[Federal Register Volume 65, Number 249 (Wednesday, December 27, 2000)]
[Notices]
[Pages 81871-81873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-33087]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Cooperative Agreement to Support the Shellfish and Seafood Safety 
Assistance Project; Notice to Accept and Consider a Single Source 
Application; Availability of Funds for Fiscal Year 2001

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 
intent to award, noncompetitively, a cooperative agreement to the 
Interstate Shellfish Sanitation Conference (ISSC) in the amount of 
$275,000 for the first year. Subject to the availability of Federal 
funds and successful performance, 4 additional years of support will be 
available. This effort will enhance FDA's molluscan shellfish 
sanitation program and provide the public greater assurance of the 
quality and safety of these products.

DATES: Submit application by January 26, 2001.

ADDRESSES: An application 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. If an application 
is hand-carried or commercially delivered, it 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: For the administrative and financial 
management aspects of this notice: Rosemary Springer, Grants Management 
Specialist (address above).
    Regarding the programmatic aspects: Paul W. Distefano, Office of 
Seafood (HFS-417), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 200 C St. SW., Washington, DC 20204 202-418-
3149.

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: (1) Enhance both the effectiveness and 
uniformity of the molluscan shellfish program by: (a) Improving the 
flow of information between Federal and State regulatory agencies, 
industry, and the consumer, and (b) 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); and (2) 
provide for research on Vibrio

[[Page 81872]]

vulnificus, which, although not normally a threat to healthy 
individuals, can cause serious illness and death in individuals with 
certain preexisting conditions and on Vibrio parahaemolyticus, which 
can cause illness in healthy individuals as well as compromised 
individuals. This research is intended to provide information to 
establish science-based controls to protect consumers from V. 
vulnificus and V. parahaemolyticus infection.

I. Availability of Funds

    FDA will fund this cooperative agreement at a level of 
approximately $275,000 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, 2001. This project may be supplemented 
over the 5 year period based on annual appropriations language.

II. Background

    Molluscan shellfish have been identified as the source of a 
majority of seafood-borne illnesses and are the subject of 
congressional, industry, and public concern. Therefore, FDA has given 
high priority to enhance the agency program and to provide the public 
greater assurance of the quality and safety of these products. One such 
enhancement has been the incorporation of FDA's seafood hazard analysis 
critical control point (HACCP) regulation into the NSSP Model 
Ordinance. FDA administers the NSSP and the NSSP Model Ordinance, which 
serves as guidance for State shellfish sanitation programs and State 
regulations concerning shellfish safety.
    In 1982, 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 
(MOU) and continues to recognize ISSC 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 grant to ISSC for 1 year and 
provided support for an additional 2 years because of satisfactory 
performance. 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 grant. Combined with 
the NMFS funds, the ISSC cooperative agreement was funded for a total 
of $465,000 over the 3 years.
    In February 1996, FDA awarded another noncompetitive cooperative 
grant to ISSC for 1 year with an additional 4 years based on 
satisfactory performance. The approved funding level per year was 
$150,000.

A. Substantial Accomplishments Under the Initial 1996 ISSC Award 
Include:

    1. Coordinated annual shellfish safety meetings of Federal 
regulators, State regulators, industry members for improving shellfish 
safety controls in the NSSP Model Ordinance.
    2. Facilitated incorporation and implementation of HACCP into the 
NSSP Model Ordinance.
    3. Facilitated the resolution of shellfish safety issues between 
several States and FDA.
    4. Coordinated the revision of NSSP Model Ordinance and assisted in 
its distribution.
    5. Coordinated development and oversight of an interim V. 
parahaemolyticus control plan.
    6. Developed an educational training video concerning illegal 
shellfish harvesting.
    7. Developed and maintained an Internet site for continuous 
accessibility to molluscan shellfish safety related information.
    Starting in September 1996, FDA awarded supplemental funding to the 
ISSC cooperative agreement providing for the implementation and 
enhancement of activities associated with V. vulnificus and V. 
parahaemolyticus.
    V. vulnificus is a pathogen found in the estuarine environment. V. 
vulnificus bacteria are not normally a threat to healthy individuals. 
However, for individuals with preexisting chronic medical conditions 
such as liver disease, alcoholism, and hemochromatosis, V. vulnificus 
can cause serious illness and death. Each year, between 12 and 40 cases 
of V. vulnificus illness associated with consumption of raw molluscan 
shellfish are reported to public health authorities in the United 
States.
    V. parahaemolyticus is also a pathogen found in the estuarine 
environment and can cause serious illness and death to individuals with 
preexisting chronic medical conditions such as liver disease and 
alcoholism. But, unlike V. vulnificus, V. parahaemolyticus bacteria can 
cause illness in healthy individuals. Each year, sporadic cases of V. 
parahaemolyticus associated with raw molluscan shellfish consumption 
are reported to public health authorities in the United States. 
Recently, however, a number of V. parahaemolyticus outbreaks associated 
with consumption of raw shellfish from the northern Pacific Coast, 
northern Atlantic Coast, and Gulf Coast have occurred.

B. Substantial Accomplishments of the ISSC in Relation to V. Vulnificus 
and V. Parahaemolyticus Supplemental Funding Include:

    1. Coordinated the development of shellstock time-temperature 
controls for V. vulnificus and V. parahaemolyticus.
    2. Provided funding for V. vulnificus virulent strain 
identification research.
    3. Provided funding for research on the effects of ice chilling on 
V. vulnificus and V. parahaemolyticus.
    4. Provided funding for research on the influence of water and air 
temperature, dissolved oxygen, and nutrients on V. parahaemolytics 
concentrations in Pacific oysters.
    5. Provided funding to conduct a retail study to define levels of 
V. vulnificus and V. parahaemolytics at points of purchase.
    6. Provided funding to conduct an economic assessment of mandating 
post-harvest treatment of oysters.
    7. Developed V. parahaemolytics laboratory methodology training 
video.
    8. Developed and broadcasted a public service announcement for 
alerting at risk consumers of the dangers associated with raw shellfish 
consumption.

III. 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, NMFS; and representatives from 
industry, academia, and foreign governments and industry. More than 30 
States are members of the ISSC, including all 23 coastal shellfish-
producing States.
    The proposed cooperative agreement with ISSC will continue: (1) To 
address the need to improve information exchange and transfer among 
States, Federal agencies, industry, and consumers; (2) to strengthen 
State activities by providing them with procedural and policy guidance, 
technical training, research, and consumer education; and (3) to 
enhance

[[Page 81873]]

research efforts and projects which will contribute significantly to 
the ISSC/FDA ability to identify scientifically defensible controls 
which reduce the incidence of V. vulnificus and V. parahaemolyticus 
illness.

IV. Substantive Involvement by FDA

    1. FDA will monitor and evaluate the ISSC's overall conduct under 
this cooperative agreement.
    2. FDA will have representation on the ISSC executive board, 
committees, and task forces.
    3. FDA will collaborate and work closely with ISSC on V. vulnificus 
and V. parahaemolyticus (e.g. continue to work on developing the V. 
vulnificus consumer education program and monitoring the implementation 
of the V. parhaemolyticus control plan).
    4. FDA will continue to work with ISSC to develop State program 
evaluation criteria (e.g. developing a Vibrio retail study that could 
include laboratory analyses of shellfish.)
    5. FDA will analyze State shellfish program data and information 
for ISSC.
    6. FDA will conduct training courses in growing area 
classification, plant sanitation, HACCP and plant standardization for 
participants of the ISSC.
    7. FDA will work with ISSC to develop new microbiological 
techniques and to develop and implement early warning systems for toxic 
algal blooms.
    8. FDA will continue to work with ISSC to establish a mechanism for 
incorporating new lab methods into the NSSP and to develop NSSP Model 
Ordinance interpretations.
    9. FDA will take any action that may be necessary to ensure 
compliance with this cooperative agreement (e.g. conducting economic 
study on post harvest treatment processes and developing patrol and 
plant inspection criteria).

V. Review Procedures and Evaluation Criteria

A. Review Procedures

    The application submitted by the ISSC will undergo noncompetitive 
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 Environmental Health 
Sciences 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 and Vibrio research.
    2. The application clearly describes the steps and a proposed 
schedule for planning, implementing and accomplishing the activities to 
be carried out under the cooperative agreement.
    3. 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.
    4. The application specifies the approach that the 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.
    5. The application specifies how the ISSC monitors the progress of 
the V. vulnificus and V. parahaemolyticus research projects and keeps 
the FDA informed of any significant advances in the understanding of or 
control of V. vulnificus and V. parahaemolyticus.
    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.

VI. 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 required and the contents 
shall be suggested by the project officer.
    The annual progress report on the V. vulnificus and V. 
parahaemolyticus research projects shall include, but is not limited 
to, the following: (1) Listing and purpose of research projects funded, 
(2) cost of each project, (3) milestones and completion dates for each 
project, (4) year-to-date results/scientific findings/public health 
findings of each project, (5) potential V. vulnificus and V. 
parahaemolyticus and control measures/strategies suggested by research 
efforts.
    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. 
Monitoring may be in the form of telephone conversations between the 
project officer/grants management specialists and the principal 
investigator. 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.

VII. 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.

VIII. 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 Rosemary Springer (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.

IX. Legend

    Unless disclosure is required 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 that 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: December 20, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-33087 Filed 12-22-00; 10:47 am]
BILLING CODE 4160-01-F