Department of Health and Human Services April 2005 – Federal Register Recent Federal Regulation Documents

Pursuant to Pub. L. 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the eighth meeting of the Advisory Committee on Organ Transplantation (ACOT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on May 9, 2005, and from 9 a.m. to 3 p.m. on May 10, 2005, at the Rockville DoubleTree Hotel, 1750 Rockville Pike, Rockville, Maryland 20852. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).

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 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 a 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 the collection of information associated with the submission of notifications of health claims or nutrient content claims based on authoritative statements of scientific bodies of the U.S. Government.

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 Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the NICEATM announce two upcoming scientific symposia entitled, ``Mechanisms of Chemically-Induced Ocular Injury and Recovery'' and ``Minimizing Pain and Distress in Ocular Toxicity Testing.''

The Food and Drug Administration (FDA) is announcing a public meeting to provide information and receive comments on the International Conference on Harmonization (ICH) in advance of its next next Steering Committee and Expert Working Group meetings in Brussels, Belgium, May 9 through 12, 2005. Scheduled for the ICH meetings is an Efficacy Brainstorming Session focusing on the review of the existing efficacy guidelines and their need for updating as well as potential new topics for consideration. To promote a fuller discussion of this topic the public meeting will be expanded to include public input on initiatives related to current ICH efficacy guidelines and consider needs for further information both within and between existing guidances. These initiatives include electronic source data, clinical development plan summaries, Health Level 7 structured product labeling, and other initiatives including information exchange standards (e.g., Electronic Common Technical Document (eCTD) and terminology standards). Date and Time: The meeting will be held on April 20, 2005, from 9 a.m. to 5:30 p.m. Location: The meeting will be held at The DoubleTree Hotel and Executive Meeting Center, 1750 Rockville Pike, Rockville, MD. A block of rooms for those wishing to attend the meeting have been set aside at the government rate. Please contact the hotel directly for your reservation: DoubleTree Hotel and Executive Meeting Center, 301-468- 1100, FAX: 301-468-0308. Contact Person: Sema Hashemi, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 3050, FAX: 301-480-0716, e-mail: Sema.Hashemi@fda.hhs.gov. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and FAX number), and written material and requests to make oral presentations, to the contact person by April 14, 2005. Transcripts: Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page. If you need special accommodations due to a disability, please contact Sema Hashemi at least 7 days in advance.

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.