Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Notices 21401

and in accordance with § 514.115

Withdrawal of approval of applications

(21 CFR 514.115), notice is given that

approval of NADAs 141–017 and 141–

018, and all supplements and

amendments thereto is hereby

withdrawn effective April 30, 2001. Any

new animal drug product that is not the

subject of an approved application is

subject to regulatory action at any time.

In a final rule published elsewhere in

this issue of the Federal Register, FDA

is amending the animal drug regulations

to reflect the withdrawal of approval of

these NADAs.

Dated: April 17, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 01–10067 Filed 4–27–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P–0788]

Neurological Devices; Reclassification

of the Totally Implanted Spinal Cord

Stimulator; Denial of Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that it has denied a petition submitted

by Advanced Neuromodulation

Systems, Inc. (ANS), to reclassify the

totally implanted spinal cord stimulator

(SCS) for treatment of chronic

intractable pain of the trunk or limbs

from class III into class II. FDA had

previously made available for public

comment the recommendation of the

Neurological Devices Panel (the Panel)

on the reclassification petition and

FDA’s tentative findings on the Panel’s

recommendation. After considering all

the available information, including the

public comments on the Panel’s

recommendation, FDA denied the

reclassification petition by order in a

letter to the petitioner.

ADDRESSES: A copy of the denial order

is available at the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Mark N. Melkerson, Center for Devices

and Radiological Health (HFZ–410),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1184.

SUPPLEMENTARY INFORMATION:

I. Background

The Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 301 et. seq.), as

amended by the Medical Device

Amendments of 1976 (the 1976

amendments) (Public Law 94–295), the

Safe Medical Devices Act of 1990

(Public Law 101–629), and the Food and

Drug Administration Modernization Act

of 1997 (Public Law 105–115),

established a comprehensive system for

the regulation of medical devices

intended for human use. Section 513 of

the act (21 U.S.C. 360c) established

three categories (classes) of devices,

depending on the regulatory controls

needed to provide reasonable assurance

of their safety and effectiveness. The

three categories of devices are class I

(general controls), class II (special

controls), and class III (premarket

approval).

Under section 513 of the act, devices

that were in commercial distribution

before May 28, 1976 (the 1976

amendments enactment date), generally

referred to as preamendments devices,

are classified after FDA has: (1)

Received a recommendation from a

device panel (an FDA advisory

committee); (2) published the panel’s

recommendation for comment, along

with a proposed regulation classifying

the device; and (3) published a final

regulation classifying the device. FDA

has classified most preamendments

devices under these procedures.

Devices that were not in commercial

distribution prior to May 28, 1976,

generally referred to as postamendments

devices, are classified automatically by

statute (section 513(f) of the act) into

class III without any FDA rulemaking

process. A postamendment device

remains in class III and requires

premarket approval, unless and until

the device is reclassified into class I or

II or FDA issues an order finding the

device substantially equivalent, under

section 513(i) of the act, to a predicate

device that does not require premarket

approval. The agency determines

whether new devices are substantially

equivalent to previously offered devices

by means of premarket notification

procedures in section 510(k) of the act

(21 U.S.C. 360(k)) and 21 CFR part 807

of the regulations.

Reclassification of classified

postamendments devices is governed by

section 513(f)(3) of the act. This section

allows FDA to initiate reclassification of

a postamendments class III device under

section 513(f)(1) of the act, or a

manufacturer or importer of a device

may petition the Secretary of Health and

Human Services (the Secretary) for the

issuance of an order reclassifying the

device in class I or class II.

FDA’s regulations in 21 CFR 860.134

set forth the procedures for the filing

and review of a petition for

reclassification of such postamendment

class III devices. To change the

classification of the device, it is

necessary that the proposed new class

have sufficient regulatory controls to

provide reasonable assurance of the

safety and effectiveness of the device for

its intended use.

Under section 513(f)(3)(B)(i) of the

act, the Secretary may, for good cause

shown, refer a reclassification petition

to a device panel for a recommendation

on the subject device’s classification.

The panel shall make a recommendation

to the Secretary respecting approval or

denial of the petition. Any such

recommendation shall contain: (1) A

summary of the reasons for the

recommendation, (2) a summary of the

data upon which the recommendation is

based, and (3) an identification of the

risks to health (if any) presented by the

device with respect to which the

petition was filed.

II. Regulatory History of the Device

The totally implanted SCS intended

for treatment of chronic intractable pain

of the trunk or limbs is a

postamendments device classified into

class III under section 513(f)(2) of the

act. Therefore, the device cannot be

placed in commercial distribution for

treatment of chronic intractable pain of

the trunk or limbs unless it is

reclassified under section 513(f)(2) of

the act, or subject to an approved PMA

under section 515 of the act.

On June 16, 1999, ANS submitted a

petition to FDA that requested

reclassification of the totally implanted

SCS intended for treatment of chronic

intractable pain of the trunk or limbs

from class III into class II. Consistent

with the act and the regulation, FDA

referred the petition to the Panel for its

recommendation on the requested

reclassification.

III. Device Description

The following device description is

based on the Panel’s recommendations

and the agency’s review: The totally

implanted spinal control stimulator

consists of an implanted pulse generator

(IPG), leads, and electrodes. The IPG

contains the internal power source that

is implanted in the patient. The

electrodes are placed on the patient’s

spinal cord and the leads from the

electrodes are connected

subcutaneously to the IPG.

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.