[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Notices]
[Pages 48994-48995]
From the Federal Register Online via the Government Printing 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
----------------------------------------------------------------------------------------------------------------
                                                                     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......................           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).......................................
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............           1,446
----------------------------------------------------------------------------------------------------------------


                               Table 2--PATH Study Baseline Hour Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     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         \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).......................................
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............         115,602
----------------------------------------------------------------------------------------------------------------

    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, OIRA_submission@omb.eop.gov 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 
PATHprojectofficer@mail.nih.gov.
    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