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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; Comment Request: Cognitive Testing of Instrumentation and Materials for the Population Assessment of Tobacco and Health (PATH) Study

SUMMARY: Proposed Collection: Title:Cognitive Testing of Instrumentation and Materials for Population Assessment of Tobacco and Health (PATH) Study.Type of Information Collection Request:New.Need and Use of Information Collection:The PATH study will establish a population-based framework for monitoring and evaluating the behavioral and health impacts of regulatory provisions implemented as part of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) by the Food and Drug Administration (FDA). NIDA is requesting generic approval from OMB for cognitive testing of the PATH study's instrumentation, supporting materials, consent forms, and methods of administration (e.g., computer assisted personal interviews [CAPI], audio computer assisted self-interviews [ACASI], web-based interviews). Cognitive testing of these materials and methods will help to ensure that their design and content are valid and meet the PATH study's objectives. Additionally, results from cognitive testing will inform the feasibility (scientific robustness), acceptability (burden to participants and study logistics) and cost of the information collection to help minimize its estimated cost and public burden.

Frequency of Response:Annual [As needed on an on-going and concurrent basis].

Affected Public:Individuals and Households.Type of Respondents:Youth (ages 12-17) and Adults (ages 18+). The annual reporting burden for the screening of respondents for the PATH study cognitive testing is presented in Table 1, and the annual reporting burden for the PATH study cognitive testing is presented in Table 2. The annualized cost to respondents for participating in screening for PATH study cognitive testing is estimated at: $6,632; and the annualized cost to respondents for participating in PATH study cognitive testing is estimated at: $20,346. There are no capital, operating or maintenance costs.

Request for Comments: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.

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,OIRA_submission@omb.eop.govor by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Kevin P. Conway, Ph.D., Deputy Director, Division of Epidemiology, Services, and Prevention Research, National Institute on Drug Abuse, 6001 Executive Blvd., Room 5185; 301-443-8755; emailPATHprojectofficer@mail.nih.gov.

Comments 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.

Dated: August 30, 2012. Glenda P. Conroy, Executive Officer (OM Director), NIDA.