[Federal Register Volume 60, Number 229 (Wednesday, November 29, 1995)]
[Notices]
[Pages 61259-61260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29086]
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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 Health Care Policy and Research (AHCPR), through the
Center for Health Care Technology (CHCT) (formerly Office of Health
Technology Assessment), announces that it is initiating a technology
assessment or technology review of the safety, efficacy, and
effectiveness of biofeedback for the treatment of hypertension.
The AHCPR is requesting information on the risks, benefits, and
costs associated with the use of this mode of treatment, and the
specific circumstances in which biofeedback is appropriate. The AHCPR
also requests information on patient selection criteria and
institutional or team criteria necessary to establish acceptable
standards for appropriate benefits and risks.
The assessment consists of a synthesis of information found in
published literature and obtained from appropriate sources in the
private sector, Public Health Service (PHS) agencies and others in the
Federal Government. AHCPR assessments and reviews are conducted in
accordance with sections 904(b) and (d) of the PHS Act (42 U.S.C. 299a-
2(b) and (d)), as described in the Federal Register of December 3,
1993. The evaluation is based on the most current knowledge concerning
the safety, clinical effectiveness, and appropriate uses of a
technology, and its relative clinical utility compared to alternative
technologies. A recommendation may be formulated to assist the Office
of Civilian Health and Medical Programs of the Uniformed Services
(OCHAMPUS), Department of Defense, in establishing coverage policy. The
information being sought by this notice is a review 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.
[[Page 61260]]
Information related to the characteristics of the patient population
most likely to benefit from biofeedback treatment of hypertension, 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
[insert date 90 days after the date of publication] to the Center for
Health Care Technology at the address below.
Thomas V. Holohan, M.D., FACP, Acting Director, Center for Health Care
Technology, AHCPR, 6000 Executive Boulevard, Suite 309, Rockville, MD
20852, Phone: (301) 594-4023.
Dated: November 20, 1995.
Clifton R. Gaus,
Administrator.
[FR Doc. 95-29086 Filed 11-28-95; 8:45 am]
BILLING CODE 4160-90-M
