Department of Health and Human Services June 7, 2007 – Federal Register Recent Federal Regulation Documents

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.

The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry and FDA staff entitled ``Assayed and Unassayed Quality Control Material.'' The guidance describes FDA's current practices concerning assayed an unassayed quality control material, including information to include in a 510(k) for assayed quality control material, as well as labeling recommendations.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the Food and Drug Administration, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent 7,014,816, issued March 21, 2006, entitled ``Food Quality Indicator Device'' [E-093-1997/0-US-03] and foreign counterparts; to Litmus, LLC, having a place of business in Little Rock, AR. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the manufacture, use, distribution and sale of the Food Quality Indicator Device as claimed in the licensed patent rights.

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

This document corrects technical errors that appeared in the proposed rule entitled ``Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates'' that appeared in the May 3, 2007 Federal Register.