53164 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Rules and Regulations 

promulgated, will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the U.S. Code. Subtitle 1, 

Section 106, describes the authority of 

the FAA Administrator. Subtitle VII, 

Aviation Programs, describes in more 

detail the scope of the agency’s 

authority. This rulemaking is 

promulgated under the authority 

described in Subtitle VII, Part A, 

Subpart I, Section 40103. Under that 

section, the FAA is charged with 

prescribing regulations to assign the use 

of airspace necessary to ensure the 

safety of aircraft and the efficient use of 

airspace. This regulation is within the 

scope of that authority as it adds 

additional controlled airspace at MidWay Regional Airport, MidlothianWaxahachie, TX. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

Adoption of the Amendment 

■ In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR Part 71 as follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for 14 CFR 

Part 71 continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 

1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR Part 71.1 of the Federal Aviation 

Administration Order 7400.9T, Airspace 

Designations and Reporting Points, 

signed August 27, 2009, and effective 

September 15, 2009, is amended as 

follows: 

Paragraph 6005 Class E airspace areas 

extending upward from 700 feet or more 

above the surface. 

* * * * * 

ASW TX E5 Midlothian-Waxahachie, TX 

[Amended] 

Mid-Way Regional Airport, TX 

(Lat. 32°27′22′′ N., long. 96°54′46′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 6.5-mile 

radius of Mid-Way Regional Airport and 

within 1.8 miles each side of the 184° bearing 

from the airport extending from the 6.5-mile 

radius to 9.8 miles south of the airport. 

* * * * * 

Issued in Fort Worth, Texas, on October 1, 

2009. 

Walter L. Tweedy, 

Acting Manager, Operations Support Group, 

ATO Central Service Center. 

[FR Doc. E9–24647 Filed 10–15–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 522 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs; Change of 

Sponsor; Sometribove Zinc 

Suspension 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor for sometribove zinc 

suspension from Monsanto Co. to 

Elanco Animal Health, A Division of Eli 

Lilly & Co. 

DATES: This rule is effective October 16, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Monsanto 

Co., 800 North Lindbergh Blvd., St. 

Louis, MO 63167, has informed FDA 

that it has transferred ownership of, and 

all rights and interest in, NADA 140– 

872 for POSILAC (sometribove zinc 

suspension) to Elanco Animal Health, A 

Division of Eli Lilly & Co., Lilly 

Corporate Center, Indianapolis, IN 

46285. Accordingly, the regulations are 

amended in 21 CFR 522.2112 to reflect 

this change of sponsorship. 

Following this change of sponsorship, 

Monsanto Co. is no longer the sponsor 

of an approved application. 

Accordingly, 21 CFR 510.600(c) is being 

amended to remove the entries for 

Monsanto Co. 

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 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

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 parts 510 and 522 are amended as 

follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1) remove the entry for 

‘‘Monsanto Co.’’; and in the table in 

paragraph (c)(2) remove the entry for 

‘‘000911’’. 

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. 

§ 522.2112 [Amended] 

■ 4. In paragraph (b) of § 522.2112, 

remove ‘‘000911’’ and add in its place 

‘‘000986’’. 

Dated: October 9, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–24881 Filed 10–15–09; 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–2009–N–0665] 

Implantation or Injectable Dosage 

Form New Animal Drugs; 

Tulathromycin 

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 


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