Proposed Collection; 60-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study-Wave 4 of Data Collection (NIDA), 22290-22291 [2016-08658]

Download as PDF 22290 Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices released from urgent medical care. Family and friends are also a valuable source of medical information that may be important to the care of injured victims (e.g., by providing family or personal medical history, information about allergies). The National Library of Medicine (NLM) aims to assist Federal, State and Local agencies in disaster relief efforts and to serve its mission of supporting national efforts to the response to disasters via the PEOPLE LOCATOR® system and related mobile app (ReUniteTM) developed as part of the intramural Lost Person Finder (LPF) R&D project. The information collection would support efforts to reunite family and friends who are separated during a emergencies, training and demonstration support activities, and would operate in declared emergencies until relief efforts have ceased in response to a particular disaster. This data collection is authorized pursuant to sections 301, 307, 465 and 478A of the Public Health Service Act [42 U.S.C. 241, 242l, 286 and 286d]. NLM has in its mission the development and coordination of communication technology to improve the delivery of health services. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 7,500. disaster. Information about missing (‘‘lost’’) people would be collected from family members or loved ones who are searching for them. Information about recovered (‘‘found’’) people could be provided by medical personnel, volunteers and other relief workers assisting in the disaster recovery effort. Information collected about missing and recovered persons would vary including any one of the following and possibly all: A photograph, name (if available for a found person), age group (child, adult) and/or range, gender, status (alive and well, injured, deceased, unknown), and location. The information collection would be voluntary. It would be activated only during times of declared ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Types of respondent Number of responses per respondent Average time per response (in hours) Total annual burden hours Emergency Care First-Responders, Physicians, Other Health Care Providers ............................................................................................................ Family members seeking a missing person .................................................... 500 50,000 100 2 3/60 3/60 2,500 5,000 Total .......................................................................................................... 50,500 150,000 ........................ 7,500 Dated: April 7, 2016. David Sharlip, Project Clearance Liaison, NLM, NIH. [FR Doc. 2016–08659 Filed 4–14–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health asabaliauskas on DSK3SPTVN1PROD with NOTICES Proposed Collection; 60-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study— Wave 4 of Data Collection (NIDA) 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 VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways 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: PATHprojectofficer@mail.nih.gov. 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—Wave 4 of Data PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 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 E:\FR\FM\15APN1.SGM 15APN1 22291 Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices 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 105,079. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total annual burden hours Form name Type of respondent 1. Household Screener .. 2. Shadow Youth Only Screener. 3. Extended Interview * .. 4. Consent for Extended Interview. 5. Individual Screener .... 6. Extended Interview * .. Households .......................................................... Households .......................................................... 86,559 56,659 1 1 14/60 5/60 20,197 4,722 Adults—Adult respondents—previous wave ....... Adults—New adults and Wave 1 youth respondents who age up to adult cohort—Wave 4. Adults—New adults ............................................. Adults—New adults and Wave 1 youth respondents who age up to adult cohort—Wave 4. Adults—New adults and Wave 1 youth respondents who age up to adult cohort—Wave 4. Adults ................................................................... 23,414 13,984 1 1 1 4/60 23,414 932 9,152 10,737 1 1 6/60 68/60 915 12,169 10,737 1 5/60 895 18,301 1 10/60 3,050 4,832 1 18/60 1,450 23,133 34,151 1 2 5/60 8/60 1,928 9,107 Adults ................................................................... Adults ................................................................... Youth—Youth respondents—previous wave ....... Youth—New youth and shadow youth who age up to youth cohort—Wave 4. Youth—New youth and shadow youth who age up to youth cohort—Wave 4. Youth ................................................................... 33,889 301 8,627 7,657 1 1 1 1 2/60 4/60 35/60 3/60 1,130 20 5,032 383 6,432 1 45/60 4,824 15,059 1 5/60 1,255 Youth ................................................................... 10,239 1 10/60 1,707 Youth ................................................................... Adults—Parents of youth respondents—previous wave. Adults—Parents of new youth and parents of Shadow youth who age up to youth cohort— Wave 4. Adults—Parents of new youth and parents of shadow youth who age up to youth cohort— Wave 4. Adults—Parents of youth respondents—previous wave. Adults—Parents of youth respondents ................ 10,239 8,800 1 1 5/60 16/60 853 2,347 7,657 1 5/60 638 6,561 1 19/60 2,078 15,360 1 3/60 768 15,059 2 8/60 4,016 Adults—Parents of shadow youth ....................... 4,684 2 8/60 1,249 .............................................................................. 49,210 496,116 ........................ 105,079 7. Consent for Biological Samples. 8. Biospecimen Collection: Urine. 9. Biospecimen Collection: Blood. 10. Tobacco Use Form .. 11. Follow-up/Tracking Participant Information Form. 12. Verification Interview 13. Validation Interview 14. Extended Interview ** 15. Assent for Extended Interview. 16. Extended Interview ** 17. Assent for urine collection. 18. Biospecimen Collection: Urine. 19. Tobacco Use Form .. 20. Parent Interview ...... 21. Parent Permission and Consent for Parent Interview. 22. Parent Interview ...... 23. Parent permission for urine collection. 24. Follow-up/Tracking Participant Information Form for Youth (completed by parents). 25. Follow-up/Tracking Participant Information Form for sample shadow youth (completed by parents). asabaliauskas on DSK3SPTVN1PROD with NOTICES Total ........................ Adults—New adults and Wave 1 youth respondents who age up to adult cohort—Wave 4. Adults ................................................................... Adults ................................................................... Dated: April 5, 2016. Genevieve deAlmeida-Morris, Project Clearance Liaison, National Institute on Drug Abuse, NIH. [FR Doc. 2016–08658 Filed 4–14–16; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\15APN1.SGM 15APN1

Agencies

[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22290-22291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08658]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Proposed Collection; 60-Day Comment Request; Population
Assessment of Tobacco and Health (PATH) Study--Wave 4 of Data
Collection (NIDA)

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) Ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) Ways 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:
PATHprojectofficer@mail.nih.gov. 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--Wave 4 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

[[Page 22291]]

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 105,079.

Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total annual
Form name Type of respondent respondents responses per response (in burden hours
respondent hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Household Screener.......................... Households............................. 86,559 1 14/60 20,197
2. Shadow Youth Only Screener.................. Households............................. 56,659 1 5/60 4,722
3. Extended Interview *........................ Adults--Adult respondents--previous 23,414 1 1 23,414
wave.
4. Consent for Extended Interview.............. Adults--New adults and Wave 1 youth 13,984 1 4/60 932
respondents who age up to adult
cohort--Wave 4.
5. Individual Screener......................... Adults--New adults..................... 9,152 1 6/60 915
6. Extended Interview *........................ Adults--New adults and Wave 1 youth 10,737 1 68/60 12,169
respondents who age up to adult
cohort--Wave 4.
7. Consent for Biological Samples.............. Adults--New adults and Wave 1 youth 10,737 1 5/60 895
respondents who age up to adult
cohort--Wave 4.
8. Biospecimen Collection: Urine............... Adults................................. 18,301 1 10/60 3,050
9. Biospecimen Collection: Blood............... Adults--New adults and Wave 1 youth 4,832 1 18/60 1,450
respondents who age up to adult
cohort--Wave 4.
10. Tobacco Use Form........................... Adults................................. 23,133 1 5/60 1,928
11. Follow-up/Tracking Participant Information Adults................................. 34,151 2 8/60 9,107
Form.
12. Verification Interview..................... Adults................................. 33,889 1 2/60 1,130
13. Validation Interview....................... Adults................................. 301 1 4/60 20
14. Extended Interview **...................... Youth--Youth respondents--previous wave 8,627 1 35/60 5,032
15. Assent for Extended Interview.............. Youth--New youth and shadow youth who 7,657 1 3/60 383
age up to youth cohort--Wave 4.
16. Extended Interview **...................... Youth--New youth and shadow youth who 6,432 1 45/60 4,824
age up to youth cohort--Wave 4.
17. Assent for urine collection................ Youth.................................. 15,059 1 5/60 1,255
18. Biospecimen Collection: Urine.............. Youth.................................. 10,239 1 10/60 1,707
19. Tobacco Use Form........................... Youth.................................. 10,239 1 5/60 853
20. Parent Interview........................... Adults--Parents of youth respondents-- 8,800 1 16/60 2,347
previous wave.
21. Parent Permission and Consent for Parent Adults--Parents of new youth and 7,657 1 5/60 638
Interview. parents of Shadow youth who age up to
youth cohort--Wave 4.
22. Parent Interview........................... Adults--Parents of new youth and 6,561 1 19/60 2,078
parents of shadow youth who age up to
youth cohort--Wave 4.
23. Parent permission for urine collection..... Adults--Parents of youth respondents-- 15,360 1 3/60 768
previous wave.
24. Follow-up/Tracking Participant Information Adults--Parents of youth respondents... 15,059 2 8/60 4,016
Form for Youth (completed by parents).
25. Follow-up/Tracking Participant Information Adults--Parents of shadow youth........ 4,684 2 8/60 1,249
Form for sample shadow youth (completed by
parents).
---------------------------------------------------------------
Total...................................... ....................................... 49,210 496,116 .............. 105,079
--------------------------------------------------------------------------------------------------------------------------------------------------------

Dated: April 5, 2016.
Genevieve deAlmeida-Morris,
Project Clearance Liaison, National Institute on Drug Abuse, NIH.
[FR Doc. 2016-08658 Filed 4-14-16; 8:45 am]
BILLING CODE 4140-01-P

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