Department of Health and Human Services January 5, 2011 – Federal Register Recent Federal Regulation Documents
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Office of the Assistant Secretary for Planning and Evaluation; Medicare Program; Meeting of the Technical Advisory Panel on Medicare Trustee Reports
This notice announces public meetings of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Panel will discuss the long- term rate of change in health spending and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the long run. The Panel's discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. Although panelists are not limited in the topics they may discuss, the Panel is not expected to discuss or recommend changes in current or future Medicare provider payment rates or coverage policy. Meeting Dates: January 10, 2011, 9 a.m. to 6 p.m. and January 28, 2011, 9:30 a.m.-5 p.m. e.t.
Office of Child Support Enforcement Privacy Act of 1974; System of Records
In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, the Office of Child Support Enforcement (OCSE) is publishing notice that it will rescind a notice of a system of records entitled ``Location and Collection System,'' 09-90-0074, establish two new systems of records entitled ``OCSE National Directory of New Hires'' and ``OCSE Debtor File,'' and amend an existing system of records entitled ``OCSE Federal Case Registry of Child Support Orders.''
Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia Burgdorferi; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi.'' FDA is issuing this draft guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection of antibodies to Borrelia burgdorferi. These devices are used to aid in the diagnosis of Lyme disease. This draft guidance is not final nor is it in effect at this time.
Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus and Staphylococcus aureus; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA).'' The draft guidance document provides industry and Agency staff with updated recommendations for studies to establish the analytical and clinical performance of nucleic acid-based in vitro diagnostic devices (IVDs) intended for the detection and differentiation of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA). This draft guidance is not final nor is it in effect at this time.
Medicare Program; End-Stage Renal Disease Quality Incentive Program
This final rule will implement a quality incentive program (QIP) for Medicare outpatient end-stage renal disease (ESRD) dialysis providers and facilities with payment consequences beginning January 1, 2012, in accordance with section 1881(h) of the Act (added on July 15, 2008 by section 153(c) of the Medicare Improvements for Patients and Providers Act (MIPPA)). Under the ESRD QIP, ESRD payments made to dialysis providers and facilities under section 1881(b)(14) of the Social Security Act will be reduced by up to two percent if the providers/facilities fail to meet or exceed a total performance score with respect to performance standards established with respect to certain specified measures.
Requirements for Importers of Nonhuman Primates
CDC is proposing to amend its regulations for the importation of live nonhuman primates (NHPs) by extending existing requirements for the importation of Macaca fascicularis (cynomolgus), Chlorocebus aethiops (African green), and Macaca mulatta (rhesus) monkeys to all NHPs. Filovirus testing will continue to be required only for Old World NHPs. CDC also is proposing to reduce the frequency at which importers of cynomolgus, African green, and rhesus monkeys are required to renew their registrations, (from every 180 days to every two years). CDC proposes to incorporate existing guidelines into the regulations and add new provisions to address: NHPs imported as part of a trained animal act; NHPs imported or transferred by zoological societies; The transfer of NHPs from approved laboratories; and Non-live imported NHP products. CDC is also proposing that all NHPs be imported only through ports of entry where a CDC quarantine station is located.
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