Opportunity RFA-FD-11-001

The summary for the Opportunity RFA-FD-11-001 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.

Opportunity RFA-FD-11-001: 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 (that is, one with prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostics and vaccines will qualify for orphan status only if the U.S. population to whom they will be administered is fewer than 200,000 people per year. 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 the estimated prevalence of the orphan disease or condition (or in the case of a vaccine or diagnostic, information to support the estimates of how many people will be administered the diagnostic or vaccine annually) and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development. Support will be in the form of a research project (R01) grant. The Research Project (R01) grant is an award made to support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing the investigator's specific interest and competencies, based on the mission of the FDA. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project. See Section III.1.1.B for multiple PD/PIs. All awards will be subject to all policies and requirements that govern the research grant programs of the PHS as incorporated in the HHS Grants Policy Statement, dated January 1, 2007 (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm), including the provisions of 42 CFR Part 52 and 45 CFR Parts 74 and 92. The regulations issued under Executive Order 12372 do not apply to this program. The NIH modular grant program does not apply to this FDA grant program. All grant awards are subject to applicable requirements for clinical investigations imposed by sections 505, 512, and 515 of the act, section 351 of the PHS Act, regulations issued under any of these sections, and other applicable HHS statutes and regulations regarding human subject protection.Except for applications for studies of medical foods that do not need pre-market approval, FDA will only award grants to support pre-market 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 (CFDA), No. 93.103. The following definitions are provided to illustrate drug and biologic products study phases. Devices and medical foods may have alternative considerations.Phase 1 studies include the initial introduction of an investigational new drug (IND) into humans, are usually conducted in healthy volunteer subjects, and are designed to determine the metabolic and pharmacological actions of the product in humans, and the side effects, including those associated with increasing drug doses. In some Phase 1 studies that include subjects with the rare disorder, it may also be possible to gain early evidence on effectiveness. Phase 2 studies include early controlled clinical studies conducted to: (1) Evaluate the effectiveness of the product for a particular indication in patients with the disease or condition and (2) determine the common short-term side effects and risks associated with it.Phase 3 studies gather more information about effectiveness and safety that is necessary to evaluate the overall risk-benefit ratio of the product and to provide an acceptable basis for product labeling. In addition to the requirement for an active IND/IDE discussed in Section V.3 of this document, documentation of assurances with the Office of Human Research Protection (OHRP) (see Section IV.5.A of this document) must be on file with the FDA grants management office before an award is made. Any institution receiving Federal funds must have an institutional review board (IRB) of record even if that institution is overseeing research conducted at other performance sites. To avoid funding studies that may not receive or may experience a delay in receiving IRB approval, documentation of IRB approval and Federal Wide Assurance (FWA or assurance) for the IRB of record for all performance sites must be on file with the FDA grants management office before an award to fund the study will be made. In addition, if a grant is awarded, grantees will be informed of any additional documentation that should be submitted to FDA's IRB. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the FDA provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.FDA grants policies as described in the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/adminis/gpd/index.htm will apply to the applications submitted and awards made in response to this FOA.