Department of Health and Human Services July 29, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA), Office of Critical Path Programs and the Clinical Trials Transformation Initiative (CTTI) are cosponsoring a 3-day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials. This training course is intended to provide investigators with expertise in the design, conduct, and analysis of clinical trials; improve the quality of clinical trials; and enhance the safety of trial participants. Senior FDA staff will communicate directly with clinical investigators on issues of greatest importance for successful clinical research. Date and Time: The training course will be held on November 7 and 8, 2011, from 8 a.m. to 5 p.m., and on November 9, 2011, from 8 a.m. to 3:30 p.m. Location: The course will be held at the National Labor College, 10000 New Hampshire Ave., Silver Spring, MD 20903-0002. Contact Person: Leonard Sacks, Office of Critical Path Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4174, Silver Spring, MD 20993, 301-796-8502. Registration: Register by October 21, 2011. The registration fee is $400 per person. The fee includes course materials and onsite lunch. Early registration is recommended because seating is limited. There will be no onsite registration. Register online for the training course at the registration/ information Web site at https://www.trialstransformation.org/fda- clinical-investigator-training-course or by FAX to 919-660-1769. An e- mail will be sent confirming your registration. Attendees are responsible for their own accommodations. A block of rooms has been reserved under ``FDA Clinical Investigator Course'' at the National Labor College at a reduced conference rate. Reservations can be made at https://www.supportnlc.org/Room_Reservations.html or by calling 301-431-6400. FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register. Registration materials, payment procedures, accommodation information, and a detailed description of the course can be found at https://www.trialstransformation.org/fda-clinical-investigato r- training-course. If you need special accommodations due to a disability, please contact Leonard Sacks at least 7 days in advance. Persons attending the course are advised that FDA is not responsible for providing access to electrical outlets.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through June 2012.

The Food and Drug Administration (FDA) is announcing the re- establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging Drugs Advisory Committee in the Agency's list of standing advisory committees in FDA's regulations.