Department of Health and Human Services April 16, 2014 – Federal Register Recent Federal Regulation Documents

This proposed rule would amend the fire safety standards for Medicare and Medicaid participating hospitals, critical access hospitals (CAHs), long-term care facilities, intermediate care facilities for individuals with intellectual disabilities (ICF-IID), ambulatory surgery centers (ASCs), hospices which provide inpatient services, religious non-medical health care institutions (RNHCIs), and programs of all-inclusive care for the elderly (PACE) facilities. Further, this proposed rule would adopt the 2012 edition of the Life Safety Code (LSC) and eliminate references in our regulations to all earlier editions. It would also adopt the 2012 edition of the Health Care Facilities Code, with some exceptions. We are providing the LSC citation, a description of the 2012 requirement, and an explanation of its benefits for health care facilities, patients, staff, and visitors over the 2000 version in each occupancy section.

The Food and Drug Administration (FDA) is announcing the rescheduling of a February 13, 2014, public workshop convened by the Institute of Medicine (IOM) entitled ``Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks in Drug Regulatory Decision-Making,'' published in the Federal Register of January 10, 2014. Due to inclement weather, the Federal Government was closed on February 13, 2014. We are rescheduling the public workshop to May 12, 2014, and extending the comment period for the public docket.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Orphan Drug Products: Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (Form FDA 3671).