Department of Health and Human Services June 27, 2012 – 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.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Implementation of the Food and Drug Administration Amendments Act of 2007'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance published in the Federal Register of June 22, 2010.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Data to Support Food and Nutrition Product Communications as Used by the Food and Drug Administration'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 Food and Drug Administration (FDA) is announcing that a collection of information entitled ```Real Time' Surveys of Consumers' Knowledge, Perceptions and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls'' has been approved by the Office of Management and Budget (OMB) 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 publication of the following document entitled ``NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012.'' NIOSH is making available a copy of Appendix A at https:// www.cdc.gov/niosh/docs/2012-150. Background: The NIOSH Alert: NIOSH published Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings in September 2004 (https://www.cdc.gov/niosh/docs/ 2004-165/). Appendix A of this Alert defined hazardous drugs and provided a list of drugs that were considered hazardous and required special handling. In 2010, NIOSH published an update to this list (https://www.cdc.gov/niosh/docs/2010-167/). Since publishing the 2010 update to the list, NIOSH reviewed approximately 70 new drugs that received FDA approval and approximately 180 drugs that received new special warnings (usually black box warnings) based on reported adverse effects in patients covering the time period from October 2007 to December 2009. From this list of approximately 250 drugs, NIOSH determined 26 drugs to have one or more characteristics of a hazardous drug. In addition, NIOSH removed 15 drugs from the 2012 list because they did not meet the NIOSH definition, were no longer available in the U.S or were regulated by other government entities. NIOSH published this preliminary list for comment in NIOSH Docket Number 190. After expert panel review, public review and comment, and review of the scientific literature, NIOSH has developed a revised list of hazardous drugs. Along with drugs initially identified in the 2010 Hazardous Drug List, NIOSH is adding a total of 26 new drugs to the 2012 NIOSH List of Hazardous Drugs and is deleting 15 drugs. This guidance document does not have the force and effect of law.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). 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 Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Advisory Council will discuss implementation of the National Plan to Address Alzheimer's Disease.

AHRQ has delisted Medical Informatics as a Patient Safety Organization (PSO) due to its failure to correct a deficiency. The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity is to conduct activities to improve patient safety and the quality of health care delivery. HHS issued the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs.