23292 Federal Register / Vol. 63, No. 81 /Tuesday, April 28, 1998 / Notices

and in sections VI and VII of the

SUPAC–MR guidance.

This draft guidance represents the

agency’s current thinking on scale-up

and postapproval equipment changes

for immediate release and modified

release solid oral dosage forms regulated

by CDER. 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 requirement

of the applicable statute, regulations, or

both.

Interested persons may submit written

comments on the draft guidance to the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 The draft guidance and

received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: April 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–11197 Filed 4–27–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0238]

Guidance Document for Industry and

CDRH Staff for the Preparation of

Investigational Device Exemptions and

Premarket Approval Applications for

Bone Growth Stimulator Devices;

Draft; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

entitled ‘‘Guidance Document for

Industry and CDRH Staff for the

Preparation of Investigational Device

Exemptions and Premarket Approval

Applications for Bone Growth

Stimulator Devices.’’ This guidance is

not final or in effect at this time. The

purpose of this document is to suggest

to the device manufacturer or

investigation sponsor important

information which should be presented

in investigational device exemption

(IDE) and premarket approval (PMA)

applications in order to provide

reasonable assurance of the safety and

effectiveness of these devices for their

intended uses.

DATES: Written comments concerning

this guidance must be submitted by July

27, 1998.

ADDRESSES: Submit written requests for

single copies on a 3.5’’ diskette of the

draft guidance document entitled

‘‘Guidance Document for Industry and

CDRH Staff for the Preparation of

Investigational Device Exemptions and

Premarket Approval Applications for

Bone Growth Stimulator Devices’’ to the

Division of Small Manufacturers

Assistance, Center for Devices and

Radiological (HFZ–220), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818. Written

comments concerning this guidance

document must be submitted to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Comments should

be identified with the docket number

found in brackets in the heading of this

document. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the guidance document.

FOR FURTHER INFORMATION CONTACT: John

S. Goode, Center for Devices and

Radiological Health (HFZ–410), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2036.

SUPPLEMENTARY INFORMATION:

I. Background

The preparation of a guidance

document for Bone Growth Stimulator

applications was first initiated by the

Division of Surgical and Rehabilitation

Devices (DSRD) of the Office of Device

Evaluation (ODE) in conjunction with

the Division of Physical Sciences (DPS)

and Life Sciences (DLS) of the Office of

Science and Technology in 1985. The

purpose of the document was to suggest

to the device manufacturer or

investigation sponsor important

information which should be presented

in IDE and PMA applications in order

to provide reasonable assurance of the

safety and effectiveness of these devices

for their intended uses. The document

went through extensive review by

representatives of DSRD, DPS, DLS, the

Orthopedic and Rehabilitation Devices

(ORD) Advisory Panel, and industry

representatives. Comments and

recommendations generated by these

reviews resulted in a revised draft

document, which was presented for

discussion during an open public

session of the ORD Advisory Panel

meeting held on October 31, 1986.

Subsequent to the panel meeting, the

Health Industry Manufacturers

Association organized a task force

which again reviewed the document

and suggested changes to the Center for

Devices and Radiological Health (CDRH)

on February 15, 1988. As a result, a final

guidance document was issued on

August 12, 1988. This revised draft of

the guidance document was initiated in

response to discussions and

correspondences with sponsors of bone

growth stimulator devices and other

interested parties, and it provides

additional guidance detailing the ODE’s

present perspective on issues relating to

these devices. The revised draft

guidance will be considered by the ORD

Advisory Panel in a meeting to be held

on April 28, 1998, at 9200 Corporate

Blvd., Rockville, MD.

II. Significance of Guidance

This guidance document represents

the agency’s current thinking on IDE

and PMA applications for Bone Growth

Stimulators. 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), which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (62 FR 8961, February 27,

1997). This draft guidance document is

issued as a Level 1 guidance consistent

with GGP’s.

III. Electronic Access

In order to receive copies of the draft

guidance document entitled ‘‘Guidance

Document for Industry and CDRH Staff

for the Preparation of Investigational

Device Exemptions and Premarket

Approval Applications for Bone Growth

Stimulator Devices’’ 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 (487) followed by the

pound sign (#). Then follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the guidance document may also do

so using the World Wide Web (WWW).

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
Federal Register / Vol. 63, No. 81 /Tuesday, April 28, 1998 / Notices 23293

regular basis, the CDRH home page

includes the draft guidance document

entitled ‘‘Guidance Document for

Industry and CDRH Staff for the

Preparation of Investigational Device

Exemptions and Premarket Approval

Applications for Bone Growth

Stimulator Devices,’’ 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://www.fda.gov/cdrh. The

guidance document entitled ‘‘Guidance

Document for Industry and CDRH Staff

for the Preparation of Investigational

Device Exemptions and Premarket

Approval Applications for Bone Growth

Stimulator Devices’’ will be available at

http://www.fda.gov/cdrh/draftgui.html.

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.

IV. Comments

Interested persons may, on or before

July 27, 1998, submit to Dockets

Management Branch (address above)

written comments regarding this draft

guidance. 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.

Dated: April 22, 1998.

D. B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–11158 Filed 4–27–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0233]

Guidance for Industry on PAC–ATLS:

Postapproval Changes—Analytical

Testing Laboratory Sites; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘PAC–ATLS: Postapproval

Changes—Analytical Testing Laboratory

Sites.’’ This guidance provides

recommendations to pharmaceutical

sponsors of new drug applications

(NDA’s) and abbreviated new drug

applications (ANDA’s) who intend to

change an analytical testing laboratory

site for components, drug product

containers, closures, packaging

materials, in-process materials, or drug

products during the postapproval

period. This guidance is intended to

ease the burden of notification, under

certain circumstances, for analytical

testing laboratory site changes currently

requiring prior approval supplements

under the human drug regulations.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Copies of this guidance for

industry are available on the Internet at

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

index.htm. Submit written requests for

single copies of the guidance for

industry entitled ‘‘PAC–ATLS:

Postapproval Changes—Analytical

Testing Laboratory Sites,’’ 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

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Nancy B. Sager, Center for Drug

Evaluation and Research (HFD–357),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–5629.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance for industry entitled ‘‘PAC–

ATLS: Postapproval Changes—

Analytical Testing Laboratory Sites.’’

This guidance is intended to ease the

burden of notification, under certain

circumstances, for analytical testing

laboratory site changes currently

requiring prior approval supplements

under § 314.70 (21 CFR 314.70). FDA

regulations at § 314.70(a) provide that

applicants may make changes to an

approved application in accordance

with a guidance, notice, or regulation

published in the Federal Register that

provides for a less burdensome

notification of the change (for example,

by notification at the time a supplement

is submitted or in the next annual

report).

This guidance for industry represents

the agency’s current thinking on

postapproval changes in analytical

testing laboratory sites. 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, at any time,

submit written comments on the

guidance 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 guidance and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: April 21, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–11198 Filed 4–27–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Environmental

Health Sciences; Notice of Meeting of

National Advisory Environmental

Health Sciences Council

Pursuant to Pub. L. 92–463, notice is

hereby given of the meeting of the

National Advisory Environmental

Health Sciences Council, May 18–19,

1998, Building 31, Conference Room 10,

National Institutes of Health, Bethesda,

Maryland.

This meeting will be open to the

public from 8:30 a.m. to approximately

3:20 p.m. on May 18 for the report of the

Director, NIEHS, and for discussion of

the NIEHS budget, program policies and