59840 Federal Register / Vol. 62, No. 214 / Wednesday, November 5, 1997 / Proposed Rules

animal drugs, the sponsor shall

demonstrate by substantial evidence, as

defined in this section, that the

combination new animal drug will have

the effect it purports or is represented to

have under the conditions of use

prescribed, recommended, or suggested

in the proposed labeling and that each

active ingredient or animal drug

contributes to the effectiveness of the

combination new animal drug.

4. Section 514.111 is amended by

revising paragraph (a)(5) to read as

follows:

§ 514.111 Refusal to approve an

application.

(a) * * *

(5) Evaluated on the basis of

information submitted as part of the

application and any other information

before the Food and Drug

Administration with respect to such

drug, there is lack of substantial

evidence as defined in § 514.4.

* * * * *

Dated: October 30, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–29275 Filed 10–31–97; 2:48 pm]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 58

[AD–FRL–5903–6]

RIN 2060–AF71

Ambient Air Quality Surveillance for

Lead

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: Lead air pollution levels

measured near the Nation’s roadways

have decreased 97 percent between

1976 and 1995 with the elimination of

lead in gasoline used by on-road mobile

sources. Because of this historic

decrease, EPA is shifting its ambient air

monitoring focus from measuring lead

air pollutant concentrations emanating

from mobile source emissions toward a

focus on stationary point sources of lead

air pollution. Today’s action proposes to

revise the part 58 lead air monitoring

regulations to allow many lead

monitoring stations to be discontinued

while maintaining a core lead

monitoring network in urban areas to

track continued compliance with the

lead National Ambient Air Quality

Standards (NAAQS). This action also

requires lead ambient air monitoring

around lead stationary sources. This

action is being taken at the direct

request of numerous State and local

agencies whose on-road mobile sourceoriented lead monitors have been

reporting peak lead air pollution values

that are many times less than the

quarterly lead NAAQS of 1.5μg/m3 for

many years. Approximately 70 of the

National Air Monitoring Stations

(NAMS) and a number of the State and

Local Air Monitoring Stations (SLAMS)

could be discontinued with this action,

thus making more resources available to

those State and local agencies to deploy

lead air quality monitors around

heretofore unmonitored lead stationary

sources.

DATES: Comments must be submitted on

or before December 5, 1997.

ADDRESSES: Comments should be

submitted (in duplicate, if possible) to:

Air Docket (LE–131), US Environmental

Protection Agency, Attn. Docket No. A–

91–22, 401 M Street, SW, Washington,

D.C. 20460.

FOR FURTHER INFORMATION CONTACT:

Brenda Millar, Emissions, Monitoring,

and Analysis Division (MD–14), Office

of Air Quality Planning and Standards,

U.S. Environmental Protection Agency,

Research Triangle Park, North Carolina

27711, Telephone: (919) 541–4036, email:millar.brenda@email.epa.gov.

SUPPLEMENTARY INFORMATION:

I. Authority

Sections 110, 301(a), and 319 of the

Clean Air Act as amended 42 U.S.C.

7410, 7601(a), 7619.

II. Background

The current ambient air monitoring

regulations that pertain to lead air

sampling were written in the 1970’s

when lead emissions from on-road

mobile sources (e.g., automobiles,

trucks) were the predominant lead air

emission source affecting our

communities. As such, the current lead

monitoring requirements focus

primarily upon the idea of determining

the air quality impacts from major

roadways and urban traffic arterial

highways. Since the 1970’s, lead has

been removed from gasoline sources for

on-road vehicles (on-oad vehicles now

account for less than 1 percent of total

lead emissions), and a 97 percent

decrease in lead air pollution levels

measured in our neighborhoods and

near roadways has occurred nationwide.

Because of this historic decrease, EPA is

reducing its requirements for measuring

lead air pollutant concentrations near

major highways, and is focusing on

stationary point sources and their

impacts on neighboring populations.

The current lead air monitoring

regulations require that each urbanized

area with a population of 500,000 or

more operate at least two lead NAMS,

one of which must be a roadwayoriented site and the second must be a

neighborhood site with nearby traffic

arteries or other major roadways. There

are approximately 85 NAMS in

operation and reporting data for 1996.

This action would reduce this NAMS

requirement to include one NAMS site

in one of the two largest Metropolitan

Statistical Areas (MSA/CMSA) within

each of the ten EPA Regions, and one

NAMS population-oriented site in each

populated area (either a MSA/CMSA,

town, or county) where lead violations

have been measured over the most

recent 8 calendar quarters. This latter

requirement is designed to provide

information to citizens living in areas

that have one or more lead stationary

sources that are causing recent air

quality violations. At present, the MSA/

CMSAs, cities, or counties that have one

or more quarterly Pb NAAQS violations

that would be subject to this

requirement include:

TABLE 1.—CMSA/MSA’S OR COUNTIES WITH ONE OR MORE LEAD NAAQS VIOLATIONS IN 1995–1996

CMSA/MSA or county Contributing lead source(s)

Philadelphia-Wilmington-Atlantic City CMSA ........................................... Franklin Smelter in Philadelphia County, PA.

Tampa-St. Petersburg-Clearwater MSA ................................................... Gulf Coast Lead in Hillsborough County, FL.

Memphis MSA .......................................................................................... Refined Metals in Shelby County, TN.

Nashville MSA .......................................................................................... General Smelting in Williamson County, TN.

St. Louis MSA ........................................................................................... Chemetco in Madison County, IL, and Doe Run in Jefferson County,

MO.

Cleveland-Akron CMSA ............................................................................ Master Metals in Cuyahoga County, OH.

Iron County, MO ....................................................................................... ASARCO in/near Hogan, MO.
Federal Register / Vol. 62, No. 214 / Wednesday, November 5, 1997 / Proposed Rules 59841

TABLE 1.—CMSA/MSA’S OR COUNTIES WITH ONE OR MORE LEAD NAAQS VIOLATIONS IN 1995–1996—Continued

CMSA/MSA or county Contributing lead source(s)

Omaha MSA ............................................................................................. ASARCO in Douglas County, NE.

Lewis and Clark County, MT .................................................................... ASARCO in/near East Helena, MT.

Data from these NAMS will be used

to assess national trends in lead ambient

air pollution. Figure 1 demonstrates the

effect that these monitoring reductions

will have on our national lead air

pollutant trends.

For other monitoring within the

SLAMS network, EPA is proposing to

require, State and local agencies to focus

their efforts toward establishing air

monitoring networks around lead

stationary sources which are causing or

have a potential to cause exceedances of

the quarterly lead NAAQS. Many of

these sources have been identified

through EPA’s ongoing Lead NAAQS

Attainment Strategy, and monitoring

has already been established. In general,

stationary sources emitting five or more

tons per year are considered to be

candidates for additional lead

monitoring, although smaller stationary

sources may also be problematic

depending upon the facility’s size and

proximity to neighborhoods. EPA

recommends a minimum of two sites

per source, one located for stack

emission impacts and the other for

fugitive emission impacts. Variations of

this two-site network are expected as

source type, topography, locations of

neighboring populations, and other

factors play a role in how to most

appropriately design such a network.

EPA guidance for lead monitoring

around point sources has been

developed and is available through a

variety of sources including the

National Technical Information Service

(703–487–4650), and electronic forms

accessible through EPA’s Office of Air

Quality Planning & Standards

Technology Transfer Network, Ambient

Monitoring Technology Information

Center (AMTIC) bulletin board system at

http://ttnwww.rtpnc.epa.gov.

In addition to the changes to the lead

monitoring requirements, EPA proposes

several minor changes to update and

correct regulatory provisions to current

practices. Specifically this affects 40

CFR part 58 sections 58.31, 58.34, 58.41,

Appendix B, Appendix D sections 3.2

and 3.3, and Appendix G sections 1 and

2b.

III. Administrative Requirements

Section

A. Executive Order 12866

Under Executive Order 12866 (58 FR

51735, October 4, 1993), EPA must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

Office of Management and Budget

(OMB) review and to the requirements

of the Executive Order. The Order

defines ‘‘significant regulatory action’’

as one that is likely to result in a rule

that may:

(1) Have an annual effect on the

economy of $100 million or more or

adversely affect in a material way the

economy, a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local, or governments or

communities;

(2) Create a serious inconsistency or

otherwise interfere with an action taken

or planned by another Agency;

(3) Materially alter the budgetary

impact of entitlements, grants, user fees,

or loan programs or the rights and

obligations or recipients thereof; or

(4) Raise novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in the Executive Order.

It has been determined that this rule

is not a ‘‘significant regulatory action’’

under the terms of the Executive Order

12866 and is therefore not subject to

formal OMB review.

B. Paperwork Reduction Act

Today’s action does not impose any

new information collection burden. This

action proposes to revise the part 58 air

monitoring regulations for lead to allow

many monitoring sites to be

discontinued. The Office of

Management and Budget (OMB) has

previously approved the information

collection requirements in the part 58

regulation under the provisions of the

Paperwork Reduction Act, 44 U.S.C.

3501 et seq. and has assigned OMB

control number 2060–0084 (EPA ICR

No. 0940.13 and revised by 0940.14).

C. Impact on Small Entities

The Regulatory Flexibility Act (RFA)

generally requires an agency to conduct

a regulatory flexibility analysis of any

rule subject to notice and comment

rulemaking requirements unless the

agency certifies that the rule will not

have a significant economic impact on

a substantial number of small entitites.

Small entities include small businesses,

small not-for-profit enterprises, and

small governmental jurisdictions whose

jurisdictions are less than 50,000

people. This proposal will not have a

significant impact on a substantial

number of small entities because it does

not impact small entities whose

jurisdictions cover less than 50,000

people. Pursuant to the provision of 5

USC 605(b), I certify that this action will

not have a significant economic impact

on a substantial number of small

entities.

Since this modification is classified as

minor, no additional reviews are

required.

D. Unfunded Mandates Reform Act of

1995

Under section 202 of the Unfunded

Mandates Reform Act of 1995

(‘‘Unfunded Mandates Act’’), signed

into law on March 22, 1995, EPA must

prepare a budgetary impact statement to

accompany any proposed or final

standards that include a Federal

mandate that may result in estimated

costs to State, local, or tribal

governments, or to the private sector, of,

in the aggregate, $100 million or more.

Under section 205, EPA must select the

most cost-effective and least

burdensome alternative that achieves

the objectives of the standard and is

consistent with statutory requirements.

Section 203 requires EPA to establish a

plan for informing and advising any

small governments that may be

significantly or uniquely impacted by

the standards. The EPA has determined

that this action does not include a

Federal mandate that may result in

estimated costs of $100 million or more

to either State, local, or tribal

governments. Therefore, the

requirements of the Unfunded Mandates

Act of 1995 do not apply to this action.

List of Subjects in 40 CFR Part 58

Environmental protection, Air

pollution control, Intergovernmental

relations, Reporting and recordkeeping

requirements, Quality assurance

requirements.
59842 Federal Register / Vol. 62, No. 214 / Wednesday, November 5, 1997 / Proposed Rules

Carol W. Browner,

Administrator.

[FR Doc. 97–29293 Filed 11–4–97; 8:45 am]

BILLING CODE 6560–50–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 36

[CC Docket No. 80–286; FCC 97–354]

Jurisdictional Separations Reform and

Referral to the Federal-State Joint

Board

AGENCY: Federal Communications

Commission.

ACTION: Proposed rule.

SUMMARY: On October 2, 1997, the

Commission adopted a Notice of

Proposed Rulemaking (NPRM), that

initiates a proceeding with the goal of

reviewing comprehensively the Part 36

jurisdictional separations procedures to

ensure that they meet the objectives of

the Telecommunication Act of 1996

(1996 Act), and to consider changes that

may need to be made to the

jurisdictional separations process in

light of changes in the law, technology,

and market structure of the

telecommunications industry. Pursuant

to section 410(c) of the Communications

Act, the Commission refers the issues

raised in the NPRM to the Federal-State

Joint Board established in CC Docket

No. 80–286 (Separations Joint Board) for

preparation of a recommended decision.

This NPRM contains proposed or

modified information collections subject

to the Paperwork Reduction Act of 1995

(PRA). It has been submitted to the

Office of Management and Budget

(OMB) for review under the PRA. OMB,

the general public, and other Federal

agencies are invited to comment on the

proposed or modified information

collections contained in this

proceeding.

DATES: Pursuant to applicable

procedures set forth in §§ 1.415 and

1.419 of the Commission’s rules, 47 CFR

1.415 and 1.419, interested parties may

file comments on or before December

10, 1997, and reply comments on or

before January 26, 1998. Written

comments by the public on the

proposed and/or modified information

collections are due December 10, 1997.

Written comments must be submitted by

the Office of Management and Budget

(OMB) on the proposed and/or modified

information collections on or before

January 5, 1998.

ADDRESSES: Parties should send their

comments or reply comments to Office

of the Secretary, Federal

Communications Commission, 1919 M

Street, N.W., Room 222, Washington,

D.C. 20554. Parties should also send a

paper copy, and a copy on 3.5 inch

diskette formatted in an IBM compatible

form using, if possible, WordPerfect 5.1

for Windows software, to Connie

Chapman of the Common Carrier

Bureau’s Accounting and Audits

Division, 2000 L Street, N.W., room

258H, Washington, D.C. 20554. Parties

also must serve comments on the

Federal-State Joint Board in accordance

with the service list (See Attachment).

Commenters should also provide one

copy of any documents filed in this

proceeding to the Commission’s copy

contractor, International Transcription

Service, 1231 20th Street, N.W.,

Washington, D.C. 20036.

In addition to filing comments with

the Secretary, a copy of any comments

on the information collections

contained herein should be submitted to

Judy Boley, Federal Communications

Commission, Room 234, 1919 M Street,

N.W., Washington, DC 20554, or via the

Internet to jboley@fcc.gov, and to

Timothy Fain, OMB Desk Officer, 10236

NEOB, 725–17th Street, N.W.,

Washington, DC 20503 or via the

Internet to fainlt@al.eop.gov.

FOR FURTHER INFORMATION CONTACT:

Lynn Vermillera, Accounting and

Audits Division, Common Carrier

Bureau, (202) 418–7120. Alternate

contact, Connie Chapman (202) 418–

0885. For additional information

concerning the information collections

contained in this Notice contact Judy

Boley at 202–418–0214, or via the

Internet at jboley@fcc.gov.

SUPPLEMENTARY INFORMATION: This is a

summary of the Commission’s Notice of

Proposed Rulemaking adopted October

2, 1997, and released October 7, 1997

The full text of this Commission NPRM

is available for inspection and copying

during normal business hours in the

FCC Public Reference Room (Room

239), 1919 M St., N.W., Washington,

D.C. The complete text of this NPRM

may also be purchased from the

Commission’s copy contractor,

International Transcription Service,

1231 20th Street, N.W., Washington,

D.C. 20036.

Summary of Notice of Proposed

Rulemaking

1. The NPRM seeks comment on the

changes in law, technology, and market

structure of the telecommunications

industry that affect the separations

process. It then seeks comment on the

criteria that should be used to evaluate

the existing separations process and

proposals to reform the process in light

of the goals of our comprehensive

review.

2. In addition, the NPRM seeks

comment on whether separations rules

are still needed during the transition

period from a regulated to a competitive

marketplace. In this section, the

Commission seeks comment on whether

some form of separations must exist

under the 1930 Smith v. Illinois

decision, or whether statutory,

regulatory and market changes since

that decision have been so pronounced

and persuasive as to make its holding

inapplicable in the new deregulatory

environment.

3. The NPRM then seeks comment on

industry proposals to replace the

existing Part 36 separations rules. In

particular, the NPRM seeks comment on

three industry proposals. The NPRM

first seeks comment on NYNEX’s

proposal to separate costs for individual

incumbent local exchange carriers

(ILECs) in a given study area based on

a single, frozen, interstate allocation

factor. It then seeks comment on Bell

South’s proposal to separate costs in

each study area based on two factors,

one for investment and one for

expenses. It then seeks comment on

Southwestern Bell’s proposal to

consolidate the several dozen plant and

service categories in the existing

separations rules into four cost

categories.

4. The NPRM then evaluates the

existing separations rules and seeks

comment on how various separations

reform options would affect prices and

revenue requirements. In this section,

the NPRM seeks comment on revisions

to the definition of ‘‘study area.’’ It also

seeks comment on whether the existing

set of plant, expense, and service

categories should be revised. The NPRM

also seeks comment on whether there is

a need to revise the way in which costs

are apportioned to each category and the

way in which those costs are then

apportioned to the interstate and

intrastate jurisdiction.

5. The NPRM also seeks comment on

whether and how to separate the costs

associated with interconnection. In this

section, the Commission proposes two

alternatives for allocating the costs of

providing interconnection between the

state and federal jurisdiction. The first

alternative is for the costs, once

identified in part 32 as proposed in the

companion NPRM on accounting for

interconnection, to be removed entirely

from the separations process and

allocated through a process designed to

apply exclusively to these costs. The

second alternative is that the costs, once

identified in part 32, be separated