[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7206-7207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICE

National Institutes of Health


Proposed Information Collection; 60-day Comment Request: 
Population Assessment of Tobacco and Health (PATH) Study

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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.
    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.

DATES: Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received by April 7, 
2014.

FOR FURTHER INFORMATION CONTACT: 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: [email protected]. Formal requests for 
additional plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: 
    Proposed Collection: Population Assessment of Tobacco and Health 
(PATH) Study--Second 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, expires 11/30/2015) for the Population Assessment of 
Tobacco and Health (PATH) Study to conduct the second 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 75,124.

                                        Estimated Annualized Burden Hours
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                                                                     Estimated        Average        Estimated
                                                     Estimated       number of     burden hours    total annual
        Type of respondent and instrument            number of     responses per   per response    burden hours
                                                    respondents     respondent      (in hours)       requested
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Adults--Extended Interview......................          38,740               1               1          38,740
Adults--Baseline youth respondents who age into            2,717               1            2/60              91
 adult cohort--Consent for Extended Interview...
Adults--Baseline youth respondents who age into            2,500               1           68/60           2,833
 adult cohort--Extended Interview...............
Adults--Adult respondents who refused                      1,452               1            4/60              97
 biospecimen collection at Baseline but who
 consent for Wave 2--Consent for Biological
 Samples........................................
Adults--Baseline youth respondents who age into            2,500               1            4/60             167
 the adult cohort--Consent for Biological
 Samples........................................
Adults--Biospecimen Collection: Urine...........          12,387               1           10/60           2,065
Adults--Biospecimen Collection: Buccal Cell.....           2,387               1           18/60             716

[[Page 7207]]

 
Adults--Biospecimen Collection: Blood...........           2,303               1           18/60             691
Adults--Tobacco Use Form........................          17,077               1            4/60           1,138
Adults--Follow-up/Tracking Participant                    41,239               2            8/60          10,997
 Information Form...............................
Youth--Extended Interview.......................          12,392               1           32/60           6,609
Youth--Shadow youth who age into youth cohort--            2,734               1            2/60              91
 Assent for Extended Interview..................
Youth--Shadow youth who age into youth cohort--            2,515               1           42/60           1,761
 Extended Interview.............................
Adult--Parent Interview.........................          12,392               1           14/60           2,891
Adults--Parents of Shadow youth who age into               2,734               1            2/60              91
 youth cohort--Parent Permission and Consent for
 Parent Interview...............................
Adults--Parents of Shadow youth who age into               2,515               1           17/60             713
 youth cohort--Parent Interview.................
Adults--Follow-up/Tracking Participant                    14,907               2            8/60           3,975
 Information Form for Youth (completed by
 parents).......................................
Adults--Follow-up/Tracking Participant                     5,468               2            8/60           1,458
 Information Form for sample Shadow youth
 (completed by parents).........................
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    Dated: January 31, 2014.
Glenda J. Conroy,
Executive Officer (OM Director), National Institute on Drug Abuse, NIH.
[FR Doc. 2014-02603 Filed 2-5-14; 8:45 am]
BILLING CODE 4140-01-P