67818 Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Rules and Regulations 

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. 

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 the 

congressional review requirements in 5 

U.S.C. 801–808.

List of Subjects in 21 CFR Part 522

Animal drugs.

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under the 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to the 

Center for Veterinary Medicine, 21 CFR 

part 522 is amended as follows:

PART 522–IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows:

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

■ 2. Section 522.2478 is amended by 

revising paragraphs (d)(1)(i)(C), 

(d)(1)(ii)(C), and (d)(2)(iii) to read as 

follows:

§ 522.2478 Trenbolone acetate and 

estradiol benzoate.

* * * * *

(d) * * *

(1) * * *

(i) * * *

(C) Limitations. Implant 

subcutaneously in ear only. Safety and 

effectiveness have not been established 

in veal calves. A withdrawal period has 

not been established for this product in 

preruminating calves. Do not use in 

calves to be processed for veal.

(ii) * * *

(C) Limitations. Implant 

subcutaneously in ear only. Safety and 

effectiveness have not been established 

in veal calves. A withdrawal period has 

not been established for this product in 

preruminating calves. Do not use in 

calves to be processed for veal.

(2) * * *

(iii) Limitations. Implant 

subcutaneously in ear only. Not for 

subsequent breeding dairy or beef 

replacement heifers. Safety and 

effectiveness have not been established 

in veal calves. A withdrawal period has 

not been established for this product in 

preruminating calves. Do not use in 

calves to be processed for veal.

Dated: November 10, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine.

[FR Doc. 04–25878 Filed 11–19–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage 

Form New Animal Drugs; Estradiol

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 a supplemental new animal 

drug application (NADA) filed by Ivy 

Laboratories, Division of Ivy Animal 

Health, Inc. The supplemental NADA 

provides for the addition of statements 

to labeling of subcutaneous implants 

containing estradiol warning against the 

use of these products in calves to be 

processed for veal.

DATES: This rule is effective November 

22, 2004.

FOR FURTHER INFORMATION CONTACT: Eric 

S. Dubbin, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0232, email: edubbin@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: Ivy 

Laboratories, Division of Ivy Animal 

Health, Inc., 8857 Bond St., Overland 

Park, KS 66214, filed a supplement to 

NADA 118–123 for ENCORE (estradiol) 

and COMPUDOSE (estradiol). The 

supplemental NADA provides for the 

addition of statements to labeling 

warning against the use of these 

products in calves to be processed for 

veal. The supplemental application is 

approved as of October 28, 2004, and 

the regulations are amended in 21 CFR 

522.840 to reflect the approval and a 

current format. 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 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. 

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 the 

congressional review requirements in 5 

U.S.C. 801–808.

List of Subjects in 21 CFR Part 522

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 522 is amended as follows:

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows:

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

■ 2. Section 522.840 is revised to read as 

follows:

§ 522.840 Estradiol.

(a) Specifications. Each silicone 

rubber implant contains 25.7 or 43.9 

milligrams (mg) estradiol and is coated 

with not less than 0.5 mg 

oxytetracycline powder.

(b) Sponsor. See No. 021641 in 

§ 510.600(c) of this chapter.

(c) Related tolerances. See § 556.240 

of this chapter.

(d) Conditions of use. For 

implantation in steers and heifers as 

follows:

(1) Amount. Insert one 25.7-mg 

implant every 200 days; insert one 43.9-

mg implant every 400 days.

(2) Indications for use. For increased 

rate of weight gain in suckling and 

pastured growing steers; for improved 

feed efficiency and increased rate of 

weight gain in confined steers and 

heifers. No additional effectiveness may 

be expected from reimplanting in less 

than 200 days for the 25.7-mg implant 

or 400 days for the 43.9-mg implant.

Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Rules and Regulations 67819

(3) Limitations. For subcutaneous ear 

implantation in steers and heifers only. 

Safety and effectiveness have not been 

established in veal calves. A withdrawal 

period has not been established for this 

product in preruminating calves. Do not 

use in calves to be processed for veal.

Dated: November 10, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine.

[FR Doc. 04–25877 Filed 11–19–04; 8:45 am]

BILLING CODE 4160–01–S

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[OR–04–002; FRL–7835–2] 

Approval and Promulgation of State 

Implementation Plans: Oregon

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: The EPA approves numerous 

revisions to the Oregon State 

Implementation Plan (SIP) in the State 

of Oregon Administrative Rules (OAR) 

relating to the inspection and 

maintenance (I/M) of motor vehicles. 

These revisions were submitted to EPA 

by the Director of the Oregon 

Department of Environmental Quality 

(ODEQ) on November 5, 1999, 

September 15, 2000, November 27, 

2000, January 10, 2003, and April 22, 

2004. 

The revisions were submitted in 

accordance with the requirements of 

section 110 of the Clean Air Act 

(hereinafter CAA or Act). 

EPA is also approving the renumbering of the Motor Vehicle section 

of the Oregon Administrative Rules. 

Two non-SIP related rules are also 

removed from the SIP in this action.

DATES: This direct final rule will be 

effective on January 21, 2005, without 

further notice, unless EPA receives 

comment by December 22, 2004. If 

comments are received, EPA will 

publish a timely withdrawal of the 

direct final rule in the Federal Register

informing the public that the rule will 

not take effect.

ADDRESSES: Submit your comments, 

identified by Docket ID No. OR–04–002, 

by one of the following methods: 

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• E-mail: R10aircom@epa.gov.

• Fax: (206)–553–0110. 

• Mail: Office of Air, Waste, and 

Toxics, Environmental Protection 

Agency, Mail code: OAWT–107, 1200 

Sixth Ave., Seattle, Washington 98101. 

• Hand Delivery: Environmental 

Protection Agency, Office of Air, Waste, 

and Toxics, OAWT–107, 9th Floor, 1200 

Sixth Ave., Seattle, Washington 98101. 

Such deliveries are only accepted 

during normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. OR–04–002. EPA’s policy 

is that all comments received will be 

included in the public docket without 

change, including any personal 

information provided, unless the 

comment includes information claimed 

to be Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. Do 

not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov, or email. The federal regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an e-mail 

comment directly to EPA without going 

through regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD-ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. For additional instructions on 

submitting comments, go to A. General 

Information of the SUPPLEMENTARY

INFORMATION section of this document. 

Docket: Publicly available docket 

materials are available in hard copy at 

the Office of Air, Waste, and Toxics, 

EPA Region 10, Mail code: OAQ–107, 

1200 Sixth Ave., Seattle, Washington 

98101; open from 8 a.m.—4:30 p.m. 

Monday through Friday, excluding legal 

holidays. The telephone number is (206) 

553–1463.

FOR FURTHER INFORMATION CONTACT:

Wayne Elson, Office of Air, Waste and 

Toxics, EPA Region 10, Mail code: 

OAWT–107, 1200 Sixth Avenue, Seattle 

WA 98101, telephone number: (206) 

553–1463, or e-mail address: 

elson.wayne@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information 

The information in this section is 

organized as follows:

A. What Should I Consider as I Prepare My 

Comments for EPA? 

B. What SIP Amendments Is EPA Approving? 

C. What Are I/M Programs? 

D. What Changes Have Been Made to 

Oregon’s I/M Program That EPA Is 

Approving? 

E. What Is the Enhanced Test Waiver and 

Why Is It Needed? 

F. What Is a Qualified Household for the 

Enhanced Test Waiver? 

G. Will This Waiver Affect Air Quality? 

H. What Is On-Board Diagnostic (OBD) 

Testing? 

I. What Is On-Site Vehicle Testing? 

J. What Is Clean-Screen Testing? 

K. What Is the Self-Service Test? 

L. Are Clean Screen Testing and Self-Service 

Testing Required Tests? 

M. Why Is EPA Taking No Action on Clean 

Screen Testing and the Self Service Test? 

N. How Will These Approvals Change 

Ongoing Air Quality Planning in 

Oregon?

A. What Should I Consider as I Prepare 

My Comments for EPA? 

1. Submitting Confidential Business 

Information (CBI). Do not submit this 

information to EPA through 

regulations.gov or e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD ROM that 

you mail to EPA, mark the outside of the 

disk or CD ROM as CBI and then 

identify electronically within the disk or 

CD ROM the specific information that is 

claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 Code of Federal Regulations (CFR) 

part 2. 

2. Tips for Preparing Your Comments.

When submitting comments, remember 

to: 

• Identify the rulemaking by docket 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

• Follow directions—The agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

CFR part or section number. 

• Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

• Describe any assumptions and 

provide any technical information and/

or data that you used. 

• If you estimate potential costs or 

burdens, explain how you arrived at