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Submission for OMB Review; 30-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study-3rd Wave (NIDA)

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, 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 11, 2015, pages 7619-7620 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 Institute on Drug Abuse (NIDA), 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, 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.

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To obtain a copy of the data collection plans and instruments or request more information on the proposed project, contact: Dr. Kevin P. Conway, Deputy Director, Division of Epidemiology, Services, and Prevention Research, NIDA, NIH, 6001 Executive Boulevard, Room 5185, Rockville, MD 20852; or call non-toll-free number (301) 443-8755 or Email your request, including your address to: Formal requests for additional plans and instruments must be requested in writing.

Proposed Collection: Population Assessment of Tobacco and Health (PATH) Study—Third Wave of Data Collection—0925-0664—Revision, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), in partnership with the Food and Drug Administration (FDA).

Need and Use of Information Collection: This is a revision request (OMB 0925-0664, expires 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 national longitudinal cohort study of tobacco use behavior and health among the U.S. household population of adults age 18 and older and youth ages 12 to 17. The Study conducts annual interviews and collects biospecimens from adults to assess within-person changes and between-person differences in tobacco-product use behaviors and related health conditions over time. Its longitudinal, population-based data will help to enhance the evidence base that informs FDA's regulatory actions under the Family Smoking Prevention and Control Act to protect the Nation's public health and reduce its burden of tobacco-related morbidity and mortality.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 54,434.

Estimated Annualized Burden Hours

Form or activity nameType of respondentNumber of respondentsNumber of responses per respondentAverage burden per response (in hours)Total annual burden hours
Adult Extended InterviewAdults25,4441125,444
Consent for Adult Extended InterviewAdults2,04614/60136
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Adult Extended Interview (Aged-up)Adults1,780168/602,017
Consent for Biological SamplesAdults1,78015/60148
Biospecimen Collection: UrineAdults13,805110/602,301
Biospecimen Collection: BloodAdults765118/60230
Tobacco Use FormAdults14,57015/601,214
Follow-up/Tracking Participant Information Form for AdultsAdults27,22428/607,260
Youth Extended InterviewYouth9,625135/605,615
Assent for Youth Extended InterviewYouth1,92313/6096
Youth Extended Interview (Aged-up)Youth1,923145/601,442
Parent InterviewParents9,818116/602,618
Parent Permission and Consent for Parent InterviewParents2,16115/60180
Parent Interview (Aged-up)Parents1,961119/60621
Verification InterviewAdults35,56412/601,185
Validation InterviewAdults3,57914/60239
Follow-up/Tracking Participant Information Form for YouthParents11,54828/603,079
Follow-up/Tracking Participant Information Form for Sample Shadow YouthParents2,28228/60609
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Dated: June 12, 2015.

Genevieve deAlmeida-Morris,

Project Clearance Liaison, NIDA, NIH.

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[FR Doc. 2015-14902 Filed 6-16-15; 8:45 am]