[Federal Register Volume 67, Number 20 (Wednesday, January 30, 2002)]
[Notices]
[Pages 4456-4457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2212]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0016]


Withdrawal of Guidance Document on Professional Flexible Labeling 
of Antimicrobial Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing a 
guidance for industry (#66) entitled ``Professional Flexible Labeling 
of Antimicrobial Drugs.'' This guidance, which was issued in August 
1998, is being withdrawn because it does not represent current agency 
thinking on the development of professional flexible labeling for 
therapeutic veterinary prescription antimicrobial drugs. The agency 
intends to develop a new document on this topic.

DATES: Submit written or electronic comments at any time.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments 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.

FOR FURTHER INFORMATION CONTACT: Andrew J. Beaulieu, Center for 
Veterinary Medicine (HFV-1), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20851, 301-827-2954.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is withdrawing a guidance for industry (#66) entitled 
``Professional Flexible Labeling of Antimicrobial Drugs.'' This 
guidance addresses the development of professional flexible labeling 
for prescription therapeutic antimicrobial new animal drugs. This 
guidance is being withdrawn because the agency now believes that the 
``broad indication'' that was described in the guidance, particularly 
the very broad indication used as an example, is not consistent with 
the kind of database that typically can be generated to support an 
antimicrobial new animal drug approval. In the Federal Register of July 
28, 1999 (64 FR 40746), the agency revised its definition of 
``substantial evidence'' in the animal drug regulations (21 CFR 514.4). 
In light of that definition and experience regarding the manner in 
which products are being advertised or otherwise promoted for use under 
the ``broad indication'' provision of the guidance, FDA is withdrawing 
this guidance. The guidance no longer reflects the agency's current 
thinking on how sponsors can provide substantial evidence of 
effectiveness for all of the conditions that could fall within a 
``broad'' (or ``collective'') indication on the label of a prescription 
therapeutic antimicrobial new animal drug.
    The agency intends to develop a new guidance on this issue and will 
publish it as a level 1 draft guidance in accordance with the agency's 
good guidance practices in 21 CFR 10.115. The focus of the revisions 
will be the ``Indications'' and ``Microbiology'' sections of the 
guidance. The guidance revisions will more clearly set out the basis 
for the ``Indication'' section as ``substantial evidence of 
effectiveness''. In the interim, sponsors of antimicrobial products 
should consult with the Center for Veterinary Medicine (CVM) at FDA for 
more detailed information regarding acceptable content for the 
``Indications'' and ``Microbiology'' sections of the labeling. In 
general, CVM encourages sponsors to discuss all aspects of product 
development through

[[Page 4457]]

presubmission conferences and other meetings with CVM.

II. Significance of Guidance

    This information is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public.

III. Comments

    The agency welcomes comments on its efforts to review existing 
guidances related to the development of new animal drug products and 
revise, reformat, or withdraw them, as appropriate.
    Interested persons may submit written or electronic comments on 
agency guidance documents to the Dockets Management Branch (address 
above) at any time. Two copies of any written comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. A copy of received comments is available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: January 23, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-2212 Filed 1-29-02; 8:45 am]
BILLING CODE 4160-01-S