28874 Federal Register / Vol. 74, No. 116 / Thursday, June 18, 2009 / Rules and Regulations 

already submitted to the Board’s TERP 

for review. This action simply specifies 

that such data must be accepted by the 

TERP for all treatment equipment prior 

to its use under the program. 

The Board’s Food Quality and Safety 

Committee (committee) met on April 22, 

2008, to consider this change. The 

committee considered maintaining the 

status quo whereby equipment could be 

used under the program that had 

completed validation testing, but had 

not been accepted by the TERP. The 

committee concluded that acceptance 

by the TERP was important in order to 

help ensure that all treatment 

equipment consistently meets the 4-log 

requirement of the program. The Board 

agreed with the committee and 

ultimately recommended that the term 

‘‘validation’’ be revised accordingly. 

This action does not impose any 

additional reporting and recordkeeping 

requirements on California almonds 

handlers, process authorities, or almond 

manufacturers. As with all Federal 

marketing order programs, reports and 

forms are periodically reviewed to 

reduce information requirements and 

duplication by industry and public 

sector agencies. 

AMS is committed to complying with 

the E-Government Act, to promote the 

use of the Internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

In addition, USDA has not identified 

any relevant Federal rules that 

duplicate, overlap, or conflict with this 

rule. 

Further, the committee and Board 

meetings where this issue was discussed 

were widely publicized throughout the 

California almond industry and all 

interested persons were invited to 

attend the meetings and participate in 

deliberations on all issues. The issue 

was discussed at two committee 

meetings in April 2008 and at two Board 

meetings, one in April and one in May 

2008. All of these meetings were public 

meetings, and all entities, both large and 

small, were able to express views on 

this issue. Finally, interested persons 

are invited to submit information on the 

regulatory and informational impacts of 

this action on small businesses. 

A small business guide on complying 

with fruit, vegetable, and specialty crop 

marketing agreements and orders may 

be viewed at: http://www.ams.usda.gov/ 

AMSv1.0/ams.fetchTemplateData.do?

template=TemplateN&page=Marketing

OrdersSmallBusinessGuide. Any 

questions about the compliance guide 

should be sent to Jay Guerber at the 

previously mentioned address in the 

FOR FURTHER INFORMATION CONTACT

section. 

This rule invites comments on a 

revision to the outgoing quality control 

requirements currently prescribed under 

the almond marketing order. Any 

comments received will be considered 

prior to finalization of this rule. 

After consideration of all relevant 

material presented, including the 

Board’s recommendation, and other 

information, it is found that this interim 

final rule, as hereinafter set forth, will 

tend to effectuate the declared policy of 

the Act. 

Pursuant to 5 U.S.C. 553, it is also 

found and determined upon good cause 

that it is impracticable, unnecessary, 

and contrary to the public interest to 

give preliminary notice prior to putting 

this rule into effect and that good cause 

exists for not postponing the effective 

date of this rule until 30 days after 

publication in the Federal Register 

because: (1) This rule makes a revision 

to the requirements concerning 

validation contained in the current 

regulations to help ensure that all 

treatment equipment meets a 4-log 

reduction in Salmonella in almonds; (2) 

handlers are aware of this action since 

the Board unanimously recommended 

this revision at a public meeting, and 

interested parties had an opportunity to 

provide input; and (3) this rule provides 

a 60-day comment period and any 

comments received will be considered 

prior to finalization of this rule. 

List of Subjects in 7 CFR Part 981 

Almonds, Marketing agreements, 

Nuts, Reporting and recordkeeping 

requirements. 

■ For the reasons set forth in the 

preamble, 7 CFR part 981 is amended as 

follows: 

PART 981—ALMONDS GROWN IN 

CALIFORNIA 

■ 1. The authority citation for 7 CFR 

part 981 continues to read as follows: 

Authority: 7 U.S.C. 601–674. 

■ 2. Paragraph (b)(3)(i) in § 981.442 is 

revised to read as follows: 

§ 981.442 Quality control. 

* * * * * 

(b) * * * 

(3) * * * 

(i) Validation means that the 

treatment technology and equipment 

have been demonstrated to achieve in 

total a minimum 4-log reduction of 

Salmonella bacteria in almonds. 

Validation data prepared by a Boardapproved process authority must be 

submitted to and accepted by the TERP 

for each piece of equipment used to 

treat almonds prior to its use under the 

program. 

* * * * * 

Dated: June 12, 2009. 

Craig Morris, 

Acting Associate Administrator. 

[FR Doc. E9–14281 Filed 6–17–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2009–N–0665] 

Oral Dosage Form New Animal Drugs; 

Toceranib 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect the 

original approval of a new animal drug 

application (NADA) filed by Pharmacia 

& Upjohn Co., a Division of Pfizer, Inc. 

The NADA provides for the veterinary 

prescription use of toceranib phosphate 

tablets in dogs for treatment of 

recurrent, cutaneous mast cell tumors. 

DATES: This rule is effective June 18, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8337, 

email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pharmacia 

& Upjohn Co., a Division of Pfizer, Inc., 

235 East 42d St., New York, NY 10017, 

filed NADA 141–295 that provides for 

veterinary prescription use of 

PALLADIA (toceranib phosphate) 

Tablets in dogs for the treatment of 

Patnaik grade II or III, recurrent, 

cutaneous mast cell tumors with or 

without regional lymph node 

involvement. The NADA is approved as 

of May 22, 2009, and the regulations are 

amended in 21 CFR part 520 to reflect 

the approval. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 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 Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

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.