[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7619-7620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02832]
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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
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) 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.
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--Third 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, Exp. Date 9/30/2016) for the Population Assessment of
Tobacco and Health (PATH) Study to conduct the third 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 53,459.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent and instrument Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Adults--Adult respondents at Wave 1 or 25,692 1 1 25,692
Wave 2--Extended Interview.............
Adults--Wave 1 youth respondents who age 2,317 1 4/60 154
up to adult cohort at Wave 3--Consent
for Extended Interview.................
Adults--Wave 1 youth respondents who age 1,738 1 68/60 1,970
up to adult cohort at Wave 3--Extended
Interview..............................
Adults--Wave 1 youth respondents who age 1,738 1 5/60 145
up to adult cohort at Wave 3--Consent
for Biological Samples.................
Adults--Biospecimen Collection: Urine... 13,703 1 10/60 2,284
[[Page 7620]]
Adults--Biospecimen Collection: Blood... 869 1 18/60 261
Adults--Tobacco Use Form................ 14,572 1 4/60 971
Adults--Follow-up/Tracking Participant 27,430 2 8/60 7,315
Information Form.......................
Youth--Youth respondents at Wave 1 or 9,515 1 32/60 5,075
Wave 2--Extended Interview.............
Youth--Shadow youth who age up to youth 2,420 1 3/60 121
cohort at Wave 3--Assent for Extended
Interview..............................
Youth--Shadow youth who age up to youth 1,912 1 42/60 1,338
cohort at Wave 3--Extended Interview...
Adult--Youth respondents at Wave 1 or 9,705 1 14/60 2,265
Wave 2--Parent Interview...............
Adults--Parents of Shadow youth who age 2,420 1 5/60 202
up to youth cohort at Wave 3--Parent
Permission and Consent for Parent
Interview..............................
Adults--Parents of Shadow youth who age 1,950 1 17/60 553
up to youth cohort at Wave 3--Parent
Interview..............................
Adults--Verification Interview.......... 35,564 1 2/60 1,185
Adults--Validation Interview............ 3,613 1 4/60 241
Adults--Follow-up/Tracking Participant 11,427 2 8/60 3,047
Information Form for Youth (completed
by parents)............................
Adults--Follow-up/Tracking Participant 2,401 2 8/60 640
Information Form for sample Shadow
youth (completed by parents)...........
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Dated: February 5, 2015.
Genevieve deAlmeida-Morris,
Project Clearance Liaison, National Institute on Drug Abuse, NIH.
[FR Doc. 2015-02832 Filed 2-10-15; 8:45 am]
BILLING CODE 4140-01-P