[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Notices]
[Page 37059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14988]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0419]


Draft Guidance for Industry on Active Controls in Studies To 
Demonstrate Effectiveness of a New Animal Drug for Use in Companion 
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availability of a draft guidance for industry 204 entitled 
``Active Controls in Studies to Demonstrate Effectiveness of a New 
Animal Drug for Use in Companion Animals.''
    This draft guidance advises industry on the use of active controls 
in studies intended to provide substantial evidence of effectiveness of 
new animal drugs for use in companion animals. The intent of the 
guidance is to provide information to clinical investigators who 
conduct studies using active controls and have a basic understanding of 
statistical principles.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 20, 2012.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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Lisa M. Troutman, Center for 
Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8322, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
204 entitled ``Active Controls in Studies to Demonstrate 
Effectiveness of a New Animal Drug for Use in Companion Animals.'' The 
purpose of this draft guidance is to provide information to clinical 
investigators who conduct studies using active controls and have a 
basic understanding of statistical principles. The draft guidance 
advises industry on the use of active controls in studies intended to 
provide substantial evidence of effectiveness of new animal drugs for 
use in companion animals. The draft guidance compares studies that use 
active controls to studies that use either placebo concurrent controls 
or untreated concurrent controls, and it uses these comparisons to 
illustrate the advantages and disadvantages of using a study with an 
active control. Examples are provided to illustrate some of the 
different outcomes that are possible when employing active controls in 
studies.

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 this 
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 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 21 CFR part 514 have been approved under 
OMB control number 0910-0032.

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. 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: June 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14988 Filed 6-19-12; 8:45 am]
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