[Federal Register Volume 77, Number 97 (Friday, May 18, 2012)]
[Notices]
[Pages 29667-29668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12017]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 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), 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: 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. It is scheduled to begin in the fall of 2013 under the
direction of the National Institutes of Health
[[Page 29668]]
(NIH) National Institute on Drug Abuse (NIDA), and in partnership with
the Food and Drug Administration (FDA). Using annual interviews and the
collection of bio-specimens from adults, the 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, 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: $24,495; and the annualized cost to
respondents for the baseline data collection is: $1,947,567. There are
no Capital Costs to report. There are no Operating or Maintenance Costs
to report.
Table 1--PATH Study Field Test Hour Burden Estimates
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Estimated Estimated
Estimated number of Average total annual
Type of respondents number of responses per burden hours burden hours
respondents respondent per response requested
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Adults--Household Screener...................... 1,295 1 22/60 479
Adults--Individual Screener..................... 840 1 6/60 84
Adults--Extended Interview...................... 590 1 1 26/60 844
Adults--Tobacco Use Form........................ 590 1 2/60 18
Youth--Extended Interview....................... 100 1 55/60 92
Adult--Parent Interview......................... 100 1 24/60 40
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Total....................................... 3,515 1 .............. 1,557
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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 22/60 37,364
Adults--Individual Screener..................... 63,000 1 6/60 6,300
Adults--Extended Interview...................... 42,730 1 1 26/60 61,104
Adults--Tobacco Use Form........................ 42,730 1 2/60 1,282
Youth--Extended Interview....................... 16,857 1 55/60 15,508
Adult--Parent Interview......................... 16,857 1 24/60 6,743
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Total....................................... 283,157 1 .............. 128,301
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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.
FOR FURTHER INFORMATION CONTACT: 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
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.
Dated: May 11, 2012.
Helio Chaves,
Deputy Executive Officer (OM Director), NIDA.
[FR Doc. 2012-12017 Filed 5-17-12; 8:45 am]
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