Document ID: FDA-2012-D-0419-0004
Agency: fda
Document Type: Notice
Title: Guidance for Industry on Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals; Availability
Posted Date: 2013-10-24T04:00Z

[Federal Register Volume 78, Number 206 (Thursday, October 24, 2013)]
[Notices]
[Pages 63477-63478]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24894]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 guidance for industry 204 entitled ``Active 
Controls in Studies to Demonstrate Effectiveness of a New Animal Drug 
for Use in Companion Animals.'' This 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: 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-

[[Page 63478]]

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, 
lisa.troutman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 20, 2012 (77 FR 37059), FDA 
published the notice of availability for a draft guidance entitled 
``Draft Guidance for Industry on Active Controls in Studies to 
Demonstrate Effectiveness of a New Animal Drug for Use in Companion 
Animals,'' giving interested persons until August 20, 2012, to comment 
on the draft guidance. FDA received several comments on the draft 
guidance and those comments were considered as the guidance was 
finalized. In response to stakeholder comments, FDA provided one 
additional example and clarified other examples in the Appendix section 
of the guidance. In addition, editorial changes were made to improve 
clarity. The guidance announced in this notice finalizes the draft 
guidance dated June 20, 2012.

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

IV. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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: October 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24894 Filed 10-23-13; 8:45 am]
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