Department of Health and Human Services July 30, 2007 – Federal Register Recent Federal Regulation Documents

The Centers for Medicare & Medicaid Services CMS inadvertently published a new system of records titled ``Post Acute Care Payment Reform/Continuity of Assessment Report and Evaluation Demonstration and Evaluation (PAC-CARE)'' System No. 09-70-0569 in the Federal Register (FR) on Thursday, April 19, 2007 (72 FR 19711). CMS is withdrawing the notice due to comments received that a routine use disclosure provision necessary to carry out essential parts of the demonstration project was inadvertently omitted. The notice of a new system of records will be republished at a later date with the routine use included.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Lawrence Livermore National Laboratory, Livermore, California, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Lawrence Livermore National Laboratory. Location: All areas. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1950 through December 31, 1973.

In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13) and Office of Management and Budget (OMB) regulations at 5 CFR Part 1320 (60 FR 44978, August 29, 1995), this notice announces the intention of the Department of Bioethics, National Institutes of Health (NIHDCB) to request approval for a new information collection, Physicians' Experience of Ethical Dilemmas and Resource Allocation. The proposed information collection was previously published in the Federal Register on May 17, 2007, on pages 27817-18 and allowed 60-days for public comment. Two 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: Physicians' Experience of Ethical Dilemmas and Resource Allocation. Type of Information Collection Request: New. Need and Use of Information Collection: Health care costs are rising ceaselessly and there are currently no generally accepted way of controlling them. This study will access the experience of physicians regarding resource allocation in clinical practice, and how allocation decisions made at other levels shapes this experience. The primary objectives of the study are to determine if physicians make decisions to withhold interventions on the basis of cost, how often they report doing so, what types of care are withheld, and what criteria are used in making such decisions. The findings will provide valuable information concerning: (1) The practice of resource allocation in clinical practice, (2) the possible effects of perceived constraints on this practice; and (3) international comparisons on these two aspects. Frequency of Response: Once. Affected Public: Individuals or households; Businesses or other for-profit; Not-for- profit institutions. Type of Respondents: Physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 250; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.3674; and Estimated Total Annual Burden Hours Requested: 91.85. The annualized cost to respondents is estimated at: $5,218. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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, New Executive Office Building, Room 10235, Washington, DC 20503, 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: Dr. Marion Danis, Department of Bioethics, DCB, CC, NIH, Building 10, Room 1C 118, 9000 Rockville Pike, Bethesda, MD 20892-1156, or call non-toll-free number 301-435-8727 or e-mail your request, including your address to: mdanis@cc.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.