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This department is offering research grants to conduct clinical studies on the safety and effectiveness of products intended for rare diseases. The goal is to support the development of products that provide superior therapy for conditions where no current treatment exists. Applicants must demonstrate the rarity of the disease or condition being studied and how the research will contribute to product approval or development. The closing date for applications is Oct 16, 2014.
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Opportunity ID: 189254
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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:: | |
| Category of Funding Activity:: | Business and Commerce |
| Category Explanation:: | |
| Expected Number of Awards:: | 40 |
| Assistance Listings Number(s):: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement:: | No |
| Version:: | Synopsis 3 |
| Posted Date:: | Dec 10, 2012 |
| Last Updated Date:: | Jan 09, 2014 |
| Original Closing Date for Applications:: | Oct 16, 2014 |
| Current Closing Date for Applications:: | Oct 16, 2014 |
| Archive Date:: | Nov 15, 2014 |
| Estimated Total Program Funding:: | $ 14,100,000 |
| Award Ceiling:: | $400,000 |
| Award Floor:: | $200,000 |
Eligibility
| Eligible Applicants:: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 3 | 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 |
| Synopsis 2 | 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. | |
| Synopsis 1 | republishing FOA |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | 93.103 |
| Competition ID: | ADOBE-FORMS-B1 |
| Competition Title: | ADOBE-FORMS-C |
| Opportunity Package ID: | PKG00136470 |
| Opening Date: | Dec 10, 2012 |
| Closing Date: | Oct 16, 2014 |
| Agency Contact Information:: | Vieda HUBBARD |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V2.0] PHS 398 Research Plan [V2.0] PHS 398 Cover Page Supplement [V2.0] Research & Related Budget [V1.3] Research and Related Senior/Key Person Profile (Expanded) [V2.0] Research And Related Other Project Information [V1.3] Project/Performance Site Location(s) [V2.0] |
| optional_forms |
Planned Enrollment Report [V1.0] PHS 398 Cumulative Inclusion Enrollment Report [V1.0] R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.3] |
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Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| 93.103 | ADOBE-FORMS-B1 | ADOBE-FORMS-C | PKG00136470 | Dec 10, 2012 | Oct 16, 2014 | View | Vieda HUBBARD | Organization Applicants |
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