[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Notices]
[Pages 19996-19997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8521]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0012]
Cooperative Agreement With the University of Mississippi's
National Center for Natural Products Research (U01) To Develop and
Disseminate Botanical Natural Product Research With an Emphasis on
Public Safety
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 a cooperative agreement
with the University of Mississippi's National Center for Natural
Products Research (UM-NCNPR). The goal of the cooperative agreement is
to promote the efficient development and dissemination of natural
products research and science and the programs developed under the
agreement will complement the diverse activities of both the public and
private sectors.
DATES: Important dates are as follows:
1. The application due date is May 1, 2011.
2. The anticipated start date is June 1, 2011.
3. The opening date is April 11, 2011.
4. The expiration date is May 2, 2011.
For Further Information and Additional Requirements Contact:
Scientific/Programmatic Contacts:
Jeanne I. Rader, Center for Food Safety and Applied Nutrition (HFS-
715), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1786,
FAX: 301-436-2622, e-mail: [email protected]; or
Steven L. Robbs, Center for Food Safety and Applied Nutrition (HFS-
006), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2146,
FAX: 301-436-2618, e-mail: [email protected]; or
LaQuia S. Geathers, Center for Food Safety and Applied Nutrition (HFS-
680), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2821,
FAX: 301-436-2629, e-mail: [email protected].
Grants Management Contact:
Vieda Hubbard, Office of Acquisitions and Grants Services (HFA-500),
5630 Fishers Lane, Rm. 2141, Rockville, MD 20857, 301-827-7177, FAX:
301-827-7101, 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://grants2.nih.gov/grants/guide and http://www.fda.gov/Food/NewsEvents/default.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA-FD-11-004
Catalog of Federal Domestic Assistance Number(s): 93.103 https://www.cfda.gov.
A. Background
The primary focus of the UM-NCNPR/FDA cooperative agreement is to
develop and disseminate botanical natural product research with an
emphasis on public safety according to the needs of FDA. The
cooperative research, education, and outreach programs developed by UM-
NCNPR will address scientific issues related to the safety of botanical
dietary supplements (BDS) and botanical ingredients and will complement
the diverse activities of both the public and private sectors.
B. Research Objectives
This cooperative agreement will define the research projects,
workshops, conferences, partnerships with academia, industry, non-
governmental organizations, and international organizations and other
activities on which the FDA and UM-NCNPR will collaborate.
Specifically, this cooperative agreement will provide continued support
so that UM-NCNPR can:
Assist in the identification and development of a list of
BDS and botanical ingredients, based on safety concerns, trends, and
knowledge of botanicals being marketed in the United States, to
prioritize for further research.
Acquire, validate, and characterize authenticated
reference materials, including raw and processed plant materials and
purified natural products of relevance to FDA, for evaluation of their
safety.
Exchange technical and scientific information, analytical
methods, and reference material with FDA scientists and other
stakeholders.
Collaborate with FDA scientists in research areas of
mutual interest.
Coordinate scientific workshops and conferences on BDS-
related topics of public health relevance to address high priority
science and research needs.
C. Eligibility Information
NCNPR has the unique capability to bring together diverse
scientific
[[Page 19997]]
expertise on BDS and botanical ingredients from: (1) The faculty in the
UM School of Pharmacy, including researchers in the Departments of
Pharmacognosy, Medicinal Chemistry, Pharmaceutics, Pharmacology, and
the Research Institute of Pharmaceutical Sciences; (2) research
scientists in the U.S. Department of Agriculture/Agricultural Research
Service's (USDA/ARS) National Products Utilization Research unit who
are physically co-located and programmatically integrated in the UM-
NCNPR; (3) close academic links and historical collaborations with
agriculture and botanical programs and facilities within the UM system;
(4) successful research collaborations with the dietary supplement
industry; and (5) established formal agreements with several
international academic institutions.
These collaborations give UM-NCNPR the unique ability to provide
essential scientific expertise and botanical and chemical resources
that will continue to assist FDA in its mission to ensure the safety of
BDS and botanical ingredients.
FDA believes that continued support of UM-NCNPR is appropriate
because it is uniquely qualified to fulfill the objectives of the
proposed cooperative agreement. FDA has determined that UM-NCNPR is the
only institution with the unique capability of providing a broad range
of highly relevant scientific expertise and facilities that are
physically co-located and singularly dedicated to natural products
research. UM is a comprehensive research institution with numerous
academic programs relevant to natural products.
II. Award Information/Funds Available
A. Award Amount
The estimated amount of support in Fiscal Year (FY) 2011 will be
for up to $2.1 million (direct plus indirect costs), with the
possibility of 4 additional years of support for up to $2.5 million per
year, subject to the availability of funds. Future year amounts will
depend on annual appropriations and successful performance.
B. Length of Support
The award will provide 1 year of support, with the possibility of 4
additional years of support, contingent upon satisfactory performance
in the achievement of project and program reporting objectives during
the preceding year and the availability of Federal FY appropriations.
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://www.fda.gov/Food/NewsEvents/default.htm or http://grants2.nih.gov/grants/guide. (FDA has
verified the Web site addresses throughout this document, but FDA is
not responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.) 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: April 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8521 Filed 4-8-11; 8:45 am]
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