Department of Health and Human Services June 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the issuance of seven Emergency Use Authorizations (EUAs) (the Authorizations), two of which were amended after initial issuance, for certain in vitro diagnostic devices. FDA is issuing the Authorizations and amendments thereto under the Federal Food, Drug, and Cosmetic Act (the act). The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostics. The Authorizations follow the determination by the then Acting Secretary of the U.S. Department of Health and Human Services Charles E. Johnson (the Acting Secretary) that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza A, or 2009 H1N1 flu) that affects, or has the significant potential to affect, national security. On the basis of such determination, the Acting Secretary declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics, accompanied by emergency use information subject to the terms of any authorization issued under the act. The Authorizations, which include explanations of the reasons for their issuance or reissuance, are reprinted in this document.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Avoiding Readmissions in Hospitals Serving Diverse Patients.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.

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 a survey on Consumers' Emotional and Cognitive Reactions to Food Recalls.

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.

This document corrects technical errors in the notice entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and Fiscal Year 2010 Rates and to the Long-Term Care Hospital Prospective Payment System and Rate Year 2010 Rates: Final Fiscal Year 2010 Wage Indices and Payment Rates Implementing the Affordable Care Act'' which appeared in the June 2, 2010 Federal Register.

The Food and Drug Administration (FDA) and the Federal Communications Commission (FCC) are jointly sponsoring a public meeting entitled ``Enabling the Convergence of Communications and Medical Systems: Ways to Update Regulatory and Information Processes.'' The purpose of this meeting is to identify the challenges and risks posed by the proliferation of new sophisticated medical implants and other devices that utilize radio communications to effectuate their function, as well as challenges and risks posed by the development and integration of broadband communications technology with healthcare devices and applications. While the general format for this meeting is outlined in this document, the details will be further informed by the comments received, and a final agenda will be published on the Internet in the future.

The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft document entitled ``CDER Data Standards Plan Version 1.0'' (draft plan). The draft plan outlines the general approach proposed for development of a comprehensive data standards program in the Center for Drug Evaluation and Research (CDER). The draft plan identifies key objectives for a data standards program at CDER, processes to be developed to ensure successful use of those standardized data, and a set of recommended projects to begin in calendar year (CY) 2010.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet, Inc. The supplemental NADA provides for the manufacture of florfenicol Type B medicated swine feeds.

The Food and Drug Administration (FDA) is confirming the effective date of April 27, 2010, for the final rule that appeared in the Federal Register of March 26, 2010. The final rule amended the color additive regulations by increasing the permitted use level of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp.