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

Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Proposed Rules 70327

1The RPA is also not currently attaining the PM–

10 NAAQS. A summary of more recent air quality

data can be found in the docket. 2All violating PM–10 samplers in RPA operated

on a 1-in-6 day sampling schedule. Since sampling

is not performed every day, any exceedance of the

24-hour NAAQS is adjusted such that the

exceedance is now considered a violation. The

procedures for calculating the number of violations

is specified in 40 CFR part 50, appendix K.

3 If certain conditions are met, EPA may extend

this attainment deadline to no later than December

31, 2006. CAA section 188(e).

provide for the attainment of the PM–10

NAAQS. Pursuant to section 189(a)(2),

those SIP revisions were to be submitted

to EPA by November 15, 1991.

B. Reclassification as Serious

Nonattainment

EPA has the responsibility, pursuant

to sections 179(c) and 188(b)(2) of the

Act, of determining within 6 months of

the applicable attainment date, whether

PM–10 nonattainment areas have

attained the NAAQS. Section 179(c)(1)

of the Act provides that these

determinations are to be based upon an

area’s ‘‘air quality as of the attainment

date’’, and section 188(b)(2) is

consistent with this requirement. EPA

makes the determinations of whether an

area’s air quality is meeting the PM–10

NAAQS based upon air quality data

gathered at monitoring sites in the

nonattainment area. These data are

reviewed to determine the area’s air

quality status in accordance with EPA

guidance at 40 CFR part 50, appendix K.

Pursuant to appendix K, attainment of

the annual PM–10 standard is achieved

when the annual arithmetic mean PM–

10 concentration is equal to or less than

50 μg/m3. Attainment of the 24-hour

standard is determined by calculating

the expected number of exceedances of

the 150 μg/m3 limit per year. The 24-

hour standard is attained when the

expected number of exceedances is 1.0

or less. A total of 3 consecutive years of

clean air quality data is generally

necessary to show attainment of the 24-

hour and annual standards for PM–10.

A complete year of air quality data, as

referred to in 40 CFR part 50, appendix

K, is comprised of all 4 calendar

quarters with each quarter containing

data from at least 75 percent of the

scheduled sampling days.

Under section 188(b)(2)(A), a

moderate PM–10 nonattainment area

must be reclassified as serious by

operation of law after the statutory

attainment date if the Administrator

finds that the area has failed to attain

the NAAQS. Pursuant to section

188(b)(2)(B) of the Act, EPA must

publish a notice in the Federal Register

identifying those areas that failed to

attain the standard and the resulting

reclassifications.

II. Today’s Action

EPA is, by today’s action, proposing

to find that the RPA did not attain either

the 24-hour or annual PM–10 NAAQS

by the required attainment date of

December 31, 1994. As discussed below,

this proposed finding is based upon air

quality data which revealed violations

of the PM–10 NAAQS during 1992–

1994.1

A. Ambient Air Monitoring Data

The following table lists each of the

monitoring sites in the RPA where the

24-hour and annual PM–10 NAAQS

were violated during 1992–1994:

SITES VIOLATING PM–10 NAAQS 2

Site

24-hour exceedances

(micrograms per cubic meter,

μg/m3)

Annual averages (micrograms per cubic meter)

Concentration Date

1992 1993 1994

Reno—N. Lake St. ................................................................ 167 48 μg/m3 1/25/93.

Reno—Galetti Way ............................................................... ........................ ........................ 48 μg/m3 ........ 55 μg/m3 ........ 52 μg/m3

The Reno—N. Lake St. monitoring site

in the RPA violated the 24-hour PM–10

NAAQS during 1992–1994. This site

recorded a concentration of 167

micrograms per cubic meter on January

25, 1993.

The Reno—N. Lake St. monitoring site

operates on a one-in-six day sampling

schedule. Generally, if PM–10 sampling

is scheduled less than every day, EPA

requires the adjustment of observed

exceedances to account for incomplete

sampling. In the case of the Reno—N.

Lake St. site, one exceedance of the 24-

hour NAAQS was observed in 1993.

After adjusting for incomplete sampling,

the number of exceedances of the

NAAQS in 1993 at this site was 6.4.

According to 40 CFR part 50, the 24-

hour NAAQS is attained when the

expected number of days per calendar

year with a 24-hour average

concentration above 150 μg/m3 is equal

to or less than one. In the simplest case,

the number of expected exceedances at

a site is determined by recording the

number of exceedances in each calendar

year and then averaging them over the

past three calendar years. Therefore

from 1992–1994, the number of

expected exceedances at the the Reno—

N. Lake St. monitoring site was 2.1. This

exceedance causes the Reno—N. Lake

St. site to be in violation of the 24-hour

PM–10 NAAQS.

In addition, the annual PM–10

NAAQS was violated at the Reno—

Galetti Way site in RPA. Based on the

monitoring data collected during 1992–

1994, the Reno—Galetti site had an

annual average of 52 μg/m3.

B. SIP Requirements for Serious Areas

PM–10 nonattainment areas

reclassified as serious under section

188(b)(2) of the CAA are required to

submit, within 18 months of the area’s

reclassification, SIP revisions providing

for the implementation of best available

control measures (BACM) no later than

four years from the date of

reclassification. The SIP also must

contain, among other things, a

demonstration that the implementation

of BACM will provide for attainment of

the PM–10 NAAQS no later than

December 31, 2001.3 See CAA sections

188(c)(2) and 189(b). EPA has provided

specific guidance on developing serious

area PM–10 SIP revisions in an

addendum to the General Preamble to

Title I of the Clean Air Act. See 59 FR

41998 (August 16, 1994).

III. Request for Public Comment

The EPA is requesting comment on all

aspects of today’s proposal. As

indicated at the outset of this notice,

EPA will consider any comments

received by December 7, 2000.

IV. Administrative Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this proposed

action is not a ‘‘significant regulatory

action’’ and therefore is not subject to

review by the Office of Management and

Budget.

70328 Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Proposed Rules

Under section 188(b)(2) of the CAA,

findings of failure to attain is based

solely upon air quality considerations

and the subsequent nonattainment area

reclassification must occur by operation

of law in light of those air quality

conditions. These actions do not, inand-of themselves, impose any new

requirements on any sectors of the

economy. In addition, because the

statutory requirements are clearly

defined with respect to the differently

classified areas, and because those

requirements are automatically triggered

by classifications that, in turn, are

triggered by air quality values, findings

of failure to attain and reclassification

cannot be said to impose a materially

adverse impact on State, local, or tribal

governments or communities.

Accordingly, the Administrator

certifies that this proposed rule will not

have a significant economic impact on

a substantial number of small entities

under the Regulatory Flexibility Act (5

U.S.C. 601 et seq.).

Similarly, because the proposed

finding of failure to attain is a factual

determination based on air quality

considerations and the resulting

reclassification must occur by operation

of law and, do not impose any federal

intergovernmental mandate, these

actions do not contain any unfunded

mandate or significantly or uniquely

affect small governments, as described

in the Unfunded Mandates Reform Act

of 1995 (Public Law 104–4). For the

same reason, this proposed rule also

does not significantly or uniquely affect

the communities of Indian tribal

governments, as specified by Executive

Order 13084 (63 FR 27655, May 10,

1998).

For the same reasons, this proposed

finding of failure to attain and resulting

reclassification will not 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, as specified in

Executive Order 13132 (64 FR 43255,

August 10, 1999). These proposed

actions are also not subject to Executive

Order 13045 (62 FR 19885, April 23,

1997), because they are not

economically significant. Finally, for the

same reason that this proposed finding

of failure to attain is a factual

determination based on air quality

considerations and the resulting

reclassification must occur by operation

of law, the requirements of section 12(d)

of the National Technology Transfer and

Advancement Act of 1995 (15 U.S.C.

272 note) do not apply.

As required by section 3 of Executive

Order 12988 (61 FR 4729, February 7,

1996), in issuing this proposed finding

of failure to attain, EPA has taken the

necessary steps to eliminate drafting

errors and ambiguity, minimize

potential litigation, and provide a clear

legal standard for affected conduct. EPA

has complied with Executive Order

12630 (53 FR 8859, March 15, 1988) by

examining the takings implications of

the rule in accordance with the

‘‘Attorney General’s Supplemental

Guidelines for the Evaluation of Risk

and Avoidance of Unanticipated

Takings’’ issued under the executive

order. This proposed finding of failure

to attain does not impose an information

collection burden under the provisions

of the Paperwork Reduction Act of 1995

(44 U.S.C. 3501 et seq.).

List of Subjects in 40 CFR Part 81

Environmental protection, Air

pollution control, National parks,

Wilderness areas.

Authority: 42 U.S.C. 7401–7671q.

Dated: November 13, 2000.

Felicia Marcus,

Regional Administrator, Region 9.

[FR Doc. 00–29879 Filed 11–21–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 300

[FRL–6859–2]

National Oil and Hazardous

Substances Pollution Contingency

Plan; National Priorities List

AGENCY: Environmental Protection

Agency.

ACTION: Proposed deletion of the John

Deere Ottumwa Works Site (Site) from

the National Priorities List (NPL).

SUMMARY: The Environmental Protection

Agency (EPA) Region VII proposes to

delete the John Deere Ottumwa Works

site from the National Priorities List

(NPL) and requests public comment on

this action. The NPL constitutes

Appendix B to Part 300 of the National

Oil and Hazardous Substances Pollution

Contingency Plan (NCP), which EPA

promulgated pursuant to Section 105 of

the Comprehensive Environmental

Response, Compensation and Liability

Act of 1980 (CERCLA), as amended. The

EPA has determined that the site poses

no significant threat to public health or

the environment, as defined by

CERCLA, and therefore, further

remedial measures pursuant to CERCLA

are not appropriate.

We are publishing this rule without

prior proposal because the Agency

views this as a noncontroversial

revision and anticipates no dissenting

comments. A detailed rationale for this

approval is set forth in the direct final

rule. If no dissenting comments are

received, no further activity is

contemplated. If EPA receives

dissenting comments, the direct final

action will be withdrawn and all public

comments received will be addressed in

a subsequent final rule based on this

proposed rule. The EPA will not

institute a second comment period. Any

parties interested in commenting should

do so at this time.

DATES: Comments concerning this

Action must be received by December

22, 2000.

ADDRESSES: Comments may be mailed to

Debra Kring, Environmental Protection

Specialist, Superfund Division, U.S.

Environmental Protection Agency,

Region VII, 901 North 5th Street, Kansas

City, KS 66101. Comprehensive

information on this site is available

through the public docket which is

available for viewing at the Site

information repository at U.S. EPA

Region VII, Superfund Division Records

Center, 901 North 5th Street, Kansas

City, KS 66101.

FOR FURTHER INFORMATION CONTACT:

Debra Kring, Environmental Protection

Specialist, U.S. Environmental

Protection Agency, 901 North 5th Street,

Kansas City, KS 66101, fax (913) 551–

7063.

SUPPLEMENTARY INFORMATION: For

additional information, see the Direct

Final Action which is located in the

Rules Section of this Federal Register.

Dated: August 17, 2000.

William Rice,

Acting Regional Administrator, Region VII.

[FR Doc. 00–29643 Filed 11–21–00; 8:45 am]

BILLING CODE 6560–50–U

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

50 CFR Part 679

[I.D. No. 111500B]

Fisheries of the Exclusive Economic

Zone Off Alaska; Commencement of

Groundfish Fisheries in 2001

AGENCY: National Marine Fisheries

Service (NMFS), National Oceanic and

Atmospheric Administration (NOAA),

Commerce.