[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
