[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Notices]
[Pages 8091-8092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03004]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1049]


Conditional Approval of New Animal Drugs; 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 use of statutory changes to expand the use of 
conditional approval to additional categories of new animal drugs. 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 
September 30, 2015.
    Date and Time: The public meeting will be held on March 16, 2015, 
from 1 p.m. until 4 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 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 industry, the feasibility of pursuing statutory 
revisions, consistent with the Agency's mission to protect and promote 
the public health, that may expand the use of conditional approvals to 
other appropriate categories of new animal drug applications and 
develop recommendations by September 30, 2015.
    Currently, the conditional approval provisions allow an applicant 
to market a new animal drug intended for a minor species or a minor use 
in a major species after the applicant has demonstrated that the drug 
is safe and can be manufactured according to standards applicable to 
approval of applications under section 512(b)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b(b)(1)). FDA and members of 
regulated industry jointly agreed to explore, as part of the 
performance goals outlined in the ADUFA III goals letter, statutory 
changes to expand the use of conditional approval to other appropriate 
categories of new animal drugs.
    This public meeting is intended to provide an additional 
opportunity for public comment. The Agency is especially interested in 
receiving comments during the meeting on the categories of new animal 
drug applications that would be considered ``appropriate'' and why; 
concerns, if any, that might arise due to the expansion of the 
Conditional Approval process; and the length of marketing exclusivity, 
if any, that should be associated with the expansion of the Conditional 
Approval process.
    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-1049 
to receive comments on the issue (79 FR 53430, 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 September 30, 2015.

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-1049. 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-1049. Received comments may be seen in the Division

[[Page 8092]]

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-1049, 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. 2015-03004 Filed 2-12-15; 8:45 am]
BILLING CODE 4164-01-P