[Federal Register Volume 77, Number 151 (Monday, August 6, 2012)]
[Notices]
[Pages 46764-46765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19086]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0011]
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 assertion that the product to be studied meets the
statutory criteria to qualify for the grant 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 6, 2013; February 5,
2014. The resubmission due dates are October 15, 2013; October 15,
2014.
2. The anticipated start dates are November 2013; November 2014.
3. The opening date is December 6, 2013.
4. The expiration date is February 6, 2014; October 16, 2014
(resubmission).
For Further Information and Additional Requirements Contact:
Katherine Needleman, Office of Orphan Products Development, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5271,
Silver Spring, MD 20993-0002, Phone: 301-796-8660, Email:
[email protected]; or Vieda Hubbard, Office of
Acquisitions & Grant Services, 5630 Fishers Lane, rm. 2034, Rockville,
MD 20857, Phone: 301-827-7177, Email: [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.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA-FD-13-001
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.
The term ``rare disease or condition'' is defined in section 528 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ee). FDA generally
considers drugs, devices, and medical foods potentially eligible for
grants under the OPD grant program if they are indicated for a disease
or condition that has a prevalence, not incidence, of fewer than
200,000 people in the United States. Diagnostics and vaccines are
considered potentially eligible for such grants only if the U.S.
population to whom they will be administered is fewer than 200,000
people in the United States 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 products.
Applicants must include in the application's Background and
Significance section documentation to support the assertion that the
product to be studied meets the statutory criteria to qualify for the
grant 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 FY 2014 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 2015 will be similar to FY
2014. 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
[[Page 46765]]
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 & 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 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19086 Filed 8-3-12; 8:45 am]
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