Department of Health and Human Services December 16, 2005 – Federal Register Recent Federal Regulation Documents

For more than a quarter century, the National Toxicology Program (NTP) testing program has provided extensive and useful scientific information for predicting human health hazards and protecting public health. The NTP periodically conducts reviews of animal models used in its bioassays to critically analyze their predictive power and determine whether the protocols for these studies should be altered. As part of this effort, the NTP is convening a workshop titled ``Hormonally-Induced Reproductive Tumors: Relevance of Rodent Bioassays.'' The 2\1/2\ day workshop will be held on May 22-24, 2006, at the Marriott Raleigh Crabtree Valley, 4500 Marriott Drive, Raleigh, NC 27612. The workshop's overall goal is to determine the adequacy and relevance to human disease outcome of rodent models for four types of hormonally-induced reproductive tumors (ovary, mammary gland, prostate, and testis). Other topics for discussion include proposed modes of action (for each tumor type and for hormonal tumors in general), dose response for tumor induction, predictiveness of rodent pre-neoplastic events for humans, the importance of the inclusion of an in utero exposure in the etiology of specific tumors, and the concept of ``additivity to background'' when normal hormones are present with homeostatic control mechanisms. The program will include plenary sessions as well as four breakout group sessions for in-depth discussions. This meeting is open to the public with time set aside for public comments. Attendance is limited by the space available to approximately 100 public attendees. Individuals may register to attend the workshop on a first-come, first-served basis per the procedures outlined below. A copy of the agenda and any additional information about the workshop, including background materials, public comments, and invited participants, will be posted on the NTP Web site when available (see NTP Web site https://ntp.niehs.nih.gov select ``Meetings and Workshops'').

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.

The National Toxicology Program (NTP) established the Nanotechnology Working Group (``the NWG'') to the NTP Board of Scientific Counselors in 2005 to enhance public and stakeholder input into the NTP nanotechnology research program. The second meeting of the NWG is scheduled for March 15, 2006 at the Holiday Inn-Rosslyn at Key Bridge (1900 N Fort Myer Drive, Arlington, VA 22209). This meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on any topic discussed at the meeting. A copy of the agenda and any additional information about the meeting will be posted on the NTP website when available (see NTP Web site https://ntp.niehs.nih.gov select ``Meetings and Workshops'').

The Food and Drug Administration (FDA) is withdrawing approval of 15 new animal drug applications (NADAs) because the products are no longer manufactured or marketed. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of the NADAs.