[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]
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