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

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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 VII, Other Information - Required Federal Citations, for policies related to this announcement.