88 Federal Register / Vol. 63, No. 1 / Friday, January 2, 1998 / Notices

for patient management. Complicated

retinal detachments or recurrent retinal

detachments occur most commonly in

eyes with proliferative vitreoretinopathy

(PVR), proliferative diabetic retinopathy

(PDR), cytomegalovirus (CMV) retinitis,

giant tears, and following perforating

injuries. SILIKON 1000 is also indicated

for primary use in detachments due to

acquired immune deficiency syndrome

(AIDS) related CMV retinitis and other

viral infections affecting the retina. On January 13, 1997, the Ophthalmic

Devices Panel of the Medical Devices

Advisory Committee, an FDA advisory

committee, reviewed and recommended

approval of the application. On

September 25, 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

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 February 2, 1998, 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 1, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–34156 Filed 12–31–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0519]

Vitrophage, Inc.; Premarket Approval

of VITREON

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application submitted

by Vitrophage, Inc., Lyons, IL, for

premarket approval, under the Federal

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

of VITREON . After reviewing the

recommendation of the Ophthalmic

Devices Panel, FDA’s Center for Devices

and Radiological Health (CDRH)

notified the applicant, by letter of

September 30, 1997, of the approval of

the application.

DATES: Petitions for administrative

review by February 2, 1998.

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

December 6, 1991, Vitrophage, Inc.,

Lyons, IL 60534, submitted to CDRH an

application for premarket approval of

VITREON. The device is a purified

perfluorocarbon liquid and is indicated

for use as an intraoperative surgical aid

during vitreoretinal surgery in patients

with primary and recurrent complicated

retinal detachments. Complicated cases

include giant retinal tear or retinal

dialysis, proliferative vitreoretinopathy,

proliferative diabetic retinopathy,

tractional retinal detachments, and

blunt or penetrating ocular trauma.

On October 19, 1995, the Ophthalmic

Devices Panel of the Medical Devices

Advisory Committee, an FDA advisory

committee, reviewed and recommended

approval of the application. On

September 30, 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

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 February 2, 1998, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,
Federal Register / Vol. 63, No. 1 / Friday, January 2, 1998 / Notices 89

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 1, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–34157 Filed 12–31–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0514]

CDRH Interim Regulatory Policy for

External Penile Rigidity Devices;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is making

available a policy from its Center for

Devices and Radiological Health (CDRH)

entitled ‘‘CDRH Interim Regulatory

Policy for External Penile Rigidity

Devices.’’ The document outlines

several changes in how FDA regulates

external penile rigidity devices

including constriction rings, vacuum

pumps, and penile splints.

DATES: Written comments concerning

this guidance may be submitted at any

time.

ADDRESSES: Written comments

concerning this guidance must be

submitted to the contact person.

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

policy. Submit written requests for

single copies of the ‘‘CDRH Interim

Regulatory Policy for External Penile

Rigidity Implants’’ to the Division of

Small Manufacturers Assistance, Center

for Devices and Radiological Health

(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.

FOR FURTHER INFORMATION CONTACT:

Donald St. Pierre, Center for Devices

and Radiological Health (HFZ–450),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2194.

SUPPLEMENTARY INFORMATION:

I. Background

External penile rigidity devices are

unclassified medical devices designed

to promote or maintain sufficient penile

rigidity for sexual intercourse. This

document clarifies when premarket

review is required for new external

penile rigidity devices using a uniform

approach. The new policy also allows

manufacturers the option of marketing

external penile rigidity devices as

prescription and/or over the counter

(OTC) devices.

This guidance document represents

the agency’s current thinking on

regulation of external penile rigidity

devices. 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 (61 FR 8961,

February 27, 1997). This guidance is

issued as Level 2 guidance consistent

with GGP’s.

II. Electronic Access

Persons interested in obtaining a copy

of the guidance may do so using the

World Wide Web (WWW). The Center

for Devices and Radiological Health

(CDRH) maintains an entry on the

World Wide Web 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 CDRH

Interim Regulatory Policy for External

Penile Rigidity 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 CDRH

Interim Regulatory Policy for External

Penile Rigidity Devices will be available

at http://www.fda.gov/cdrh/ode/

expenrig.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.

III. Comments

Interested persons may at any time

submit written comments on the

guidance document to the contact

person. Comments will be considered in

determining whether to revise or revoke

the guidance document.

Dated: December 1, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–34158 Filed 12-31-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1904–NC]

RIN 0938–AI24

Medicare Program; Schedule of Limits

on Home Health Agency Costs Per

Visit for Cost Reporting Periods

Beginning on or After October 1, 1997

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice with comment period.

SUMMARY: This notice sets forth a

revised schedule of limits on home

health agency costs that may be paid

under the Medicare program for cost

reporting periods beginning on or after

October 1, 1997. These limits replace

the per visit limits that were set forth in

our July 1, 1996 notice with comment

period (61 FR 34344) and supersede

those set forth in our July 1, 1997 notice

with comment period (62 FR 35608).

This notice also provides, in accordance

with the Balanced Budget Act of 1997,

that there be no changes in the home

health per visit limits for cost reporting

periods beginning on or after July 1,

1997 and before October 1, 1997 (that is,

the cost limits set forth in our July 1,

1996 notice will apply to cost reporting