Department of Health and Human Services September 2009 – Federal Register Recent Federal Regulation Documents
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Government-Owned Inventions; Availability for Licensing
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.
Privacy Act of 1974; Report of Modified or Altered System; Indian Health Service Scholarship and Loan Repayment Programs
Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a SOR, ``Indian Health Service Scholarship and Loan Repayment Programs,'' System No. 09-17-0002. We propose to modify the SOR to reflect current program changes, statutory and implementation changes. Under the system name, we propose to clarify language under the ``Categories of individuals covered by the system'' section; to include statutory authorities for the grants program under the ``Authority for maintenance of the system'' section; to include the IHS Grants Program (Indians Into Nursing, Indians Into Medicine, and Indians Into Psychology) and the IHS Health Professions Support Branch in the ``Purposes'' section; various minor language edits to routine use number 4 for litigation as these records are not Health Insurance Portability and Accountability Act (HIPAA) protected records; add a new routine use number 20 to comply with Office of Management and Budget (OMB) (M)emorandum 07-16 Safeguarding Against and Responding to the Breach of Personally Identifiable Information of May 22, 2007 and the HHS Directive memoranda dated September 19, 2007 to incorporate Notification of Breach Routine Use language; and finally minor administrative and program edits to other sections of the SOR.
Renewal of Charter for the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020
As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the U.S. Department of Health and Human Services is hereby announcing that the charter for the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 (Healthy People 2020 Advisory Committee; HPAC) has been renewed.
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Test Method Evaluation Report: The Reduced Murine Local Lymph Node Assay, an Alternative Test Method Using Fewer Animals To Assess the Allergic Contact Dermatitis Potential of Chemicals and Products; Availability of ICCVAM Recommended Murine Local Lymph Node Assay Performance Standards; Notice of Transmittal to Federal Agencies of ICCVAM Test Method Recommendations for the Reduced Murine Local Lymph Node Assay, Updated Murine Local Lymph Node Assay Test Method Protocol, and Murine Local Lymph Node Assay Test Method Performance Standards
NICEATM announces availability of the ICCVAM Test Method Evaluation Report: The Reduced Murine Local Lymph Node Assay: An Alternative Test Method Using Fewer Animals to Assess the Allergic Contact Dermatitis Potential of Chemicals and Products (NIH Publication 09-6439). The TMER provides ICCVAM's evaluation and recommendations for the reduced Murine Local Lymph Node Assay (rLLNA) test method as a reduction alternative that uses fewer animals compared to the traditional Murine Local Lymph Node Assay (LLNA) for assessing the potential of test substances to cause allergic contact dermatitis (ACD). The report includes ICCVAM's recommendations on (a) the usefulness and limitations of the rLLNA, (b) an updated ICCVAM LLNA test method protocol, which includes the procedures for conducting the rLLNA, (c) future studies to further characterize the usefulness and limitations of the rLLNA, and (d) rLLNA test method performance standards. The TMER includes the report of an international independent scientific peer review panel (hereafter, Panel) and the final rLLNA background review document (BRD). The BRD provides the data and analyses used to evaluate the current validation status of the rLLNA test method for assessing the ACD potential of chemicals and products. ICCVAM concluded that the scientific validity of the rLLNA has been adequately evaluated and that the performance of the rLLNA, when conducted in accordance with the ICCVAM-recommended LLNA test method protocol, is sufficient to distinguish between skin sensitizers and non-sensitizers. ICCVAM also concluded that the rLLNA would reduce animal use by 40% for each test compared to the traditional, multi-dose LLNA. Accordingly, ICCVAM recommends that the rLLNA test method should be routinely considered before conducting the traditional, multi-dose LLNA, and used where appropriate as the initial test to determine the potential of chemicals and products to produce ACD. For testing situations that require dose-response information, rLLNA-positive substances will need to be tested with the traditional multi-dose LLNA. This testing should be done using the updated ICCVAM-recommended test method protocol, which reduces animal use by 20% compared to the original ICCVAM-recommended test method protocol by decreasing the minimum number of animals per dose group from five to four.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff: Humanitarian Device Exemption Regulation: Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
National Institute of Environmental Health Sciences; Submission for OMB Review; Comment Request; The Sister Study PHASE 2: Environmental and Genetic Risk Factors for Breast Cancer
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on 10 July 2009 on page 33259 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.
``CORRECTED Version of Request for Information Regarding Development and Operation of a Transplantation Sentinel Network''
The Centers for Disease Control and Prevention (CDC) is seeking information on development and operation of a national transplantation sentinel network (TSN) for the United States, including resources needed for management of such a system. The purpose of the network is to detect and prevent disease transmission from organ and tissue allografts recovered for transplantation.
Submission for OMB Review; Comment Request
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Clinical Center, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 14, 2009, page 22749 and allowed 60-days for public comment. One comment was received:
Medicare Programs; End-Stage Renal Disease Prospective Payment System
This proposed rule would implement a case-mix adjusted bundled prospective payment system (PPS) for Medicare outpatient end-stage renal disease (ESRD) dialysis facilities beginning January 1, 2011, in compliance with the statutory requirement of the Medicare Improvements for Patients and Providers Act (MIPPA), enacted July 15, 2008. The proposed ESRD PPS would replace the current basic case-mix adjusted composite payment system and the methodologies for the reimbursement of separately billable outpatient ESRD services.
Medicare Program; Town Hall Meeting on End-Stage Renal Disease Prospective Payment System
This notice announces the date, time, and location of the town hall meeting to discuss the Medicare End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) proposed rule. This meeting provides a forum for interested parties including, but not limited to beneficiaries, caregivers, providers, and other industry representatives to make oral statements in response to the ESRD PPS proposed rule. The meeting is open to the public, but registration is required and attendance is limited to space available.
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