40534 Federal Register / Vol. 63, No. 145 /Wednesday, July 29, 1998 / Notices

Assistance, Center for Devices and

Radiological Health (HFZ–220), Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850. Send one selfaddressed adhesive label to assist that

office in processing your request, or fax

your request to 301–443–8818. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

guidance.

Submit written comments on this

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Steward Crumpler, Center for Devices

and Radiological Health (HFZ–340),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–4659.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a document entitled‘‘ Guidance on the

Performance Standard for Electrode

Lead Wires and Patient Cables.’’ This

guidance document addresses the

implementation of the Performance

Standard for Electrode Lead Wires and

Patient Cables. This standard was issued

to address the electrocution hazard

posed by unprotected patient electrical

connectors. Since May 11, 1998,

electrode lead wires or patient cables

intended for use with any of the

following devices have been required to

comply with the standard:

1. Breathing frequency monitors,

2. Ventilatory effort monitors (Apnea

detectors),

3. Electrocardiographs (ECG’s),

4. Radio frequency physiological

signal transmitters and receivers,

5. Cardiac monitors,

6. Electrocardiograph electrodes

(including pre-wired ECG electrodes),

7. Patient transducer and electrode

cables (including connectors),

8. Medical magnetic tape recorders

(e.g. Holter monitors),

9. Arrhythmia detectors and alarms,

10. Telephone Electrocardiograph

transmitters and receivers.

Manufacturers and users have an

additional 2 years to prepare for the

second phase of implementation of the

standard. Beginning on May 9, 2000,

any electrode lead wire or patient cable

lead intended for use with any medical

device must comply with the standard.

The performance standard

incorporates the specific requirements

of international standard, IEC–60601,

clause 56.3(c), which requires leads to

be constructed in such a manner as to

preclude patient contact with hazardous

voltages or, for certain devices, contact

with electrical ground. Design changes

and labeling changes need to be

considered by manufacturers and

importers of the devices referenced

previously.

Adapters can be used to convert

devices already in the marketplace so

they can accept electrode wires and

patient cables that comply with the new

performance standard.

This guidance document represents

the agency’s current thinking on the

performance standard for electrode lead

wires and patient cables. It does not

create or confer any rights for or on any

person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the applicable statute,

regulations, or both. The agency has

adopted good guidance practices

(GGP’s) (62 FR 8961, February 27, 1997),

which set forth the agency’s policy for

the development, issuance and use of

guidance documents. This is a Level 1

guidance document in accordance with

the GGP’s. The guidance document was

made available on the World Wide Web

(WWW) in March 1998 in order to

provide guidance before the May 11,

1998, effective date of the first phase of

implementation. Due to the risk of

serious injury or death associated with

the use of unprotected electrode leads

and patient cables, this guidance is

being implemented while the agency

receives public input.

II. Comments

Interested persons may, on or before

October 27, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

guidance document. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The guidance

document and received comments may

be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

III. Electronic Access

In order to receive the ‘‘Guidance on

the Performance Standard for Electrode

Lead Wires and Patient Cables’’ via your

fax machine, call the CDRH Facts-OnDemand (FOD) system at 800–899–0381

or 301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at second

voice prompt press 2, and then enter the

document number (1197) followed by

the pound sign (#). Then follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the guidance may also do so using the

WWW. The Center for Devices and

Radiological Health (CDRH) maintains

an entry on the WWW for easy access

to information including text, graphics,

and files that may be downloaded to a

personal computer with access to the

Web. Updated on a regular basis, the

CDRH home page includes the

‘‘Guidance on the Performance Standard

for Electrode Lead Wires and Patient

Cables,’’ device safety alerts, Federal

Register reprints, information on

premarket submissions (including lists

of approved applications and

manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at ‘‘http://ww.fda.gov/cdrh’’.

A text-only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

800–222–0185 (terminal settings are 8/

1/N). Once the modem answers, press

Enter several times and then select

menu choice 1: FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS TOPICS PAGE, arrow down to the

FDA home page (do not select the first

CDRH entry). Then select Medical

Devices and Radiological Health. From

there select CENTER FOR DEVICES

AND RADIOLOGICAL HEALTH for

general information, or arrow down for

specific topics.

Dated: July 17, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–20240 Filed 7–28–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–3009–N]

RIN 0938–AI99

Medicare Program; Peer Review

Organization Contracts: Solicitation of

Statements of Interest From In-State

Organizations—Alaska, Delaware, the

District of Columbia, Hawaii, Idaho,

Illinois, Kentucky, Maine, Nebraska,

Nevada, South Carolina, Vermont, and

Wyoming

AGENCY: Health Care Financing

Administration, HHS.

ACTION: Notice.
Federal Register / Vol. 63, No. 145 /Wednesday, July 29, 1998 / Notices 40535

SUMMARY: This notice, in accordance

with section 1153(i) of the Social

Security Act, gives at least 6 months’

advance notice of the expiration dates of

contracts with out-of-State Utilization

and Quality Control Peer Review

Organizations. It also specifies the

period of time in which in-State

organizations may submit a statement of

interest so that they may be eligible to

compete for these contracts.

DATES: Written statements of interest

must be received at the address

specified no later than 5 p.m. EST,

August 28, 1998. Due to staffing and

resource limitations, we cannot accept

statements submitted by facsimile (FAX)

transmission.

ADDRESSES: Statements of interest must

be submitted to the—Health Care

Financing Administration, Acquisitions

and Grants Groups, OICS, Attn.: Edward

L. Hughes, 7500 Security Boulevard,

Mail Stop C2–21–15, Baltimore,

Maryland 21244–1850.

FOR FURTHER INFORMATION CONTACT: Udo

Nwachukwu, (410) 786–7234.

SUPPLEMENTARY INFORMATION:

I. Background

The Peer Review Improvement Act of

1982 (title I, subtitle C of the Tax Equity

and Fiscal Responsibility Act of 1982

(TEFRA), Pub. L. 97–248) amended Part

B of title XI of the Social Security Act

(the Act) by establishing the Utilization

and Quality Peer Review Organization

(PRO) program.

PROs currently review certain health

care services furnished under title XVIII

of the Act (Medicare) and under certain

other Federal programs to determine

whether those services are reasonable,

medically necessary, furnished in the

appropriate setting, and are of a quality

that meets professionally-recognized

standards. PRO activities are a part of

the Health Care Quality Improvement

Program (HCQIP), a program which

supports our mission to ensure health

care security for our beneficiaries. The

HCQIP rests on the belief that a plan’s,

provider’s, or practitioner’s own

internal quality management system is

key to good performance. The HCQIP is

carried out locally by the PRO in each

State. Under the HCQIP, PROs provide

critical tools (for example, quality

indicators and information) for plans,

providers, and practitioners to improve

the quality of care furnished to

Medicare beneficiaries. The Congress

created the PRO program in order to

redirect, simplify, and enhance the costeffectiveness and efficiency of the peer

review process.

In June 1984, we began awarding

contracts to PROs. We currently

maintain 53 PRO contracts with

organizations that provide medical

review activities for the 50 United

States, the District of Columbia, Puerto

Rico, and the Virgin Islands. The

organizations that are eligible to

contract as PROs have satisfactorily

demonstrated that they are either

physician-sponsored or physicianaccess organizations in accordance with

sections 1152 and 1153 of the Act and

our regulations at 42 CFR 462.102 and

462.103. A physician-sponsored

organization is one that is both

composed of a substantial number of the

licensed doctors of medicine or

osteopathy practicing medicine or

surgery in the respective review area

and is representative of the physicians

practicing in the review area. A

physician-access organization is one

that has available to it, by arrangement

or otherwise, the services of a sufficient

number of licensed doctors of medicine

or osteopathy practicing medicine or

surgery in the review area to ensure

adequate peer review of the services

furnished by the various medical

specialties and subspecialties. In

addition, the organization must not be a

health care facility, health care facility

association, or a health care facility

affiliate, and must have a consumer

representative on its governing board.

The Omnibus Budget Reconciliation

Act of 1987 (Pub. L. 100–203) amended

section 1153 of the Act by adding new

paragraph (i) that prohibits the Secretary

from renewing the contract of any PRO

that is not an in-State organization

without first publishing in the Federal

Register a notice announcing when the

contract will expire. This notice must be

published no later than 6 months before

the date the contract expires and must

specify the period of time during which

an in-State organization may submit a

proposal for the contract. If one or more

qualified in-State organizations submit a

proposal within the specified period of

time, we may not automatically renew

the contract on a noncompetitive basis,

but must instead provide for

competition for the contract in the same

manner used for a new contract. An inState organization is defined as an

organization that has its primary place

of business in the State in which review

will be conducted (or, that is owned by

a parent corporation, the headquarters

of which is located in that State).

There are currently 13 PRO contracts

with entities that do not meet the

statutory definition of an in-State

organization. The areas affected for

purposes of this notice and their

respective expiration dates are as

follows:

Delaware—March 31, 1999

Illinois—March 31, 1999

Kentucky—March 31, 1999

Nevada—March 31, 1999

Vermont—March 31, 1999

Wyoming—March 31, 1999

Alaska—June 30, 1999

District of Columbia—June 30, 1999

Idaho—June 30, 1999

Maine—June 30, 1999

Hawaii—September 30, 1999

Nebraska—September 30, 1999

South Carolina—September 30, 1999

II. Provisions of the Notice

This notice announces the scheduled

expiration dates of the current contracts

between us and the out-of-State PROs

responsible for review in the areas

mentioned above.

Interested in-State organizations may

submit statements of interest to be the

PRO for these States. We must receive

the statements no later than August 28,

1998, and, in its statement of interest,

the organization must furnish materials

that demonstrate that it meets the

definition of an in-State organization.

Specifically, the organization must have

its primary place of business in the State

in which review will be conducted or be

a subsidiary of a parent corporation,

whose headquarters is located in that

State. In its statement, each interested

organization must further demonstrate

that it meets the following requirements:

A. Be Either a Physician-Sponsored or a

Physician-Access Organization

1. Physician-Sponsored Organization

a. The organization must be composed

of a substantial number of the licensed

doctors of medicine and osteopathy

practicing medicine or surgery in the

review area, and be representative of the

physicians practicing in the review area.

b. The organization must not be a

health care facility, health care facility

association, or health care facility

affiliate.

c. In order to meet the substantial

number requirement of A.1.a., an

organization must be composed of at

least 10 percent of the licensed doctors

of medicine and osteopathy practicing

medicine or surgery in the review area.

In order to meet the representation

requirement of A.1.a., an organization

must state and have documentation in

its files demonstrating that it is

composed of at least 20 percent of the

licensed doctors of medicine and

osteopathy practicing medicine or

surgery in the review area. Alternately,

if the organization does not demonstrate

that it is composed of at least 20 percent

of the licensed doctors of medicine and

osteopathy practicing medicine or
40536 Federal Register / Vol. 63, No. 145 /Wednesday, July 29, 1998 / Notices

surgery in the review area, the

organization must demonstrate in its

statement of interest through letters of

support from physicians or physician

organizations, or through other means,

that it is representative of the area

physicians.

2. Physician-Access Organization

a. The organization must have

available to it, by arrangement or

otherwise, the services of a sufficient

number of licensed doctors of medicine

or osteopathy practicing medicine or

surgery in the review area to ensure

adequate peer review of the services

provided by the various medical

specialties and subspecialties.

b. The organization must not be a

health facility, health care facility

association, or health care facility

affiliate.

c. An organization meets the

requirements of A.2.a. if it demonstrates

that it has available to it at least one

physician in every generally recognized

specialty; and has an arrangement or

arrangements with physicians under

which the physicians would conduct

review for the organization.

B. Have at Least one Individual who is

a Representative of Consumers on its

Governing Board

If one or more organizations meet the

above requirements in a PRO area and

submit statements of interest in

accordance with this notice, we will

consider those organizations to be

potential sources for the 13 contracts

upon their expiration. These

organizations will be entitled to

participate in a full and open

competition for the PRO contract to

provide medical review services.

III. Information Collection

Requirements

This notice contains information

collection requirements that have been

approved by the Office of Management

and Budget (OMB) under the authority

of the Paperwork Reduction Act of 1995

(44 U.S.C. Chapter 35) and assigned

OMB Control Number 0938–0526.

Authority: Section 1153 of the Social

Security Act (42 U.S.C. 1320c–2).

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance Program; and No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: June 1, 1998.

Nancy-Ann Min Deparle,

Administrator, Health Care Financing

Administration.

[FR Doc. 98–20253 Filed 7–28–98; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; Notice of Closed

Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Child Health and Human Development,

Special Emphasis Panel Health Services

Research and Intervention in Safe

Motherhood in Rural Balochistan, Pakistan.

Date: August 11, 1998.

Time: 12:00 PM to 5:30 PM.

Agenda: To review and evaluate grant

applications.

Place: 6100 Executive Blvd., Room 5E01,

Rockville, MD 20852.

Contact Person: Hameed Khan, PHD,

Scientific Review Administrator, Division of

Scientific Review, National Institute of Child

Health and Human Development, National

Institutes of Health, 6100 Executive Blvd.,

Room 5E01, Bethesda, MD 20892, (301) 496–

1485.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.865, Research for Mothers

and Children; 93.864, Population Research;

93.929, Center for Medical Rehabilitation

Research; 93.209, Contraception and

Infertility Loan Repayment Program, National

Institutes of Health, HHS).

Dated: July 22, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–20273 Filed 7–28–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; Notice of Closed

Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Child Health and Human Development,

Special Emphasis Panel, The Effects of

Swimming Lessons on the Risk of Drowning

Among Children Ages 1–5 Years.

Date: August 24, 1998.

Time: 1:00 PM to 5:30 PM.

Agenda: To review and evaluate grant

applications.

Place: 6100 Executive Blvd., Room 5E01

Rockville, MD 20852.

Contact Person: Hameed Khan, PHD,

Scientific Review Administrator, Division of

Scientific Review, National Institute of Child

Health and Human Development, National

Institutes of Health, 6100 Executive Blvd.,

Room 5E01, Bethesda, MD 20892, (301) 496–

1485.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.864, Population Research;

93.865, Research for Mothers and Children;

93.929. Center for Medical Rehabilitation

Research; 93.209, Contraception and

Infertility Loan Repayment Program, National

Institutes of Health, HHS)

Dated: July 22, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–20274 Filed 7–28–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Diabetes and

Digestive and Kidney Diseases; Notice

of Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice