OpportunityTitle: Clinical Studies of Safety and Effectiveness of Orphan Products; Research Project Grant (R01)
CategoryExplanation: 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&apos;s Web site at www.fda.gov/orphan.     Cl;ose Date Explanation  Resubmission Application Due Dates:  Application Resubmission/Receipt Date: October 15, 2009, and October 15, 2010     Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years.
AdditionalInformationOnEligibility: Eligible Organizations: 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 HHS may apply. Agencies that are part of HHS may not apply. For-profit 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.     The following are also included: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Non-domestic (non-U.S.) Entity; Small Business; For-Profit Organization (Other than Small Business); State Government; Regional Organization; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Other: Eligible agencies of the Federal government; Faith-based or community based organizations.
Description: 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&#146; specific interests and competencies based on the mission 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&apos;s Web site at www.fda.gov/orphan. The goal of FDA&apos;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&apos;s &#147;Background and Significance&#148; 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.
GrantorContactEmailDescription: Marc.Pitts@FDA.HHS.GOV
GrantorContactText: Marc Pitts &lt;br/&gt;Senior Grants Management Spec &lt;br/&gt;Phone 301-827-7162
CloseDateExplanation: Resubmission Application Due Dates:  Application Resubmission/Receipt Date: October 15, 2009, and October 15, 2010     Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years.    On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).