Department of Health and Human Services April 2, 2010 – Federal Register Recent Federal Regulation Documents

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)(4). On April 26, 2009, the then Acting Secretary of HHS determined that a public health emergency exists nationwide involving Swine Influenza A (now known as 2009 H1N1 Influenza A, or 2009 H1N1 Influenza) that affects or has significant potential to affect national security. On the basis of this determination, on April 26 and April 27, 2009, the then Acting Secretary declared emergencies justifying the authorization of emergency use of certain in vitro diagnostic, antiviral, and personal respiratory protection products accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs (Commissioner) under 21 U.S.C. 360bbb- 3(a). The then Acting Secretary also specified that these declarations are declarations of emergency as defined by former Secretary Michael O. Leavitt in the October 10, 2008 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Influenza Antivirals Oseltamivir Phosphate and Zanamavir, as amended, and the December 17, 2008 Declaration under the PREP Act for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices. The Secretary renewed the then Acting Secretary's determination that a public health emergency exists nationwide involving Swine Influenza A (now known as 2009 H1N1 Influenza) on July 24, October 1, and December 28, 2009, and March 26, 2010. Also on March 26, 2010, the Secretary renewed the then Acting Secretary's declarations of emergency justifying the authorization of emergency use of certain in vitro diagnostic, antiviral, and personal respiratory protection products accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs (Commissioner) under 21 U.S.C. 360bbb-3(a).

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).

This notice announces a meeting to discuss the technical specifications for AHRQ's common definitions and reporting formats (Common Formats) Version 1.1 that allow for reporting of patient safety information to Patient Safety Organizations (PSOs). The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b-23) authorizes the collection of this information in a standardized manner, as explained in the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008: 73 FR 70731- 70814. As authorized by the Secretary of HHS, AHRQ coordinates the development of the Common Formats that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events. More information on the Common Formats Version 1.1, including the technical specifications, can be obtained through AHRQ's PSO Web site: https://www.PSO.AHRQ.gov/.