48298 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Notices

Type of report Number of

respondents

Hours per

response

Total burden

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Total ................................................................................................................................... 694 ........................ 18,064

Send comments to Patricia Royston,

HRSA Reports Clearance Officer, Room

14–36, Parklawn Building, 5600 Fishers

Lane, Rockville, MD 20857. Written

comments should be received within 60

days of this Notice.

Dated: September 5, 1997.

Jane Harrison,

Acting Director, Division of Policy Review

and Coordination.

[FR Doc. 97–24347 Filed 9–12–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Consensus Development Conference

on Acupuncture

Notice is hereby given of the NIH

Consensus Development Conference on

‘‘Acupuncture,’’ which will be held

November 3–5, 1997, in the Natcher

Conference Center of the National

Institutes of Health, 9000 Rockville

Pike, Bethesda, Maryland 20892. The

conference begins at 8:30 a.m. on

November 3, at 8 a.m. on November 4,

and at 9 a.m. on November 5.

Acupuncture and moxibustion are the

two best known aspects of traditional

Chinese medicine (TCM) in the U.S. and

are used by many Americans.

Acupuncture is a family of procedures

involving penetration of specific

superficial anatomic locations on the

skin called acupuncture points with

thin, solid, generally metallic, needles.

Closely related to and often practices

with acupuncture is moxibustion, the

local and focused application of heat to

acupuncture points using a compressed,

powdered combustible substance

(moxa), which is burned at or near the

points to be stimulated.

There are a variety of approaches to

functional diagnosis and treatment in

American acupuncture that incorporate

medical traditions from China, Japan,

Korea, France, and other countries.

Because an acupuncture treatment

involves a procedure rather than a drug,

it has been very difficult to study using

the gold standard of randomized

double-blind trials. Nevertheless,

acupuncture is used by millions of

American patients and performed by

thousands of physicians, dentists,

masters-degree level acupuncturists,

and other practitioners for relief or

prevention of pain and a variety of

health problems. The FDA, after years of

deliberation, recently removed

acupuncture needles from the category

of ‘‘experimental medical devices’’ and

now regulates them just as it does other

devices such as surgical scalpels and

hypodermic syringes, under good

manufacturing practices and single-use

standards of sterility.

Over the years, NIH has funded a

variety of research studies on

acupuncture, including studies on the

mechanisms by which acupuncture may

have its effects as well as clinical trials

and other studies. There is also a

considerable body of international

literature on the risks and benefits of

acupuncture, and the World Health

Organization (WHO) has listed a variety

of medical conditions that may benefit

from the use of acupuncture and/or

moxibustion. Such applications may

include prevention and treatment of

nausea and vomiting; treatment of pain

and addictions to alcohol, tobacco, and

other drugs; prevention of pulmonary

problems such as asthma and bronchitis

and rehabilitation from neurological

damage such as stroke.

To address the most important issues

regarding the American use of

acupuncture, the NIH has organized this

21⁄2 day conference to evaluate the

scientific and medical data on the uses,

risks, and benefits of acupuncture

procedures for a variety of conditions.

The conference will bring together

national and international experts in the

fields of acupuncture, pain, psychology,

psychiatry, physical medicine and

rehabilitation, drug abuse,

pulmonology, health policy,

epidemiology, statistics, physiology,

and biophysics as well as

representatives from the public.

After 11⁄2 days of presentations and

audience discussion, an independent,

non-Federal consensus panel chaired by

Dr. David Ramsay, president of the

University of Maryland Medical Center,

will weigh the scientific evidence and

write a draft statement that it will

present to the audience on the third day.

The consensus statement will address

the following key questions:

* What is the efficacy of acupuncture,

compared with placebo or sham

acupuncture, in the conditions for

which sufficient data are available to

evaluate?

* What is the place of acupuncture in

the treatment of various conditions (for

which sufficient data are available), in

comparison with or in combination with

other interventions (including no

intervention)?

* What is known about the biological

effects of acupuncture that helps us

understand how it works?

* What issues need to be addressed

so that acupuncture may be

appropriately incorporated into today’s

health care system?

* What are the directions for future

research?

The primary sponsors of this meeting

are the NIH Office of Alternative

Medicine and the NIH Office of Medical

Applications of Research. The

conference is cosponsored by the

National Cancer Institute, the National

Institute of Arthritis and

Musculoskeletal and Skin Diseases, the

National Heart, Lung, and Blood

Institute, the National Institute of

Allergy and Infectious Diseases, the

National Institute on Drug Abuse, and

the NIH Office of Research on Women’s

Health.

Advance information on the

conference program and conference

registration materials may be obtained

from Prospect Associates, 1801

Rockville Pike, Suite 500, Rockville,

Maryland 20852, (301) 468–MEET, by email at

NIHconsensus@ProspectAssoc.com, or

by visiting http://consensus.nih.gov on

the World Wide Web.

The consensus statement will be

submitted for publication in

professional journals and other

publications. In addition, the statement

will be available beginning November 5,

1997, from the NIH Consensus Program

Information Center, P.O. Box 2577,

Kensington, Maryland 20891, phone 1–

888–NIH–CONSENSUS (1–888–644–

2667) and from the NIH Consensus

Development Program site on the World

Wide Web at http://consensus.nih.gov.

Dated: September 3, 1997.

Ruth L. Kirschstein,

Deputy Director, NIH.

[FR Doc. 97–24274 Filed 9–12–97; 8:45 am]

BILLING CODE 4140–01–M