Department of Health and Human Services February 2006 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Center for Complementary and Alternative Medicine (NCCAM), at the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: NCCAM Customer Service Data Collection. Type of Information Collection Request: Renewal. Need and Use of Information Collection: NCCAM provides the public, patients, families, health care providers, complementary and alternative medicine (CAM) practitioners, and others with the latest scientifically based information on CAM and information about NCCAM's programs through a variety of channels, including its toll-free telephone information service and its quarterly newsletter. To ensure that NCCAM is effectively serving all audiences, NCCAM needs to continue to measure customer satisfaction with NCCAM telephone interactions and the NCCAM newsletter and to assess which audiences are being reached through these channels. This effort involves a telephone survey consisting of 10 questions, which are asked of 25 percent of all callers, for an annual total of approximately 1,210 respondents; a print newsletter survey consisting of 10 questions, which is sent to all print newsletter subscribers, for an annual total of approximately 339 respondents; and an online newsletter survey consisting of 14 questions, which all visitors to the newsletter page on the NCCAM Web site have the option of completing until an annual total of 500 responses are received. NCCAM uses the data collected from the surveys to characterize NCCAM users and help program staff measure user satisfaction, assess impact of their communication efforts, tailor services to the public and health care providers, measure service use among special populations, and assess the most effective media and messages to reach these audiences. Frequency of Response: Once for the telephone survey, and three times for the newsletter survey (once every year to measure any changes in customer satisfaction and/or audience profile). Affected Public: Individuals and households. Type of Respondents: For the telephone survey, patients, spouses/family/friends of patients, health care providers, physicians, CAM practitioners, or other individuals contacting the NCCAM Clearinghouse; for the print newsletter survey, subscribers to the print NCCAM newsletter; and for the online newsletter survey, visitors to the newsletter page on NCCAM's Web site. The annual reporting burden is as follows.

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.

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

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (171) entitled ``Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.'' This guidance describes the procedures that the agency recommends for the review of requests for waiver of in vivo demonstration of bioequivalence for generic soluble powder oral dosage form products and Type A medicated articles.

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 the availability of a document entitled ``Guidance for Industry and FDA Staff: Whole Grain Label Statements.'' The draft guidance is intended to provide guidance to industry about what the agency considers to be ``whole grain'' and to assist manufacturers in labeling their products.

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 PR Pharmaceuticals, Inc. The supplemental NADA provides for subcutaneous injection, in the ear only, of a suspension implant of estradiol benzoate microspheres for increased rate of weight gain in suckling beef calves. It also adds the indication for use for increased rate of weight gain in steers fed in confinement for slaughter, previously approved at a lower dose, to the higher approved dose level.