[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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