21402 Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Notices

IV. Recommendation of the Panel

At a public meeting held on

September 16 and 17, 1999, the Panel

recommended that the totally implanted

SCS intended for aid in the treatment of

chronic intractable pain of the trunk or

limbs be reclassified from class III into

class II. In the Federal Register of

September 6, 2000 (65 FR 54053), FDA

published for public comment a notice

of the Panel’s recommendation and

FDA’s tentative findings on the Panel

recommendation. FDA invited

interested persons to comment by

October 6, 2000. In response to a

request, FDA later extended the

comment period to November 4, 2000.

V. FDA’s Decision

FDA received 22 comments in

response to the September 6, 2000,

notice of panel recommendation. The

comments are discussed in detail in the

order denying the reclassification

petition and in an attachment to that

order. Although FDA’s earlier tentative

findings supported reclassification, the

agency has now concluded that class II

controls are not adequate to address the

risks associated with the device. The

most serious risk to health presented by

the device is the risk of device failure.

Device failure is frequently the result of

improper device design. Device failure

always requires reoperation with all of

the attendant risks of secondary surgery.

Many of the comments suggested that

general controls and special controls

could not adequately control the risk of

device failure.

After carefully reviewing the

information in the petition, the

information presented at the Panel

meeting, the Panel’s deliberations, the

published literature, the Medical Device

Reports, and the comments on the

notice of panel recommendation, FDA

has completed its evaluation of the risks

to health associated with the use of the

totally implanted SCS intended for

treatment of chronic intractable pain of

the trunk or limbs.

FDA determined that the petitioner

had not demonstrated that special

controls would provide reasonable

assurance of the safety and effectiveness

of the device. Specifically, FDA

determined that special controls, such

as bench and animal testing, cannot

substitute for actual clinical trials

designed to demonstrate the safety and

effectiveness of these devices. FDA also

determined that the risks to health

associated with the manufacturing

process could only be addressed

through the degree of regulatory

oversight applied to class III devices.

Therefore, on February 23, 2001, FDA

issued an order to the petitioner

denying the petition for reclassification.

FDA has placed a copy of the order

denying the petition on display at the

Dockets Management Branch (address

above) in the above referenced docket.

A copy of the order may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: April 18, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–10619 Filed 4–27–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Technical Electronic Product Radiation

Safety Standards Committee; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Technical

Electronic Product Radiation Safety

Standards Committee.

General Function of the Committee:

To provide advice on technical

feasibility, reasonableness, and

practicality of performance standards

for electronic products to control the

emission of radiation under 21 U.S.C.

360kk(f).

Date and Time: The meeting will be

held on May 17, 2001, 8:30 a.m. to 5

p.m..

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: Orhan H. Suleiman,

Center for Devices and Radiological

Health (HFZ–240), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850, 301–594–3332, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12399. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will hear an

informal review of ongoing activities

associated with electronic products.

Following the overview, FDA will

specifically discuss its concern about

radiation doses associated with x-ray

computed tomography, digital x-ray

imaging systems, and its current

thinking about amending the U.S.

performance standard for these systems.

In the afternoon, FDA will briefly

review the history and current program

for products for which performance

standards exist. This review will

include discussion of microwave ovens,

television receivers, and laser products.

Following this review, FDA will discuss

current research and public health

concerns associated with cellular

telephones.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by May 10, 2001. On May 17,

2001, oral presentations from the public

will be scheduled between

approximately 10:30 a.m. and 11 a.m.,

and between 2 p.m. and 2:30 p.m. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before May 10, 2001, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: April 23, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–10625 Filed 4–27–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–3067–N]

Medicare Program; Request for

Nominations for Members for the

Medicare Coverage Advisory

Committee (MCAC)

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice requests

nominations for consideration for

members of the Medicare Coverage

Advisory Committee.

DATES: Nominations will be considered

if we receive them at the designated

address, as provided below, no later

than 5 p.m. on May 30, 2001.