54018 Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2010–N–0002] 

Oral Dosage Form New Animal Drugs; 

Praziquantel and Pyrantel 

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 Bayer 

HealthCare LLC. The supplement 

provides for two new sizes of 

praziquantel and pyrantel pamoate 

tablets used in cats and kittens for the 

removal of various internal parasites 

and for a revised kitten age and weight 

restriction. 

DATES: This rule is effective September 

3, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8337, 

email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Bayer 

HealthCare LLC, Animal Health 

Division, P.O. Box 390, Shawnee 

Mission, KS 66201, filed a supplement 

to NADA 141–008 for DRONTAL 

(praziquantel and pyrantel pamoate) 

Tablets used in cats and kittens for the 

removal of various internal parasites. 

The supplement provides for two new 

tablet sizes and for a revised kitten age 

and weight restriction. The 

supplemental NADA is approved as of 

June 15, 2010, and 21 CFR 520.1871 is 

amended to reflect the approval. 

FDA has determined under 21 CFR 

25.33 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 520 

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 520 is 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. In § 520.1871, in paragraph (b)(1), 

remove ‘‘tablet’’ and in its place add 

‘‘tablets’’; and revise paragraphs (a)(1), 

(d)(1)(i), and (d)(1)(iii) to read as 

follows: 

§ 520.1871 Praziquantel and pyrantel. 

(a) * * * 

(1) Each tablet contains 13.6 

milligrams (mg) praziquantel and 54.3 

mg pyrantel base (as pyrantel pamoate), 

18.2 mg praziquantel and 72.6 mg 

pyrantel base (as pyrantel pamoate), or 

27.2 mg praziquantel and 108.6 mg 

pyrantel base (as pyrantel pamoate). 

* * * * * 

(d) * * * 

(1) * * * 

(i) Dosage. Administer a minimum 

dose of 2.27 mg praziquantel and 9.2 mg 

pyrantel pamoate per pound of body 

weight according to the dosing tables on 

labeling. May be given directly by 

mouth or in a small amount of food. Do 

not withhold food prior to or after 

treatment. If reinfection occurs, 

treatment may be repeated. 

* * * * * 

(iii) Limitations. Not for use in kittens 

less than 2 months of age or weighing 

less than 2.0 pounds. Consult your 

veterinarian before giving to sick or 

pregnant animals. 

* * * * * 

Dated: August 31, 2010. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–22043 Filed 9–2–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2010–N–0002] 

Implantation or Injectable Dosage 

Form New Animal Drugs; Florfenicol 

and 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 

Intervet, Inc. The supplemental NADA 

adds Mycoplasma bovis to the bovine 

respiratory disease (BRD) pathogens for 

which use of an injectable solution 

containing florfenicol and flunixin 

meglumine is an approved treatment. 

DATES: This rule is effective September 

3, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Cindy L. Burnsteel, Center for 

Veterinary Medicine (HFV–130), Food 

and Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 240–276– 

8341, e-mail: 

cindy.burnsteel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Intervet, 

Inc., 56 Livingston Ave., Roseland, NJ 

07068, filed a supplement to NADA 

141–299 that provides for use of 

RESFLOR GOLD (florfenicol and 

flunixin meglumine), a combination 

drug injectable solution. The 

supplement adds M. bovis to the BRD 

pathogens for which the use of this 

product is approved. The supplemental 

NADA is approved as of June 7, 2010, 

and the regulations in 21 CFR 522.956 

are amended to reflect the approval. 

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 

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

supplemental approval qualifies for 3 

years of marketing exclusivity beginning 

on the date of approval. 

The agency has determined under 21 

CFR 25.33 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. 


erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Rules and Regulations 54019 

■ 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. In § 522.956, revise paragraph (d)(2) 

to read as follows: 

§ 522.956 Florfenicol and flunixin. 

* * * * * 

(d) * * * 

(2) Indications for use. For treatment 

of bovine respiratory disease (BRD) 

associated with Mannheimia 

haemolytica, Pasteurella multocida, 

Histophilus somni, and Mycoplasma 

bovis, and control of BRD-associated 

pyrexia in beef and non-lactating dairy 

cattle. 

* * * * * 

Dated: August 31, 2010. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–22039 Filed 9–2–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2010–N–0002] 

New Animal Drugs for Use in Animal 

Feed; Ractopamine 

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 Elanco Animal Health, A Division of 

Eli Lilly & Co. The supplemental 

NADAs provide for administering a 

Type C medicated feed containing 

ractopamine hydrochloride as a top 

dress on Type C medicated feeds 

containing monensin, USP, or 

monensin, USP, and tylosin phosphate 

to cattle fed in confinement for 

slaughter. 

DATES: This rule is effective September 

3, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Suzanne J. Sechen, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8105, email: suzanne.sechen@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 141–225 that 

provides for use of OPTAFLEXX 

(ractopamine hydrochloride) and 

RUMENSIN (monensin, USP) Type A 

medicated articles to formulate two-way 

combination drug Type C medicated 

feeds for cattle fed in confinement for 

slaughter. Elanco Animal Health also 

filed a supplement to NADA 141–224 

that provides for use of OPTAFLEXX 

(ractopamine hydrochloride), 

RUMENSIN (monensin, USP), and 

TYLAN (tylosin phosphate) Type A 

medicated articles to formulate threeway combination drug Type C 

medicated feeds for cattle fed in 

confinement for slaughter. 

The supplemental NADAs provide for 

administering ractopamine 

hydrochloride Type C medicated feeds 

as a top dress on Type C medicated 

feeds containing monensin, USP, or 

monensin, USP, and tylosin phosphate 

to cattle fed in confinement for 

slaughter as the means by which the 

two-way or three-way combinations will 

be created. Supplemental NADA 141– 

224 is approved as of June 7, 2010; 

supplemental NADA 141–225 is 

approved as of June 17, 2010; and the 

regulations in 21 CFR 558.500 are 

amended to reflect the approvals. 

In accordance with the freedom of 

information provisions of 21 CFR part 

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

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 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 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 § 558.500, add paragraphs 

(e)(2)(xii) and (e)(2)(xiii) to read as 

follows: 

§ 558.500 Ractopamine. 

* * * * * 

(e) * * * 

(2) * * * 

Ractopamine in 

grams/ton 

Combination in 

grams/ton Indications for use Limitations Sponsor 

*******

(xii) Not to exceed 800; to 

provide 70 to 400 mg/ 

head/day.

Monensin 10 to 40 to 

provide 0.14 to 0.42 

mg monensin/lb of 

body weight, depending on severity of 

coccidiosis challenge, 

up to 480 mg/head/ 

day. 

Cattle fed in confinement for 

slaughter: As in paragraph 

(e)(2)(i) of this section; for prevention and control of coccidiosis 

due to Eimeria bovis and E. 

zuernii. 

Top dress ractopamine in a minimum of 1.0 lb of medicated feed 

during the last 28 to 42 days on 

feed. Not for animals intended for 

breeding. See § 558.355(d). 

000986 


erowe on DSK5CLS3C1PROD with RULES