Department of Health and Human Services May 2010 – Federal Register Recent Federal Regulation Documents

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.

This final rule revises the November 25, 2008 final rule entitled, ``Medicaid Programs; Premiums and Cost Sharing (73 FR

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.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Partnerships to Advance the National Occupational Research Agenda (NORA)''.

This notice announces a public meeting to receive comments and recommendations (including accompanying data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for a specified list of new Clinical Procedural Terminology (CPT) codes for clinical laboratory tests in calendar year (CY) 2011. The meeting provides a forum for interested parties to make presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for CY 2011, which will be effective on January 1, 2011. The development of the codes for clinical laboratory tests is largely performed by the CPT Editorial Panel and will not be further discussed at the meeting.

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.

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.

In accordance with the Privacy Act of 1974 (5 U.S.C. 522a), as amended, OCSE is publishing notice of a computer matching program between OCSE and state agencies administering the Temporary Assistance for Needy Families (TANF) program.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), will hold a second public meeting concerning the proposed rule for Total Inward Leakage Requirements for Respirators that was published in the Federal Register on Friday, October 30, 2009 (74 FR 56141). The purpose of the meeting is to allow participants to make presentations to NIOSH, share results of any new research that may be available or in process in the area of filtering facepiece or other half-mask respirator inward leakage measurement, and offer any additional comments on the anticipated economic impact of the proposed rule.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated May 2010. The guidance announced in this notice provides blood collecting establishments and manufacturers of plasma derivatives with comprehensive FDA recommendations intended to minimize the possible risk of transmission of CJD and vCJD from blood and blood products. This guidance document amends the January 2002 guidance document of the same title by: Incorporating donor deferral recommendations for donors who have received a transfusion of blood or blood components in France since 1980, providing updated scientific information on CJD and vCJD, revising labeling recommendations for Whole Blood and blood components intended for transfusion, and recognizing AABB's full Donor History Questionnaire Version 1.3 as an acceptable mechanism for collection of donor history information. The guidance announced in this notice supersedes the guidance document entitled ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated January 2002 (2002 guidance), and the draft guidance document entitled ``Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products''' dated August 2006 (2006 draft guidance).

This proposed rule would revise the conditions of participation (CoPs) for both hospitals and critical access hospitals (CAHs). These revisions would allow for a new credentialing and privileging process for physicians and practitioners providing telemedicine services.