Federal Register / Vol. 63, No. 145 /Wednesday, July 29, 1998 / Notices 40533

ACTION: Notice.

SUMMARY: The Food and Drug

Administration’s (FDA’s) Office of Drug

Evaluation IV (ODE IV), Center for Drug

Evaluation and Research (CDER), is

announcing the availability of several

draft guidance documents on the

development of antimicrobial drug

products. A general draft guidance

document entitled ‘‘Developing

Antimicrobial Drugs—General

Considerations for Clinical Trials’’

discusses issues common to the

development of all antimicrobial drugs.

The companion draft guidance

documents address issues related to

developing drugs to treat individual

indications. These draft guidance

documents are intended to help

sponsors design clinical trials that will

yield information the agency can use to

determine whether the antimicrobial

drug under study is safe and effective in

the treatment of the specific infection

studied. Key elements of these draft

guidance documents will be discussed

at a July 29, 30, and 31, 1998, Anti–

Infective Drugs Advisory Committee

meeting.

DATES: Written comments on the draft

guidance documents may be submitted

by October 27, 1998. General comments

on agency guidance documents are

welcome at any time.

ADDRESSES: Copies of the draft guidance

documents are available on the Internet

at ‘‘http://www.fda.gov/cder/guidance/

index.htm’’. Submit written requests for

single copies of the draft guidance

documents to the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send one

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments on the draft

guidance documents to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Renata Albrecht, Center for Drug

Evaluation and Research (HFD–590),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2336.

SUPPLEMENTARY INFORMATION: FDA’s

divisions of Anti–Infective Drug

Products, Special Pathogens and

Immunologic Drug Products, and Anti–

Viral Drug Products in CDER’s ODE IV

are issuing the first documents in a

series of draft guidance documents that

are intended to assist sponsors in

designing, carrying out, and analyzing

the results of clinical trials for the

development of antimicrobial drug

products. A general draft guidance

document entitled ‘‘Developing

Antimicrobial Drugs—General

Considerations for Clinical Trials’’

discusses issues common to all

antimicrobial drugs. The companion

draft guidance documents address

issues related to developing drugs to

treat individual indications. Key

elements from these draft guidance

documents and related issues will be

discussed at an Anti–Infective Drugs

Advisory Committee meeting on July 29,

30, and 31, 1998 (63 FR 34655, June 25,

1998).

In the Federal Register of July 21,

1998 (63 FR 39096), ODE IV announced

its plans for revising existing guidance

documents and preparing new guidance

documents on the development of

antimicrobial drug products for the

treatment of infections. ODE IV is

reviewing, updating, consolidating, and

revising its existing guidance

documents and identifying topics for

future guidance documents. In that

notice, ODE IV explained its plan and

requested public comment on topics for

future guidance document development.

The draft guidance documents are a part

of ODE IV’s guidance development plan. The general draft guidance document

being made available is entitled

‘‘Developing Antimicrobial Drugs—

General Considerations for Clinical

Trials.’’ The draft companion guidances

are being made available on individual

indications as follows: • Uncomplicated urinary tract

infections, • Uncomplicated and complicated

skin and skin structure infections, • Community-acquired pneumonia,

• Nosocomial pneumonia,

• Acute bacterial exacerbation of

chronic bronchitis, • Secondary bacterial infection of

acute bronchitis, • Acute otitis media,

• Acute uncomplicated gonorrhea,

• Acute sinusitus,

• Complicated urinary tract infections

and pyelonephritis, • Bacterial prostatitis,

• Early Lyme disease,

• Empiric therapy of febrile

neutropenia, • Vulvovaginal candidiasis,

• Streptococcal pharyngitis and

tonsillitis, • Bacterial meningitis, and

• Bacterial vaginosis. Additional guidances are under

development.

The information in these draft

guidance documents represents the

agency’s current thinking on developing

antimicrobial drug products. 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 requirements of the

applicable statute, regulations, or both.

Interested persons may submit written

comments on the draft guidance

documents to the Dockets Management

Branch (address above). 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 draft guidance

documents and received comments may

be seen in the office above between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: July 23, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20239 Filed 7–28–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0448]

Guidance on the Performance

Standard for Electrode Lead Wires and

Patient Cables; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance entitled

‘‘Guidance on the Performance Standard

for Electrode Lead Wires and Patient

Cables.’’ The guidance document

provides information on the

electrocution hazard posed by

unprotected patient electrical

connectors. This guidance is intended to

help affected parties understand the

steps needed to achieve compliance

with the performance standard for

electrode lead wires and patient cables.

DATES: Written comments concerning

this guidance must be received by

October 27, 1998.

ADDRESSES: Submit written requests for

single copies on a 3.5’’ diskette of the

guidance entitled ‘‘Guidance on the

Performance Standard for Electrode

Lead Wires and Patient Cables’’ to the

Division of Small Manufacturers
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.