Tobacco Products Scientific Advisory Committee; Notice of Meeting, 52051-52052 [2017-24379]
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52051
Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name
Health Department Workers (Control Restaurants) Visit 3.
Restaurant Environment Observation Form ..
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2017–24416 Filed 11–8–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Prenatal Alcohol and Other
Drug Exposures in Child Welfare
(PAODE–CW) Study.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS) is proposing a data
collection activity as part of the Prenatal
Alcohol and Other Drug Exposures in
Child Welfare (PAODE–CW) Study. The
study examines the current state of
child welfare practice regarding the
identification and provision of services
for children with prenatal substance
exposures, including alcohol and other
drugs.
The descriptive study will document
the policies and practices of child
welfare agencies and related
organizations to identify, assess, and
refer to services children who may have
been exposed to prenatal substances
and/or diagnosed with a resulting
condition such as fetal alcohol spectrum
Average
burden per
response
(in hours)
Number of
responses per
respondent
Number of
respondents
Type of respondents
54
1
30/60
disorders (FASD). The study will
document procedures as well as
challenges faced and lessons learned to
inform the field of practice as well as
policy makers, program administrators,
and funders at various levels.
The proposed information collection
activities consist of semi-structured
interviews and surveys conducted at 28
child welfare agency sites. Focus groups
conducted at 8 of the 28 sites will gather
information on needs, challenges, and
strategies to support children with
prenatal substance exposures and their
families within the child welfare
system.
Respondents: State and child welfare
agency directors, child welfare staff and
supervisors; agency partners and service
providers; and family members and
caregivers of children who have been
prenatally exposed to substances.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
sradovich on DSK3GMQ082PROD with NOTICES
Local Agency Staff Interview Protocol—Frontline Only ...................................
Local Agency Staff Interview Protocol—Ongoing Only ...................................
Local Agency Staff Interview Protocol—Frontline and Ongoing .....................
Local Agency Medical Staff Interview Protocol ...............................................
Local Agency Director Interview Protocol ........................................................
Focus Group of Caregivers .............................................................................
Local Agency Staff Survey ..............................................................................
Service Provider Survey ..................................................................................
Local Agency Data Staff Interview Protocol ....................................................
Estimated Total Annual Burden
Hours: 255.11.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35)
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington, DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
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27.5
27.5
15
14
14
32
280
12
6
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
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Number of
responses per
respondent
Average
burden hours
per response
1
1
1
1
1
1
1
1
1
Total burden
hours
1
1
1.25
1
1
1.5
.33
.33
1.5
27.5
27.5
18.75
14
14
48
92.4
3.96
9
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017–24420 Filed 11–8–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5994]
Tobacco Products Scientific Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\09NON1.SGM
09NON1
52052
ACTION:
Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Tobacco Products
Scientific Advisory Committee. The
general function of the committee is to
provide advice and recommendations to
the Agency on FDA’s regulatory issues.
The meeting will be open to the public.
DATES: The meeting will be held on
January 24, 2018, from 8:30 a.m. to 5
p.m. and January 25, 2018, from 8 a.m.
to 3 p.m.
ADDRESSES: FDA White Oak Conference
Center, Building 31, the Great Room
(Rm. 1503), 10903 New Hampshire
Ave., 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/AboutAdvisory
Committees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Caryn Cohen, Office of Science, Center
for Tobacco Products, Food and Drug
Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 1–877–287–1373, email:
TPSAC@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.
SUPPLEMENTARY INFORMATION:
Agenda: On January 24 and 25, 2018,
the committee will discuss modified
risk tobacco product applications,
submitted by Philip Morris Products
S.A. for IQOS system with Marlboro
Heatsticks, IQOS system with Marlboro
Smooth Menthol Heatsticks, and IQOS
system with Marlboro Fresh Menthol
Heatsticks.
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
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SUMMARY:
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17:32 Nov 08, 2017
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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 4, 2018.
Oral presentations from the public will
be scheduled between approximately 8
a.m. and 9 a.m. on January 25, 2018.
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 December 27, 2017. 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
December 28, 2017.
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 Caryn Cohen
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: October 31, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017–24379 Filed 11–8–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–2300]
Evaluating Drug Effects on the Ability
To Operate a Motor Vehicle; Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Evaluating Drug Effects on the Ability
to Operate a Motor Vehicle.’’ The
purpose of this guidance is to assist
sponsors in the evaluation of the effects
of psychoactive drugs on the ability to
operate a motor vehicle. Driving is a
complex activity involving a wide range
of cognitive, perceptual, and motor
activities. Reducing the incidence of
motor vehicle accidents (MVAs) that
occur because of drug-impaired driving
is a public health priority. This
guidance finalizes the draft guidance
issued on January 16, 2015, of the same
name.
DATES: The announcement of the
guidance is published in the Federal
Register on November 9, 2017.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
E:\FR\FM\09NON1.SGM
09NON1
Agencies
[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Notices]
[Pages 52051-52052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24379]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5994]
Tobacco Products Scientific Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
[[Page 52052]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Tobacco Products Scientific
Advisory Committee. The general function of the committee is to provide
advice and recommendations to the Agency on FDA's regulatory issues.
The meeting will be open to the public.
DATES: The meeting will be held on January 24, 2018, from 8:30 a.m. to
5 p.m. and January 25, 2018, from 8 a.m. to 3 p.m.
ADDRESSES: FDA White Oak Conference Center, Building 31, the Great Room
(Rm. 1503), 10903 New Hampshire Ave., 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.
FOR FURTHER INFORMATION CONTACT: Caryn Cohen, Office of Science, Center
for Tobacco Products, Food and Drug Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD
20993-0002, 1-877-287-1373, email: TPSAC@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.
SUPPLEMENTARY INFORMATION:
Agenda: On January 24 and 25, 2018, the committee will discuss
modified risk tobacco product applications, submitted by Philip Morris
Products S.A. for IQOS system with Marlboro Heatsticks, IQOS system
with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro
Fresh Menthol Heatsticks.
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 4, 2018. Oral presentations from the public will be scheduled
between approximately 8 a.m. and 9 a.m. on January 25, 2018. 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
December 27, 2017. 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 December 28,
2017.
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 Caryn Cohen 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: October 31, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-24379 Filed 11-8-17; 8:45 am]
BILLING CODE 4164-01-P