[Federal Register Volume 69, Number 226 (Wednesday, November 24, 2004)]
[Notices]
[Pages 68384-68385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25979]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0479]
Draft Risk Assessment of Streptogramin Resistance in Enterococcus
faecium Attributable to the Use of Streptogramins in Animals;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of, and is requesting comment on, a draft risk assessment
of the potential impact that food-animal use of streptogramin
antimicrobials has on the resistance to chemically similar
streptogramins used to treat human enterococcal infections. The
veterinary drug of interest in this risk assessment is the
streptogramin, virginiamycin, a drug approved for use in chicken,
turkey, swine, and cattle feed. FDA will consider information received
during the comment period in its preparation of a final risk
assessment.
DATES: Submit written or electronic comments on the draft risk
assessment document by January 24, 2005. FDA will accept comments,
data, and information after the deadline, but to assure consideration
by the agency, we must receive comments by this date.
ADDRESSES: Single copies of this draft risk assessment are available
from the Communications Staff (HFV-12), Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Please enclose a self-addressed, adhesive label to assist that office
in processing your request. This draft risk assessment is also
available on the Internet at: http://www.fda.gov/cvm/antimicrobial/antimicrobial.htm.
Send written comments on this draft risk assessment to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to: http://www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm.
FOR FURTHER INFORMATION CONTACT: Barry Hooberman, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-8557, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
[[Page 68385]]
I. Background
In the Federal Register of April 19, 2000 (65 FR 20992), FDA's
Center for Veterinary Medicine (CVM) announced plans to develop a
prototypic risk assessment (RA) model that accounts for the transfer of
resistance determinants from bacteria in food-producing animals to
bacteria in humans. CVM also requested comments on their approach to
the RA model, requested that scientific data and information relevant
to the conduct of the RA be submitted, and indicated its intention to
work with stakeholders to assess potential risks.
The outcome of our work is a document entitled ``Draft Risk
Assessment of Streptogramin Resistance in Enterococcus faecium
Attributable to the Use of Streptogramins in Animals.'' This draft risk
assessment specifically addresses the link between the use of the
streptogramin antimicrobial, virginiamycin, in food-producing animals
and the development of resistance to the related streptogramins,
quinupristin-dalfopristin, used to treat human enterococcal infections.
Enterococcus bacteria include commensal strains normally present in the
intestines of animals and man. This risk assessment focuses on the
opportunistic pathogen Enterococcus faecium.
In an effort to better ensure broad awareness of this Federal
Register notice, FDA will make copies available through the FDA Dockets
Listserv (http://www.fda.gov/ohrms/dockets/FDAMAIL/DMBemaillist.htm).
To be added to any of FDA's free e-mail subscription services go to:
http://www.fda.gov. Click on ``Subscribe to FDA's E-mail Lists'', then
follow the instructions provided.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Two copies of mailed comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. The
draft guidance and received comments are available for public
examination in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
Dated: November 13, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-25979 Filed 11-23-04; 8:45 am]
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