[Federal Register Volume 76, Number 226 (Wednesday, November 23, 2011)]
[Notices]
[Page 72422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Evaluating the Effectiveness of 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availability of draft guidance for industry 217 entitled 
``Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing 
Animals.''
    The draft guidance, when finalized, is intended to provide guidance 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 The draft guidance also suggests times 
during the evaluation of effectiveness when sponsors may wish to 
consult with CVM.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 23, 2012.

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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of draft guidance for industry 
217 entitled ``Evaluating the Effectiveness of Anticoccidial 
Drugs In Food-Producing Animals.'' The draft guidance discusses general 
considerations for the evaluation of the efficacy of anticoccidial 
drugs in poultry, minor species and food-producing mammals. Draft 
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.
    This draft guidance discusses general considerations regarding 
protocol development, study conduct, animal welfare, substantial 
evidence of effectiveness, feed preparation, drug assays, and 
combination approvals.
    This draft guidance discusses CVM considerations for studies used 
to substantiate effectiveness of anticoccidial drugs in poultry, 
including battery studies and commercial field studies. In addition, 
the draft GFI discusses CVM considerations for studies used to 
substantiate effectiveness of anticoccidial drugs in food-producing 
mammals, in minor species, and for minor uses.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the Agency's current thinking on 
evaluating the effectiveness of anticoccidial drugs in food-producing 
animals. 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 draft 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 nos. 0910-0032 and 0910-0117.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

V. Electronic Access

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

    Dated: November 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-30149 Filed 11-22-11; 8:45 am]
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