
[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Page 69634]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28156]



[[Page 69634]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0784]


Guidance for Industry on Evaluating the Effectiveness of 
Anticoccidial Drugs in Food-Producing Animals; 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 guidance for industry 217 entitled 
``Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing 
Animals.'' The guidance provides guidance to industry for designing and 
conducting clinical effectiveness studies and describes criteria that 
the Center for Veterinary Medicine (CVM) thinks are the most 
appropriate for the evaluation of the effectiveness of anticoccidial 
drugs intended for use in poultry and other food-producing animals. The 
guidance suggests times during the evaluation of effectiveness when 
sponsors may wish to consult with CVM.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Emily R. Smith, Center for Veterinary 
Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8344, emily.smith2@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of November 23, 2011 (76 FR 72422), FDA 
published the notice of availability for a draft guidance entitled 
``Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing 
Animals,'' giving interested persons until January 23, 2012, to comment 
on the draft guidance. FDA received one comment on the draft guidance 
and that comment was considered as the guidance was finalized. No 
changes other than editorial changes were made to improve clarity. This 
guidance for industry 217 supersedes the CVM draft guidance 
for industry 40, entitled ``Draft Guideline for the Evaluation 
of The Efficacy of Anticoccidial Drugs and Anticoccidial Drug 
Combinations in Poultry,'' dated April 1992. The guidance announced in 
this notice finalizes the draft guidance dated November 23, 2011.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance 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 if such approach 
satisfies the requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this guidance have been approved under 
OMB control numbers 0910-0032 and 0910-0117.

IV. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: November 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28156 Filed 11-19-12; 8:45 am]
BILLING CODE 4160-01-P


