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This draft guidance sets forth the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

57308 Federal Register / Vol. 65, No. 185 / Friday, September 22, 2000 / Proposed Rules

Branch, Waste Management Division,

U.S. Environmental Protection Agency

at the above address and phone number.

SUPPLEMENTARY INFORMATION: For

additional information, please see the

immediate final rule published in the

‘‘Rules and Regulations’’ section of this

Federal Register.

Dated: September 12, 2000.

A. Stanley Meiburg,

Acting Regional Administrator, Region 4.

[FR Doc. 00–24433 Filed 9–21–00; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

50 CFR Part 660

[I.D. 091800E]

RIN 0648-AO41

Fisheries off West Coast States and in

the Western Pacific; Pacific Coast

Groundfish Fishery; Amendment 13

AGENCY: National Marine Fisheries

Service (NMFS), National Oceanic and

Atmospheric Administration (NOAA),

Commerce.

ACTION: Notice of availability of an

amendment to a fishery management

plan; request for comments.

SUMMARY: NMFS announces that the

Pacific Fishery Management Council

(Council) has submitted Amendment 13

to the Pacific Coast Groundfish Fishery

Management Plan (FMP) for Secretarial

review. Amendment 13 is intended to

make the FMP consistent with

Magnuson-Stevens Fishery

Conservation and Management Act

(Magnuson-Stevens Act) bycatch

provisions,to increase flexibility in the

annual management measures

framework to manage for protection of

overfished and depleted stocks, and to

remove outdated and unused limited

entry permit endorsements.

DATES: Comments on Amendment 13

must be received on or before November

21, 2000.

ADDRESSES: Comments on Amendment

13 or supporting documents should be

sent to Donna Darm, Acting

Administrator, Northwest Region,

NMFS, Sand Point Way NE., BIN

C15700, Seattle, WA 98115-0070; or to

Rebecca Lent, Administrator, Southwest

Region, NMFS, 501 West Ocean

Boulevard, Suite 4200, Long Beach, CA

90802-4213.

Copies of Amendment 13 and the

Environmental Assessment/ Regulatory

Impact Review (RIR) are available from

Donald McIsaac, Executive Director,

Pacific Fishery Management Council,

2130 SW Fifth Ave., Suite 224, Portland,

OR 97201.

FOR FURTHER INFORMATION CONTACT:

Yvonne deReynier at 206-526-6140,

Svein Fougner at 562-980-4000; or the

Pacific Fishery Management Council at

503-326-6352.

SUPPLEMENTARY INFORMATION: The

Magnuson-Stevens Act requires that

each regional fishery management

council submit any new FMP or plan

amendment it prepares to NMFS for

review and approval, disapproval, or

partial approval. The Magnuson-Stevens

Act also requires that NMFS, upon

receiving an FMP or amendment,

immediately publish a notification in

the Federal Register that the FMP or

amendment is available for public

review and comment. NMFS will

consider the public comments received

during the comment period described

here in determining whether to approve

the FMP or amendment.

Amendment 13 would address the

Magnuson-Stevens Act National

Standard 9 bycatch provisions by:

revising the FMP definition of the term

‘‘bycatch’’, changing the standardized

reporting methodologies, and

recommending new bycatch reduction

measures. Amendment 13 would

establish an increased utilization

program in the at-sea whiting fisheries.

This program would allow at-sea

whiting processing vessels that carry

more than one observer to retain all of

their non-whiting groundfish bycatch

for processing into fish meal or for

donating to food banks. Measures that

would be authorized and may be

considered for future Council

development include: shorter fishing

seasons and higher cumulative landing

limits; permit stacking in the limited

entry fleet; gear modification

requirements; catch allocation to, or

gear flexibility for, gear types with lower

bycatch rates; improvements in the

species-to-species landings limit ratio;

and time/area closures to protect

incidentally caught species.

In addition to addressing bycatch,

Amendment 13 would increase

flexibility in the groundfish annual

specifications and management

measures process to allow the Council

to more easily develop measures that

protect overfished and depleted species.

This increased flexibility would

include: achieving the overfished

species rebuilding plans, reducing

bycatch, preventing overfishing,

allowing the harvest of healthy stocks as

much as possible while protecting and

rebuilding overfished and depleted

stocks, and equitably distributing the

burdens of rebuilding among the various

fishing sectors.

Finally, Amendment 13 would amend

the limited entry permit provisions to

remove unused and outdated limited

entry permit endorsements. This last

revision is essentially a housekeeping

measure to address changes in the

character of the groundfish fisheries,

particularly the fully utilized status of

all FMP-managed Pacific coast

groundfish stocks.

Public comments on Amendment 13

must be received by November 21, 2000

to be considered by NMFS in the

decision whether to approve

Amendment 13. A proposed rule to

implement Amendment 13 has been

submitted for Secretarial review and

approval. NMFS expects to publish and

request public comment on the

proposed regulations to implement

Amendment 13 in the near future.

Authority: 16 U.S.C. 1801 et seq.

Dated: September 19, 2000.

Bruce C. Morehead,

Acting Director, Office of Sustainable

Fisheries, National Marine Fisheries Service.

[FR Doc. 00–24458 Filed 9–21–00; 8:45 am]

BILLING CODE 3510–22–S