Federal Register / Vol. 74, No. 116 / Thursday, June 18, 2009 / Rules and Regulations 28875 

1061, Rockville, MD 20852, between 9 

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

Friday. 

Under section 512(c)(2)(F)(i) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(i)), this 

approval qualifies for 5 years of 

marketing exclusivity beginning on the 

date of approval. 

FDA has determined under 21 CFR 

25.33 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 the 

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. Add § 520.2475 to read as follows: 

§ 520.2475 Toceranib. 

(a) Specifications. Each tablet 

contains 10, 15, or 50 milligrams (mg) 

toceranib as toceranib phosphate. 

(b) Sponsor. See No. 000009 in 

§ 510.600 of this chapter. 

(c) Conditions of use—(1) Dogs—(i) 

Amount. Administer an initial dose of 

3.25 mg per kilogram (1.48 mg per 

pound) body weight, orally every other 

day. 

(ii) Indications for use. For the 

treatment of Patnaik grade II or III, 

recurrent, cutaneous mast cell tumors 

with or without regional lymph node 

involvement. 

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

(2) [Reserved]. 

Dated: June 12, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–14299 Filed 6–17–09; 8:45 am] 

BILLING CODE 4160–01–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 55 

[OAR–2004–0091; FRL–8912–7] 

Outer Continental Shelf Air 

Regulations Consistency Update for 

California 

AGENCY: Environmental Protection 

Agency (‘‘EPA’’). 

ACTION: Final rule—consistency update. 

SUMMARY: EPA is finalizing the update 

of the Outer Continental Shelf (‘‘OCS’’) 

Air Regulations proposed in the Federal 

Register on March 17, 2009. 

Requirements applying to OCS sources 

located within 25 miles of states’ 

seaward boundaries must be updated 

periodically to remain consistent with 

the requirements of the corresponding 

onshore area (‘‘COA’’), as mandated by 

section 328(a)(1) of the Clean Air Act 

Amendments of 1990 (‘‘the Act’’). The 

portion of the OCS air regulations that 

is being updated pertains to the 

requirements for OCS sources for which 

the Ventura County Air Pollution 

Control District (Ventura County APCD) 

is the designated COA. The intended 

effect of approving the requirements 

contained in the ‘‘Ventura County Air 

Pollution Control District Requirements 

Applicable to OCS Sources’’ (May 2009) 

is to regulate emissions from OCS 

sources in accordance with the 

requirements onshore. 

DATES: Effective Date: This rule is 

effective on July 20, 2009. 

The incorporation by reference of 

certain publications listed in this rule is 

approved by the Director of the Federal 

Register as of July 20, 2009. 

ADDRESSES: EPA has established docket 

number OAR–2004–0091 for this action. 

The index to the docket is available 

electronically at http:// 

www.regulations.gov and in hard copy 

at EPA Region IX, 75 Hawthorne Street, 

San Francisco, California. While all 

documents in the docket are listed in 

the index, some information may be 

publicly available only at the hard copy 

location (e.g., copyrighted material), and 

some may not be publicly available in 

either location (e.g., CBI). To inspect the 

hard copy materials, please schedule an 

appointment during normal business 

hours with the contact listed in the FOR

FURTHER INFORMATION CONTACT section. 

FOR FURTHER INFORMATION CONTACT: 

Cynthia G. Allen, Air Division, U.S. 

EPA Region IX, (415) 947–4120, 

allen.cynthia@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, the terms 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ refer to U.S. EPA. 

Organization of this document: The 

following outline is provided to aid in 

locating information in this preamble. 

Table of Contents 

I. Background 

II. Public Comment 

III. EPA Action 

IV. Statutory and Executive Order Reviews 

I. Background 

On March 17, 2009 (74 FR 11330), 

EPA proposed to approve requirements 

into the OCS Air Regulations pertaining 

to Ventura County APCD. These 

requirements are being promulgated in 

response to the submittal of rules from 

this California air pollution control 

agency. EPA has evaluated the proposed 

requirements to ensure that they are 

rationally related to the attainment or 

maintenance of federal or state ambient 

air quality standards or Part C of title I 

of the Act, that they are not designed 

expressly to prevent exploration and 

development of the OCS and that they 

are applicable to OCS sources. 40 CFR 

55.1. EPA has also evaluated the rules 

to ensure that they are not arbitrary or 

capricious. 40 CFR 55.12(e). In addition, 

EPA has excluded administrative or 

procedural rules. 

Section 328(a) of the Act requires that 

EPA establish requirements to control 

air pollution from OCS sources located 

within 25 miles of states’ seaward 

boundaries that are the same as onshore 

requirements. To comply with this 

statutory mandate, EPA must 

incorporate applicable onshore rules 

into 40 CFR part 55 as they exist 

onshore. This limits EPA’s flexibility in 

deciding which requirements will be 

incorporated into part 55 and prevents 

EPA from making substantive changes 

to the requirements it incorporates. As 

a result, EPA may be incorporating rules 

into part 55 that do not conform to all 

of EPA’s state implementation plan 

(SIP) guidance or certain requirements 

of the Act. Consistency updates may 

result in the inclusion of state or local 

rules or regulations into part 55, even 

though the same rules may ultimately be 

disapproved for inclusion as part of the 

SIP. Inclusion in the OCS rule does not 

imply that a rule meets the requirements 

of the Act for SIP approval, nor does it 

imply that the rule will be approved by 

EPA for inclusion in the SIP. 

II. Public Comment 

EPA’s proposed actions provided a 

30-day public comment period. During 

this period, we received no comments 

on the proposed actions. 

28876 Federal Register / Vol. 74, No. 116 / Thursday, June 18, 2009 / Rules and Regulations 

III. EPA Action 

In this document, EPA takes final 

action to incorporate the proposed 

changes into 40 CFR part 55. No 

changes were made to the proposed 

action. EPA is approving the proposed 

action under section 328(a)(1) of the 

Act, 42 U.S.C. 7627. Section 328(a) of 

the Act requires that EPA establish 

requirements to control air pollution 

from OCS sources located within 25 

miles of states’ seaward boundaries that 

are the same as onshore requirements. 

To comply with this statutory mandate, 

EPA must incorporate applicable 

onshore rules into Part 55 as they exist 

onshore. 

IV. Statutory and Executive Order 

Reviews 

Under the Clean Air Act, the 

Administrator is required to establish 

requirements to control air pollution 

from OCS sources located within 25 

miles of States’ seaward boundaries that 

are the same as onshore air control 

requirements. To comply with this 

statutory mandate, EPA must 

incorporate applicable onshore rules 

into part 55 as they exist onshore. 42 

U.S.C. 7627(a)(1); 40 CFR 55.12. Thus, 

in promulgating OCS consistency 

updates, EPA’s role is to maintain 

consistency between OCS regulations 

and the regulations of onshore areas, 

provided that they meet the criteria of 

the Clean Air Act. Accordingly, this 

action simply updates the existing OCS 

requirements to make them consistent 

with requirements onshore, without the 

exercise of any policy discretion by 

EPA. For that reason, this action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

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

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because it does 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, 

nor does it impose substantial direct 

compliance costs on tribal governments, 

nor preempt tribal law. 

Under the provisions of the 

Paperwork Reduction Act, 44 U.S.C. 

3501 et seq., OMB has approved the 

information collection requirements 

contained in 40 CFR part 55 and, by 

extension, this update to the rules, and 

has assigned OMB control number 

2060–0249. Notice of OMB’s approval of 

EPA Information Collection Request 

(‘‘ICR’’) No. 1601.06 was published in 

the Federal Register on March 1, 2006 

(71 FR 10499–10500). The approval 

expires January 31, 2009. As EPA 

previously indicated (70 FR 65897– 

65898 (November 1, 2005)), the annual 

public reporting and recordkeeping 

burden for collection of information 

under 40 CFR part 55 is estimated to 

average 549 hours per response. Burden 

means the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, or disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; develop, acquire, 

install, and utilize technology and 

systems for the purposes of collecting, 

validating, and verifying information, 

processing and maintaining 

information, and disclosing and 

providing information; adjust the 

existing ways to comply with any 

previously applicable instructions and 

requirements; train personnel to be able 

to respond to a collection of 

information; search data sources; 

complete and review the collection of 

information; and transmit or otherwise 

disclose the information. 

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. The OMB control 

numbers for EPA’s regulations in 40 

CFR are listed in 40 CFR part 9 and are 

identified on the form and/or 

instrument, if applicable. In addition, 

the table in 40 CFR part 9 of currently 

approved OMB control numbers for 

various regulations lists the regulatory 

citations for the information 

requirements contained in 40 CFR part 

55. 

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 action 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). 

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 August 17, 2009. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this action 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 55 

Environmental protection, 

Administrative practice and procedures, 

Air pollution control, Hydrocarbons, 

Incorporation by reference, 

Intergovernmental relations, Nitrogen 

dioxide, Nitrogen oxides, Outer 

Continental Shelf, Ozone, Particulate 

matter, Permits, Reporting and 

recordkeeping requirements, Sulfur 

oxides. 

Dated: May 1, 2009. 

Laura Yoshii, 

Acting Regional Administrator, Region IX. 

■ Title 40 of the Code of Federal 

Regulations, part 55, is to be amended 

as follows: 

Federal Register / Vol. 74, No. 116 / Thursday, June 18, 2009 / Rules and Regulations 28877 

PART 55—[AMENDED] 

■ 1. The authority citation for part 55 

continues to read as follows: 

Authority: Section 328 of the Clean Air Act 

(42 U.S.C. 7401 et seq.) as amended by Public 

Law 101–549. 

■ 2. Section 55.14 is amended by 

revising paragraph (e)(3)(ii)(H) to read as 

follows: 

§ 55.14 Requirements that apply to OCS 

sources located within 25 miles of States’ 

seaward boundaries, by State. 

* * * * * 

(e) * * * 

(3) * * * 

(ii) * * * 

(H) Ventura County Air Pollution 

Control District Requirements 

Applicable to OCS Sources, May, 2009. 

* * * * * 

■ 3. Appendix A to CFR Part 55 is 

amended by revising paragraph (b)(8) 

under the heading ‘‘California’’ to read 

as follows: 

Appendix A to Part 55—Listing of State 

and Local Requirements Incorporated 

by Reference Into Part 55, by State 

* * * * * 

California 

* * * * * 

(b) * * * 

(8) The following requirements are 

contained in Ventura County Air Pollution 

Control District Requirements Applicable to 

OCS Sources: 

Rule 2 Definitions (Adopted 04/13/04) 

Rule 5 Effective Date (Adopted 04/13/04) 

Rule 6 Severability (Adopted 11/21/78) 

Rule 7 Zone Boundaries (Adopted 06/14/ 

77) 

Rule 10 Permits Required (Adopted 04/13/ 

04) 

Rule 11 Definition for Regulation II 

(Adopted 03/14/06) 

Rule 12 Applications for Permits (Adopted 

06/13/95) 

Rule 13 Action on Applications for an 

Authority to Construct (Adopted 06/13/95) 

Rule 14 Action on Applications for a Permit 

to Operate (Adopted 06/13/95) 

Rule 15.1 Sampling and Testing Facilities 

(Adopted 10/12/93) 

Rule 16 BACT Certification (Adopted 06/ 

13/95) 

Rule 19 Posting of Permits (Adopted 05/23/ 

72) 

Rule 20 Transfer of Permit (Adopted 05/23/ 

72) 

Rule 23 Exemptions from Permits (Adopted 

04/08/08) 

Rule 24 Source Recordkeeping, Reporting, 

and Emission Statements (Adopted 09/15/ 

92) 

Rule 26 New Source Review—General 

(Adopted 03/14/06) 

Rule 26.1 New Source Review—Definitions 

(Adopted 11/14/06) 

Rule 26.2 New Source Review— 

Requirements (Adopted 05/14/02) 

Rule 26.3 New Source Review—Exemptions 

(Adopted 03/14/06) 

Rule 26.6 New Source Review— 

Calculations (Adopted 03/14/06) 

Rule 26.8 New Source Review—Permit To 

Operate (Adopted 10/22/91) 

Rule 26.10 New Source Review—PSD 

(Adopted 01/13/98) 

Rule 26.11 New Source Review—ERC 

Evaluation At Time of Use (Adopted 05/ 

14/02) 

Rule 26.12 Federal Major Modifications 

(Adopted 06/27/06) 

Rule 28 Revocation of Permits (Adopted 07/ 

18/72) 

Rule 29 Conditions on Permits (Adopted 

03/14/06) 

Rule 30 Permit Renewal (Adopted 04/13/ 

04) 

Rule 32 Breakdown Conditions: Emergency 

Variances, A., B.1., and D. only. (Adopted 

02/20/79) 

Rule 33 Part 70 Permits—General (Adopted 

09/12/06) 

Rule 33.1 Part 70 Permits—Definitions 

(Adopted 09/12/06) 

Rule 33.2 Part 70 Permits—Application 

Contents (Adopted 04/10/01) 

Rule 33.3 Part 70 Permits—Permit Content 

(Adopted 09/12/06) 

Rule 33.4 Part 70 Permits—Operational 

Flexibility (Adopted 04/10/01) 

Rule 33.5 Part 70 Permits—Time frames for 

Applications, Review and Issuance 

(Adopted 10/12/93) 

Rule 33.6 Part 70 Permits—Permit Term 

and Permit Reissuance (Adopted 10/12/93) 

Rule 33.7 Part 70 Permits—Notification 

(Adopted 04/10/01) 

Rule 33.8 Part 70 Permits—Reopening of 

Permits (Adopted 10/12/93) 

Rule 33.9 Part 70 Permits—Compliance 

Provisions (Adopted 04/10/01) 

Rule 33.10 Part 70 Permits—General Part 

70 Permits (Adopted 10/12/93) 

Rule 34 Acid Deposition Control (Adopted 

03/14/95) 

Rule 35 Elective Emission Limits (Adopted 

11/12/96) 

Rule 36 New Source Review—Hazardous 

Air Pollutants (Adopted 10/06/98) 

Rule 42 Permit Fees (Adopted 04/08/08) 

Rule 44 Exemption Evaluation Fee 

(Adopted 04/08/08) 

Rule 45 Plan Fees (Adopted 06/19/90) 

Rule 45.2 Asbestos Removal Fees (Adopted 

08/04/92) 

Rule 47 Source Test, Emission Monitor, and 

Call-Back Fees (Adopted 06/22/99) 

Rule 50 Opacity (Adopted 04/13/04) 

Rule 52 Particulate Matter-Concentration 

(Grain Loading)(Adopted 04/13/04) 

Rule 53 Particulate Matter-Process Weight 

(Adopted 04/13/04) 

Rule 54 Sulfur Compounds (Adopted 06/ 

14/94) 

Rule 56 Open Burning (Adopted 11/11/03) 

Rule 57 Incinerators (Adopted 01/11/05) 

Rule 57.1 Particulate Matter Emissions from 

Fuel Burning Equipment (Adopted 01/11/ 

05) 

Rule 62.7 Asbestos—Demolition and 

Renovation (Adopted 09/01/92) 

Rule 63 Separation and Combination of 

Emissions (Adopted 11/21/78) 

Rule 64 Sulfur Content of Fuels (Adopted 

04/13/99) 

Rule 67 Vacuum Producing Devices 

(Adopted 07/05/83) 

Rule 68 Carbon Monoxide (Adopted 04/13/ 

04) 

Rule 71 Crude Oil and Reactive Organic 

Compound Liquids (Adopted 12/13/94) 

Rule 71.1 Crude Oil Production and 

Separation (Adopted 06/16/92) 

Rule 71.2 Storage of Reactive Organic 

Compound Liquids (Adopted 09/26/89) 

Rule 71.3 Transfer of Reactive Organic 

Compound Liquids (Adopted 06/16/92) 

Rule 71.4 Petroleum Sumps, Pits, Ponds, 

and Well Cellars (Adopted 06/08/93) 

Rule 71.5 Glycol Dehydrators (Adopted 12/ 

13/94) 

Rule 72 New Source Performance Standards 

(NSPS) (Adopted 09/9/08) 

Rule 73 National Emission Standards for 

Hazardous Air Pollutants (NESHAPS 

(Adopted 09/9/08) 

Rule 74 Specific Source Standards 

(Adopted 07/06/76) 

Rule 74.1 Abrasive Blasting (Adopted 11/ 

12/91) 

Rule 74.2 Architectural Coatings (Adopted 

11/13/01) 

Rule 74.6 Surface Cleaning and Degreasing 

(Adopted 11/11/03—effective 07/01/04) 

Rule 74.6.1 Batch Loaded Vapor Degreasers 

(Adopted 11/11/03—effective 07/01/04) 

Rule 74.7 Fugitive Emissions of Reactive 

Organic Compounds at Petroleum 

Refineries and Chemical Plants (Adopted 

10/10/95) 

Rule 74.8 Refinery Vacuum Producing 

Systems, Waste-water Separators and 

Process Turnarounds (Adopted 07/05/83) 

Rule 74.9 Stationary Internal Combustion 

Engines (Adopted 11/08/05) 

Rule 74.10 Components at Crude Oil 

Production Facilities and Natural Gas 

Production and Processing Facilities 

(Adopted 03/10/98) 

Rule 74.11 Natural Gas-Fired Residential 

Water Heaters-Control of NOx (Adopted 04/ 

09/85) 

Rule 74.11.1 Large Water Heaters and Small 

Boilers (Adopted 09/14/99) 

Rule 74.12 Surface Coating of Metal Parts 

and Products (Adopted 04/08/08) 

Rule 74.15 Boilers, Steam Generators and 

Process Heaters (Adopted 11/08/94) 

Rule 74.15.1 Boilers, Steam Generators and 

Process Heaters (Adopted 06/13/00) 

Rule 74.16 Oil Field Drilling Operations 

(Adopted 01/08/91) 

Rule 74.20 Adhesives and Sealants 

(Adopted 01/11/05) 

Rule 74.23 Stationary Gas Turbines 

(Adopted 1/08/02) 

Rule 74.24 Marine Coating Operations 

(Adopted 11/11/03) 

Rule 74.24.1 Pleasure Craft Coating and 

Commercial Boatyard Operations (Adopted 

01/08/02) 

Rule 74.26 Crude Oil Storage Tank 

Degassing Operations (Adopted 11/08/94) 

Rule 74.27 Gasoline and ROC Liquid 

Storage Tank Degassing Operations 

(Adopted 11/08/94) 

Rule 74.28 Asphalt Roofing Operations 

(Adopted 05/10/94) 

Rule 74.30 Wood Products Coatings 

(Adopted 06/27/06) 

Rule 75 Circumvention (Adopted 11/27/78) 

28878 Federal Register / Vol. 74, No. 116 / Thursday, June 18, 2009 / Rules and Regulations 

Rule 101 Sampling and Testing Facilities 

(Adopted 05/23/72) 

Rule 102 Source Tests (Adopted 04/13/04) 

Rule 103 Continuous Monitoring Systems 

(Adopted 02/09/99) 

Rule 154 Stage 1 Episode Actions (Adopted 

09/17/91) 

Rule 155 Stage 2 Episode Actions (Adopted 

09/17/91) 

Rule 156 Stage 3 Episode Actions (Adopted 

09/17/91) 

Rule 158 Source Abatement Plans (Adopted 

09/17/91) 

Rule 159 Traffic Abatement Procedures 

(Adopted 09/17/91) 

Rule 220 General Conformity (Adopted 05/ 

09/95) 

Rule 230 Notice to Comply (Adopted 9/9/ 

08) 

[FR Doc. E9–13603 Filed 6–17–09; 8:45 am] 

BILLING CODE 6560–50–P