65348 Federal Register / Vol. 60, No. 243 / Tuesday, December 19, 1995 / Notices

Medical Devices Advisory Committee,

an FDA advisory committee, for review

and recommendation because the

information in the PMA substantially

duplicates information previously

reviewed by this panel.

On August 15, 1995, 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 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 part 12 (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

§ 10.33(b) (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 the 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 January 18, 1996, 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: November 29, 1995.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 95–30697 Filed 12–18–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95M–0398]

Cochlear Corp.; Premarket Approval of

New Indication for Use for the Nucleus

22–Channel Cochlear Implant

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the supplemental

application by Cochlear Corp.,

Englewood, CO, for premarket approval,

under section 515 of the Federal Food,

Drug, and Cosmetic Act (the act), of a

new indication for use for the Nucleus

22–Channel Cochlear Implant. FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of August 21, 1995, of the

approval of the application.

DATES: Petitions for administrative

review by January 18, 1996.

ADDRESSES: Address 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:

Marilyn Flack, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2080.

SUPPLEMENTARY INFORMATION: On August

8, 1992, Cochlear Corp., Englewood, CO

80112, submitted to CDRH a

supplemental application for premarket

approval of an expanded indication for

use for the Nucleus 22–Channel

Cochlear Implant. The device was

originally approved in 1985 for use in

adults who demonstrated postlinguistic,

bilateral, sensorineural hearing loss and

obtained little or no benefit from

conventional amplification. It was

approved in 1990 for use in children

who demonstrated bilateral, profound,

sensorineural hearing loss and obtained

little or no benefit from conventional

amplification or vibrotactile hearing

aids. The expanded indication for use

now includes patients, 18 years and

older, who have bilateral, postlinguistic,

sensorineural hearing impairment and

obtain limited benefit from appropriate

binaural hearing aids. Limited benefit

from amplification is defined by test

scores of 30 percent correct or less in

the best-aided listening condition on

tape-recorded tests of open-set sentence

recognition. These patients typically

have low frequency residual hearing in

the moderate-to-profound range and

profound (greater than or equal to 90

dBHL) hearing loss in the mid-to-high

speech frequencies.

On April 20, 1995, the Ear, Nose and

Throat Devices Advisory Panel, an FDA

advisory panel, reviewed and

recommended approval of the

supplemental application.

On August 21, 1995, CDRH approved

the supplemental 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 (21 U.S.C. 360e(g)), for

administrative review of CDRH’s

decision to approve this supplemental

application. A petitioner may request

either a formal hearing under part 12 (21

CFR part 12) of FDA’s administrative

practices and procedures regulations or

a review of the supplemental

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 §

10.33(b) (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 the review

to be used, the persons who may

participate in the review, the time and
Federal Register / Vol. 60, No. 243 / Tuesday, December 19, 1995 / Notices 65349

place where the review will occur, and

other details.

Petitioners may, at any time on or

before January 18, 1996, 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: December 4, 1995.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 95–30815 Filed 12–18–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95M–0395]

Pharmacia, Inc.; Premarket Approval of

Model WS–100 Pliolens UltravioletAbsorbing Silicone Posterior Chamber

Intraocular Lens

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by

Pharmacia, Inc., Dublin, OH, for

premarket approval, under the Federal

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

of Model WS–100 Pliolens ultravioletabsorbing silicone posterior chamber

intraocular lens. FDA’s Center for

Devices and Radiological Health (CDRH)

notified the applicant, by letter of July

20, 1995, of the approval of the

application.

DATES: Petitions for administrative

review by January 18, 1996.

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:

Ashley A. Boulware, Center for Devices

and Radiological Health (HFZ–460),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2053.

SUPPLEMENTARY INFORMATION: On

February 28, 1994, Pharmacia, Inc.,

Dublin, OH 43017, submitted to CDRH

an application for premarket approval of

Model WS–100 Pliolens ultravioletabsorbing silicone posterior chamber

intraocular lens. The device is a

posterior chamber intraocular lens and

is indicated for primary implantation for

the visual correction of aphakia in

persons 60 years of age or older in

whom a cataractous lens has been

removed by extracapsular cataract

extraction.

In accordance with the provisions of

section 515(c)(2) of the act (21 U.S.C.

360e(c)(2)) as amended by the Safe

Medical Devices Act of 1990, this

premarket approval application (PMA)

was not referred to the Ophthalmic

Devices Panel of the Medical Devices

Advisory Committee, an FDA advisory

committee, for review and

recommendation because the

information in the PMA substantially

duplicates information previously

reviewed by this panel. On July 20,

1995, 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 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 part 12 (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

§ 10.33(b) (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 the 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 January 18, 1996, 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: November 29, 1995.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 95–30698 Filed 12–18–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0253J]

Analysis Regarding The Food and

Drug Administration’s Jurisdiction

Over Nicotine-Containing Cigarettes

and Smokeless Tobacco Products;

Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; analysis regarding

agency jurisdiction; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that appeared in the Federal

Register of August 11, 1995 (60 FR

41453). In the notice, FDA published a

document entitled ‘‘Nicotine In

Cigarettes And Smokeless Tobacco

Products Is A Drug And These Products

Are Nicotine Delivery Devices Under

the Federal Food, Drug, and Cosmetic

Act,’’ and announced the availability of

appendices to this document. The

agency has identified some proofreading

inaccuracies in the references listed in

the document. This document corrects

those errors.

FOR FURTHER INFORMATION CONTACT:

Phillip L. Chao, Office of Policy (HF–

23), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–3380.

In FR Doc. 95–20052, appearing on

page 41453 in the Federal Register of