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Proposed Information Collection; 60-day Comment Request: Population Assessment of Tobacco and Health (PATH) Study

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National Institutes of Health, HHS.




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.


Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received by April 7, 2014.

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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: Formal requests for additional plans and instruments must be requested in writing.

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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

Type of respondent and instrumentEstimated number of respondentsEstimated number of responses per respondentAverage burden hours per response (in hours)Estimated total annual burden hours requested
Adults—Extended Interview38,7401138,740
Adults—Baseline youth respondents who age into adult cohort—Consent for Extended Interview2,71712/6091
Adults—Baseline youth respondents who age into adult cohort—Extended Interview2,500168/602,833
Adults—Adult respondents who refused biospecimen collection at Baseline but who consent for Wave 2—Consent for Biological Samples1,45214/6097
Adults—Baseline youth respondents who age into the adult cohort—Consent for Biological Samples2,50014/60167
Adults—Biospecimen Collection: Urine12,387110/602,065
Adults—Biospecimen Collection: Buccal Cell2,387118/60716
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Adults—Biospecimen Collection: Blood2,303118/60691
Adults—Tobacco Use Form17,07714/601,138
Adults—Follow-up/Tracking Participant Information Form41,23928/6010,997
Youth—Extended Interview12,392132/606,609
Youth—Shadow youth who age into youth cohort—Assent for Extended Interview2,73412/6091
Youth—Shadow youth who age into youth cohort—Extended Interview2,515142/601,761
Adult—Parent Interview12,392114/602,891
Adults—Parents of Shadow youth who age into youth cohort—Parent Permission and Consent for Parent Interview2,73412/6091
Adults—Parents of Shadow youth who age into youth cohort—Parent Interview2,515117/60713
Adults—Follow-up/Tracking Participant Information Form for Youth (completed by parents)14,90728/603,975
Adults—Follow-up/Tracking Participant Information Form for sample Shadow youth (completed by parents)5,46828/601,458
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Dated: January 31, 2014.

Glenda J. Conroy,

Executive Officer (OM Director), National Institute on Drug Abuse, NIH.

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[FR Doc. 2014-02603 Filed 2-5-14; 8:45 am]