Department of Health and Human Services December 1, 2010 – Federal Register Recent Federal Regulation Documents

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Ames Laboratory, Ames, Iowa, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 6, 2010, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of a guidance document entitled ``Guidance on IRB Approval of Research with Conditions.'' The guidance document provides OHRP's first formal guidance on this topic. The document, which is available on OHRP's Web site at https://www.hhs.gov/ohrp/policy/conditionalapproval2010.html or https://www.hhs.gov/ohrp/policy/conditionalapproval2010.pdf, is intended primarily for institutional review boards (IRB), investigators, Department of Health and Human Services (HHS) funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS. The guidance document announced in this notice finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57486). OHRP received comments on the draft guidance document from 12 individuals and organizations, and those comments were considered as the guidance was finalized.

The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with Iowa State University, is announcing a public workshop entitled ``Food Labeling Workshop.'' This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups. Date and Time: This public workshop will be held on March 3 and 4, 2011, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Scheman Conference Center, Lincoln Way and University Avenue, Iowa State Center, Ames, IA. Contact: David Arvelo, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, or email: david.arvelo@fda.hhs.gov. For information on accommodation options, visit https:// www.fshn.hs.iastate.edu/foodlabel/register.php or contact Dr. Ruth MacDonald, 2312 Food Sciences Building, Iowa State University, Ames, IA 50011, 515-294-5991, FAX: 515-294-8181, email: ruthmacd@iastate.edu. Registration: You are encouraged to register by February 21, 2011. The workshop has a $250 registration fee to cover the cost of facilities, materials, lunch on day 1, and breaks. There is no registration fee for FDA employees. Seats are limited; please submit your registration as soon as possible. Workshop space will be filled in order of receipt of registration. Those accepted into the workshop will receive confirmation. Registration will close after the workshop is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $350 payable to: ``Iowa State University.'' If you need special accommodations due to a disability, please contact Dr. Ruth MacDonald (see Contact) at least 14 days in advance. Registration Form Instructions: To register, please complete the online registration form at https://www.fshn.hs.iastate.edu/foodlabel/ register.php, or submit your full name, business or organization name, complete mailing address, telephone number, email address, optional fax number, and any special accommodations required due to disability, along with a check or money order for $250 payable to ``Iowa State University.'' Mail to: Dr. Ruth MacDonald, Food Science and Human Nutrition, 2312 Food Sciences Building, Ames, IA 50011. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Requests for workshop handouts may be obtained through David Arvelo (see Contact).

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 US 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.