[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 

[[Page 558]]
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 

[[Page 559]]
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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