[Federal Register Volume 67, Number 129 (Friday, July 5, 2002)]
[Notices]
[Pages 44854-44857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16817]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Cooperative Agreement To Support the Joint Institute for Food 
Safety and Applied Nutrition; Notice of Intent To Renew a Cooperative 
Agreement; RFA-FDA-CFSAN-02-04

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
intention to accept and consider a single source application for the 
award of a cooperative agreement in fiscal year (FY) 2002 to the 
University of Maryland, College Park (UMCP) to support the Joint 
Institute for Food Safety and Applied Nutrition (JIFSAN), which is 
located on the University of Maryland campus in College Park, MD. An 
estimated amount of support in FY 2002 will be up to $3 million per 
year (direct and indirect costs), with an additional 4 years of 
support. Competition is limited to UMCP because of the unique 
partnership between FDA and UMCP. The cooperative agreement will 
continue to allow for a more efficient use of research, education, and 
outreach resources which enhances overall public health by expanding 
and improving food safety and nutrition programs as well as other 
program areas that impact on public health policy.

DATES: Submit the application by August 19, 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 workday.

ADDRESSES: The completed application should be submitted to Peggy 
Jones, Grants Management Officer, Division of Contracts and Procurement 
Management (HFA-520), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857. If the application is either hand carried or 
commercially delivered, it should be addressed to Peggy Jones, 5630 
Fishers Lane, rm. 2129, Rockville, MD 20857, 301-827-7160, FAX 301-827-
7101, e-mail address: [email protected].
    The application forms are available either from Peggy Jones (see 
ADDRESSES) or by the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html. NOTE: Do not send the application to the Center for 
Scientific Research (CSR), National Institutes of Health (NIH).

FOR FURTHER INFORMATION CONTACT:   
    Regarding the administrative and financial management aspects of 
this notice: Peggy Jones (see ADDRESSES).
    Regarding the programmatic aspects: Christine L. Hileman, Center 
for Food Safety and Applied Nutrition (HFS-006), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, 202-205-7153; e-
mail: [email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing its intention to accept 
and consider a single source application from UMCP for a cooperative 
agreement to support JIFSAN. FDA's authority to enter into grants and 
cooperative agreements is set out in 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 under 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 paper copy of the ``Healthy People 2010'' 
objectives, volumes I and II, conference edition (B0074) for $22 per 
set, by writing to the Office of Disease Prevention and Health 
Promotion Communication Support Center (Center), P.O. Box 37366, 
Washington, DC 20013-7366. Each of the 28 chapters of ``Healthy People 
2010'' is priced at $2 per copy. Telephone orders can be placed to the 
Center on 301-468-5690. The Center also sells the complete conference 
edition in CD-ROM format (B0071) for $5. This publication is available 
as well on the Internet at http://health.gov/healthypeople. Internet 
viewers should proceed to ``Publications.''

I. Background

    Through a formal Memorandum of Understanding (MOU) between FDA and 
UMCP, JIFSAN was established in April 1996. JIFSAN creates a 
partnership that allows for more efficient use of research, education, 
and outreach resources, thereby enhancing overall public health by 
expanding and improving food safety and nutrition programs as well as 
in other program areas that impact on public health policy. The primary 
focus of JIFSAN is food safety and nutrition, specifically as related 
to risk analysis, applied microbiology, natural toxins, chemical 
contaminants, animal health sciences, biotechnology and food 
composition and nutrition. JIFSAN also encompasses other program areas 
such as cosmetics, dietary supplements, and food labeling.
    In the Federal Register of May 22, 1997 (62 FR 28049), FDA 
published a request for a single source application for a cooperative 
agreement to support JIFSAN. The application was reviewed and approved 
by an ad hoc panel of experts. The panel's approval recommendation was 
then approved by the National Advisory Environmental Health Sciences 
Council in September 1997. FDA awarded the cooperative agreement to 
UMCP on September 30, 1997.
    In the Federal Register of July 26, 1999 (64 FR 40380), FDA 
published a

[[Page 44855]]

notice of its intention to noncompetitively supplement the cooperative 
agreement with UMCP. FDA awarded the noncompetitive supplement to the 
cooperative agreement with UMCP on September 29, 1999.
    JIFSAN is a jointly administered, multidisciplinary research, 
education, and outreach program. Under the cooperative agreement, UMCP 
has established and staffed the JIFSAN at the UMCP campus. UMCP has 
established core facilities that enable FDA and the University to share 
resources, such as major laboratory instrumentation, and has initiated 
a mechanism to permit access to the university's library facilities for 
appropriate FDA employees. Programs initiated by JIFSAN have 
demonstrated that the benefits from this partnership are substantial. 
The unique administrative structure of JIFSAN allows it to most 
effectively use resources to plan, organize, and run multidisciplinary, 
multiinstitutional programs in research, education, and outreach. The 
structure and policies of a major land-grant university offer the 
flexibility needed to enable JIFSAN to create and operate strategic 
alliances involving multiple partners and multiple funding sources. 
JIFSAN provides a neutral environment in which experts from industry, 
consumer and trade groups, international organizations, government 
agencies, and academia pool their resources and ideas to provide the 
scientific bases for the development of sound public health policy.

II. Goals and Objectives

A. Concept

    FDA believes that the cooperative research with UMCP through JIFSAN 
will further research related to food safety, will help to ensure the 
security of the American food supply, and will provide opportunities to 
leverage additional resources so that important national and 
international problems in food, nutrition, animal health science 
activities, cosmetics, dietary supplements, biotechnology, and food 
labeling can be addressed in a timely manner. FDA also believes that 
cooperative research through JIFSAN will promote the efficient use of 
the complementary resources (e.g., major instrumentation, space, 
information, and computer technologies) of both parties. All research 
will be related to FDA program requirements that ensure the safety of 
food.

B. Project Emphasis

    The purpose of this cooperative agreement will be to continue to:
    1. Develop a critical mass of scientific expertise to address 
ongoing and increasingly complex key public health issues, to provide 
early warning of emerging problems, to provide support during 
emergencies and crisis situations, and to provide scientific expertise 
in close proximity to FDA's administrative office to expedite 
regulatory policy and decisions. (All official regulatory activities, 
however, will be performed by FDA employees only);
    2. Provide a collaborative environment and expertise for more 
efficient use of current resources devoted to risk analysis and 
biotechnology research and related activities;
    3. Develop more effective methods for communicating public health 
policy and risk associated with both microbial and chemical hazards to 
the general public by going beyond the study of the science to the 
study of how that science is heard and understood;
    4. Share resources to enhance the research infrastructure and 
provide for effective use of increasingly sophisticated scientific 
equipment with high acquisition, installation, and maintenance costs 
and the corresponding expertise of both parties; and
    5. Establish mechanisms for exchange of technical information and 
scientific concepts between FDA, other Federal and State agencies, 
industry, academia, consumer and trade groups, and international 
organizations.

C. Summary of Future Objectives

    The MOU between FDA and UMCP continues to provide the essential 
foundation for a vigorous, high quality scientific research program to 
support sound regulatory policy and performance. FDA faces an 
increasing number of critical and complex food safety issues. Having a 
nearby source of complementary and specialized scientific expertise and 
facilities, enhances FDA's ability to respond rapidly to regulatory 
challenges and to expedite regulatory policy and decisions. FDA 
believes that JIFSAN is a sound investment to ensure the public health 
of American consumers. It provides an opportunity for extensive 
cooperation with University scientists, and it will significantly 
stimulate collaborative efforts between Government, academia, industry, 
and consumers to improve and ensure a safe food supply.
    The American people will benefit from this type of collaboration 
because it will ensure that FDA is positioned to respond rapidly in 
crisis situations to protect, promote, and enhance the health of the 
public.

III. Mechanism of Support

A. Award Instrument

    Support of this program, if awarded, will be in the form of a 
cooperative agreement. In FY 2002, FDA anticipates providing up to $3 
million (direct and indirect costs) for this award. It is anticipated 
that funding will remain at this level in the subsequent noncompetitive 
years unless appropriations change. The award will be subject to all 
policies and requirements that govern the research grant programs of 
the PHS, including the provisions of 42 CFR part 52, 45 CFR part 74, 
and the PHS grants policy statement.

B. Length of Support

    The length of support will be 1 year, with the possibility of an 
additional 4 years of noncompetitive support. Continuation, beyond the 
first year, will be based upon satisfactory performance during the 
preceding year and the availability of Federal fiscal year 
appropriations.

IV. Reasons for Single Source Selection

    UMCP is uniquely qualified to fulfill the objectives of the 
proposed cooperative agreement. UMCP is in close proximity to the 
congressionally directed location of FDA's Center for Food Safety and 
Applied Nutrition's (CFSAN's) and Center for Veterinary Medicine's 
(CVM's) offices and laboratories in Prince Georges's County, MD. UMCP 
has vast resources, which complement and greatly expand FDA's research, 
scientific, and outreach resources. UMCP is the Washington region's 
most comprehensive research institution, with numerous academic 
programs relevant to FDA's mission and the resources to support CFSAN's 
areas of interest, including: Microbiology, chemistry, food science, 
animal health sciences, biotechnology, agriculture, public policy, risk 
assessment, computational science, economics, and survey methodology. 
UMCP serves as the primary center for graduate study and research and 
provides undergraduate instruction across a broad spectrum of academic 
disciplines. The University extends its vast intellectual resources to 
the community through innovative projects designed to serve 
individuals, governments, and the private sector throughout the State 
of

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Maryland, the nation, and the international community. In 1988 the 
General Assembly of Maryland designated UMCP as the flagship 
institution for the University of Maryland System, which consists of 11 
campuses across the State and offers programs at some 200 sites 
worldwide.
    The University has developed core facilities to provide effective 
use of state-of-the-art scientific instrumentation with high 
acquisition, installation, and maintenance costs to conduct research at 
the forefront of science. An electron microscopy facility jointly 
supported by FDA and the University opened in 2000. CFSAN has moved its 
nuclear magnetic resonance (NMR) instrumentation and personnel to the 
University's NMR facility in the Chemistry building. These 
instrumentation centers complement CFSAN's resources and expertise.
    The University has developed a food safety risk analysis 
clearinghouse with oversight from the interagency risk assessment 
consortium (RAC) established under the auspices of the former 
administration's Food Safety Initiative. The intent of the 
clearinghouse is to provide a centralized information source in areas 
of risk analysis related to food safety with initial emphasis on 
microbial pathogens and their toxins. The unique feature of this 
clearinghouse model lies in the examinations and documentation of 
state-of-the-art methods, data sources, and current results of on-going 
risk assessments so that a much more complete and up-to-date picture of 
risk assessment is assembled.
    Acknowledging the importance of an interdisciplinary approach to 
knowledge, the University maintains organized research units outside 
the usual department structures (i.e., Department of Chemistry and 
Biochemistry and Department of Molecular, Cell and Microbial Biology, 
etc.). Through the collaborative projects, FDA has access to additional 
University resources that include: (1) The Center for Research in 
Public Communication, where cooperative projects related to risk 
communication studies could be developed; (2) the Survey Research 
Center and the Institute for Philosophy and Public Policy, which will 
promote more efficient development and dissemination of public policy; 
(3) the University of Maryland's Biotechnology Institute, including its 
Center for Agricultural Biotechnology, which will facilitate the 
development of a biotechnology program focused on food safety and 
nutrition; and (4) the Maryland Fire and Rescue Institute, which will 
facilitate the maintenance of emergency response readiness credentials 
of the FDA Safety Staff who are responsible for maintaining and 
ensuring safety and regulatory compliance at FDA facilities where 
collaborative research is conducted.
    Collaboration between the public and the private sectors has proven 
to be an efficient means for both FDA and the University to remain 
current with scientific and technical advances related to food safety 
and applied nutrition. These collaborative programs produce knowledge 
and expertise that can be used by all segments of the food safety and 
nutrition community, as well as by public health organizations, other 
Federal agencies, and academic institutions in the performance of their 
roles. The partnership between FDA and UMCP provides both the technical 
and educational expertise for effective creation of technology transfer 
mechanisms that facilitate the movement of new technology and provides 
fundamental food safety and nutrition information to the public and 
private sector.

V. Reporting Requirements

    Program progress reports and financial status reports will be 
required annually, based on date of award. These reports will be due 
within 90 days after the end of the budget period. A final program 
progress report and financial status report will be due 90 days after 
expiration of the project period of the cooperative agreement.

VI. Delineation of Substantive Involvement

    Substantive involvement by the awarding agency is inherent in the 
cooperative agreement award. Accordingly, FDA will have substantial 
involvement in the program activities of the projects funded by the 
cooperative agreement. Substantive involvement includes, but is not 
limited to, the following:
    1. FDA will have prior approval of the appointment of all key 
administrative and scientific personnel proposed by the grantee.
    2. FDA will be directly involved in the guidance and development of 
the program and of the personnel management structure for the program.
    3. FDA scientists will participate, with the grantee, in 
determining and carrying out the methodological approaches to be used. 
Collaboration will also include data analysis, interpretation of 
findings, and, where appropriate, coauthorship of publications.

VII. Review Procedures

    First, the grants management and program staff will review the 
application submitted in response to this request for application (RFA) 
for responsiveness. To be responsive, an application must: (1) Be 
received by the specified due date, (2) be submitted in accordance with 
sections VIII. ``Submission Requirements'' and IX.A. ``Submission 
Instructions'' of this document, (3) not exceed the recommended funding 
amount stated in the SUMMARY of this document, (4) address the specific 
program goals and objectives as detailed in section II.B. ``Project 
Emphasis'', and (5) bear the original signatures of both the principal 
investigator and the University's authorized official. Staff will 
consider the application nonresponsive if it does not contain the 
information set forth in this section. If the application is found to 
be nonresponsive, the staff will return the application to the 
applicant without further consideration. The staff will also consider 
an application nonresponsive for any of the following reasons: (1) The 
applicant organization is ineligible, (2) it is received after the 
specified receipt date, (3) it is incomplete, (4) it is illegible, (5) 
it is not responsive to the RFA, or (6) the material presented is 
insufficient to permit an adequate review.
    Next, if the application is responsive, it will undergo a dual peer 
review. A responsive application will be reviewed first for scientific 
and technical merit by an ad hoc panel of experts in areas associated 
with food safety, nutrition, animal health sciences, biotechnology, and 
risk analysis. The application will then be presented to the National 
Advisory Environmental Health Sciences Council for their concurrence 
with the ad hoc panel's recommendation.

VIII. Submission Requirements

    The original and two copies of the completed Grant Application Form 
PHS 398 (rev. 4/98 or Rev. 5/01) with copies of the appendices for each 
of the copies, must be delivered to Peggy Jones (see ADDRESSES). No 
supplemental or addendum material will be accepted after the receipt 
date.

IX. Method of Application

A. Submission Instruction

    An application from UMCP will be accepted during normal business 
hours, 8 a.m. to 4:30 p.m., Monday through Friday, on or before the 
established receipt date. The application will be considered received 
on time if sent or mailed on or before the receipt date as

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evidenced by a legible U.S. Postal Service dated postmark or a legible 
dated receipt from a commercial carrier, unless it arrives too late for 
orderly processing. Private metered postmarks shall not be acceptable 
as proof of timely mailing. An application not received on time will 
not be considered for review and will be returned to the applicant. 
(The applicant should note that the U.S. Postal Service does not 
uniformly provide dated postmarks. Before relying on this method, 
applicants should check with their local post office.) Do not send the 
application to the CSR, NIH. The application must be submitted via mail 
or hand delivered as stated above. FDA is unable to receive the 
application electronically. The applicant is advised that FDA does not 
adhere to the page limitations or the type size and line spacing 
requirements imposed by NIH for its applications.

B. Format for Application

    Submission of the application must be on Grant Application Form PHS 
398 (Rev. 4/98 or Rev. 5/01). All ``General Instructions'' and 
``Specific Instructions'' in the application kit must be followed with 
the exception of the receipt dates and the mailing label address.
    The face page of the application must reflect the request for 
application number, RFA-FDA CFSAN-02-3.
    Data and information included in the application, if identified by 
the applicant as trade secret or confidential commercial information 
will be given treatment as such 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).
    Information collection requirements requested on Form PHS 398 and 
the instructions have been submitted by PHS to the Office of Management 
and Budget (OMB) and were approved and assigned OMB control number 
0925-001.

    Dated: June 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-16817 Filed 7-3-02; 8:45 am]
BILLING CODE 4160-01-S