| Page Range | 43217-43219 | |
| FR Document | 2016-15644 |
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)] [Notices] [Pages 43217-43219] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15644] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study--Fourth Wave of Data Collection AGENCY: National Institute of Health, HHS. SUMMARY: 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 [[Page 43218]] collection was previously published in the Federal Register on April 15, 2016, pages 22290--22291 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The 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, [email protected] 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. FOR FURTHER INFORMATION CONTACT: 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. Proposed Collection: Population Assessment of Tobacco and Health (PATH) Study--Fourth Wave 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 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 94,798. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Total Number of Number of burden per annual Form name Type of respondent respondents responses per response burden respondent (in hours) hours ---------------------------------------------------------------------------------------------------------------- 1. Household Screener............ Households.............. 48,018 1 14/60 11,204 2. Individual Screener........... Adults--New adults...... 9,152 1 6/60 915 3. Extended Interview............ Adults--New adults and 10,737 1 68/60 12,169 Wave 1 youth respondents who age up to adult cohort at Wave 4. 4. Extended Interview............ Adults--Adult 23,414 1 1 23,414 respondents at previous wave. 5. Parent Interview.............. Adults--Parents of new 6,561 1 19/60 2,078 youth and parents of shadow youth who age up to youth cohort at Wave 4. 6. Parent Interview.............. Adults--Parents of youth 8,800 1 16/60 2,347 respondents at previous wave. 7. Extended Interview............ Youth--New youth and 6,432 1 45/60 4,824 shadow youth who age up to youth cohort at Wave 4. 8. Extended Interview............ Youth--Youth respondents 8,627 1 35/60 5,032 at previous wave. 9. Tobacco Use Form.............. Adults.................. 23,133 1 5/60 1,928 10. Tobacco Use Form............. Youth................... 10,239 1 5/60 853 11. Shadow Youth Only Screener... Households.............. 41,207 1 5/60 3,434 12. Verification Interview....... Adults.................. 33,889 1 2/60 1,130 13. Validation Interview......... Adults.................. 301 1 4/60 20 14. Biospecimen Collection: Blood Adults--New adults and 4,832 1 18/60 1,450 Wave 1 youth respondents who age up to adult cohort at Wave 4. 15. Biospecimen Collection: Urine Adults.................. 18,301 1 10/60 3,050 16. Biospecimen Collection: Urine Youth................... 10,239 1 10/60 1,707 17. Follow-up/Tracking Adults.................. 34,151 2 8/60 9,107 Participant Information Form. 18. Follow-up/Tracking Adults--Parents of youth 15,059 2 8/60 4,016 Participant Information Form for respondents. Youth (completed by parents). [[Page 43219]] 19. Follow-up/Tracking Adults--Parents of 4,684 2 8/60 1,249 Participant Information Form for shadow youth. sample shadow youth (completed by parents). 20. Consent for Extended Adults--New adults and 13,984 1 4/60 932 Interview. Wave 1 youth respondents who age up to adult cohort at Wave 4. 21. Parent Permission and Consent Adults--Parents of new 7,657 1 5/60 638 for Parent Interview. youth and parents of Shadow youth who age up to youth cohort at Wave 4. 22. Assent for Extended Interview Youth--New youth and 7,657 1 3/60 383 shadow youth who age up to youth cohort at Wave 4. 23. Consent for Biological Adults--New adults and 10,737 1 5/60 895 Samples. Wave 1 youth respondents who age up to adult cohort at Wave 4. 24. Parent permission for urine Adults--Parents of youth 15,360 1 3/60 768 collection. respondents at previous wave. 25. Assent for urine collection.. Youth................... 15,059 1 5/60 1,255 ---------------------------------------------------- Total........................ ........................ 388,229 442,123 ........... 94,798 ---------------------------------------------------------------------------------------------------------------- Dated: June 27, 2016. Genevieve deAlmeida, Project Clearance Liaison, National Institute on Drug Abuse, NIH. [FR Doc. 2016-15644 Filed 6-30-16; 8:45 am] BILLING CODE 4140-01-P
| 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 30 days of the date of this publication. | |
| Contact | 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 | |
| FR Citation | 81 FR 43217 |