[Federal Register Volume 71, Number 72 (Friday, April 14, 2006)]
[Notices]
[Pages 19526-19527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5527]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0138]


Draft Guidance for Industry: Recommended Study Design and 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availability of a draft guidance for industry (178) entitled 
``Recommended Study Design and Evaluation of Effectiveness Studies for 
Swine Respiratory Disease Claims.'' This draft guidance provides 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DATES: Submit written or electronic comments on this draft guidance by

[[Page 19527]]

June 28, 2006 to ensure their adequate consideration in preparation of 
the final document. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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. Submit written comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments should be 
identified with the full title of the guidance and the docket number 
found in brackets in the heading of this document. Submit electronic 
comments on the guidance via the Internet at http://www.fda.gov/dockets/ecomments.
    See the SUPPLEMENTARY INFORMATION section for electronic access to 
the draft guidance document.

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

    The purpose of this draft guidance is to provide the Center for 
Veterinary Medicine's current thinking regarding the recommended design 
and evaluation of effectiveness studies for SRD claims. This guidance 
identifies specific detailed recommendations for sponsors of new animal 
drug applications to consider when designing and writing protocols for 
SRD effectiveness studies.

II. Significance of Guidance

    This Level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft 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 alternate method may be used as long as 
it satisfies the requirements of applicable statutes and regulations.

III. Comments

    This draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding this draft guidance document. 
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 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.

IV. Electronic Access

    Electronic comments may be submitted on the Internet at http://www.fda.gov/dockets/ecomments. Copies of the guidance document entitled 
``Recommended Study Design and Evaluation of Effectiveness Studies for 
Swine Respiratory Disease Claims'' may be obtained from the CVM Home 
Page (http://www.fda.gov/cvm) and from the Division of Dockets 
Management Web site (http://www.fda.gov/ohrms/dockets/default.htm).

    Dated: April 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5527 Filed 4-13-06; 8:45 am]
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