[Federal Register Volume 70, Number 3 (Wednesday, January 5, 2005)]
[Notices]
[Pages 913-914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-111]


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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; Extension 
of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
February 23, 2005, the comment period for the notice that appeared in 
the Federal Register of November 24, 2004 (69 FR 68384). In the notice, 
FDA requested comments 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 agency is taking this action in response 
to a request for an extension to allow interested persons additional 
time to submit comments.

DATES: Submit written and electronic comments by February 23, 2005.

ADDRESSES: Submit written comments 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.fda.gov/dockets/ecomments.

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:

I. Background

    In the Federal Register of November 24, 2004 (69 FR 68384), FDA 
published a notice with a 60-day comment period to request comments 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.
    The agency has received a request for a 60-day extension of the 
comment period for the notice. This request conveyed concern that the 
current 60-day comment period does not allow sufficient time to develop 
a meaningful or thoughtful response to the notice.

[[Page 914]]

    FDA has considered the request and is extending the comment period 
for the notice for an additional 30 days, until February 23, 2005. The 
agency believes that a 30-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
the preparation of the final risk assessment.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on this document. Submit 
a single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 28, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 05-111 Filed 1-4-05; 8:45 am]
BILLING CODE 4160-01-S