70998 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations 

revised labeling for the veterinary 

prescription use of injectable boldenone 

solution in horses. 

DATES: This rule is effective November 

25, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7543, email: melanie.berson@fda.gov. 

SUPPLEMENTARY INFORMATION: Fort 

Dodge Animal Health, A Division of 

Wyeth Holdings Corp., P.O. Box 1339, 

Fort Dodge, IA 50501, filed a 

supplement to NADA 34–705 that 

provides for veterinary prescription use 

of EQUIPOISE (boldenone 

undecylenate) by injection in horses. 

The supplemental NADA provides for a 

revised indication and food safety 

warning on labeling. The supplemental 

NADA is approved as of October 7, 

2005, and the regulations are amended 

in 21 CFR 522.204 to reflect the 

approval and a current format. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data. Therefore, a 

freedom of information summary is not 

required. 

FDA 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 522.204 is revised to read 

as follows: 

§ 522.204 Boldenone. 

(a) Specifications. Each milliliter of 

solution contains 25 or 50 milligrams 

(mg) boldenone undecylenate. 

(b) Sponsor. See No. 053501 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in horses—(1) 

Amount. 0.5 mg per pound body weight 

by intramuscular injection. Treatment 

may be repeated at 3-week intervals. 

(2) Indications for use. As an aid for 

treating debilitated horses when an 

improvement in weight, hair coat, or 

general physical condition is desired. 

(3) Limitations. Do not administer to 

horses intended for human 

consumption. Federal law restricts this 

drug to use by or on the order of a 

licensed veterinarian. 

Dated: November 15, 2005. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 05–23295 Filed 11–23–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 522 and 556 

New Animal Drugs; Flunixin 

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 

Schering-Plough Animal Health Corp. 

The supplemental NADA provides for 

the veterinary prescription use of 

flunixin meglumine solution by 

intramuscular injection for the control 

of pyrexia associated with swine 

respiratory disease. 

DATES: This rule is effective November 

25, 2005. 

FOR FURTHER INFORMATION CONTACT: Joan 

C. Gotthardt, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.gov. 

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095 

Morris Ave., Union, NJ 07083, filed a 

supplement to NADA 101–479 that 

provides for the veterinary prescription 

use of BANAMINE-S (flunixin 

meglumine) Injectable Solution by 

intramuscular injection for the control 

of pyrexia associated with swine 

respiratory disease. The supplemental 

NADA is approved as of November 1, 

2005, and the regulations are amended 

in 21 CFR 522.970 and 556.286 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 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. 

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

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360b(c)(2)(F)(iii)), 

this supplemental approval qualifies for 

3 years of marketing exclusivity 

beginning November 1, 2005. 

FDA has determined under 

§ 25.33(d)(5) 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 

21 CFR Part 522 

Animal drugs. 

21 CFR Part 556 

Animal drugs, Foods. 

■ 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 parts 522 and 556 are 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 522.970 is amended by 

adding paragraph (e)(3) to read as 

follows: 

§ 522.970 Flunixin. 

* * * * * 

Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations 70999 

(e) * * * 

(3) Swine—(i) Amount. Administer 

2.2 mg/kg (1.0 mg/lb) of body weight as 

a single intramuscular injection. 

(ii) Indications for use. For the control 

of pyrexia associated with swine 

respiratory disease. 

(iii) Limitations. Swine must not be 

slaughtered for human consumption 

within 12 days of last treatment. 

PART 556—TOLERANCES FOR 

RESIDUES OF NEW ANIMAL DRUGS 

IN FOOD 

■ 3. The authority citation for 21 CFR 

part 556 continues to read as follows: 

Authority: 21 U.S.C. 342, 360b, 371. 

■ 4. Section 556.286 is amended by 

adding paragraph (b)(2) to read as 

follows: 

§ 556.286 Flunixin. 

* * * * * 

(b) * * * 

(2) Swine. The tolerance for flunixin 

free acid (the marker residue) is: 

(i) Liver (the target tissue). 30 ppb. 

(ii) Muscle. 25 ppb. 

* * * * * 

Dated: November 15, 2005. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 05–23294 Filed 11–23–05; 8:45 am] 

BILLING CODE 4160–01–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[R05–OAR–2005–IN–0007; FRL–7999–3] 

Approval and Promulgation of 

Implementation Plan; Indiana 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: The EPA is approving 

Indiana’s April 8, 2005, submittal which 

revises existing sulfur dioxide (SO2) 

emission limits for sources in Dearborn 

County, makes minor corrections 

removing obsolete rule language, and 

updates information for sources listed in 

the rule. These revisions will not result 

in an increase in SO2 emissions in 

Dearborn County because no emission 

limits were increased. 

DATES: This rule is effective on January 

24, 2006, unless EPA receives adverse 

written comments by December 27, 

2005. If EPA receives adverse 

comments, EPA will publish a timely 

withdrawal of the rule in the Federal 

Register and inform the public that the 

rule will not take effect. 

ADDRESSES: Submit comments, 

identified by Regional Material in 

EDocket (RME) ID No. R05–OAR–2005–

IN–0007, by one of the following 

methods: 

Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

Agency Web site: http:// 

docket.epa.gov/rmepub/. Regional RME, 

EPA’s electronic public docket and 

comments system, is EPA’s preferred 

method for receiving comments. Once 

in the system, select ‘‘quick search,’’

then key in the appropriate RME Docket 

identification number. Follow the online instructions for submitting 

comments. 

E-mail: mooney.john@epa.gov. 

Fax: (312) 886–5824. 

Mail: You may send written 

comments to: John M. Mooney, Chief, 

Criteria Pollutant Section, Air Programs 

Branch (AR–18J), U.S. Environmental 

Protection Agency, 77 West Jackson 

Boulevard, Chicago, Illinois 60604. 

Hand delivery: Deliver your 

comments to: John M. Mooney, Chief, 

Criteria Pollutant Section, Air Programs 

Branch, (AR–18J), U.S. Environmental 

Protection Agency, Region 5, 77 West 

Jackson Boulevard, 18th floor, Chicago, 

Illinois 60604. 

Such deliveries are only accepted 

during the Regional Office’s normal 

hours of operation. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 a.m. to 

4:30 p.m. excluding Federal holidays. 

Instructions: Direct your comments to 

RME ID No. R05–OAR–2005–IN–0007. 

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 RME, regulations.gov, 

or e-mail. The EPA RME Web site and 

the Federal regulations.gov Web site are 

‘‘anonymous access’’ systems, 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 RME or 

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 Section I of 

the SUPPLEMENTARY INFORMATION section 

of the related proposed rule which is 

published in the Proposed Rules section 

of this Federal Register. 

Docket: All documents in the 

electronic docket are listed in the RME 

index at http://docket.epa.gov/rmepub/. 

Although listed in the index, some 

information is not publicly available, 

i.e., CBI or other information whose 

disclosure is restricted by statute. 

Publicly available docket materials are 

available either electronically in RME or 

in hard copy at Environmental 

Protection Agency, Region 5, Air and 

Radiation Division, 77 West Jackson 

Boulevard, Chicago, Illinois 60604. We 

recommend that you telephone Charles 

Hatten, Environmental Engineer, at 

(312) 886–6031 before visiting the 

Region 5 office. This Facility is open 

from 8:30 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays. 

FOR FURTHER INFORMATION CONTACT: 

Charles Hatten, Environmental 

Engineer, Criteria Pollutant Section, Air 

Programs Branch (AR–18J), U.S. 

Environmental Protection Agency, 

Region 5, 77 West Jackson Boulevard, 

Chicago, Illinois 60604, (312) 886–6031, 

hatten.charles@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document whenever 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 

EPA. This supplementary information 

section is arranged as follows: 

I. General Information. 

A. Does This Action Apply to Me? 

B. How Can I Get Copies of This Document 

and Other Related Information? 

C. How and to Whom Do I Submit 

Comments? 

II. What Is EPA Approving? 

III. What Are the Changes From the Current 

Rule? 

IV. What Action Is EPA Taking Today? 

V. Statutory and Executive Order Reviews. 

I. General Information 

A. Does This Action Apply to Me? 

This action only applies to specific 

SO2 sources located in Dearborn 

County, Indiana.