Department of Health and Human Services September 26, 2011 – Federal Register Recent Federal Regulation Documents

This document corrects technical errors in the final rule entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2012'' that appeared in the August 8, 2011 Federal Register.

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 Food and Drug Administration (FDA) is announcing the availability of its report of scientific and medical literature and information concerning the use of non-standardized allergenic extracts in the diagnosis and treatment of allergic disease. The report is provided in a data file entitled ``Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts in the Diagnosis and Treatment of Allergic Disease.'' FDA is making this report available to provide information and obtain comments from public and private stakeholders. FDA will also seek input on the report from the Allergenic Products Advisory Committee (APAC) at a meeting to be held on October 25, 2011. FDA has not made any regulatory decisions concerning the report or the products discussed in the scientific literature and information cited. FDA will review comments and other information it receives, as part of its continued oversight of regulated products.

The Food and Drug Administration (FDA) is announcing that it has reorganized the Center for Drug Evaluation and Research (CDER) by establishing two offices and their substructures under the Office of Medical Policy: Office of Prescription Drug Promotion (OPDP) and Office of Medical Policy Initiatives (OMPI). OPDP will consist of the Division of Direct-to-Consumer Promotion and the Division of Professional Promotion. OMPI will consist of the Division of Medical Policy Development and Division of Medical Policy Programs.

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.