[Federal Register Volume 72, Number 190 (Tuesday, October 2, 2007)]
[Notices]
[Page 56079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19412]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0138]


Guidance for Industry: Recommended Study Design and Evaluation of 
Effectiveness Studies for Swine Respiratory Disease Claims; 
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 (178) entitled 
``Recommended Study Design and Evaluation of Effectiveness Studies for 
Swine Respiratory Disease Claims.'' This guidance provides 
recommendations to industry relating to study design and describes the 
criteria that the Center for Veterinary Medicine (CVM) intends to use 
to evaluate effectiveness studies for swine respiratory disease (SRD) 
claims.

DATES: Submit written or electronic 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 written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to either http://www.fda.gov/dockets/ecomments or http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Michelle L. Stull, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-5058, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of April 14, 2006 (71 FR 19526), FDA 
published a notice of availability of a draft guidance entitled 
``Recommended Study Design and Evaluation of Effectiveness Studies for 
Swine Respiratory Disease Claims.'' The notice gave interested persons 
until June 28, 2006, to comment on the draft guidance. FDA received a 
few comments on the draft guidance. We considered those comments as we 
finalized the guidance. The guidance, announced in this document, 
finalizes the draft guidance that we announced on April 14, 2006.
    The purpose of the guidance is to provide the Center for Veterinary 
Medicine's (CVM's) current thinking regarding the recommended design 
and evaluation of effectiveness studies for swine respiratory disease 
(SRD) claims. This guidance identifies specific, detailed 
recommendations for sponsors of new animal drug applications to 
consider when they design and write protocols for SRD effectiveness 
studies.

II. 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 514.1 have been approved under OMB 
Control Number 0910-0032.

III. 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.

IV. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the guidance. Submit a single copy of electronic comments or 
two paper copies of any mailed comments, except that individuals may 
submit one paper copy. Comments are to be identified with the full 
title of the guidance and the docket number found in brackets in the 
heading of this document. A copy of the guidance and received comments 
are available for public examination 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 from 
either the CVM home page (http://www.fda.gov/cvm) or the Division of 
Dockets Management Web site (http://www.fda.gov/ohrms/dockets/default.htm).

    Dated: September 24, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-19412 Filed 10-1 -07; 8:45 am]
BILLING CODE 4160-01-S