Department of Health and Human Services February 21, 2006 – 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.

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, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in: E-171-2002, ``Cell Culturing and Storage Systems, Devices and Methods'' U.S. Patent Application 10/334,565 filed December 30, 2002; European Patent Application 03808601.3; rights are also pending in Canada and Australia; to KW Company, LLC, a New York company having its headquarters in Woodstock, New York. The United States of America is the assignee of the patent rights of the above invention. The contemplated exclusive license may be granted in the field of sales of devices for cell culturing, monitoring and containment.

The Food and Drug Administration (FDA) is canceling the meeting on the Animal Drug User Fee Act scheduled for February 24, 2006. This meeting was announced in the Federal Register of December 28, 2005 (70 FR 76851). FDA will continue to seek public comments relative to the program's overall performance and reauthorization as directed by Congress. FDA will publish another notice in the Federal Register announcing any plans for rescheduling the public meeting.

This notice announces the third meeting of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

This notice announces the third meeting of the American Health Information Community Electronic Health Record Workgroup in accordance with the Federal Adivsory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

NIOSH intends to review and evaluate toxicity data for the halogenated anesthetic agents of isoflurane, desflurane, and sevoflurane. The current NIOSH recommended exposure limit (REL) of 2 parts per million (ppm) as a 60-minute ceiling for the halogenated gases (chloroform, trichloroethylene, halothane, methoxyflurane, fluroxene, and enflurane) was established in 1977 [NIOSH 1977]. The halogenated anesthetic agents, isoflurane, desflurane, and sevoflurane, were subsequently introduced and are not included in the 1977 NIOSH recommendation. Isoflurane, desflurane, and sevoflurane are commonly used for anesthesia in modern hospitals; however, no occupational exposure limits exist for these agents. NIOSH is requesting: (1) Comments and information relevant to the evaluation of health risks associated with occupational exposure to isoflurane, desflurane, and sevoflurane, (2) reports or other data that demonstrate adverse health effects in workers exposed to isoflurane, desflurane, and sevoflurane, and (3) information pertinent to establishing a REL for isoflurane, desflurane, and sevoflurane.