Newsbriefs NEMA Releases and Radiological Health (CDRH) at will apply assessment methods devel- Intraoperative Gamma the FDA announced on April 1 the oped by the group to their own prob- Probe Standard signing of an interagency agreement lems, and carry with them the princi- establishing a joint Laboratory for the ples and tools for longer-term use The National Electrical Manufac- Assessment of Medical Imaging Sys- when they leave. turers Association (NEMA) announced tems (LAMIS). The purpose of this Codirectors of the program are on March 1 the release of a standard effort is to assess and optimize high- Peter Kirchner, MD, acting director that provides uniform criteria for resolution, high-dimensional medical of the Intramural Science Program at NEWSLINE conducting and reporting perfor- imaging systems. NIBIB, and David Brown, PhD, di- mance measures and quality control According to a joint press release, rector of the Division of Electronics tests on nonimaging intraoperative the goals of LAMIS are to develop and Computer Science, Office of Sci- gamma probes for surgical applica- evaluation methodology based on ad- ence and Technology at CDRH. tions. NU 3-2004, Performance Mea- vanced statistical tools, determine National Institute of Biomedical surements and Quality Control fundamental limitations imposed on Imaging and Bioengineering Guidelines for Non-Imaging Intraop- imaging systems, characterize and erative Gamma Probes, is the first Center for Devices and optimize medical imaging systems standard to address instrumentation Radiological Health and components, build consensus, in the rapidly emerging clinical prac- provide advanced image evaluation tice of sentinel lymph node detection methods, and develop an environ- March NRC ACMUI in diagnosis and treatment planning ment conducive to rapid deployment Meeting in cancer. of improved imaging systems and The Nuclear Regulatory Com- “This standard will make it pos- components to the patient commu- mission (NRC) held a meeting of the sible to compare devices from differ- nity. In addition, optimal hardware Advisory Committee on the Medical ent manufacturers against the com- designs and approaches for image re- Uses of Isotopes (ACMUI) on March mon criteria to ensure that devices construction and extracting features 1 and 2 at its Rockville, MD, head- operate properly, and it will allow will be pursued. quarters. users to be confident in the devices “The joint agreement with CDRH A closed session on the first they select,” said Carl Bosch, chair of is an exciting opportunity for the morning focused on ethical and the NEMA Intraoperative Gamma NIBIB and will provide us with an- security-related issues. In addition to Probe Task Force, which developed other avenue for exploring innovative a briefing for NRC Commissioners, the standard. and high-quality technologies and in- the open segments of the meeting in- The advantages of sentinel node terdisciplinary research that will lead cluded discussions on proposed identification and biopsy are cur- to improved healthcare. The CDRH changes to abnormal occurrence cri- rently being investigated in breast medical imaging program is stellar, teria and defining medical events in- cancer, melanoma, urologic tumors and we are proud to collaborate with volving prostate seed implants. Tran- and a range of other malignancies. an organization of this caliber,” said scripts of the meeting and written Other clinical applications of gamma NIBIB Director Roderic I. Pettigrew, comments are available at www. probes, such as localization of para- PhD, MD. “CDRH welcomes this op- nrc.gov/reading-rm/doc-collections/ thyroid tumors around the thyroid portunity to collaborate with NIBIB,” acmui/tr. gland, are also expected to benefit said CDRH Director David W. Nuclear Regulatory Commission from the standard’s guidance about Feigal, MD, MPH. “Not only will performance and routine quality as- this new agreement strengthen the NRC Proposes New Fees surance. imaging programs of both organiza- The Nuclear Regulatory Com- Information about purchase of tions, but it will also benefit the pub- mission announced on February 3 its NU 3-2004 is available at www. lic by leading to the earlier availabil- proposed amendments to regulations nema.org/r/std/nu3/. ity of safe, effective medical imaging for the licensing, inspection, and an- National Electrical Manufacturers technologies.” nual fees it charges applicants and Association To carry out the mission of the licensees for fiscal year (FY) 2004. new laboratory, a multidisciplinary The agency is required to collect NIBIB and CDRH team of clinicians, scientists, and nearly all of its annual appropriated Establish Joint mathematicians/statisticians will be budget from licensing and inspection Laboratory assembled. The team will work with services and from annual fees paid by The National Institute of Biomed- visiting scientists and trainees who licensees. The proposed annual fees ical Imaging and Bioengineering may range from graduate and medi- were determined under the “re-base- (NIBIB) at the National Institutes of cal students to senior researchers and lining” method, with some licensees Health and the Center for Devices clinicians. Visitors to the laboratory (including transporters) seeing higher 28N THE JOURNAL OF NUCLEAR MEDICINE • Vol. 45 • No. 4 • April 2004 Newsbriefs fees, and others, including 2 of 3 agency to agency. For example, it is biomedical industries with total sales nuclear medicine–related licensee the policy of CMS is to post all elec- of more than $100 million per year. categories, seeing lower fees. Pro- tronic comments (including person- Industry participants were asked to posed fees include: radiographers, ally identifiable and confidential in- address 2 questions: (1) what is the $12,000 (down from $12,200 in the formation within the comment) on major problem that needs to be second half of 2003); broad scope their Web site for the public to re- solved or research advance needed medical, $25,100 (up from $24,700); view after the comment period that will provide a significant im- and distribution of radiopharmaceuti- closes. Other agencies may have dif- provement in health care from your NEWSLINE cals, $4,500 (down from $4,700). ferent policies regarding the publica- industry, and (2) how can NIBIB and Nuclear Regulatory Commission tion of comments. industry collaborate to facilitate translation of research results to pa- Government Agencies NIBIB Focuses on Optical tient applications and anticipated per- Accept Comments on sonnel needs? The final report pre- Technologies, Biomedical sents the proceedings, including Proposed Regulations Industry problems and research needs identi- Online The National Institute of Biomed- fied and recommendations for Private citizens, companies, and ical Imaging and Bioengineering NIBIB and industry activities. The others who want to respond to pro- (NIBIB) and the Department of En- report can be accessed at www. posed federal regulations, including ergy (DOE) Office of Biological and nibib.nih.gov/events/Industry/NIBIB_ those affecting the Nuclear Regula- Environmental Research (OBER) IndustryWorkshop_FinalReport.pdf. tory Commission and the Centers for partnered to sponsor a “Joint NIBIB/ The National Institute of Biomedical Medicare & Medicaid (CMS), may DOE Workshop on Biomedical Im- Imaging and Bioengineering now submit their comments electron- aging: Optical and X-Ray Technolo- ically via a new Web site, www. gies” on February 10 and 11 at the Regulations.gov. Bethesda (MD) Marriott Hotel. Two Nuclear Medicine The Regulations.gov website was days of information exchange that in- Facilities Struggle in Iraq designed to serve as the central on- cluded presentations, plenary discus- During 2003, Iraq’s 240 public line rulemaking portal of the United sions, and poster displays were aimed hospitals and 95% of its private clin- States government. Regulations.gov at communicating and identifying po- ics reopened to patients, but scattered enables users to search, view, and tential synergies and collaborations reports coming from workers indicate comment on proposed regulations based on (l) biomedical research that shortages remain in physicians, from approximately 160 federal de- needs that could be addressed using nursing and auxiliary staff, pharma- partments and agencies. The site al- optical technologies at DOE labora- ceuticals, equipment, and even furni- lows visitors to search by keyword, tories, (2) related DOE national lab- ture such as beds and chairs. Nuclear department, or agency to find pro- oratory capabilities and programs for medicine and radiation therapy are posed regulations, each with a link to NIH intramural and extramural staff, among the hardest hit specialties, a form for submitting comments di- and (3) funding opportunities for fu- with supplies of radioisotopes and ra- rectly to the appropriate department ture research. About 100 attendees diopharmaceuticals erratic when or agency. participated in the meeting, including available at all. “They are talking but In addition to comments on pro- DOE national laboratory investiga- we’ve got nothing since the arrival of posed or final regulations, the new tors, NIH intramural investigators, the Americans,” Baghdad radiologist system, rolled out on January 30, will NIH extramural program directors, Shaemaa al-Hiali told Reuters news be open for comment on other docu- and representatives from other gov- service on February 4. “Our hospitals ments, including policy notices solic- ernment agencies. Peter