[Federal Register Volume 75, Number 151 (Friday, August 6, 2010)]
[Notices]
[Pages 47602-47603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19354]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0394]
Clinical Studies of Safety and Effectiveness of Orphan Products
Research Project Grant (R01)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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).
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: [email protected].
Vieda Hubbard, Division of Acquisition Support and Grants, Office
of Acquisitions & Grant Services, 5630 Fishers Lane, Rockville, MD
20857, 301-827-7177, e-mail: [email protected].
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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\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.)
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
[[Page 47603]]
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.
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.
Dated: July 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19354 Filed 8-5-10; 8:45 am]
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