Department of Health and Human Services October 2009 – Federal Register Recent Federal Regulation Documents

This document corrects technical errors and typographical errors that appeared in the final rules and interim final rule with comment period published in the Federal Register on August 27, 2009 entitled ``Medicare Program; Changes to the 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.''

This document contains interim final rules implementing sections 101 through 103 of the Genetic Information Nondiscrimination Act of 2008. These provisions prohibit discrimination based on genetic information in health insurance coverage and group health plans.

The Secretary of Homeland Security determined on September 23, 2008 that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agentsin this case, Bacillus anthracis. On the basis of this determination, the Secretary of Health and Human Services is renewing the October 1, 2008 declaration by former Secretary Michael O. Leavitt of an emergency justifying the authorization of emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued by the Food and Drug Commissioner under 21 U.S.C. 360bbb-3(a). This notice is being issued in accordance with section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(4).

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 food additive petitions regarding animal feed.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.

This notice announces the award of expansion supplement grants to five grantees under the Family and Youth Services Bureau (FYSB)/ Family Violence Prevention and Services Program. Expansion supplement awards are made to four technical assistance (TA) providers to support their capacity to enhance victim services by providing more extensive TA to local domestic violence programs and State domestic violence coalitions under the Open Doors to Safety: Capacity-Building Grant (Capacity-Building) project. The supplemental funds, coupled with the TA providers' expertise, will enable Open Doors Safety Capacity- Building project grantees to receive more training and site-specific consultation, so that they may build program capacity. The awards will also support State-level collaboration between domestic violence organizations and child welfare agencies. These combined efforts will strengthen the ability of domestic violence programs and their partners to better serve survivors who have diverse backgrounds, experiences, and abilities.

The Food and Drug Administration (FDA) has determined the regulatory review period for EMEND FOR INJECTION and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.