E6-5527. Draft Guidance for Industry: Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims; Availability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.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (#178) entitled “Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims.” This draft guidance provides recommendations to industry relating to study design and describes the criteria that the Center for Veterinary Medicine (CVM) intends to use to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Submit written or electronic comments on this draft guidance by June 28, 2006 to ensure their adequate consideration in preparation of the final document.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Submit written requests for single copies of the draft guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.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See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.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: [e-mail].

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The purpose of this draft guidance is to provide the Center for Veterinary Medicine's current thinking regarding the recommended design and evaluation of effectiveness studies for SRD claims.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.