Department of Health and Human Services July 21, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public workshop to discuss the issues associated with the development and implementation of feasibility trials for local treatment of breast cancer by thermal ablation (i.e., cryoablation, focused ultrasound, interstitial laser, microwave, radiofrequency ablation). We are inviting individuals, companies, organizations, and other stakeholders to attend this public workshop to discuss how standardized protocols for evaluation of tissue biopsy pathology, selection of tumors amenable to ablation, image guidance for ablation, post-ablation imaging and assessment, and tissue pathology of ablated specimens can be developed and used in breast cancer thermal ablation clinical trials. The public workshop will also serve as a forum for discussing where within the multispecialty care path involving operative therapy, chemotherapy, and radiation therapy, thermal ablation may play a role. Date and Time: The public workshop will be held on September 15, 2008, from 9 a.m. to 6 p.m. Online registration is available at https:// www.blsmeetings.net/2008ThermalAblationWorkshop until 5 p.m. on August 30, 2008 (see section III of this document for details). Location: The public workshop will be held at the FDA White Oak Campus, conference rooms 2047 F and G (https://grouper.ieee.org/groups/ scc34/sc2/meetinginfo/MeetingWhiteOak15-18OCT2007/WhiteOak CampusInfo2007.pdf) located at 10903 New Hampshire Ave., Silver Spring, MD 20993. Contact: Binita Ashar, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3600, e-mail: Binita.Ashar@FDA.HHS.gov. If you need special accommodations due to a disability, please contact Paula Gumbs at 301-594-4453 at least 7 days in advance.

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Kellex/Pierpont facility in Jersey City, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 2008, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC: