This grant, offered by the Food and Drug Administration’s Center for Veterinary Medicine (FDA/CVM), supports the development and testing of new animal drugs for minor uses in major species or for use in minor species (MUMS). It aims to help defray costs associated with qualified safety and effectiveness testing required for FDA approval of MUMS-designated drugs. Eligible applicants include entities developing veterinary drugs or their research partners. A key requirement is holding a minor use or minor species designation from FDA/CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS) and having an Investigational New Animal Drug (INAD) file open. Additionally, the proposed study protocol must be reviewed and concurred by FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) before applying.
Opportunity ID: 331604
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-179 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs (R01) |
| 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: | 6 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | Feb 18, 2021 |
| Last Updated Date: | Nov 12, 2021 |
| Original Closing Date for Applications: | Feb 03, 2024 |
| Current Closing Date for Applications: | Feb 02, 2024 This FOA has multiple close dates: February 4, 2022; July 29, 2022; February 3, 2023; July 28, 2023; February 2, 2024 By 11:59 PM Eastern Time. |
| Archive Date: | Mar 04, 2024 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Independent school districts Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses City or township 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 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 Private institutions of higher education Native American tribal governments (Federally recognized) County governments Small businesses State governments |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education InstitutionsPublic/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 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 Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState 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 OtherIndependent 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: |
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.
|
| Link to Additional Information: | FULL ANNOUNCEMENT |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Rene A Vasquez
Phone 301-796-3546 Email:rene.vasquez@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Update close dates | Nov 12, 2021 | |
| update close date | Feb 18, 2021 | |
| updating closing date | Feb 18, 2021 | |
| Feb 18, 2021 |
DISPLAYING: Synopsis 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-179 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs (R01) |
| 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: | 6 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | Feb 18, 2021 |
| Last Updated Date: | Nov 12, 2021 |
| Original Closing Date for Applications: | Feb 03, 2024 |
| Current Closing Date for Applications: | Feb 02, 2024 This FOA has multiple close dates: February 4, 2022; July 29, 2022; February 3, 2023; July 28, 2023; February 2, 2024 By 11:59 PM Eastern Time. |
| Archive Date: | Mar 04, 2024 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Independent school districts Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses City or township 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 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 Private institutions of higher education Native American tribal governments (Federally recognized) County governments Small businesses State governments |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education InstitutionsPublic/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 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 Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState 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 OtherIndependent 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: |
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.
|
| Link to Additional Information: | FULL ANNOUNCEMENT |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Rene A Vasquez
Phone 301-796-3546 Email:rene.vasquez@fda.hhs.gov |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-179 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs (R01) |
| 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: | 6 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Feb 18, 2021 |
| Last Updated Date: | Nov 12, 2021 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Feb 02, 2024 This FOA has multiple close dates:
February 4, 2022; July 29, 2022; February 3, 2023; July 28, 2023; February 2, 2024 By 11:59 PM Eastern Time. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. Late applications will not be accepted for this NOFO. |
| Archive Date: | Mar 04, 2024 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Special district governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Independent school districts |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education InstitutionsPublic/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 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 Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState 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 OtherIndependent 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: |
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.
|
| Link to Additional Information: | FULL ANNOUNCEMENT |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Rene A Vasquez
Phone 301-796-3546 Email:rene.vasquez@fda.hhs.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-179 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs (R01) |
| 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: | 6 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Feb 18, 2021 |
| Last Updated Date: | Nov 10, 2021 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Feb 04, 2022 |
| Archive Date: | Mar 04, 2024 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Special district governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Independent school districts |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education InstitutionsPublic/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 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 Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState 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 OtherIndependent 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: |
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.
|
| Link to Additional Information: | FULL ANNOUNCEMENT |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Rene A Vasquez
Phone 301-796-3546 Email:rene.vasquez@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-179 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs (R01) |
| 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: | 6 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Feb 18, 2021 |
| Last Updated Date: | Feb 18, 2021 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Feb 03, 2024 |
| Archive Date: | Mar 04, 2024 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Special district governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Independent school districts |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education InstitutionsPublic/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 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 Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState 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 OtherIndependent 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: |
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.
|
| Link to Additional Information: | FULL ANNOUNCEMENT |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Rene A Vasquez
Phone 301-796-3546 Email:rene.vasquez@fda.hhs.gov |
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Rene A Vasquez Phone 301-796-3546 Email: rene.vasquez@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-21-179-FORMS-G | FORMS G – For due dates on or after January 25, 2022 | PKG00270077 | Nov 12, 2021 | Nov 24, 2022 | View |
| 93.103 | PAR-21-179-FORMS-H | FORMS H – For due dates on or after January 25, 2023 | PKG00278672 | Nov 24, 2022 | Feb 02, 2024 | View |
Package 1
Mandatory forms
331604 RR_SF424_5_0-5.0.pdf
331604 PHS398_CoverPageSupplement_5_0-5.0.pdf
331604 RR_OtherProjectInfo_1_4-1.4.pdf
331604 PerformanceSite_4_0-4.0.pdf
331604 RR_KeyPersonExpanded_4_0-4.0.pdf
331604 RR_Budget_3_0-3.0.pdf
331604 PHS398_ResearchPlan_4_0-4.0.pdf
331604 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
331604 RR_SubawardBudget30_3_0-3.0.pdf
331604 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
331604 RR_SF424_5_0-5.0.pdf
331604 PHS398_CoverPageSupplement_5_0-5.0.pdf
331604 RR_OtherProjectInfo_1_4-1.4.pdf
331604 PerformanceSite_4_0-4.0.pdf
331604 RR_KeyPersonExpanded_4_0-4.0.pdf
331604 RR_Budget_3_0-3.0.pdf
331604 PHS398_ResearchPlan_5_0-5.0.pdf
331604 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
331604 RR_SubawardBudget30_3_0-3.0.pdf
331604 PHS_AssignmentRequestForm_3_0-3.0.pdf
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