Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting, 20328-20329 [2013-07841]
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20328
Federal Register / Vol. 78, No. 65 / Thursday, April 4, 2013 / Notices
therapy in adult males for conditions
associated with a deficiency or absence
of testosterone. The safety discussion
will focus on postmarketing reports of
oil microembolism in the lungs and
potential anaphylactic reactions. In
addition to AVEED, other approved
testosterone injectable products will be
referenced, especially in regard to oil
microembolism and potential
anaphylactic reactions reported for
those products.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: March 27, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
Dated: March 27, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–07842 Filed 4–3–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Peripheral and Central Nervous
System Drugs Advisory Committee;
Notice of Meeting
AGENCY:
ACTION:
[FR Doc. 2013–07843 Filed 4–3–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices
Advisory Committee: Notice of
Postponement of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is postponing the
meeting of the Orthopaedic and
Rehabilitation Devices Panel of the
Medical Devices Advisory Committee
scheduled for April 5, 2013. The
meeting was announced in the Federal
Register of November 29, 2012 (77 FR
71195). The meeting is postponed
because key participants were
unavailable due to unforeseen
scheduling conflicts. In the meantime,
FDA analysis of industry-submitted
documents is ongoing. A new meeting
date will be announced in the Federal
Register.
FOR FURTHER INFORMATION CONTACT:
Jamie Waterhouse, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1611, Silver Spring,
MD 20993–0002,
Jamie.Waterhouse@fda.hhs.gov, 301–
796–3063, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). Please call the Information Line
for up-to-date information on this
meeting.
wreier-aviles on DSK5TPTVN1PROD with NOTICES
SUMMARY:
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14:48 Apr 03, 2013
Jkt 229001
Food and Drug Administration,
HHS.
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: Peripheral and
Central Nervous System 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 May 22, 2013, 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.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Glendolynn S.
Johnson, 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, email:
PCNS@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://
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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 May 22, 2013, the
committee will discuss new drug
application (NDA) 204569, for
suvorexant tablets, submitted by Merck
Sharp and Dohme Corp., Worldwide
Regulatory Group. The proposed
indication is for insomnia characterized
by difficulties with sleep onset and/or
maintenance.
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 May 8, 2013. 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 April 30,
2013. 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 May 1, 2013.
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 physical
E:\FR\FM\04APN1.SGM
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Federal Register / Vol. 78, No. 65 / Thursday, April 4, 2013 / Notices
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Glendolynn
S. Johnson 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: March 27, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–07841 Filed 4–3–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB review; 30-day
Comment Request: A Generic
Submission for Formative Research,
Pretesting, and Customer Satisfaction
of NCI’s Communication and
Education Resources (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on January 2, 2013
(Volume 78, Page 105) and allowed 60days for public comment. Two public
comments were received and responded
to. The purpose of this notice is to allow
an additional 30 days for public
comment. The National Cancer Institute
(NCI), the National Institutes of Health
may not conduct or sponsor, and the
SUMMARY:
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: NIH
Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, contact: Nina
Goodman, Public Health Advisor, Office
of Communications and Education
(OCE), NCI, NIH, 6116 Executive Blvd.,
Suite 400, Rockville, MD 20892, call
non-toll-free number (301) 435–7789 or
email your request, including your
address to: goodmann@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: A Generic
Submission For Formative Research,
Pretesting, and Customer Satisfaction of
NCI’s Communication and Education
Resources, 0925–0046, Expiration Date
2/28/2013, Reinstatement without
Change, National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: In order to carry out NCI’s
legislative mandate to educate and
disseminate information about cancer
prevention, detection, diagnosis, and
treatment to a wide variety of audiences
and organizations, it is beneficial for
NCI through its Office of
Communications and Education (OCE),
to pretest NCI communications
strategies, concepts, and messages while
they are under development. This
pretesting, or formative evaluation,
helps ensure that the messages,
communication materials, and
information services created by NCI
have the greatest capacity of being
received, understood, and accepted by
their target audiences. Since NCI’s OCE
is also responsible for the design,
implementation, and evaluation of
education programs over the entire
cancer continuum, and management of
NCI initiatives that address specific
challenges in cancer research and
treatment, it is also necessary to ensure
that customers are satisfied with
programs. This customer satisfaction
research helps ensure the relevance,
utility, and appropriateness of the many
educational programs and products that
OCE and NCI produce. OCE will use a
variety of qualitative (focus groups,
interviews) and quantitative (paper,
phone, in-person, and web surveys)
methodologies to conduct this formative
and customer satisfaction research,
allowing NCI to: (1) Understand
characteristics (attitudes, beliefs, and
behaviors) of the intended target
audience and use this information in the
development of effective
communication tools and strategies; (2)
use a feedback loop to help refine,
revise, and enhance messages, materials,
products, and programs—ensuring that
they have the greatest relevance, utility,
appropriateness, and impact for/to
target audiences; and (3) expend limited
program resource dollars wisely and
effectively. The participants may
include, but are not limited to, cancer
patients, their families, the general
public, health providers, the media,
voluntary groups, scientific and medical
organizations (affected public could
include individuals or households;
businesses or other for profit; not-forprofit institutions; and Federal
Government; State, Local, or Tribal
Government).
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated burden, over three years for
this generic request are 6,600 hours.
3-YEAR ESTIMATED BURDEN HOURS (GENERIC REQUEST)
Number of
respondents
wreier-aviles on DSK5TPTVN1PROD with NOTICES
Category of respondents
Form name
Individuals,
Households,
Local,
State, and Federal Governments,
and Private Sector.
Focus Groups, Individual In-Depth
Interviews, Brief Interviews, Surveys, Website Usability Testing.
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Frequency of
response per
respondent
33,000
E:\FR\FM\04APN1.SGM
1
04APN1
Time per
response
(in hours)
12/60
Burden hours
6,600
Agencies
[Federal Register Volume 78, Number 65 (Thursday, April 4, 2013)]
[Notices]
[Pages 20328-20329]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07841]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Peripheral and Central Nervous System 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: Peripheral and Central Nervous System 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 May 22, 2013, 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. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
Contact Person: Glendolynn S. Johnson, 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, email: PCNS@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 May 22, 2013, the committee will discuss new drug
application (NDA) 204569, for suvorexant tablets, submitted by Merck
Sharp and Dohme Corp., Worldwide Regulatory Group. The proposed
indication is for insomnia characterized by difficulties with sleep
onset and/or maintenance.
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 May
8, 2013. 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 April 30, 2013. 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 May 1, 2013.
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
physical
[[Page 20329]]
disabilities or special needs. If you require special accommodations
due to a disability, please contact Glendolynn S. Johnson 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: March 27, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-07841 Filed 4-3-13; 8:45 am]
BILLING CODE 4160-01-P