[Federal Register: April 14, 2006 (Volume 71, Number 72)]
[Notices]
[Page 19526-19527]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap06-56]
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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Draft Guidance for Industry: Recommended Study Design and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availability of a draft guidance for industry (178) entitled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 This draft guidance provides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DATES: Submit written or electronic comments on this draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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the draft guidance document.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:
michelle.stull@fda.hhs.gov.
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The purpose of this draft guidance is to provide the Center for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]
BILLING CODE 4160-01-S