81 FR 8508 - Pediatric Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 33 (February 19, 2016)

Page Range		8508-8509
FR Document		2016-03469
Federal Register, Volume 81 Issue 33 (Friday, February 19, 2016)
[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8508-8509]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03469]


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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.

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    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: 
http://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-hotel-washington-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: 
[email protected], 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 http://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 http://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 http://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
8508 Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Activity burden per Total hours
respondents per disclosures disclosure
respondent

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. be accessed at: http:// committee meeting to be held on
Leslie Kux, doubletree3.hilton.com/en/hotels/ September 15 and 16, 2016, on the FDA
Associate Commissioner for Policy. maryland/doubletree-by-hilton-hotel- White Oak Campus, 10903 New
[FR Doc. 2016–03457 Filed 2–18–16; 8:45 am] washington-dc-silver-spring-DCASSDT/ Hampshire Ave., Building 31
BILLING CODE 4164–01–P
index.html. Conference Center, the Great Room (rm.
Contact Person: Marieann Brill, Office 1503), Silver Spring, MD 20993–0002.
of the Commissioner, Food and Drug Following the presentation on the
DEPARTMENT OF HEALTH AND Administration, 10903 New Hampshire proposed framework for the September
HUMAN SERVICES Ave., Bldg. 32, rm. 5154, Silver Spring, meeting, there will be an hour of open
MD 20993, 240–402–3838, email: public hearing from 9:30 a.m. to 10:30
Food and Drug Administration marieann.brill@fda.hhs.gov, or FDA a.m. to provide an opportunity for the
Advisory Committee Information Line, public to provide input concerning the
[Docket No. FDA–2016–N–0567]
1–800–741–8138 (301–443–0572 in the topics before the PAC, including the use
Pediatric Advisory Committee; Notice Washington, DC area). A notice in the of opioids for control of severe pain in
of Meeting Federal Register about last minute the pediatric population. To assist with
modifications that impact a previously the planning of this advisory committee
AGENCY: Food and Drug Administration, announced advisory committee meeting meeting, FDA is establishing a public
HHS. cannot always be published quickly docket [Docket No. FDA–2016–N–0584]
ACTION: Notice; request for comments. enough to provide timely notice. to receive input on appropriate pediatric
Therefore, you should always check the development plans for prescription
This notice announces a forthcoming Agency’s Web site at http:// opioid drugs. The docket will remain
meeting of a public advisory committee www.fda.gov/AdvisoryCommittees/ open following the September advisory
of the Food and Drug Administration default.htm and scroll down to the committee meeting. Comments about
(FDA). The meeting will be open to the appropriate advisory committee meeting the upcoming September advisory
public. link, or call the advisory committee committee meeting should not be
Name of Committee: Pediatric information line to learn about possible submitted to the docket number listed at
Advisory Committee. modifications before coming to the the top of this Federal Register notice
General Function of the Committee: meeting. [Docket No. FDA–2016–N–0567]. Please
To provide advice and Agenda: On April 12, 2016, the also see the ADDRESSES section of this
recommendations to the Agency on Pediatric Advisory Committee (PAC) notice for further docket information.
FDA’s regulatory issues. will meet to discuss pediatric-focused The pediatric-focused safety reviews
Date and Time: The meeting will be safety reviews, as mandated by the Best for the Centers will then occur. The PAC
held on April 12, 2016, from 8 a.m. to Pharmaceuticals for Children Act (Pub. will meet to discuss the following
5:30 p.m. L. 107–109) and the Pediatric Research products (listed by FDA Center):
ADDRESSES: FDA is establishing a public Equity Act (Pub. L. 108–155). See the • Center for Biologics Evaluation and
docket [Docket No. FDA–2016–N–0567] list of the products in this document to Research (CBER):
to receive input on pediatric-focused be discussed. Æ FLULAVAL QUADRIVALENT
safety reviews and appropriate pediatric In addition, FDA will be providing (influenza virus vaccine)
development plans for prescription information on a proposed public Æ FLULAVAL TRIVALENT (influenza
opioid drugs. Comments about the advisory committee meeting for virus vaccine)
upcoming September advisory September 15 and 16, 2016, on Æ FLUZONE QUADRIVALENT
committee meeting should not be appropriate pediatric development (influenza virus vaccine)
submitted to the docket number listed at plans for prescription opioid drugs. • Center for Drug Evaluation and
the top of this Federal Register notice Prior to the safety reviews and the open Research (CDER):
[Docket No. FDA–2016–N–0567], which public hearing (see later in this section Æ ACIPHEX SPRINKLES (rabeprazole
is to provide an opportunity for the for further information), FDA will sodium)
public to provide input concerning the present, from approximately 8:30 to 9:30 Æ SKYLA (levonorgestrel-releasing
products before the Committee on April a.m., a framework of current plans for a intrauterine system)
asabaliauskas on DSK5VPTVN1PROD with NOTICES

12, 2016. 2-day joint meeting of the PAC, the Æ MYCAMINE (micafungin sodium)
Location: Double Tree by Hilton Anesthetic and Analgesic Drug Products Æ NOXAFIL (posaconazole)
Hotel, 8727 Colesville Rd., Silver Advisory Committee, and the Drug Æ PRECEDEX (dexmedetomidine
Spring, MD 20910, 301–589–5200. Safety and Risk Management Advisory hydrocholoride)
Answers to commonly asked questions Committees. Æ SABRIL (vigabatrim)
including information regarding special Elsewhere in this issue of the Federal Æ SEROQUEL (quetiapine fumarate)
accommodations due to a disability, Register, FDA is publishing an and SEROQUEL XR (quetiapine
visitor parking, and transportation may announcement of this advisory fumarate extended-release)

VerDate Sep<11>2014 17:59 Feb 18, 2016 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\19FEN1.SGM 19FEN1
Document Created: 2018-02-02 14:32:09
Document Modified: 2018-02-02 14:32:09
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; request for comments.
FR Citation		81 FR 8508
81 FR 8508 - Pediatric Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 33 (February 19, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
