[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61504-61505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24905]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0497]
Global Implementation of the Veterinary Medicinal Products
Guidelines
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces its intention
to accept and consider a single source application for a cooperative
agreement to the World Organization for Animal Health (OIE). The OIE is
the intergovernmental organization responsible for improving animal
health worldwide and is recognized by the World Trade Organization
(WTO) as a reference for international sanitary rules, with 175 Member
Countries and Territories. The purpose of this agreement is to continue
outreach that began in fiscal year (FY) 2009 to expand capacity
building to support OIE's services and activities that are needed to
carry out OIE's Veterinary International Conference on Harmonization
(VICH) Global Outreach to disseminate and implement VICH guidelines at
the country level.
FOR FURTHER INFORMATION CONTACT:
Program Contact: Merton V. Smith, Center for Veterinary Medicine
(HFV-1), Food and Drug Administration, 7519 Standish Pl., rm. 177,
Rockville, MD 20855, 240-276-9025, FAX: 240-276-9030, email:
[email protected].
Management Contact: Katherine C. Bond, Office of the Commissioner,
Food and Drug Administration, White Oak Bldg. 32, rm. 3300, 10903 New
Hampshire Ave., Silver Spring, MD 20993, 301-796-8318, FAX: 301-595-
5058, email: [email protected].
Grants Contact: Kimberly Pendleton, Division of Acquisition and
Grants (HFA-500), Food and Drug Administration, 5630 Fishers Lane, rm.
2104, Rockville, MD 20857, 301-827-9363, FAX: 301-827-7101, email:
[email protected].
For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please contact Kimberly Pendleton.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA-FD-10-010
Catalog of Federal Domestic Assistance Number(s): 93.103 https://www.cfda.gov
A. Background
FDA announces its intention to accept and consider a single source
application for award of a cooperative agreement to the OIE in support
of international technical capacity building activities that help to
assure that U.S. imports of veterinary medicinal products are safe,
effective, and of high quality and that food from treated animals is
safe and wholesome; to assist foreign regulators in developing and
using rigorous safety standards; to develop and foster mutually
beneficial regulatory partnerships; and to leverage resources for
capacity building through appropriate training and other activities.
B. Research Objectives
Promote and enhance in OIE Members good veterinary
governance, which includes the compliance of Veterinary Services with
OIE
[[Page 61505]]
international standards, as an instrumental and essential prerequisite
to the establishment and effective implementation of adequate and
appropriate legislation covering all aspects of products for veterinary
use, including registration, quality control, distribution, monitoring
of quantities and final use.
Develop and improve international and regional cooperation
in the establishment and enforcement of legislation to harmonize the
regulatory framework between OIE Member States so as to assist
countries in need to effectively institute and maintain such
mechanisms.
Encourage countries to allocate appropriate human and
financial resources to veterinary services and laboratories to
correctly implement the OIE standards and guidelines related to
veterinary products and their control.
Enhance capacities of national focal points for OIE on
matters related to veterinary products according to the suggested terms
of reference and encourage his/her participation in training sessions
and appropriate international gatherings and meetings.
Promote the responsible and prudent use of veterinary
medicinal products, in particular of antimicrobials used in veterinary
medicine, and the monitoring of the quantities used and potential
existence or development of antimicrobial resistance in disease-causing
organisms affecting both humans and animals.
Actively encourage the recognition and application of the
international recommendations, guidelines and tools developed by the
OIE and adopted by the World Assembly of Delegates on veterinary
products.
C. Eligibility Information
The following organizations/institutions are eligible to apply: The
OIE.
II. Award Information/Funds Available
A. Award Amount
FDA anticipates providing one award of $565,000 (total costs
including indirect costs) in fiscal year (FY) 2010 in support of this
project. Subject to the availability of funds and successful
performance, 1 additional year of support up to $565,000 per year will
be available.
B. Length of Support
The support will be 1 year with the possibility of an additional
year of noncompetitive support. Continuation beyond the first year will
be based on satisfactory performance during the preceding year, receipt
of a non-competing continuation application and available Federal FY
appropriations.
Dated: September 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24905 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S