[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
                                                 ---------------------------------------------------------------
    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
----------------------------------------------------------------------------------------------------------------
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
                                                 ---------------------------------------------------------------
    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]
BILLING CODE 4140-01-P