80 FR 9731 - Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing Escherichia coli in Cattle; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 36 (February 24, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI #229) entitled ``Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle.''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.

[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Notices]
[Pages 9731-9732]
From the Federal Register Online  [www.thefederalregister.org]
[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Cattle; Draft Guidance for Industry; Availability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availability of a draft guidance for industry (GFI #229) entitled 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 27, 2015.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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