Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Proposed Rules 70325

out further than other portions of the

ATBA. The proposed ATBA amendment

will permit ships in two opposing traffic

patterns located just outside the

boundary of the ATBA to increase the

distance between them, thus increasing

maritime safety in the area. The

proposed amendment will not result in

bringing ship traffic any closer to the

reef than the other parts of the ATBA

and, by reducing the potential for

collisions, the amendment is beneficial

for the protection of the marine

environment.

The north- and east-bound vessels

utilize the Gulf Stream in this area

while the south- and west-bound vessels

try to take advantage of countercurrents

from eddies off of the Gulf Stream. The

existing configuration of the ATBA near

the coral reef known as ‘‘the Elbow,’’

when examined in relation to the axis

of the Gulf Stream, results in a potential

convergence of northeasterly bound and

southwesterly bound traffic. The

potential risk of collision increases

when the Gulf Stream meanders closer

to ‘‘the Elbow.’’ The proposed revision

of the ATBA boundary will permit ships

in these two opposing traffic patterns to

increase the distance between them,

thus increasing maritime safety in the

area. A collision in this area could cause

oil and other material to seep into the

Florida Keys damaging marine

sanctuary resources, the marine

environment, and quite possibly, the

recreational, tourism and fishing

industries of the Florida Keys.

In March 2000, the USCG conducted

a survey of mariners, who frequently

travel through this area, to see whether

they believed ‘‘the Elbow’’ of the ATBA

to be a safety hazard for vessels

traveling in that area. Close to half of the

mariners surveyed felt that ‘‘the Elbow’’

created a ‘‘pinch point’’ for south- and

west-bound vessels that attempt to stay

out of both the ATBA and the lanes of

traffic for the north- and east-bound

vessels. The USCG subsequently

recommended the revision of the ATBA

boundary in order to increase maritime

safety in the area.

Based on these recommendations, and

its own draft environmental assessment

of the recommendations, NOAA

proposes to amend the boundary of the

northernmost ATBA. This action is not

expected to have a significant adverse

impact on the environment.

Miscellaneous Requirements

Executive Order 12866

This proposed rule has been

determined to be not significant for

purposes of Executive Order 12866.

Regulatory Flexibility Act

The Chief Counsel for Regulations of

the Department of Commerce has

certified to the Chief Counsel for

Advocacy of the Small Business

Administration that the proposed rule is

not expected to have a significant

economic impact on a substantial

number of small entities. The existing

ATBA and the proposed boundary

change do not apply to a substantial

number of small entities because the

ATBA only applies to tank vessels and

those vessels greater than 50 meters in

length. Most of the vessels subject to

this rule are foreign flagged vessels that

are owned or chartered by large

corporations. This measure is not

expected to have any impact on the

small business community.

Accordingly, an initial regulatory

flexibility analysis was not prepared.

National Environmental Policy Act

Requirements

NOAA has concluded that this

regulatory action does not constitute a

major federal action significantly

affecting the quality of the human

environment. Therefore, an

environmental impact statement is not

required. A draft environmental

assessment has been prepared. It is

available for comment (see ADDRESSES).

Plain Language Requirement

The President has directed all

agencies to use plain language in their

communications with the public,

including regulations. To comply with

this directive, we seek public comment

on any ambiguity or unnecessary

complexity arising from the language

used in this rule (see ADDRESSES).

List of Subjects in 15 CFR Part 922

Administrative practice and

procedure, Coastal zone, Marine

resources, Penalties, Recreation and

recreation areas, Reporting and

recordkeeping requirements, Research.

Capt. Ted I. Lillestolen,

Deputy Assistant Administrator for Ocean

Services and Coastal Zone Management.

Accordingly, for the reasons set forth

in the preamble, 15 CFR Part 922 is

proposed to be amended as follows:

PART 922—NATIONAL MARINE

SANCTUARY PROGRAM

REGULATIONS

1. The authority citation for part 922

continues to read as follows:

Authority: 16 U.S.C. 1431 et seq.

922 Appendix VII—[AMENDED]

Subpart P—Florida Keys National

Marine Sanctuary

2. Appendix VII to subpart P of part

922 is amended in the table by

redesignating the entries for points 23

through 51 as 24 through 52, and by

revising the entries under ‘‘In the

Vicinity of the Florida Keys’’ to read as

follows:

Appendix VII to Subpart P of Part

922—Areas To Be Avoided Boundary

Coordinates

IN THE VINCINITY OF THE FLORIDA

KEYS

[Reference Charts: United States 11466, 27th

Edition—September 1, 1990 and United

States 11450, 4th Edition—August 11,

1990]

Point Latitude Longitude

1 ...... 25°45.00′N ......... 80°06.10′W.

2 ...... 25°38.70′N ......... 80°02.70′W.

3 ...... 25°22.00′N ......... 80°03.00′W.

4 ...... 25°06.38′N ......... 80°10.48′W.

5 ...... 24°56.37′N ......... 80°19.26′W.

6 ...... 24°37.90′N ......... 80°47.30′W.

7 ...... 24°29.20′N ......... 81°17.30′W.

8 ...... 24°22.30′N ......... 81°43.17′W.

9 ...... 24°28.00′N ......... 81°43.17′W.

10 .... 24°28.70′N ......... 81°43.50′W.

11 .... 24°29.80′N ......... 81°43.17′W.

12 .... 24°33.10′N ......... 81°35.15′W.

13 .... 24°33.60′N ......... 81°26.00′W.

14 .... 24°38.20′N ......... 81°07.00′W.

15 .... 24°43.20′N ......... 80°53.20′W.

16 .... 24°46.10′N ......... 80°46.15′W.

17 .... 24°51.10′N ......... 80°37.10′W.

18 .... 24°57.50′N ......... 80°27.50′W.

19 .... 25°09.90′N ......... 80°16.20′W.

20 .... 25°24.00′N ......... 80°09.10′W.

21 .... 25°31.50′N ......... 80°07.00′W.

22 .... 25°39.70′N ......... 80°06.85′W.

23 .... 25°45.00′N ......... 80°06.10′W.

* * * * *

[FR Doc. 00–29824 Filed 11–21–00; 8:45 am]

BILLING CODE 3510–08–P

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.

70326 Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Proposed Rules

SUMMARY: The Food and Drug

Administration (FDA) is reopening for

90 days the comment period for the

submission of comments regarding 3 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 order to allow more time to

submit comments to FDA regarding 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 for

comment of two guidance documents

that are special controls for three

devices.

DATES: Submit written comments on the

proposed rule by February 20, 2001.

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 6

of the 38 devices. 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 became publicly

available for comment. In the Federal

Register of April 19, 2000 (65 FR

20933), FDA reopened the comment

period on the proposed reclassification

of those six devices.

FDA also identified an additional

three devices for which the agency had

not issued the guidance documents

proposed as special controls for

comment in accordance with the GGP

policy. Elsewhere in this issue of the

Federal Register, FDA is announcing

the availability for comment of two

guidance documents that are special

controls for three devices. 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

three devices:

• Indwelling blood carbon dioxide

partial pressure (Pco2) analyzer (21 CFR

868.1150),

• Indwelling blood hydrogen ion

concentration (pH) analyzer (21 CFR

868.1170), and

• Indwelling blood oxygen partial

pressure (Po2) analyzer (21 CFR

868.1200).

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding the

proposed rule only with respect to the

three devices listed above by February

20, 2001. 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 are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: October 31, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–29839 Filed 11–21–00; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 81

[NV–032–FON; FRL–6905–6]

Clean Air Act Reclassification;

Nevada—Reno Planning Area;

Particulate Matter of 10 Microns or

Less (PM–10)

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: In this action EPA proposes to

find that the Reno (Washoe County)

Planning Area (RPA) has not attained

the PM–10 national ambient air quality

standards (NAAQS) by the Clean Air

Act (CAA) mandated attainment date for

moderate nonattainment areas. Section

188(c)(1) of the Act established an

attainment date of no later than

December 31, 1994 for areas classified

as moderate nonattainment areas under

section 107(d)(4)(B) of the CAA. This

proposed finding is based on monitored

air quality data for the PM–10 NAAQS

during the years 1992–1994. If EPA

takes final action on this proposed

finding, the RPA will be reclassified by

operation of law as a serious

nonattainment area under section

188(b)(2)(A) of the CAA.

DATES: Comments on this proposed

finding must be received in writing by

December 7, 2000.

ADDRESSES: Comments should be

addressed to Manny Aquitania, U.S.

Environmental Protection Agency,

Region 9, Air Division, Planning Office

(AIR–2), 75 Hawthorne Street, San

Francisco, California 94105.

FOR FURTHER INFORMATION CONTACT: For

monitoring data questions contact

Manny Aquitania, U.S. EPA, Region 9,

Air Division, Technical Support Office

(AIR–7), 75 Hawthorne Street, San

Francisco, California 94105; (415) 744–

1299, aquitania.manny@epa.gov. For

other questions contact Doris Lo, U.S.

Environmental Protection Agency,

Region 9, Air Division, Planning Office

(AIR–2), 75 Hawthorne Street, San

Francisco, California 94105, (415) 744–

1287, lo.doris@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Background

A. CAA Requirements and EPA Actions

Concerning Designation and

Classification

On November 15, 1990, the date of

enactment of the 1990 Clean Air Act

Amendments, PM–10 areas meeting the

qualifications of section 107(d)(4)(B) of

the Act were designated nonattainment

by operation of law. Once an area is

designated nonattainment, section 188

of the Act outlines the process for

classification of the area and establishes

the area’s attainment date. Pursuant to

section 188(a), all PM–10 nonattainment

areas were initially classified as

moderate by operation of law upon

designation as nonattainment. These

nonattainment designations and

moderate area classifications were

codified in 40 CFR part 81 in a Federal

Register notice published on November

6, 1991 (56 FR 56694). The Reno

Planning Area (RPA) was designated

nonattainment and classified as

moderate. See 40 CFR 81.329.

States containing areas which were

designated as moderate nonattainment

by operation of law under section

107(d)(4)(B) were to develop and submit

state implementation plans (SIPs) to