Conditional Approval of New Animal Drugs; Public Meeting; Request for Comments, 8091-8092 [2015-03004]
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Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices
provided that no person is required to
supply specific information pertaining
to the commenter, other than that
necessary for self-identification, as a
condition of the Agency’s full
consideration of the comment.
Dated: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
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
Food and Drug Administration,
HHS.
Notification of public meeting;
request for comments.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
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:
Laura.Bradbard@fda.hhs.gov.
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
VerDate Sep<11>2014
21:56 Feb 12, 2015
Jkt 235001
SUPPLEMENTARY INFORMATION:
I. Background
[FR Doc. 2015–02976 Filed 2–12–15; 8:45 am]
AGENCY:
opportunity to speak, please send a brief
summary of your comments. Early
registration for the meeting is
encouraged due to limited time and
space.
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.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
8091
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 https://
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
E:\FR\FM\13FEN1.SGM
13FEN1
8092
Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
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 https://
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 https://
www.regulations.gov, Docket No. FDA–
2014–N–1049, and at FDA’s CVM Web
site at: https://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 https://www.fda.gov/
ForIndustry/UserFees/
AnimalDrugUserFeeActADUFA/
ucm042891.htm.
Dated: February 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
I. Background
[FR Doc. 2015–03004 Filed 2–12–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1050]
tkelley on DSK3SPTVN1PROD with NOTICES
Regulation of Combination Drug
Medicated Feeds; Public Meeting;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notification of public meeting;
request for comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing a public meeting to
explore the feasibility of pursuing
VerDate Sep<11>2014
21:56 Feb 12, 2015
Jkt 235001
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:
Laura.Bradbard@fda.hhs.gov.
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.
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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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
E:\FR\FM\13FEN1.SGM
13FEN1
]]>Agencies
[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Notices]
[Pages 8091-8092]
From the Federal Register Online via the Government Printing 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:
Laura.Bradbard@fda.hhs.gov.
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 https://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 https://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 https://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 https://www.regulations.gov,
Docket No. FDA-2014-N-1049, and at FDA's CVM Web site at: https://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 https://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
