Department of Health and Human Services March 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for A180 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 animal drug product.

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) has determined the regulatory review period for EMTRIVA 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.

The Food and Drug Administration (FDA) has determined the regulatory review period for ONYX LES 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 medical device.

The Food and Drug Administration (FDA) has determined the regulatory review period for REVLIMID 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.

The Food and Drug Administration (FDA) has determined that DURICEF (cefadroxil USP) Tablets, 1 gram (g), and Capsules, 500 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve abbreviated new drug applications (ANDAs) for cefadroxil USP tablets, 1 g, and cefadroxil USP capsules, 500 mg.

This notice announces the sixth meeting 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. The primary purpose of the sixth meeting is to enable the EMTALA TAG to hear additional testimony and further consider written responses from medical societies and other organizations on specific issues considered by the EMTALA TAG at previous meetings. The public is permitted to attend this meeting and, to the extent that time permits and at the discretion of the Chairperson, the EMTALA TAG may hear comments from the floor.

This notice invites nominations of members to the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). There will be two vacancies on the Panel as of October 1, 2007. Consequently, this solicitation is for two new members. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary, DHHS, (the Secretary) and the Administrator, CMS, (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We consider the Panel's advice as CMS prepares its annual updates of the hospital Outpatient Prospective Payment System (OPPS). The Secretary rechartered the Panel in 2006 for a 2-year period effective through November 21, 2008. Nominations: We will consider nominations if they are received no later than 5 p.m. on May 30, 2007. Please mail or hand deliver nominations to the following address: CMS; Attn: Shirl Ackerman-Ross, Designated Federal Official (DFO), Advisory Panel on APC Groups; Center for Medicare Management, Hospital & Ambulatory Policy Group, Division of Outpatient Care; 7500 Security Boulevard, Mail Stop C4-05-17; Baltimore, MD 21244-1850. Web site: For additional information on the APC Panel and updates to the Panel's activities, search our Web site at the following: http:/ /www.cms.hhs.gov/FACA/05AdvisoryPanelonAmbulatory PaymentClassificationGroups.asp#TopOfPage. E-Mail Address: The E-mail address for the Panel is as follows: CMSAPCPanel@cms.hhs.gov. News media representatives must contact our Public Affairs Office at (202) 690-6145. Advisory Committees' Information Lines: The CMS Advisory Committees' Information Line is 1-877-449-5659 (toll free) and (410) 786-9379 (local).

This notice announces the extension of the expiration date for certain geographic reclassifications as implemented by Division B, Title I, section 106 of the Tax Relief and Health Care Act of 2006. These geographic classifications, which affected hospitals' wage indices, were previously set to expire on March 31, 2007 and are now extended to September 30, 2007.