[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Notices]
[Pages 48994-48995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20068]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Population Assessment
of Tobacco and Health (PATH) Study
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the
National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request to review and approve the
information collection listed below. This proposed information
collection was previously published in the Federal Register on May 18,
2012, pages 29667-29668 and allowed 60-days for public comment. Two
public comments were received. The purpose of this notice is to allow
an additional 30 days for public comment. The National Institutes of
Health may not conduct or sponsor, and the 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.
Proposed Collection: Title: Population Assessment of Tobacco and
Health (PATH) Study. Type of Information Collection Request: NEW. Need
and Use of Information Collection:
This is a large national longitudinal cohort study on tobacco use
behavior and health in the United States conducted under the direction
of the National Institutes of Health (NIH) National Institute on Drug
Abuse (NIDA) and in partnership with the Food and Drug Administration
(FDA). The field test is scheduled to begin in the fall of 2012 and the
baseline collection is scheduled to begin in the fall of 2013. Using
annual interviews and the collection of biospecimens from adults, the
PATH study is designed to establish a population-based framework for
monitoring and evaluating the behavioral and health impacts of
regulatory provisions by FDA as it meets its mandate under the Family
Smoking Prevention and Tobacco Control Act (FSPTCA) to regulate
tobacco-product advertising, labeling, marketing, constituents,
ingredients, and additives. These regulatory changes are expected to
influence tobacco-product risk perceptions, exposures, and use patterns
in the short term, and to reduce tobacco-related morbidity and
mortality in the long term. By measuring and accurately reporting
tobacco product use behaviors and health effects associated with these
regulatory changes, this study will provide an empirical evidence base
to inform the development,
[[Page 48995]]
implementation, and evaluation of tobacco-product regulations in the
U.S.
Frequency of Response: Annually. Affected Public: Individuals or
households. Type of Respondents: Youth (ages 12-17) and Adults (ages
18+). The annual reporting burden for the field test is presented in
Table 1, and the annual reporting burden for the baseline data
collection is presented in Table 2. The annualized cost to respondents
for the field test is estimated at: $22,993; and the annualized cost to
respondents for the baseline data collection is: $1,792,156. There are
no capital, operating, or maintenance costs.
Table 1--PATH Study Field Test Hour Burden Estimates
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Estimated Estimated
Estimated number of Average burden total annual
Type of respondents number of responses per hours per burden hours
respondents respondent response requested
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Adults--Household Screener...................... 1,295 1 \17/60\ 367
Adults--Individual Screener..................... 840 1 \6/60\ 84
Adults--Extended Interview...................... 590 1 1\9/60\ 679
Adults--Biospecimen Collection Forms............ 590 1 \9/60\ 89
Adults--Tobacco Use Form........................ 590 1 \2/60\ 20
Adults--Followup/Tracking Participant 590 2 \6/60\ 118
Information Form...............................
Youth--Extended Interview....................... 100 1 \35/60\ 58
Adult--Parent Interview......................... 100 1 \19/60\ 32
Adults--Followup/Tracking Participant 100 2 \8/60\ 27
Information Form for Youth (completed by
parents).......................................
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Total....................................... .............. .............. .............. 1,446
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Table 2--PATH Study Baseline Hour Burden Estimates
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Estimated Estimated
Estimated number of Average burden total annual
Type of respondents number of responses per hours per burden hours
respondents respondent response requested
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Adults--Household Screener...................... 100,983 1 \17/60\ 28,612
Adults--Individual Screener..................... 63,000 1 \6/60\ 6,300
Adults--Extended Interview...................... 42,730 1 1\9/60\ 49,140
Adults--Biospecimen Collection Forms............ 42,730 1 \9/60\ 6,410
Adults--Tobacco Use Form........................ 42,730 1 \2/60\ 1,424
Adults--Followup/Tracking Participant 42,730 2 \6/60\ 8,546
Information Form...............................
Youth--Extended Interview....................... 16,857 1 \35/60\ 9,833
Adult--Parent Interview......................... 16,857 1 \19/60\ 5,338
Adults--Followup/Tracking Participant 16,857 2 \8/60\ 4,495
Information Form for Youth (completed by
parents).......................................
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Total....................................... .............. .............. .............. 115,602
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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 collection techniques or other forms
of information technology.
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, [email protected] or by fax to 202-395-6974,
Attention: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, 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; 301-443-8755; email
[email protected].
Comments 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.
Dated: August 7, 2012.
Glenda J. Conroy,
Executive Officer (OM Director) NIDA.
[FR Doc. 2012-20068 Filed 8-14-12; 8:45 am]
BILLING CODE 4140-01-P