Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Rules and Regulations 38341 

Aviation Programs,’’ describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in ‘‘Subtitle VII, 

Part A, Subpart III, Section 44701: 

General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

product(s) identified in this rulemaking 

action. 

Regulatory Findings 

We determined that this AD will not 

have federalism implications under 

Executive Order 13132. This AD will 

not have a substantial direct effect 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. 

Therefore, I certify this AD: 

1. Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866; 

2. Is not a ‘‘significant rule’’ under the 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979); and 

3. Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

We prepared an economic evaluation 

of the estimated costs to comply with 

this AD and placed it in the AD docket. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Safety. 

Adoption of the Amendment 

■ Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA amends 14 CFR part 39 as 

follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new AD: 

2009–15–15 Bell Helicopter Textron 

Canada (BHTC): Amendment 39–15978; 

Docket No. FAA–2009–0227; Directorate 

Identifier 2007–SW–65–AD. 

Effective Date 

(a) This airworthiness directive (AD) 

becomes effective on September 8, 2009. 

Other Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to Model 427 

helicopters, serial numbers 56001 through 

56057, 58001, and 58002, certificated in any 

category. 

Reason 

(d) Transport Canada states in the 

mandatory continuing airworthiness 

information (MCAI) that it has been 

determined that the existing hardware 

connecting the vertical fin to the tail rotor 

gearbox needs to be upgraded to prevent the 

vertical fin from becoming loose. BHTC has 

received reports of loose vertical fins 

discovered during inspections. Investigation 

revealed that the current vertical fin 

attachment hardware may not provide 

adequate clamp-up. If not corrected, the 

vertical fin could become loose and cause 

vibration, which could lead to subsequent 

loss of control of the helicopter. 

Actions and Compliance 

(e) Within the next 150 hours time-inservice, unless already done, do the 

following: 

(1) Remove the vertical fin and visually 

inspect the inboard and outboard surfaces of 

the vertical fin where it attaches to the tail 

rotor gearbox support for a crack, an 

elongated bolt hole, fretting, distortion and 

corrosion. 

(2) Visually inspect the tail rotor gearbox 

support attachment legs for a crack, fretting 

and corrosion. 

(f) If a crack, elongated bolt hole, fretting, 

distortion or corrosion is detected, repair or 

replace the part with an airworthy part before 

further flight. 

(g) Reinstall the vertical fin. 

Differences Between This AD and the MCAI 

AD 

(h) This AD differs from the MCAI AD as 

follows: 

(1) We do not require compliance ‘‘no later 

than November 27, 2007’’, because that date 

has passed. 

(2) We refer to the compliance time as 

‘‘hours time-in-service’’ rather than ‘‘air time 

hours.’’ 

Other Information 

(i) Alternative Methods of Compliance 

(AMOCs): The Manager, Safety Management 

Group, FAA, has the authority to approve 

AMOCs for this AD, if requested using the 

procedures found in 14 CFR 39.19. Send 

information to ATTN: Sharon Miles, Aviation 

Safety Engineer, FAA, Rotorcraft Directorate, 

Regulations and Guidance Group, 2601 

Meacham Blvd., Fort Worth, Texas 76137, 

telephone (817) 222–5122, fax (817) 222– 

5961. 

Related Information 

(j) Mandatory Continuing Airworthiness 

Information (MCAI) Transport Canada 

Airworthiness Directive CF–2007–22, dated 

September 14, 2007, and Bell Helicopter 

Textron Alert Service Bulletin No. 427–06– 

15, dated December 14, 2006, contain related 

information. 

Subject 

(k) Joint Aircraft System/Component 

(JASC) Code: 5553, Vertical Stabilizer, Attach 

Fittings. 

Issued in Fort Worth, Texas, on July 14, 

2009. 

Judy I. Carl, 

Acting Manager, Rotorcraft Directorate, 

Aircraft Certification Service. 

[FR Doc. E9–18431 Filed 7–31–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 524 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs; Nitrofurazone 

Ointment 

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 an original abbreviated new 

animal drug application (ANADA) filed 

by First Priority, Inc. The ANADA 

provides for use of nitrofurazone 

ointment on horses for prevention or 

treatment of superficial bacterial 

infections. 

DATES: This rule is effective August 3, 

2009. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, 

e-mail: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: First 

Priority, Inc., 1585 Todd Farm Dr., 

Elgin, IL 60123, filed ANADA 200–425 

for use of Nitrofurazone Soluble 

Dressing in horses for prevention or 

treatment of superficial bacterial 

infections of wounds, burns, and 

cutaneous ulcers. First Priority, Inc.’s 

Nitrofurazone Soluble Dressing is 

approved as a generic copy of FURA– 

ZONE (nitrofurazone) ointment, 

sponsored by Squire Laboratories, Inc., 

under NADA 132–427. In addition, First 

Priority, Inc., has informed FDA of a 

change of address. The ANADA is 

approved as of July 13, 2009, and 


sroberts on DSKD5P82C1PROD with RULES
38342 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Rules and Regulations 

§§ 510.600 and 524.1580b (21 CFR 

510.600 and 524.1580b) are amended to 

reflect the approval. 

In addition, FDA has found that the 

pioneer sponsor’s drug labeler code 

(DLC) was inadvertently omitted from 

§ 524.1580b during format changes in 

2005 (70 FR 50181; August 26, 2005). At 

this time, § 524.1580b is amended to 

include Squire Laboratories, Inc.’s DLC. 

Section 524.1580b is also amended to 

reflect current food safety warnings. 

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. 

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 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 524 

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 524 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. 

§ 510.600 [Amended] 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), in the entry for ‘‘First 

Priority, Inc.’’ and in the table in 

paragraph (c)(2), in the entry for 

’’058829’’, remove ‘‘1585 Todd Farm 

Dr.’’ and in its place add ‘‘1590 Todd 

Farm Dr.’’. 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 524 continues to read as follows: 

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

■ 4. In § 524.1580b, add paragraph (b)(3) 

and revise paragraph (d)(3) to read as 

follows: 

§ 524.1580b Nitrofurazone ointment. 

* * * * * 

(b) * * * 

(3) See Nos. 017153 and 058829 for 

use on horses. 

* * * * * 

(d) * * * 

(3) Limitations. For use only on dogs, 

cats, and horses. Do not use in horses 

intended for human consumption. 

Federal law prohibits the use of this 

product in food-producing animals. In 

case of deep or puncture wounds or 

serious burns, use only as recommended 

by veterinarian. If redness, irritation, or 

swelling persists or increases, 

discontinue use; consult veterinarian. 

Dated: July 28, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–18337 Filed 7–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF STATE 

22 CFR Parts 123, 124, 126, and 129 

[Public Notice: 6716] 

Amendment to the International Traffic 

in Arms Regulations: Congressional 

Certification Regarding South Korea 

AGENCY: Department of State. 

ACTION: Final rule. 

SUMMARY: The Department of State is 

amending the International Traffic in 

Arms Regulations (ITAR) regarding 

Congressional certification for the 

Republic of Korea (also referred to as 

South Korea). South Korea is now in the 

same category as the countries in the 

North Atlantic Treaty Organization 

(NATO), Japan, Australia, and New 

Zealand concerning certification to 

Congress, requiring such certification 

prior to granting any license for export 

of major defense equipment sold under 

a contract in the amount of $25,000,000 

or more, or for defense articles or 

defense services sold under a contract in 

the amount of $100,000,000 or more, 

provided the transfer does not include 

any other countries. The ITAR is being 

amended at numerous sections to reflect 

these statutory changes and to update 

two provisions. 

DATES: Effective Date: This rule is 

effective August 3, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Director Charles B. Shotwell, Office of 

Defense Trade Controls Policy, 

Department of State, Telephone (202) 

663–2792 or Fax (202) 261–8199; E-mail 

DDTCResponseTeam@state.gov. ATTN: 

Regulatory Change, South Korea. 

SUPPLEMENTARY INFORMATION: Section 

203 of the Public Law 110–429 

amended, inter alia, Sections 

3(d)(3)(A)(i), 36(c), and 36(d)(2)(A) of 

the Arms Export Control Act by 

inserting ‘‘Republic of Korea’’ before 

‘‘New Zealand.’’ This amendment added 

South Korea to the category of countries 

for which higher dollar thresholds apply 

for mandatory certification to Congress 

in advance of approving the export or 

transfer of defense articles and defense 

services. South Korea is now in the 

same category as the countries in the 

North Atlantic Treaty Organization 

(NATO), Japan, Australia, and New 

Zealand concerning certification to 

Congress, requiring such certification 

prior to granting any license for export 

of major defense equipment sold under 

a contract in the amount of $25,000,000 

or more, or for defense articles or 

defense services sold under a contract in 

the amount of $100,000,000 or more, 

provided the transfer does not include 

any other countries. The ITAR is being 

amended at numerous sections, as 

described below, to reflect these 

statutory changes and to update two 

provisions. 

Section 123.9(e) of the ITAR is being 

amended to add ‘‘South Korea.’’ This 

section is also being amended to correct 

outdated information regarding the 

dollar limits for sales without prior 

written approval and to add New 

Zealand to the list of countries eligible 

for certain reexports or retransfers 

without prior written approval. 

Section 123.15 of the ITAR entitled 

‘‘Congressional certification pursuant to 

Section 36(c) of the Arms Export 

Control Act’’ is being amended to add 

‘‘South Korea’’ at sections 123.15(a)(1), 

123.15(a)(2), and 123.15(b). 

Section 124.11 of the ITAR entitled 

‘‘Congressional certification pursuant to 

Section 36(d) of the Arms Export 

Control Act’’ is being amended to add 

‘‘South Korea’’ at section 124.11(b). 

Section 126.8 of the ITAR entitled 

‘‘Proposals to foreign persons relating to 

significant military equipment’’ is being 


sroberts on DSKD5P82C1PROD with RULES