Federal Register / Vol. 72, No. 40 / Thursday, March 1, 2007 / Rules and Regulations 9243 

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. 

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

Federal Food, Drug, and Cosmetic Act 

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

original approval of NADA 141–262 

qualifies for 5 years of marketing 

exclusivity beginning January 29, 2007. 

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

act, this original approval of NADA 

141–263 qualifies for 3 years of 

marketing exclusivity beginning January 

29, 2007. 

The agency has determined under 21 

CFR 25.33(d)(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 Parts 520 and 

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 parts 520 and 522 are amended as 

follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

■ 2. Section 520.1315 is added to read 

as follows: 

§ 520.1315 Maropitant. 

(a) Specifications. Each tablet 

contains 16, 24, 60, or 160 milligrams 

(mg) maropitant as maropitant citrate. 

(b) Sponsor. See No. 000069 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Indications for use and amount. For the 

prevention of acute vomiting, 

administer a minimum of 2.0 mg per 

kilogram (/kg) body weight once daily 

for up to 5 consecutive days. For the 

prevention of vomiting due to motion 

sickness, administer a minimum of 8.0 

mg/kg body weight once daily for up to 

2 consecutive days. 

(2) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 4. Section 522.1315 is added to read 

as follows: 

§ 522.1315 Maropitant. 

(a) Specifications. Each milliliter of 

solution contains 10 milligrams (mg) 

maropitant as maropitant citrate. 

(b) Sponsor. See No. 000069 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount. Administer 1.0 mg per 

kilogram body weight by subcutaneous 

injection once daily for up to 5 

consecutive days. 

(2) Indications for use. For the 

prevention and treatment of acute 

vomiting. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

Dated: February 16, 2007. 

Stephen F. Sundlof, 

Director, Center for Veterinary Medicine. 

[FR Doc. E7–3402 Filed 2–28–07; 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 

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 a supplemental abbreviated 

new animal drug application (ANADA) 

filed by Ivy Laboratories, Division of Ivy 

Animal Health, Inc. The supplemental 

ANADA provides for the addition of 

tylosin tartrate to an approved 

subcutaneous implant containing 

trenbolone and estradiol used for 

increased rate of weight gain and 

improved feed efficiency in steers and 

heifers fed in confinement for slaughter. 

DATES: This rule is effective March 1, 

2007. 

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: eric.dubbin@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Ivy 

Laboratories, Div. of Ivy Animal Health, 

Inc., 8857 Bond St., Overland Park, KS 

66214, filed a supplement to ANADA 

200–346 for COMPONENT TE–200 with 

TYLAN (trenbolone acetate and 

estradiol with tylosin tartrate), a 

subcutaneous implant used for 

increased rate of weight gain and 

improved feed efficiency in steers and 

heifers fed in confinement for slaughter. 

The supplemental ANADA provides for 

the addition of a pellet containing 29 

milligrams (mg) tylosin tartrate to the 

approved COMPONENT TE–200 

implant for steers and heifers fed in 

confinement for slaughter. The 

supplemental application is approved as 

of January 26, 2007, 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), 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 approval qualifies for 3 years of 

marketing exclusivity beginning January 

26, 2007. 

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. 


rwilkins on PROD1PC63 with RULES
9244 Federal Register / Vol. 72, No. 40 / Thursday, March 1, 2007 / Rules and Regulations 

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. In § 522.2477, add paragraph 

(d)(2)(i)(F) to read as follows: 

§ 522.2477 Trenbolone acetate and 

estradiol. 

* * * * * 

(d) * * * 

(2) * * * 

(i) * * * 

(F) 200 mg trenbolone acetate and 20 

mg estradiol (one implant consisting of 

11 pellets, each of 10 pellets containing 

20 mg trenbolone acetate and 2 mg 

estradiol, and 1 pellet containing 29 mg 

tylosin tartrate) per implant dose. 

* * * * * 

Dated: February 12, 2007. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E7–3620 Filed 2–28–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

New Animal Drugs For Use in Animal 

Feeds; Monensin 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

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 

Elanco Animal Health. The 

supplemental NADA provides for minor 

revisions to labeling of monensin Type 

A medicated articles for chickens. FDA 

is also amending the regulations to 

simplify the organization of special 

labeling requirements for formulations 

(Type A medicated articles, Type B and 

Type C medicated feeds) containing 

monensin for poultry and game birds. 

This action is being taken to improve 

the clarity of the regulations. 

DATES: This rule is effective March 1, 

2007. 

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.hhs.gov. 

SUPPLEMENTARY INFORMATION: Elanco 

Animal Health, A Division of Eli Lilly 

& Co., Lilly Corporate Center, 

Indianapolis, IN 46285, filed a 

supplement to NADA 38–878 that 

provides for use of COBAN 60 and 

COBAN 90 (monensin, USP) Type A 

medicated articles in feed of chickens. 

The supplement provides for minor 

revisions to labeling. The supplemental 

NADA is approved as of February 7, 

2007, and the regulations in 21 CFR 

558.355 are amended to reflect the 

approval. 

In addition, FDA is taking this 

opportunity to amend the regulations to 

simplify the organization of special 

labeling requirements for formulations 

(Type A medicated articles, Type B and 

Type C medicated feeds) containing 

monensin for poultry and game birds. 

Similar restructuring was done recently 

for monensin formulations used in 

ruminants (71 FR 66231, November 14, 

2006). This action is being taken to 

improve the clarity of the regulations. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

information. 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 558 

Animal drugs, Animal feeds. 

■ 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 558 is amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

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

■ 2. In § 558.355, revise paragraphs (a), 

(b)(1), (b)(4), (b)(6), (d)(4), (d)(5), and 

(d)(8); and add paragraphs (d)(9)(iv) 

through (d)(9)(vi), and (d)(10)(iv) 

through (d)(10)(vi) to read as follows: 

§ 558.355 Monensin. 

(a) Specifications. Type A medicated 

articles containing monensin, USP. 

(b) * * * 

(1) To No. 000986: 36.3 (for export 

only), 44, 45, 60, or 90.7 grams per 

pound for use as in paragraphs (f)(1)(i) 

and (f)(4) of this section. 

* * * * * 

(4) To No. 000986: 45, 60, or 90.7 

grams per pound for use as in paragraph 

(f)(2) of this section. 

* * * * * 

(6) To No. 000986: 45, 60, or 90.7 

grams per pound for use as in paragraph 

(f)(5) of this section. 

* * * * * 

(d) * * * 

(4) Liquid Type B feeds shall bear an 

expiration date of 8 weeks after its date 

of manufacture. 

(5) All Type A medicated articles 

containing monensin shall bear the 

following warning statement: When 

mixing and handling monensin Type A 

medicated articles, use protective 

clothing, impervious gloves, and a dust 

mask. Operators should wash 

thoroughly with soap and water after 

handling. If accidental eye contact 

occurs, immediately rinse thoroughly 

with water. 

* * * * * 

(8) Type A medicated articles 

containing monensin intended for use 

in chickens, turkeys, and quail shall 

bear the following statements: 

(i) Do not allow horses, other equines, 

mature turkeys, or guinea fowl access to 

feed containing monensin. Ingestion of 

monensin by horses and guinea fowl has 

been fatal. 

(ii) Must be thoroughly mixed in feeds 

before use. 

(iii) Do not feed undiluted. 

(iv) Do not feed to laying chickens. 

(v) Do not feed to chickens over 16 

weeks of age. 

(vi) For replacement chickens 

intended for use as cage layers only. 

(vii) Some strains of turkey coccidia 

may be monensin tolerant or resistant. 

Monensin may interfere with 

development of immunity to turkey 

coccidiosis. 


rwilkins on PROD1PC63 with RULES