70046 Federal Register / Vol. 70, No. 223 / Monday, November 21, 2005 / Rules and Regulations 

Unsafe Condition 

(d) This AD results from the discovery of 

a hole in the upper frame of the firewall for 

the auxiliary power unit (APU). We are 

issuing this AD to ensure that the APU 

compartment is isolated from the rest of the 

airplane in the event of an APU fire. If the 

APU compartment is not isolated, smoke 

could enter the passenger cabin in the event 

of an APU fire. 

Compliance 

(e) You are responsible for having the 

actions required by this AD performed within 

the compliance times specified, unless the 

actions have already been done. 

Modification 

(f) Within 2,500 flight hours or 365 days 

after the effective date of this AD, whichever 

occurs later, modify the APU firewall upper 

frame, part number 145–51249–001 or 120–

10731–001, in accordance with the 

Accomplishment Instructions of EMBRAER 

Service Bulletin 145LEG–53–0020, Revision 

01, dated September 21, 2005 (for Model 

EMB–135BJ airplanes); or EMBRAER Service 

Bulletin 145–53–0057, Revision 01, dated 

September 20, 2005 (for Model EMB–135ER, 

–135KE, –135KL, and –135LR airplanes; and 

Model EMB–145, –145ER, –145MR, –145LR, 

–145XR, –145MP, and –145EP airplanes); as 

applicable. 

Modifications Accomplished According to 

Previous Issue of Service Bulletins 

(g) Modifications accomplished before the 

effective date of this AD according to 

EMBRAER Service Bulletin 145LEG–53–

0020, dated November 30, 2004; and 

EMBRAER Service Bulletin 145–53–0057, 

dated November 30, 2004; are considered 

acceptable for compliance with the 

corresponding action specified in this AD. 

Alternative Methods of Compliance 

(AMOCs) 

(h)(1) The Manager, International Branch, 

ANM–116, Transport Airplane Directorate, 

FAA, has the authority to approve AMOCs 

for this AD, if requested in accordance with 

the procedures found in 14 CFR 39.19. 

(2) Before using any AMOC approved in 

accordance with § 39.19 on any airplane to 

which the AMOC applies, notify the 

appropriate principal inspector in the FAA 

Flight Standards Certificate Holding District 

Office. 

Related Information 

(i) Brazilian airworthiness directive 2005–

04–03, dated April 30, 2005, also addresses 

the subject of this AD. 

Material Incorporated by Reference 

(j) You must use EMBRAER Service 

Bulletin 145LEG–53–0020, Revision 01, 

dated September 21, 2005; or EMBRAER 

Service Bulletin 145–53–0057, Revision 01, 

dated September 20, 2005; as applicable, to 

perform the actions that are required by this 

AD, unless the AD specifies otherwise. The 

Director of the Federal Register approved the 

incorporation by reference of these 

documents in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51. Contact Empresa 

Brasileira de Aeronautica S.A. (EMBRAER), 

P.O. Box 343—CEP 12.225, Sao Jose dos 

Campos–SP, Brazil, for a copy of this service 

information. You may review copies at the 

Docket Management Facility, U.S. 

Department of Transportation, 400 Seventh 

Street, SW., room PL–401, Nassif Building, 

Washington, DC; on the Internet at http:// 

dms.dot.gov; or at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at the NARA, call (202) 741–6030, 

or go to http://www.archives.gov/ 

federal_register/code_of_federal_regulations/ 

ibr_locations.html. 

Issued in Renton, Washington, on 

November 9, 2005. 

Kalene C. Yanamura, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 05–22792 Filed 11–18–05; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 556 and 558 

New Animal Drugs; Florfenicol 

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 new animal drug 

application (NADA) filed by ScheringPlough Animal Health Corp. The NADA 

provides for the use of florfenicol by 

veterinary feed directive in catfish feed 

for the control of mortality due to 

enteric septicemia of catfish. 

DATES: This rule is effective November 

21, 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 

NADA 141–246 that provides for use of 

AQUAFLOR (florfenicol) Type A 

medicated article by veterinary feed 

directive to formulate Type C medicated 

feeds for the control of mortality due to 

enteric septicemia of catfish associated 

with Edwardsiella ictaluri. The NADA 

is approved as of October 24, 2005, and 

the regulations are amended in 21 CFR 

556.283 and in part 558 (21 CFR part 

558) by revising § 558.4 and by adding 

new § 558.261 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 573(c) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 360ccc-2), this approval 

qualifies for 7 years of exclusive 

marketing rights beginning October 24, 

2005, because the new animal drug has 

been declared a designated new animal 

drug by FDA under section 573(a) of the 

act. 

The agency has carefully considered 

the potential environmental impact of 

this action and has concluded that the 

action will not have a significant impact 

on the human environment and that an 

environmental impact statement is not 

required. FDA’s finding of no significant 

impact and the evidence supporting that 

finding, contained in an environmental 

assessment, may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

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 556 

Animal drugs, Foods. 

21 CFR Part 558 

Animal drugs, Animal feeds. 

■ 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 556 and 558 are amended as 

follows: 

PART 556—TOLERANCES FOR 

RESIDUES OF NEW ANIMAL DRUGS 

IN FOOD 

■ 1. The authority citation for 21 CFR 

part 556 continues to read as follows: 

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

■ 2. Add paragraphs (b)(3) and (c) in 

§ 556.283 to read as follows: 

§ 556.283 Florfenicol. 

* * * * * 

Federal Register / Vol. 70, No. 223 / Monday, November 21, 2005 / Rules and Regulations 70047 

(b) * * * 

(3) Catfish. The tolerance for 

florfenicol amine (the marker residue) in 

muscle (the target tissue) is 1 ppm. 

(c) Related conditions of use. See 

§§ 520.955, 522.955, and 558.261 of this 

chapter. 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 3. The authority citation for 21 CFR 

part 558 continues to read as follows: 

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

■ 4. In paragraph (d) of § 558.4, in the 

‘‘Category II’’ table, add an entry in 

alphabetical order for ‘‘Florfenicol’’ to 

read as follows: 

§ 558.4 Requirement of a medicated feed 

mill license. 

* * * * * 

(d) * * * 

CATEGORY II 

Drug Assay limits percent 1 Type A Type B maximum (100x) Assay limits percent 1 Type B/C 2

* * * * * * * 

Florfenicol 90–110 n/a 80–110 

* * * * * * * 

1Percent of labeled amount. 

2Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a 

Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for 

the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed. 

* * * * * 

■ 5. Add § 558.261 to read as follows: 

§ 558.261 Florfenicol. 

(a) Specifications. Type A medicated 

article containing 500 grams florfenicol 

per kilogram. 

(b) Sponsor. See No. 000061 in 

§ 510.600(c) of this chapter. 

(c) Special considerations—(1) 

Federal law limits this drug to use 

under the professional supervision of a 

licensed veterinarian. See § 558.6 of this 

chapter for additional requirements. 

(2) The expiration date of veterinary 

feed directives (VFDs) for florfenicol 

must not exceed 15 days from the date 

of issuance. VFDs for florfenicol shall 

not be refilled. 

(d) Related tolerances. See § 556.283 

of this chapter. 

(e) Conditions of use—(1) Catfish—(i) 

Amount. 10 milligrams per kilogram of 

fish daily for 10 consecutive days. 

(ii) Indications for use. For the control 

of mortality due to enteric septicemia of 

catfish associated with Edwardsiella 

ictaluri. 

(iii) Limitations. Feed containing 

florfenicol shall not be fed to catfish for 

more than 10 days. Following 10 days 

administration, fish should be reevaluated by a licensed veterinarian 

before reinitiating a further course of 

therapy. A dose-related decrease in 

hematopoietic/lymphopoietic tissue 

may occur. The time required for the 

hematopoietic/lymphopoietic tissues to 

regenerate was not evaluated. The 

effects of florfenicol on reproductive 

performance have not been determined. 

Feeds containing florfenicol must be 

withdrawn 12 days prior to slaughter. 

(2) [Reserved] 

Dated: November 8, 2005. 

Andrew J. Beaulieu, 

Acting Director, Center for Veterinary 

Medicine. 

[FR Doc. 05–22935 Filed 11–18–05; 8:45 am] 

BILLING CODE 4160–01–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[R04–OAR–2005–KY–0001–200521(c); FRL–

7999–5] 

Approval and Promulgation of 

Implementation Plans and Designation 

of Areas for Air Quality Planning 

Purposes; Kentucky; Redesignation of 

the Christian County, Kentucky Portion 

of the Clarksville-Hopkinsville 8-Hour 

Ozone Nonattainment Area to 

Attainment for Ozone; Correction 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; correction. 

SUMMARY: On October 21, 2005, at 70 FR 

61232, EPA published a withdrawal 

action of a direct final rule approving 

the redesignation of the Christian 

County, Kentucky portion of the 

Clarksville-Hopkinsville 8-hour ozone 

nonattainment area to attainment for 

ozone. This document corrects a Code of 

Federal Regulations (CFR) reference 

contained in the withdrawal action. 

DATES: This correction is effective 

November 21, 2005. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Sean Lakeman, Regulatory Development 

Section, Air Planning Branch, Air, 

Pesticides and Toxics Management 

Division, U.S. Environmental Protection 

Agency Region 4, 61 Forsyth Street, 

SW., Atlanta, Georgia 30303–8960. The 

telephone number is (404) 562–9043. 

Mr. Lakeman can also be reached via 

electronic mail at 

lakeman.sean@epa.gov. 

SUPPLEMENTARY INFORMATION: EPA is 

making a correction to the document 

published October 21, 2005 (70 FR 

61232), which withdrew the direct final 

rule published September 22, 2005, (70 

FR 55550) approving the redesignation 

of the Christian County, Kentucky 

portion of the Clarksville-Hopkinsville 

8-hour ozone nonattainment area to 

attainment for ozone. EPA is correcting 

the citation to the CFR contained in the 

October 21, 2005, withdrawal action to 

exclude an erroneous reference to 40 

CFR 52.919. The last paragraph after the 

signature block on page 61232 should 

read as follows: ‘‘Accordingly, the 

amendment to 40 CFR 52.920 and 40 

CFR 81.318 (which published in the 

Federal Register on September 22, 2005, 

at 70 FR 55550) is withdrawn as of 

October 21, 2005.’’

Dated: November 15, 2005. 

J.I. Palmer Jr., 

Regional Administrator, Region 4. 

[FR Doc. 05–23086 Filed 11–18–05; 8:45 am] 

BILLING CODE 6560–50–P