[Federal Register Volume 61, Number 5 (Monday, January 8, 1996)]
[Notices]
[Pages 557-559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-229]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Program Announcement Number FDA-CFSAN-96.1 Cooperative Agreement
for Shellfish and Seafood Safety Assistance Project; Availability of
Funds for Fiscal Year 1996
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA), Center for Food Safety
and Applied Nutrition (CFSAN), Office of Seafood (OS), is announcing
its intention to award, noncompetitively, a
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cooperative agreement to the Interstate Shellfish Sanitation Conference
(ISSC) in the amount of $150,000 for the first year. An additional 4
years of support are available, depending upon the availability of
Federal funds and successful performance. This effort, authorized by
the Public Health Service Act, will enhance FDA's molluscan shellfish
sanitation program and provide the public greater assurance of the
quality and safety of these products.
FOR FURTHER INFORMATION CONTACT: Robert L. Robins, Office of
Facilities, Acquisitions, and Central Services (HFA-522), Food and Drug
Administration, Park Bldg., rm. 340, 5600 Fishers Lane, Rockville, MD
20857, 301-443-6170.
Regarding the programmatic aspects of this program contact: Paul W.
DiStefano, Office of Seafood, Center for Food Safety and Applied
Nutrition (HFS-417), 200 C St. SW., Washington, DC 20204, 202-418-3177.
SUPPLEMENTARY INFORMATION: This project is authorized under section 301
of the Public Health Service Act (42 U.S.C. 241). This activity is
generally described in the Catalog of Federal Domestic Assistance at
93.103. This application is not subject to review as governed by
Executive Order 12372, Intergovernmental Review of Federal Programs (45
CFR part 100).
This project will enhance both the effectiveness and uniformity of
the molluscan shellfish program by: (1) Improving the flow of
information between Federal and State regulatory agencies, industry,
and the consumer; and (2) strengthening State activities by providing
assistance in such areas as procedural and policy guidance, technical
training, research, consumer education, and the assurance of conformity
to the National Shellfish Sanitation Program (NSSP).
I. Restricted Eligibility
The Commissioner of the Food and Drug Administration, as authorized
by the Public Health Service Grants Administration Manual, Part 144.3,
has determined that this program should be awarded as a cooperative
agreement without competition to the ISSC. Only the ISSC has the
established relationships with the necessary State and local
governments, the shellfish industry, other Federal agencies, and FDA to
achieve the objective of this project. Therefore, no other applications
are solicited or will be accepted.
II. Availability of Funds
FDA will fund this cooperative agreement at a level of
approximately $150,000 for the first year. An additional 4 years of
support will be available, depending upon fiscal year appropriations,
continued support from other government agencies, and successful
performance. It is anticipated that this cooperative agreement will
commence on or before March 1, 1996.
III. Background
Molluscan shellfish have been identified as the source of a
majority of seafood-borne illnesses and have become a subject of
congressional, industry, and public concern. FDA has therefore given
high priority to efforts to enhance the agency program and to provide
the public greater assurance of the quality and safety of these
products. Unique problems associated with the consumption of raw
molluscan shellfish, e.g., oysters, clams, mussels, and scallops, led
to establishment of the NSSP in 1925. FDA administers the NSSP and the
Manuals of Operation, parts I and II, which serve as guidance for State
shellfish sanitation programs and State regulations.
In 1983, the ISSC was formed to provide a formal structure wherein
State regulatory authorities can establish updated guidelines and
procedures for the uniform application of that guidance for the
sanitary control of the shellfish industry. The ISSC is a voluntary
organization and is open to all persons interested in fostering
controls that will ensure sources of safe and sanitary shellfish. In
1984, FDA recognized the ISSC through a memorandum of understanding and
continues to recognize it as the primary voluntary national
organization of State shellfish regulatory officials that will provide
guidance and counsel to the States on matters of sanitary control of
shellfish.
In 1993, FDA awarded a noncompetitive cooperative agreement to ISSC
for 1 year and provided support for an additional 2 years because of
satisfactory performance. The cooperative agreement expires on February
28, 1996. FDA received $75,000 a year from the Department of Commerce,
National Oceanic and Atmospheric Administration, National Marine
Fisheries Services (NMFS) in support of the cooperative agreement.
Combined with the NMFS funds, the ISSC cooperative agreement was funded
for $165,000 the first year and $150,000 each for the second and third
years, for a total of $465,000. Substantive accomplishments over the
first 3 years of the cooperative agreement include:
1. Mediation of differences between FDA and States regarding
compliance with the NSSP Manuals of Operation;
2. Coordination of FDA/State/NMFS efforts to develop a marine
biotoxin dockside testing program;
3. Co-sponsoring of the 1994 Vibrio vulnificus workshop;
4. Compilation of a comprehensive collection of V. vulnificus
reference materials for use by the ISSC;
5. Negotiation and adoption of a V. vulnificus water temperature/
time to temperature control matrix for reducing the risk of V.
vulnificus illness;
6. Dissemination of FDA warnings/information to States/industry;
7. Administration of the National Indicator Study;
8. Development of a model shellfish code;
9. Development of a formal process for establishing binding
interpretations of the NSSP Manual of Operations;
10. Coordination of the development of a Shellfish Information
Management System (SIMS); and
11. Participation in regional shellfish meetings to coordinate
national efforts in shellfish sanitation.
IV. Purpose
The ISSC was formed as a partnership of State shellfish control
officials representing both environmental and public health agencies;
Federal agencies including FDA, the Environmental Protection Agency,
and the Department of Commerce, National Marine Fisheries Service; and
representatives from industry, academia, and foreign governments and
industry. More than 25 States are members of the ISSC, including all 23
coastal shellfish-producing States.
The proposed cooperative agreement with ISSC will continue to: (1)
Address the need to improve information exchange and transfer among
States, Federal agencies, industry, and consumers; and (2) strengthen
State activities by providing them with procedural and policy guidance,
technical training, research, and consumer education.
V. Substantive Involvement by the FDA
To achieve the purpose of this project, ISSC shall be responsible
for conducting the following activities:
1. Interact with States in resolving problems between States or
between FDA and a State regarding conformity to the NSSP;
2. Communicate procedures and policy statements to guide States in
executing the NSSP;
3. Interact with States in developing uniform and effective
evaluation criteria;
4. Provide program auxiliary support in facilitating State
involvement in
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technical training, research, consumer education, coordinating the
collection of data and maintaining the National Shellfish Register of
Classified Estuarine Waters, and coordinating the development of a
digitized mapping network (SIMS);
5. Interact with States to implement V. vulnificus consumer
educational programs, develop risk reduction controls for V.
vulnificus, and develop criteria for assessing V. vulnificus risk
reduction controls; and-
6. Obtain information from States and industry to provide
consistent and coordinated input to FDA and implement a Model Shellfish
Code.
FDA will monitor and evaluate the ISSC's conduct under this
cooperative agreement. FDA will take any actions that may be necessary
to ensure compliance with this cooperative agreement. Future support
under this agreement will be contingent upon satisfactory performance
of this project and the availability of Federal fiscal year
appropriations.
VI. Review Procedure and Evaluation Criteria
A. Review Procedure
The application submitted by the ISSC will undergo dual peer
review. The application will be reviewed for scientific and technical
merit by a panel of experts based upon the applicable evaluation
criteria. If the application is recommended for approval, it will then
be presented to the National Advisory Council for their concurrence.
B. Evaluation Criteria
The application will be reviewed and evaluated according to the
following criteria:
1. The application clearly states an understanding of the -purpose
and objectives of the cooperative agreement in the overall seafood
safety program; the key role and responsibility of the ISSC; and the
steps, with a proposed -schedule, for planning, implementing, and
accomplishing the activities to be carried out under this project.
2. The application describes the applicant's ability to perform the
responsibilities under this project by providing qualified staff. The
application also demonstrates that the ISSC has the financial and other
resources required for this project.
3. The application specifies the intended approach that ISSC will
use to maintain and to continue working with both the States and
industry to ensure the exchange of information among the States,
industry, and consumers on seafood safety.
4. The application adequately describes how ISSC will maintain and
coordinate the collection of data to keep the National Shellfish
Register for Classified Estuarine Waters up-to-date. The application
also describes how ISSC will coordinate the development of a digitized
mapping network.
In addition, the agency will determine whether the estimated cost
of the project is reasonable. The application shall include a detailed
budget that shows: (1) Anticipated costs for personnel, travel,
communications and postage, equipment, and supplies; and (2) the
sources of funds to meet those needs.
VII. Reporting Requirements
FDA requires an annual Financial Status Report (FSR) (SF-269).
Under FDA procedures, the original and two copies of this report must
be submitted to FDA's Grants Management Office within 90 days of the
budget period expiration date. An annual project progress report is
also required. The contents of this report shall be suggested by the
project officer at a later date.
A final project progress report, FSR, and Invention Statement must
be submitted within 90 days from the expiration date of the project
period as noted on the Notice of Grant Award.
Program monitoring will be conducted on an ongoing basis, and
written reports may be done by the project officer. Monitoring may be
in the form of telephone conversations between the project officer/
grants management specialist and the principal investigator, and site
visits may be made by either program or grants management staff. The
results of the visits will be recorded in the official grant file and
may be available to the grantee upon request.
VIII. Mechanism of Support
Support for this project will be in the form of a cooperative
agreement. This agreement will be subject to all policies and
requirements that govern the research grant programs of the Public
Health Service, including provisions of 42 CFR part 52 and 45 CFR part
74.
Dated: December 28, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-229 Filed 1-5-96; 8:45 am]
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