81 FR 22290 - Proposed Collection; 60-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study-Wave 4 of Data Collection (NIDA)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 73 (April 15, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 73 (April 15, 2016)
| Page Range | 22290-22291 | |
| FR Document | 2016-08658 |
[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)] [Notices] [Pages 22290-22291] From the Federal Register Online [www.thefederalregister.org] [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: [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--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
![22290 Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices
released from urgent medical care. disaster. Information about missing emergencies, training and
Family and friends are also a valuable (‘‘lost’’) people would be collected from demonstration support activities, and
source of medical information that may family members or loved ones who are would operate in declared emergencies
be important to the care of injured searching for them. Information about until relief efforts have ceased in
victims (e.g., by providing family or recovered (‘‘found’’) people could be response to a particular disaster. This
personal medical history, information provided by medical personnel, data collection is authorized pursuant to
about allergies). The National Library of volunteers and other relief workers sections 301, 307, 465 and 478A of the
Medicine (NLM) aims to assist Federal, assisting in the disaster recovery effort. Public Health Service Act [42 U.S.C.
State and Local agencies in disaster Information collected about missing and 241, 242l, 286 and 286d]. NLM has in
relief efforts and to serve its mission of recovered persons would vary including its mission the development and
supporting national efforts to the any one of the following and possibly coordination of communication
response to disasters via the PEOPLE all: A photograph, name (if available for technology to improve the delivery of
LOCATOR® system and related mobile a found person), age group (child, adult) health services.
app (ReUniteTM) developed as part of and/or range, gender, status (alive and OMB approval is requested for 3
the intramural Lost Person Finder (LPF) well, injured, deceased, unknown), and years. There are no costs to respondents
R&D project. The information collection location. The information collection other than their time. The total
would support efforts to reunite family would be voluntary. It would be estimated annualized burden hours are
and friends who are separated during a activated only during times of declared 7,500.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average time Total annual
Number of
Types of respondent responses per per response burden
respondents respondent (in hours) hours
Emergency Care First-Responders, Physicians, Other Health Care Pro-
viders ............................................................................................................ 500 100 3/60 2,500
Family members seeking a missing person .................................................... 50,000 2 3/60 5,000
Total .......................................................................................................... 50,500 150,000 ........................ 7,500
Dated: April 7, 2016. proposed collection of information, Collection (NIDA)—0925–0664,
David Sharlip, including the validity of the expiration date 8/31/2018—
Project Clearance Liaison, NLM, NIH. methodology and assumptions used; (3) REVISION—NIDA, NIH, in partnership
[FR Doc. 2016–08659 Filed 4–14–16; 8:45 am] Ways to enhance the quality, utility, and with the Food and Drug Administration
BILLING CODE 4140–01–P
clarity of the information to be (FDA).
collected; and (4) Ways to minimize the Need and Use of Information
burden of the collection of information Collection: This is a revision request
DEPARTMENT OF HEALTH AND on those who are to respond, including (OMB number 0925–0664, expiration
HUMAN SERVICES the use of appropriate automated, date 8/31/2018) for the Population
electronic, mechanical, or other Assessment of Tobacco and Health
National Institutes of Health technological collection techniques or (PATH) Study to conduct the fourth
other forms of information technology. wave of data collection. The PATH
Proposed Collection; 60-Day Comment To Submit Comments and For Further
Request; Population Assessment of Study is a large national longitudinal
Information: To obtain a copy of the cohort study on tobacco use behavior
Tobacco and Health (PATH) Study— data collection plans and instruments,
Wave 4 of Data Collection (NIDA) and health among the U.S. household
submit comments in writing or request population of adults age 18 and older
Summary: In compliance with the more information on the proposed and youth ages 12 to 17. On an annual
requirement of Section 3506(c)(2)(A) of project, contact: Kevin P. Conway, basis, the PATH Study conducts
the Paperwork Reduction Act of 1995, Ph.D., Deputy Director, Division of interviews with and collects
for opportunity for public comment on Epidemiology, Services, and Prevention biospecimens from adults and youth to
proposed data collection projects, the Research, National Institute on Drug help inform the development,
National Institute on Drug Abuse Abuse, 6001 Executive Boulevard, Room implementation, and evaluation of
(NIDA), National Institutes of Health 5185; or call non-toll-free number (301) tobacco-product regulations by FDA in
(NIH), will publish periodic summaries 443–8755; or Email your request, meeting its mission under the Family
of proposed projects to be submitted to including your address to: Smoking Prevention and Tobacco
the Office of Management and Budget PATHprojectofficer@mail.nih.gov. Control Act (TCA) to regulate tobacco
(OMB) for review and approval. Formal requests for additional plans and products, including tobacco-product
Written comments and/or suggestions instruments must be requested in advertising, labeling, marketing,
from the public and affected agencies writing. constituents, ingredients, and additives.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
are invited on one or more of the Comment Due Date: Comments The longitudinal design of the PATH
following points: (1) Whether the regarding this information collection are Study provides it with the capacity to
proposed collection of information is best assured of having their full effect if measure and report within-person
necessary for the proper performance of received within 60 days of the date of changes and between-person differences
the function of the agency, including this publication. in tobacco product use behaviors and
whether the information will have Proposed Collection: Population health effects within the cohort over
practical utility; (2) The accuracy of the Assessment of Tobacco and Health time. These data will help to inform
agency’s estimate of the burden of the (PATH) Study—Wave 4 of Data regulatory decisions and actions by FDA
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![Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices 22291
and FDA’s evaluations of associations OMB approval is requested for 3 estimated annualized burden hours are
between its regulations and tobacco use years. There are no costs to respondents 105,079.
behaviors and health indicators in the other than their time. The total
population.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total annual
Form name Type of respondent responses per
respondents response burden hours
respondent (in hours)
1. Household Screener .. Households .......................................................... 86,559 1 14/60 20,197
2. Shadow Youth Only Households .......................................................... 56,659 1 5/60 4,722
Screener.
3. Extended Interview * .. Adults—Adult respondents—previous wave ....... 23,414 1 1 23,414
4. Consent for Extended Adults—New adults and Wave 1 youth respond- 13,984 1 4/60 932
Interview. ents 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 respond- 10,737 1 68/60 12,169
ents who age up to adult cohort—Wave 4.
7. Consent for Biological Adults—New adults and Wave 1 youth respond- 10,737 1 5/60 895
Samples. ents who age up to adult cohort—Wave 4.
8. Biospecimen Collec- Adults ................................................................... 18,301 1 10/60 3,050
tion: Urine.
9. Biospecimen Collec- Adults—New adults and Wave 1 youth respond- 4,832 1 18/60 1,450
tion: Blood. ents who age up to adult cohort—Wave 4.
10. Tobacco Use Form .. Adults ................................................................... 23,133 1 5/60 1,928
11. Follow-up/Tracking Adults ................................................................... 34,151 2 8/60 9,107
Participant Information
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 Youth—New youth and shadow youth who age 7,657 1 3/60 383
Interview. up to youth cohort—Wave 4.
16. Extended Interview ** Youth—New youth and shadow youth who age 6,432 1 45/60 4,824
up to youth cohort—Wave 4.
17. Assent for urine col- Youth ................................................................... 15,059 1 5/60 1,255
lection.
18. Biospecimen Collec- Youth ................................................................... 10,239 1 10/60 1,707
tion: Urine.
19. Tobacco Use Form .. Youth ................................................................... 10,239 1 5/60 853
20. Parent Interview ...... Adults—Parents of youth respondents—previous 8,800 1 16/60 2,347
wave.
21. Parent Permission Adults—Parents of new youth and parents of 7,657 1 5/60 638
and Consent for Par- Shadow youth who age up to youth cohort—
ent Interview. Wave 4.
22. Parent Interview ...... Adults—Parents of new youth and parents of 6,561 1 19/60 2,078
shadow youth who age up to youth cohort—
Wave 4.
23. Parent permission Adults—Parents of youth respondents—previous 15,360 1 3/60 768
for urine collection. wave.
24. Follow-up/Tracking Adults—Parents of youth respondents ................ 15,059 2 8/60 4,016
Participant Information
Form for Youth (com-
pleted by parents).
25. Follow-up/Tracking Adults—Parents of shadow youth ....................... 4,684 2 8/60 1,249
Participant Information
Form for sample shad-
ow youth (completed
by parents).
Total ........................ .............................................................................. 49,210 496,116 ........................ 105,079
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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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Document Created: 2016-04-15 00:54:59
Document Modified: 2016-04-15 00:54:59
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. | |
| FR Citation | 81 FR 22290 |
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