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Notice

Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development (OPD) grant program. 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.

DATES:

Important dates are as follows:

1. The application due dates are February 2, 2011; February 1, 2012. The resubmission due dates are October 14, 2011; October 15, 2012.

2. The anticipated start dates are November 2010; November 2012.

3. The opening date is December 2, 2010.

4. The expiration date is February 2, 2012; October 16, 2012 (resubmission).

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FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:

Katherine Needleman, Orphan Products Grants Program, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5271, Silver Spring, MD 20993-0002, 301-796-8660, e-mail: katherine.needleman@fda.hhs.gov.

Vieda Hubbard, Division of Acquisition Support and Grants, Office of Acquisitions & Grant Services, 5630 Fishers Lane, Rockville, MD 20857, 301-827-7177, e-mail: vieda.hubbard@fda.hhs.gov.

For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at http://grants.nih.gov/​grants/​guide (select the “Request for Applications” link), http://www.grants.gov (see “For Applicants” section), and http://www.fda.gov/​ForIndustry/​DevelopingProductsforRareDiseasesConditions/​WhomtoContactaboutOrphanProductDevelopment/​ucm134580.htm.1

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SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-11-001

93.103

A. Background

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.

B. Research Objectives

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 Start Printed Page 47603products. 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.

C. Eligibility Information

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 the Department of Health and Human Services (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.

II. Award Information/Funds Available

A. Award Amount

Of the estimated fiscal year (FY) 2012 funding ($14.1 million), approximately $10 million will fund noncompeting continuation awards, and approximately $4.1 million will fund 5 to 10 new awards, subject to availability of funds. It is anticipated that funding for the number of noncompeting continuation awards and new awards in FY 2013 will be similar to FY 2012. Phase 1 studies are eligible for grants of up to $200,000 per year for up to 3 years. Phase 2 and 3 studies are eligible for grants of up to $400,000 per year for up to 4 years. Please note that the dollar limitation will apply to total costs (direct plus indirect). Budgets for each year of requested support may not exceed the $200,000 or $400,000 total cost limit, whichever is applicable.

B. Length of Support

The length of support will depend on the nature of the study. For those studies with an expected duration of more than 1 year, a second, third, or fourth year of noncompetitive continuation of support will depend on the following factors: (1) Performance during the preceding year; (2) compliance with regulatory requirements of IND/investigational device exemption (IDE); and (3) availability of Federal funds.

III. Electronic Application, Registration, and Submission

Only electronic applications will be accepted. To submit an electronic application in response to this FOA, applicants should first review the full announcement located at http://grants.nih.gov/​grants/​guide. For all electronically submitted applications, the following steps are required.

  • Step 1: Obtain a Dun and Bradstreet (DUNS) Number
  • Step 2: Register With Central Contractor Registration
  • Step 3: Obtain Username and Password
  • Step 4: Authorized Organization Representative (AOR) Authorization
  • Step 5: Track AOR Status
  • Step 6: Register With Electronic Research Administration (eRA) Commons

Steps 1 through 5, in detail, can be found at http://www07.grants.gov/​applicants/​organization_​registration.jsp. Step 6, in detail, can be found at https://commons.era.nih.gov/​commons/​registration/​registrationInstructions.jsp. After you have followed these steps, submit electronic applications to: http://www.grants.gov.

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Dated: July 30, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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Footnotes

1.  FDA has verified the Web site addresses throughout this document, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

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[FR Doc. 2010-19354 Filed 8-5-10; 8:45 am]

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