[Federal Register Volume 60, Number 156 (Monday, August 14, 1995)]
[Notices]
[Page 41891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19991]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Health Care Policy and Research


Notice of Evaluation of Medical Technology

    The Agency for Health Care Policy and Research (AHCPR), through the 
Center or Health Care Technology (CHCT) (formerly OHTA), announces that 
it is conducting an evaluation of the safety, effectiveness, and 
clinical utility of positron emission tomography (PET), using fluorine 
18 labelled 2-deoxy-2-fluoro-D-glucose (FDG), as a diagnostic and 
management tool for use in patients with focal or partial epilepsy.
    This evaluation will be concerned with the use of FDG-PET in the 
localization of seizure focus for possible surgical excision and seeks 
to answer the following questions: (1) Does FDG-PET provide information 
of value to a clinician that is not otherwise available? (2) What is 
the extent of any incremental benefit obtained from the use of FDG-PET 
when the information obtained is comparable to that available from 
other diagnostic modalities? (3) How does the sensitivity and 
specificity of FDG-PET compare with other diagnostic modalities 
currently in use? (4) Where does FDG-PET fit in the overall scheme of 
diagnostic testing? Should it be used in lieu of, or in addition to 
other diagnostic modalities? (5) What patient selection criteria should 
be applied?
    AHCPR is interested in receiving information based on review and 
assessment of past, current, and planned research related to this 
technology, as well as a bibliography of published, controlled clinical 
trials and other well-designed clinical studies. Also requested is 
information related to the characteristics of the patient population 
most likely to benefit from the use of FDG-PET as well as information 
on the clinical acceptability, effectiveness, and the extent of use of 
this technology. Information relevant to this review should be 
submitted in writing to CHCT at the address below.
    To enable the interested scientific community to evaluate the 
information included in this review, AHCPR will discuss in the review 
only those data and analyses for which a source(s) can be cited. 
Respondents are therefore encouraged to include with their submission a 
written consent permitting AHCPR to cite the source of the data and 
comments provided. Otherwise, in accordance with the confidentiality 
statute governing information collected by AHCPR, 42 U.S.C. 299a-1(c), 
no information received will be published or disclosed which could 
identify an individual or entity described in the information or could 
identify an entity or individual supplying the information.
    Dependent upon the quality and quantity of the scientific data, 
CHCT will prepare an assessment, review, or other evaluation of the 
technology under consideration. (The AHCPR Technology Assessment 
process was described in the December 3, 1993 Federal Register (58 FR 
63988)).
    Written material should be submitted to: Thomas V. Holohan, M.D., 
Acting Director, Center for Health Care Technology, Agency for Health 
Care Policy and Research, 6000 Executive Boulevard, Suite 309, 
Rockville, MD 20852, Phone: (301) 594-4023, Fax: (301) 594-4030.

    Dated: August 8, 1995.
Clifton R. Gaus,
Administrator.
[FR Doc. 95-19991 Filed 8-11-95; 8:45 am]
BILLING CODE 4160-90-M