[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