Document ID: FDA-2011-N-0010-0003
Agency: fda
Document Type: Notice
Title: Cooperative Agreement to Support Shellfish Safety Assistance Project
Posted Date: 2011-06-28T04:00Z

[Federal Register Volume 76, Number 124 (Tuesday, June 28, 2011)]
[Notices]
[Pages 37815-37817]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16119]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0010]

Cooperative Agreement To Support Shellfish Safety Assistance 
Project

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 Food Safety is announcing its 
intent to award a single source cooperative agreement to support the 
Interstate Shellfish Sanitation Conference (ISSC). The purpose of this 
cooperative agreement is to enhance the FDA molluscan shellfish 
sanitation program and provide the public greater assurance of the 
quality and safety of these products.

DATES: Important dates are as follows:
    1. The application due date is July 15, 2011.
    2. The anticipated start date is September 1, 2011.
    3. The opening date is June 28, 2011.
    4. The expiration date is July 16, 2011.

For Further Information and Additional Requirements Contact:
    For Programmatic and Technical Concerns and Questions: Paul 
DiStefano, Center for Food Safety and Applied Nutrition (HFS-325), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 240-402-1410.
    For Administrative and Financial Concerns and Questions: Gladys 
Melendez-Bohler, Office of Acquisitions and Grants Services (HFA-500), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1078, Rockville, 
MD 20857, 301-827-7175.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-11-023, 93.103.

A. Background

    The CFSAN Office of Food Safety is announcing its intent to award, 
a single source cooperative agreement to the ISSC in the amount of 
$325,000 for fiscal year 2011, direct and indirect costs combined. 
Subject to the

[[Page 37816]]

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.
    Molluscan shellfish have been recognized by FDA as a significant 
source of seafood-borne illnesses and continue to be the subject of 
congressional, State, industry, and public concern. FDA has given high 
priority to enhance the Agency's shellfish safety program and to 
provide the public greater assurance of the quality and safety of these 
products. FDA administers the National Shellfish Sanitation Program 
(NSSP). Under that program the NSSP Model Ordinance serves as guidance 
for State shellfish sanitation programs and the issuance of State 
regulations and laws concerning shellfish safety. This cooperative 
agreement will enhance FDA efforts to help ensure that shellfish is 
free of harmful pathogens.

B. Research Objectives

    This 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; (2) strengthen State 
activities by providing them with procedural and policy guidance, 
technical training, research, consumer education, and support for 
States to participate in ISSC biennial meetings and ISSC committee 
meetings; and (3) promote efforts and projects, including research, 
that will contribute significantly to the ability of FDA and States to 
identify and implement scientifically defensible food safety controls 
to reduce the risk of illness associated with molluscan shellfish 
consumption, including Vibrio vulnificus and V. parahaemolyticus. 
Research efforts will provide information and data that can be used to 
reduce assumptions and tighten modeling outputs of the V. vulnificus 
and V. parahaemolyticus risk assessments developed by the Food and 
Agriculture Organization of the World Health Organization and FDA. 
Substantive accomplishments of the ISSC under previous cooperative 
agreements include:
    1. Coordination of annual shellfish safety meetings of Federal 
regulators, State regulators, and industry members for the purpose of 
developing improved science based shellfish safety controls in the NSSP 
Model Ordinance for implementation by State shellfish control agencies 
and the shellfish industry;
    2. Facilitation of the incorporation and implementation of Hazard 
Analysis and Critical Control Point (HACCP) into the NSSP Model 
Ordinance;
    3. Facilitation of an ISSC Unresolved Issues Process to resolve 
shellfish safety program discrepancies between FDA and States, ensuring 
continued compliance with NSSP shellfish safety controls;
    4. Coordination of NSSP Model Ordinance revisions and electronic 
online availability;
    5. Coordination with FDA on the development and oversight of a V. 
parahaemolyticus control plan;
    6. Development of an educational training video concerning the 
risks and control of illegal shellfish harvesting;
    7. Development of an education training video concerning the public 
health implications associated with overboard waste discharges from 
harvest vessels;
    8. Development of accredited online training courses for medical 
professionals concerning Vibrio illness and shellfish consumption;
    9. Development and maintenance of a World Wide Web site for 
continuous accessibility to molluscan shellfish safety information, 
including up-to-date information regarding outbreaks and recalls;
    10. Coordination, development and oversight of a V. vulnificus 
control plan;
    11. In conjunction with FDA, conduct of retail and processing plant 
product sampling studies to examine Vibrios in molluscan shellfish that 
have undergone a post harvest process to reduce levels of Vibrios; and;
    12. In conjunction with FDA, conduct of a retail shellfish study to 
look at the occurrence of pathogens in molluscan shellfish, including 
norovirus, Hepatitis A virus, Salmonella, and Vibrios; and
    13. In conjunction with FDA, development of a risk-based approach 
to evaluating State compliance with NSSP Model Ordinance requirements 
for controlling the safety of molluscan shellfish.
    Other substantive accomplishments of the ISSC include facilitating 
and coordinating development of shellstock time-temperature controls 
for V. vulnificus and V. parahaemolyticus; funding support for V. 
vulnificus virulent strain identification research; funding support to 
research the effects of ice chilling on V. vulnificus; funding support 
to research the influence of water and air temperature, dissolved 
oxygen, and nutrients on V. parahaemolyticus concentrations in Pacific 
oysters; funding support to conduct an economic assessment of mandating 
post-harvest treatment of oysters; funding support to conduct a 
consumer acceptance study of oysters that have been post-harvest 
treated to reduce Vibrio levels to nondetect; development of a V. 
vulnificus laboratory methodology training video; and development and 
broadcast of a public service announcement to alert at risk consumers 
of the dangers associated raw shellfish consumption.
    This project will (1) enhance both the effectiveness and uniformity 
of the national molluscan shellfish safety program by improving the 
flow of information between Federal and State regulatory agencies, 
industry, and consumers; (2) strengthen State activities by providing 
assistance in such areas as procedural and policy guidance, technical 
training, research, consumer education, and conformity with 
requirements of the NSSP Model Ordinance; (3) provide for research 
opportunities related to shellfish safety; and (4) bring to final 
resolution the development and implementation by States and industry of 
effective Vibrio risk control plans that are consistent with current 
science, epidemiology, and HACCP based food safety measures.
    Substantive involvement by FDA will include:
    (1) FDA will monitor 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 the ISSC on V. 
vulnificus and V. parahaemolyticus risk reduction efforts. FDA will 
continue to monitor State activities to ensure illness/risk reduction 
goals of the ISSC V. vulnificus control plan are met and continue to 
monitor State activities to ensure that the ISSC V. parahaemolyticus 
control plan is fully implemented.
    (4) FDA will continue to work with ISSC to develop State program 
evaluation criteria.
    (5) FDA will analyze State shellfish program data and information 
and work through the ISSC to resolve any State shellfish program 
problems that may impact public health.
    (6) FDA will conduct training courses in growing area 
classification, plant sanitation, and HACCP and plant standardization 
for participants of the ISSC, including online training modules.
    (7) FDA will work with the ISSC to develop new microbiological and 
marine biotoxin techniques and to develop and implement early warning 
systems for toxic algal blooms and new

[[Page 37817]]

strategies for managing areas affected by toxic algal blooms.
    (8) FDA will continue to work with ISSC to establish improved 
mechanisms for incorporating new lab methods into the NSSP.
    (9) FDA will work with the ISSC to develop NSSP Model Ordinance 
interpretations.
    (10) FDA will take any action that may be necessary to ensure 
compliance with this cooperative agreement including, but not limited 
to the pursuit of science-based HACCP controls for managing the risk of 
Vibrios, and developing patrol, growing area classification, and plant 
inspection criteria.

C. Eligibility Information

    Competition is limited to ISSC because it has unique capacity found 
nowhere else. ISSC is the primary voluntary National organization of 
State shellfish regulatory officials that provides guidance and counsel 
to the States and industry on matters of sanitary control of molluscan 
shellfish. ISSC is the only organization that has the established 
formal structure, procedures, and expertise to direct all components 
(public health, environmental, resource management, and enforcement) of 
an effective National shellfish safety program, and has operated 
satisfactorily in this capacity since 1993. This effort will enhance 
FDA's molluscan shellfish safety program and provide the public greater 
assurance of the quality and safety of shellfish products.

II. Award Information/Funds Available

A. Award Amount

    The annual allocation to the ISSC under this cooperative agreement, 
including support in the amount of $75,000.00 from the National Marine 
Fisheries Services will be $325,000.00.
    Subject to the availability of Federal funds and successful 
performance, 4 additional years of support will be available. CFSAN 
intends to fund 1 year of award to begin in September 1, 2011. Subject 
to annual appropriations and successful performance, 4 additional years 
of noncompetitive award will be available.

B. Length of Support

    September 1, 2011, to August 31, 2016.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to the funding 
opportunity announcement (FOA), applicants should first review the full 
announcement located at http://www.fda.gov/Food/NewsEvents/default.htm. 
(FDA has verified the Web site addresses throughout this document, but 
FDA is not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.) Persons 
interested in applying for a grant may obtain an application at http://grants2.nih.gov/grants/funding/phs398/phs398.html. For all paper 
application submissions, the following steps are required:
     Step 1: Obtain a Dun and Bradstreet Data Universal 
Numbering System (DUNS) Number
     Step 2: Register With Central Contractor Registration
     Step 3: Register With Electronic Research Administration 
(eRA) Commons
    Steps 1 and 2, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be 
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp.
    After you have followed these steps, submit paper applications to: 
Gladys Melendez-Bohler, Office of Acquisition and Grants Services (HFA-
500), Food and Drug Administration, 5630 Fishers Lane, rm. 1078, 
Rockville, MD 20857, 301-827-7175, e-mail: gladys.bohler@fda.hhs.gov.

    Dated: June 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16119 Filed 6-27-11; 8:45 am]
BILLING CODE 4160-01-P