[Federal Register: February 19, 2004 (Volume 69, Number 33)]
[Notices]
[Page 7760-7761]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe04-66]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1993D-0398]
Guidance for Industry: Assessment of the Effects of Antimicrobial
Drug Residues from Food of Animal Origin on the Human Intestinal Flora;
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 for industry (52) entitled
``Assessment of the Effects of Antimicrobial Drug Residues from Food of
Animal Origin on the Human Intestinal Flora.'' This guidance is a
revision of the guidance document 52 entitled
``Microbiological Testing of Antimicrobial Drug Residues in Food,''
which was implemented in 1996. In this guidance, the agency recommends
a pathway approach for assessing the microbiological safety of
antimicrobial drug residues in food, rather than the approach described
in the 1996 version of the guidance. The agency's decision to revise
this guidance is based on new information available to the agency.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written comments on this guidance 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 and the docket number found in
brackets 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 to the
Communications Staff (HFV-12), Center for Veterinary Medicine (CVM),
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests.
FOR FURTHER INFORMATION CONTACT: Haydee Fernandez, Center for
Veterinary Medicine (HFV-150), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6981, e-mail:
afernand@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
[[Page 7761]]
I. Background
In the Federal Register of December 27, 2001 (66 FR 66910), FDA
published a notice of availability for a draft guidance document
entitled ``Assessment of the Effects of Antimicrobial Drug Residues
from Food of Animal Origin on the Human Intestinal Flora.'' The agency
gave interested persons until March 27, 2002, to comment on the draft
guidance. FDA received several comments that were considered in the
preparation of this guidance document. This guidance replaces former
guidance 52 entitled ``Microbiological Testing of
Antimicrobial Drug Residues in Food.'' A document entitled ``History
and Scientific Issues Related to Guidance 52'' provides the
scientific rationale for the revisions made (Docket No. 93D-0398).
CVM is aware that the International Cooperation on Harmonisation of
Technical Requirements for Registration of Veterinary Medicinal
Products (VICH) is currently drafting a related guideline and that this
guidance may be superceded at a future date by the guideline published
by VICH.
II. Paperwork Reduction Act of 1995
FDA is announcing that a collection of information entitled
``Guidance for Industry: Assessment of the Effects of Antimicrobial
Drug Residues from Food of Animal Origin on the Human Intestinal
Flora'' has been approved by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995. In the Federal Register of
March 4, 2003 (68 FR 10253), 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 0910-0521. It expires on January 31, 2007. 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.
III. Significance of Guidance
This level 1 guidance document is being issued consistent with
FDA's good guidance practices regulation (21 CFR 10.115). This guidance
document represents the agency's current thinking on the topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
as long as it satisfies the requirements of applicable statutes and
regulations.
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 will periodically review the comments
in the docket and, where appropriate, amend the guidance. The agency
will notify the public of any such amendments through a notice in the
Federal Register.
V. Electronic Access
Persons with access to the Internet may obtain a copy of the
guidance document entitled ``Guidance for Industry: Assessment of the
Effects of Antimicrobial Drug Residues from Food of Animal Origin on
the Human Intestinal Flora'' from FDA's CVM 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. 04-3557 Filed 2-18-04; 8:45 am]
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