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: Please note that there is only one receipt date for FY 2009 and one receipt date for FY 2010.1. BackgroundOPD was created to identify andpromote the development of orphanproducts. Orphan products are drugs,biologics, medical devices, and foods formedical purposes that are indicated fora rare disease or condition (that is, onewith a prevalence, not incidence, offewer than 200,000 people in the UnitedStates). Diagnostic tests and vaccines will qualify only if the U.S. populationof intended use is fewer than 200,000people a year. Additional informationabout OPD is available on FDAs Website at www.fda.gov/orphan.2. Program Research GoalsThe goal of FDAs OPD grant programis to support the clinical development ofproducts for use in rare diseases orconditions where no current therapyexists or where the product willimprove the existing therapy. FDAprovides grants for clinical studies onsafety and/or effectiveness that willeither result in, or substantiallycontribute to, market approval of theseproducts. Applicants must include inthe applications Background andSignificance section documentation tosupport the estimated prevalence of theorphan disease or condition and anexplanation of how the proposed studywill either help gain product approvalor provide essential data needed forproduct development. All fundedstudies are subject to the requirementsof the Federal Food, Drug, and CosmeticAct (the act) (21 U.S.C. 331 et seq.),regulations issued under it, andapplicable Department of Health andHuman Services (HHS) statutes andregulations.Inclusion of Women And Minorities inClinical ResearchApplicants for PHS clinical researchgrants are encouraged to includeminorities and women in studypopulations so research findings can beof benefit to all people at risk of thedisease or condition under study. It isrecommended that applicants placespecial emphasis on includingminorities and women in studies ofdiseases, disorders, and conditions thatdisproportionately affect them. Thispolicy applies to research subjects of allages. If women or minorities areexcluded or poorly represented inclinical research, the applicant shouldprovide a clear and compelling rationalethat shows inclusion is inappropriate.Inclusion of Children as Participants inClinical Research.FDA regulations at 21 CFR part 50,subpart D contain additionalrequirements that must be met by IRBsreviewing clinical investigationsregulated by FDA and involvingchildren as subjects. FDA is part ofHHS; accordingly, the research projectgrants under this program are supportedby HHS, and HHS regulations at 45 CFRpart 46, subpart D also apply to researchinvolving children as subjects.Standards for Privacy of IndividuallyIdentifiable Health InformationHHS issued final modification to theStandards for Privacy of IndividuallyIdentifiable Health Information, thePrivacy Rule, on August 14, 2002.The Privacy Rule is a federal regulationunder the Health Insurance Portabilityand Accountability Act (HIPAA) of 1996that governs the protection ofindividually identifiable healthinformation, and is administered andenforced by the HHS Office for CivilRights (OCR).PHS is committed to achieving thehealth promotion and diseaseprevention objectives of HealthyPeople 2010, a PHS-led nationalactivity for setting priority areas. ThisFunding Opportunity Announcement isrelated to one or more of the priorityareas. Potential applicants may obtain a copy of Healthy People 2010 at http://www.health.gov/healthypeople.Smoke-Free WorkplaceThe PHS strongly encourages all grantrecipients to provide a smoke-freeworkplace and discourage the use of alltobacco products. In addition, PublicLaw 103-227, the Pro-Children Act of1994, prohibits smoking in certainfacilities (or in some cases, any portionof a facility) in which regular or routineeducation, library, day care, health care,or early childhood developmentservices are provided to children. Thisis consistent with the PHS mission toprotect and advance the physical andmental health of the American people.