tribal governments)
Independent school districts
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Private institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Special district governments
For profit organizations other than small businesses
State governments
Small businesses
Additional Information on Eligibility:

Additional Information

Agency Name: Food and Drug Administration
Description:

The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products. 

Link to Additional Information: RFA-FD-24-008 Funding Opportunity Announcement
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Terrin Brown

Grantor
Email:terrin.brown@fda.hhs.gov

DISPLAYING: Synopsis 1

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-24-008
Funding Opportunity Title: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
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: 1
Assistance Listings: 93.103 — Food and Drug Administration Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: Jan 15, 2024
Last Updated Date: Jan 15, 2024
Original Closing Date for Applications:
Current Closing Date for Applications: Mar 31, 2024
Archive Date: Apr 30, 2024
Estimated Total Program Funding: $250,000
Award Ceiling: $250,000
Award Floor:

Eligibility

Eligible Applicants: Public and State controlled institutions of higher education
County governments
Public housing authorities/Indian housing authorities
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”
Native American tribal organizations (other than Federally recognized tribal governments)
Independent school districts
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Private institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Special district governments
For profit organizations other than small businesses
State governments
Small businesses
Additional Information on Eligibility:

Additional Information

Agency Name: Food and Drug Administration
Description:

The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products. 

Link to Additional Information:
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Terrin Brown

Grantor

Phone 2404027610
Email:terrin.brown@fda.hhs.gov

Related Documents

Packages

Agency Contact Information: Terrin Brown
Grantor
Email: terrin.brown@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-24-008 FORM H PKG00284421 Jan 15, 2024 Apr 08, 2024 View

Package 1

Mandatory forms

351806 RR_SF424_5_0-5.0.pdf

351806 PHS398_CoverPageSupplement_5_0-5.0.pdf

351806 RR_OtherProjectInfo_1_4-1.4.pdf

351806 PerformanceSite_4_0-4.0.pdf

351806 RR_KeyPersonExpanded_4_0-4.0.pdf

351806 RR_Budget_3_0-3.0.pdf

351806 PHS398_ResearchPlan_5_0-5.0.pdf

351806 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf

Optional forms

351806 RR_SubawardBudget30_3_0-3.0.pdf

351806 PHS_AssignmentRequestForm_3_0-3.0.pdf

2025-07-12T02:58:24-05:00

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