Document ID: FDA-2011-D-0023-0004
Agency: fda
Document Type: Notice
Title: Guidance for Industry Target Animal Safety and Effectiveness Protocol Development and Submission; Availability
Posted Date: 2011-09-29T04:00Z

[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Pages 60503-60504]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25115]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0023]

Guidance for Industry on Target Animal Safety and Effectiveness 
Protocol Development and Submission; 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 (215) entitled 
``Target Animal Safety and Effectiveness Protocol Development and 
Submission.'' The purpose of this document is to provide sponsors 
guidance in preparation of study protocols for review by the Center for 
Veterinary Medicine, Office of New Animal Drug Evaluation. The 
recommendations included in this guidance are intended to reduce the 
time to protocol concurrence.

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: Angela Clarke, Center for Veterinary 
Medicine (HFV-112), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8318; e-mail: angela.clarke@fda.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of February 3, 2011 (76 FR 6143), FDA 
published the notice of availability for a draft guidance entitled 
``Target Animal Safety and Effectiveness Protocol Development and 
Submission,'' giving interested persons until April 19, 2011, to 
comment on the draft guidance. FDA received one comment on the draft 
guidance and that comment was considered as the guidance was finalized. 
Changes include editorial revisions to improve clarity regarding how 
and when data collection forms and standard operating procedures should 
be included with the protocol submission. The guidance announced in 
this notice finalizes the draft guidance dated February 2, 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 no. 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. 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 guidance at 
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

[[Page 60504]]

    Dated: September 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25115 Filed 9-28-11; 8:45 am]
BILLING CODE 4160-01-P