[Federal Register Volume 67, Number 62 (Monday, April 1, 2002)]
[Notices]
[Pages 15400-15402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7819]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cooperative Agreement to Support the World Health Organization
International Programme on Chemical Safety; Notice to Accept and
Consider a Single Source Application; Availability of Funds for Fiscal
Year 2002; RFA-FDA-CFSAN-02-2
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) is announcing its intent to accept and
consider a single source application for the award of a cooperative
agreement to the World Health Organization (WHO) to support the
International Programme on Chemical Safety (IPCS). FDA anticipates
providing $140,000 (direct and indirect costs) in fiscal year 2002 in
support of this project. Subject to the availability of Federal funds
and successful performance, two additional years of support up to
$140,000 per year (direct and indirect costs) will be available.
The cooperative agreement assures FDA's participation in important
international standard setting activities for food ingredients,
contaminants, and veterinary drug residues which provides the public
with greater assurance of the quality and safety of food sold in the
United States.
DATES: Submit applications by May 1, 2002.
ADDRESSES: Application forms are available from, and completed
applications should be submitted to: Rosemary Springer, 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 5630 Fishers Lane, rm. 2129, Rockville, MD 20857, FAX
301-827-7101. Application forms can also be found at http://www.nih.gov/grants/phs398/forms_toc.html. Do not send the application
to the Center for Scientific Review, National Institutes of Health
(NIH). An application not received by FDA in time for orderly
processing will be returned to the applicant without consideration. FDA
can not receive an application electronically.
FOR FURTHER INFORMATION CONTACT:
Regarding the administrative and financial management aspects of this
notice: Rosemary Springer (see ADDRESSES), e-mail: fda.gov">rspringe@oc.fda.gov.
Regarding the programmatic aspects: Mitchell Cheeseman, Center for Food
Safety and Applied Nutrition (HFS-205), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3083, e-
mail: Mitchell. Cheeseman @CFSAN. fda.gov.
I. Introduction
FDA is announcing its intention to accept and consider a single
source application from the WHO to support the International Programme
on Chemical Safety. FDA's authority to enter into grants and
cooperative agreements is detailed under section 301 of the Public
Health Service Act (42
[[Page 15401]]
U.S.C. 241). FDA's research program is described in the Catalog of
Federal Domestic Assistance No. 93.103. Before entering into
cooperative agreements, FDA carefully considers the benefits such
agreements will provide to the public. This application is not subject
to review as governed by Executive Order 12372, Intergovernmental
Review of Federal Programs (45 CFR part 100).
II. Background
Under section 409 of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 348), premarket approval is required for food additives
intended for direct addition to food. FDA grants approval for the use
of such food additives by issuance of a regulation prescribing the
conditions under which the additive may be safely used, including any
specifications regarding identity or purity that the additive must
meet.
New animal drugs also require premarket approval under section 512
of the act (21 U.S.C 360b). As with food additives, FDA establishes
appropriate limitations and specifications for the use of animal drugs.
Since the early 1980s, FDA has provided support for the WHO
International Programme on Chemical Safety.
IPCS is a cooperative venture of three United Nations agencies:
WHO, International Labor Organization (ILO), and the United Nations
Environmental Programme (UNEP). WHO is the executing agency and manages
the Central Unit in Geneva.
The IPCS organizational setting provides an umbrella that allows
for timely collaboration in undertaking multinational cooperative
activities, which is an important step in serving the world community.
The various programs under the International Programme on Chemical
Safety significantly contribute in the development of international
standards. An important program under IPCS is the Food and Agriculture
Organization/WHO Joint Expert Committee on Food Additives (JECFA),
which is the scientific advisory body to the Codex Alimentarius
Commission for food additives, contaminants, and residues of veterinary
drugs in food. Relevant standards, guidelines, and recommendations for
food additives, contaminants, and veterinary drug residues established
by the Codex Alimentarius Commission are specifically recognized by the
World Trade Organization (WTO) as necessary to protect human health,
and are presumed to be consistent with the 1994 Uruguay Round of the
General Agreement on Tariffs and Trade (GATT). GATT requires that
countries consider Codex standards when establishing measures to ensure
food safety.
Since its inception in 1962, FDA has participated in the standard-
setting activities of the Codex Alimentarius Commission, including
developing standards for food additives, contaminants, and veterinary
drug residues. The result of this interaction has been to maintain the
high safety standard for foods entering the United States from abroad
and to facilitate trade between the United States and the 164 other
countries that participate in the development of, and recognize, Codex
standards. It is important that FDA continues to participate in such
standard development in order to maintain input into the development of
appropriate scientific standards for the protection of the safety of
food ingredients and to share information on the development of such
standards around the world.
FDA's participation in international harmonization and
international standard setting activities enhances the Agency's ability
to achieve international standards that are favorable; ensures that the
safety of the U.S. food supply is not compromised by inadequate
international standards; and promotes the safe use of food additives in
foods in international trade and thereby enhances the safe use of food
additives in imported food. Participation in international standard
setting activities also reduces the likelihood of challenges involving
food additives being brought before WTO either by the U.S. Government
or against the U.S. Government.
III. Objectives
The following activities to be supported by this cooperative
agreement are:
1. Schedule, plan, and conduct appropriate work groups and
committee meetings, which have emphasis on food additives and
contaminants, and the evaluation of residues in veterinary drugs in
food.
2. Identify advisers and prepare working papers summarizing the
data on substances under consideration.
3. Prepare written working papers and technical documents for
JECFA, for the Codex Committee on Food Additives and Contaminants, and
for the Codex Committee on Residues of Veterinary Drugs in Food.
IV. Delineation of Substantive Involvement
Substantive involvement by the awarding agency is inherent in the
cooperative agreement award. Accordingly, FDA will have substantial
involvement in the program activities of the project funded by the
cooperative agreement. Substantive involvement includes, but is not
limited to, the following:
1. FDA will participate as head of the U.S. Delegation in the
Sessions of the Codex Committee on Food Additives and Contaminants
(CCFAC). This includes participation in all ad hoc working groups
associated with CCFAC. This participation includes, but is not limited
to, serving as chair for the CCFAC ad hoc Working Group on the General
Standard for Food Additives (GSFA), and the CCFAC ad hoc Working Group
on Specifications, and participating in the CCFAC's ad hoc Working
Group on Contaminants and Toxins.
2. FDA will participate in the Codex Committee on Residues of
Veterinary Drugs in Food (CCRVDF). Current participation includes, but
is not limited to, chair of CCRVDF and head of the U. S. Delegation to
CCRVDF.
3. FDA will provide official comments to the Codex Secretariat on
discussion documents, position papers, draft Codex standards, and other
documents associated with CCFAC and CCRVDF that are circulated for
comment. FDA will ensure that these comments are consistent with
current agency policy on the use of food additives and the presence of
contaminants in food (CCFAC), and on the presence of veterinary drug
residues in food (CCRVDF).
4. FDA will work closely with the Codex Secretariat to provide, as
needed, in accordance with charges given to the U.S. Delegation by
CCFAC or CCRVDF, expert assistance in the timely development of Codex
documents, which may include, but are not limited to, technical
documents (e.g., associated with Meeting Reports of CCFAC and/or
CCRVDF), databases, and draft Codex Standards (e.g., GSFA).
5. FDA will provide expert advice to FAO/WHO JECFA. This advice may
include, but is not limited to, the areas of food additive
specification development, estimation of intake of food additives and
contaminants, risk assessment, and safety assessment of food additives,
contaminants, and veterinary drug residues in food.
V. Availability of Funds
It is anticipated that FDA will fund this cooperative agreement at
a level of
[[Page 15402]]
approximately $140,000 for the first year. An additional 2 years of
support will be available, depending upon fiscal year appropriations,
and successful performance.
VI. Reasons for Single-Source Selection
Competition is limited to WHO/IPCS because it is the parent
organization of JECFA, which provides scientific advice to the Codex
Alimentarius Commission. The international food standards established
by the Codex Alimentarius Commission are recognized by WTO as necessary
to protect public health and presumed to be consistent with the
Sanitary and Phytosanitary Agreement of GATT. These programs under IPCS
are the only such programs in existence and make IPCS unique as a
participant in international standard setting for food ingredients,
contaminants, and veterinary drug residues. Awarding this cooperative
agreement will ensure that the risk assessments provided by JECFA to
the Codex Alimentarius Commission are science-based, ensure that food
sold in the United States is safe, and enhance the safe use of food
additives in imported food.
VII. Submission Requirements
The original and two copies of the completed grant application form
PHS 398 (rev. 5/01) with copies of the appendices for each of the
copies, should be submitted to Rosemary Springer (see ADDRESSES). The
outside of the mailing package should be labeled ``Response to RFA-FDA-
CFSAN-02-2''. The application will be accepted during normal working
hours, 8 a.m. to 4:30 p.m., Monday through Friday, on or before May 1,
2002. Information collection requirements requested on Form PHS 398 and
the instructions have been submitted by the Public Health Service (PHS)
to the Office of Management and Budget (OMB) and were approved and
assigned OMB control number 0925-0001.
VIII. Reporting Requirements
An annual financial status report (FSR) (SF-269) is required. The
original and two copies of the report must be submitted to FDA's Grants
Management Officer within 90 days of the budget expiration date of the
grant. Failure to file FSR in a timely fashion will be grounds for
suspension or termination of the grant.
An annual program progress report is also required. The
noncompeting continuation application (PHS 2590) will be considered the
annual program progress report.
A final program progress report, FSR (SF-269), and invention
statement must be submitted within 90 days after the expiration of the
project period as noted on the notice of grant award.
IX. Review Procedures and Evaluation Criteria
A. Review Procedures
The application submitted by WHO/ IPCS will first be reviewed by
grants management and program staff for responsiveness. The requested
budget must not exceed $140,000 (direct and indirect costs). The
application will be considered nonresponsive if it is not in compliance
with this document. If an application is found to be nonresponsive, it
will be returned to the applicant without further consideration.
The application submitted by IPCS will undergo noncompetitive dual
peer review. The application will be reviewed for scientific and
technical merit by an ad hoc 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. Review Criteria
The application will be reviewed and evaluated according to the
following criteria:
1. The application clearly demonstrates an understanding of the
purpose and objectives of the cooperative agreement regarding the
safety of food ingredients, contaminants, and veterinary drug residues.
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. The application
presents a clear plan and schedule of steps to accomplish the goals of
the cooperative agreement.
3. The application establishes the applicant's ability to perform
the responsibilities under the cooperative agreement including the
availability of appropriate staff and sufficient funding.
4. The application specifies the manner in which interaction with
FDA will be maintained throughout the lifetime of the project.
5. The application specifies how IPCS will monitor progress of the
work under the cooperative agreement and how progress will be reported
to FDA.
6. 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.
X. 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 PHS, including
provisions of 42 CFR part 52, 45 CFR parts 74 and 92, and PHS's grants
policy statement. The regulations issued under Executive Order 12372 do
not apply. The length of support will be 1 year with the possibility of
an additional 2 years of noncompetitive support. Continuation beyond
the first year will be based upon satisfactory performance during the
preceding year and the availability of Federal fiscal year
appropriations. The NIH modular grant program does not apply to this
FDA program.
XI. Legend
Unless disclosure is required under 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: March 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-7819 Filed 3-27-02; 2:54 pm]
BILLING CODE 4160-01-S