Opportunity ID: 354573
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-216 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | May 29, 2024 |
| Last Updated Date: | May 29, 2024 |
| Original Closing Date for Applications: | Jan 29, 2027 Application Due Dates are as follows: July 29, 2024; January 31, 2025; July 25, 2025; January 30, 2026; July 24, 2026; January 29, 2027 |
| Current Closing Date for Applications: | Jan 29, 2027 Application Due Dates are as follows: July 29, 2024; January 31, 2025; July 25, 2025; January 30, 2026; July 24, 2026; January 29, 2027 |
| Archive Date: | Feb 28, 2027 |
| Estimated Total Program Funding: | $250,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Native American tribal governments (Federally recognized) County governments For profit organizations other than small businesses Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Independent school districts State governments Public and State controlled institutions of higher education |
| Additional Information on Eligibility: | • Faith-based or Community-based Organizations• Regional Organizations• Non-domestic (non-U.S.) Entities (Foreign Organizations) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
This Notice of Funding Opportunity (NOFO) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop or support the development of designated new animal drugs intended for minor uses in major species or for use in minor species (MUMS). The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing that could be used to satisfy the requirements for FDA approval of MUMS-designated drugs. Only entities developing drugs for veterinary use or parties working as research partners with such entities are eligible for grants. The organization (or applicant) seeking approval of the new animal drug under investigation must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species “designation” granted by FDA/CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use, in accordance with the provisions of section 573 of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR part 516. FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must have reviewed and concurred with the proposed study protocol before an applicant can submit a grant application. |
| Link to Additional Information: | PAR-24-216 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 |
|---|---|---|
| Close date updated. | May 29, 2024 | |
| Clarification on close date has been added. | May 29, 2024 | |
| Link Description has been added. | May 29, 2024 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-216 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | May 29, 2024 |
| Last Updated Date: | May 29, 2024 |
| Original Closing Date for Applications: | Jan 29, 2027 Application Due Dates are as follows: July 29, 2024; January 31, 2025; July 25, 2025; January 30, 2026; July 24, 2026; January 29, 2027 |
| Current Closing Date for Applications: | Jan 29, 2027 Application Due Dates are as follows: July 29, 2024; January 31, 2025; July 25, 2025; January 30, 2026; July 24, 2026; January 29, 2027 |
| Archive Date: | Feb 28, 2027 |
| Estimated Total Program Funding: | $250,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Native American tribal governments (Federally recognized) County governments For profit organizations other than small businesses Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Independent school districts State governments Public and State controlled institutions of higher education |
| Additional Information on Eligibility: | • Faith-based or Community-based Organizations• Regional Organizations• Non-domestic (non-U.S.) Entities (Foreign Organizations) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
This Notice of Funding Opportunity (NOFO) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop or support the development of designated new animal drugs intended for minor uses in major species or for use in minor species (MUMS). The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing that could be used to satisfy the requirements for FDA approval of MUMS-designated drugs. Only entities developing drugs for veterinary use or parties working as research partners with such entities are eligible for grants. The organization (or applicant) seeking approval of the new animal drug under investigation must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species “designation” granted by FDA/CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use, in accordance with the provisions of section 573 of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR part 516. FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must have reviewed and concurred with the proposed study protocol before an applicant can submit a grant application. |
| Link to Additional Information: | PAR-24-216 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: | PAR-24-216 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | May 29, 2024 |
| Last Updated Date: | May 29, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | – Application Due Dates are as follows: July 29, 2024; January 31, 2025; July 25, 2025; January 30, 2026; July 24, 2026; January 29, 2027 |
| Archive Date: | Feb 28, 2027 |
| Estimated Total Program Funding: | $250,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Small businesses Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities State governments |
| Additional Information on Eligibility: | • Faith-based or Community-based Organizations• Regional Organizations• Non-domestic (non-U.S.) Entities (Foreign Organizations) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
This Notice of Funding Opportunity (NOFO) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop or support the development of designated new animal drugs intended for minor uses in major species or for use in minor species (MUMS). The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing that could be used to satisfy the requirements for FDA approval of MUMS-designated drugs. Only entities developing drugs for veterinary use or parties working as research partners with such entities are eligible for grants. The organization (or applicant) seeking approval of the new animal drug under investigation must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species “designation” granted by FDA/CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use, in accordance with the provisions of section 573 of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR part 516. FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must have reviewed and concurred with the proposed study protocol before an applicant can submit a grant application. |
| Link to Additional Information: | PAR-24-216 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: | PAR-24-216 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 29, 2024 |
| Last Updated Date: | May 29, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jan 29, 2027 Application Due Dates are as follows: July 29, 2024; January 31, 2025; July 25, 2025; January 30, 2026; July 24, 2026; January 29, 2027 |
| Archive Date: | Feb 28, 2027 |
| Estimated Total Program Funding: | $250,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Small businesses Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities State governments |
| Additional Information on Eligibility: | • Faith-based or Community-based Organizations • Regional Organizations • Non-domestic (non-U.S.) Entities (Foreign Organizations) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
This Notice of Funding Opportunity (NOFO) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop or support the development of designated new animal drugs intended for minor uses in major species or for use in minor species (MUMS). The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing that could be used to satisfy the requirements for FDA approval of MUMS-designated drugs. Only entities developing drugs for veterinary use or parties working as research partners with such entities are eligible for grants. The organization (or applicant) seeking approval of the new animal drug under investigation must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species “designation” granted by FDA/CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use, in accordance with the provisions of section 573 of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR part 516. FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must have reviewed and concurred with the proposed study protocol before an applicant can submit a grant application. |
| Link to Additional Information: | PAR-24-216 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 |
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 | PAR-24-216 | FORM H | PKG00286737 | May 29, 2024 | Jan 29, 2027 | View |
Package 1
Mandatory forms
Optional forms
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