Department of Health and Human Services January 11, 2011 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse, the National Institutes of Health 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 in Vol. 75 No. 144, pages 44265-44266, on July 28, 2010 and allowed 60 days for public comment. One public comment was received on the instruments outlined in the 60- day notice. A response to this request was sent to the interested party. The purpose of this notice is to allow an additional 30 days for public comment. 5 CFR 1320.5 (General requirements) Reporting and Recordkeeping Requirements: Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. Proposed Collection: Title: Online Skills Training for PCPs on Substance Abuse. Type of Information Collection Request: New. Need and Use of Information Collection: This research will evaluate the effectiveness of the Online Skills Training for PCPs on Substance Abuse, via the Web site SBIRTTraining.com, to positively impact the knowledge, attitudes, intended behaviors and clinical skills of primary care physicians in the U.S. who treat substance abuse patients. The Online Skills Training for PCPs on Substance Abuse is a new program developed with funding from the National Institute on Drug Abuse. The primary goal is to assess the impact of the training program on knowledge, attitude, intended behavior, and clinical skills. A secondary goal is to assess learner satisfaction with the program. If the program is a success, there will be a new, proven resource available to primary care physicians to improve their ability to assess and treat substance use disorders. In order to evaluate the effectiveness of the program, information will be collected from primary care physicians before exposure to the Web based materials (pre-test), after exposure to the Web based materials (post-test), and 4-6 weeks after the program has been completed (follow-up). Frequency of Response: On occasion. Affected Public: Primary care physicians who treat patients who have substance abuse. Type of Respondents: Physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 80. Estimated Number of Responses per Respondent: 3. Average Burden Hours per Response: 0.75. Estimated Total Annual Burden Hours Requested: 180. The annualized cost to respondents is estimated at: $13,500. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) is announcing the opening of a public docket to provide a forum to facilitate communication regarding the conduct of clinical trials needed to verify and describe the clinical benefit of midodrine hydrochloride (HCl) when used to treat symptomatic orthostatic hypotension.