[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Pages 43217-43219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15644]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; Population 
Assessment of Tobacco and Health (PATH) Study--Fourth Wave of Data 
Collection

AGENCY: National Institute of Health, HHS.

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health (NIH) has 
submitted to the Office of Management and Budget (OMB) a request for 
review and approval of the information collection listed below. This 
proposed information

[[Page 43218]]

collection was previously published in the Federal Register on April 
15, 2016, pages 22290--22291 and allowed 60-days for public comment. No 
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.
    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, [email protected] or by fax to (202) 395-6974, 
Attention: NIH Desk Officer.
    Comment 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.

FOR FURTHER INFORMATION CONTACT: 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.
    Proposed Collection: Population Assessment of Tobacco and Health 
(PATH) Study--Fourth Wave 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 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 94,798.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                            Average      Total
                                                              Number of      Number of     burden per    annual
            Form name                 Type of respondent     respondents   responses per    response     burden
                                                                            respondent     (in hours)    hours
----------------------------------------------------------------------------------------------------------------
1. Household Screener............  Households..............       48,018               1        14/60     11,204
2. Individual Screener...........  Adults--New adults......        9,152               1         6/60        915
3. Extended Interview............  Adults--New adults and         10,737               1        68/60     12,169
                                    Wave 1 youth
                                    respondents who age up
                                    to adult cohort at Wave
                                    4.
4. Extended Interview............  Adults--Adult                  23,414               1            1     23,414
                                    respondents at previous
                                    wave.
5. Parent Interview..............  Adults--Parents of new          6,561               1        19/60      2,078
                                    youth and parents of
                                    shadow youth who age up
                                    to youth cohort at Wave
                                    4.
6. Parent Interview..............  Adults--Parents of youth        8,800               1        16/60      2,347
                                    respondents at previous
                                    wave.
7. Extended Interview............  Youth--New youth and            6,432               1        45/60      4,824
                                    shadow youth who age up
                                    to youth cohort at Wave
                                    4.
8. Extended Interview............  Youth--Youth respondents        8,627               1        35/60      5,032
                                    at previous wave.
9. Tobacco Use Form..............  Adults..................       23,133               1         5/60      1,928
10. Tobacco Use Form.............  Youth...................       10,239               1         5/60        853
11. Shadow Youth Only Screener...  Households..............       41,207               1         5/60      3,434
12. Verification Interview.......  Adults..................       33,889               1         2/60      1,130
13. Validation Interview.........  Adults..................          301               1         4/60         20
14. Biospecimen Collection: Blood  Adults--New adults and          4,832               1        18/60      1,450
                                    Wave 1 youth
                                    respondents who age up
                                    to adult cohort at Wave
                                    4.
15. Biospecimen Collection: Urine  Adults..................       18,301               1        10/60      3,050
16. Biospecimen Collection: Urine  Youth...................       10,239               1        10/60      1,707
17. Follow-up/Tracking             Adults..................       34,151               2         8/60      9,107
 Participant Information Form.
18. Follow-up/Tracking             Adults--Parents of youth       15,059               2         8/60      4,016
 Participant Information Form for   respondents.
 Youth (completed by parents).

[[Page 43219]]

 
19. Follow-up/Tracking             Adults--Parents of              4,684               2         8/60      1,249
 Participant Information Form for   shadow youth.
 sample shadow youth (completed
 by parents).
20. Consent for Extended           Adults--New adults and         13,984               1         4/60        932
 Interview.                         Wave 1 youth
                                    respondents who age up
                                    to adult cohort at Wave
                                    4.
21. Parent Permission and Consent  Adults--Parents of new          7,657               1         5/60        638
 for Parent Interview.              youth and parents of
                                    Shadow youth who age up
                                    to youth cohort at Wave
                                    4.
22. Assent for Extended Interview  Youth--New youth and            7,657               1         3/60        383
                                    shadow youth who age up
                                    to youth cohort at Wave
                                    4.
23. Consent for Biological         Adults--New adults and         10,737               1         5/60        895
 Samples.                           Wave 1 youth
                                    respondents who age up
                                    to adult cohort at Wave
                                    4.
24. Parent permission for urine    Adults--Parents of youth       15,360               1         3/60        768
 collection.                        respondents at previous
                                    wave.
25. Assent for urine collection..  Youth...................       15,059               1         5/60      1,255
                                                            ----------------------------------------------------
    Total........................  ........................      388,229         442,123  ...........     94,798
----------------------------------------------------------------------------------------------------------------


    Dated: June 27, 2016.
Genevieve deAlmeida,
Project Clearance Liaison, National Institute on Drug Abuse, NIH.
[FR Doc. 2016-15644 Filed 6-30-16; 8:45 am]
 BILLING CODE 4140-01-P