
[Federal Register Volume 81, Number 83 (Friday, April 29, 2016)]
[Notices]
[Pages 25677-25678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1050]


Recommendations on the Regulation of Combination Drug Medicated 
Feeds; Availability; Reopening of Comment Period; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of comment period; request 
for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period and requesting public input on possible modifications to 
the current review processes for new animal drug applications (NADAs) 
for the use of multiple new animal drugs in combination drug medicated 
feeds. We are also announcing the availability of a Center for 
Veterinary Medicine (CVM) recommendations document for the animal drug 
user fee negotiating committee.

DATES: Submit either electronic or written comments by July 29, 2016.

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-2014-N-1050 for ``Regulation of Combination Drug Medicated Feeds.'' 
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.

[[Page 25678]]

     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.

FOR FURTHER INFORMATION CONTACT: Linda M. Wilmot, Center for Veterinary 
Medicine (HFV-120), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0829, linda.wilmot@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 9, 2014 
(79 FR 53431), FDA announced that it was beginning to explore possible 
modifications to the current review processes for NADAs for the use of 
multiple new animal drugs in combination drug medicated feeds. This 
effort is consistent with the stated performance goal in the Animal 
Drug User Fee Amendments of 2013 (ADUFA III) goals letter.
    In the same notice, FDA announced the opening of a docket to 
receive public input. Originally, interested persons were given until 
September 9, 2015, to provide comment. In a February 13, 2015 (80 FR 
8092), notice of a public meeting on this subject, FDA extended the 
comment period until March 31, 2016. At this time, FDA is reopening the 
comment period until July 29, 2016.
    A summary of FDA recommendations, ``Recommendations on the 
Regulation of Combination Drug Medicated Feeds,'' has been placed in 
the FDA Docket. Persons with access to the Internet may obtain this 
document at the CVM FOIA Electronic Reading Room: http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm.

    Dated: April 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10028 Filed 4-28-16; 8:45 am]
BILLING CODE 4164-01-P


