[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Notices]
[Pages 8092-8093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03002]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Regulation of Combination Drug Medicated Feeds; Public Meeting; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meeting; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public 
meeting to explore the feasibility of pursuing statutory revisions that 
may modify the current requirement that the use of multiple new animal 
drugs in the same medicated feed be subject to an approved application. 
This policy exploration is consistent with a stated performance goal in 
the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals letter. 
FDA is requesting that you submit any comments related to this issue by 
March 31, 2016.
    Date and Time: The public meeting will be held on March 16, 2015, 
from 9 a.m. until 12 p.m.
    Location: The public meeting will be held at the Center for 
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., 
3rd Floor, Rockville, MD 20855. Parking is free.
    Contact Person: Laura Bradbard, Center for Veterinary Medicine, 
Food and Drug Administration, 7519 Standish Pl., Rm. 159, Rockville, MD 
20855, 240-276-9109, FAX: 240-276-9020, email: 
[email protected].
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this meeting must 
register by March 10, 2015. For general questions about the meeting, 
for assistance to register for the meeting, to request an opportunity 
to make an oral presentation, or to request special accommodations due 
to a disability, contact Laura Bradbard (see Contact Person). Please 
include your name, organization, and contact information. If you are 
requesting an opportunity to speak, please send a brief summary of your 
comments. Early registration for the meeting is encouraged due to 
limited time and space.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA considers the timely review of the safety and effectiveness of 
new animal drugs to be central to the Agency's mission to protect and 
promote the public health. Before 2004, the timeliness and 
predictability of the new animal drug review program was a concern. The 
Animal Drug User Fee Act enacted in 2003 (Pub. L. 108-130; hereinafter 
referred to as ``ADUFA I''), authorized FDA to collect user fees for 5 
years--fiscal year (FY) 2004 to FY 2008--that were to be dedicated to 
expediting the review of new animal drug applications (NADAs) according 
to certain performance goals and to expand and modernize the new animal 
drug review program. The Agency agreed to meet a comprehensive set of 
performance goals established to show significant improvement in the 
timeliness and predictability of the new animal drug review process. 
The implementation of ADUFA I provided a significant funding increase 
that enabled FDA to increase the number of staff dedicated to the new 
animal drug application review process.
    In 2008, before ADUFA I expired, Congress passed the Animal Drug 
User Fee Amendments of 2008 (Pub. L. 110-316; hereinafter referred to 
as ``ADUFA II''), which included an extension of ADUFA for an 
additional 5 years--FY 2009 to FY 2013. ADUFA II performance goals were 
established based on ADUFA I FY 2008 review timeframes. In addition, 
FDA provided program enhancements to reduce review cycles and improve 
communications during reviews.
    In 2013, before ADUFA II expired, Congress passed ADUFA III (Pub. 
L. 113-14), which was signed by the President on June 13, 2013. Like 
its predecessors, ADUFA III includes its own comprehensive set of 
performance goals. One such goal, as stated in the ADUFA III goals 
letter, is: Beginning in early FY 2014, the Agency agrees to explore, 
in concert with affected parties, the feasibility of pursuing statutory 
revisions, consistent with the Agency's mission to protect and promote 
the public health, that may modify the current requirement that the use 
of multiple new animal drugs in the same medicated feed be subject to 
an approved application and develop recommendations by September 30, 
2016.
    Currently, the use of multiple new animal drugs in the same 
medicated feed (i.e., a combination drug medicated feed) requires an 
approved NADA for each new animal drug in the combination and a 
separate approved NADA for the combination new animal drug itself (21 
U.S.C. 360b(d)(4); 21 CFR 514.4(c)). FDA and members of regulated 
industry jointly agreed to explore, as part of the performance goals 
outlined in the ADUFA III goals letter, potential changes to the 
approval process for the use of a combination drug medicated feed. The 
intent of this exploration is to consider changes intended to allow 
combination drug medicated feeds to be made available to the end user 
in the most efficient manner possible while protecting and promoting 
the public health.
    This public meeting is intended to provide an additional 
opportunity for public comment. Although in the ADUFA III performance 
goals letter FDA only agreed to explore the feasibility of pursuing 
statutory changes, the Agency also invites comment on potential changes 
to procedures and requirements

[[Page 8093]]

related to the approval process for these products that can be 
accomplished under the Agency's existing statutory authority. FDA will 
consider comments received at this meeting as it moves forward with 
this process.
    FDA has already opened public docket FDA Docket No. FDA-2014-N-1050 
to receive comments on the issue (79 FR 53431, September 9, 2014). 
Although you can comment on this document at any time, to ensure that 
the Agency considers your comment before finalizing work on the 
exploration process described in this document, submit either 
electronic or written comments by March 31, 2016.

II. Participation in a Public Meeting

    While oral presentations from specific individuals and 
organizations may be limited due to time constraints during the public 
meeting, stakeholders may submit electronic or written comments 
discussing any issues of concern to the administration record (the 
docket). All relevant data and documentation should be submitted with 
the comments to Docket No. FDA-2014-N-1050. Submit electronic comments 
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. It is only necessary to 
send one set of comments. Identify comments with the docket number FDA-
2014-N-1050. 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.

III. Comments, Transcripts, and Recorded Video

    Information and data submitted voluntarily to FDA during the public 
meeting will become part of the administrative record and will be 
accessible to the public at http://www.regulations.gov. The transcript 
of the proceedings from the public meeting will become part of the 
administrative record. Please be advised that as soon as a transcript 
is available, it will be accessible at http://www.regulations.gov, 
Docket No. FDA-2014-N-1050, and at FDA's CVM Web site at: http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm. It may also be viewed at the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. A transcript will also be available in 
either hardcopy or on CD-ROM, after submission of a Freedom of 
Information request. Written requests are to be sent to the Division of 
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 
Parklawn Dr., Element Bldg., Rockville, MD 20857. Additionally, FDA 
will be recording the meeting via Adobe Connect on March 16, 2015. Once 
the recording has been made 508 compliant, it will be accessible at 
FDA's CVM Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm.

    Dated: February 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03002 Filed 2-12-15; 8:45 am]
BILLING CODE 4164-01-P