Department of Health and Human Services September 7, 2012 – Federal Register Recent Federal Regulation Documents
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Submission for OMB Review; Comment Request: Cognitive Testing of Instrumentation and Materials for the Population Assessment of Tobacco and Health (PATH) Study
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 23, 2012, page 30540 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. 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.
Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections
The Office for Human Research Protections (OHRP), a program office in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill two positions on the Committee membership that will be vacated during the 2013 calendar year.
Health Information Technology Implementation
HRSA will be transferring the American Recovery and Reinvestment Act (ARRA) (section 330 of the Public Health Service Act) Health Information Technology Implementation for Health Center Controlled Networks (HCCN) funds originally awarded to Southwest Virginia Community Health Systems (SVCHS), to support the implementation of a HCCN in the state of Virginia to enhance the quality and efficiency of primary and preventive care as a safety net through the effective use of Health Information Technology (HIT).
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