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