Federal Register / Vol. 72, No. 219 / Wednesday, November 14, 2007 / Rules and Regulations 63987 

Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Fort 

Dodge Animal Health, Division of 

Wyeth Holdings Corp., P.O. Box 1339, 

Fort Dodge, IA 50501, filed a 

supplement to NADA 65–440 for 

AUREOMYCIN (chlortetracycline) 

Soluble Powder Concentrate, approved 

for oral use in medicated drinking water 

of chickens, growing turkeys, swine, 

calves, beef cattle, and nonlactating 

dairy cattle for the control and/or 

treatment of various bacterial diseases. 

The supplemental NADA provides for 

label revisions. The supplemental 

application is approved as of October 

18, 2007, and the regulations are 

amended in 21 CFR 520.445b to reflect 

the approval. 

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. 

The agency has determined under 

§ 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 Parts 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 § 520.445b, revise paragraph 

(b)(2) and add paragraph (d)(5) to read 

as follows: 

§ 520.445b Chlortetracycline powder. 

* * * * * 

(b) * * * 

(2) No. 053501 for use as in paragraph 

(d)(5) of this section. 

* * * * * 

(d) * * * 

(5) Use in a drench or drinking water 

as follows: 

(i) Chickens—(A) Amount. 200 to 400 

mg/gal, for 7 to 14 days. 

(1) Indications for use. Control of 

infectious synovitis caused by M. 

synoviae susceptible to 

chlortetracycline. 

(2) Limitations. Prepare fresh solution 

daily; use as the sole source of 

chlortetracycline; do not use for more 

than 14 consecutive days; do not use in 

laying chickens; do not administer to 

chickens within 24 hours of slaughter. 

(B) Amount. 400 to 800 mg/gal, for 7 

to 14 days. 

(1) Indications for use. Control of 

chronic respiratory disease (CRD) and 

air-sac infections caused by M. 

gallisepticum and E. coli susceptible to 

chlortetracycline. 

(2) Limitations. As in paragraph 

(d)(5)(i)(A)(2) of this section. 

(C) Amount. One thousand mg/gal, for 

7 to 14 days. 

(1) Indications for use. Control of 

mortality due to fowl cholera caused by 

Pasteurella multocida susceptible to 

chlortetracycline. 

(2) Limitations. As in paragraph 

(d)(5)(i)(A)(2) of this section. 

(ii) Growing Turkeys—(A) Amount. 

400 mg/gal, for 7 to 14 days. 

(1) Indications for use. Control of 

infectious synovitis caused by 

Mycoplasma synoviae susceptible to 

chlortetracycline. 

(2) Limitations. Prepare fresh solution 

daily; use as the sole source of 

chlortetracycline; do not use for more 

than 14 consecutive days; do not 

administer to growing turkeys within 24 

hours of slaughter. 

(B) Amount. 25 mg/lb body weight 

daily, for 7 to 14 days. 

(1) Indications for use. Control of 

complicating bacterial organisms 

associated with bluecomb (transmissible 

enteritis, coronaviral enteritis) 

susceptible to chlortetracycline. 

(2) Limitations. As in paragraph 

(d)(5)(ii)(A)(2) of this section. 

(iii) Swine—(A) Amount. 10 mg/lb 

body weight daily, for 3 to 5 days. 

(B) Indications for use. Control and 

treatment of bacterial enteritis (scours) 

caused by E. coli and Salmonella spp., 

and bacterial pneumonia associated 

with Pasteurella spp., A. 

pleuropneumoniae, and Klebsiella spp. 

susceptible to chlortetracycline. 

(C) Limitations. Prepare fresh solution 

daily; use as the sole source of 

chlortetracycline; do not use for more 

than 5 days; do not administer to swine 

within 24 hours of slaughter. 

(iv) Calves, beef cattle, and 

nonlactating dairy cattle—(A) Amount. 

10 mg/lb body weight daily in divided 

doses, for 3 to 5 days. 

(B) Indications for use. Control and 

treatment of bacterial enteritis (scours) 

caused by Escherichia coli and 

Salmonella spp., and bacterial 

pneumonia associated with Pasteurella 

spp., Histophilus spp., and Klebsiella 

spp. susceptible to chlortetracycline. 

(C) Limitations. Prepare fresh solution 

daily; use as a drench; use as the sole 

source of chlortetracycline; do not use 

for more than 5 days; do not administer 

to cattle within 24 hours of slaughter; do 

not use in lactating dairy cattle; do not 

administer this product with milk or 

milk replacers; administer 1 hour before 

or 2 hours after feeding milk or milk 

replacers; a withdrawal period has not 

been established in preruminating 

calves; do not use in calves to be 

processed for veal. 

Dated: November 2, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–22261 Filed 11–13–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

[DOD–2007–HA–0118] 

32 CFR Part 199 

TRICARE, Formerly Known as the 

Civilian Health and Medical Program of 

the Uniformed Services (CHAMPUS); 

Coverage of Physician Assistant 

Services 

AGENCY: Department of Defense. 

ACTION: Administrative correction. 

SUMMARY: This action corrects the 

reference to a re-designated paragraph 

within this part regarding the allowable 

charge for physician assistant services. 

This document is published to improve 

the accuracy of 32 CFR part 199. 

DATES: Effective Dates: November 14, 

2007. 

ADDRESSES: TRICARE Management 

Activity, 16401 East Centretech 

Parkway, Aurora, CO 80011. 

FOR FURTHER INFORMATION CONTACT: 

Michael Kottyan, Office of Medical 

Benefits and Reimbursement Systems, 

TRICARE Management Activity, 

telephone (303) 676–3520. 

SUPPLEMENTARY INFORMATION: The final 

rule published in the Federal Register 

on August 1, 1990 (55 FR 31179) 

provided the authority for CHAMPUS 

payment of services rendered by 

physician assistants (PA) and included 

a reference to a paragraph elsewhere in 

this part. Subsequent actions redesignated that paragraph. This action 


rmajette on PROD1PC64 with RULES
63988 Federal Register / Vol. 72, No. 219 / Wednesday, November 14, 2007 / Rules and Regulations 

provides the correct designation of the 

paragraph being referenced. 

List of Subjects in 32 CFR Part 199 

Claims, Handicapped, Health 

insurance, Military personnel. 

■ Accordingly, 32 CFR part 199 is 

amended as follows: 

PART 199—[AMENDED] 

■ 1. The authority citation for part 199 

continues to read as follows: 

Authority: 5 U.S.C. 301; 10 U.S.C. chapter 

55. 

■ 2. Section 199.6(c)(3)(iii)(H) is 

amended by revising ‘‘199.14(g)(1)(iii)’’

to read ‘‘199.14(j)(1)(ix)’’. 

■ 3. Paragraph 199.14(j) is amended by 

revising ‘‘provers’’ to read ‘‘providers’’. 

Dated: November 5, 2007. 

L.M. Bynum, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense. 

[FR Doc. 07–5624 Filed 11–13–07; 8:45 am] 

BILLING CODE 5001–06–M 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 49 

[EPA–R01–OAR–2005–TR–0001; A–1–FRL–

8491–7] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Mohegan Tribe of Indians of 

Connecticut 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is approving a Tribal 

Implementation Plan (TIP) submitted by 

the Mohegan Tribe of Indians of 

Connecticut. The TIP establishes an 

enforceable cap on nitrogen oxide 

emissions from stationary sources 

owned by the Mohegan Tribal Gaming 

Authority and located within the 

external boundaries of the Mohegan 

Reservation. This action is intended to 

help attain the National Ambient Air 

Quality Standards (NAAQS) for groundlevel ozone. This action is being taken 

in accordance with the Clean Air Act. 

DATES: Effective Date: This rule is 

effective on December 14, 2007. 

ADDRESSES: EPA has established a 

docket for this action under Docket 

Identification No. EPA–R01–OAR–

2005–TR–0001. All documents in the 

docket are listed on the 

www.regulations.gov Web site. 

Although listed in the index, some 

information is not publicly available, 

i.e., CBI or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically through 

www.regulations.gov or in hard copy at 

the Office of Ecosystem Protection, U.S. 

Environmental Protection Agency, EPA 

New England Regional Office, One 

Congress Street, Suite 1100, Boston, 

MA. EPA requests that if at all possible, 

you contact the contact listed in the FOR

FURTHER INFORMATION CONTACT section to 

schedule your inspection. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 to 4:30, 

excluding legal holidays. 

Copies of the documents relevant to 

this action are also available for public 

inspection during normal business 

hours, by appointment at the Mohegan 

Tribe, Mohegan Environmental 

Protection Department, 49 Sandy Desert 

Road, Uncasville, CT 06382, telephone 

number (860) 862–6112. 

FOR FURTHER INFORMATION CONTACT: Ida 

E. McDonnell, Air Permits, Toxics and 

Indoor Air Unit, Office of Ecosystem 

Protection, U.S. Environmental 

Protection Agency, EPA New England 

Regional Office, One Congress Street, 

11th floor, (CAP), Boston, MA 02114–

2023, telephone number (617) 918–

1653, fax number (617) 918–0653, email mcdonnell.ida@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document whenever 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 

EPA. 

Organization of this document. The 

following outline is provided to aid in 

locating information in this preamble. 

I. Background and Purpose 

II. Final Action 

III. Statutory and Executive Order Reviews 

I. Background and Purpose 

On September 6, 2007 (72 FR 51204) 

EPA published a Notice of Proposed 

Rulemaking (NPR) for the Mohegan 

Tribe of Indians of Connecticut. 

The NPR proposed approval of the 

Mohegan Tribal Implementation Plan 

(TIP) consisting of a tribal ordinance, 

entitled ‘‘Area Wide NOX Emissions 

Limitation Regulation,’’ that establishes 

a limit on nitrogen oxide (NOX) 

emissions from stationary sources 

owned by the Mohegan Tribal Gaming 

Authority and located within the 

external boundaries of the Mohegan 

Reservation. The formal TIP was 

submitted by Mohegan Tribe of Indians 

of Connecticut on May 4, 2005 and 

amended on August 22, 2007. 

Other specific requirements of the 

Tribal Implementation Plan and the 

rationale for EPA’s proposed action are 

explained in the NPR and will not be 

restated here. No public comments were 

received on the NPR. 

II. Final Action 

EPA is approving the Mohegan Tribal 

Implementation Plan that was submitted 

by the Mohegan Tribe of Indians of 

Connecticut on May 4, 2005, and 

amended on August 22, 2007 for 

limiting NOX emissions from stationary 

sources owned by the Mohegan Tribal 

Gaming Authority to 49 TPY. 

III. Statutory and Executive Order 

Reviews 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993), this action is 

not a ‘‘significant regulatory action’’ and 

therefore is not subject to review by the 

Office of Management and Budget. For 

this reason, this action is also not 

subject to Executive Order 13211, 

‘‘Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001). This action merely approves 

tribal law as meeting Federal 

requirements and imposes no additional 

requirements beyond those imposed by 

tribal law. Accordingly, the 

Administrator certifies that this rule 

will not have a significant economic 

impact on a substantial number of small 

entities under the Regulatory Flexibility 

Act (5 U.S.C. 601 et seq.). Because this 

rule approves pre-existing requirements 

under tribal law and does not impose 

any additional enforceable duty beyond 

that required by tribal law, it does not 

contain any unfunded mandate or 

significantly or uniquely affect small 

governments, as described in the 

Unfunded Mandates Reform Act of 1995 

(Pub. L. 104–4). 

Since this rule simply approves preexisting tribal law, it does not result in 

any direct costs or preemption of tribal 

law as specified by Executive Order 

13175 (65 FR 67249, November 9, 2000). 

Nonetheless, EPA has consulted 

extensively with the Mohegan Tribe 

concerning this proposed TIP approval. 

This action also does not have 

Federalism implications because it does 

not have substantial direct effects on the 

States, on the relationship between the 

national government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132 (64 FR 43255, 

August 10, 1999), because it merely 

approves a tribal rule implementing a 

federal standard within the exterior 

boundaries of the Tribe’s reservation, 


rmajette on PROD1PC64 with RULES