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

The Food and Drug Administration (FDA) is amending the animal drug regulations for food substances affirmed as generally recognized as safe (GRAS) in feed and drinking water of animals to correct a cross-reference. This action is being taken to improve the accuracy of the regulations.

The NTP announces the availability of the draft background documents for captafol and ortho-nitrotoluene on August 1, 2007, from the RoC Web site (https://ntp.niehs.nih.gov/go/10091 see captafol or ortho-nitrotoluene) or in printed text from the RoC (see FOR FURTHER INFORMATION CONTACT below). The NTP invites the submission of public comments on the two draft background documents (see SUPPLEMENTARY INFORMATION below). The expert panel will meet on October 15-16, 2007, at the Sheraton Chapel Hill Hotel, Chapel Hill, North Carolina, to peer review the draft background documents for captafol and ortho- nitrotoluene and once completed make a recommendation regarding the listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) for captafol and ortho-nitrotoluene in the 12th Edition of the RoC (12th RoC). The RoC expert panel meeting is open to the public with time scheduled for oral public comments. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the NTP will post the final version of the background documents and the expert panel peer review reports on the RoC Web site.

The Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS) is issuing this Advance Notice of Proposed Rulemaking (ANPRM) to begin the process of revising the regulations that cover the importation of dogs and cats (42 CFR 71.51), including by extending these regulations to cover domesticated ferrets. This ANPRM will also address the importation of African rodents (42 CFR 71.56) into the United States. HHS/CDC is also considering the need for additional regulations to prevent the introduction of zoonotic diseases into the United States. The input received from stakeholders and other interested parties via the ANPRM process will lead to a Notice of Proposed Rulemaking (NPRM), with the aim of improving HHS's ability to prevent importation of communicable diseases into the United States. The scope of this ANPRM does not include the non-human primate regulations (42 CFR 71.53).

This notice announces the seventh meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

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.

This notice announces an administrative hearing to be held on September 4, 2007, at 150 S. Independence Mall West, Suite 216, Conference Room 241, Pennsylvania Room, The Public Ledger Building, Philadelphia, PA 19106-3499, to reconsider CMS' decision to disapprove Virginia's title XXI SPA No. 6. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by (15 days after publication).

Attached is the proposed Research Plan for the National Children's Study (NCS). The purpose of this notice is to inform scientific reviewers, professional colleagues, contributors, and all who are interested in this ground-breaking initiative, of the opportunity for review and comment. The Research Plan describes the Study's background, design, measures, and the rationale for their selections in sufficient detail so that readers can understand the basis of the Study and how it will be carried out. This plan was developed with input from scientists and other professionals across the country and from multiple federal agencies, especially the National Institute of Child Health and Human Development (NICHD) and the National Institute of Environmental Health Sciences (NIEHS) at the National Institutes of Health (NIH), the Centers for Disease Control and Prevention, and the U.S. Environmental Protection Agency (EPA). We welcome constructive comments and proposals for how the National Children's Study might address the pressing health concerns of our nation's children even more effectively. Procedures for commenting and communicating about the Research Plan are found on the NCS Web site at: https://www.nationalchildrensstudy.gov/research/researchplan/ index.cfm.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This proposed notice with comment period acknowledges the receipt of a deeming application from the American Osteopathic Association (AOA) for continued recognition as a national accrediting organization for Critical Access Hospitals (CAH) that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act (the Act) requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This notice invites all organizations representing physicians to submit nominations for consideration to fill four seats on the Practicing Physicians Advisory Council (the Council) that will be vacated by current Council members in 2008. This notice also announces a quarterly meeting of the Council. The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.