Federal Register / Vol. 62, No. 62 / Tuesday, April 1, 1997 / Notices 15527

an FDA advisory committee, reviewed

and recommended approval of the

application. On November 26, 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 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 May 1, 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: February 20, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–8114 Filed 3–31–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97M–0120]

Angelini Pharmaceuticals, Inc.;

Premarket Approval of the 2-In-1 Drop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Angelini

Pharmaceuticals, Inc., River Edge, NJ,

for premarket approval, under the

Federal Food, Drug, and Cosmetic Act

(the act), of the 2-In-1 Drop. FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of February 13, 1997, of the

approval of the application.

DATES: Petitions for administrative

review by May 1, 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:

James F. Saviola, Center for Devices and

Radiological Health (HFZ–460), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1744.

SUPPLEMENTARY INFORMATION: On May

25, 1994, Angelini Pharmaceuticals,

Inc., River Edge, NJ 07661, submitted to

CDRH an application for premarket

approval of the 2-In-1 Drop. The device

is a contact lens drop, packaged in a

single-use container, that is indicated

for use with soft (hydrophilic) contact

lenses (including disposables) and rigid

gas permeable contact lenses as a

lubricating and rewetting agent during

the wearing period and as a wetting

agent to cushion lenses prior to

placement on the eye. The 2-In-1 Drop

may also be used in place of a daily

cleaner as part of an appropriate

chemical disinfection regimen.

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

application was not referred to the

Ophthalmic Devices Panel of the

Medical Device Advisory Committee, an

FDA advisory committee, for review and

recommendation because the

information in the application

substantially duplicates information

previously reviewed by this panel.

On February 13, 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 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 1, 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
15528 Federal Register / Vol. 62, No. 62 / Tuesday, April 1, 1997 / Notices

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. 97–8169 Filed 3–31–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97M–0122]

Xillix Technologies Corp.; Premarket

Approval of Xillix LIFE-Lung

Fluoresence Endoscopy System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application submitted

by Hogan and Hartson, Washington, DC,

U.S. representative for Xillix

Technologies Corp., Richmond, B.C.,

Canada, for premarket approval, under

the Federal Food, Drug, and Cosmetic

Act (the act), of Xillix LIFE-Lung

Fluoresence Endoscopy System. After

reviewing the recommendation of the

Ear, Nose, and Throat Devices Panel,

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of September 19,

1996, of the approval of the application.

DATES: Petitions for administrative

review by May 1, 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:

Kirby J. Cooper, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2080.

SUPPLEMENTARY INFORMATION: On

December 21, 1995, Hogan and Hartson,

Washington, DC, U.S. representative for

Xillix Technologies Corp., Richmond,

B.C. Canada, submitted to CDRH an

application for premarket approval of

Xillix LIFE-Lung Fluorescence

Endoscopy System. The device is a

fluorescence endoscopy system and is

indicated for use as an adjunct to white

light bronchoscopy, using an Olympus

BF-20D bronchoscope, to enhance the

physician’s ability to identify and locate

bronchial tissue, suspicious for

moderate/severe dysplasia or worse, for

biopsy and histologic evaluation in the

following patient populations:

1. Patients with known or previously

diagnosed lung cancer; and

2. Patients with suspected lung cancer

including: (a) Patients with Stage I

completely resected lung cancer, with

no evidence of metastatic disease, who

are at risk for secondary disease; and (b)

patients suspected of having lung cancer

because of clinical symptoms such as

positive sputum cytology, hemoptysis,

unresolved pneumonia, persistent

cough, or positive x-ray.

On June 11, 1996, the Ear, Nose, and

Throat Devices Panel of the Medical

Devices Advisory Committee, an FDA

advisory committee, reviewed and

recommended approval of the

application. On September 19, 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 1, 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. 97–8170 Filed 3–31–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 35, United

States Code, as amended by the

Paperwork Reduction Act of 1995,

Public Law 104–13), the Health

Resources and Services Administration

(HRSA) will publish periodic

summaries of proposed projects being

developed for submission to OMB under

the Paperwork Reduction Act of 1995.

To request more information on the

proposed project or to obtain a copy of

the data collection plans, call the HRSA

Reports Clearance Officer on (301) 443–

1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.