Pediatric Advisory Committee; Notice of Meeting, 8508-8509 [2016-03469]
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8508
Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Including a domestic address or phone number and a
statement of its purpose on OTC drug labeling (21
U.S.C. 502(x)) ..................................................................
300
3
900
4
3,600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–03457 Filed 2–18–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0567]
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ACTION:
Notice; request for comments.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric
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 12, 2016, from 8 a.m. to
5:30 p.m.
ADDRESSES: FDA is establishing a public
docket [Docket No. FDA–2016–N–0567]
to receive input on pediatric-focused
safety reviews and appropriate pediatric
development plans for prescription
opioid drugs. Comments about the
upcoming September advisory
committee meeting should not be
submitted to the docket number listed at
the top of this Federal Register notice
[Docket No. FDA–2016–N–0567], which
is to provide an opportunity for the
public to provide input concerning the
products before the Committee on April
12, 2016.
Location: Double Tree by Hilton
Hotel, 8727 Colesville Rd., Silver
Spring, MD 20910, 301–589–5200.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
VerDate Sep<11>2014
17:59 Feb 18, 2016
Jkt 238001
be accessed at: https://
doubletree3.hilton.com/en/hotels/
maryland/doubletree-by-hilton-hotelwashington-dc-silver-spring-DCASSDT/
index.html.
Contact Person: Marieann Brill, Office
of the Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 5154, Silver Spring,
MD 20993, 240–402–3838, email:
marieann.brill@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). 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 12, 2016, the
Pediatric Advisory Committee (PAC)
will meet to discuss pediatric-focused
safety reviews, as mandated by the Best
Pharmaceuticals for Children Act (Pub.
L. 107–109) and the Pediatric Research
Equity Act (Pub. L. 108–155). See the
list of the products in this document to
be discussed.
In addition, FDA will be providing
information on a proposed public
advisory committee meeting for
September 15 and 16, 2016, on
appropriate pediatric development
plans for prescription opioid drugs.
Prior to the safety reviews and the open
public hearing (see later in this section
for further information), FDA will
present, from approximately 8:30 to 9:30
a.m., a framework of current plans for a
2-day joint meeting of the PAC, the
Anesthetic and Analgesic Drug Products
Advisory Committee, and the Drug
Safety and Risk Management Advisory
Committees.
Elsewhere in this issue of the Federal
Register, FDA is publishing an
announcement of this advisory
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
committee meeting to be held on
September 15 and 16, 2016, on the FDA
White Oak Campus, 10903 New
Hampshire Ave., Building 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Following the presentation on the
proposed framework for the September
meeting, there will be an hour of open
public hearing from 9:30 a.m. to 10:30
a.m. to provide an opportunity for the
public to provide input concerning the
topics before the PAC, including the use
of opioids for control of severe pain in
the pediatric population. To assist with
the planning of this advisory committee
meeting, FDA is establishing a public
docket [Docket No. FDA–2016–N–0584]
to receive input on appropriate pediatric
development plans for prescription
opioid drugs. The docket will remain
open following the September advisory
committee meeting. Comments about
the upcoming September advisory
committee meeting should not be
submitted to the docket number listed at
the top of this Federal Register notice
[Docket No. FDA–2016–N–0567]. Please
also see the ADDRESSES section of this
notice for further docket information.
The pediatric-focused safety reviews
for the Centers will then occur. The PAC
will meet to discuss the following
products (listed by FDA Center):
• Center for Biologics Evaluation and
Research (CBER):
Æ FLULAVAL QUADRIVALENT
(influenza virus vaccine)
Æ FLULAVAL TRIVALENT (influenza
virus vaccine)
Æ FLUZONE QUADRIVALENT
(influenza virus vaccine)
• Center for Drug Evaluation and
Research (CDER):
Æ ACIPHEX SPRINKLES (rabeprazole
sodium)
Æ SKYLA (levonorgestrel-releasing
intrauterine system)
Æ MYCAMINE (micafungin sodium)
Æ NOXAFIL (posaconazole)
Æ PRECEDEX (dexmedetomidine
hydrocholoride)
Æ SABRIL (vigabatrim)
Æ SEROQUEL (quetiapine fumarate)
and SEROQUEL XR (quetiapine
fumarate extended-release)
E:\FR\FM\19FEN1.SGM
19FEN1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices
Æ SKYLA (levonorgestrel-releasing
intrauterine system)
Æ SYMBAX (fluoxetine
hydrocholoride and olanzapine)
Æ VYVANSE CAPSULES
(lisdexamfetamine dimesylate)
Æ XELODA (capecitabine)
• Center for Devices and Radiological
Health (CDRH):
Æ IMPELLA RP SYSTEM
(humanitarian use device (HUD))
Æ LIPSORBER LA-15 SYSTEM (HUD)
Æ MEDTRONIC ACTIVA DYSTONIA
THERAPY (HUD)
In addition to the agenda items, the
PAC will remain in public session over
the lunch hour on April 12, 2016, to
hear a presentation and provide
feedback on an FDA proposal for a riskbased approach to the pediatric-focused
safety reviews mandated by the Best
Pharmaceuticals for Children Act and
the Pediatric Research Equity Act. The
working lunch currently is scheduled
between approximately 12:30 p.m. and
1:15 p.m.
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
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before April 5, 2016. Oral
presentations from the public will be
scheduled between approximately 9:30
a.m. and 10:30 a.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before March
28, 2016. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
VerDate Sep<11>2014
17:59 Feb 18, 2016
Jkt 238001
hearing session. The contact person will
notify interested persons regarding their
request to speak by March 29, 2016.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Marieann Brill
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 16, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–03469 Filed 2–18–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0096]
Determining the Extent of Safety Data
Collection Needed in Late-Stage
Premarket and Postapproval Clinical
Investigations; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Determining the Extent of Safety Data
Collection Needed in Late-Stage
Premarket and Postapproval Clinical
Investigations.’’ The guidance is
intended to help sponsors determine the
amounts and types of safety data to
collect in late-stage premarket and
postapproval clinical investigations
based on what is already known about
a drug’s safety profile. Sponsors collect
extensive safety data in clinical
investigations of drug and biological
products conducted to support
marketing approval (premarket) and
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
after approval (postapproval). FDA
believes that selective safety data
collection may be possible for some latestage premarket and postapproval
clinical investigations because certain
aspects of a drug’s safety profile will be
sufficiently well-established and
comprehensive data collection is not
needed. This guidance finalizes the
draft guidance issued in February 2012.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Notice of availability.
SUMMARY:
8509
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–D–0096 for ‘‘Determining the
Extent of Safety Data Collection Needed
E:\FR\FM\19FEN1.SGM
19FEN1
]]>Agencies
[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8508-8509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03469]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0567]
Pediatric Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Pediatric 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 12, 2016, from 8
a.m. to 5:30 p.m.
ADDRESSES: FDA is establishing a public docket [Docket No. FDA-2016-N-
0567] to receive input on pediatric-focused safety reviews and
appropriate pediatric development plans for prescription opioid drugs.
Comments about the upcoming September advisory committee meeting should
not be submitted to the docket number listed at the top of this Federal
Register notice [Docket No. FDA-2016-N-0567], which is to provide an
opportunity for the public to provide input concerning the products
before the Committee on April 12, 2016.
Location: Double Tree by Hilton Hotel, 8727 Colesville Rd., Silver
Spring, MD 20910, 301-589-5200. Answers to commonly asked questions
including information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
https://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-hotel-washington-dc-silver-spring-DCASSDT/.
Contact Person: Marieann Brill, Office of the Commissioner, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5154,
Silver Spring, MD 20993, 240-402-3838, email:
marieann.brill@fda.hhs.gov, or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 12, 2016, the Pediatric Advisory Committee (PAC)
will meet to discuss pediatric-focused safety reviews, as mandated by
the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the
Pediatric Research Equity Act (Pub. L. 108-155). See the list of the
products in this document to be discussed.
In addition, FDA will be providing information on a proposed public
advisory committee meeting for September 15 and 16, 2016, on
appropriate pediatric development plans for prescription opioid drugs.
Prior to the safety reviews and the open public hearing (see later in
this section for further information), FDA will present, from
approximately 8:30 to 9:30 a.m., a framework of current plans for a 2-
day joint meeting of the PAC, the Anesthetic and Analgesic Drug
Products Advisory Committee, and the Drug Safety and Risk Management
Advisory Committees.
Elsewhere in this issue of the Federal Register, FDA is publishing
an announcement of this advisory committee meeting to be held on
September 15 and 16, 2016, on the FDA White Oak Campus, 10903 New
Hampshire Ave., Building 31 Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993-0002. Following the presentation on the
proposed framework for the September meeting, there will be an hour of
open public hearing from 9:30 a.m. to 10:30 a.m. to provide an
opportunity for the public to provide input concerning the topics
before the PAC, including the use of opioids for control of severe pain
in the pediatric population. To assist with the planning of this
advisory committee meeting, FDA is establishing a public docket [Docket
No. FDA-2016-N-0584] to receive input on appropriate pediatric
development plans for prescription opioid drugs. The docket will remain
open following the September advisory committee meeting. Comments about
the upcoming September advisory committee meeting should not be
submitted to the docket number listed at the top of this Federal
Register notice [Docket No. FDA-2016-N-0567]. Please also see the
ADDRESSES section of this notice for further docket information.
The pediatric-focused safety reviews for the Centers will then
occur. The PAC will meet to discuss the following products (listed by
FDA Center):
Center for Biologics Evaluation and Research (CBER):
[cir] FLULAVAL QUADRIVALENT (influenza virus vaccine)
[cir] FLULAVAL TRIVALENT (influenza virus vaccine)
[cir] FLUZONE QUADRIVALENT (influenza virus vaccine)
Center for Drug Evaluation and Research (CDER):
[cir] ACIPHEX SPRINKLES (rabeprazole sodium)
[cir] SKYLA (levonorgestrel-releasing intrauterine system)
[cir] MYCAMINE (micafungin sodium)
[cir] NOXAFIL (posaconazole)
[cir] PRECEDEX (dexmedetomidine hydrocholoride)
[cir] SABRIL (vigabatrim)
[cir] SEROQUEL (quetiapine fumarate) and SEROQUEL XR (quetiapine
fumarate extended-release)
[[Page 8509]]
[cir] SKYLA (levonorgestrel-releasing intrauterine system)
[cir] SYMBAX (fluoxetine hydrocholoride and olanzapine)
[cir] VYVANSE CAPSULES (lisdexamfetamine dimesylate)
[cir] XELODA (capecitabine)
Center for Devices and Radiological Health (CDRH):
[cir] IMPELLA RP SYSTEM (humanitarian use device (HUD))
[cir] LIPSORBER LA-15 SYSTEM (HUD)
[cir] MEDTRONIC ACTIVA DYSTONIA THERAPY (HUD)
In addition to the agenda items, the PAC will remain in public
session over the lunch hour on April 12, 2016, to hear a presentation
and provide feedback on an FDA proposal for a risk-based approach to
the pediatric-focused safety reviews mandated by the Best
Pharmaceuticals for Children Act and the Pediatric Research Equity Act.
The working lunch currently is scheduled between approximately 12:30
p.m. and 1:15 p.m.
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 the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
April 5, 2016. Oral presentations from the public will be scheduled
between approximately 9:30 a.m. and 10:30 a.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before March 28, 2016. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by March 29, 2016.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Marieann Brill at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: February 16, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-03469 Filed 2-18-16; 8:45 am]
BILLING CODE 4164-01-P
