Department of Health and Human Services April 2012 – Federal Register Recent Federal Regulation Documents

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.

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 information collection for administrative detention and banned medical devices.

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

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

This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a worldwide, exclusive license to practice the inventions embodied in the patent application referred to below to Sanitas Inc., having a place of business in La Jolla, California. The patent rights in these inventions have been assigned to the government of the United States of America. The patent application(s) to be licensed are:

The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards 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); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF 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:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act.'' This guidance document establishes the procedures for the submission, FDA review, and FDA response to requests for information regarding the class in which a device has been classified.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Jose Concepcion for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Mr. Concepcion was convicted of conspiracy to commit an offense against the United States, that the conduct that served as the basis for the felony conspiracy conviction relates to the development or approval, including the process for development or approval, of any drug product and relates to the regulation of drug products under the FD&C Act, and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Mr. Concepcion was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Concepcion failed to request a hearing. Mr. Concepcion's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA) has determined the regulatory review period for FLECTOR 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 issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Shashikant Shah for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Shah was convicted of one count of conspiracy to commit an offense against the United States for conduct relating to the development and approval, including the process for development and approval, of a drug product and to the regulation of drug products under the FD&C Act. In addition, the type of conduct underlying the conviction undermined the process for the regulation of drugs. Mr. Shah was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Shah failed to request a hearing, which constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (219) entitled ``Draft Guidance for Industry on Statistical Evaluation of Stability Data, VICH GL51.'' This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the VICH guidance entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products, GL3(R)'' to propose a retest period or shelf life in a registration application.