Department of Health and Human Services December 7, 2005 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration published a notice in the Federal Register of November 22, 2005 (70 FR 70623) announcing an Advisory Commission on Childhood Vaccines meeting on December 12, 2005. The document announced that the public can join the meeting by attending in person or by audio conference call. The meeting will now be held by audio conference call only. This document amends the notice by changing the place of the meeting.

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 ``Risk Management, Corrective and Preventive Actions, and Training: An Educational Forum.'' This public workshop is intended to provide information about FDA's medical device quality systems regulation (QSR) to regulated industry, particularly small businesses. Date and Time: The public workshop will be held on April 28, 2006, from 8 a.m. to 5 p.m. Location: The public workshop will be held at The Westin City Center, 650 North Pearl St., Dallas, TX 75201. Directions to the facility are available at the FMDIC Web site at https://www.fmdic.org/. Contact Person: David Arvelo or Cassandra Davis, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952 or 214-253-4951, FAX: 214-253-4970, e-mail oraswrsbr@ora.fda.gov. Registration: FMDIC has a $150 early registration fee. Early registration begins on February 1, 2006, and ends April 14, 2006. Registration is $175 from April 15, 2006, to April 28, 2006. 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. Course space will be filled in order of receipt of registration with appropriate fees. Seats are limited; please submit registration form as soon as possible. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site will be done 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 $175 payable to the FMDIC. The registration fee will be used to offset expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. If you need special accommodations due to a disability, please contact David Arvelo or Cassandra Davis at least 7 days in advance.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of public workshop on FDA clinical trial statutory and regulatory requirements. This workshop was announced in the Federal Register of September 21, 2005 (70 FR 55405). The amendment is made to reflect a change in the Location portion of the document. There are no other changes.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the Citizens' Health Care Working Group (the Working Group) mandated by section 1014 of the Medicare Modernization Act.