80 FR 74776 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 229 (November 30, 2015)

Page Range		74776-74777
FR Document		2015-30296

Federal Register, Volume 80 Issue 229 (Monday, November 30, 2015)

[Federal Register Volume 80, Number 229 (Monday, November 30, 2015)]
[Notices]
[Pages 74776-74777]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30296]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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: Psychopharmacologic Drugs 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 February 3, 2016, from 8 a.m. to 5 
p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 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: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Kalyani Bhatt, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, PDAC@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 http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the

[[Page 74777]]

appropriate advisory committee meeting link, or call the advisory 
committee information line to learn about possible modifications before 
coming to the meeting.
    Agenda: During the morning session, the committee will discuss 
cognitive dysfunction in major depressive disorder (MDD). This is an 
evolving concept and experts in the field have not yet reached 
consensus as to whether cognitive dysfunction in MDD is a distinct 
entity. The committee will consider the clinical presentation of 
cognitive dysfunction in MDD, as well as methods for assessing this 
condition.
    During the afternoon session, the committee will discuss new drug 
application 204447/supplemental new drug application 006, for the 
effectiveness of vortioxetine for the treatment of cognitive 
dysfunction in MDD, submitted by Takeda Development Center Americas, 
Inc.
    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 
January 20, 2016. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.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 January 11, 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 January 12, 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 Kalyani Bhatt 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: November 23, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-30296 Filed 11-27-15; 8:45 am]
 BILLING CODE 4164-01-P

74776 Federal Register / Vol. 80, No. 229 / Monday, November 30, 2015 / Notices

proposed rule, the comments must be suggested that you arrive at 7500 Authority: Section 503 of Pub. L. 108–173.
received via email to newtech@ Security Boulevard no later than 8:30 Dated: November 12, 2015.
cms.hhs.gov by the date specified in the a.m. e.s.t. if you are attending the Town Andrew M. Slavitt,
DATES section of this notice. Hall Meeting in person so that you will Acting Administrator, Centers for Medicare
be able to arrive promptly for the & Medicaid Services.
B. Conference Call, Live Streaming, and meeting.
Webinar Information Security measures include the
[FR Doc. 2015–30314 Filed 11–27–15; 8:45 am]
BILLING CODE 4120–01–P
For participants who cannot attend following:
the Town Hall Meeting in person, an • Presentation of government-issued
open toll-free phone line, (877) 267– photographic identification to the
Federal Protective Service or Guard DEPARTMENT OF HEALTH AND
1577, has been made available. The
Service personnel. The Real ID Act of HUMAN SERVICES
Meeting Place meeting ID is 998–698–
471. 2005 (Pub. L. 109–13), establishes Food and Drug Administration
Also, there will be an option to view minimum standards for the issuance of
and participate in the Town Hall state-issued driver’s licenses and [Docket No. FDA–2015–N–0001]
Meeting via live streaming technology identification (ID) cards. It prohibits
or a webinar. Information on the option Federal agencies from accepting an Psychopharmacologic Drugs Advisory
to participate via live streaming official driver’s license or ID card from Committee; Notice of Meeting
technology or a webinar will be a state unless the Department of AGENCY: Food and Drug Administration,
provided through an upcoming listserv Homeland Security determines that the HHS.
notice and posted on the New state is in compliance with the Real ID
Act. (For information regarding the ACTION: Notice.
Technology Web site at http://
www.cms.gov/Medicare/Medicare-Fee- states or territories that are not in This notice announces a forthcoming
for-Service-Payment/ compliance with the Real ID Act see meeting of a public advisory committee
AcuteInpatientPPS/newtech.html. http://www.dhs.gov/real-id- of the Food and Drug Administration
Continue to check the Web site for enforcement-brief.) If a state or territory (FDA). The meeting will be open to the
updates. is listed on the http://www.dhs.gov/real- public.
id-enforcement-brief Web site as non- Name of Committee:
C. Disclaimer compliant, a photographic ID (such as a Psychopharmacologic Drugs Advisory
We cannot guarantee reliability for driver’s license) issued by one of those Committee.
live streaming technology or a webinar. states or territories will not be accepted General Function of the Committee:
as identification to enter Federal
III. Registration Instructions To provide advice and
buildings. Visitors from these states/
recommendations to the Agency on
The Division of Acute Care in CMS is territories will need to provide
FDA’s regulatory issues.
coordinating the meeting registration for alternative proof of identification (such
the Town Hall Meeting on substantial as a passport) to gain entrance into Date and Time: The meeting will be
clinical improvement. While there is no Baltimore-based CMS buildings. held on February 3, 2016, from 8 a.m.
registration fee, individuals planning to • Inspection of vehicle’s interior and to 5 p.m.
attend the Town Hall Meeting in person exterior (this includes engine and trunk Location: FDA White Oak Campus,
must register to attend. inspection) at the entrance to the 10903 New Hampshire Ave., Bldg. 31
Registration may be completed on- grounds. Parking permits and Conference Center, the Great Room (rm.
line at the following Web address: instructions will be issued after the 1503), Silver Spring, MD 20993–0002.
http://www.cms.gov/Medicare/ vehicle inspection. Answers to commonly asked questions
Medicare-Fee-for-Service-Payment/ • Inspection, via metal detector or including information regarding special
AcuteInpatientPPS/newtech.html. other applicable means of all persons accommodations due to a disability,
Select the link at the bottom of the page entering the building. We note that all visitor parking, and transportation may
‘‘Register to Attend the New Technology items brought into CMS, whether be accessed at: http://www.fda.gov/
Town Hall Meeting’’. After completing personal or for the purpose of AdvisoryCommittees/
the registration, on-line registrants presentation or to support a AboutAdvisoryCommittees/
should print the confirmation page(s) presentation, are subject to inspection. ucm408555.htm.
and bring it with them to the meeting(s). We cannot assume responsibility for Contact Person: Kalyani Bhatt, Center
If you are unable to register on-line, coordinating the receipt, transfer, for Drug Evaluation and Research, Food
you may register by sending an email to transport, storage, set-up, safety, or and Drug Administration, 10903 New
newtech@cms.hhs.gov. Please include timely arrival of any personal Hampshire Ave., Bldg. 31, Rm. 2417,
your name, address, telephone number, belongings or items used for Silver Spring, MD 20993–0002, 301–
email address and fax number. If seating presentation or to support a 796–9001, FAX: 301–847–8533, PDAC@
capacity has been reached, you will be presentation. fda.hhs.gov, or FDA Advisory
notified that the meeting has reached Note: Individuals who are not registered in Committee Information Line, 1–800–
capacity. advance will not be permitted to enter the 741–8138 (301–443–0572 in the
building and will be unable to attend the Washington, DC area). A notice in the
IV. Security, Building, and Parking meeting. The public may not enter the Federal Register about last minute
Guidelines building earlier than 45 minutes prior to the modifications that impact a previously
jstallworth on DSK7TPTVN1PROD with NOTICES

Because this meeting will be located convening of the meeting. announced advisory committee meeting
on Federal property, for security All visitors must be escorted in all cannot always be published quickly
reasons, any persons wishing to attend areas other than the lower level lobby enough to provide timely notice.
this meeting must register by the date and cafeteria area and first floor Therefore, you should always check the
specified in the DATES section of this auditorium and conference areas in the Agency’s Web site at http://
notice. Please allow sufficient time to go Central Building. Seating capacity is www.fda.gov/AdvisoryCommittees/
through the security checkpoints. It is limited to the first 250 registrants. default.htm and scroll down to the

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Document Modified: 2018-03-01 11:11:44

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.
FR Citation		80 FR 74776

80 FR 74776 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 229 (November 30, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration