[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7206-7207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02603]
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DEPARTMENT OF HEALTH AND HUMAN SERVICE
National Institutes of Health
Proposed Information Collection; 60-day Comment Request:
Population Assessment of Tobacco and Health (PATH) Study
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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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), the 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.
DATES: Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received by April 7,
2014.
FOR FURTHER INFORMATION CONTACT: 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.
SUPPLEMENTARY INFORMATION:
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 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 75,124.
Estimated Annualized Burden Hours
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Estimated Average Estimated
Estimated number of burden hours total annual
Type of respondent and instrument number of responses per per response burden hours
respondents respondent (in hours) requested
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Adults--Extended Interview...................... 38,740 1 1 38,740
Adults--Baseline youth respondents who age into 2,717 1 2/60 91
adult cohort--Consent for Extended Interview...
Adults--Baseline youth respondents who age into 2,500 1 68/60 2,833
adult cohort--Extended Interview...............
Adults--Adult respondents who refused 1,452 1 4/60 97
biospecimen collection at Baseline but who
consent for Wave 2--Consent for Biological
Samples........................................
Adults--Baseline youth respondents who age into 2,500 1 4/60 167
the adult cohort--Consent for Biological
Samples........................................
Adults--Biospecimen Collection: Urine........... 12,387 1 10/60 2,065
Adults--Biospecimen Collection: Buccal Cell..... 2,387 1 18/60 716
[[Page 7207]]
Adults--Biospecimen Collection: Blood........... 2,303 1 18/60 691
Adults--Tobacco Use Form........................ 17,077 1 4/60 1,138
Adults--Follow-up/Tracking Participant 41,239 2 8/60 10,997
Information Form...............................
Youth--Extended Interview....................... 12,392 1 32/60 6,609
Youth--Shadow youth who age into youth cohort-- 2,734 1 2/60 91
Assent for Extended Interview..................
Youth--Shadow youth who age into youth cohort-- 2,515 1 42/60 1,761
Extended Interview.............................
Adult--Parent Interview......................... 12,392 1 14/60 2,891
Adults--Parents of Shadow youth who age into 2,734 1 2/60 91
youth cohort--Parent Permission and Consent for
Parent Interview...............................
Adults--Parents of Shadow youth who age into 2,515 1 17/60 713
youth cohort--Parent Interview.................
Adults--Follow-up/Tracking Participant 14,907 2 8/60 3,975
Information Form for Youth (completed by
parents).......................................
Adults--Follow-up/Tracking Participant 5,468 2 8/60 1,458
Information Form for sample Shadow youth
(completed by parents).........................
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Dated: January 31, 2014.
Glenda J. Conroy,
Executive Officer (OM Director), National Institute on Drug Abuse, NIH.
[FR Doc. 2014-02603 Filed 2-5-14; 8:45 am]
BILLING CODE 4140-01-P