# + 2

(,1 1/,1(

Citation: 66 Fed. Reg. 63166 2001

Content downloaded/printed from HeinOnline (http://heinonline.org) Mon Jun 18 17:55:48 2012

-- Your use of this HeinOnline PDF indicates your acceptance of HeinOnline's Terms and Conditions of the license agreement available at http://heinonline.org/HOL/License

-- The search text of this PDF is generated from uncorrected OCR text.

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

Dated: November 9, 2001. Stephen F. Sundlof, Director,Center forVeterinaryMedicine. [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 ofan abbreviated new animal drug application (ANADA)filedby First Priority, Inc. The ANADA provides for oral use ofivermectin solution in horses for the treatment and control ofvarious species ofinternal 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 andDrug 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 PRIMECTINT M (ivermectin) Equine Oral Liquid. The application provides for oral use ofa 1.0 percent ivermectin solution in horses for the treatment and control ofvarious species of gastrointestinal nematodes, lungworms, stomach bots, and cutaneous larvae and microfilariae. First Priority's PRIMECTIN T M Equine Oral Liquid is approved as a generic copy ofMerial Ltd.'s EQVALAN R (ivermectin) Oral Liquid for Horses, approved under NADA 140-439. ANADA 200-321 is approved as ofSeptember 7,2001, and 21 CFR 520.1195 is amended to reflect the approval. The basis ofapproval is discussed in the freedom ofinformation summary.

In accordance with the freedom of information provisions of21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval ofthis application may be seen in the Dockets Management Branch (HFA-305), Food andDrug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(1) thatthis action is ofa 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 meetthe definition of"rule" in 5U.S.C. 804(3)(A) because it is a rule of "particular applicability." Therefore, it isnot subject to congressional review requirements in 5 U.S.C. 801-808.
List ofSubjects in 21 CFRPart520

Animal drugs. Therefore, under the Federal Food, Drug, andCosmetic Act and under authority delegated tothe Commissioner ofFood andDrugs 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) andparagraph (c)(1); in paragraph (c)(2) by removing "It is used in horses"; and in paragraph (c)(3) by removing the first sentence toread as follows:
§520.1195 Ivermectin liquid.

(c) Conditionsofuse in horses-(1) Amount. 200 micrograms per kilogram ofbody weight as a single dose by stomach tube or as an oral drench.

Dated: November 9,2001. Stephen F. Sundlof, Director,Center forVeterinaryMedicine. [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 AirAct FullApproval ofthe Operating Permits Program for the Pinal County AirQuality Control District,AZ
AGENCY: Environmental Protection Agency (EPA). ACTION: Finalrule. SUMMARY: EPA istaking 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 inthe 1990 Clean Air Act (CAA) Amendments that permitting authorities develop, and submit to EPA, programs for issuing operating permits to allmajor 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 itsprogram to satisfy the conditions ofthe interim approval, and EPAproposed full approval in the FederalRegister on September 20, 2001, contingent upon Pinal submitting the rules to EPA as arevision to itspart 70 program. Pinal County did so, and EPA did not receive any comments on the proposed action. This action promulgates final full approval ofthe 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 ofthe submitted title V
program atthe following location: Pinal County Air Quality Control District, Building F, 31 North Pinal Street, Florence, Arizona 85232. FOR FURTHER INFORMATION CONTACT: Emmanuelle Rapicavoli, EPARegion 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 onthe Pinal County Air

QualityControl District operatingpermits
program II. EPA's Final Action II. Effective date ofEPA's full approval of

thePinal County Air Quality Control District operating permits program I. Background onthe Pinal County Air QualityControl DistrictOperating PermitsProgram

The Clean Air Act (CAA) Amendments of1990 required all state and local permitting authorities to develop operating permitsprograms 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,

HeinOnline -- 66 Fed. Reg. 63166 2001

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

substantially, but not fully, met the requirements ofpart 70, EPA granted interim approval to theprogram in a rulemaking published on October 30, 1996. See 61 FR 55910. The interim approval notice described the conditions thathad tobe met in order for the District program to receive full approval.

After Pinal revised its program to address the conditions ofthe interim approval, EPApromulgated 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 itspart 70 program. See 66 FR 48402.
II. EPA's Final Action

EPA is granting full approval tothe operating permits program submitted by the Pinal County Air Quality Control District based onthe revisions adopted

on September 5, 2001, and submitted to EPA on September 18, 2001, which satisfactorily address theprogram deficiencies identified in EPA's October 30, 1996 interim approval (61FR 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 PCR 3-1-050

..................................... PermitApplication Requirements

................................ ...... ........................... 9/5/01 9/18/01 PCR 3-1-081

..................................... PermitConditions

.................................................... 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 assertjurisdiction over Indian country. To date, no tribal government in Pinal County has applied to EPAfor approval to administer a title V program in Indian country within the County. EPA regulations at40 CFR part 49 govern how eligible Indian tribes may be approved byEPA to implement

atitle V program on Indian reservations andin 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 inMichiganv. EPA, (D.C. Cir. No. 99-1151). On October 30, 2001, the court issued its decision inthe case, vacating aprovision that would have allowed EPAto treat areas over which EPA determines there is a question regarding the area's status as ifit is Indian country, and remanding toEPA for further proceedings. EPA will respond to the court's remand and explain EPA's approach for further implementation ofpart 71 in Indian country in a future action.

III. Effective Date ofEPA's Full Approval ofthe PinalCounty Air Quality ControlDistrict Operating PermitsProgram

EPA isusing the good cause exception under the Administrative Procedure Act (APA)to make the full approval ofthe District's program effective on November 30, 2001. In relevant part, the APAprovides thatpublication 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 andpublished with the rule." 5 U.S.C. 553(d)(3). Section 553(b)(3)(B) of the APAprovides that good cause may be supported by an agency determination that a delay in the effective date isimpracticable, unnecessary, or contrary to the public interest. EPA finds that itis necessary andin the public interest to make this action effective sooner than 30 days following publication. In this case, EPA believes that itis in the public interest for the program to take effectbefore December 1, 2001.EPA's interim approval ofPinal County's program expires on December 1, 2001. In the absence ofthis full approval ofPinal County's amended program taking effect

onNovember 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 ofthe fully-approved state program. EPA believes itis in the public interest for sources, thepublic andPinal County to avoid any gap in coverage ofthe 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 5years under an interim approval. Through this action, EPA is approving a fewrevisions 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 isrelatively minor, in particular ifcompared to the changes between a state-established and administered program andthe federal program.
AdministrativeRequirements

Under Executive Order 12866, "Regulatory Planning and Review" (58 FR 51735, October 4, 1993), this final approval is not a "significant regulatory action" andtherefore is not subject to review by the Office ofManagement and Budget.Under the Regulatory Flexibility Act (5U.S.C. 601 etseq.)the Administrator certifies that this final approval will not have a significant economic impact on a substantial number of small entitiesbecause it merely approves state law asmeeting federal requirements andimposes no additional requirements beyond those imposedby state law. Thisrule 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 dutiesbeyond that required by state law. This rule also does not havetribal implications because it will nothave a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or onthe distribution ofpower 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 itwill not have substantial direct effects on the States,

onthe relationship between the national government and the States, or on the distribution ofpower and responsibilities among the various levels ofgovernment, 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 ofpower and responsibilities between the State and the Federal government established in the Clean Air Act. This final approval alsois not subject to Executive Order 13045, "Protection ofChildren 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, orUse" (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 ofinformation subject to the provisions ofthe 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

aperson is not required to respond to,
a collection ofinformation unless it displays a currentlyvalid OMB control number.

In reviewing State operating permit programs submitted pursuant totitle V ofthe Clean Air Act, EPAwill approve State programs provided that they meet the requirements ofthe Clean Air Act andEPA's regulations codified at 40 CFR part 70. In this context, inthe absence ofa prior existing requirement for the State touse voluntary consensus standards (VCS), EPAhas no authority to disapprove a State operating permit program for failure to use VCS. Itwould thus be inconsistent with applicable law for EPA, when itreviews an operating permit program, touse VCS in place of

a State program that otherwise satisfies the provisions ofthe Clean Air Act. Thus, the requirements ofsection 12(d) ofthe 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 agencypromulgating the rule must submit arule report, which includes a copy ofthe rule, to each House ofthe Congress and tothe Comptroller General ofthe United States. EPAwill submit a report containing this rule and other required information to the U.S. Senate, the U.S. House ofRepresentatives, and the Comptroller General ofthe United Statesprior to publication ofthe rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This actionis not a "major rule" as defined by 5U.S.C. 804(2). This rule will be effective on November 30, 2001.

Under section 307(b)(1) ofthe Clean Air Act, petitions forjudicial review of this action must be filed in the United States Court ofAppeals for the appropriate circuit by February 4, 2002. Filing apetition for reconsideration by the Administrator ofthis final rule does not affectthe finality ofthis rule for the purposes ofjudicial review nor does it extend the time within which a petition forjudicial review may be filed, and shall not postpone the effectiveness of suchrule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

List ofSubjects in 40 CFRPart 70

Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Operating permits, Reporting andrecordkeeping requirements.

Dated: November 27, 2001. Wayne Nastri, RegionalAdministrator, Region 9.

40 CFR part 70, chapter I, title 40 of the Code ofFederal Regulations is amended as follows:

PART 70-[AMENDED]

1.The authority citation for part 70 continues to read asfollows:

Authority: 42 U.S.C. 7401, etseq. 2.Appendix A to part 70 is amended by adding paragraph (d)(3) under Arizona to read as follows: Appendix A toPart 70-Approval Status ofState 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 FullApproval of Operating Permit Program; New Jersey
AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.
SUMMARY: The EPAis promulgating final full approval ofthe operating permit program submittedby the State ofNew Jersey in accordance with Title V ofthe Clean Air Act (the Act) and its implementing regulations. This approved program allows NewJersey to issue federally enforceable operating permitsto all major stationary sources and to certain other sources within the State'sjurisdiction. 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 normalbusiness hours atthe following location: U.S. Environmental Protection Agency, Region 2, 290 Broadway, 25thFloor, New York,New York 10007-1866. FOR FURTHER INFORMATION CONTACT: Steven C. Riva, Chief, Permitting Section, AirPrograms 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 operatingpermits program? 2. What isbeing addressed in this document?

3. What are the program changes thatEPA is approving?

4.What is involved in this final action? 5. What is the effective date ofEPA's final full approval oftheNew Jersey titleV program?
1. What Is the Operating Permits Program?

Title V ofthe Clean AirAct (CAA) and its implementing regulations at 40 CFR part 70 (part 70) direct all states to develop and implement operating permit programs thatmeet certain criteria. Operating permit programs are intended to consolidate into single 63168 Federal Register/Vol. 66,

HeinOnline -- 66 Fed. Reg. 63168 2001