21400 Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Notices

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–26, Rockville,

MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

when appropriate, and other forms of

information technology.

Survey of Single-Use Medical Device

Reuse and Reprocessing in Hospitals

Section 1701(a)(4) of the Public

Health Service Act (42 U.S.C.

300u(a)(4)) authorizes FDA to conduct

research relating to health information.

The ‘‘Survey of Single-Use Medical

Device Reuse and Reprocessing in

Hospitals’’ will provide information on

the frequency, nature, and scope of

reuse and reprocessing of single-use

medical devices by U.S. hospitals. The

survey will provide statistically reliable

estimates of the number of U.S.

hospitals that are currently reusing and

internally reprocessing single-use

medical devices, whether they have

registered with FDA, whether they are

aware of the FDA educational materials

on the reuse of single-use medical

devices, and, if they are not currently

internally reprocessing single-use

devices, whether they have reused and

reprocessed single-use medical devices

in the past 3 years.

FDA will use these results to estimate

the number of U.S. hospitals that reused

and reprocessed single-use medical

devices in the past, and those that

currently reuse and internally reprocess

single-use medical devices. This

information will help FDA design its

inspection plan, modify its education

program, and evaluate the economic

impact of current and future policies

regarding single-use medical devices.

The respondents to this collection of

information will be U.S. hospitals.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN FOR TELEPHONE SURVEY1

No. of Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

4,480 1 4,480 0.125 560

1There are no capital costs or operating and maintenance costs associated with this collection of information.

This is a one-time survey. The burden

estimate for the telephone survey is

based on a pretest of a preliminary

survey instrument administered to nine

hospitals.

Dated: April 24, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–10626 Filed 4–27–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0170]

Abbott Laboratories’ Sarafloxacin for

Poultry; Withdrawal of Approval of

NADAs

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of two new animal drug

applications (NADAs) sponsored by

Abbott Laboratories. The NADAs

provide for use of sarafloxacin to treat

poultry. In a final rule published

elsewhere in this issue of the Federal

Register, FDA is amending the animal

drug regulations by removing the

portions reflecting approval of these

NADAs.

DATES: Withdrawal of approval is

effective April 30, 2001.

FOR FURTHER INFORMATION CONTACT:

Mohammad I. Sharar, Center for

Veterinary Medicine (HFV–216), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0159.

SUPPLEMENTARY INFORMATION: Abbott

Laboratories, North Chicago, IL 60064,

is sponsor of the following NADAs: (1)

NADA 141–017 SaraFlox (sarafloxacin

hydrochloride) WSP, a water-soluble

powder used in the drinking water of

broiler chickens and growing turkeys for

control of mortality associated with

Escherichia coli in (21 CFR 520.2095);

and (2) NADA 141–018 SaraFlox

(sarafloxacin hydrochloride) Injection,

an injectable solution used in 18-day

embryonated broiler eggs and day-old

broiler chickens for control of early

chick mortality associated with E. coli

(21 CFR 522.2095).

The sponsor was informed by FDA

that, on the basis of new data and

information before it, there is a question

of human food safety, due to the use of

fluoroquinolones such as sarafloxacin in

poultry. After being informed by FDA of

this question, Abbott Laboratories

requested voluntary withdrawal of

approval of NADAs 141–017 and 141–

018. By doing so, the firm waived its

opportunity for hearing.

Therefore, under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10), redelegated to the Center

for Veterinary Medicine (21 CFR 5.84),

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.