[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)]
[Notices]
[Pages 26236-26237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10234]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0755]


Compliance Policy Guide Sec. 690.150 Labeling and Marketing of 
Dog and Cat Food Diets Intended To Diagnose, Cure, Mitigate, Treat, or 
Prevent Diseases; 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 compliance policy guide (CPG) entitled ``Compliance 
Policy Guide Sec. 690.150 Labeling and Marketing of Dog and Cat Food 
Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent 
Diseases.'' This CPG provides guidance to FDA staff on issues related 
to dog and cat diets that are labeled and/or marketed as intending to 
diagnose, cure, mitigate, treat, or prevent diseases and to provide all 
or most nutrients in support of meeting the animal's total daily 
nutrient requirements. This CPG finalizes the draft CPG entitled 
``Compliance Policy Guide Sec. 690.150 Labeling and Marketing of 
Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, 
Treat, or Prevent Disease in Dogs and Cats,'' dated September 10, 2012.

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.
     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-2012-D-0755 for ``Compliance Policy Guide Sec. 690.150 Labeling and 
Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, 
Mitigate, Treat, or Prevent Diseases.'' 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

[[Page 26237]]

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 the 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 requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: William J. Burkholder, Center for 
Veterinary Medicine, Division of Animal Feeds (HFV-220), Food and Drug 
Administration, 7519 Standish Place, Rockville, MD 20855, 240-402-5900; 
email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of September 10, 2012 (77 FR 55480), FDA 
published the notice of availability for a draft CPG entitled 
``Compliance Policy Guide Sec. 690.150 Labeling and Marketing of 
Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, 
Treat, or Prevent Disease in Dogs and Cats'' giving interested persons 
until November 9, 2012, to comment on the draft CPG. FDA received 
several comments on the draft CPG and those comments were considered as 
the CPG was finalized.
    FDA revised the title of the final CPG. The final CPG is entitled 
``Compliance Policy Guide Sec. 690.150 Labeling and Marketing of Dog 
and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or 
Prevent Diseases.'' In addition to revising the title, editorial 
changes were made to improve clarity.
    The CPG announced in this notice finalizes the draft CPG dated 
September 10, 2012.

II. Significance of Guidance

    This level 1 CPG is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on labeling and marketing of dog and cat 
food diets intended to diagnose, cure, mitigate, treat, or prevent 
diseases. 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 the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3 and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. In the Federal Register of 
September 10, 2012 (77 FR 55480), FDA published a notice announcing the 
availability of the draft CPG. This document contained a Paperwork 
Reduction Act burden analysis and requested comments on a proposed 
collection of information (77 FR 55480 at 55481). We have concluded 
that our guidance to FDA staff with respect to factors to consider when 
determining whether to take regulatory action against an article of dog 
or cat food does not impose collection of information burdens on the 
public. In addition, to the extent that we obtain information during an 
enforcement action, this collection is exempt from OMB review under 44 
U.S.C. 3518(c)(1)(B) and 5 CFR 1320.4(a)(2) as collection of 
information obtained during the conduct of a civil action to which the 
United States or any official or agency thereof is a party, or during 
the conduct of an administrative action, investigation, or audit 
involving an agency against specific individuals or entities. The 
regulations in 5 CFR 1320(c) provide that the exception in 5 CFR 
1320.4(a)(2) applies during the entire course of the investigation, 
audit, or action, but only after a case file or equivalent is opened 
with respect to a particular party. Such a case file would be opened, 
for example, as part of the decision to detain a drug or an article of 
food.

IV. Electronic Access

    Persons with access to the Internet may obtain the CPG at either 
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm under ``Compliance Policy 
Guides'' or http://www.regulations.gov.

    Dated: April 25, 2016.
Katherine Bent,
Assistant Commissioner for Compliance Policy.
[FR Doc. 2016-10234 Filed 4-29-16; 8:45 am]
 BILLING CODE 4164-01-P