[Federal Register Volume 61, Number 180 (Monday, September 16, 1996)]
[Notices]
[Pages 48706-48707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23669]


-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Cooperative Agreement for Shellfish and Seafood Safety Assistance 
Project; Intent to Supplement for Fiscal Year 1996

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of intent.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA), Center for Food Safety 
and Applied Nutrition, Office of Seafood, is announcing its intention 
to supplement the current year of the cooperative agreement with the 
Interstate Shellfish Sanitation Conference (ISSC) in the amount of 
$165,000. This money will provide for research of Vibrio vulnificus 
which, although not normally a threat to healthy individuals, can cause 
serious illness and death in individuals with certain preexisting 
conditions. The research is intended to provide information to 
establish science-based controls to protect at-risk consumers from V. 
vulnificus infection.

ADDRESSES: An application form is available from, and the completed 
form should be submitted to Robert L. Robins, Division of Contracts and 
Procurement Management (HFA-520), Food and Drug Administration, Park 
Bldg., 5600 Fishers Lane, rm. 3-40, Rockville, MD 20857, 301-443-6170. 
Applications hand-carried or commercially delivered should be addressed 
to the Park Bldg., 12420 Parklawn Dr., rm. 3-40, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: 
    Regarding the administrative and financial management aspects of 
this notice: Robert L. Robins (address above).
    Regarding the programmatic aspects of this notice: Paul W. 
DiStefano, Office of Seafood, Center for Food Safety and Applied 
Nutrition (HFS-417), Food and Drug Administration, 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 Program (45 
CFR 100). Under this supplement, the ISSC will make funds available to 
State agencies, academic institutions, and private and public 
organizations for V. vulnificus research through a competitive process.

I. Restricted Eligibility

    On October 20, 1995, the Commissioner of Food and Drugs, as 
authorized by the Public Health Service (PHS) Grants Administration 
Manual, Part 144.3, determined that a single source cooperative 
agreement could be awarded to the ISSC without competition. This 
supplemental application will provide for the implementation and 
enhancement of activities associated with V. vulnificus described and 
authorized under the original application, FD-U-000891-01 dated January 
4, 1996.

II. Availability of Funds

    FDA will fund this supplement to the cooperative agreement at a 
total level of $165,000. The original cooperative agreement has an 
additional 4 years of support which are contingent upon the 
availability of fiscal year appropriations, continued support from 
other government agencies, and successful performance. FDA anticipates 
that this supplement to the cooperative agreement will commence on or 
before September 30, 1996.

III. Background

    V. vulnificus is a pathogen found in the estuarine environment. V. 
vulnificus bacteria are not normally a threat to healthy individuals. 
However, in 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 31 cases 
of V. vulnificus illness associated with consumption of raw molluscan 
shellfish are reported to public health authorities in the United 
States.
    The paucity of scientific data associated with V. vulnificus has 
hindered efforts by public health officials, including FDA, to 
establish science based controls to protect at-risk consumers from V. 
vulnificus infection.

IV. Purpose

    This supplement to FDA's current cooperative agreement will enable 
the ISSC to award, through a competitive process, V. vulnificus 
research projects. Research efforts made possible by this supplement 
will complement existing efforts under FDA's current cooperative 
agreement with the ISSC and provide public health officials with better 
science and an enhanced understanding of V. vulnificus. Innovative 
research efforts will contribute significantly to the ISSC's and to 
FDA's ability to identify scientifically defensible controls that will 
help to reduce the incidence of V. vulnificus illness.

V. Substantive Involvement by FDA

    FDA will collaborate with the ISSC in the preparation of the 
Requests For Application and any other solicitation materials. FDA will 
review and comment on the methods of solicitation as proposed by the 
ISSC, provide technical assistance in the form of guidance and 
participation in the competitive review of all applications, and 
collaborate with the ISSC in the final selection of subgrantees.
    In the event that the ISSC does not have written policies governing 
the objective review for awarding subgrants, the ISSC has agreed to 
adhere to the PHS Grant Policy Statement governing ``Objective Review'' 
to the extent that it is applicable. All decisions by the objective 
review panel are final and are not appealable.

VI. Review Procedure and Evaluation Criteria

A. Review Procedure

    The application submitted by the ISSC will undergo a noncompetitive 
dual peer review. The application will be reviewed for scientific and 
technical merit by a panel of experts based upon applicable evaluation 
criteria. If the application is recommended for approval, it will then 
be presented to the National Advisory Environmental Health Sciences 
Council.

B. Evaluation Criteria

    The application will be reviewed and evaluated according to the 
following criteria:
    1. The application must clearly present an understanding of the 
purpose and objectives of the supplement to the cooperative agreement 
in conducting V. vulnificus research and set out the steps, with a 
proposed schedule for planning, implementing, and accomplishing the 
activities, to be carried out under this project.
    2. The application must describe the ISSC's ability to perform its 
responsibilities under this project by providing qualified staff. The

[[Page 48707]]

application must also demonstrate that the ISSC has the financial and 
other resources required for this project.
    3. The application must specify the approach that the ISSC will use 
to solicit proposals for V. vulnificus research.
    4. The ISSC application must explain how the ISSC will monitor the 
progress of selected research projects, and how it will keep FDA 
informed of any significant advances in the understanding of or control 
of V. vulnificus.
    In addition, FDA will determine whether the estimated cost of the 
project is reasonable. The application must 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 Requirement

    All terms and conditions of the current award shall remain in full 
force and effect for the supplemental award.
    As a result of this supplemental award, annual project progress 
reports must also include the following:
    1. Listing of research projects funded.
    2. Specific purpose of each project.
    3. Cost of each project.
    4. Anticipated completion and milestone dates for each project.
    5. Year-to-date results/scientific findings/public health findings 
of each project.
    6. Potential V. vulnificus control measures/strategies suggested by 
research efforts.

VIII. Mechanism of Support

    Support for this project will be in the form of a supplement to 
FDA's cooperative agreement with the ISSC. This agreement will be 
subject to all policies and requirements that govern the research grant 
programs of the PHS, including provisions of 42 CFR part 52 and 45 CFR 
part 74.

    Dated: September 10, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-23669 Filed 9-13-96; 8:45 am]
BILLING CODE 4160-01-F