Proposed Collection; 60-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study, 7619-7620 [2015-02832]
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Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices
Recognized Standards, Recognition List
Number: 039’’ will be available https://
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RegulationandGuidance/Standards/
ucm123792.htm.
You may access ‘‘Guidance on the
Recognition and Use of Consensus
Standards,’’ and the searchable database
for ‘‘FDA Recognized Consensus
Standards’’ at https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/Standards.
VI. Submission of Comments and
Effective Date
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
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heading of this document. Received
comments may be seen in the Division
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and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
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modifications to the list of recognized
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039. These modifications to the list of
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publication of this notice in the Federal
Register.
Dated: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–02801 Filed 2–10–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Population Assessment of
Tobacco and Health (PATH) Study
In compliance with the
requirement of Section 3506(c)(2)(A) of
SUMMARY:
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute on Drug Abuse
(NIDA), 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.
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)
The quality, utility, and clarity of the
information to be collected; and (4) The
approaches used 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 collection techniques or
other forms of information technology.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing or request
more information on the proposed
project, contact: Kevin P. Conway,
Ph.D., Deputy Director, Division of
Epidemiology, Services, and Prevention
Research, National Institute on Drug
Abuse, 6001 Executive Boulevard, Room
5185; or call non-toll-free number (301)–
443–8755; or Email your request,
including your address to:
PATHprojectofficer@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Comment 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.
Proposed Collection: Population
Assessment of Tobacco and Health
(PATH) Study—Third Wave of Data
Collection—0925–0664–REVISION—
National Institutes of Health (NIH),
National Institute on Drug Abuse
(NIDA), in partnership with the Food
and Drug Administration (FDA).
Need and Use of Information
Collection: This is a revision request
(OMB 0925–0664, Exp. Date 9/30/2016)
for the Population Assessment of
Tobacco and Health (PATH) Study to
conduct the third wave of data
collection. The PATH Study is a large
national longitudinal cohort study on
tobacco use behavior and health among
the U.S. household population of adults
age 18 and older and youth ages 12 to
17. The PATH Study conducts annual
interviews and collects biospecimens
from adults to help inform the
development, implementation, and
evaluation of tobacco-product
regulations by FDA in meeting its
mission under the Family Smoking
Prevention and Tobacco Control Act
(TCA) to regulate tobacco products,
including tobacco-product advertising,
labeling, marketing, constituents,
ingredients, and additives. The
longitudinal design of the PATH Study
provides it with the capacity to measure
and report within-person changes and
between-person differences in tobacco
product use behaviors and health effects
within the cohort over time. These data
will help to inform regulatory decisions
and actions by FDA and FDA’s
evaluations of associations between its
regulations and tobacco use behaviors
and health indicators in the population.
OMB approval is requested for 3
years. There are no capital, operating, or
maintenance costs to report. There are
no costs to respondents other than their
time. The total estimated annualized
burden hours are 53,459.
ESTIMATED ANNUALIZED BURDEN HOURS
tkelley on DSK3SPTVN1PROD with NOTICES
Adults—Adult respondents at Wave 1 or Wave 2—Extended
Interview .......................................................................................
Adults—Wave 1 youth respondents who age up to adult cohort at
Wave 3—Consent for Extended Interview ...................................
Adults—Wave 1 youth respondents who age up to adult cohort at
Wave 3—Extended Interview .......................................................
Adults—Wave 1 youth respondents who age up to adult cohort at
Wave 3—Consent for Biological Samples ...................................
Adults—Biospecimen Collection: Urine ...........................................
VerDate Sep<11>2014
17:07 Feb 10, 2015
Jkt 235001
PO 00000
Number of
responses per
respondent
Number of
respondents
Type of respondent and instrument
Frm 00056
Fmt 4703
Average burden
per response
(in hours)
Total annual
burden hours
25,692
1
1
25,692
2,317
1
4/60
154
1,738
1
68/60
1,970
1,738
13,703
1
1
5/60
10/60
145
2,284
Sfmt 4703
E:\FR\FM\11FEN1.SGM
11FEN1
7620
Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Adults—Biospecimen Collection: Blood ..........................................
Adults—Tobacco Use Form ............................................................
Adults—Follow-up/Tracking Participant Information Form ..............
Youth—Youth respondents at Wave 1 or Wave 2—Extended
Interview .......................................................................................
Youth—Shadow youth who age up to youth cohort at Wave 3—
Assent for Extended Interview .....................................................
Youth—Shadow youth who age up to youth cohort at Wave 3—
Extended Interview .......................................................................
Adult—Youth respondents at Wave 1 or Wave 2—Parent Interview ..............................................................................................
Adults—Parents of Shadow youth who age up to youth cohort at
Wave 3—Parent Permission and Consent for Parent Interview
Adults—Parents of Shadow youth who age up to youth cohort at
Wave 3—Parent Interview ...........................................................
Adults—Verification Interview ..........................................................
Adults—Validation Interview ............................................................
Adults—Follow-up/Tracking Participant Information Form for
Youth (completed by parents) ......................................................
Adults—Follow-up/Tracking Participant Information Form for sample Shadow youth (completed by parents) ..................................
Dated: February 5, 2015.
Genevieve deAlmeida-Morris,
Project Clearance Liaison, National Institute
on Drug Abuse, NIH.
[FR Doc. 2015–02832 Filed 2–10–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
tkelley on DSK3SPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; NIAMS
Clinical Study Applications.
Date: March 20, 2015.
Time: 8:00 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications
VerDate Sep<11>2014
17:07 Feb 10, 2015
Jkt 235001
Number of
responses per
respondent
Number of
respondents
Type of respondent and instrument
1
1
2
18/60
4/60
8/60
261
971
7,315
9,515
1
32/60
5,075
2,420
1
3/60
121
1,912
1
42/60
1,338
9,705
1
14/60
2,265
2,420
1
5/60
202
1,950
35,564
3,613
1
1
1
17/60
2/60
4/60
553
1,185
241
11,427
2
8/60
3,047
2,401
2
8/60
640
Dated: February 5, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–02758 Filed 2–10–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Amended Notice
of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Neurological Disorders and Stroke
Special Emphasis Panel, March 16,
2015, 08:00 a.m. to March 17, 2015,
06:00 p.m., Bethesda North Marriott
Hotel & Conference Center, Montgomery
County Conference Center Facility, 5701
Marinelli Road, North Bethesda, MD
20852 which was published in the
Federal Register on January 23, 2015,
80FRN3613.
Frm 00057
Fmt 4703
Total annual
burden hours
869
14,572
27,430
Place: National Institutes of Health, One
Democracy Plaza, Suite 800, 6701 Democracy
Boulevard, Bethesda, MD 20892.
Contact Person: Kan Ma, Ph.D., Scientific
Review Officer, Scientific Review Branch
National Institute of Arthritis,
Musculoskeletal and Skin Diseases, NIH,
6701 Democracy Boulevard, Suite 814,
Bethesda, MD 20892, 301–451–4838 mak2@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
PO 00000
Average burden
per response
(in hours)
Sfmt 4703
The meeting has been changed to a
teleconference meeting. The date and
time remain the same. The meeting is
closed to the public.
Dated: February 5, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–02757 Filed 2–10–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Microbiology,
Infectious Diseases and AIDS Initial Review
Group; Microbiology and Infectious Diseases
B Subcommittee.
E:\FR\FM\11FEN1.SGM
11FEN1
]]>Agencies
[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7619-7620]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02832]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Population
Assessment of Tobacco and Health (PATH) Study
SUMMARY: 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), 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.
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) The quality, utility, and clarity of the information to be
collected; and (4) The approaches used 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 collection techniques or other forms of information
technology.
To Submit Comments and for Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing
or request more information on the proposed project, contact: Kevin P.
Conway, Ph.D., Deputy Director, Division of Epidemiology, Services, and
Prevention Research, National Institute on Drug Abuse, 6001 Executive
Boulevard, Room 5185; or call non-toll-free number (301)-443-8755; or
Email your request, including your address to:
PATHprojectofficer@mail.nih.gov. Formal requests for additional plans
and instruments must be requested in writing.
Comment 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.
Proposed Collection: Population Assessment of Tobacco and Health
(PATH) Study--Third Wave of Data Collection--0925-0664-REVISION--
National Institutes of Health (NIH), National Institute on Drug Abuse
(NIDA), in partnership with the Food and Drug Administration (FDA).
Need and Use of Information Collection: This is a revision request
(OMB 0925-0664, Exp. Date 9/30/2016) for the Population Assessment of
Tobacco and Health (PATH) Study to conduct the third wave of data
collection. The PATH Study is a large national longitudinal cohort
study on tobacco use behavior and health among the U.S. household
population of adults age 18 and older and youth ages 12 to 17. The PATH
Study conducts annual interviews and collects biospecimens from adults
to help inform the development, implementation, and evaluation of
tobacco-product regulations by FDA in meeting its mission under the
Family Smoking Prevention and Tobacco Control Act (TCA) to regulate
tobacco products, including tobacco-product advertising, labeling,
marketing, constituents, ingredients, and additives. The longitudinal
design of the PATH Study provides it with the capacity to measure and
report within-person changes and between-person differences in tobacco
product use behaviors and health effects within the cohort over time.
These data will help to inform regulatory decisions and actions by FDA
and FDA's evaluations of associations between its regulations and
tobacco use behaviors and health indicators in the population.
OMB approval is requested for 3 years. There are no capital,
operating, or maintenance costs to report. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 53,459.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent and instrument Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Adults--Adult respondents at Wave 1 or 25,692 1 1 25,692
Wave 2--Extended Interview.............
Adults--Wave 1 youth respondents who age 2,317 1 4/60 154
up to adult cohort at Wave 3--Consent
for Extended Interview.................
Adults--Wave 1 youth respondents who age 1,738 1 68/60 1,970
up to adult cohort at Wave 3--Extended
Interview..............................
Adults--Wave 1 youth respondents who age 1,738 1 5/60 145
up to adult cohort at Wave 3--Consent
for Biological Samples.................
Adults--Biospecimen Collection: Urine... 13,703 1 10/60 2,284
[[Page 7620]]
Adults--Biospecimen Collection: Blood... 869 1 18/60 261
Adults--Tobacco Use Form................ 14,572 1 4/60 971
Adults--Follow-up/Tracking Participant 27,430 2 8/60 7,315
Information Form.......................
Youth--Youth respondents at Wave 1 or 9,515 1 32/60 5,075
Wave 2--Extended Interview.............
Youth--Shadow youth who age up to youth 2,420 1 3/60 121
cohort at Wave 3--Assent for Extended
Interview..............................
Youth--Shadow youth who age up to youth 1,912 1 42/60 1,338
cohort at Wave 3--Extended Interview...
Adult--Youth respondents at Wave 1 or 9,705 1 14/60 2,265
Wave 2--Parent Interview...............
Adults--Parents of Shadow youth who age 2,420 1 5/60 202
up to youth cohort at Wave 3--Parent
Permission and Consent for Parent
Interview..............................
Adults--Parents of Shadow youth who age 1,950 1 17/60 553
up to youth cohort at Wave 3--Parent
Interview..............................
Adults--Verification Interview.......... 35,564 1 2/60 1,185
Adults--Validation Interview............ 3,613 1 4/60 241
Adults--Follow-up/Tracking Participant 11,427 2 8/60 3,047
Information Form for Youth (completed
by parents)............................
Adults--Follow-up/Tracking Participant 2,401 2 8/60 640
Information Form for sample Shadow
youth (completed by parents)...........
----------------------------------------------------------------------------------------------------------------
Dated: February 5, 2015.
Genevieve deAlmeida-Morris,
Project Clearance Liaison, National Institute on Drug Abuse, NIH.
[FR Doc. 2015-02832 Filed 2-10-15; 8:45 am]
BILLING CODE 4140-01-P
