This grant is for supporting the development and testing of new animal drugs for minor use in major species or for minor species. Issued by the FDA Center for Veterinary Medicine, this R01 grant aims to defray costs associated with qualified safety and effectiveness testing of designated Minor Use Minor Species (MUMS) animal drugs. Eligibility is strictly limited to products designated under section 573 of the Federal Food, Drug, and Cosmetic Act. The primary purpose is to advance new animal drug products towards approval or conditional approval, ensuring their availability for specific, underserved veterinary needs. Applicants must clearly articulate how their proposed research will contribute to gaining product approval or conditional approval.
Opportunity ID: 53836
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-10-001 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs; Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Business and Commerce Consumer Protection Education Employment, Labor and Training Environment Health Regional Development Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 10 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 6 |
| Posted Date: | Apr 16, 2010 |
| Last Updated Date: | Mar 25, 2011 |
| Original Closing Date for Applications: | May 14, 2010 This FOA has Multiple Receipt Dates.
The first Application Receipt/Due Date is 05/14/2010. The Second Application Receipt/Due Date is September 3, 2010. The Third Application Receipt/Due Date is February 4, 2011. The Fourth and Final Receipt/Due Date is August 5, 2011. |
| Current Closing Date for Applications: | May 14, 2010 This FOA has Multiple Receipt Dates.
The first Application Receipt/Due Date is 05/14/2010. The Second Application Receipt/Due Date is September 3, 2010. The Third Application Receipt/Due Date is February 4, 2011. The Fourth and Final Receipt/Due Date is August 5, 2011. ATTENTION: AS OF MAY 7, 2011 APPLICANTS WILL NO LONGER BE ABLE TO SUBMIT GRANTS USING THE ADOBE-FORMS-A TEMPLATE PACKAGE. THIS PACKAGE WILL EXPIRE. IF YOU DON’T SUBMIT YOUR ADOBE – FORMS- A PACKAGE BEFORE MAY 7, 2011 YOU MUST USE ADOBE FORMS B1 TO APPLY TO THE FINAL RECEIPT DATE OF 8/5/2011 |
| Archive Date: | – |
| Estimated Total Program Funding: | $750,000 |
| Award Ceiling: | $100,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Independent school districts Public housing authorities/Indian housing authorities City or township governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Private institutions of higher education State governments County governments |
| Additional Information on Eligibility: | Hispanic-serving Institutions of Higher Education•Historically Black Colleges and Universities (HBCUs)•Tribally Controlled Colleges and Universities (TCCUs) •Alaska Native and Native Hawaiian Serving Institutions Faith-based or Community-based Organization*Federal Government Agencies (that are not part of HHS) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | This FOA is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions/organizations that propose to develop, or support the development of, new animal drugs for intended minor use in major species or intended use in minor species. Only new animal drug products that have been designated in accordance with the provisions of section 573 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and 21 CFR Part 516 are eligible for grants. FDA is authorized to provide grants for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing. This FOA relates to grants to assist in defraying the costs of qualified safety and effectiveness testing when a grant will either result in, or substantially contribute to, approval or conditional approval of a designated MUMS drug. Applicants must include an explanation of how the proposed study will help gain product approval or conditional approval in the applications Background and Significance section. All funded studies are subject to the requirements of the act (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Vieda Hubbard
Grants Management Specialist Office of Acquisitions & Grants Services, FDA 5630 Fishers Lane, Room 1079 Rockville, MD 20857 Phone: (301) 827-7177 Email:Vieda.Hubbard@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| ATTENTION: AS OF MAY 7, 2011 APPLICANTS WILL NO LONGER BE ABLE TO SUBMIT GRANTS USING THE ADOBE-FORMS-A TEMPLATE PACKAGE. THIS PACKAGE WILL EXPIRE.
IF YOU DON’T SUBMIT YOUR ADOBE – FORMS- A PACKAGE BEFORE MAY 7, 2011 YOU MUST USE ADOBE FORMS B1 TO APPLY TO THE FINAL RECEIPT DATE OF 8/6/2011 |
Mar 25, 2011 | |
| Modified to reflect corrections to the Previously Released Funding Opportunity Announcement. | Mar 25, 2011 | |
| Modified to reflect corrections to the Previously Released Funding Opportunity Announcement. | Apr 21, 2010 | |
| This Update is to Notify Applicants that the FOA RFA-FD-10-001 "Minor Use Minor Species Development of Drugs; Research Project Grant (R01)" is currently being revised to reflect how to electronically Submit an Application to the FDA. See Section IV. Application and Submission Information.
The Revised FOA will be re-published on the NIH Guide for Grants and Contracts. Please check the following Link for the revised FOA. http://grants.nih.gov/grants/guide/search_results.htm?year=active&scope=rfa All Questions and concerns should be directed to following FOA Points of Contact: Grants Management Specialist- Vieda Hubbard at 301-827-7177 vieda.hubbard@fda.hhs.gov Program Officer – Michelle Fuller at 240-276-9736 michelle.fuller@fda.hhs.gov |
Apr 21, 2010 | |
| This Update is to Notify Applicants that the FOA RFA-FD-10-001 "Minor Use Minor Species Development of Drugs; Research Project Grant (R01)" is currently being revised to reflect how to electronically Submit an Application to the FDA. See Section IV. Application and Submission Information.
The Revised FOA will be re-published on the NIH Guide for Grants and Contracts. Please check the following Link for the revised FOA. http://grants.nih.gov/grants/guide/search_results.htm?year=active&scope=rfa All Questions and concerns should be directed to following FOA Points of Contact: Grants Management Specialist- Vieda Hubbard at 301-827-7177 vieda.hubbard@fda.hhs.gov Program Officer – Michelle Fuller at 240-276-9736 michelle.fuller@fda.hhs.gov |
Apr 16, 2010 | |
| Apr 16, 2010 |
DISPLAYING: Synopsis 6
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-10-001 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs; Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Business and Commerce Consumer Protection Education Employment, Labor and Training Environment Health Regional Development Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 10 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 6 |
| Posted Date: | Apr 16, 2010 |
| Last Updated Date: | Mar 25, 2011 |
| Original Closing Date for Applications: | May 14, 2010 This FOA has Multiple Receipt Dates.
The first Application Receipt/Due Date is 05/14/2010. The Second Application Receipt/Due Date is September 3, 2010. The Third Application Receipt/Due Date is February 4, 2011. The Fourth and Final Receipt/Due Date is August 5, 2011. |
| Current Closing Date for Applications: | May 14, 2010 This FOA has Multiple Receipt Dates.
The first Application Receipt/Due Date is 05/14/2010. The Second Application Receipt/Due Date is September 3, 2010. The Third Application Receipt/Due Date is February 4, 2011. The Fourth and Final Receipt/Due Date is August 5, 2011. ATTENTION: AS OF MAY 7, 2011 APPLICANTS WILL NO LONGER BE ABLE TO SUBMIT GRANTS USING THE ADOBE-FORMS-A TEMPLATE PACKAGE. THIS PACKAGE WILL EXPIRE. IF YOU DON’T SUBMIT YOUR ADOBE – FORMS- A PACKAGE BEFORE MAY 7, 2011 YOU MUST USE ADOBE FORMS B1 TO APPLY TO THE FINAL RECEIPT DATE OF 8/5/2011 |
| Archive Date: | – |
| Estimated Total Program Funding: | $750,000 |
| Award Ceiling: | $100,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Independent school districts Public housing authorities/Indian housing authorities City or township governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Private institutions of higher education State governments County governments |
| Additional Information on Eligibility: | Hispanic-serving Institutions of Higher Education•Historically Black Colleges and Universities (HBCUs)•Tribally Controlled Colleges and Universities (TCCUs) •Alaska Native and Native Hawaiian Serving Institutions Faith-based or Community-based Organization*Federal Government Agencies (that are not part of HHS) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | This FOA is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions/organizations that propose to develop, or support the development of, new animal drugs for intended minor use in major species or intended use in minor species. Only new animal drug products that have been designated in accordance with the provisions of section 573 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and 21 CFR Part 516 are eligible for grants. FDA is authorized to provide grants for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing. This FOA relates to grants to assist in defraying the costs of qualified safety and effectiveness testing when a grant will either result in, or substantially contribute to, approval or conditional approval of a designated MUMS drug. Applicants must include an explanation of how the proposed study will help gain product approval or conditional approval in the applications Background and Significance section. All funded studies are subject to the requirements of the act (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Vieda Hubbard
Grants Management Specialist Office of Acquisitions & Grants Services, FDA 5630 Fishers Lane, Room 1079 Rockville, MD 20857 Phone: (301) 827-7177 Email:Vieda.Hubbard@fda.hhs.gov |
DISPLAYING: Synopsis 5
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-10-001 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs; Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Business and Commerce Consumer Protection Education Employment, Labor and Training Environment Health Regional Development Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 10 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 5 |
| Posted Date: | Mar 25, 2011 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 14, 2010 This FOA has Multiple Receipt Dates.
The first Application Receipt/Due Date is 05/14/2010. The Second Application Receipt/Due Date is September 3, 2010. The Third Application Receipt/Due Date is February 4, 2011. The Fourth and Final Receipt/Due Date is August 5, 2011. |
| Archive Date: | – |
| Estimated Total Program Funding: | $750,000 |
| Award Ceiling: | $100,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | 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 For profit organizations other than small businesses Special district governments County governments Independent school districts State governments Private institutions of higher education City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Small businesses Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Hispanic-serving Institutions of Higher Education•Historically Black Colleges and Universities (HBCUs)•Tribally Controlled Colleges and Universities (TCCUs) •Alaska Native and Native Hawaiian Serving Institutions Faith-based or Community-based Organization*Federal Government Agencies (that are not part of HHS) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | This FOA is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions/organizations that propose to develop, or support the development of, new animal drugs for intended minor use in major species or intended use in minor species. Only new animal drug products that have been designated in accordance with the provisions of section 573 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and 21 CFR Part 516 are eligible for grants. FDA is authorized to provide grants for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing. This FOA relates to grants to assist in defraying the costs of qualified safety and effectiveness testing when a grant will either result in, or substantially contribute to, approval or conditional approval of a designated MUMS drug. Applicants must include an explanation of how the proposed study will help gain product approval or conditional approval in the applications Background and Significance section. All funded studies are subject to the requirements of the act (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Martin Bernard
Contract Specialist 5630 Fisher Lane, Room 1004E Rockville, MD 20857 T: 301.443.5869 F: 301.827.5869 Email:Martin.Bernard@fda.hhs.gov |
DISPLAYING: Synopsis 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-10-001 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs; Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Business and Commerce Consumer Protection Education Employment, Labor and Training Environment Health Regional Development Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 10 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | Apr 21, 2010 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 14, 2010 This FOA has Multiple Receipt Dates.
The first Application Receipt/Due Date is 05/14/2010. The Second Application Receipt/Due Date is September 3, 2010. The Third Application Receipt/Due Date is February 4, 2011. The Fourth and Final Receipt/Due Date is August 5, 2011. |
| Archive Date: | – |
| Estimated Total Program Funding: | $750,000 |
| Award Ceiling: | $100,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | 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 For profit organizations other than small businesses Special district governments County governments State governments Independent school districts Private institutions of higher education City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Small businesses Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Hispanic-serving Institutions of Higher Education•Historically Black Colleges and Universities (HBCUs)•Tribally Controlled Colleges and Universities (TCCUs) •Alaska Native and Native Hawaiian Serving Institutions Faith-based or Community-based Organization |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | This FOA is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions/organizations that propose to develop, or support the development of, new animal drugs for intended minor use in major species or intended use in minor species. Only new animal drug products that have been designated in accordance with the provisions of section 573 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and 21 CFR Part 516 are eligible for grants. FDA is authorized to provide grants for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing. This FOA relates to grants to assist in defraying the costs of qualified safety and effectiveness testing when a grant will either result in, or substantially contribute to, approval or conditional approval of a designated MUMS drug. Applicants must include an explanation of how the proposed study will help gain product approval or conditional approval in the applications Background and Significance section. All funded studies are subject to the requirements of the act (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Martin Bernard
Contract Specialist 5630 Fisher Lane, Room 1004E Rockville, MD 20857 T: 301.443.5869 F: 301.827.5869 Email:Martin.Bernard@fda.hhs.gov |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-10-001 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs; Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Business and Commerce Consumer Protection Education Employment, Labor and Training Environment Health Regional Development Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 10 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Apr 21, 2010 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 14, 2010 This FOA has Multiple Receipt Dates.
The first Application Receipt/Due Date is 05/14/2010. The Second Application Receipt/Due Date is September 3, 2010. The Third Application Receipt/Due Date is February 4, 2011. The Fourth and Final Receipt/Due Date is August 5, 2011. |
| Archive Date: | – |
| Estimated Total Program Funding: | $750,000 |
| Award Ceiling: | $100,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | 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 For profit organizations other than small businesses Special district governments County governments State governments Independent school districts Private institutions of higher education City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Small businesses Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Hispanic-serving Institutions of Higher Education•Historically Black Colleges and Universities (HBCUs)•Tribally Controlled Colleges and Universities (TCCUs) •Alaska Native and Native Hawaiian Serving Institutions Faith-based or Community-based Organization |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | This FOA is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions/organizations that propose to develop, or support the development of, new animal drugs for intended minor use in major species or intended use in minor species. Only new animal drug products that have been designated in accordance with the provisions of section 573 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and 21 CFR Part 516 are eligible for grants. FDA is authorized to provide grants for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing. This FOA relates to grants to assist in defraying the costs of qualified safety and effectiveness testing when a grant will either result in, or substantially contribute to, approval or conditional approval of a designated MUMS drug. Applicants must include an explanation of how the proposed study will help gain product approval or conditional approval in the applications Background and Significance section. All funded studies are subject to the requirements of the act (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Martin Bernard
Contract Specialist 5630 Fisher Lane, Room 1004E Rockville, MD 20857 T: 301.443.5869 F: 301.827.5869 Email:Martin.Bernard@fda.hhs.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-10-001 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs; Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Business and Commerce Consumer Protection Education Employment, Labor and Training Environment Health Regional Development Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 10 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Apr 16, 2010 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 14, 2010 This FOA has Multiple Receipt Dates.
The first Application Receipt/Due Date is 05/14/2010. The Second Application Receipt/Due Date is September 3, 2010. The Third Application Receipt/Due Date is February 4, 2011. The Fourth and Final Receipt/Due Date is August 5, 2011. |
| Archive Date: | – |
| Estimated Total Program Funding: | $750,000 |
| Award Ceiling: | $100,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | 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 For profit organizations other than small businesses Special district governments County governments Independent school districts State governments Private institutions of higher education City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Small businesses Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Hispanic-serving Institutions of Higher Education•Historically Black Colleges and Universities (HBCUs)•Tribally Controlled Colleges and Universities (TCCUs) •Alaska Native and Native Hawaiian Serving Institutions Faith-based or Community-based Organization |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | This FOA is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions/organizations that propose to develop, or support the development of, new animal drugs for intended minor use in major species or intended use in minor species. Only new animal drug products that have been designated in accordance with the provisions of section 573 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and 21 CFR Part 516 are eligible for grants. FDA is authorized to provide grants for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing. This FOA relates to grants to assist in defraying the costs of qualified safety and effectiveness testing when a grant will either result in, or substantially contribute to, approval or conditional approval of a designated MUMS drug. Applicants must include an explanation of how the proposed study will help gain product approval or conditional approval in the applications Background and Significance section. All funded studies are subject to the requirements of the act (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Martin Bernard
Contract Specialist 5630 Fisher Lane, Room 1004E Rockville, MD 20857 T: 301.443.5869 F: 301.827.5869 Email:Martin.Bernard@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-10-001 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs; Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Agriculture Business and Commerce Consumer Protection Education Employment, Labor and Training Environment Health Regional Development Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 10 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 16, 2010 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 14, 2010 This FOA has Multiple Receipt Dates.
The first Application Receipt/Due Date is 05/14/2010. The Second Application Receipt/Due Date is September 3, 2010. The Third Application Receipt/Due Date is February 4, 2011. The Fourth and Final Receipt/Due Date is August 5, 2011. |
| Archive Date: | – |
| Estimated Total Program Funding: | $750,000 |
| Award Ceiling: | $100,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | 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 For profit organizations other than small businesses Special district governments County governments Independent school districts State governments Private institutions of higher education City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Small businesses Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Hispanic-serving Institutions of Higher Education•Historically Black Colleges and Universities (HBCUs)•Tribally Controlled Colleges and Universities (TCCUs) •Alaska Native and Native Hawaiian Serving Institutions Faith-based or Community-based Organization |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | This FOA is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions/organizations that propose to develop, or support the development of, new animal drugs for intended minor use in major species or intended use in minor species. Only new animal drug products that have been designated in accordance with the provisions of section 573 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and 21 CFR Part 516 are eligible for grants. FDA is authorized to provide grants for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing. This FOA relates to grants to assist in defraying the costs of qualified safety and effectiveness testing when a grant will either result in, or substantially contribute to, approval or conditional approval of a designated MUMS drug. Applicants must include an explanation of how the proposed study will help gain product approval or conditional approval in the applications Background and Significance section. All funded studies are subject to the requirements of the act (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Martin Bernard
Contract Specialist 5630 Fisher Lane, Room 1004E Rockville, MD 20857 T: 301.443.5869 F: 301.827.5869 Email:Martin.Bernard@fda.hhs.gov |
Related Documents
Folder 53836 Full Announcement-1 -> sf424_rr_guide_general_adobe_vera.pdf
Folder 53836 Full Announcement-2 -> sf424_rr_guide_general_adobe_verb.pdf
Folder 53836 Full Announcement-2 -> not-od-11-007 nih, ahrq, cdc, fda & niosh to require use of updated electronic application forms in 2011.pdf
Packages
| Agency Contact Information: | Vieda Hubbard Grants Management Specialist Office of Acquisitions & Grants Services, FDA 5630 Fishers Lane, Room 1079 Rockville, MD 20857 Phone: (301) 827-7177 Email: Vieda.Hubbard@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 | ADOBE-FORMS-B1 | SUPERCEDES ADOBE-FORMS-A | PKG00043590 | Mar 25, 2011 | Aug 06, 2011 | View |
Package 1
Mandatory forms
53836 RR_SF424_1_2-1.2.pdf
53836 RR_OtherProjectInfo_1_3-1.3.pdf
53836 RR_KeyPersonExpanded_1_2-1.2.pdf
53836 RR_Budget-1.1.pdf
53836 PerformanceSite_1_4-1.4.pdf
53836 PHS398_ResearchPlan_1_3-1.3.pdf
53836 PHS398_CoverPageSupplement_1_4-1.4.pdf
53836 PHS398_Checklist_1_3-1.3.pdf
Optional forms
53836 RR_SubawardBudget-1.2.pdf
53836 PHS_CoverLetter_1_2-1.2.pdf
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