[Federal Register: November 24, 2004 (Volume 69, Number 226)]
[Page 68384-68385]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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; 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: bhooberm@cvm.fda.gov.


[[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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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]