Clinical Studies of Safety and Effectiveness of Orphan Products

Original Closing Date for Applications:
Feb 06, 2008 All Applications must be received by the close of business on the establised receipt date. The Application Receipt Date is February 6, 2008.

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 a year. Additional information about OPD is available on FDA’s Web site at www.fda.gov/orphan. 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. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations. Inclusion of Women And Minorities in Clinical Research Applicants for 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. Inclusion of Children as Participants in Clinical Research. FDA regulations at 21 CFR part 50, subpart D contain additional requirements that must be met by IRBs reviewing clinical investigations regulated by FDA and involving children as subjects. FDA is part of HHS; accordingly, the research project grants under this program are supported by HHS, and HHS regulations at 45 CFR part 46, subpart D also apply to research involving children as subjects. Standards for Privacy of Individually Identifiable Health Information HHS issued final modification to the ‘‘Standards for Privacy of Individually Identifiable Health Information,’’ the ‘‘Privacy Rule,’’ on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR). PHS is committed to achieving the health promotion and disease prevention objectives of ‘‘Healthy People 2010,’’ a PHS-led national activity for setting priority areas. This Funding Opportunity Announcement is related to one or more of the priority areas. Potential applicants may obtain a copy of ‘‘Healthy People 2010’’ at http:// www.health.gov/healthypeople. Smoke-Free Workplace The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103–227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Link to Full Announcement
http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-12881.pdf
If you have difficulty accessing the full announcement electronically, please contact:
Marc Pitts Senior Grants Management Specialist Phone 301-827-7162 Marc.Pitts@FDA.HHS.GOV