[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).........................
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* 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