[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Notices]
[Pages 37754-37755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15584]


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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

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 for review and approval of the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on February 
6, 2014, pages 7206-7207, and allowed 60-days for public comment. One 
public comment was 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,

[[Page 37755]]

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--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 enables it 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.
    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 56,939. Factors accounting for the difference between 
the baseline and Wave 2 total hours include the following: (1) Wave 2 
does not have a screening phase; (2) as indicated in Supporting 
Statement B, a 86 percent response rate for adult interviews and a 90 
percent response rate for youth interviews are projected for Wave 2; 
and (3) fewer biological samples will be collected in Wave 2.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated                       Estimated
                                                     Estimated       number of    Average burden   total annual
        Type of respondent and instrument            number of     responses per     hours per     burden hours
                                                    respondents     respondent       response        requested
----------------------------------------------------------------------------------------------------------------
Adults--Extended Interview......................        * 27,113               1               1          27,113
Adults--Baseline youth respondents who age into            2,295               1            2/60              77
 adult cohort--Consent for Extended Interview...
Adults--Baseline youth respondents who age into          * 1,990               1           68/60           2,255
 adult cohort--Extended Interview...............
Adults--Baseline youth respondents who age into            1,990               1            4/60             133
 the adult cohort--Consent for Biological
 Samples........................................
Adults--Biospecimen Collection: Urine...........          11,373               1           10/60           1,896
Adults--Biospecimen Collection: Blood...........             896               1           18/60             269
Adults--Tobacco Use Form........................          12,269               1            4/60             818
Adults--Follow-up/Tracking Participant                    33,615               2            8/60           8,964
 Information Form...............................
Youth--Extended Interview.......................       ** 10,537               1           32/60           5,620
Youth--Shadow youth who age into youth cohort--            2,338               1            2/60              78
 Assent for Extended Interview..................
Youth--Shadow youth who age into youth cohort--         ** 2,105               1           42/60           1,474
 Extended Interview.............................
Parent Interview................................          10,748               1           14/60           2,508
Parents of Shadow youth who age into youth                 2,338               1            2/60              78
 cohort--Parent Permission and Consent for
 Parent Interview...............................
Parents of Shadow youth who age into youth                 2,147               1           17/60             608
 cohort--Parent Interview.......................
Parents of youth--Follow-up/Tracking Participant          14,165               2            8/60           3,777
 Information Form for Youth.....................
Adults--Follow-up/Tracking Participant                     4,772               2            8/60          1,273
 Information Form for sample Shadow youth
 (completed by parents).........................
----------------------------------------------------------------------------------------------------------------
* Estimated total number of adult extended interview respondents is 27,113 adults from Wave 1 + 1,990 youth from
  Wave 1 who turn 18 by Wave 2 = 29,103.
**Estimated total number of youth extended interview respondents is 10,537 youth from Wave 1+ 2,105 shadow youth
  who turn 12 by Wave 2 = 12,642.


    Dated: June 25, 2014.
Genevieve R. deAlmeida,
Project Clearance Liaison, National Institute on Drug Abuse.
[FR Doc. 2014-15584 Filed 7-1-14; 8:45 am]
BILLING CODE 4140-01-P