The FDA Orphan Products Development grant aims to support clinical studies for rare diseases lacking effective therapies. The grant funds research on safety and effectiveness to obtain market approval for new treatments. Applicants must demonstrate the rarity of the disease and how the study contributes to product approval or development. Closing date: Oct 18, 2018.
Opportunity ID: 269013
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-001 |
| 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 Natural Resources 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: | Oct 22, 2014 |
| Last Updated Date: | Oct 19, 2016 |
| Original Closing Date for Applications: | Oct 18, 2018 Application Due Date(s): February 4, 2015; February 3, 2016; February 1, 2017; February 7, 2018.
Resubmission Due Date(s): October 15, 2015; October 14, 2016; October 16, 2017; October 15, 2018). This FOA uses non-standard due dates |
| Current Closing Date for Applications: | Oct 18, 2018 Application Due Date(s): February 4, 2015; February 3, 2016; February 1, 2017; February 7, 2018.Resubmission Due Date(s): October 15, 2015; October 14, 2016; October 16, 2017; October 15, 2018). This FOA uses non-standard due dates |
| Archive Date: | Nov 17, 2018 |
| Estimated Total Program Funding: | $14,100,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $250,000 |
Eligibility
| Eligible Applicants: | Small businesses City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities County governments Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education State governments Independent school districts 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 organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) 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 Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession 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: | 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 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Dan Lukash
Grants Management Specialist Phone 240-402-7596 Email:daniel.lukash@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Grantor contact changed to Dan Lukash 240/402-7596 daniel.lukash@fda.hhs.gov | Oct 19, 2016 | |
| Oct 19, 2016 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-001 |
| 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 Natural Resources 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: | Oct 22, 2014 |
| Last Updated Date: | Oct 19, 2016 |
| Original Closing Date for Applications: | Oct 18, 2018 Application Due Date(s): February 4, 2015; February 3, 2016; February 1, 2017; February 7, 2018.
Resubmission Due Date(s): October 15, 2015; October 14, 2016; October 16, 2017; October 15, 2018). This FOA uses non-standard due dates |
| Current Closing Date for Applications: | Oct 18, 2018 Application Due Date(s): February 4, 2015; February 3, 2016; February 1, 2017; February 7, 2018.Resubmission Due Date(s): October 15, 2015; October 14, 2016; October 16, 2017; October 15, 2018). This FOA uses non-standard due dates |
| Archive Date: | Nov 17, 2018 |
| Estimated Total Program Funding: | $14,100,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $250,000 |
Eligibility
| Eligible Applicants: | Small businesses City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities County governments Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education State governments Independent school districts 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 organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) 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 Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession 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: | 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 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Dan Lukash
Grants Management Specialist Phone 240-402-7596 Email:daniel.lukash@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-001 |
| 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 Natural Resources 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 19, 2016 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Oct 18, 2018 Application Due Date(s): February 4, 2015; February 3, 2016; February 1, 2017; February 7, 2018.
Resubmission Due Date(s): October 15, 2015; October 14, 2016; October 16, 2017; October 15, 2018). This FOA uses non-standard due dates |
| Archive Date: | Nov 17, 2018 |
| Estimated Total Program Funding: | $14,100,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $250,000 |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities State governments Special district 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 City or township governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses Private institutions of higher education Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts |
| 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 Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Indian/Native American Tribal Governments (Federally Recognized) |
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 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Vieda Hubbard
Grants Management Specialist Phone 240-402-7588 Email:vieda.hubbard@fda.hhs.gov |
Related Documents
Folder 269013 Full Announcement-2 -> RFA-FD-15-001 FINAL in NIH MAY TEMPLATE.pdf
Folder 269013 Other Supporting Documents-SF 424 Form D instructions -> NIH application general-forms-e instructions.pdf
Packages
| Agency Contact Information: | Dan Lukash Grants Management Specialist Phone 240-402-7596 Email: daniel.lukash@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 | PKG00209268 | Dec 08, 2014 | Oct 16, 2018 | View |
Package 1
Mandatory forms
269013 RR_SF424_2_0-2.0.pdf
269013 PHS398_CoverPageSupplement_4_0-4.0.pdf
269013 RR_OtherProjectInfo_1_4-1.4.pdf
269013 PerformanceSite_2_0-2.0.pdf
269013 RR_KeyPersonExpanded_2_0-2.0.pdf
269013 RR_Budget_1_4-1.4.pdf
269013 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
269013 RR_SubawardBudget30_1_4-1.4.pdf
269013 PHS_AssignmentRequestForm_2_0-2.0.pdf
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