Psychopharmacologic Drugs Advisory Committee; Notice of Meeting, 74776-74777 [2015-30296]
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74776
Federal Register / Vol. 80, No. 229 / Monday, November 30, 2015 / Notices
proposed rule, the comments must be
received via email to newtech@
cms.hhs.gov by the date specified in the
DATES section of this notice.
B. Conference Call, Live Streaming, and
Webinar Information
For participants who cannot attend
the Town Hall Meeting in person, an
open toll-free phone line, (877) 267–
1577, has been made available. The
Meeting Place meeting ID is 998–698–
471.
Also, there will be an option to view
and participate in the Town Hall
Meeting via live streaming technology
or a webinar. Information on the option
to participate via live streaming
technology or a webinar will be
provided through an upcoming listserv
notice and posted on the New
Technology Web site at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
AcuteInpatientPPS/newtech.html.
Continue to check the Web site for
updates.
C. Disclaimer
We cannot guarantee reliability for
live streaming technology or a webinar.
jstallworth on DSK7TPTVN1PROD with NOTICES
III. Registration Instructions
The Division of Acute Care in CMS is
coordinating the meeting registration for
the Town Hall Meeting on substantial
clinical improvement. While there is no
registration fee, individuals planning to
attend the Town Hall Meeting in person
must register to attend.
Registration may be completed online at the following Web address:
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/newtech.html.
Select the link at the bottom of the page
‘‘Register to Attend the New Technology
Town Hall Meeting’’. After completing
the registration, on-line registrants
should print the confirmation page(s)
and bring it with them to the meeting(s).
If you are unable to register on-line,
you may register by sending an email to
newtech@cms.hhs.gov. Please include
your name, address, telephone number,
email address and fax number. If seating
capacity has been reached, you will be
notified that the meeting has reached
capacity.
IV. Security, Building, and Parking
Guidelines
Because this meeting will be located
on Federal property, for security
reasons, any persons wishing to attend
this meeting must register by the date
specified in the DATES section of this
notice. Please allow sufficient time to go
through the security checkpoints. It is
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suggested that you arrive at 7500
Security Boulevard no later than 8:30
a.m. e.s.t. if you are attending the Town
Hall Meeting in person so that you will
be able to arrive promptly for the
meeting.
Security measures include the
following:
• Presentation of government-issued
photographic identification to the
Federal Protective Service or Guard
Service personnel. The Real ID Act of
2005 (Pub. L. 109–13), establishes
minimum standards for the issuance of
state-issued driver’s licenses and
identification (ID) cards. It prohibits
Federal agencies from accepting an
official driver’s license or ID card from
a state unless the Department of
Homeland Security determines that the
state is in compliance with the Real ID
Act. (For information regarding the
states or territories that are not in
compliance with the Real ID Act see
https://www.dhs.gov/real-idenforcement-brief.) If a state or territory
is listed on the https://www.dhs.gov/realid-enforcement-brief Web site as noncompliant, a photographic ID (such as a
driver’s license) issued by one of those
states or territories will not be accepted
as identification to enter Federal
buildings. Visitors from these states/
territories will need to provide
alternative proof of identification (such
as a passport) to gain entrance into
Baltimore-based CMS buildings.
• Inspection of vehicle’s interior and
exterior (this includes engine and trunk
inspection) at the entrance to the
grounds. Parking permits and
instructions will be issued after the
vehicle inspection.
• Inspection, via metal detector or
other applicable means of all persons
entering the building. We note that all
items brought into CMS, whether
personal or for the purpose of
presentation or to support a
presentation, are subject to inspection.
We cannot assume responsibility for
coordinating the receipt, transfer,
transport, storage, set-up, safety, or
timely arrival of any personal
belongings or items used for
presentation or to support a
presentation.
Note: Individuals who are not registered in
advance will not be permitted to enter the
building and will be unable to attend the
meeting. The public may not enter the
building earlier than 45 minutes prior to the
convening of the meeting.
All visitors must be escorted in all
areas other than the lower level lobby
and cafeteria area and first floor
auditorium and conference areas in the
Central Building. Seating capacity is
limited to the first 250 registrants.
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Authority: Section 503 of Pub. L. 108–173.
Dated: November 12, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2015–30314 Filed 11–27–15; 8:45 am]
BILLING CODE 4120–01–P
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.
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: https://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 https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
E:\FR\FM\30NON1.SGM
30NON1
jstallworth on DSK7TPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 229 / Monday, November 30, 2015 / Notices
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 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 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.
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15:23 Nov 27, 2015
Jkt 238001
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
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: 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
publishing this notice of petitions
received under the National Vaccine
Injury Compensation Program (the
Program), as required by Section
2112(b)(2) of the Public Health Service
(PHS) Act, as amended. While the
Secretary of Health and Human Services
is named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact the Clerk, United States
Court of Federal Claims, 717 Madison
Place, NW., Washington, DC 20005,
(202) 357–6400. For information on
HRSA’s role in the Program, contact the
SUMMARY:
PO 00000
Frm 00032
Fmt 4703
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74777
Director, National Vaccine Injury
Compensation Program, 5600 Fishers
Lane, Room 11C–26, Rockville, MD
20857; (301) 443–6593, or visit our Web
site at: https://www.hrsa.gov/
vaccinecompensation/.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of Health and Human
Services, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters, who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
October 1, 2015, through October 31,
2015. This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
case number. In cases where the Court
has redacted the name of a petitioner
and/or the case number, the list reflects
such redaction.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
E:\FR\FM\30NON1.SGM
30NON1
Agencies
[Federal Register Volume 80, Number 229 (Monday, November 30, 2015)]
[Notices]
[Pages 74776-74777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30296]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://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 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
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 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: 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