6018 Federal Register / Vol. 73, No. 22 / Friday, February 1, 2008 / Rules and Regulations 

Injectable Solution. The supplemental 

NADA provides for treatment of 

infectious bovine keratoconjunctivitis 

associated with Moraxella bovis and the 

addition of a pathogen, Mycoplasma 

hyopneumoniae, to the indication for 

use for treatment of swine respiratory 

disease. The application is approved as 

of December 28, 2007, and the 

regulations are amended in 21 CFR 

522.2630 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(a)(1) and (d)(5) 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. In § 522.2630, revise paragraphs 

(d)(1)(ii) and (d)(2)(ii) to read as follows: 

§ 522.2630 Tulathromycin. 

* * * * * 

(d) * * * 

(1) * * * 

(ii) Indications for use. For the 

treatment of bovine respiratory disease 

(BRD) associated with Mannheimia 

haemolytica, Pasteurella multocida, and 

Histophilus somni (Haemophilus 

somnus), and Mycoplasma bovis; for the 

control of respiratory disease in cattle at 

high risk of developing BRD associated 

with M. haemolytica, P. multocida, H. 

somni, and M. bovis; and for the 

treatment of infectious bovine 

keratoconjunctivitis (IBK) associated 

with Moraxella bovis. 

* * * * * 

(2) * * * 

(ii) Indications for use. For the 

treatment of swine respiratory disease 

(SRD) associated with Actinobacillus 

pleuropneumoniae, Pasteurella 

multocida, Bordetella bronchiseptica, 

Haemophilus parasuis, and 

Mycoplasma hyopneumoniae. 

* * * * * 

Dated: January 24, 2008. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E8–1906 Filed 1–31–08; 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 

Feed; Zilpaterol 

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 Intervet, 

Inc. The NADA provides for use of 

zilpaterol, monensin, and tylosin in 

three-way combination Type B and 

Type C medicated feeds for cattle fed in 

confinement for slaughter. 

DATES: This rule is effective February 1, 

2008. 

FOR FURTHER INFORMATION CONTACT: 

Gerald L. Rushin, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8103, email: gerald.rushin@cvm.fda.gov. 

SUPPLEMENTARY INFORMATION: Intervet, 

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

Millsboro, DE 19966, filed NADA 141–

276 that provides for use of ZILMAX 

(zilpaterol hydrochloride), and 

RUMENSIN (monensin), and TYLAN 

(tylosin phosphate) Type A medicated 

articles to make dry and liquid threeway combination Type B and Type C 

medicated feeds used for increased rate 

of weight gain, improved feed 

efficiency, and increased carcass 

leanness; for prevention and control of 

coccidiosis due to Eimeria bovis and E. 

zuernii; and for reduction of incidence 

of liver abscesses caused by 

Fusobacterium necrophorum and 

Arcanobacterium (Actinomyces) 

pyogenes in cattle fed in confinement 

for slaughter during the last 20 to 40 

days on feed. The NADA is approved as 

of January 10, 2008, and the regulations 

in 21 CFR 558.355, 558.625, and 

558.665 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. 

The agency has determined under 21 

CFR 25.33(a)(2) 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, add paragraph 

(f)(7)(iv) to read as follows: 

§ 558.355 Monensin. 

* * * * * 

(f) * * * 

(7) * * * 


pwalker on PROD1PC71 with PROPOSALS
Federal Register / Vol. 73, No. 22 / Friday, February 1, 2008 / Rules and Regulations 6019 

(iv) Zilpaterol alone or in combination 

as in § 558.665. 

■ 3. In § 558.625, add paragraph 

(f)(2)(ix) to read as follows: 

§ 558.625 Tylosin. 

* * * * * 

(f) * * * 

(2) * * * 

(ix) Zilpaterol alone or in combination 

as in § 558.665. 

■ 4. In § 558.665, revise paragraph (e) to 

read as follows: 

§ 558.665 Zilpaterol. 

* * * * * 

(e) Conditions of use in cattle. It is 

administered in feed as follows: 

Zilpaterol in 

grams/ton 

Combination in 

grams/ton Indications for use Limitations Sponsor 

(1) 6.8 to provide 

60 to 90 mg/ 

head/day 

Cattle fed in confinement for slaughter: For 

increased rate of weight gain, improved 

feed efficiency, and increased carcass 

leanness in cattle fed in confinement for 

slaughter during the last 20 to 40 days 

on feed. 

Feed continuously as the sole ration during 

the last 20 to 40 days on feed. Withdrawal period: 3 days. 

057926 

(2) [Reserved] 

(3) [Reserved] 

(4) 6.8 to provide 

60 to 90 mg/ 

head/day 

Monensin 10 to 

40, plus tylosin 

8 to 10 

Cattle fed in confinement for slaughter: As 

in paragraph (e)(1) of this section; for 

prevention and control of coccidiosis due 

to Eimeria bovis and E. zuernii; and for 

reduction of incidence of liver abscesses 

caused by Fusobacterium necrophorum 

and Arcanobacterium (Actinomyces) 

pyogenes. 

As in paragraph (e)(1) of this section; see 

§§ 558.355(d) and 558.625(c) of this 

chapter. Monensin and tylosin as provided by No. 000986 in § 510.600(c) of 

this chapter. 

057926 

Dated: January 24, 2008. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E8–1903 Filed 1–31–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE INTERIOR 

National Indian Gaming Commission 

25 CFR Parts 502, 522, 559 and 573 

RIN 3141–AA23 

Facility License Standards 

AGENCY: National Indian Gaming 

Commission (‘‘NIGC’’ or 

‘‘Commission’’). 

ACTION: Final rule. 

SUMMARY: The rule adds new sections 

and a new part to the Commission’s 

regulations that require tribes to adopt 

and enforce standards for facility 

licenses. These standards will help the 

Commission ensure that each place, 

facility or location where class II or 

class III gaming will occur is located on 

Indian lands eligible for gaming as 

required by the Indian Gaming 

Regulatory Act. The rules will ensure 

that gaming facilities are constructed, 

maintained and operated in a manner 

that adequately protects the 

environment and the public health and 

safety. 

DATES: Effective March 3, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Penny J. Coleman, Acting General 

Counsel, at 202–632–7003; fax 202–

632–7066 (not toll-free numbers). 

SUPPLEMENTARY INFORMATION: 

I. Background 

On October 17, 1988, Congress 

enacted the Indian Gaming Regulatory 

Act (‘‘IGRA’’ or ‘‘Act’’), 25 U.S.C. 2701–

21, creating the National Indian Gaming 

Commission (‘‘NIGC’’ or ‘‘Commission’’) 

and developing a comprehensive 

framework for the regulation of gaming 

on Indian lands. 25 U.S.C. 2702. The 

NIGC was granted, among other things, 

the authority to promulgate such 

regulations and guidelines as it deems 

appropriate to implement the provisions 

of IGRA, 25 U.S.C. 2706(b)(10), as well 

as oversight and enforcement authority, 

including the authority to monitor tribal 

compliance with the Act, Commission 

regulations, and tribal gaming 

ordinances. 

First, the IGRA allows gaming on 

Indian lands pursuant to 25 U.S.C. 

2703(4), and it contains a general 

prohibition against gaming on lands 

acquired into trust by the United States 

for the benefit of the tribe after the Act’s 

effective date of October 17, 1988, 

unless one of several exceptions are 

met. 25 U.S.C. 2719. The Commission 

has jurisdiction only over gaming 

operations on Indian lands and 

therefore must establish that it has 

jurisdiction as a prerequisite to its 

monitoring, enforcement, and oversight 

duties. 25 U.S.C. 2702(3). 

Second, the NIGC needs to obtain 

information on a tribe’s environmental 

and public health and safety laws to 

oversee the implementation of approved 

tribal gaming ordinances. Before 

opening a gaming operation, a tribe 

must adopt an ordinance governing 

gaming activities on its Indian lands. 25 

U.S.C. 2710. The Act specifies a number 

of mandatory provisions to be contained 

in each tribal gaming ordinance and 

subjects such ordinances to the NIGC 

Chairman’s approval. Id. Approval by 

the Chairman is predicated on the 

inclusion of each of the Act’s specified 

mandatory provisions in the tribal 

gaming ordinance. Id. Among these is a 

requirement that the ordinance must 

contain a provision ensuring that ‘‘the 

construction and maintenance of the 

gaming operation, and the operation of 

that gaming is conducted in a manner 

that adequately protects the 

environment and the public health and 

safety.’’ 25 U.S.C. 2710(b)(2)(E). Since 

1993, when the Commission became 

operational, the Chairman has required 

each tribal gaming ordinance submitted 

for approval to include the express 

environmental and public health and 

safety statement set out in 25 U.S.C. 

2710(b)(2)(E). 

The Commission believes that tribes 

must have some form of basic laws in 

the following environmental and public 

health and safety areas: (1) Emergency 

preparedness, including but not limited 


pwalker on PROD1PC71 with PROPOSALS