[Federal Register: October 27, 2003 (Volume 68, Number 207)]
[Notices]
[Page 61221]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc03-76]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1998D-1146]
Guidance for Industry: Evaluating the Safety of Antimicrobial New
Animal Drugs With Regard to Their Microbiological Effects on Bacteria
of Human Health Concern; 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 a guidance (152) entitled ``Guidance for
Industry: Evaluating the Safety of Antimicrobial New Animal Drugs with
Regard to Their Microbiological Effects on Bacteria of Human Health
Concern.'' This guidance document discusses a recommended approach for
assessing the safety of antimicrobial new animal drugs with regard to
their microbiological effects on bacteria of human health concern.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written comments on the guidance document 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.fda.gov/dockets/ecomments. Comments should be
identified with the full title of the guidance document and the docket
number found in the heading of this document. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
Submit written requests for single copies of the guidance document
to the Communications Staff (HFV-12), Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests.
FOR FURTHER INFORMATION CONTACT: Jeffrey M. Gilbert, Center for
Veterinary Medicine (HFV-157), 7500 Standish Pl., Rockville, MD 20855, 301-827-0233, e-mail: jgilbert@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 13, 2002 (67 FR 58058), FDA
published a notice of availability for a draft guidance entitled
``Guidance for Industry: Evaluating the Safety of Antimicrobial New
Animal Drugs With Regard to Their Microbiological Effects on Bacteria
of Human Health Concern'' giving interested persons until November 27,
2002, to submit comments. FDA considered all comments received and,
where appropriate, incorporated them into the guidance.
This document provides guidance for industry on a possible process
for evaluating the potential effects of antimicrobial new animal drugs
on non-target bacteria as part of the new animal drug application
process. This guidance document outlines a risk assessment approach for
evaluating the microbial food safety of antimicrobial new animal drugs.
Alternative processes that may be more appropriate to a sponsor's drug
and its intended conditions of use, may be used to characterize the
microbial food safety of that drug. FDA's purpose in this guidance is
to ensure the safety of animal drugs used in food-producing animals and
to evaluate the human health impact of their intended use.
II. Significance of Guidance
This level 1 guidance is being issued consistent with FDA's good
guidance practices (21 CFR 10.115). The guidance represents the
agency's current thinking about the safety of new animal drugs, with
regard to their microbiological effects on bacteria of human health
concern. The document does not create or confer any rights for or on
any person and will not operate to bind FDA or the public. Alternative
methods may be used as long as they satisfy the requirements of the
applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
FDA is announcing that a collection of information entitled
``Guidance for Industry: Evaluating the Safety of Antimicrobial New
Animal Drugs With Regard to Their Microbiological Effects on Bacteria
of Human Health Concern'' has been approved by the Office of Management
and Budget (OMB) under the Paperwork Reduction Act of 1995. In the
Federal Register of September 19, 2003 (68 FR 54906), the agency
announced that the proposed information collection had been submitted
to OMB for review and clearance under 44 U.S.C. 3507. According to the
Paperwork Reduction Act of 1995, a collection of information should
display a valid OMB control number. The valid OMB control number for
this information collection is 0910-0522 (expires April 30, 2005). A
copy of the supporting statement for this information collection is
available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
IV. Comments
As with all of FDA's guidances, the public is encouraged to submit
written or electronic comments with new data or other new information
pertinent to this guidance. FDA periodically will review the comments
in the docket and, where appropriate, will amend the guidance. The
agency will notify the public of any such amendments through a notice
in the Federal Register. Interested persons may submit to the Division
of Dockets Management (see ADDRESSES) written or electronic comments on
the final guidance at any time. Comments should be identified with the
docket number found in brackets in the heading of this document. A copy
of the document 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.
V. Electronic Access
Persons with access to the Internet may obtain a copy of the
guidance document entitled ``Guidance for Industry: Evaluating the
Safety of Antimicrobial New Animal Drugs With Regard to Their
Microbiological Effects on Bacteria of Human Health Concern'' from the
Center for Veterinary Medicine home page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm.
Dated: October 6, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-27113 Filed 10-23-03; 12:30 pm]
BILLING CODE 4160-01-S