FDA: Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

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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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