[Federal Register Volume 59, Number 56 (Wednesday, March 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6768]
[[Page Unknown]]
[Federal Register: March 23, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Health Care Policy and Research
Notice of Assessment of Medical Technology
The Agency for Heath Care Policy and Research (AHCPR), through the
Office of Health Technology Assessment (OHTA), announces that it is
initiating an assessment of the safety and effectiveness of isolated
pancreas transplants in the treatment of insulin dependent diabetes
mellitus. This assessment will also be concerned with the specific
criteria for the selection of patients for pancreas transplantation and
the cost effectiveness of the technology.
The assessment consists of a synthesis of information found in the
published literature and obtained from appropriate organizations in the
private sector and from Public Health Service (PHS) agencies and others
in the Federal Government. AHCPR assessments are conducted in
accordance with sections 904(b) and (d) of the PHS Act (42 U.S.C. 299a-
2(b) and (d)). Based on the assessment, a recommendation will be
formulated to assist the Office of Civilian Health and Medical Program
of the Uniformed Services (OCHAMPUS) in establishing CHAMPUS coverage
policy. The information being sought by this notice is a review and
evaluation 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. Information related to
the characteristics of the patient population most likely to benefit
from pancreas transplantation, as well as information on the clinical
acceptability, effectiveness, and the extent of use of this technology
is also being sought.
The AHCPR is interested in receiving information which would help
in the evaluation or review of the technology as described above. To
enable the interested scientific community to evaluate the information
included in the assessment, AHCPR will discuss in the assessment only
those data and analyses for which a source(s) can be cited. Respondents
are therefore encouraged to include with their submissions a written
consent permitting AHCPR to cite the sources 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.
Any person or group wishing to provide AHCPR with information
relevant to this assessment should do so in writing no later than June
21, 1994 to the Office of Health Technology Assessment at the address
below.
Thomas V. Holohan, M.D., Director, Office of Health Technology
Assessment, AHCPR, 6000 Executive Boulevard, suite 309, Rockville, MD
20852, phone: (301) 594-4023.
Dated: March 16, 1994.
J. Jarrett Clinton, M.D.,
Administrator.
[FR Doc. 94-6768 Filed 3-22-94; 8:45 am]
BILLING CODE 4160-90-P
