Regulation of Combination Drug Medicated Feeds; Public Meeting; Request for Comments, 8092-8093 [2015-03002]
Download as PDF
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
Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices
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.
tkelley on DSK3SPTVN1PROD with NOTICES
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 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–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 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–1050, 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
VerDate Sep<11>2014
21:56 Feb 12, 2015
Jkt 235001
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. 2015–03002 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–2015–N–0001]
The Tobacco Products Scientific
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: The Tobacco
Products Scientific Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on April 9, 2015, from 8:30 a.m. to
5 p.m. and April 10, 2015, from 8 a.m.
to 5 p.m.
Location: FDA White Oak, 10903 New
Hampshire Ave., Building 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Caryn Cohen, Office
of Science, Center for Tobacco Products,
Food and Drug Administration,
Document Control Center, Bldg. 71, Rm.
G335, 10903 New Hampshire Ave.,
Silver Spring, MD 20993–0002, 1–877–
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
8093
287–1373, email: TPSAC@fda.hhs.gov.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site at
https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: On April 9 and 10, 2015, the
Committee will discuss modified risk
tobacco product applications submitted
by Swedish Match North America Inc.
for 10 tobacco products:
• MR0000020: General Loose,
smokeless tobacco, loose snus, 1.59 oz
(45g), cardboard can (SKU 4852);
• MR0000021: General Dry Mint
Portion Original Mini, smokeless
tobacco, snus portions, 0.21 oz (6g), 20
0.3g portions, plastic can (SKU 4800);
• MR0000022: General Portion
Original Large, smokeless tobacco, snus
portions, 0.9 oz (24g), 24 1g portions,
plastic can (SKU 4880);
• MR0000023: General Classic Blend
Portion White Large, smokeless tobacco,
snus portions, 0.48 oz (13.5g), 15 0.9g
portions, plastic can (SKU 4877);
• MR0000024: General Classic Blend
Portion White Large, smokeless tobacco,
snus portions, 0.38 oz (10.8g), 12 0.9g
portions, plastic can (SKU 4878);
• MR0000025: General Mint Portion
White Large, smokeless tobacco, snus
portions, 0.9 oz (24g), 24 1g portions,
plastic can (SKU 4352);
• MR0000026: General Nordic Mint
Portion White Large, smokeless tobacco,
snus portions, 0.48 oz (13.5g), 15 0.9g
portions, plastic can (SKU 4876);
• MR0000027: General Nordic Mint
Portion White Large, smokeless tobacco,
snus portions, 0.38 oz (10.8g), 12 0.9g
portions, plastic can (SKU 4875);
• MR0000028: General Portion White
Large, smokeless tobacco, snus portions,
0.9 oz (24g), 24 1g portions, plastic can
(SKU 4881); and
• MR0000029: General Wintergreen
Portion White Large, smokeless tobacco,
snus portions, 0.9 oz (24g), 24 1g
portions, plastic can (SKU 4882).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
E:\FR\FM\13FEN1.SGM
13FEN1
Agencies
[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Notices]
[Pages 8092-8093]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03002]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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 (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 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-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 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-1050, 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. 2015-03002 Filed 2-12-15; 8:45 am]
BILLING CODE 4164-01-P