The FDA’s Orphan Products Development (OPD) program is offering this grant to support the clinical development of products for rare diseases or conditions. This grant is for the purpose of funding clinical studies that assess the safety and/or effectiveness of these products. The ultimate goal is to generate data that will either result in, or substantially contribute to, the market approval of therapies for rare diseases, particularly where no current treatment exists or a superior alternative is being developed. Applicants must provide documentation confirming the rarity of the disease and explain how their proposed study will aid product approval or provide essential development data.
Opportunity ID: 189254
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-001 |
| Funding Opportunity Title: | Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | CategoryExplanation |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Business and Commerce Community Development Consumer Protection Education Environment Food and Nutrition Health Information and Statistics Natural Resources Regional Development Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 40 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Aug 03, 2012 |
| Last Updated Date: | Jan 09, 2014 |
| Original Closing Date for Applications: | Oct 16, 2014 February 6, 2014, October 16, 2014 Resubmission Close dates |
| Current Closing Date for Applications: | Oct 16, 2014 Regular Submission Dates: February 6, 2013 and February 5, 2014 Resubmission Dates: |
| Archive Date: | Nov 15, 2014 |
| Estimated Total Program Funding: | $14,100,000 |
| Award Ceiling: | $400,000 |
| Award Floor: | $200,000 |
Eligibility
| Eligible Applicants: | State governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than 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 Native American tribal governments (Federally recognized) County governments Special district governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education For profit organizations other than small businesses |
| Additional Information on Eligibility: | Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product being developed will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application’s Background and Significance section documentation to support the assertion that the orphan disease or condition to be studied is a rare disease or condition and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development. |
| 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 Email:vieda.hubbard@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| FDA is required to change the application package to Form C as of January 25, 2014. If a organization have submitted an application prior to this date, the application will be accepted. If not, the organization will be required to start the application process over and use Form C. | Jan 09, 2014 | |
| This FOA/RFA October 15, 2013 close date has been Extended to November 8, 2013, due the Government Shutdown. The Revised Resubmission Close Date is November 8, 2013. | Jan 09, 2014 | |
| republishing FOA | Oct 24, 2013 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-001 |
| Funding Opportunity Title: | Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | CategoryExplanation |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Business and Commerce Community Development Consumer Protection Education Environment Food and Nutrition Health Information and Statistics Natural Resources Regional Development Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 40 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Aug 03, 2012 |
| Last Updated Date: | Jan 09, 2014 |
| Original Closing Date for Applications: | Oct 16, 2014 February 6, 2014, October 16, 2014 Resubmission Close dates |
| Current Closing Date for Applications: | Oct 16, 2014 Regular Submission Dates: February 6, 2013 and February 5, 2014 Resubmission Dates: |
| Archive Date: | Nov 15, 2014 |
| Estimated Total Program Funding: | $14,100,000 |
| Award Ceiling: | $400,000 |
| Award Floor: | $200,000 |
Eligibility
| Eligible Applicants: | State governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than 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 Native American tribal governments (Federally recognized) County governments Special district governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education For profit organizations other than small businesses |
| Additional Information on Eligibility: | Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product being developed will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application’s Background and Significance section documentation to support the assertion that the orphan disease or condition to be studied is a rare disease or condition and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development. |
| 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 Email:vieda.hubbard@fda.hhs.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-001 |
| Funding Opportunity Title: | Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Business and Commerce Community Development Consumer Protection Education Environment Food and Nutrition Health Information and Statistics Natural Resources 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: | Jan 09, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Oct 16, 2014 Regular Submission Dates: February 6, 2013 and February 5, 2014 Resubmission Dates: |
| Archive Date: | Nov 15, 2014 |
| Estimated Total Program Funding: | $14,100,000 |
| Award Ceiling: | $400,000 |
| Award Floor: | $200,000 |
Eligibility
| Eligible Applicants: | Special district governments Native American tribal organizations (other than Federally recognized tribal governments) City or township governments For profit organizations other than small businesses State governments Public and State controlled institutions of higher education 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 Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments |
| Additional Information on Eligibility: | Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product being developed will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application’s Background and Significance section documentation to support the assertion that the orphan disease or condition to be studied is a rare disease or condition and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development. |
| 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 Phone 301-827-7177 Email:vieda.hubbard@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-001 |
| Funding Opportunity Title: | Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Business and Commerce Community Development Consumer Protection Education Environment Food and Nutrition Health Information and Statistics Natural Resources 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: | Oct 24, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Oct 16, 2014 February 6, 2014, October 16, 2014 Resubmission Close dates |
| Archive Date: | Nov 15, 2014 |
| Estimated Total Program Funding: | $14,100,000 |
| Award Ceiling: | $400,000 |
| Award Floor: | $200,000 |
Eligibility
| Eligible Applicants: | Special district governments Native American tribal organizations (other than Federally recognized tribal governments) City or township governments For profit organizations other than small businesses State governments Public and State controlled institutions of higher education 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 Small businesses County governments |
| Additional Information on Eligibility: | Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product being developed will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application’s Background and Significance section documentation to support the assertion that the orphan disease or condition to be studied is a rare disease or condition and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development. |
| 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 Phone 301-827-7177 Email:vieda.hubbard@fda.hhs.gov |
Related Documents
Folder 189254 Full Announcement-6 -> rfa-fd-13-001.pdf
Folder 189254 Other Supporting Documents-Instructions 1 -> sf424_rr_guide_general_adobe_verc.pdf
Packages
| Agency Contact Information: | Vieda HUBBARD Grants Management Specialist 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 | ADOBE-FORMS-C | PKG00136470 | Dec 10, 2012 | Oct 16, 2014 | View |
Package 1
Mandatory forms
189254 RR_SF424_2_0-2.0.pdf
189254 PHS398_ResearchPlan_2_0-2.0.pdf
189254 PHS398_CoverPageSupplement_2_0-2.0.pdf
189254 RR_Budget_1_3-1.3.pdf
189254 RR_KeyPersonExpanded_2_0-2.0.pdf
189254 RR_OtherProjectInfo_1_3-1.3.pdf
189254 PerformanceSite_2_0-2.0.pdf
Optional forms
189254 PlannedReport-1.0.pdf
189254 PHS398_CumulativeInclusionReport-1.0.pdf
189254 RR_SubawardBudget30_1_3-1.3.pdf
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