[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Notices]
[Pages 9731-9732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03694]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-0235]
Evaluating the Effectiveness of New Animal Drugs for the
Reduction of Pathogenic Shiga Toxin-Producing Escherichia coli in
Cattle; Draft Guidance for Industry; Availability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availability of a draft guidance for industry (GFI #229) entitled
``Evaluating the Effectiveness of New Animal Drugs for the Reduction of
Pathogenic Shiga Toxin-Producing E. coli in Cattle.'' The purpose of
this document is to provide recommendations to industry relating to
study design and describe criteria the Center for Veterinary Medicine
(CVM) thinks are the most appropriate for the evaluation of the
effectiveness of new animal drugs that are intended to reduce
pathogenic Shiga toxin-producing E. coli (STEC) in cattle.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 27, 2015.
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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Joshua R. Hayes, Center for Veterinary
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0651, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
(GFI #229) entitled ``Evaluating the Effectiveness of New Animal Drugs
for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in
Cattle.'' This draft guidance provides recommendations to industry
relating to study design and describes criteria CVM thinks are the most
appropriate for the evaluation of the effectiveness of new animal drugs
that are intended to reduce pathogenic STEC in cattle. It discusses
general considerations regarding the development of protocols, study
conduct, animal welfare, substantial evidence of effectiveness,
experimental parameters, nutritional content of experimental diets, and
the assessment of drug concentrations in experimental diets. It also
discusses the studies and analyses CVM recommends for sponsors
[[Page 9732]]
to substantiate the effectiveness of pathogenic STEC reduction drugs.
II. Significance of Guidance
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the Agency's current thinking on this
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 draft 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 part 514 have been approved under
OMB control number 0910-0032.
IV. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and will be posted to the docket at http://www.regulations.gov.
V. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.
Dated: February 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03694 Filed 2-23-15; 8:45 am]
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