15714 Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Notices

DATES: Petitions for administrative

review by May 2, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Colin M. Pollard, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1180.

SUPPLEMENTARY INFORMATION: On

December 30, 1987, Richard Wolf

Medical Instruments Corp., Vernon

Hills, IL 60061, submitted to CDRH an

application for premarket approval of

the Hulka Clip Tubal Occlusion

Device and Applicator System. The

device is a contraceptive tubal occlusion

device and is indicated for female

sterilization (permanent contraception)

by occluding the fallopian tubes.

On May 25, 1988, the Obstetrics and

Gynecology Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

application subject to the submission of

the data from the long-term animal

carcinogenic studies demonstrating the

safety of the device materials. On

September 5, 1996, CDRH approved the

application by a letter to the applicant

from the Director of the Office of Device

Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under 21 CFR

part 12 of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under 21 CFR 10.33(b).

A petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of review to be used,

the persons who may participate in the

review, the time and place where the

review will occur, and other details.

Petitioners may, at any time on or

before May 2, 1997 file with the Dockets

Management Branch (address above)

two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: March 7, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–8274 Filed 4–1–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97M–0121]

Medtronic, Inc.; Premarket Approval of

the Legend Plus Pacing System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by

Medtronic, Inc., Minneapolis, MN, for

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of the Legend Plus Pacing System.

After reviewing the recommendation of

the Circulatory System Devices Panel,

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of February 7, 1997,

of the approval of the application.

DATES: Petitions for administrative

review by May 2, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Mitchell J. Shein, Center for Devices and

Radiological Health (HFZ–450), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8517.

SUPPLEMENTARY INFORMATION: On July

21, 1993, Medtronic, Inc., Minneapolis,

MN 55432, submitted to CDRH an

application for premarket approval of

the Legend Plus Pacing System. The

device consists of the following

components: The Legend Plus Pulse

Generator Models 8446 and 8448; the

Model 9790 and 9790C Programmers

with the Model 9891 Baseline Software

and the Model 9807 Software. The

device system includes implantable

pulse generators and associated

programming hardware and software

and is indicated for permanent

ventricular or atrial pacing applications.

Their use is indicated in the treatment

of patients who may benefit from a

pacing rate that changes in response to

activity.

Ventricular indications include: (1)

Chronic atrial flutter or fibrillation with

slow ventricular response; (2) sinus

node dysfunction or sick sinus

syndrome (e.g., sinus bradycardia, sinus

arrest and/or exit block, bradycardiatachycardia syndrome, chronotropic

insufficiency, etc.,); and (3) AV block.

Atrial indications include: Sinus node

dysfunction or sick sinus syndrome

(e.g., sinus bradycardia, sinus arrest

and/or exit block, bradycardiatachycardia syndrome, etc.,) with intact

AV conduction.

On May 9, 1995, the Circulatory

System Devices Panel of the Medical

Devices Advisory Committee, an FDA

advisory committee, reviewed and

recommended approval of the

application. On February 7, 1997, CDRH

approved the application by a letter to

the applicant from the Director of the

Office of Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested
Federal Register / Vol. 62, No. 63 / Wednesday, April 2, 1997 / Notices 15715

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under 21 CFR

part 12 of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under 21 CFR 10.33(b).

A petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of review to be used,

the persons who may participate in the

review, the time and place where the

review will occur, and other details.

Petitioners may, at any time on or

before May 2, 1997 file with the Dockets

Management Branch (address above)

two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: March 4, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–8273 Filed 4–1–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 94D–0017]

International Conference on

Harmonisation; Draft Guideline on

Dose Selection for Carcinogenicity

Studies of Pharmaceuticals:

Addendum on the Limit Dose;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

draft guideline entitled ‘‘Dose Selection

for Carcinogenicity Studies of

Pharmaceuticals: Addendum on the

Limit Dose.’’ The draft guideline was

prepared under the auspices of the

International Conference on

Harmonisation of Technical

Requirements for Registration of

Pharmaceuticals for Human Use (ICH).

The draft guideline is intended to define

the conditions under which it would be

considered acceptable to use a ‘‘limit

dose’’ for the high dose selection of

nongenotoxic pharmaceuticals in longterm carcinogenicity studies. The draft

guideline is an addendum to an earlier

ICH guideline on criteria for

establishing uniformity among

international regulatory agencies for

dose selection for carcinogenicity

studies of human pharmaceuticals.

DATES: Written comments by June 2,

1997.

ADDRESSES: Submit written comments

on the draft guideline to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Copies of the draft guideline are

available from the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

5473.

FOR FURTHER INFORMATION CONTACT:

Regarding the guideline: Joseph J.

DeGeorge, Center for Drug

Evaluation and Research (HFD–24),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–594–6758.

Regarding the ICH: Janet J. Showalter,

Office of Health Affairs FY–20),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–0864.

SUPPLEMENTARY INFORMATION: In recent

years, many important initiatives have

been undertaken by regulatory

authorities and industry associations to

promote international harmonization of

regulatory requirements. FDA has

participated in many meetings designed

to enhance harmonization and is

committed to seeking scientifically

based harmonized technical procedures

for pharmaceutical development. One of

the goals of harmonization is to identify

and then reduce differences in technical

requirements for drug development

among regulatory agencies.

ICH was organized to provide an

opportunity for tripartite harmonization

initiatives to be developed with input

from both regulatory and industry

representatives. FDA also seeks input

from consumer representatives and

others. ICH is concerned with

harmonization of technical

requirements for the registration of

pharmaceutical products among three

regions: The European Union, Japan,

and the United States. The six ICH

sponsors are the European Commission,

the European Federation of

Pharmaceutical Industries Associations,

the Japanese Ministry of Health and

Welfare, the Japanese Pharmaceutical

Manufacturers Association, the Centers

for Drug Evaluation and Research and

Biologics Evaluation and Research,

FDA, and the Pharmaceutical Research

and Manufacturers of America. The ICH

Secretariat, which coordinates the

preparation of documentation, is

provided by the International

Federation of Pharmaceutical

Manufacturers Associations (IFPMA).

The ICH Steering Committee includes

representatives from each of the ICH

sponsors and the IFPMA, as well as

observers from the World Health

Organization, the Canadian Health

Protection Branch, and the European

Free Trade Area.

At a meeting held on November 6,

1996, the ICH Steering Committee

agreed that a draft guideline entitled

‘‘Dose Selection for Carcinogenicity

Studies of Pharmaceuticals: Addendum

on the Limit Dose’’ should be made

available for public comment. The draft

guideline is the product of the Safety

Expert Working Group of the ICH.

Comments about this draft will be

considered by FDA and the Safety

Expert Working Group.

The draft guideline is an addendum to

an ICH final guideline published in the

Federal Register of March 1, 1995 (60

FR 11278), entitled ‘‘Guideline on Dose

Selection for Carcinogenicity Studies of

Pharmaceuticals.’’ The draft guideline is

intended to define the conditions under

which it would be considered

acceptable to use a ‘‘limit dose’’ for the

high dose selection of nongenotoxic

pharmaceuticals in long-term

carcinogenicity studies.

Although not required, FDA has in

the past provided a 75- or 90-day

comment period for draft ICH

guidelines. However, the comment

period for this draft guideline has been

shortened to 60 days so that comments

may be received by FDA in time to be

reviewed and then discussed at a July

1997 ICH meeting involving this

guideline.

This draft guideline represents the

agency’s current thinking on dose

selection for carcinogenicity studies of