[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7619-7620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02832]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day 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), 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.
    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: 
<a href="/cdn-cgi/l/email-protection#0d5d4c59457d7f6267686e79626b6b646e687f4d606c646123636465236a627b"><span class="__cf_email__" data-cfemail="267667726e5654494c4345524940404f454354664b474f4a08484f4e08414950">[email protected]</span></a>. Formal requests for additional plans 
and instruments must be requested in writing.
    Comment 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.
    Proposed Collection: Population Assessment of Tobacco and Health 
(PATH) Study--Third 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, Exp. Date 9/30/2016) for the Population Assessment of 
Tobacco and Health (PATH) Study to conduct the third 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 53,459.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                Number of      Average burden
    Type of respondent and instrument         Number of       responses per     per response      Total annual
                                             respondents       respondent        (in hours)       burden hours
----------------------------------------------------------------------------------------------------------------
Adults--Adult respondents at Wave 1 or              25,692                 1                 1            25,692
 Wave 2--Extended Interview.............
Adults--Wave 1 youth respondents who age             2,317                 1              4/60               154
 up to adult cohort at Wave 3--Consent
 for Extended Interview.................
Adults--Wave 1 youth respondents who age             1,738                 1             68/60             1,970
 up to adult cohort at Wave 3--Extended
 Interview..............................
Adults--Wave 1 youth respondents who age             1,738                 1              5/60               145
 up to adult cohort at Wave 3--Consent
 for Biological Samples.................
Adults--Biospecimen Collection: Urine...            13,703                 1             10/60             2,284

[[Page 7620]]

 
Adults--Biospecimen Collection: Blood...               869                 1             18/60               261
Adults--Tobacco Use Form................            14,572                 1              4/60               971
Adults--Follow-up/Tracking Participant              27,430                 2              8/60             7,315
 Information Form.......................
Youth--Youth respondents at Wave 1 or                9,515                 1             32/60             5,075
 Wave 2--Extended Interview.............
Youth--Shadow youth who age up to youth              2,420                 1              3/60               121
 cohort at Wave 3--Assent for Extended
 Interview..............................
Youth--Shadow youth who age up to youth              1,912                 1             42/60             1,338
 cohort at Wave 3--Extended Interview...
Adult--Youth respondents at Wave 1 or                9,705                 1             14/60             2,265
 Wave 2--Parent Interview...............
Adults--Parents of Shadow youth who age              2,420                 1              5/60               202
 up to youth cohort at Wave 3--Parent
 Permission and Consent for Parent
 Interview..............................
Adults--Parents of Shadow youth who age              1,950                 1             17/60               553
 up to youth cohort at Wave 3--Parent
 Interview..............................
Adults--Verification Interview..........            35,564                 1              2/60             1,185
Adults--Validation Interview............             3,613                 1              4/60               241
Adults--Follow-up/Tracking Participant              11,427                 2              8/60             3,047
 Information Form for Youth (completed
 by parents)............................
Adults--Follow-up/Tracking Participant               2,401                 2              8/60               640
 Information Form for sample Shadow
 youth (completed by parents)...........
----------------------------------------------------------------------------------------------------------------


    Dated: February 5, 2015.
Genevieve deAlmeida-Morris,
Project Clearance Liaison, National Institute on Drug Abuse, NIH.
[FR Doc. 2015-02832 Filed 2-10-15; 8:45 am]
BILLING CODE 4140-01-P


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