[Federal Register Volume 61, Number 3 (Thursday, January 4, 1996)]
[Notices]
[Page 353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-125]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95S-0199]


Report of the Fluoroquinolone Working Group; 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 the report of the Center for Veterinary Medicine's 
(CVM's) Fluoroquinolone Working Group (FQWG). The report addresses 
issues and contains recommendations regarding policies and procedures 
related to approval of fluoroquinolone (FQ) antimicrobial drugs in food 
animals. The report of the FQWG is in response to concerns that 
approval of FQ drugs for use in food animals may result in increased 
development of FQ resistance in zoonotic organisms harbored by food 
animals that are transmitted to humans and cause disease.

DATES: Written comments on the report may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the report to 
the Communication and Education Branch (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855. Send two self-addressed adhesive labels to assist that office 
in processing your requests. Submit written comments on the report to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
rm. 1-23, 12420 Parklawn Dr., Rockville MD, 20857. Requests and 
comments should be identified with the docket number found in brackets 
in the heading of this document. A copy of the report and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Linda A. Grassie, Center for 
Veterinary Medicine (HFV-12), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1755.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of the 
report of CVM's FQWG. The report addresses issues and recommendations 
concerning approval of FQ drugs for use in food animals. In response to 
concerns that approval of FQ drugs for use in food animals may result 
in increased development of FQ resistance in zoonotic organisms 
harbored by food animals that are transmitted to humans and cause 
disease. FDA convened a joint meeting of the CVM and Center for Drug 
Evaluation and Research advisory committees on May 11 and 12, 1994. 
Members of the joint advisory committee stated that FQ drugs could be 
approved for use in food animals, if CVM restricts their use so that 
FQ's are safe and effective under approved conditions of use and 
recommended that CVM monitor the emergence of FQ resistance. In 
response to the public health concerns that were raised, CVM formed the 
FQWG to provide recommendations of policies and procedures relevant to 
the approval of FQ drugs in food animals. FDA is announcing that the 
report of the FQWG has been accepted by the Director, CVM, and is 
available for public inspection and comment.
     Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments on the report of 
CVM's FQWG. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in the heading of this document. The report, 
appendices, and comments may be seen at the Dockets Management Branch 
(address above), between 9 a.m. and 4 p.m., Monday through Friday.
     The report and recommendations represent the agency's current 
position on the issues discussed therein, however, they do not create 
or confer any rights, privileges, or benefits for or on any person, nor 
do they operate to bind FDA in any way. CVM will consider any comments 
received in determining the continued appropriateness of the 
recommendations in the report regarding the approval of FQ's for animal 
use.

    Dated: December 27, 1995.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-125 Filed 1-3-96; 8:45 am]
BILLING CODE 4160-01-F