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Citation: 66 Fed. Reg. 63166 2001 

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No. 234/Wednesday, December 5, 2001/Rules and Regulations

Dated: November 9, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 01-30039 Filed 12-4-01; 8:45 am]

BILLING CODE 4160-01-S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Ivermectin Liquid

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of an abbreviated new animal

drug application (ANADA) filed by First

Priority, Inc. The ANADA provides for

oral use of ivermectin solution in horses

for the treatment and control of various

species of internal and cutaneous

parasites.

DATES: This rule is effective December 5,

2001.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary

Medicine (HFV-102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: First

Priority, Inc., 1585 Todd Farm Dr.,

Elgin, IL 60123, filed ANADA 200-321

for PRIMECTINTM (ivermectin) Equine

Oral Liquid. The application provides

for oral use of a 1.0 percent ivermectin

solution in horses for the treatment and

control of various species of

gastrointestinal nematodes, lungworms,

stomach bots, and cutaneous larvae and

microfilariae. First Priority's

PRIMECTIN TM Equine Oral Liquid is

approved as a generic copy of Merial

Ltd.'s EQVALAN R (ivermectin) Oral

Liquid for Horses, approved under

NADA 140-439. ANADA 200-321 is

approved as of September 7, 2001, and

21 CFR 520.1195 is amended to reflect

the approval. The basis of approval is

discussed in the freedom of information

summary.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA-305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday.

The agency has determined under 21

CFR 25.33(a)(1) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

This rule does not meet the definition

of "rule" in 5 U.S.C. 804(3)(A) because

it is a rule of "particular applicability."

Therefore, it is not subject to

congressional review requirements in 5

U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 520 is amended as follows:

PART 520-ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: 21 U.S.C. 360b.

2. Section 520.1195 is amended in

paragraph (b) by adding "058829," after

"051259"; by revising the heading of

paragraph (c) and paragraph (c)(1); in

paragraph (c)(2) by removing "It is used

in horses"; and in paragraph (c)(3) by

removing the first sentence to read as

follows:

§520.1195 Ivermectin liquid.

(c) Conditions of use in horses-(1)

Amount. 200 micrograms per kilogram

of body weight as a single dose by

stomach tube or as an oral drench.

Dated: November 9, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 01-30076 Filed 12-4-01; 8:45 am]

BILLING CODE 4160-01-S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 70

[AZ060-OPP; FRL-7112-8]

Clean Air Act Full Approval of the

Operating Permits Program for the

Pinal County Air Quality Control

District, AZ

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is taking final action to

fully approve the Pinal County Air

Quality Control District (Pinal or

District) operating permits program. The

Pinal program was submitted in

response to the directive in the 1990

Clean Air Act (CAA) Amendments that

permitting authorities develop, and

submit to EPA, programs for issuing

operating permits to all major stationary

sources and to certain other sources

within the permitting authorities'

jurisdiction. On October 30, 1996, EPA

granted interim approval to Pinal's

operating permits program. The District

revised its program to satisfy the

conditions of the interim approval, and

EPA proposed full approval in the

Federal Register on September 20, 2001,

contingent upon Pinal submitting the

rules to EPA as a revision to its part 70

program. Pinal County did so, and EPA

did not receive any comments on the

proposed action. This action

promulgates final full approval of the

Pinal operating permits program.

EFFECTIVE DATE: This rule is effective on

November 30, 2001.

ADDRESSES: Copies of Pinal's submittal

and other supporting information used

in developing this final full approval are

available for inspection during normal

business hours at the following location:

U.S. Environmental Protection Agency,

Region 9, 75 Hawthorne Street, San

Francisco, California 94105. You may

also see copies of the submitted title V

program at the following location: Pinal

County Air Quality Control District,

Building F, 31 North Pinal Street,

Florence, Arizona 85232.

FOR FURTHER INFORMATION CONTACT:

Emmanuelle Rapicavoli, EPA Region 9,

at (415) 972-3969 or

rapicavoli.emmanuelle@epa.gov.

SUPPLEMENTARY INFORMATION: This

section contains additional information

about our final rulemaking, organized as

follows:

I. Background on the Pinal County Air

Quality Control District operating permits

program

II. EPA's Final Action

II. Effective date of EPA's full approval of

the Pinal County Air Quality Control

District operating permits program

I. Background on the Pinal County Air

Quality Control District Operating

Permits Program

The Clean Air Act (CAA)

Amendments of 1990 required all state

and local permitting authorities to

develop operating permits programs that

meet certain federal criteria. Pinal's

operating permits program was

submitted in response to this directive.

Because the District program

63166 Federal Register/Vol. 66,

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Federal Register/Vol. 66, No. 234/Wednesday, December 5, 2001/Rules and Regulations 63167

substantially, but not fully, met the

requirements of part 70, EPA granted

interim approval to the program in a

rulemaking published on October 30,

1996. See 61 FR 55910. The interim

approval notice described the

conditions that had to be met in order

for the District program to receive full

approval.

After Pinal revised its program to

address the conditions of the interim

approval, EPA promulgated a proposal

to approve the District's title V

operating permits program on

September 20, 2001, contingent upon

Pinal submitting the rules that were

adopted on September 5, 2001, as a

revision to its part 70 program. See 66

FR 48402.

II. EPA's Final Action

EPA is granting full approval to the

operating permits program submitted by

the Pinal County Air Quality Control

District based on the revisions adopted

on September 5, 2001, and submitted to

EPA on September 18, 2001, which

satisfactorily address the program

deficiencies identified in EPA's October

30, 1996 interim approval (61 FR

55910). In addition, EPA is approving,

as a title V operating permits program

revision, additional changes to Pinal's

rules. The deficiency corrections and

the additional program revisions are

described in detail in the September 20,

2001 proposal and its accompanying

technical support document. See 66 FR

48402.

The rules for which we are granting

final approval are listed below.

Rule No. Rule title Adoption Submittal

date date

PCR 1-3-140 (79) ............................. Definitions (definition of stationary source only) ............................................ 9/5/01 9/18/01

PCR 3-1-040 ..................................... Applicability and Classes of Permits .............................................................. 9/5/01 9/18/01

PCR 3-1-045 ..................................... Transition from Installation and Operating Permit Program ........................... 9/5/01 9/18/01

PC R 3-1-050 ..................................... Perm it A pplication Requirem ents ................................ ........................... ...... 9/5/01 9/18/01

PC R 3-1-081 ..................................... Perm it C onditions .................................................... 9/5/01 9/18/01

PCR 3-4-420 ..................................... Standards of Conditional Orders .................................................................... 9/5/01 9/18/01

PCR 3-5-490 ..................................... Application for Coverage under a General Permit ......................................... 9/5/01 9/18/01

PCR 3-5-550 ..................................... Revocations of Authority to Operate under a General Permit ....................... 9/5/01 9/18/01

In its program submission, Pinal

County did not assert jurisdiction over

Indian country. To date, no tribal

government in Pinal County has applied

to EPA for approval to administer a title

V program in Indian country within the

County. EPA regulations at 40 CFR part

49 govern how eligible Indian tribes

may be approved by EPA to implement

a title V program on Indian reservations

and in non-reservation areas over which

the tribe has jurisdiction. EPA's part 71

regulations govern the issuance of

federal operating permits in Indian

country. EPA's authority to issue

permits in Indian country was

challenged in Michigan v. EPA, (D.C.

Cir. No. 99-1151). On October 30, 2001,

the court issued its decision in the case,

vacating a provision that would have

allowed EPA to treat areas over which

EPA determines there is a question

regarding the area's status as if it is

Indian country, and remanding to EPA

for further proceedings. EPA will

respond to the court's remand and

explain EPA's approach for further

implementation of part 71 in Indian

country in a future action.

III. Effective Date of EPA's Full

Approval of the Pinal County Air

Quality Control District Operating

Permits Program

EPA is using the good cause exception

under the Administrative Procedure Act

(APA) to make the full approval of the

District's program effective on

November 30, 2001. In relevant part, the

APA provides that publication of "a

substantive rule shall be made not less

than 30 days before its effective date,

except-* * * (3) as otherwise

provided by the agency for good cause

found and published with the rule." 5

U.S.C. 553(d)(3). Section 553(b)(3)(B) of

the APA provides that good cause may

be supported by an agency

determination that a delay in the

effective date is impracticable,

unnecessary, or contrary to the public

interest. EPA finds that it is necessary

and in the public interest to make this

action effective sooner than 30 days

following publication. In this case, EPA

believes that it is in the public interest

for the program to take effect before

December 1, 2001. EPA's interim

approval of Pinal County's program

expires on December 1, 2001. In the

absence of this full approval of Pinal

County's amended program taking effect

on November 30, the federal program

under 40 CFR part 71 would

automatically take effect in Pinal

County and would remain in place until

the effective date of the fully-approved

state program. EPA believes it is in the

public interest for sources, the public

and Pinal County to avoid any gap in

coverage of the state program, as such a

gap could cause confusion regarding

permitting obligations. Furthermore, a

delay in the effective date is

unnecessary because Pinal County has

been administering the title V permit

program for 5 years under an interim

approval. Through this action, EPA is

approving a few revisions to the existing

and currently operational program. The

change from the interim approved

program which substantially met the

part 70 requirements, to the fully

approved program is relatively minor, in

particular if compared to the changes

between a state-established and

administered program and the federal

program.

Administrative Requirements

Under Executive Order 12866,

"Regulatory Planning and Review" (58

FR 51735, October 4, 1993), this final

approval is not a "significant regulatory

action" and therefore is not subject to

review by the Office of Management and

Budget. Under the Regulatory Flexibility

Act (5 U.S.C. 601 et seq.) the

Administrator certifies that this final

approval will not have a significant

economic impact on a substantial

number of small entities because it

merely approves state law as meeting

federal requirements and imposes no

additional requirements beyond those

imposed by state law. This rule does not

contain any unfunded mandates and

does not significantly or uniquely affect

small governments, as described in the

Unfunded Mandates Reform Act of 1995

(Public Law 104-4) because it approves

pre-existing requirements under state

law and does not impose any additional

enforceable duties beyond that required

by state law. This rule also does not

have tribal implications because it will

not have a substantial direct effect on

one or more Indian tribes, on the

relationship between the Federal

Government and Indian tribes, or on the

distribution of power and

responsibilities between the Federal

Government and Indian tribes, as

HeinOnline -- 66 Fed. Reg. 63167 2001
No. 234/Wednesday, December 5, 2001/Rules and Regulations

specified by Executive Order 13175,

"Consultation and Coordination with

Indian Tribal Governments" (65 FR

67249, November 9, 2000). This rule

also does not have Federalism

implications because it 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, "Federalism"

(64 FR 43255, August 10, 1999). This

rule merely approves existing

requirements under state law, and does

not alter the relationship or the

distribution of power and

responsibilities between the State and

the Federal government established in

the Clean Air Act. This final approval

also is not subject to Executive Order

13045, "Protection of Children from

Environmental Health Risks and Safety

Risks" (62 FR 19885, April 23, 1997) or

Executive Order 13211, "Actions

Concerning Regulations That

Significantly Affect Energy Supply,

Distribution, or Use" (66 FR 28355 (May

22, 2001), because it is not a significant

regulatory action under Executive Order

12866. This action will not impose any

collection of information subject to the

provisions of the Paperwork Reduction

Act, 44 U.S.C. 3501 et seq., other than

those previously approved and assigned

OMB control number 2060-0243. For

additional information concerning these

requirements, see 40 CFR part 70. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number.

In reviewing State operating permit

programs submitted pursuant to title V

of the Clean Air Act, EPA will approve

State programs provided that they meet

the requirements of the Clean Air Act

and EPA's regulations codified at 40

CFR part 70. In this context, in the

absence of a prior existing requirement

for the State to use voluntary consensus

standards (VCS), EPA has no authority

to disapprove a State operating permit

program for failure to use VCS. It would

thus be inconsistent with applicable law

for EPA, when it reviews an operating

permit program, to use VCS in place of

a State program that otherwise satisfies

the provisions of the Clean Air Act.

Thus, 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.

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. A major rule

cannot take effect until 60 days after it

is published in the Federal Register.

This action is not a "major rule" as

defined by 5 U.S.C. 804(2). This rule

will be effective on November 30, 2001.

Under section 307(b)(1) of the Clean

Air Act, petitions for judicial review of

this action must be filed in the United

States Court of Appeals for the

appropriate circuit by February 4, 2002.

Filing a petition for reconsideration by

the Administrator of this final rule does

not affect the finality of this rule for the

purposes of judicial review nor does it

extend the time within which a petition

for judicial review may be filed, and

shall not postpone the effectiveness of

such rule or action. This action may not

be challenged later in proceedings to

enforce its requirements. (See section

307(b)(2).)

List of Subjects in 40 CFR Part 70

Environmental protection,

Administrative practice and procedure,

Air pollution control, Intergovernmental

relations, Operating permits, Reporting

and recordkeeping requirements.

Dated: November 27, 2001.

Wayne Nastri,

Regional Administrator, Region 9.

40 CFR part 70, chapter I, title 40 of

the Code of Federal Regulations is

amended as follows:

PART 70-[AMENDED]

1. The authority citation for part 70

continues to read as follows:

Authority: 42 U.S.C. 7401, et seq.

2. Appendix A to part 70 is amended

by adding paragraph (d)(3) under

Arizona to read as follows:

Appendix A to Part 70-Approval

Status of State and Local Operating

Permits Programs

Arizona

(d) * * *

* * *

(3) revisions submitted on September 18,

2001. Full approval is effective on November

30, 2001.

[FR Doc. 01-30100 Filed 12-4-01; 8:45 am]

BILLING CODE 6560-50-P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 70

[NJO02; FRL-7113-1]

Clean Air Act Final Full Approval of

Operating Permit Program; New Jersey

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: The EPA is promulgating final

full approval of the operating permit

program submitted by the State of New

Jersey in accordance with Title V of the

Clean Air Act (the Act) and its

implementing regulations. This

approved program allows New Jersey to

issue federally enforceable operating

permits to all major stationary sources

and to certain other sources within the

State's jurisdiction.

EFFECTIVE DATE: November 30, 2001.

ADDRESSES: Copies of the State's

submittal and other supporting

information used in developing the final

full approval are available for inspection

during normal business hours at the

following location: U.S. Environmental

Protection Agency, Region 2, 290

Broadway, 25th Floor, New York, New

York 10007-1866.

FOR FURTHER INFORMATION CONTACT:

Steven C. Riva, Chief, Permitting

Section, Air Programs Branch, at the

above EPA office in New York or at

telephone number (212) 637-4074.

SUPPLEMENTARY INFORMATION: This

section provides additional information

by addressing the following questions:

1. What is the operating permits program?

2. What is being addressed in this

document?

3. What are the program changes that EPA

is approving?

4. What is involved in this final action?

5. What is the effective date of EPA's final

full approval of the New Jersey title V

program?

1. What Is the Operating Permits

Program?

Title V of the Clean Air Act (CAA)

and its implementing regulations at 40

CFR part 70 (part 70) direct all states to

develop and implement operating

permit programs that meet certain

criteria. Operating permit programs are

intended to consolidate into single

63168 Federal Register/Vol. 66,

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