Clinical Studies of Safety and Effectiveness of Orphan Products

The summary for the Clinical Studies of Safety and Effectiveness of Orphan Products grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, 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 as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.
Clinical Studies of Safety and Effectiveness of Orphan Products: I. Funding Opportunity Description The Food and Drug Administration (FDA) is announcing changes to its Office of Orphan Products Development (OPD) grant program for fiscal year (FY) 2007 and FY 2008. This announcement supersedes the previous announcement of this program, which was published in the Federal Register of January 14, 2005 (70 FR 2642). Please note that there is only one receipt date for FY 2007 and one receipt date for FY 2008.1. Background 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 per year.2. Program Research Goals 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. 301 et seq.) and regulations issued under it.II. Award Information Except for applications for studies of medical foods that do not need premarket approval, FDA will only award grants to support premarket clinical studies to determine safety and effectiveness for approval under section 505 or 515 of the act (21 U.S.C. 355, or 360e) or safety, purity, and potency for licensing under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262). FDA will support the clinical studies covered by this notice under the authority of section 301 of the PHS Act (42 U.S.C. 241). FDA's research program is described in the Catalog of Federal Domestic Assistance, No. 93.103. Applicants for Public Health Service (PHS) clinical research grants are encouraged to include minorities and women in study populations so research findings can be of benefit to all people at risk of the disease or condition under study. It is recommended that applicants place special emphasis on including minorities and women in studies of diseases, disorders, and conditions that disproportionately affect them. This policy applies to research subjects of all ages. If women or minorities are excluded or poorly represented in clinical research, the applicant should provide a clear and compelling rationale that shows inclusion is inappropriate. PHS strongly encourages all grant recipients to provide a smoke-free workplace and to discourage the use of all tobacco products. This is consistent with PHS' mission to protect and advance the physical and mental health of the American people. FDA is committed to achieving the health promotion and disease prevention objectives of ``Healthy People 2010,'' a national effort designed to reduce morbidity and mortality and to improve quality of life. Applicants may obtain a paper copy of the ``Healthy People 2010'' objectives, vols. I and II, for $70 ($87.50 foreign) S/N 017-000-00550-9, by writing to the Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Telephone orders can be placed to 202-512-2250. The document is also available in CD-ROM format, S/N 017-001-00549-5 for $19 ($23.50 foreign) as well as on the Internet at http://www.healthypeople.gov/.
Federal Grant Title: Clinical Studies of Safety and Effectiveness of Orphan Products
Federal Agency Name: Food and Drug Administration
Grant Categories: Science and Technology Health
Type of Opportunity: Discretionary
Funding Opportunity Number: FDA-OPD-FY-2007-2008
Type of Funding: Grant
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: No deadline provided
Original Application Deadline: Feb 07, 2007 All Applications should be received
Posted Date: Nov 20, 2006
Creation Date: Dec 12, 2006
Archive Date: Mar 09, 2007
Total Program Funding: $4,200,000
Maximum Federal Grant Award: $350,000
Minimum Federal Grant Award: $200,000
Expected Number of Awards: 12
Cost Sharing or Matching: No
Applicants Eligible for this Grant
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Information on Eligibility
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 the Department of Health and Human Services (HHS) may apply. Agencies that are part of HHS may not apply. Forprofit 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. An application that has received two prior disapprovals is not eligible to apply.
Link to Full Grant Announcement
Information not provided
Grant Announcement Contact
Marc Pitts
Senior Grants Management Specialist
Phone 301-827-7162 [email protected] Marc Pitts
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