
[Federal Register: April 28, 2008 (Volume 73, Number 82)]
[Notices]               
[Page 22956-22958]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap08-61]                         

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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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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I. Funding Opportunity Description

    The Food and Drug Administration (FDA) is announcing its intention 
to receive and consider a single source application for the award of a 
cooperative agreement (U01), a new Sole Source, Competitive 
Continuation in fiscal year 2008 to the World Health Organization (WHO) 
International Programme on Chemical Safety (IPCS). This Request for 
Applications (RFA) is supported by the Center for Food Safety and 
Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). 
This program is described in the Catalog of Federal Domestic Assistance 
No. 93.103 under RFA Number: RFA-FD-08-002. A copy of the complete RFA 
can also be viewed on CFSAN's Web site (http://www.cfsan.fda.gov) and 
on CVM's Web site (http://www.fda.gov/cvm).
    This RFA will strengthen and allow WHO to continue their work in 
important international risk assessment and standard setting activities 
for food ingredients, contaminants, and veterinary drug residues in 
food. WHO/IPCS is an umbrella organization that provides for timely 
international collaboration on multinational cooperative activities. 
Various programs under the WHO/IPCS, such as the Joint Food and 
Agriculture (FAO)/WHO Expert Committee on Food Additives (JECFA), 
significantly contribute to internationally-recognized, science-based 
risk assessments of food additives, contaminants, and residues of 
veterinary drugs in foods. The Codex Alimentarius Commission (CAC) 
relies on JECFA's scientific advice when establishing international 
standards for foods. The WHO/IPCS also supports

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FAO/WHO Expert Consultations on risk assessments for emerging or cross-
cutting issues (e.g., non-dioxin-like polychlorinated biphenyls (PCBs), 
allergenicity of foods derived from biotechnology, risk-benefit 
assessment of the use of active chlorine species in food processing). 
The evaluations that are produced by these Expert Consultations provide 
a sound scientific basis for Codex's standard-setting activities that 
contribute to improved public health and food safety worldwide.
    The following activities are to be supported by this cooperative 
agreement:
    1. Schedule, plan, and conduct appropriate work groups, 
consultations, and committee meetings, which have emphasis on, but are 
not limited to, food additives, contaminants, and residues of 
veterinary drugs in food.
    2. Identify advisers, and prepare written working papers 
summarizing the data on substances under consideration.
    3. Prepare written working papers and technical documents for the 
JECFA, and for the FAO/WHO Expert Consultations related to food 
additives, contaminants, and residues of veterinary drugs in food.

II. Award Information

A. Mechanism of Support

    This funding opportunity will use a cooperative agreement award 
mechanism. In the cooperative agreement mechanism, the Project 
Director/Principal Investigator (PD/PI) retains the primary 
responsibility and dominant role for planning, directing, and executing 
the proposed project, with NIH staff being substantially involved as a 
partner with the Principal Investigator.
    Receipt Date: Within 45 days after the publication of this 
announcement in the Federal Register.

B. Funds Available

    The estimated amount of funds available for support of this 
cooperative agreement is $120,000 (direct and indirect costs) for 
fiscal year 2008. It is anticipated that an additional 4 years of 
support will be available at $90,000 per year, depending on annual 
appropriations and successful performance.
    This award will be funded based on the quality of the application 
received and is subject to the availability of Federal funds to support 
the project. In addition, if a cooperative agreement is awarded, the 
grantee will be informed of any additional documentation that should be 
submitted to the FDA.

III. Eligibility Information

Eligible Institutions

    Competition is limited to the WHO/IPCS because, as the parent 
organization of the JECFA, it is solely responsible for providing 
scientific advice, including risk assessments, to the CAC on matters 
related to food additives, contaminants, and residues of veterinary 
drugs in food. Thus, the programs under the IPCS are unique. It is 
essential that the WHO/IPCS be able to provide science-based risk 
assessments that are of the highest integrity, as these assessments 
form the basis of international standards that both protect public 
health and promote fair trade practices. Awarding this cooperative 
agreement to the WHO/IPCS will ensure that JECFA's risk assessments are 
science-based, will enhance the safe use of food additives, will ensure 
that residues of veterinary drugs in imported foods are safe, and will 
help to ensure that food sold in the United States is safe.

IV. Application and Submission Information

    The PHS 398 application instructions are available at http://
grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format. Applicants must use the currently approved version of the PHS 
398. For further assistance contact Grants Info at 301-435-0714, e-
mail: GrantsInfo@nih.gov.
    Telecommunications for the hearing impaired: TTY 301-451-0088.

A. Content and Form of Application Submission

    Applications must be prepared using the most current PHS 398 
research grant application instructions and forms. Applications must 
have a Dun & Bradstreet Data Universal Numbering System (DUNS) number 
as the universal identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 866-
705-5711 or through the Web site at http://www.dnb.com/us/. The DUNS 
number should be entered on line 11 of the face page of the PHS 398 
form.
    The title and number of this funding opportunity must be typed on 
lines 1 and 2 of the face page of the application form and the YES box 
must be checked.
    Required 398 Application Components must be submitted in Non 
Modular format as follows:
    Form Page 1: Face Page; Form Page 2: Description, Performance 
Sites, Key Personnel, Other Significant Contributors; Form Page 3: 
Table of Contents; Form Page 4: Detailed Budget for Initial Budget 
Period: Form Page 5: Budget for Entire Proposed Period of Support: 
Biographical Sketch Format Page; Resources Format Page; Checklist Form 
Page: Personal Data Form Page; Other Support Format Page; Personnel 
Report Format Page.

B. Sending an Application to FDA

    The application must be prepared using the forms found in the PHS 
398 instructions for preparing a research grant application. 
Applications will be accepted in hard copy or electronically at http://
www.grants.gov. A signed hard copy original application and three 
signed photocopies should be sent to:
    Food and Drug Administration/OAGS/GAAT/Gladys M. Bohler, 5630 
Fishers Lane, rm. 2105, HFA-500, Rockville, MD 20857 (U.S. Postal 
Service Express or regular mail).
    FDA will also accept the application for this program 
electronically via http://www.grants.gov. The applicant is encouraged 
to apply electronically by visiting the Web site http://www.grants.gov 
and following instructions under ``Apply for Grants.'' The required 
application, SF 424 (R&R) can be completed and submitted online. The 
package should be labeled, ``Response to RFA FD-08-002.'' If you 
experience technical difficulties with your online submission you 
should contact Gladys M. Bohler by telephone at 301-827-7168 or by e-
mail at gladys.melendez-bohler@fda.hhs.gov
    Information about submitting an application electronically can be 
found on the http://www.grants.gov Web site.
PHS 398 Research Plan Component Sections via Grants.gov
    Items 2 through 5 of the PHS 398 Research Plan component are 
limited to 25 pages. While each section of the Research Plan component 
needs to be uploaded separately as a PDF attachment, applicants are 
encouraged to construct the Research Plan component as a single 
document, separating sections into distinct PDF attachments just before 
uploading the files. This approach will enable applicants to better 
monitor formatting requirements such as page limits. All attachments 
must be provided to FDA in PDF format, filenames must be included with 
no spaces or special characters, and a pdf extension must be used.
    In order to apply electronically the applicant must have a DUNS 
number and register in the central contractor registration (CCR) 
database.

C. Intergovernmental Review

    This initiative is not subject to intergovernmental review under 
the terms of Executive Order 12372.

[[Page 22958]]

D. Other Submission Requirements and Information

    Several additional separate actions are required before an 
applicant institution/organization can submit an application.
    Organizational DUNS--As of October 1, 2003, applicants are required 
to have a DUNS number to apply for a grant or cooperative agreement 
from the Federal Government. The DUNS number is a nine-digit 
identification number, which uniquely identifies business entities. 
Obtaining a DUNS number is easy and there is no charge. To obtain a 
DUNS number applicants should go to http://www.grants.gov/RequestaDUNS.
    Central Contractor Registration--Applicants must register with the 
CCR database. This database is a government-wide warehouse of 
commercial and financial information for all organizations conducting 
business with the Federal Government. The preferred method for 
completing a registration is at http://www.ccr.gov. This Web site 
provides a CCR handbook with detailed information on data you will need 
prior to beginning the online preregistration as well as steps to walk 
you through the registration process. You must have a DUNS number to 
begin your registration. For foreign entities the Web site is http://
www.grants.gov/RequestaDUNS.gov. In order to access Grants.gov an 
applicant will be required to register with the Credential Provider. 
Information about this is available at https://apply.grants.gov/
OrcRegister.
    A copy of the complete RFA can also be viewed on FDA's Center for 
Food Safety and Applied Nutrition Web site at http://www.cfsan.fda.gov/
list.html.
Foreign Applications (Non-domestic (non-U.S.) Entity)
     Indicate how the proposed project has specific relevance 
to the mission and objectives of FDA and has the potential for 
significantly advancing sciences in the United States.
     Research grant applications from foreign or international 
organizations may not be funded unless approved by the National Cancer 
Institute National Advisory Board.

IV. Agency Contacts

A. Scientific/Research Contacts

    For issues regarding the programmatic aspects of this document, 
contact Susan E. Carberry at 301-436-1269 or by e-mail: 
susan.carberry@fda.hhs.gov.

B. Financial or Grants Management Contacts

    For issues regarding the administrative and financial management 
aspects, contact Gladys Melendez-Bohler at 301-827-7168 or by e-mail: 
gladys.melendez-bohler@fda.hhs.gov.

    Dated: April 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9251 Filed 4-25-08; 8:45 am]

BILLING CODE 4160-01-S
