Regulatory Update
Nuclear Regulatory Commission: Part 35 Update
NRC commissioners have been sent the staff-proposed final rule: "Medical Use of Byproduct Material—Recognition of Specialty Boards." If approved, the rule will be finalized through publication in the Federal Register. The rule modifies requirements for recognition of specialty boards whose certification may be used to demonstrate the adequacy of the training and experience of authorized users, authorized medical physicists, authorized nuclear pharmacists, and radiation safety officers. It also revises the requirements for demonstrating the adequacy of training and experience for the alternate pathway.
To access a copy of the proposed final rule, go to the ACR Web site (www.acr.org) and select Federal Agency Relations under the Advocacy and ACRa tab.
Department of Energy Budget Cuts Threaten Nuclear Medicine Research
Funding for nuclear medicine programs in the Department of Energy's (DOE) Office of Science is slated for drastic cuts in the federal fiscal year (FY) '06 budget proposal. If adopted, DOE funding for medical applications research would be slashed from its current level of approximately $37 million in FY '05 to $13.6 million in FY '06. The ACR, along with the Society of Nuclear Medicine, is lobbying Congress and the administration to oppose budget cuts to this important program. Members are encouraged to join in advocacy efforts by sending a letter to their legislators.
FDA-NCI Fellowship Program to Bridge Research, Regulation in Cancer Product Development
The Food and Drug Administration (FDA) and the National Cancer Institute (NCI) have created a research and regulatory review fellowship program to facilitate the development of a new generation of molecular-based cancer products. The program will train researchers to bridge the processes from scientific discovery through clinical development and regulatory review of cancer therapies and diagnostic products. Researchers would gain valuable experience through instruction and work opportunities at NCI and FDA. The goal is to help advance new products by exposing researchers to regulatory requirements in the early stages of cancer product development. For additional information on the programs, go to the FDA Web site, www.fda.gov.