Department of Health and Human Services October 11, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Region, Dallas District Office, in collaboration with the FDA Medical Device Industry Coalition (FMDIC), is announcing a public workshop entitled ``Quality System Regulation Educational Forum on Design Controls.'' This public workshop is intended to provide information about FDA's Medical Device Quality Systems Regulation (QSR) to the regulated industry, particularly small businesses. Date and Time: The public workshop will be held on April 4, 2008, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Omni Mandalay Hotel at Las Colinas, 221 East Las Colinas Blvd., Dallas (Irving), TX 75039. Directions to the facility are available at the FMDIC Web site at https://www.fmdic.org/. Contact Person: David Arvelo, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, e-mail david.arvelo@fda.hhs.gov. Registration: FMDIC has a $250 early registration fee. Early registration ends March 21, 2008. Registration is $350 thereafter. To register online, please visit https://www.fmdic.org/. As an alternative, you may send registration information including name, title, firm name, address, telephone and fax numbers, and e-mail, along with a check or money order for the appropriate amount payable to the FMDIC, to Dr. William Hyman, Texas A&M University, Department of Biomedical Engineering, 3120 TAMU, College Station, TX 75843-3120. Registration onsite will be accepted on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $350 payable to the FMDIC. The registration fee will be used to offset expenses of hosting the event, including meals, refreshments, meeting rooms, and materials. If you need special accommodations due to a disability, please contact David Arvelo (see Contact Person) at least 21 days in advance. Transcripts: Transcripts of this event will not be available due to the format of this workshop. Event handouts may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.

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.

This notice announces the 19th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the 15th meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).