Department of Health and Human Services September 2005 – Federal Register Recent Federal Regulation Documents

This document corrects typographical and technical errors that appeared in the August 4, 2005 Federal Register, entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2006.''

This document corrects technical errors in the final rule that appeared in the August 12, 2005 Federal Register entitled ``Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2006 Rates.''

This document corrects technical errors that appeared in the FY 2006 Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) regulation entitled ``Inpatient Rehabilitation Facility Prospective Payment System for FY 2006'' (70 FR 47880).

This notice announces the selection of a new member of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions.

This proposed rule would implement section 1016 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) (Pub. L. 108-173) by establishing the loan forgiveness criteria for qualifying hospitals who receive loans under the Health Care Infrastructure Improvement Program.

The Food and Drug Administration (FDA) is amending its regulations concerning the maximum sodium levels permitted for foods that bear the implied nutrient content claim ``healthy.'' The agency is retaining the currently effective, less restrictive, ``first-tier'' sodium level requirements for all food categories, including individual foods (480 milligrams (mg)) and meals and main dishes (600 mg), and is dropping the ``second-tier'' (more restrictive) sodium level requirements for all food categories. Based on the comments received about technological barriers to reducing sodium in processed foods and poor sales of products that meet the second-tier sodium level, the agency has determined that requiring the more restrictive sodium levels would likely inhibit the development of new ``healthy'' food products and risk substantially eliminating existing ``healthy'' products from the marketplace. After reviewing the comments and evaluating the data from various sources, FDA has become convinced that retaining the higher first-tier sodium level requirements for all food products bearing the term ``healthy'' will encourage the manufacture of a greater number of products that are consistent with dietary guidelines for a variety of nutrients. The agency has also revised the regulatory text of the ``healthy'' regulation to clarify the scope and meaning of the regulation and to reformat the nutrient content requirements for ``healthy'' into a more readable set of tables, consistent with the Presidential Memorandum instructing that regulations be written in plain language.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on reprocessed single-use device labeling.

This notice announces the first meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).

This Notice announces the administrative close-out of the Ricky Ray Hemophilia Relief Fund Program (the Program). All business concerning petitions and related payment documentation associated with the Program will conclude on October 31, 2005. As of that date, the Program will cease to accept or process any additional documentation submitted by individuals (or their representatives) relating to the eligibility or payment of petitions still pending. Remaining funds will be returned to the United States Treasury, and the Program will archive all outstanding documentation at the Washington National Records Center in Suitland, Maryland, in accordance with the requirements of the National Archives and Records Administration.

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 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 providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration and the National Library of Medicine (NLM). The purpose of this MOU is to assign responsibilities to FDA's Center for Drug Evaluation and Research (CDER) and NLM for the distribution of product labeling.