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

57304 Federal Register / Vol. 65, No. 185 / Friday, September 22, 2000 / Proposed Rules

monitors (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.

In subsequent years, FDA initiated a

series of actions to provide for the

development of a mandatory

performance standard for the subset of

breathing frequency monitors,

commonly called neonatal apnea

monitors, that are intended to be used

on infants to detect the cessation of

respiratory air flow. Early actions

included the initiation of a proceeding

under section 514(b) of the act (21

U.S.C. 360d(b)) (48 FR 31392, July 8,

1983), and the issuance of an invitation

for interested persons to submit an

existing standard as a proposed

standard or to submit an offer to

develop a proposed standard (51 FR

6886, February 26, 1986).

Thereafter, FDA issued a grant award

to the Emergency Care Research

Institute (ECRI) to develop a proposed

standard for the neonatal apnea monitor

(53 FR 13296, April 22, 1988). However,

the proposed standard ECRI developed

did not cover certain performance

requirements for the device. As a

consequence, FDA initiated notice and

comment rulemaking to develop a

performance standard for the infant

apnea monitor, which would include

the neonatal apnea monitor. FDA

intended that the standard would

encompass monitors used in hospitals

and in patients’ homes to detect and

alarm upon the cessation of respiratory

air flow (i.e., apnea) in children under

3 years old.

In the Federal Register of January 4,

1989 (54 FR 187), FDA made available

for public comment its ‘‘First Draft

Proposed Standard for the Infant Apnea

Monitor, October 1988.’’ In the Federal

Register of December 6, 1989 (54 FR

50437), FDA announced the public

availability of its ‘‘Second Draft

Proposed Standard for the Infant Apnea

Monitor October, 1989.’’ After

considering comments received on these

drafts, and comments made at public

meetings, including the Seventh and

Eighth Conference(s) on Apnea of

Infancy, FDA issued a proposed rule

setting forth requirements for a

mandatory performance standard for the

infant apnea monitor (60 FR 9762,

February 21, 1995).

II. Summary of Requirements in the

Proposed Standard

The mandatory performance standard

proposed by FDA on February 21, 1995,

specified requirements for infant apnea

monitors in four areas: Patient

monitoring, electrical characteristics,

mechanical and environmental

characteristics, and labeling. Certain

provisions required conformance, to the

extent specified, with identified

international standards.

Proposed patient monitoring

provisions included: Requirements for

primary and secondary monitoring

modalities, visual and audible alarms

(status indicators), a remote alarm unit

for monitors intended for home use, and

a self-test mechanism. Proposed

electrical requirements included:

Provisions for battery backup, operation

from ungrounded power sources,

limitation of leakage current, and

operational specifications and test

procedures ensuring electromagnetic

compatibility. Proposed mechanical and

environmental requirements mandated:

Tamper proof controls, protection

against misconnections, and resistance

to normal shock, vibration, temperature

extremes, and fluid spills. Proposed

labeling provisions specified:

Information that manufacturers would

be required to provide to operators and

health care practitioners, including

specific product labels.

III. Summary of Comments Received on

the Proposed Standard

FDA received more than 100

comments from manufacturers,

hospitals, physicians, medical societies,

and national trade associations. A

number of comments objected to the 1-

year effective date of the standard. One

comment claimed that the cost of

compliance would exceed $100 million.

Another maintained that the need for

the standard was based on outdated data

and that FDA had not established that

the standard was necessary to provide

reasonable assurance of the device’s

safety and effectiveness.

Most comments addressed terms,

definitions, specifications, and/or

technical requirements proposed in the

standard. Many commented on the

terms ‘‘breath,’’ ‘‘breathing,’’ ‘‘cessation

of breathing,’’ and ‘‘breathing effort;’’

others on the definitions of infant apnea

monitor, operator, primary monitoring

modality, and secondary monitoring

modality. Comments concerning

primary and secondary monitoring

modalities focused on proposed

requirements for apnea duration

settings, activation times for warning

indicators, and sensor fault alarms.

Some comments questioned the

adequacy of requirements for visual and

audible warning indicators. Others

objected to requirements for resetting

silenced alarms, low battery warning

indicators, and minimum battery

capacity. Comments on proposed

electromagnetic compatibility

requirements included objections to

three levels of radiated electromagnetic

testing and three voltage levels of fast

transient burst testing. Comments also

suggested that alarming or degradation

of the monitor during immunity testing

should be considered an acceptable

response and testing endpoint.

Some comments wanted temperature

ranges raised for monitor operations and

surfaces contacting patients. Comments

about labeling objected generally that

some of the proposed requirements were

duplicative, or unnecessary, or were not

a manufacturer responsibility.

IV. Withdrawal of the Proposed

Standard

FDA is withdrawing the proposed

rule issued on February 21, 1995 (60 FR

9762), and terminating the proceeding

for the development of a mandatory

performance standard for the infant

apnea monitor, in accordance with

section 514(b)(3)(A) of the act. FDA no

longer believes that the special control

of a mandatory standard is necessary, at

this time, to provide reasonable

assurance of the safety and effectiveness

of this device (i.e., an apnea monitor

used on an infant/child under 3 years

old). The agency considered the

following factors in reaching this

conclusion: (1) Reductions in at-risk

infant populations, (2) few deaths and

serious injuries reported to FDA for

infant/child apnea monitors attributed

to monitor design problems or

malfunctions, (3) improved technology,

(4) alternative development of

consensus standards, and (5)

compliance costs versus risks and

benefits.

A. Declining Death Rates Within At-Risk

Infant Populations

Current U.S. medical opinion

continues to support the consensus

statement and report issued on the

subject of infantile apnea and home

monitoring, in accordance with the

National Institutes of Health (NIH)

Consensus Development Conference,

held on September 29 to October 1,

1986. There was consensus agreement,

at that conference, with respect to the

relationship of neonatal and infant

apnea to each other and to infant

morbidity, especially from sudden

infant death syndrome (SIDS). The

conferees agreed that apnea of

Federal Register / Vol. 65, No. 185 / Friday, September 22, 2000 / Proposed Rules 57305

1 ‘‘Infantile Apnea and Home Monitoring,’’ NIH

Consensus Statement Online 1986, September 29 to

October 1; 6(6): 1–10, pp. 1–3. 2 ID. at pp. 6–7.

3American Academy of Pediatrics, Task Force on

Infant Positioning and SIDS, ‘‘Positioning and

SIDS,’’ Pediatrics 89 (6): 1120–1126, June 1992. 4U.S. Department of Health and Human Services,

‘‘Reduction in SIDS Deaths Helps Bring Low Infant

Mortality,’’ Washington, DC, Press Release, October

9, 1996. 5National Center for Health Statistics, ‘‘Births

and Deaths: Preliminary Data for 1998,’’ National

Vital Statistics Reports; vol. 47, No. 25, table 15, p.

32. Hyattsville, MD, National Center for Health

Statistics, 1999.

6National Center for Health Statistics, ‘‘Deaths:

Final Data for 1997,’’ National Vital Statistics

Reports; vol. 47, No. 19, table 27, p. 86. Hyattsville,

MD, National Center for Health Statistics, 1999.

7See National Center for Health Statistics, note 5,

supra.

prematurity is not a risk factor for SIDS.

The conferees also agreed that an ALTE

would encompass any episode

experienced by infants characterized by

some combination of apnea (central or

occasionally obstructive), color change,

marked change in muscle tone, choking,

or gagging. The conferees agreed that

such an episode is considered a risk

factor for sudden death (including

SIDS).1 Thus, while the conferees

generally agreed that there was no

evidence of a direct relationship

between apnea experienced by infants

and SIDS deaths, certain

pathophysiological consequences of

apnea were not excluded as possible

contributors to sudden infant death.

Regarding home monitoring, the

consensus conference concluded that

there were no reports of scientifically

designed studies of the effectiveness of

electronic home monitoring of

premature infants for ALTE’s, or for

other pathologic conditions. However,

there was agreement that

cardiorespiratory monitoring was

effective in preventing death due to

apnea for certain infants, such as those

with a history of recurrent or severe

apnea. It was also agreed that

cardiorespiratory monitoring, or an

alternative therapy, was medically

indicated for certain groups of infants at

high risk for sudden death, such as

infants with one or more ALTE’s,

symptomatic preterm infants, siblings of

multiple SIDS victims, and others.2

FDA also notes the dramatic drop that

has occurred in SIDS deaths as

increased numbers of healthy infants

have been placed on their backs to

sleep, as a method of reducing the risk

of SIDS, under the 19923 and 1996

recommendations of the American

Academy of Pediatrics and the national

‘‘Back to Sleep’’ campaign launched in

1994 under the coordination of the

National Institute of Child Health and

Human Development. The number of

SIDS deaths has declined by over 48

percent from 4,891 deaths in 19924 to

2,529 deaths in 1998.5

FDA is also aware of the general

reductions over the past 7 years in

infant mortality rates. The infant (under

1 year) mortality rate has dropped from

8.5 infant deaths per 1,000 live births in

19926 to a 7.2 rate in 1998.7 FDA

believes that these reductions in infant

mortality rates, in conjunction with

reduced numbers of SIDS deaths, serve

to reduce the population, and attendant

risks, of infants subject to apnea of

infancy (i.e., ‘‘pathological’’ apnea of 20

seconds or longer associated with

bradycardia, cyanosis, pallor, and/or

marked hypotonia), and infants subject

to ALTE’s, including prone sleeping,

and other risk factors for SIDS.

B. Deaths, and Serious Injuries

Attributable to Infant/Child Apnea

Monitors

Under the Medical Device Reporting

(21 CFR part 803) and Medical Device

Distributor Reporting (21 CFR part 804)

regulations, FDA has received

manufacturer MDR reports, user facility

reports, distributor MDR reports (until

February 1998), and voluntary reports

and complaints of alleged adverse

events associated with the use of apnea

detectors, breathing frequency monitors,

respiratory monitors, and related

devices. From 1986 through 1991, FDA

received approximately 150 reports of

deaths, and 31 reports of serious injuries

allegedly associated with these devices.

In MDR reports received by FDA

during the past 8 years, few deaths or

serious injuries of children have been

reported for apnea monitor usage that

could be attributed to monitor problems

as the cause of the adverse events. From

July 1992 to October 1997, the MDR

data base lists receipt of reports alleging

20 deaths and 16 serious injuries that

might be associated with apnea

monitors. Sixteen deaths and 5 serious

injury incidents could be identified as

involving infants and children under 3

years old. For 1998 and 1999, data base

reports identify six of six alleged deaths

and three of four serious injuries as

involving patients under 3 years of age.

Since 1992, 22 deaths and 8 serious

injuries have allegedly occurred during

the use of infant/child apnea monitors.

In two of those deaths reported since

July 1992 were device problems

considered to have caused or

contributed directly to the reported

event. In a February 1993 incident (User

Report No. 3200010000–1993–0008), the

audible alarm of a respiration rate

monitor reportedly did not sound at the

decrease in respiration during the

seizure of a 3-month-old infant who

subsequently could not be resuscitated.

In an August 1993 incident (User Report

No. 1402080000–1993–0002), the

electrical power source of an apnea

monitor allegedly changed from the

battery mode to the alternating current

mode, resulting in the electrocution of

the infant.

Similarly, in three of the serious

injury events reported after July 1992

were monitor problems thought to be

causal factors. In 1992 (User Report No.

3300270000–1992–002) and 1998

(Voluntary Report No. MW1014260)

incidents, electrode connections

reportedly caused red skin irritations,

with skin breakdowns or burns.

Multiple false bradycardia alarming

resulted in unnecessary hospitalization

of an infant in one October 1997

incident (Voluntary Report No.

MW1012327).

FDA considers the continuing low

number of reported deaths and serious

injuries in which a monitor problem is

the possible cause of the adverse event

to be a factor that lessens the need for

a mandatory performance standard for

the infant/child apnea monitor at this

time. Moreover, as discussed below, the

agency believes that newer technologies

will reduce these small numbers even

further.

C. Improved Technology

Monitors to detect apnea in infants

have been used in hospitals and

patients’ homes since the early 1970’s.

Methods to detect respiration have

included mattress motion sensors,

capnometry, impedance pneumography,

inductive plethysmography, and others.

Impedance pneumography, utilizing

electrodes, leads, and patient cables,

remains the most prevalent method, but

other methods have been developed,

including those that utilize

nonelectrical or pneumatic sensors and

telemetric respiratory detection.

Various detection modalities and

features have been added to improve

apnea monitor designs, including: Heart

rate; oxygen saturation and airway

carbon dioxide monitoring; noise

suppression; automatic sensitivity

adjustments; signal processing

algorithms; and the capacity to record,

display, print, and retain in memory,

both patient and equipment data. The

use of heart rate monitoring modalities

in impedance pneumography units and

the inclusion of recording and memory

capabilities have improved the general

performance of home-use infant/child

apnea monitors. For example, the

introduction in the late 1980’s of homeuse monitors with internal memory has

aided in determining monitor activity

57306 Federal Register / Vol. 65, No. 185 / Friday, September 22, 2000 / Proposed Rules

8 ‘‘Reviewer Guidance For Premarket Notification

Submissions November 1993, Anesthesiology and

Respiratory Devices Branch, Division of

Cardiovascular, Respiratory, and Neurological

Devices.’’

during adverse events. These newer

technologies are in most hospital units,

in configurable modules that include

programmable apnea detection

modalities. Approximately 90 percent of

hospital monitoring systems in current

use already comply with the February

21, 1995, proposed standard for infant/

child apnea monitors (now withdrawn).

Moreover, apnea monitors for home

use that were introduced into

commercial distribution after November

1993 were cleared for marketing under

evaluation criteria described in a

guidance document8 used by reviewers

in the Center for Devices and

Radiological Health’s (CDRH’s) Office of

Device Evaluation (ODE). This

‘‘Reviewer Guidance’’ was made

available to industry through the

Center’s Division of Small

Manufacturers’ Assistance and is still

used by ODE reviewers in evaluating

510(k) submissions for home-use

respiratory devices. Many performance,

labeling, and testing recommendations

included in the guidance document

correspond to requirements in the

proposed standard. Thus, CDRH

believes that most home-use apnea

monitors that received 510(k) clearance

after November 1993 already meet most

of the provisions of the proposed

standard. Some apnea monitors

distributed before this time, however,

may not conform to certain

requirements of the proposed standard.

D. Alternative Development of

Consensus Standards

In 1995 (60 FR 9762), FDA proposed

to make compliance with certain

requirements of the infant apnea

monitor standard contingent upon

meeting specified provisions of 13

standards developed by other

organizations. Since then, global efforts

to harmonize standards and domestic

efforts to develop consensus standards

have increased. FDA’s historical support

of these efforts has also been

strengthened by the FDA Modernization

Act of 1997, which added new section

514(c) to the act, allowing FDA to

recognize consensus standards that may

be used to satisfy device review

requirements identified by the agency.

In the Federal Register of February 25,

1998 (63 FR 9561), FDA provided public

notice of its policy on this use of

standards and published its first list of

FDA-recognized consensus standards

related to medical devices.

FDA believes global harmonization

and domestic standardization are

producing widely accepted consensus

standards embodying the latest

scientific developments. In a draft

guidance to industry, providing

recommended criteria for infant/child

apnea monitors, FDA will identify the

latest versions of 17 international and

domestic consensus standards that have

some applicability to performance and

testing criteria, particularly

electromagnetic compatibility test

methods, which the agency considers

appropriate for these devices. The

agency believes these consensus

standards are applicable as well to

apnea monitors used on patients of any

age. After considering comments on the

draft guidance and further evaluating

clinical study criteria, FDA will modify

the draft document and issue final

guidance setting out minimum

performance, testing, labeling, and

clinical criteria that it considers

necessary to assure the safety and

effectiveness of any apnea monitor type

of device.

Manufacturers will have the

flexibility to follow the consensus

standards, and other recommendations,

set out in the agency’s apnea monitor

guidance or to use alternative

approaches of equal or better merit (e.g.,

in the use of test procedures). As

standards referenced in the agency’s

guidance become FDA-recognized

consensus standards, industry will be

able to obtain expedited marketing

clearance by certifying conformance to

them. FDA believes this process will

provide reasonable assurance of the

safety and effectiveness of the apnea

monitor type of device used on patient

populations of any age, including the

infant/child apnea monitor.

E. Compliance Costs versus Risks and

Benefits

Following its review of comments on

the proposed standard, FDA assessed

the cost and analyzed the economic

impact of various modified versions of

the proposed standard. FDA concluded

that, if the standard were issued as a

final regulation with a 1-year effective

date, the one-time cost of complying

with the modified standard would be

approximately $146.8 million. Annual

compliance costs would be about $2.7

million. Extending the effective date to

3 years would reduce the one-time

compliance cost to an estimated $89.7

million, while annual costs would

remain at $2.7 million.

The largest portion of estimated onetime costs were costs that would be

associated with the market removal and

correction of infant apnea monitors that

did not meet the requirements of the

standard. CDRH made the assessment

that certain home-use infant apnea

monitors marketed before November

1993 would not meet some

recommendations set forth in the

guidance made available on that date.

CDRH also believed that some of these

monitors would not meet certain

requirements of the February 21, 1995,

proposed standard. After a final

standard based on the proposed one

went into effect, noncompliant monitors

would have to be removed from the

market and corrected, for example, to

provide visual indication of a change in

apnea duration from a setting of 20

seconds, to change the color of some

visual indicators, to change the volume

level for audible alarms, and/or to add

shielding and/or filtering to provide

additional electromagnetic

compatibility.

In light of reductions in at-risk infant

populations, few recent deaths or

serious injuries attributable to

malfunctions, improvements in post1993 monitor technology, and

standardization developments, FDA has

concluded that a mandatory

performance standard is not necessary

to provide reasonable assurance of the

safety and effectiveness of the infant(/

child) apnea monitor, and that the

benefit to the public health would not

justify the costs to industry to comply

with the standard.

V. Alternative Actions—Classification,

Industry Guidance, and Education

Program

A. Classification

Elsewhere in this issue of the Federal

Register, FDA is proposing to create a

separate classification for the generic

type of device known as the apnea

monitor. The generic apnea monitor

would include the infant/child apnea

monitor intended for use on infants less

than 12 months old and children less

than 3 years old to detect and alarm

upon apnea and its pathophysiological

consequences. The apnea monitor

device will remain classified in class II,

but will be subject to a special control.

The special control is a FDA guidance

to industry. FDA believes that this

special control will provide reasonable

assurance of the safety and effectiveness

of the apnea monitor device, including

the infant/child apnea monitor.

B. FDA Guidance to Industry (Special

Controls)

Elsewhere in this issue of the Federal

Register, FDA is announcing the

availability for comment of a draft

guidance document for industry

Federal Register / Vol. 65, No. 185 / Friday, September 22, 2000 / Proposed Rules 57307

concerning infant/child apnea monitors.

This draft guidance sets forth the

agency’s current position regarding

minimum performance characteristics,

test procedures and criteria, labeling,

and, as appropriate, clinical testing that

will provide reasonable assurance of the

safety and effectiveness of this kind of

apnea monitor device. This guidance

includes basic concepts that were

included in the proposed standard for

infant apnea monitors, but updates,

consolidates, or eliminates certain

elements of the proposed standard on

the basis of comments received in

response to the proposal and the

continuing development and FDA

recognition of appropriate consensus

standards. Although the proposed

standard did not require clinical testing,

the guidance document addresses this

subject.

As noted above, FDA believes the

performance, testing, labeling, and

clinical parameters in the draft industry

guidance for infant/child apnea

monitors are applicable as well to apnea

monitors used on patients in every age

group. After considering comments on

this guidance and further evaluating

clinical criteria, FDA will issue final

industry guidance identifying minimum

performance, testing, labeling, and

clinical criteria as the special control for

the entire apnea monitor group of

devices. Once this special control is

established, new products seeking to

enter the market will be required to

conform with the special control. The

final guidance document will describe a

means by which an apnea monitor

device may comply with the

requirements of special controls for

class II devices.

Designation of the agency’s guidance

document as a special control means

that manufacturers attempting to

establish that their device is

substantially equivalent to a predicate

apnea monitor, including one used to

monitor apnea in children under 3 years

of age, should demonstrate that the

proposed device complies with either

the specific recommendations of this

guidance or some alternative control

that provides equivalent assurances of

safety and effectiveness. FDA recognizes

that older products already on the

market will not be required to meet this

special control. The agency expects,

however, that labeling on the newer

devices and other market forces will

encourage manufacturers of these older

devices to comply with the guidance.

FDA also expects the education

program, described below, to accelerate

the improvement of these older

products.

FDA is participating with the

Association for the Advancement of

Medical Instrumentation in a separate

effort to develop clinically-based test

methods and clinically-derived bench

tests for measuring the effectiveness of

monitoring modalities in detecting

apnea. At the conclusion of this effort,

the agency may consider these tests to

be referee test methods.

C. Education Program

FDA intends to develop an education

program targeted to reach manufacturers

of the infant/child apnea monitor,

manufacturers of accessories marketed

for use with this device, distributors and

rental companies handling the devices,

users, including hospitals and other

health care services, and other

consumers. This particular audience is

targeted initially because infants and

children under 3 years of age are

particularly subject to the

pathophysiological consequences of

prolonged apneas lasting over 20

seconds in duration.

The purpose of this program will be

to inform the target audience of FDA’s

current position regarding performance

characteristics and specifications, test

methods and results, and labeling

information the agency believes are

appropriate for the infant/child apnea

monitor. The program also will advise

the target audience that some monitors

previously cleared for marketing prior to

November 1993 may not meet the

agency’s current recommendations and,

although they may adequately detect

and alarm upon prolonged episodes of

central apnea, they may not be adequate

for detection of episodes of obstructive

apnea or mixed apnea.

As circumstances warrant, FDA may

direct additional educational efforts at

parties involved with apnea monitors

used on patient populations of other

ages.

Dated: September 12, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–24335 Filed 9–21–00; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 271

[FRL–6874–5]

Tennessee: Final Authorization of

State Hazardous Waste Management

Program Revisions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: Tennessee has applied to EPA

for Final authorization of the changes to

its hazardous waste program under the

Resource Conservation and Recovery

Act (RCRA). EPA proposes to grant final

authorization to Tennessee. In the

‘‘Rules and Regulations’’ section of this

Federal Register, EPA is authorizing the

changes by an immediate final rule. EPA

did not make a proposal prior to the

immediate final rule because we believe

this action is not controversial and do

not expect comments that oppose it. We

have explained the reasons for this

authorization in the preamble to the

immediate final rule. Unless we get

written comments which oppose this

authorization during the comment

period, the immediate final rule will

become effective on the date it

establishes, and we will not take further

action on this proposal. If we get

comments that oppose this action, we

will withdraw the immediate final rule

and it will not take effect. We will then

respond to public comments in a later

final rule based on this proposal. You

may not have another opportunity for

comment. If you want to comment on

this action, you must do so at this time.

DATES: Send your written comments by

October 23, 2000.

ADDRESSES: Send written comments to

Narindar Kumar, Chief, RCRA Programs

Branch, Waste Management Division,

U.S. Environmental Protection Agency,

The Sam Nunn Atlanta Federal Center,

61 Forsyth Street, SW, Atlanta, Georgia

30303–3104. You can examine copies of

the materials submitted by Tennessee

during normal business hours at the

following locations: EPA Region 4

Library, The Sam Nunn Atlanta Federal

Center, 61 Forsyth Street, SW, Atlanta,

Georgia 30303–3104, Phone number:

(404)562–8190; or Tennessee

Department of Environment and

Conservation, Division of Solid Waste

Management, 5th Floor, L & C Tower,

401 Church Street, Nashville, Tennessee

37243–1535, Phone number: (615) 532–

0850.

FOR FURTHER INFORMATION CONTACT:

Narindar Kumar, Chief, RCRA Programs