Federal Register / Vol. 69, No. 224 / Monday, November 22, 2004 / Rules and Regulations 67817

the business hours defined in § 40.1 of 

this chapter) that the Commission is in 

receipt of the application. Unless the 

Commission notifies the applicant 

during the 90-day period that the 

expedited review has been terminated 

pursuant to § 38.3(b), the Commission 

will designate the applicant as a 

contract market during the 90-day 

period. If deemed appropriate by the 

Commission, the designation may be 

subject to such conditions as the 

Commission may stipulate. 

(i) The applicant must demonstrate 

compliance with the criteria for 

designation of section 5(b) of the Act, 

the core principles for operation of 

section 5(d) of the Act and the 

provisions of this part 38; 

(ii) The application must include the 

items described in § 38.3(a)(1)(ii) and 

(iii); and 

(iii) The applicant must not amend or 

supplement the application, except as 

requested by the Commission or for 

correction of typographical errors, 

renumbering or other nonsubstantive 

revisions, during the 90-day review 

period. 

(b) Termination of 90-day review. (1) 

During the 90-day period for review 

pursuant to paragraph (a)(2) of this 

section, the Commission shall notify the 

applicant seeking designation that the 

Commission is terminating review 

under this section, and will review the 

application under the 180-day time 

period and procedures of section 6(a) of 

the Act, if it appears to the Commission 

that the application: 

(i) Is materially incomplete; 

(ii) Fails in form or substance to meet 

the requirements of this part; 

(iii) Raises novel or complex issues 

that require additional time for review; 

or 

(iv) Is amended or supplemented in a 

manner that is inconsistent with 

§ 38.3(a)(2)(iii). 

(2) The Commission shall also 

terminate review under this section if 

requested in writing to do so by the 

applicant. 

(3) The termination notification shall 

identify the deficiencies in the 

application that render it incomplete, 

the manner in which the application 

fails to meet the requirements of this 

part, the novel or complex issues that 

require additional time for review, or 

the amendment or supplement that is 

inconsistent with § 38.3(a)(2)(iii). 

(c) Reinstatement of dormant 

designation. Before listing or relisting 

products for trading, a dormant 

designated contract market as defined in 

§ 40.1 of this chapter must reinstate its 

designation under the procedures of 

paragraph (a)(1) or (a)(2) of this section; 

provided, however, that an application 

for reinstatement may rely upon 

previously submitted materials that still 

pertain to, and accurately describe, 

current conditions. 

(d) Delegation of authority. (1) The 

Commission hereby delegates, until it 

orders otherwise, to the Director of the 

Division of Market Oversight or such 

other employee or employees as the 

Director may designate from time to 

time, with the concurrence of the 

General Counsel or the General 

Counsel’s delegate, authority to notify 

the applicant seeking designation under 

section 6(a) of the Act that the 

application is materially incomplete and 

the running of the 180-day period is 

stayed or that the 90-day review under 

paragraph (a)(2) of this section is 

terminated. 

(2) The Director may submit to the 

Commission for its consideration any 

matter that has been delegated in this 

paragraph. 

(3) Nothing in this paragraph 

prohibits the Commission, at its 

election, from exercising the authority 

delegated in paragraph (d)(1) of this 

section. 

(e) Request for withdrawal of 

application for designation. An 

applicant for designation may withdraw 

its application submitted pursuant to 

paragraph (a)(1) or (a)(2) of this section 

by filing such a request with the 

Commission at its Washington, DC, 

headquarters. Withdrawal of an 

application for designation shall not 

affect any action taken or to be taken by 

the Commission based upon actions, 

activities or events occurring during the 

time that the application for designation 

was pending with the Commission. 

(f) Request for vacation of 

designation. A designated contract 

market may vacate its designation under 

section 7 of the Act by filing such a 

request with the Commission at its 

Washington, DC, headquarters. Vacation 

of designation shall not affect any action 

taken or to be taken by the Commission 

based upon actions, activities or events 

occurring during the time that the 

facility was designated by the 

Commission. 

(g) Guidance for applicants.

Appendix A to this part provides 

guidance on how the criteria for 

designation under section 5(b) of the 

Act can be satisfied. Appendix B to this 

part provides guidance on how the core 

principles of section 5(d) of the Act can 

be satisfied.

Issued in Washington, DC, on November 

12, 2004, by the Commission. 

Jean A. Webb, 

Secretary of the Commission.

[FR Doc. 04–25614 Filed 11–19–04; 8:45 am] 

BILLING CODE 6351–01–P

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 Benzoate

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 Fort 

Dodge Animal Health, Division of 

Wyeth. The supplemental NADA 

provides for the addition of statements 

to labeling of subcutaneous implants 

containing trenbolone acetate and 

estradiol benzoate 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: Fort 

Dodge Animal Health, Division of 

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

IA 50501, filed a supplement to NADA 

141–043 for SYNOVEX PLUS 

(trenbolone acetate and estradiol 

benzoate) and SYNOVEX CHOICE 

(trenbolone acetate and estradiol 

benzoate), two subcutaneous implants 

products used in steers and heifers fed 

in confinement for slaughter for 

increased rate of weight gain and/or 

improved feed efficiency. 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 

522.2478 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 

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.