Federal Register / Vol. 65, No. 185 / Friday, September 22, 2000 / Proposed Rules 57301

The FAA has determined that this

proposed regulation only involves an

established body of technical

regulations for which frequent and

routine amendments are necessary to

keep them operationally current. It,

therefore, (1) is not a ‘‘significant

regulatory action’’ under Executive

Order 12866; (2) is not a ‘‘significant

rule’’ under DOT Regulatory Policies

and Procedures (44 FR 11034; February

26, 1979); and (3) does not warrant

preparation of a Regulatory Evaluation

as the anticipated impact is so minimal.

Since this is a routine matter that will

only affect air traffic procedures and air

navigation, it is certified that this rule,

when promulgated, will not have a

significant economic impact on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

The Proposed Amendment

In consideration of the foregoing, the

Federal Aviation Administration

proposes to amend 14 CFR part 71 as

follows:

PART 71—DESIGNATION OF CLASS A,

CLASS B, CLASS C, CLASS D, AND

CLASS E AIRSPACE AREAS;

AIRWAYS; ROUTES; AND REPORTING

POINTS

1. The authority citation for Part 71

continues to read as follows:

Authority: 49 U.S.C. 106(g); 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of Federal Aviation

Administration Order 7400.9H,

Airspace Designations and Reporting

Points, dated September 1, 2000, and

effective September 16, 2000, is

amended as follows:

Paragraph 500 Class D Airspace.

* * * * *

ASO FL D Gainesville, FL [Revised]

Gainesville Regional Airport, FL

(Lat. 29°41′24′′N, long. 82°16′18′′W)

That airspace extending upward from the

surface to and including 2,700 feet MSL

within a 4.3-mile radius of the Gainesville

Regional Airport. This Class D airspace area

is effective during the specific dates and

times established in advance by a Notice to

Airmen. The effective date and time will

thereafter be continuously published in the

Airport/Facility Directory.

* * * * *

Paragraph 6004 Class E4 Airspace Areas

Designated as an Extension to a Class D

Airspace Area

* * * * *

ASO FL E4 Gainesville, FL [Revised]

Gainesville Regional Airport, FL

(Lat. 29°41′24′′N, long. 82°16′18′′W)

Gators VORTAC

(Lat. 29°34′20′′N, long. 82°21′45′′W)

That airspace extending upward from the

surface within 2.4 miles each side of the

Gators VORTAC 041° radial, extending from

the 4.3-mile radius of Gainesville Regional

Airport to 7 miles northeast of the VORTAC.

This Class E4 airspace area is effective during

the specific dates and times established in

advance by a Notice to Airmen. The effective

date and time will thereafter be continuously

published in the Airport/Facility Directory.

* * * * *

Issued in College Park, Georgia, on

September 11, 2000.

Wade T. Carpenter,

Acting Manager, Air Traffic Division,

Southern Region.

[FR Doc. 00–24294 Filed 9–21–00; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. 00N–1457]

Medical Devices; Apnea Monitor;

Special Controls

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

proposed rule to create a separate

classification for the apnea monitor. The

device currently is included in the

generic type of device called breathing

frequency monitors. The apnea monitor

will remain in class II, but will be

subject to a special control. The special

control is an FDA guidance document

that identifies minimum performance,

testing, and labeling recommendations

for the device. Elsewhere in this issue

of the Federal Register, FDA is

withdrawing a proposed mandatory

standard for infant apnea monitors and

is announcing the availability of a draft

guidance document that will serve as

the special control. FDA is taking these

actions because it believes that they are

necessary to provide reasonable

assurance of the safety and effectiveness

of the apnea monitor.

DATES: Submit written comments by

December 21, 2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Joanna H. Weitershausen, Center for

Devices and Radiological Health (HFZ–

450), Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850, 301–443–8609, ext. 164.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September

10, 1982 (47 FR 39816), FDA classified

devices intended to measure or monitor

a patient’s respiratory rate into class II

(performance standards) as part of the

generic group of devices known as

breathing (ventilatory) frequency

monitors (§ 868.2375 (21 CFR

868.2375)). Under the classification

scheme set forth in section 513 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360c), as amended

by the Medical Device Amendments of

1976 (the 1976 amendments) (Public

Law 94–295), the agency determined

that performance standards were

necessary to provide reasonable

assurance of the safety and effectiveness

of these devices.

After several initial steps, described

in the notice published elsewhere in

this issue of the Federal Register

announcing the withdrawal of the

proposed rule to establish a

performance standard for the infant

apnea monitor (withdrawal), FDA

issued a proposed rule setting forth

requirements for a performance

standard for the infant apnea monitor

(60 FR 9762, February 21, 1995). For the

reasons discussed in the withdrawal,

FDA determined that it is not necessary

to establish a mandatory performance

standard for the device.

In its place, FDA has developed a

draft industry guidance document

setting forth the agency’s current

position regarding minimum

performance characteristics, test

procedures and criteria, labeling, and, as

appropriate, clinical testing for certain

apnea monitors, i.e., the infant/child

apnea monitor. The current draft

guidance identifies the monitor used on

this population because infants and

children under 3 years old are

particularly subject to the

pathophysiological consequences of

prolonged apneas lasting over 20

seconds in duration. The current draft

guidance includes basic concepts set out

in the proposed standard for the infant

apnea monitor, but updates,

consolidates, or eliminates certain

57302 Federal Register / Vol. 65, No. 185 / Friday, September 22, 2000 / Proposed Rules

1 ‘‘Reviewer Guidance for Premarket Notification

Submissions November 1993, Anesthesiology and

Respiratory Devices Branch, Division of

Cardiovascular, Respiratory, and Neurological

Devices.’’

elements of the proposed standard on

the basis of comments received on the

proposal and the continuing

development and FDA’s recognition of

appropriate consensus standards.

FDA is announcing the public

availability of this draft guidance

document in a notice published

elsewhere in this issue of the Federal

Register. Though the draft guidance

currently represents the agency’s

position with regard to the infant/child

apnea monitor, the agency believes the

performance, testing, labeling, and, as

appropriate, clinical criteria in the

guidance are applicable as well to the

apnea monitor used on patients of other

ages. In the Federal Register notice

announcing the public availability of

this draft guidance, the agency invites

comment on these specific issues.

FDA intends to modify the current

guidance in the next draft, including the

development of minimum clinical study

parameters, so that it represents the

agency’s current thinking with regard to

the apnea monitor used on any age

group. The final industry guidance

document will describe the minimum

performance, testing, labeling, and

clinical testing criteria that the agency

believes will provide, in conjunction

with the general controls of the act,

reasonable assurance of the safety and

effectiveness of the apnea monitor.

II. Proposed Rule

In this rule, FDA is proposing to

revise current § 868.2375(a) to state that

the section does not apply to the apnea

monitor. This proposed change is stated

in the last sentence.

To identify operational parameters in

conformance with technology, FDA

proposes revising the second sentence

of § 868.2375(a) from ‘‘when the

respiratory rate is outside

predetermined limits’’ to ‘‘when the

respiratory rate, averaged over time, is

outside operator settable limits.’’

Including ‘‘averaged over time’’

distinguishes the differences between a

breathing frequency monitor and an

apnea monitor. The breathing frequency

monitor averages the breath rate over a

given time (i.e., 30 seconds, 1 minute)

and, then, alarms at the settings the

operator has made. The limits are set by

the operator and, therefore, are not

predetermined. In contrast, the apnea

monitor alarms when the next breath is

not detected in a set time.

FDA also proposes adding § 868.2377

to classify the apnea monitor in class II

and designate the guidance document

entitled ‘‘Guidance for Apnea Monitor

510(k) Submissions’’ as a special control

for the device. The apnea monitor

identified in proposed § 868.2377(a)

includes, but is not limited to, the

infant/child apnea monitor intended for

use on infants under 1 year old and

children under 3 years old.

FDA will issue the final guidance

document identified as the special

control in proposed § 868.2377(b) upon

considering comments received on the

draft guidance currently entitled

‘‘Guidance for Infant/Child Apnea

Monitor 510(k) Submissions.’’ As noted

above, FDA believes the

recommendations it makes in this

guidance regarding apnea monitors used

for infants and children are applicable

as well to apnea monitors used for

patients in other age groups. Thus, FDA

will modify the final guidance

document so that it represents the

agency’s current thinking regarding the

performance characteristics, test

procedures and criteria, labeling

recommendations, and clinical study

parameters that are needed, in

conjunction with general controls, to

reasonably assure the safety and

effectiveness of the apnea monitor.

III. Environmental Impact

The agency has determined under 21

CFR 25.34(b) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

IV. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(5 U.S.C. 601–612) (as amended by

subtitle D of the Small Business

Regulatory Fairness Act of 1996 (Public

Law 104–121)), and the Unfunded

Mandates Reform Act of 1995 (Public

Law 104–4). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety

and other advantages; distributive

impacts; and equity). The agency

believes that this proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. This proposal to

classify the apnea monitor in class II as

a type of device that is separate from the

breathing frequency monitor, and

subject to the special control of industry

guidance issued by FDA, will not

require any firm that currently is legally

distributing an apnea monitor to comply

with guidance recommendations issued

by FDA for the devices. Subsequent to

FDA issuance of the final classification

rule and the final industry guidance

document, a firm submitting a 510(k)

premarket notification for a ‘‘new’’

apnea monitor will need to address

guidance recommendations. However,

the firm need only show that its device

is as safe and effective as a device that

meets guidance recommendations. The

firm may use alternative approaches if

those approaches meet the performance,

testing, labeling, and clinical study

parameters described in the guidance.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. In the past 10 years, the agency

estimates that it has received, on

average, approximately four 510(k)

submissions per year for breathing

frequency monitor devices. FDA

estimates that only one or two of these

submissions per year pertained to apnea

monitor devices. In addition, in

November 1993, the agency issued a

guidance document,1 made available to

industry, which described evaluation

criteria used by reviewers in FDA’s

Center for Devices and Radiological

Health to review 510(k) submissions for

apnea monitors. Many criteria in the

November 1993 document correspond

to performance, testing, and labeling

recommendations in the draft industry

guidance for infant/child apnea

monitors. The latter guidance, as noted

previously, will be modified and

become the special control guidance

referenced in this apnea monitor

classification proposal.

Based on the above, FDA believes

that, on average, no more than two

510(k)’s per year will be submitted for

‘‘new’’ apnea monitors by firms that

must address performance, testing, and

labeling parameters recommended in

the special control guidance document

issued by the agency as final guidance

after considering comments on the draft

guidance. The agency believes that the

final guidance document constituting

the special control will not set out

performance, testing, or labeling criteria

of a type not previously recommended

for apnea monitor devices. FDA also

believes that, under normal business

practices in response to competitive

market forces over the past 10 years, the

manufacturer of an apnea monitor will

have in place designs and procedures

that meet any updated

Federal Register / Vol. 65, No. 185 / Friday, September 22, 2000 / Proposed Rules 57303

recommendations in FDA’s final

guidance document.

Because of the above factors, FDA

believes apnea monitor manufacturers

will incur no costs other than those

associated with the submission of 510(k)

premarket notifications for ‘‘new’’

monitors. FDA has estimated this cost to

be $6,000 per submission on the basis

that it takes device firms approximately

80 hours to complete a 510(k) package

(exclusive of preparing clinical data,

research, etc.) and costs an average of

$75.00 per hour to perform this type of

work. Thus, FDA estimates the cost to

industry of this classification proposal

to be approximately $12,000 per year

($6,000 per 510(k) submission x 2

submissions per year). Therefore, the

agency certifies that this proposal, if

finalized, will not have a significant

economic impact on a substantial

number of small businesses.

Section 202(a) of the Unfunded

Mandates Reform Act of 1995 (Public

Law 104–4) requires that agencies

prepare a written statement of

anticipated costs and benefits before

proposing any rule that may result in an

expenditure by State, local, and tribal

governments, in the aggregate, or by the

private sector, of $100 million in any

one year (adjusted annually for

inflation). The Unfunded Mandates

Reform Act of 1995 does not require

FDA to prepare a statement of costs and

benefits for the proposed rule, because

the proposed rule is not expected to

result in any 1-year expenditure that

would exceed $100 million adjusted for

inflation.

V. Paperwork Reduction Act of 1995

This proposed rule contains

information collection provisions that

are subject to review by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(44 U.S.C. 3501–3520). The burden

hours required for proposed § 868.2377

are reported and approved under OMB

Control No. 0910–0120.

VI. Federalism

FDA has analyzed this proposed rule

in accordance with the principles set

forth in Executive Order 13132. FDA

has determined that the rule does not

contain policies that have substantial

direct effects on the States, on the

relationship between the National

Government and the States, or on the

distribution of power and

responsibilities among the various

levels of government. Accordingly, the

agency has concluded that the rule does

not contain policies that have

federalism implications as defined in

the order and, consequently, a

federalism summary impact statement is

not required.

VII. Submission of Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

proposal by December 21, 2000. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

List of Subjects in 21 CFR Part 868

Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 868 be amended as follows:

PART 868—ANESTHESIOLOGY

DEVICES

1. The authority citation for 21 CFR

part 868 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,

360j, 371.

2. Section 868.2375(a) is revised to

read as follows:

§ 868.2375 Breathing frequency monitor.

(a) Identification. A breathing

(ventilatory) frequency monitor is a

device intended to measure or monitor

a patient’s respiratory rate. The device

may provide an audible or visible alarm

when the respiratory rate, averaged over

time, is outside operator settable limits.

This device does not include the apnea

monitor classified in § 868.2377.

* * * * *

3. Section 868.2377 is added to

subpart C to read as follows:

§ 868.2377 Apnea monitor.

(a) Identification. An apnea monitor is

a complete system intended to alarm

primarily upon the cessation of

breathing timed from the last detected

breath. The apnea monitor includes a

secondary modality, such as heart rate

monitoring, that will alarm in response

to the physiological consequences of

apnea.

(b) Classification. Class II (special

controls) (Guidance document:

‘‘Guidance for Apnea Monitor 510(k)

Submissions’’).

Dated: September 1, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–24334 Filed 9–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 896

[Docket No. 83N–0193]

Medical Devices; Performance

Standard for the Infant Apnea Monitor;

Withdrawal Notice

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; withdrawal.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

the proposed rule it issued on February

21, 1995 (60 FR 9762). The document

set out proposed requirements for a

mandatory performance standard for the

infant apnea monitor. In light of

declining births and reduced mortality

rates for infants at risk for death due to

apparent life-threatening events

(ALTE’s), including certain apneas, and

after considering other factors, FDA no

longer believes that a mandatory

performance standard is needed for this

class II device. The agency believes that

FDA guidance to industry that identifies

minimum performance, testing, and

labeling recommendations will provide

reasonable assurance of the safety and

effectiveness of the apnea monitor,

including infant/child monitors. FDA is

making this draft guidance available for

comment through a notice published

elsewhere in this issue of the Federal

Register. Also, elsewhere in this issue of

the Federal Register, FDA is proposing

to create a separate classification for the

apnea monitor, with the FDA guidance

document as the special control.

FOR FURTHER INFORMATION CONTACT:

James J. McCue, Center for Devices and

Radiological Health (HFZ–84), Food and

Drug Administration, 2094 Gaither Rd.,

Rockville, MD 20850, 301–594–4766,

ext. 101.

SUPPLEMENTARY INFORMATION:

I. Background

On September 10, 1982 (47 FR 39816),

FDA classified devices intended to

measure or monitor a patient’s

respiratory rate into class II

(performance standards) as part of the

generic group of devices known as

breathing (ventilatory) frequency