Department of Health and Human Services September 21, 2009 – Federal Register Recent Federal Regulation Documents

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting and request for public comment on proposed enhancements to occupational health surveillance data collection through the Healthcare Personnel Safety (HPS) Component of the National Healthcare Safety Network (NHSN).

The Bureau of Indian Affairs (BIA) and Indian Health Service (IHS) are proposing to submit the information collection, titled ``Indian Self-Determination and Education Assistance Act Programs, 25 CFR 900'' to the Office of Management and Budget for renewal. The current approval, designated by OMB Control Number 1076-0136, expires on February 28, 2010. The information is collected to process contracts, grants, or cooperative agreements for award by the BIA and the IHS, as authorized by the Indian Self-Determination and Education Assistance Act. The Department of the Interior and the Department of Health and Human Services invite you to submit comments on the proposed renewal, as described below.

The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER), in collaboration with FDA's Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), and Center for Devices and Radiological Health (CDRH), is announcing a public hearing to discuss issues related to the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools. FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry. This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools. FDA is seeking input on a number of specific questions but is interested in any other pertinent information participants in the hearing would like to share.

AHRQ is announcing the availability of a document entitled: ``Patient Safety Organizations: A Compliance Self-Assessment Guide.'' The Patient Safety and Quality Improvement Act of 2005, Public Law 109- 41, 42 U.S.C. 299-b21b-26 (Patient Safety Act) provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) (42 CFR part 3) authorizes AHRQ, on behalf of the Secretary of HHS, to: list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing; and request additional information and conduct reviews (including announced or unannounced site visits) to assess PSO compliance. To assist PSOs in making the required attestations and preparing for a compliance review, AHRQ developed the sample questions in this guide to encourage each PSO to take a thorough and systematic approach to compliance. The guide recognizes that each PSO's approach to compliance may be different based upon the specific mission it has chosen, the specific activities and expertise it offers to healthcare providers, and its size and mode of operation. Thus, these questions are merely illustrative; some questions will not be applicable or even appropriate for every PSO. The guide does not establish new standards or requirements beyond those that are established by the Patient Safety Rule.