Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Proposed Rules 20933

comments. A report summarizing each

substantive public contact with FAA

personnel concerned with this

rulemaking will be filed in the docket.

Availability of NPRM’s

Any person may obtain a copy of this

Notice of Proposed Rulemaking (NPRM)

by submitting a request to the Federal

Aviation Administration, Office of

Public Affairs, Attention: Public Inquiry

Center, APA–230, 800 Independence

Avenue, S.W., Washington, DC 20591,

or by calling (202) 267–3484.

Communications must identify the

docket number of this NPRM. Persons

interested in being placed on a mailing

list for future NPRM’s should also

request a copy of Advisory Circular No.

11–2A, which describes the application

procedure.

The Proposal

The FAA is considering an

amendment to 14 CFR part 71 to

establish Class E airspace at

Minneapolis, Crystal Airport, MN, to

accommodate FAR Part 135 (14 CFR

part 135) air carrier aircraft executing

instrument flight rules procedure during

periods when the control tower is

closed. The area would be depicted on

appropriate aeronautical charts. Class E

airspace designations for airspace areas

extending upward from the surface of

the earth are published in paragraph

6002 of FAA Order 7400.9G dated

September 11, 1999, and effective

September 16, 1999, which is

incorporated by reference in 14 CFR

71.1. The Class E airspace designations

listed in this document would be

published subsequently in the Order.

The FAA has determined that this

proposed regulation only involves an

establishment body of technical

regulations for which frequent and

routine amendments are necessary to

keep them operationally current.

Therefore, this proposed regulation—(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 proposed rule 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

Accordingly, pursuant to the

authority delegated to me, 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 the Federal Aviation

Administration Order 7400.9G, Airspace

Designations and Reporting Points,

dated September 11, 1999, and effective

September 16, 1999, is amended as

follows:

* * * * *

Paragraph 6002 Class E airspace designated

as a surface area.

* * * * *

AGL MN E2 Minneapolis, Crystal Airport,

MN [New]

Crystal Airport, MN

(Lat. 45°08′42′′N., long 93°12′41′′W.)

Within a 3.8-mile radius of the

Minneapolis, Anoka County-Blaine Airport.

This Class E airspace area is effective during

the specific dates and times established in

advance by Notice to Airmen. The effective

date and time will thereafter be continuously

published in the Airport/Facility Directory.

* * * * *

Issued in Des Plaines, Illinois on March 22,

2000.

Christopher R. Blum,

Manager, Air Traffic Division.

[FR Doc. 00–9215 Filed 4–18–00; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 864, 866, 868, 870, 872,

874, 876, 878, 884, 886, and 888

[Docket No. 99N–0035]

Medical Devices; Reclassification of 38

Preamendments Class III Devices into

Class II

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; reopening of

comment period.

SUMMARY: The Food and Drug

Administration (FDA) is reopening for

90 days the comment period for the

submission of comments regarding 6 of

the 38 devices proposed for

reclassification from class III into class

II. The proposed rule was published in

the Federal Register of March 15, 1999

(64 FR 12774). The agency is taking this

action in part in response to a request

for more time to submit comments to

FDA regarding several of the guidance

documents that were not made available

when the March 15, 1999, proposed rule

was published. Elsewhere in this issue

of the Federal Register, FDA is

announcing the availability of these

guidance documents for comment.

DATES: Submit written comments on the

proposed rule by July 18, 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:

Joseph M. Sheehan, Center for Devices

and Radiological Health (HFZ–215),

Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850, 301–

827–2974.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 15,

1999 (64 FR 12774), FDA published a

proposed rule to reclassify 38

preamendments class III devices into

class II and to establish special controls

for these devices. Interested persons

were given until June 14, 1999, to

comment on the proposed rule.

A trade association requested that

FDA reopen the comment period for the

following six devices: (1) Vascular graft

prosthesis of less than 6 millimeters

diameter, (2) pacemaker lead adaptor,

(3) annuloplasty ring, (4)

cardiopulmonary bypass defoamer, (5)

cardiopulmonary bypass arterial line

blood filter, and (6) cardiopulmomonary

bypass oxygenator. The request noted

that FDA had not made the guidance

documents that were proposed as

special controls for these six devices

available for comment through the

agency’s Good Guidance Practices

(GGP’s). The request further noted that

it was impossible to comment on the

proposed reclassification without the

guidance documents being available.

Therefore, the trade association

requested that FDA extend the comment

period until at least 90 days after the

guidance documents are publicly

available for comment.

FDA also identified an additional

three devices for which the agency had

20934 Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Proposed Rules

not issued the guidance documents

proposed as special controls in

accordance with the GGP policy: The

indwelling blood carbon dioxide partial

pressure (Pco2) analyzer, the indwelling

blood hydrogen ion concentration (pH)

analyzer, and the indwelling blood

oxygen partial pressure (Po2) analyzer.

In the near future, FDA intends to

announce the availability of two

guidance documents for these three

devices and will reopen the comment

period on the reclassification of those

devices at that time.

Accordingly, FDA is reopening the

comment period for the March 15, 1999,

proposed rule to allow additional time

for interested persons to comment on

the following six devices:

TABLE 1

21 CFR Section Device Name

870.3450 Vascular graft prosthesis of less than 6 millimeters diameter

870.3620 Pacemaker lead adaptor

870.3800 Annuloplasty ring

870.4230 Cardiopulmonary bypass defoamer

870.4260 Cardiopulmonary bypass arterial line blood filter

870.4350 Cardiopulmonary bypass oxygenator

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding the

proposed rule only with respect to the

six devices listed above by July 18,

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 office above between 9 a.m.

and 4 p.m., Monday through Friday.

Dated: April 3, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–9709 Filed 4–18–00; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 261

[FRN–6581–7]

RIN 2050–AE07

Hazardous Waste Identification Rule

(HWIR); Extension of Public Comment

Period

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule; extension of the

public comment period.

SUMMARY: The Environmental Protection

Agency (EPA) is extending the comment

period on an exemption from hazardous

waste management discussed in the

proposed Hazardous Waste

Identification Rule (HWIR) Federal

Register document published on

November 19, 1999 (64 FR 63382). To

ensure we consider your comments on

the November 19, 1999 Federal Register

discussion of the concentration-based

HWIR exemption and the possible

revisions to the Land Disposal

Restriction (LDR) treatment standards

(64 FR 63382, Sections V–XX and

Sections XXI–XVI, as applicable, of the

preamble), they must be postmarked on

or before August 15, 2000.

Please note that today’s document

does not re-open the comment period on

the revisions to the mixture and

derived-from rules that were proposed

in the November 19, 1999 HWIR

proposed rule (64 FR 63382, Sections I–

IV, Sections XXI–XVI (as applicable) of

the preamble and the proposed

regulatory language amending 40 CFR

part 261). That comment period ended

February 17, 2000.

DATES: Comments must be submitted on

or before August 15, 2000.

ADDRESSES: Commenters must send an

original and two copies of their

comments referencing docket number

F–1999–WH2P–FFFFF to: (1) if using

regular US Postal Service mail: RCRA

Docket Information Center, Office of

Solid Waste (5305G), U.S.

Environmental Protection Agency

Headquarters (EPA, HQ), 1200

Pennsylvania Avenue, NW, Washington,

DC 20460–0002, or (2) if using special

delivery, such as overnight express

service: RCRA Docket Information

Center (RIC), Crystal Gateway One, 1235

Jefferson Davis Highway, First Floor,

Arlington, VA 22202. Comments may

also be submitted electronically through

the Internet to: rcra-docket@epa.gov.

Comments in electronic format should

also be identified by the docket number

F–1999–WH2P–FFFFF and must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

Commenters should not submit

electronically any confidential business

information (CBI). An original and two

copies of CBI must be submitted under

separate cover to: RCRA CBI Document

Control Officer, Office of Solid Waste

(5305W), U.S. EPA, 401 M Street, SW,

Washington, DC 20460–0002.

Public comments and supporting

materials are available for viewing in

the RCRA Information Center (RIC),

located at Crystal Gateway I, First Floor,

1235 Jefferson Davis Highway,

Arlington, VA. The RIC is open from 9

a.m. to 4 p.m., Monday through Friday,

excluding federal holidays. To review

docket materials, it is recommended

that the public make an appointment by

calling 703–603–9230. The public may

copy a maximum of 100 pages from any

regulatory docket at no charge.

Additional copies cost $0.15/page. The

index and some supporting materials

are available electronically. See the

SUPPLEMENTARY INFORMATION section for

information on accessing them.

FOR FURTHER INFORMATION CONTACT: For

general information, contact the RCRA

Hotline at 800–424–9346 or TDD 800–

553–7672 (hearing impaired). In the

Washington, DC, metropolitan area, call

703–412–9810 or TDD 703–412–3323.

For information on specific aspects of

notice, contact Tracy Atagi, Office of

Solid Waste 5304W, U.S. Environmental

Protection Agency Headquarters (EPA,

HQ), 1200 Pennsylvania Avenue, NW,

Washington, DC 20460–0002, (703) 308–

8672, atagi.tracy@epa.gov; for specific

information on the risk modeling

system, contact David Cozzie, Office of

Solid Waste 5307W, U.S. Environmental

Protection Agency, 401 M Street, SW,

Washington, DC 20460–0002, (703) 308–

0479, cozzie.david@epa.gov.

SUPPLEMENTARY INFORMATION: The notice

and other material associated with this

action can be electronically accessed on

the Internet at http://www.epa.gov/

epaoswer/hazwaste/id/hwirwste/

index.htm.

The official record for this rulemaking

will be kept in paper form. Accordingly,