[Federal Register: April 1, 2002 (Volume 67, Number 62)]
[Page 15400-15402]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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.

Regarding the administrative and financial management aspects of this 
notice: Rosemary Springer (see ADDRESSES), e-mail: 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 
    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 
    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 
    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 

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]