[Federal Register Volume 65, Number 140 (Thursday, July 20, 2000)]
[Notices]
[Pages 45083-45085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18290]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Cooperative Agreement To Support the Waste-Management Education 
and Research Consortium, New Mexico State University; Notice of Intent 
to Accept and Consider a Single Source Application

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 to the Waste-Management Education and 
Research Consortium (WERC), New Mexico State University, to support the 
Annual International Environmental Design Contest. The estimated amount 
is $100,000 per annum. Competition is limited because the WERC 
International Environmental Design Contest is the only college level 
environmental design competition of its kind.

DATES: Submit applications by August 21, 2000.

ADDRESSES: An application is available from and should be submitted to: 
Maura Stephanos, Grants Management Specialist, Grants Management Office 
(HFA-520), Division of Contracts and Procurement Management, Office of 
the Director, Food and Drug Administration, 5600 Fishers Lane, rm. 
2129, Rockville, MD 20857, 301-827-7183. (Applications hand-carried or 
commercially delivered should be addressed to rm. 2129, 5630 Fishers 
Lane, Rockville, MD 20857; FAX 301-827-7106; e-mail address: 
[email protected].

FOR FURTHER INFORMATION CONTACT:   
Regarding the administrative and financial management aspects of this 
notice: Maura Stephanos (address above).
Regarding the programmatic aspects: Wendy Buckler, Office of Plant and 
Dairy Foods and Beverages (HFS-300), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, 202-205-2923.

SUPPLEMENTAL INFORMATION: This project is authorized under section 301 
of the Public Health Service Act (the PHS Act) (42 U.S.C. 241). FDA's 
research program is described in the Catalog of Federal Domestic 
Assistance at 93.103. The application will not be subject to review as 
governed by Executive Order 12372, Intergovernmental Review of Federal 
Program (45 CFR part 100).
    The Public Health Service (PHS) strongly encourages all award 
recipients to provide a smoke-free work place 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.

I. Background

    While the American food supply is among the safest in the world, 
every year there are still millions of Americans stricken by illness 
caused by the food they consume, and the very young and elderly die as 
a result. In 1997, the President announced his Food Safety Initiative 
(FSI), the goal of which is to reduce the annual incidence of foodborne 
illnesses by enhancing the safety of the nation's food supply. As 
directed, agencies are exploring ways to strengthen systems of 
coordination, surveillance, inspections, research, risk assessment, and 
education. Through a collaborative effort between the FDA, the U.S. 
Department of Agriculture (USDA), and the Environmental Protection 
Agency (EPA), a report titled ``Food Safety from Farm to Table: A 
National Food Safety Initiative'' was released in May 1997.
    Over the last several years, the detection of outbreaks of 
foodborne illnesses associated with domestic and imported fresh fruits 
and vegetables has also increased. Imports have doubled over the past 7 
years and they are expected to increase by 30 percent by 2002. Thus, 
FDA is directing surveillance, inspection, compliance, and education 
efforts to detect and prevent harmful pathogens from reaching the 
consumer in a food safety ``farm to table'' approach. These food safety 
efforts apply to both domestic and imported produce. To that end, FDA 
and USDA issued a guidance document that is intended to assist the U.S. 
and foreign produce industry in enhancing the safety of domestic and 
imported produce by addressing common areas of concern in the growing, 
harvesting, sorting, packing, and distribution of fresh produce.
    WERC is a program of the College of Engineering at New Mexico State 
University established in 1990 under a cooperative agreement with the 
U.S. Department of Energy. Starting in 1991, WERC has conducted an 
Annual Environmental Design Contest (Contest), which is a unique 
educational experience for students from throughout the world. The 
Contest is open to any 2-year, 4-year, or graduate degree institution. 
Since 1998, there has been a separate concurrent competition for high 
school students. The Contest provides an opportunity for students to 
apply all the theories they have learned and to develop innovative 
solutions for real environmental issues. Most of the problems in the 
past dealt with waste disposal, ground water contamination, nuclear 
waste treatment, and similar subjects. The scope of problems has 
recently been broadened to include food safety and disciplines such as 
microbiology.
    Major engineering and physical science departments at leading U.S. 
universities and some foreign countries regularly compete in the 
Contest. In the ninth annual Contest in 1998 to 1999, 56 universities 
and 8 high school teams presented and demonstrated technical solutions 
combined with economics, public policy, regulations and other 
considerations vital to the environment.
    Government and industry sponsors provide tasks for the Contest. The 
tasks are technological problems for which known solutions are not 
readily available.
    In 1999, FDA entered a task entitled ``Detection of Human Waste on 
Imported Fresh Fruits and Vegetables'' for the Contest. There are 
several areas in the production of fresh fruits and vegetables that can 
contribute to food safety concerns. One of the areas is the use of 
municipal biosolids or sewage sludge (the treated by-product of human 
waste treatment) as a soil amendment for the production of fresh fruits 
and vegetables. Improperly treated sewage sludge represents a 
significant source of human pathogens. Because the consumption of 
produce contaminated by human waste poses a potential health risk, FDA 
is seeking a mechanism by which it can: (1) Determine if sewage sludge 
has been adequately treated to eliminate pathogenic microorganisms and 
(2) determine if fresh fruits and vegetables are contaminated on the 
surface by improper sewage sludge. Three schools selected the FDA task.

II. Purpose

    FDA will be one of the sponsors for the Contest administered by 
WERC and will submit task(s) to be considered by the schools. The 
school teams' imagination, fresh ideas, and innovative solutions can be 
of great importance to

[[Page 45084]]

improving the safety of the American food supply.
    WERC reviews the tasks, adjusts them to stay within Contest 
parameters, and publicizes the Contest within the academic community. 
WERC will discuss and work with FDA on revising the agency's task. FDA 
will work closely with WERC throughout the Contest; the agency can also 
have a minimum of four judges participate in the competition.
    WERC announces the Contest in the fall. The competitors are self-
selected and, they may come from anywhere in the world. The student 
teams and their faculty advisors can accept the challenge of one or 
more of the tasks.
    The teams conduct research for potential solutions, develop a 
concept for a process to complete the task, and present their findings 
(including a bench-scale demonstration of their solution) during the 
competition that is held in April. The goal of the competition is to 
design, develop, and test actual environmental processes for real-world 
problems.
    The Contest is conducted in four parts: (1) A paper that presents a 
full-scale process analysis and design, (2) an oral presentation, (3) a 
bench-scale process demonstration (with samples taken of the product 
for analysis), and (4) a poster board presentation. All of the above 
Contest elements are part of a process used to communicate and to 
advance ideas and projects towards implementation in today's business 
environment.
    The judges for the competition come from all walks of life and are 
respected as leaders within their professional communities. They are 
selected from industry, government, and academia.
    The judges will critique each student team's performance, the 
performance of the contestants against the guidance provided, and the 
technical merits and applicability of the team's proposed solutions. A 
preliminary judges' meeting is held each February to review and revise 
the criteria for judging the different tasks and to finalize the 
judging process for the upcoming Contest. The recommendations resulting 
from the meeting are recorded for subsequent Contests. The broad base 
of judges have expertise in the physical and biological sciences, 
engineering, business, economics, health and safety regulations, 
environmental regulations, public policy, and communications.
    To enhance the learning experience, WERC provides feedback on the 
teams' performance after each Contest. The faculty advisor for each 
task will be provided with the high score, the low score, the average 
score, and the score for the paper, oral, bench-scale process, and 
poster. Related comments from the judges may also be provided.
    Each year, WERC tries to bring new sponsors to the program to 
maintain diversity and to address current environmental problems.

III. Delineation of Substantive Involvement

    FDA will have substantial involvement in the activities of the 
Contest being funded by the cooperative agreement. Substantive 
involvement includes, but is not limited to, the following:
    1. FDA will work closely with WERC throughout the annual Contest. 
This may include involvement in the selection of appropriate tasks for 
the next year's contests, in order to assure that selected tasks are 
diversified and address current environmental problems. Such 
involvement may include participation by FDA staff in conference calls 
and at meetings as well as through correspondence. FDA staff may also 
act as judges.
    2. As one of several sponsors of the contest, FDA will submit 
task(s) for the Contest. The task must: (1) Represent an actual 
environmental, waste management decontamination, or microbiological 
problem for which there is no known solution, or for which existing 
solutions do not meet the desired performance criteria and (2) be 
adaptable to a bench-scale demonstration within the limitations of the 
Contest. All submitted tasks are reviewed by WERC staff and discussed 
with the tasks' sponsors before the final selection is made. Priorities 
of the FDA and possible current health issues/topics may impact on 
future task(s) that would be submitted to WERC.
    3. As a sponsor of the contest, FDA will also provide qualified 
judges, one being the project officer for the submitted task(s), for 
the Contest. All judges are bound by the WERC contest ethic to make as 
objective a decision as possible on the awards. If a judge has a 
precontest bias for or against a particular university, he or she will 
excuse themselves from judgment of that university. Other judges will 
be selected from other sponsoring companies or agencies and from 
industry, government, and academia.

IV. Review Procedures

    The application submitted by the WERC will undergo a 
noncompetitive, dual peer review. The application will be reviewed for 
scientific and technical merit by a panel of experts in the subject 
field of the specific application. If the application is recommended 
for approval it will then be presented to the National Advisory 
Environmental Health Sciences Council for concurrence with the 
recommendations made by the first level reviewers. The final funding 
decision will be made by the Commissioner of Food and Drugs or her 
designee.

V. Reporting Requirements

    A Program Progress Report and a Financial Status Report (FSR) (SF-
269) are required. An original FSR and two copies shall be submitted to 
FDA's Grants Management Officer within 90 days of the budget expiration 
date of the cooperative agreement. Failure to file the FSR (SF-269) on 
time may be grounds for suspension or termination of the agreement. 
Progress reports will be required quarterly within 30 days following 
each fiscal year quarter (January 31, April 30, July 30, October 31), 
except that the fourth report will serve as the annual report and will 
be due 90 days after the budget expiration date. CFSAN program staff 
will advise the recipient of the suggested format for the Program 
Progress Report at the appropriate time. A final FSR (SF-269), Program 
Progress Report and Invention Statement, must be submitted within 90 
days after the expiration of the project period, as noted on the Notice 
of Grant Award.
    Program monitoring of recipients will be conducted on an ongoing 
basis and written reports will be reviewed and evaluated at least 
quarterly by the Project Officer and the Project Advisory Group. 
Project monitoring may also be in the form of telephone conversations 
between the Project Officer/Grants Management Specialist and the 
Principal Investigator and/or a site visit with appropriate officials 
of the recipient organization. The results of these monitoring 
activities will be duly recorded in the official file and may be 
available to the recipient upon request.

VI. Mechanism of Support

A. Award Instrument

    Support for this program will be in the form of a cooperative 
agreement. 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.

B. Length of Support

    The length of support will be for up to 5 years. Funding beyond the 
first year will be noncompetitive and will depend on: (1) Satisfactory 
performance during the preceding year, and/or (2) the availability of 
Federal fiscal year funds.

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VII. Submission Requirements

    The original and two copies of the completed Grant Application Form 
PHS 398 (Rev. 4/98) with copies of the appendices for each of the 
copies, should be submitted to Maura Stephanos (address above). Data 
included in the application, if restricted with the legend specified 
below, may be entitled to confidential treatment as trade secret or 
confidential commercial information within the meaning of 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 the PHS to the Office of 
Management and Budget (OMB) and were approved and assigned OMB control 
number 0925-0001.

VIII. Legend

    Unless disclosure is required by the Freedom of Information Act as 
amended (5 U.S.C. 552) as determined by the freedom of information 
officials of the Department of Health and Human Services or by a court, 
data contained in the portions of this application which have been 
specifically identified by page number, paragraph, etc., by the 
applicant as containing restricted information, shall not be used or 
disclosed except for evaluation purposes.

    Dated: July 10, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-18290 Filed 7-19-00; 8:45 am]
BILLING CODE 4160-01-F