Risk Communication Advisory Committee; Notice of Meeting, 70450-70451 [2012-28462]
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70450
Federal Register / Vol. 77, No. 227 / Monday, November 26, 2012 / Notices
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priorities. CDRH’s experience in
guidance development has shown that
there are many reasons that CDRH staff
may not complete the entire agenda of
guidance documents it undertakes. Staff
are frequently diverted from guidance
development to other priority activities.
In addition, at any time new issues may
arise to be addressed in guidance that
could not have been anticipated at the
time the annual list is generated. These
issues may involve newly identified
public health issues as well as special
control documents that are necessary for
the classification of de novo devices.
FDA anticipates that feedback from
stakeholders, including draft language
for guidance documents, will allow
CDRH to better prioritize and more
efficiently draft guidances that will be
useful to industry and other
stakeholders. FDA intends to update the
list each year.
FDA invites interested persons to
submit comments on any or all of the
guidance documents on the lists. FDA
has established a docket where
comments on the FY 2013 lists, draft
language for guidance documents on
those topics, suggestions for new or
different guidances, and relative priority
of guidance documents may be
submitted (see ADDRESSES). FDA
believes this docket is an important tool
for receiving information from
interested parties and for sharing this
information with the public. Similar
information about planned guidance
development is included in the annual
Agency-wide notice issued under its
good guidance practices (21 CFR
10.115(f)(5)). The CDRH lists, however,
will be focused exclusively on devicerelated guidances and will be made
available on FDA’s Web site at the
beginning of each fiscal year from 2013
to 2017. To access the lists of guidance
documents CDRH is intending to
publish in FY 2013, visit FDA’s Web
site https://www.fda.gov/Medical
Devices/DeviceRegulationandGuidance/
Overview/MDUFAIII/ucm321367.htm
II. Request for Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
VerDate Mar<15>2010
16:24 Nov 23, 2012
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Dated: November 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–28539 Filed 11–23–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Risk Communication 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: Risk
Communication 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 12, 2013, from 8 a.m.
to 3 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993.
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: Lee L. Zwanziger,
Risk Communication Staff, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 3278,
Silver Spring, MD 20993, 301–796–
9151, FAX: 301–847–8611, email:
RCAC@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
PO 00000
Frm 00039
Fmt 4703
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to learn about possible modifications
before coming to the meeting.
Agenda: On February 12, 2013, the
Committee will discuss general factors
in risk communication about FDA
regulated products, including
approaches to avoid message fatigue and
related communication barriers such as
prevention or warning fatigue or
inaccurate risk perception.
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 28, 2013.
Oral presentations from the public will
be scheduled between approximately
10:30 a.m. and 11:30 a.m. on February
12, 2013. 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 17, 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
January 18, 2013. Interested persons can
also log on to https://collaboration.fda.
gov/rcac/ to hear and see the
proceedings.
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
disabilities or special needs. If you
require special accommodations due to
E:\FR\FM\26NON1.SGM
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70451
Federal Register / Vol. 77, No. 227 / Monday, November 26, 2012 / Notices
a disability, please contact Lee L.
Zwanziger 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/Advisory
Committees/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 19, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–28462 Filed 11–23–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Methodological Studies for
the Population Assessment of
Tobacco and Health (PATH) Study
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute on Drug Abuse
(NIDA), the National Institutes of Health
(NIH) will publish periodic summaries
of proposed projects to be submitted to
the Office of Management and Budget
(OMB) for review and approval.
Proposed Collection: Title:
Methodological Studies for Population
Assessment of Tobacco and Health
(PATH) Study. Type of Information
Collection Request: New. Need and Use
of Information Collection: The PATH
study will establish a population-based
framework for monitoring and
evaluating the behavioral and health
impacts of regulatory provisions
SUMMARY:
implemented as part of the Family
Smoking Prevention and Tobacco
Control Act (FSPTCA) by the Food and
Drug Administration (FDA). NIDA is
requesting generic approval from OMB
for methodological studies to improve
the PATH study instrumentation and
data collection procedures. These
methodological studies will support
ongoing assessment and refinement of
the PATH study’s design, and highlight
ways to improve study implementation
and techniques for retention and
followup. Data collection methods to be
used in these methodological studies
include: in-person and telephone
surveys; web and smartphone/mobile
phone surveys; and focus group and
individual in-depth qualitative
interviews. Biospecimens may also be
collected from adults.
Frequency of Response: Annual [As
needed on an on-going and concurrent
basis]. Affected Public: Individuals.
Type of Respondents: Youth (ages 12–
17) and Adults (ages 18+). Annual
Reporting Burden: See Table 1. The
annualized cost to respondents is
estimated at: $227,562. There are no
capital, operating or maintenance costs.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY—METHODOLOGICAL STUDIES FOR THE PATH STUDY
Type of
respondent
In-person and telephone surveys ............................................
Adults ........
Youth .........
Adults ........
Youth .........
Adults ........
Youth .........
3,000
2,000
3,000
2,000
800
800
1
1
1
1
1
1
11⁄2
11⁄2
11⁄2
11⁄2
2
2
4,500
3,000
4,500
3,000
1,600
1,600
...................
11,600
........................
........................
18,200
Web and smartphone/mobile phone surveys ..........................
Focus groups and individual in-depth qualitative interviews ...
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Total ..................................................................................
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
VerDate Mar<15>2010
16:24 Nov 23, 2012
Jkt 229001
Number of
respondents
Responses
per
respondent
Data collection activity
collection techniques or other forms of
information technology.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans contact Kevin
P. Conway, Ph.D., Deputy Director,
Division of Epidemiology, Services, and
Prevention Research, National Institute
on Drug Abuse, 6001 Executive Blvd.,
Room 5185; Rockville, MD 20852, or
call non-toll free number 301–443–8755
or email your request, including your
address to: PATHprojectofficer@mail.
nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00040
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Hours per
response
Annual
hour burden
Dated: November 14, 2012.
Glenda J. Conroy,
Executive Officer (OM Director), NIDA.
[FR Doc. 2012–28575 Filed 11–23–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Report of the Evidence-Based
Methodology Workshop on Polycystic
Ovary Syndrome—Request for
Comments
The National Institutes of
Health (NIH) will place in the docket for
public review and comment a report
resulting from the NIH Evidence-Based
Methodology Workshop on Polycystic
Ovary Syndrome, to be held December
SUMMARY:
E:\FR\FM\26NON1.SGM
26NON1
Agencies
[Federal Register Volume 77, Number 227 (Monday, November 26, 2012)]
[Notices]
[Pages 70450-70451]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28462]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Risk Communication 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: Risk Communication 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 12, 2013, from
8 a.m. to 3 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993.
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: Lee L. Zwanziger, Risk Communication Staff, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3278,
Silver Spring, MD 20993, 301-796-9151, FAX: 301-847-8611, email:
RCAC@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 February 12, 2013, the Committee will discuss general
factors in risk communication about FDA regulated products, including
approaches to avoid message fatigue and related communication barriers
such as prevention or warning fatigue or inaccurate risk perception.
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 28, 2013. Oral presentations from the public will be scheduled
between approximately 10:30 a.m. and 11:30 a.m. on February 12, 2013.
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 17, 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 January 18,
2013. Interested persons can also log on to https://collaboration.fda.gov/rcac/ to hear and see the proceedings.
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 disabilities or special needs. If you require special
accommodations due to
[[Page 70451]]
a disability, please contact Lee L. Zwanziger 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 19, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-28462 Filed 11-23-12; 8:45 am]
BILLING CODE 4160-01-P