[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
