[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Notices]
[Pages 63231-63232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26438]


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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; 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 guidance for industry #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: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.

[[Page 63232]]

     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-0235 for ``Evaluating the Effectiveness of New Animal Drugs 
for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in 
Cattle; Guidance for Industry; Availability.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the 
Policy and Regulations Staff (HFV-6), 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 request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Joshua R. Hayes, Center for Veterinary 
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0585, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of February 24, 2015 (80 FR 9731), FDA 
published a notice of availability for a draft guidance entitled 
``Evaluating the Effectiveness of New Animal Drugs for the Reduction of 
Pathogenic Shiga Toxin-Producing E. coli in Cattle'' giving interested 
persons until April 27, 2015, to comment on the draft guidance. FDA 
received one comment on the draft guidance. An editorial change to 
improve clarity was made in finalizing this guidance document. The 
guidance announced in this notice finalizes the guidance dated February 
2015.
    The guidance 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 to substantiate the effectiveness of pathogenic 
STEC reduction drugs.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on ``Evaluating the Effectiveness of New 
Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. 
coli in Cattle.'' It does not establish any rights for any person and 
is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of applicable statutes and 
regulations.

III. Paperwork Reduction Act of 1995

    This 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. 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: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26438 Filed 10-16-15; 8:45 am]
 BILLING CODE 4164-01-P