Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Notices 48297

IV. Regulatory Impact Statement

The Regulatory Flexibility Act, 5

U.S.C. 601 through 612, requires a

regulatory flexibility analysis for every

rule subject to proposed rulemaking

procedures under the Administrative

Procedure Act, 5 U.S.C. 552, unless we

certify that the rule will not have a

significant economic impact on a

substantial number of small entities. For

purposes of a RFA, States and

individuals are not considered small

entities. However, providers are

considered small entities. Additionally,

section 1102(b) of the Act requires us to

prepare a regulatory impact analysis if

a notice may have a significant impact

on the operations of a substantial

number of small rural hospitals. Such

an analysis must conform to the

provisions of section 604 of the RFA.

For purposes of section 1102(b) of the

Act, we define a small rural hospital as

a hospital that is located outside of a

Metropolitan Statistical Area and has

fewer than 50 beds.

We do not believe that this notice will

have a significant economic impact on

a substantial number of small entities

because it reflects no new policies or

procedures, and should have an overall

positive impact on payments to

disproportionate share hospitals by

informing States of the extent to which

DSH payments may be increased

without violating statutory limitations.

This notice sets forth no changes in our

regulations; rather, it reflects the DSH

allotments for each State as determined

in accordance with 42 CFR 447.297

through 447.299.

We have discussed the method of

calculating the preliminary FFY 1997

national DSH payment target and the

preliminary FFY 1997 individual State

DSH allotments in the previous sections

of this preamble. These calculations

should have a positive impact on

payments to disproportionate share

hospitals. Allotments will not be

reduced for high-DSH States since we

interpret the 12-percent limit as a target.

Low-DSH States’ allotments are equal to

their prior FFY DSH allotments plus

their growth and supplemental

amounts, if any.

In accordance with the provisions of

Executive Order 12866, this notice was

reviewed by the Office of Management

and Budget.

(Catalog of Federal Assistance Program No.

93.778, Medical Assistance Program)

Dated: June 5, 1997.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

Dated: July 24, 1997.

Donna E. Shalala,

Secretary.

[FR Doc. 97–24281 Filed 9–12–97; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995,

Public Law 104–13), the Health

Resources and Services Administration

(HRSA) will publish periodic

summaries of proposed projects being

developed for submission to OMB under

the Paperwork Reduction Act of 1995.

To request more information on the

proposed project or to obtain a copy of

the data collection plans, call the HRSA

Reports Clearance Officer on (301) 443–

1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project: Uniform Data

System (OMB No. 0915–0193)—

Extension and Revision—This is a

request for extension and revision of a

reporting system, the Uniform Data

System (UDS), that consolidated and

replaced annual reporting requirements

for the cluster of primary care grantees

funded by the Bureau of Primary Health

Care (BPHC), Health Resources and

Services Administration (HRSA). The

UDS includes reporting requirements

for grantees of the following primary

care programs: Community Health

Centers, Migrant Health Centers, Health

Care for the Homeless, Outreach and

Primary Health Services for Homeless

Children and Public Housing Primary

Care. Authorizing Legislation is found

in Public Law 104–299, Health Center

Consolidation Act of 1996, enacting

Section 330 of the Public Health Service

Act.

The Bureau of Primary Health Care

collects data on its programs to ensure

compliance with legislative mandates

and to report to Congress and policy

makers on program accomplishments.

To meet these objectives, BPHC requires

a core set of information collected

annually that is appropriate for

monitoring and evaluating performance

and reporting on annual trends. The

UDS includes two components: the

Universal Report, completed by all

grantees, provides data on services,

staffing, and financing; and the Grant

Report, completed by grantees funded

under the Homeless or Public Housing

Program as well as one of the other

programs, provides data on

characteristics of users whose services

fall within the scope of the Homeless or

Public Housing Program grant. The first

UDS reports were collected March 31,

1997 and analysis of data indicates that

several revisions should be made.

Program officials have noted that

additional information needs to be

collected which was included in

previous reporting systems but was

deleted from the UDS. Grantees will be

asked to provide information on the

charges, collections, bad debt write off

and contractual disallowances by payor

sources (Medicaid, Medicare, self pay

and private insurance). Existing UDS

forms are being reviewed to determine

how the revenue/income reporting can

be modified to accommodate these

changes. Additional revisions will

include annotating the forms to indicate

which lines are subtotals and the lines

to which they sum.

The proposed changes are not

expected to add significantly to the

reporting burden. Estimates of

annualized reporting burden are as

follows:

Type of report Number of

respondents

Hours per

response

Total burden

hours

Universal Report ........................................................................................................................... 694 24 16,656

Grant Report ................................................................................................................................. 88 16 1,408
48298 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Notices

Type of report Number of

respondents

Hours per

response

Total burden

hours

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