Department of Health and Human Services June 2, 2006 – Federal Register Recent Federal Regulation Documents

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the inventions embodied in: U.S. Provisional Patent Application S/N 60/378,408, filed May 6, 2002 (E-144-2002/0-US-01), PCT Application, PCT/US03/14292, filed May 6, 2003, (E-144-2002/0-PCT-02), converted into 03736557.4 (E-144-2002/0- EP-04) filed in Europe on December 3, 2004, and 2003237187 (E-144-2002/ 0-AU-05) filed in Australia on November 3, 2004, 10/513,725 (E-144- 2002/0-US-03) filed in USA on November 5, 2004, as well as 2,484,930 (E-144-2002/0-CA-06) filed in Canada on November 5, 2004, entitled ``Novel broadly cross-reactive HIV neutralizing human monoclonal antibodies selected from Fab phage display libraries using a novel strategy based on alternative antigen panning,'' Inventors: Dimiter S. Dimitrov (NCI) and Mei-Yun Zhang (SAIC), to Profectus Biosciences, Inc., having a place of business in Baltimore, Maryland. The patent rights in these inventions have been assigned to the United States of America.

The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of titanium dioxide coated mica-based pearlescent pigments as color additives in food. This action is in partial response to a petition filed by EM Industries, Inc.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q9 Quality Risk Management.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The guidance is intended to enable regulators and industry to make more effective and consistent risk- based decisions.

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) 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 PRA).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Notice of Participation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request the Office of Management and Budget (OMB) to allow the proposed information collection project ``Continuance of the Medical Expenditure Panel SurveyHousehold and Medical Provider Component through 2009''. In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed collection.