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

The summary for the Clinical Studies of Safety and Effectivness of Orphan Products; Research Project Grant (R01) Federal Grant is detailed below. It contains information such as the Catalog of Federal Domestic Assistance (CFDA) number, who is eligible for the grant, how much grant money will be awarded, important deadlines, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed in the Grant Announcement Contact section. If these sections are incomplete, please visit the website of the government agency that is offering this grant.


	Federal Grant Title:	Clinical Studies of Safety and Effectivness of Orphan Products; Research Project Grant (R01)
	CFDA Number:	93.103
	CFDA Description:	Food and Drug Administration_Research
	Federal Agency Name:	Food and Drug Administration
	Category of Funding Activity:	Health Science and Technology Other
	Category Explanation:	OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not
	Opportunity Category:	Discretionary
	Funding Opportunity Number:	RFA-FD-08-001
	Document Type:	Modification to Previous Grants Notice
	Funding Instrument Type:	Grant
	Posted Date:	Nov 29, 2007
	Creation Date:	Dec 17, 2008
	Original Closing Date for Applications:	Dec 17, 2008 This FOA RFA-FD-08-001 has been expired in accordance with the reissuance of RFA-FD-09-001
	Current Closing Date for Applications:	Information not provided
	Archive Date:	Dec 18, 2008
	Expected Number of Awards:	10
	Estimated Total Program Funding:	$4,200,000
	Federal Grant Award Ceiling:	$400,000
	Federal Grant Award Floor:	Information not provided
	Cost Sharing or Matching Requirement:	No

Applicants Eligible for this Grant: Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Small businesses Private institutions of higher education 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 Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled "Additional Information on Eligibility" for clarification) For profit organizations other than small businesses State governments Native American tribal organizations (other than Federally recognized tribal governments)
Additional Information on Eligibility: Eligible Organizations: The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal agencies that are not part of HHS may apply. Agencies that are part of HHS may not apply. For-profit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c) (4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards. The following are also included: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Non-domestic (non-U.S.) Entity; Small Business; For-Profit Organization (Other than Small Business); State Government; Regional Organization; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Other: Eligible agencies of the Federal government; Faith-based or community based organizations.
Grant Description: Research Objectives The Research Project Grant (R01) is an award to support a discrete, specified, circumscribed project to be performed by named Project Directors/Principal Investigators (PDs/PIs) in areas representing the investigators specific interests and competencies based on the mission of FDA. FDA awards R01 grants to institutions/organizations of all types. This mechanism allows the PDs/PIs to define the scientific focus or objective of the research based on particular areas of interest and competence. Although the PDs/PIs write the grant application and are responsible for conducting and supervising the research, the actual applicant is the research institution/organization.OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. Additional information regarding OPD and the FOA tips page are available on FDA's Web site at www.fda.gov/orphan. 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 will improve 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 estimated prevalence of the orphan disease or condition and an explanation of how the proposed study will either help gain product approval or provide essential data needed for product development. All funded studies are subject to the requirements of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations.For specific information about the mission of each FDA Center, see About FDA. See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Link to Full Grant Announcement: Full Announcement
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-08-001.html
Grant Announcement Contact: Marc Pitts
Senior Grants Management Spec
Phone 301-827-7162 Marc.Pitts@FDA.HHS.GOV Please contact this address should you have technical questions.
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