Document ID: FDA-2011-N-0012-0002
Agency: fda
Document Type: Notice
Title: Cooperative Agreements to Develop and Disseminate Botanical Natural Product Research, etc.: University of Mississippi National Center for Natural Products Research
Posted Date: 2011-04-11T04:00Z

[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Notices]
[Pages 19996-19997]
From the Federal Register Online via the Government Printing 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: Jeanne.Rader@fda.hhs.gov; 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: Steven.Robbs@fda.hhs.gov; 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: LaQuia.Geathers@fda.hhs.gov.

    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: 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://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]
BILLING CODE 4160-01-P