[Federal Register Volume 67, Number 119 (Thursday, June 20, 2002)]
[Notices]
[Pages 42052-42054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0264]


Cooperative Agreement to Support the National Center for Natural 
Products Research (NCNPR), University of Mississippi; Intent to 
Supplement--RFA-CFSAN-02-5 (CFDA No. 93.103)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
intention to receive and consider a noncompetitive supplement to the 
cooperative agreement with the University of Mississippi (UM) to 
support the National Center for Natural Products Research (NCNPR), 
which is located on UM's Campus at Oxford, MS, for up to $1 million per 
annum (direct plus indirect cost). The funds will provide additional 
support to the UM's NCNPR for the purpose of promoting more efficient 
development and dissemination of natural products research and science 
and will complement the diverse activities of both the public and 
private sectors that may become collaborators.

DATES: Submit the application by July 22, 2002. If this date falls on a 
weekend, it will be extended to Monday. If this date falls on a 
holiday, it will be extended to the following weekday.

ADDRESSES: An application form is available from and should be 
submitted to: Rosemary Springer, Grants Management Specialist, Division 
of Contracts and Procurement Management (HFA-520), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7182, 
e-mail [email protected]. If the application is hand carried or 
commercially delivered, it should be addressed to rm. 2129, 5630 
Fishers Lane, Rockville, MD 20857. Application forms can also be found 
at http://www.nih.gov/grants/fund/phs398/forms_toc.html. FDA is unable 
to receive applications electronically. Do not send the application to 
the National Institutes of Health, Center for Scientific Research 
(CSR).

FOR FURTHER INFORMATION CONTACT:   
    Regarding the administrative and financial management aspects of 
this notice: Rosemary Springer (see ADDRESSES).
    Regarding the programmatic aspects: Jeanne I. Rader, Center for 
food Safety and Applied Nutrition (HFS-840), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-1786 e-mail: [email protected].

SUPPLEMENTARY INFORMATION: FDA's authority to enter into grants and 
cooperative agreements is detailed under section 301 of the Public 
Health Service Act (42 U.S.C. 241). FDA's research program is described 
in the Catalog of Federal Domestic Assistance No. 93.103. Before 
entering into cooperative agreements, FDA carefully considers the 
benefits such agreements will provide to the public. This application 
is not subject to review as governed by Executive Order 12372, 
Intergovernmental Review of Federal Programs (45 CFR part 100).
    The Public Health Service (PHS) strongly encourages all award 
recipients to provide a smoke-free workplace and to discourage the use 
of all tobacco products. This is consistent with the PHS mission to 
protect and advance the physical and mental health of the American 
people.
    FDA is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2010,'' a national effort to 
reduce morbidity and mortality and to improve quality of life. 
Applicants may obtain a hard copy of the ``Healthy People 2010'' 
objectives, volumes I and II, for $70 ($87.50 foreign) S/N 017-000-
00550, by writing to the Superintendent of Documents, P.O. Box 371954, 
Pittsburgh, PA 15250-7954. Telephone orders can be placed to 202-512-
2250. The document is also available in CDX--ROM format, S/N 017-001-
00549-5 for $19 ($23.50 foreign). This publication is available as well 
on the Internet at http://www.health.gov/healthypeople. Internet 
reviewers should proceed to ``Publications.''

I. Restricted Eligibility

    On May 3, 2001 (66 FR 22236), FDA announced that a single source 
application for a cooperative agreement to support the NCNPR at the UM 
at Oxford, MS would be accepted. Supplemental funding referenced herein 
will provide for the implementation and enhancement of activities 
associated

[[Page 42053]]

with the NCNPR projects described and authorized under the original 
award FD-U-002071-01 dated September 28, 2001.

II. Availability of Funds

    FDA anticipates providing supplemental funding, during the project 
period, subject to the availability of fiscal year (FY) funding, in an 
amount up to $1 million per annum (direct and indirect costs).
    The original cooperative agreement was approved for 5 years of 
funding and currently has 4 years of noncompetitive support remaining, 
which is contingent upon the availability of FY appropriations and 
successful performance. FDA anticipates that supplemental funding of 
the cooperative agreement will commence on or before September 30, 
2002.

III. Background

    Congress amended the Federal Food, Drug, and Cosmetic Act (the act) 
with the passage of the Dietary Supplement Health and Education Act of 
1994, to create a regulatory framework for dietary supplements under 
food provisions of the act. FDA has primary responsibility for ensuring 
that appropriate regulatory actions are taken against marketed products 
that: (1) Present an unreasonable or significant risk of illness or 
injury when used according to label directions or under ordinary 
conditions of use, or (2) bear labeling that is false or misleading.
    In the Federal Register of May 3, 2001, FDA published a request for 
a single source application for a cooperative agreement to support the 
National Center for Natural Products Research, University of 
Mississippi. FDA awarded the cooperative agreement to the UM-NCNPR on 
September 28, 2001, following the review of the application by an ad 
hoc panel of experts and subsequent approval by the National Advisory 
Environmental Health Sciences Council in September 2001.
    The cooperative agreement between the UM-NCNPR and FDA was 
established to create a partnership that allows for more efficient use 
of research resources that identify and analyze specific components in 
ingredients, including botanical ingredients, thereby enhancing overall 
public health by ensuring that dietary supplements are safe and their 
labeling is truthful and not misleading. It also provides opportunities 
to address important national and international problems in natural 
products research.
    The unique needs for research in support of dietary supplements, 
with a specific emphasis on the safety of botanical ingredients, has 
been one of the key reasons for maintaining a strong research program 
with UM-NCNPR. UM-NCNPR has been determined to be 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. The UM 
is a comprehensive research institution with numerous academic programs 
relevant to natural products which can help to ensure that market 
products are safe for the American public. NCNPR has the unique 
capability to bring together diverse scientific expertise on bioactive 
natural products research from: (1) The UM faculty in the 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 NCNPR; and (3) its close 
academic links and historical collaborations with agriculture and 
botanical programs and facilities at the UM system. UM-NCNPR's ability 
to successfully and uniquely collaborate with FDA is also enhanced by 
its repository of several thousand natural product extracts and its 
long history of successful basic and applied multidisciplinary research 
to discover and develop natural products for use as bioactive 
ingredients in dietary supplements and pharmaceuticals, and for 
improving the quality and safety of dietary supplements.
    Additionally, research in UM-NCNPR is focused on using state-of-
the-art knowledge and technology to discover bioactive natural 
products, develop novel technologies or processes that facilitate the 
discovery of bioactive natural products, and provide research-based 
information on plant-derived products with health applications. These 
programs, facilities, and expertise working in conjunction with FDA 
scientists are essential for supporting the needs to ensure that sound 
science is available for ensuring the safety and truthfulness of 
labeling of marketed dietary supplement products.
    Finally, the large number of established collaborations among UM-
NCNPR scientists and other government agencies, academic organizations, 
and research institutions further enhance the collaboration in the area 
of natural products research. The primary focus of the FDA and UM-NCNPR 
collaboration is to support and benefit the public health by promoting 
more efficient development and dissemination of natural products 
research and science and to complement the diverse activities of both 
the public and private sector that may become collaborators.

IV. Purpose

    Supplemental funding to FDA's current cooperative agreement will 
provide the UM-NCNPR with the necessary resources to further conduct 
research related to the goals of the Dietary Supplement Health and 
Education Act and to leverage additional resources for natural products 
research for the benefit of the public health. These resources would:
    1. Expand the activities related to the coordination of scientific 
workshops and conferences, authenticated reference materials, 
literature reviews, and sharing of technical information;
    2. Augment and enhance overall research by sharing complementary 
resources with the collaborators by allowing FDA scientists to conduct 
collaborative research that addresses health issues and emerging health 
concerns that would improve the overall safety of natural products; and
    3. Develop additional (new) activities including activities related 
to investigation of in vitro testing of botanical dietary ingredients.
    Innovative activities made possible by supplemental funding will 
complement existing efforts under FDA's current cooperative agreement 
with the UM-NCNPR and will provide public health officials at all 
levels with sound public health information to support policy decisions 
and enhanced capabilities to communicate with their stakeholders.

V. Substantive Involvement by FDA

    All terms and conditions of the current award shall remain in full 
force and effect for the supplemental awards.

VI. Review Procedure

    The application submitted by the UM-NCNPR will undergo a 
noncompetitive, dual peer review. The application will be reviewed for 
scientific and technical merit by a panel of experts based on the 
following evaluation criteria: (1) Responsiveness to RFA, (2) adequacy 
of plan, (3) timeliness of program implementation, (4) adequacies and 
availability of research facilities, (5) ability to conduct proprietary 
research, (6) experience and conclusions, and (7) reasonableness of 
proposed budget.

[[Page 42054]]

    If the application is recommended for approval, then it will be 
presented to the National Advisory Environmental Health Sciences 
Council.

VII. Reporting Requirement

    All terms and conditions of the current award shall remain in full 
force and effect for the supplemental awards.

VIII. Mechanism of Support

    Support will be in the form of supplements to FDA's cooperative 
agreement with the UM-NCNPR. This agreement will be subject to all 
policies and requirements that govern the research grant program of the 
PHS, including provisions of 42 CFR part 52 and 45 CFR part 74.

IX. Legend

    Data and information included in the application, if identified by 
the applicant as trade secret or confidential commercial information, 
will be given confidential treatment as trade secret or confidential 
commercial information to the extent permitted by the Freedom of 
Information Act (5 U.S.C. 552(b)(4)) and FDA's implementing regulations 
(21 CFR 20.61).

    Dated: June 12, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-15492 Filed 6-19-02; 8:45 am]
BILLING CODE 4160-01-S