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

Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01): RFA-FD-15-001
SOURCE: U.S. Food and Drug Administration (FDA), Office of Orphan Products Development (OPD)
APPLICATION DEADLINE: 2/3/16, 2/1/17, 2/7/18.
$ AVAILABLE: $14.1 million in FY2016, FY2017, FY2018, and FY2019.

orphan-drugs-acts-past-and-current-scenario-with-upcoming-drugs-20-638
Background

The OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and medical foods that are indicated for a rare disease or condition. The term “rare disease or condition” is defined in 21 U.S.C. 360ee.  As a practical way to implement the statutory definition, for devices and foods as well as for drugs, FDA considers drugs, devices, and medical foods potentially eligible for grants under the OPD grant program if they are indicated for a disease or condition that has a prevalence, not incidence, of fewer than 200,000 people in the United States. Diagnostics and vaccines are considered potentially eligible for such grants only if the U.S. population to whom they will be administered is fewer than 200,000 people in the United States per year.

Research Objectives

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 proposed product 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 that the estimated prevalence of the orphan disease or condition in the United States is less than 200,000 (or in the case of a vaccine or diagnostic, information to support that the product will be administered to fewer than 200,000 people in the United States per year),and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.  Additional information may be required upon request, for example, regarding population estimate and rationale.  This additional information may be required, in part, to assure that human clinical trials of drugs are eligible to receive funding under the OPD grant program.  21 U.S.C. 360ee(b)(1)(A).See Section VIII, Other Information – Required Federal Citations, for policies related to this announcement.

– See more at: http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-001.html#sthash.KSPsucAw.dpuf
ELIGIBILITY: * Public/state/private controlled institutions of higher education.
* 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).
* Nonprofits with or without 501(c)(3) IRS status (other than institutions of higher education).
* Small businesses.
* For-profit organizations (other than small businesses).
* State governments.
* County governments.
* City or township governments.
* Special district governments.
* Indian/Native American tribal governments (federally recognized and other than federally recognized).
* U.S. territories or possessions.
* Independent school districts.
* Public housing authorities/Indian housing authorities.
* Native American tribal organizations (other than federally recognized tribal governments).
* Faith-based or community-based organizations.
* Regional organizations.
PURPOSE: 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.
CFDA: 93.103
CONTACT: Please see URL for multiple contacts.

For more information see http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-001.html
From U.S. Department of Health and Human Services, Office of Minority Health FYI Weekly Health Resources email, 10/21/15icon
Subject(s) medical research, minority health

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