[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