[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]
 
-----------------------------------------------------------------------
 
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.
 
-----------------------------------------------------------------------
 
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
 
[[Page 22957]]
 
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)
    <bullet> 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.
    <bullet> 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

Sole Source Cooperative Agreement Program Entitled "Cooperative Agreement to Support the World Health Organization (WHO) International Programme on Chemical Safety" April 28, 2008