[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22290-22291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08658]


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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--Wave 4 of Data 
Collection (NIDA)

    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) 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.
    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.
    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--Wave 4 of Data Collection (NIDA)--0925-0664, expiration 
date 8/31/2018--REVISION--NIDA, NIH, in partnership with the Food and 
Drug Administration (FDA).
    Need and Use of Information Collection: This is a revision request 
(OMB number 0925-0664, expiration date 8/31/2018) for the Population 
Assessment of Tobacco and Health (PATH) Study to conduct the fourth 
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. On an annual basis, the PATH Study conducts interviews with and 
collects biospecimens from adults and youth 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

[[Page 22291]]

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 costs to 
respondents other than their time. The total estimated annualized 
burden hours are 105,079.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total annual
                   Form name                                Type of respondent              respondents    responses per   response (in    burden hours
                                                                                                            respondent        hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Household Screener..........................  Households.............................          86,559               1           14/60          20,197
2. Shadow Youth Only Screener..................  Households.............................          56,659               1            5/60           4,722
3. Extended Interview *........................  Adults--Adult respondents--previous              23,414               1               1          23,414
                                                  wave.
4. Consent for Extended Interview..............  Adults--New adults and Wave 1 youth              13,984               1            4/60             932
                                                  respondents who age up to adult
                                                  cohort--Wave 4.
5. Individual Screener.........................  Adults--New adults.....................           9,152               1            6/60             915
6. Extended Interview *........................  Adults--New adults and Wave 1 youth              10,737               1           68/60          12,169
                                                  respondents who age up to adult
                                                  cohort--Wave 4.
7. Consent for Biological Samples..............  Adults--New adults and Wave 1 youth              10,737               1            5/60             895
                                                  respondents who age up to adult
                                                  cohort--Wave 4.
8. Biospecimen Collection: Urine...............  Adults.................................          18,301               1           10/60           3,050
9. Biospecimen Collection: Blood...............  Adults--New adults and Wave 1 youth               4,832               1           18/60           1,450
                                                  respondents who age up to adult
                                                  cohort--Wave 4.
10. Tobacco Use Form...........................  Adults.................................          23,133               1            5/60           1,928
11. Follow-up/Tracking Participant Information   Adults.................................          34,151               2            8/60           9,107
 Form.
12. Verification Interview.....................  Adults.................................          33,889               1            2/60           1,130
13. Validation Interview.......................  Adults.................................             301               1            4/60              20
14. Extended Interview **......................  Youth--Youth respondents--previous wave           8,627               1           35/60           5,032
15. Assent for Extended Interview..............  Youth--New youth and shadow youth who             7,657               1            3/60             383
                                                  age up to youth cohort--Wave 4.
16. Extended Interview **......................  Youth--New youth and shadow youth who             6,432               1           45/60           4,824
                                                  age up to youth cohort--Wave 4.
17. Assent for urine collection................  Youth..................................          15,059               1            5/60           1,255
18. Biospecimen Collection: Urine..............  Youth..................................          10,239               1           10/60           1,707
19. Tobacco Use Form...........................  Youth..................................          10,239               1            5/60             853
20. Parent Interview...........................  Adults--Parents of youth respondents--            8,800               1           16/60           2,347
                                                  previous wave.
21. Parent Permission and Consent for Parent     Adults--Parents of new youth and                  7,657               1            5/60             638
 Interview.                                       parents of Shadow youth who age up to
                                                  youth cohort--Wave 4.
22. Parent Interview...........................  Adults--Parents of new youth and                  6,561               1           19/60           2,078
                                                  parents of shadow youth who age up to
                                                  youth cohort--Wave 4.
23. Parent permission for urine collection.....  Adults--Parents of youth respondents--           15,360               1            3/60             768
                                                  previous wave.
24. Follow-up/Tracking Participant Information   Adults--Parents of youth respondents...          15,059               2            8/60           4,016
 Form for Youth (completed by parents).
25. Follow-up/Tracking Participant Information   Adults--Parents of shadow youth........           4,684               2            8/60           1,249
 Form for sample shadow youth (completed by
 parents).
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................          49,210         496,116  ..............         105,079
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: April 5, 2016.
Genevieve deAlmeida-Morris,
Project Clearance Liaison, National Institute on Drug Abuse, NIH.
[FR Doc. 2016-08658 Filed 4-14-16; 8:45 am]
 BILLING CODE 4140-01-P