68252 Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Rules and Regulations 

the AD Docket. You may get a copy of 

this summary by sending a request to us 

at the address listed under ADDRESSES. 

Include ‘‘AD Docket No. 2003–NE–51–

AD’’ in your request.

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Safety.

Adoption of the Amendment

■ Accordingly, under the authority 

delegated to me by the Administrator, 

the Federal Aviation Administration 

amends 14 CFR part 39 as follows:

PART 39—AIRWORTHINESS 

DIRECTIVES

■ 1. The authority citation for part 39 

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive:

2004–24–05 Rolls-Royce Deutschland Ltd. 

& Co KG (formerly Rolls-Royce plc):

Amendment 39–13881. Docket No. 

2003–NE–51–AD. 

Effective Date 

(a) This airworthiness directive (AD) 

becomes effective December 29, 2004. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to Rolls-Royce 

Deutschland Ltd. & Co KG (RRD) (formerly 

Rolls-Royce plc), models Spey 555–15, 555–

15H, 555–15N, and 555–15P turbojet engines, 

with magnesium split low pressure (LP) 

compressor case, part number (P/N) 

EU.73418A installed. These engines are 

installed on, but not limited to, Fokker F.28 

Mark 1000, Mark 2000, Mark 3000, and Mark 

4000 series airplanes. 

Unsafe Condition 

(d) This AD is prompted by several reports 

of bird ingestion and LP compressor stage 1 

rotor blade failures that have resulted in 

penetration of the magnesium split LP 

compressor case and damage to the airplane. 

We are issuing this AD to prevent possible 

uncontained LP compressor stage 1 rotor 

blade failures that could result in damage to 

the airplane. 

Compliance 

(e) You are responsible for having the 

actions required by this AD performed within 

60 months after the effective date of this AD, 

unless the actions have already been done. 

Replacement of Magnesium Split LP 

Compressor Case With a Serviceable 

Compressor Case 

(f) Remove the magnesium split LP 

compressor case, P/N EU.73418A, from the 

engine and install a serviceable LP 

compressor case. Information on removing 

and replacing this P/N case can be found in 

RRD Service Bulletin No. Sp72–893, Revision 

3, dated August 25, 2003. 

Alternative Methods of Compliance 

(g) The Manager, Engine Certification 

Office, has the authority to approve 

alternative methods of compliance for this 

AD if requested using the procedures found 

in 14 CFR 39.19. 

Material Incorporated by Reference 

(h) None. 

Related Information 

(i) LBA airworthiness directive 2003–261, 

dated August 25, 2003, also addresses the 

subject of this AD.

Issued in Burlington, Massachusetts, on 

November 15, 2004. 

Jay J. Pardee, 

Manager, Engine and Propeller Directorate, 

Aircraft Certification Service.

[FR Doc. 04–25790 Filed 11–23–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage 

Form New Animal Drugs; Estradiol 

Benzoate and Testosterone Propionate

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 supplemental new animal 

drug applications (NADAs) filed by Fort 

Dodge Animal Health, Division of 

Wyeth, and Ivy Laboratories, Division of 

Ivy Animal Health, Inc. The 

supplemental NADAs provide for the 

addition of statements to labeling of 

subcutaneous implants containing 

estradiol benzoate and testosterone 

propionate warning against the use of 

these products in calves to be processed 

for veal.

DATES: This rule is effective November 

24, 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: Fort 

Dodge Animal Health, Division of 

Wyeth, 800 Fifth St. NW., Fort Dodge, 

IA 50501, filed a supplement to NADA 

011–427 for SYNOVEX H (estradiol 

benzoate and testosterone propionate). 

Ivy Laboratories, Division of Ivy Animal 

Health, Inc., 8857 Bond St., Overland 

Park, KS 66214, filed a supplement to 

NADA 135–906 for COMPONENT E–H 

(estradiol benzoate and testosterone 

propionate) and COMPONENT E–H 

with TYLAN (estradiol benzoate and 

testosterone propionate with tylosin 

tartrate). The supplemental NADAs 

provide for the addition of statements to 

labeling warning against the use of these 

products in calves to be processed for 

veal. The supplemental applications are 

approved as of October 18, 2004, and 

the regulations are amended in 21 CFR 

522.842 to reflect the approvals and a 

current format. The basis of approval is 

discussed in the freedom of information 

summaries.

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), 

summaries of safety and effectiveness 

data and information submitted to 

support approval of these applications 

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 these actions are of 

a type that do 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 522.842 is revised to read as 

follows:

Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Rules and Regulations 68253

§ 522.842 Estradiol benzoate and 

testosterone propionate.

(a) Sponsors. See sponsors in 

§ 510.600(c) of this chapter for use as in 

paragraph (c) of this section.

(1) No. 000856 for use as in paragraph 

(c)(1)(i), (c)(2), and (c)(3) of this section.

(2) No. 021641 for use as in paragraph 

(c) of this section.

(b) Related tolerances. See §§ 556.240 

and 556.710 of this chapter.

(c) Conditions of use. For 

implantation in heifers as follows:

(1) Amount. (i) 20 milligrams (mg) 

estradiol benzoate and 200 mg 

testosterone propionate (one implant 

consisting of 8 pellets, each pellet 

containing 2.5 mg estradiol benzoate 

and 25 mg testosterone propionate) per 

implant dose.

(ii) 20 mg estradiol benzoate and 200 

mg testosterone propionate (one implant 

consisting of 9 pellets, each of 8 pellets 

containing 2.5 mg estradiol benzoate 

and 25 mg testosterone propionate, and 

1 pellet containing 29 mg tylosin 

tartrate) per implant dose.

(2) Indications for use. For increased 

rate of weight gain and improved feed 

efficiency.

(3) Limitations. For heifers weighing 

400 pounds or more; for subcutaneous 

ear implantation, one dose per animal; 

not for use in 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 5, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine.

[FR Doc. 04–25977 Filed 11–23–04; 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; Trenbolone 

Acetate and 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 two supplemental new 

animal drug applications (NADAs) filed 

by Intervet Inc.; three supplemental 

abbreviated new animal drug 

applications (ANADAs) filed by Ivy 

Laboratories, Division of Ivy Animal 

Health, Inc.; and a supplemental 

ANADA filed by Fort Dodge Animal 

Health, Division of Wyeth. The 

supplemental NADAs and ANADAs 

provide for the addition of statements to 

labeling of subcutaneous implants 

containing trenbolone acetate and 

estradiol warning against the use of 

these products in calves to be processed 

for veal.

DATES: This rule is effective November 

24, 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: Intervet 

Inc., 29160 Intervet Lane, P.O. Box 318, 

Millsboro, DE 19966, filed supplements 

to NADA 140–897 and NADA 140–992 

for REVALOR (trenbolone acetate and 

estradiol) implants. Ivy Laboratories, 

Division of Ivy Animal Health, Inc., 

8857 Bond St., Overland Park, KS 

66214, filed supplements to ANADA 

200–221 and ANADA 200–346 for 

COMPONENT (trenbolone acetate and 

estradiol) and COMPONENT plus 

TYLAN (trenbolone acetate and 

estradiol with tylosin tartrate) implants. 

Fort Dodge Animal Health, Division of 

Wyeth, 800 Fifth St. NW., Fort Dodge, 

IA 50501, filed a supplement to ANADA 

200–367 for SYNOVEX (trenbolone 

acetate and estradiol) implants. The 

supplemental NADAs and ANADAs 

provide for the addition of statements to 

labeling warning against the use of these 

products in calves to be processed for 

veal. The supplemental applications are 

approved as of October 28, 2004, and 

the regulations are amended in 21 CFR 

522.2477 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), 

summaries of safety and effectiveness 

data and information submitted to 

support approval of these applications 

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 these actions are of 

a type that do 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 522.2477 is amended by 

revising paragraphs (d)(1)(iii), (d)(2)(iii), 

and (d)(3)(iii) to read as follows:

§ 522.2477 Trenbolone acetate and 

estradiol.

* * * * *

(d) * * *

(1) * * *

(iii) Limitations. Implant 

subcutaneously in ear only. Do not use 

in animals intended for subsequent 

breeding or in dairy animals. 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. Do not use 

in animals intended for subsequent 

breeding or in dairy animals. 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.

(3) * * *

(iii) Limitations. Implant 

subcutaneously in ear only. Do not use 

in animals intended for subsequent 

breeding or in dairy animals. 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. 04–25978 Filed 11–23–04; 8:45 am]

BILLING CODE 4160–01–S