Department of Health and Human Services June 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 If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing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.

The Food and Drug Administration (FDA) has determined the regulatory review period for RAPLON 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) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Div. of Pfizer, Inc. The supplemental NADA provides for revising nomenclature for two bovine respiratory pathogens on labeling for spectinomycin sulfate injectable solution.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices.'' The guidance sets forth the agency's recommendations for ensuring the safety of refrigerated carrot juice and other low-acid refrigerated juices. The guidance is in response to six recent cases of botulism poisoning linked to refrigerated carrot juice that occurred in the United States and Canada.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatReceipt Date.'' This draft guidance provides information on what FDA will consider to be the receipt date for certain submissions provided in electronic format to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The receipt date of these submissions has a number of important regulatory implications. Under the draft guidance, FDA will not consider a submission to be received until it has passed a technical validation check to ensure that the submission can be opened, processed, and archived.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor address for Watson Laboratories, Inc.

The Department of Health and Human Services is pleased to announce the upcoming HHS Public Health Emergency Medical Countermeasures Enterprise Stakeholders Workshop, to be held July 31- August 2, 2007, in Washington, DC. This three-day event is an open meeting that seeks to bring together representatives from the pharmaceutical and biotechnology industries, professional societies, state and local public health organizations, the academic research and development community, public interest groups, stakeholder federal agencies, and Congress. Featured topics will include the Biomedical Advanced Research and Development Authority (BARDA); Project BioShield; the HHS PHEMCE Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats; the HHS Pandemic Influenza Implementation Plan; and contracting with HHS for medical countermeasure development and acquisition.

The Food and Drug Administration (FDA) is announcing that we have revised the Advisory Committee Information Hotline (the hotline). The hotline provides the public with access to the most current information available on FDA advisory committee meetings. This notice supersedes all previously published announcements of the hotline.

The Food and Drug Administration (FDA) has determined the regulatory review period for NAMENDA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of two applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.