81 FR 87566 - Compliance Policy Guide Sec. 615.115 on Extralabel Use of Medicated Feeds for Minor Species; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 233 (December 5, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised Compliance Policy Guide (CPG) 615.115 entitled ``Extralabel Use of Medicated Feeds for Minor Species.'' In advance of the January 1, 2017, date on which we anticipate that a number of drugs will convert from over-the-counter (OTC) to veterinary feed directive (VFD) status, this revised CPG clarifies policy and regulatory action guidance to FDA staff on the Agency's exercise of regulatory discretion with regard to the extralabel use of medicated feeds containing those drugs in minor species.

[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)]
[Notices]
[Pages 87566-87568]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29133]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-1875]


Compliance Policy Guide Sec. 615.115 on Extralabel Use of 
Medicated Feeds for Minor Species; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a revised Compliance Policy Guide (CPG) 615.115 
entitled ``Extralabel Use of Medicated Feeds for Minor Species.'' In 
advance of the January 1, 2017, date on which we anticipate that a 
number of drugs will convert from over-the-counter (OTC) to veterinary 
feed directive (VFD) status, this revised CPG clarifies policy and 
regulatory action guidance to FDA staff on the Agency's exercise of 
regulatory discretion with regard to the extralabel use of medicated 
feeds containing those drugs in minor species.

DATES: The Agency is soliciting public comment, but is implementing 
this CPG immediately because the Agency has determined that prior 
public participation is not feasible or appropriate. You may 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: https://www.regulations.gov/. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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

[[Page 87567]]

information, or other information that identifies you in the body of 
your comments, that information will be posted on https://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-1999-D-1875 for ``Compliance Policy Guide Sec. 615.115 Extralabel 
Use of Medicated Feeds for Minor Species.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://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 https://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 https://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 CPG 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 CPG.

FOR FURTHER INFORMATION CONTACT: Amber McCoig, Center for Veterinary 
Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5556, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The revised CPG is intended to clarify policy and regulatory action 
guidance to FDA staff on the Agency's exercise of regulatory discretion 
with regard to the extralabel use of medicated feed in minor species. 
We are implementing this CPG without prior public comment because we 
have determined that prior public participation is not feasible or 
appropriate (21 CFR 10.115(g)(2)). Although this CPG is immediately in 
effect, it remains subject to comment in accordance with FDA's good 
guidance practices regulation.
    The treatment of minor species is especially challenging for two 
reasons. First, many minor species, such as fish and game birds, have 
very few drugs approved for their use. As a result, veterinarians often 
times have to treat these species in an extralabel manner, using drugs 
that are not approved for them. Further, some minor species cannot 
practically be medicated in any way other than through the use of 
medicated feeds. Because extralabel use of medicated feeds is not 
permitted, veterinarians face an additional challenge to prevent 
unnecessary suffering and death of minor species.
    In 2001, FDA published CPG 615.115 to provide guidance to FDA staff 
concerning the Agency's exercise of regulatory discretion with regard 
to the extralabel use of medicated feeds in minor species. The CPG was 
silent regarding the different marketing statuses of medicated feeds 
and did not explicitly address situations involving feeds containing 
VFD drugs.
    In the Federal Register of December 12, 2013, FDA announced 
Guidance for Industry (GFI) #213 entitled ``New Animal Drugs and New 
Animal Drug Combination Products Administered in or on Medicated Feed 
or Drinking Water of Food-Producing Animals: Recommendations for Drug 
Sponsors for Voluntarily Aligning Product Use Conditions With Guidance 
for Industry #209'' (78 FR 75570). As a result of GFI #213, FDA 
anticipates that, beginning January 1, 2017, a number of drugs, 
including some drugs used in medicated feeds, will convert from OTC 
marketing status to VFD marketing status. As this conversion occurs, 
drugs that previously were available OTC for producers and 
veterinarians for use in medicated feed will become VFD drugs. Because 
the current CPG is silent regarding the different marketing statuses of 
medicated feeds, to avoid potential confusion and harm to minor species 
requiring treatment with certain drug products converting from OTC to 
VFD, the Agency has decided to revise CPG 615.115 to explicitly clarify 
our intent to exercise regulatory discretion over both OTC and VFD 
feeds. In order to inform stakeholders before January 1, 2017, of the 
Agency's expectations regarding the extralabel use of VFD feeds in 
minor species, we are implementing this CPG immediately. We are 
soliciting public comment on this CPG, but immediate implementation 
will give stakeholders the opportunity to operate under the provisions 
of this CPG before they submit comments.

II. Significance of Guidance

    This CPG is being issued as a level 1 guidance for FDA staff 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The CPG represents the current thinking of FDA on the 
extralabel use of medicated feeds for minor species. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternate approach if it satisfies the 
requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons with access to the Internet may obtain the CPG at either 
http://www.fda.gov/AnimalVeterinary/

[[Page 87568]]

GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: November 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29133 Filed 12-2-16; 8:45 am]
 BILLING CODE 4164-01-P