Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 26645 

1This 1996 final rule entitled ‘‘Operating 

Requirements: Domestic, Flag, Supplemental, 

Commuter, and On-Demand Operations: 

Corrections and Editorial Changes’’ was adopted to 

make corrections and editorial changes to the 

‘‘Commuter Operations and General Certification 

and Operations Requirements’’ final rule (60 FR 

65832; December 20, 1995). 

(ambient) lighting conditions, to prevent 

full or partial blooming of the display 

that would distract the pilot, impair the 

pilot’s ability to detect and identify 

visual references, mask flight hazards, 

or otherwise degrade task performance 

or safety. If automatic control for image 

brightness is not provided, it must be 

shown that a single manual setting is 

satisfactory for the range of lighting 

conditions encountered during a timecritical, high-workload phase of flight 

(e.g., low-visibility instrument 

approach). 

■ c. A readily accessible control must be 

provided that permits the pilot to 

immediately deactivate and reactivate 

display of the EVS image on demand 

without removing the pilot’s hands from 

the primary flight controls (yoke or 

equivalent) or thrust control. 

■ d. The EVS image on the HUD must 

not impair the pilot’s use of guidance 

information or degrade the presentation 

and pilot awareness of essential flight 

information displayed on the HUD, such 

as alerts, airspeed, attitude, altitude and 

direction, approach guidance, wind 

shear guidance, Traffic Alert and 

Collision Avoidance System (TCAS) 

resolution advisories, and unusualattitude recovery cues. 

■ e. The EVS image and the HUD 

symbols, which are spatially referenced 

to the pitch scale, outside view and 

image, must be scaled and aligned (i.e., 

conformal) to the external scene and, 

when considered singly or in 

combination, must not be misleading, 

cause pilot confusion, or increase 

workload. Airplane attitudes or crosswind conditions may cause certain 

symbols, such as the zero-pitch line or 

flight path vector, to reach field-of-view 

limits such that they cannot be 

positioned conformably with the image 

and external scene. In such cases, these 

symbols may be displayed, but with an 

altered appearance which makes the 

pilot aware that they are no longer 

displayed conformably (for example, 

‘‘ghosting’’). 

■ f. A HUD system used to display EVS 

images must, if previously certified, 

continue to meet all of the requirements 

of the original approval. 

■ 3. The safety and performance of the 

pilot tasks associated with the use of the 

pilot compartment view must be not be 

degraded by the display of the EVS 

image. Pilot tasks which must not be 

degraded by the EVS image include: 

■ a. Detection, accurate identification, 

and maneuvering, as necessary, to avoid 

traffic, terrain, obstacles, and other 

hazards of flight. 

■ b. Accurate identification and 

utilization of visual references required 

for every task relevant to the phase of 

flight. 

■ 4. Appropriate limitations must be 

stated in the Operating Limitations 

section of the airplane flight manual. 

The airplane flight manual must 

prohibit the use of the EVS for functions 

that have not been found to be 

acceptable. 

Issued in Renton, Washington, on May 6, 

2010. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2010–11309 Filed 5–11–10; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 119 

[Docket No. 28154; Amendment No. 119– 

13] 

RIN 2120–AG03 

Operating Requirements: Domestic, 

Flag, Supplemental, Commuter, and 

On-Demand Operations: Corrections 

and Editorial Changes 

AGENCY: Federal Aviation 

Administration, DOT. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Federal Aviation 

Administration (FAA) is making minor 

technical changes to a final rule 

published in the Federal Register on 

June 14, 1996. That final rule adopted 

corrections and editorial changes to 

several parts, which included an 

amendment to a section of part 119 that 

removed two subparagraphs. However, 

the FAA inadvertently did not also 

amend a separate section of part 119 to 

remove reference to the two obsolete 

subparagraphs. The FAA is issuing this 

technical amendment to correct that 

oversight. 

DATES: Effective Date: Effective on May 

12, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Alberta Brown, Flight Standards 

Service, Air Transportation Division, 

AFS–200, Federal Aviation 

Administration, 800 Independence 

Avenue, SW., Washington, DC 20591; 

telephone (202) 267–8321; e-mail: 

Alberta.Brown@faa.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Aviation Administration (FAA) 

published a final rule in the Federal 

Register on June 14, 1996 (61 FR 

30432) 1 that adopted corrections and 

editorial changes to 14 CFR parts 119, 

121, and 135. The amendment included 

one to § 119.21, which revised then 

paragraph (a) to remove (a)(3)(i) and 

(a)(3)(ii). The FAA should also have 

amended § 119.49 to remove the two 

obsolete subparagraphs referenced in 

paragraph (b)(11). The FAA is issuing 

today’s action to correct that oversight. 

This action makes the appropriate 

amendatory change to remove two 

obsolete subparagraphs in current 

§ 119.49(b)(11). With this amendatory 

change, the reference to subparagraphs 

§ 119.21(a)(3)(i) and (a)(3)(ii) will be 

removed from § 119.49(b)(11). This 

amendment will not impose any 

additional restrictions on operators 

affected by these regulations. 

Technical Amendment 

The technical amendment will 

remove the reference to § 119.21(a)(3)(i) 

and (a)(3)(ii) from § 119.49(b)(11). 

List of Subjects in 14 CFR Part 119 

Administrative practice and 

procedure, Air carriers, Aircraft, 

Aviation safety, Charter flights, 

Reporting, and recordkeeping 

requirements. 

■ Accordingly, Title 14 of the Code of 

Federal Regulations (CFR) part 119 is 

corrected by making the following 

correcting amendment: 

PART 119—CERTIFICATION: AIR 

CARRIERS AND COMMERCIAL 

OPERATORS 

■ 1. The authority citation for part 119 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 1153, 40101, 

40102, 40103, 40113, 44105, 44106, 44111, 

44701–44717, 44722, 44901, 44903, 44904, 

44906, 44912, 44914, 44936, 44938, 46103, 

46105. 

■ 2. Amend § 119.49 by revising 

paragraph (b) to read as set forth below. 

§ 119.49 Contents of operations 

specifications. 

* * * * * 

(b) Each certificate holder conducting 

supplemental operations must obtain 

operations specifications containing all 

of the following: 

(1) The specific location of the 

certificate holder’s principal base of 

operations, and, if different, the address 

that shall serve as the primary point of 

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26646 Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 

contact for correspondence between the 

FAA and the certificate holder and the 

name and mailing address of the 

certificate holder’s agent for service. 

(2) Other business names under 

which the certificate holder may 

operate. 

(3) Reference to the economic 

authority issued by the Department of 

Transportation, if required. 

(4) Type of aircraft, registration 

markings, and serial number of each 

aircraft authorized for use. 

(i) Subject to the approval of the 

Administrator with regard to form and 

content, the certificate holder may 

incorporate by reference the items listed 

in paragraph (b)(4) of this section into 

the certificate holder’s operations 

specifications by maintaining a current 

listing of those items and by referring to 

the specific list in the applicable 

paragraph of the operations 

specifications. 

(ii) The certificate holder may not 

conduct any operation using any aircraft 

not listed. 

(5) Kinds of operations authorized. 

(6) Authorization and limitations for 

routes and areas of operations. 

(7) Special airport authorizations and 

limitations. 

(8) Time limitations, or standards for 

determining time limitations, for 

overhauling, inspecting, and checking 

airframes, engines, propellers, 

appliances, and emergency equipment. 

(9) Authorization for the method of 

controlling weight and balance of 

aircraft. 

(10) Aircraft wet lease information 

required by § 119.53(c). 

(11) Any authorization or requirement 

to conduct supplemental operations as 

provided by § 119.21(a)(3). 

(12) Any authorized deviation or 

exemption from any requirement of this 

chapter. 

(13) An authorization permitting, or a 

prohibition against, accepting, handling, 

and transporting materials regulated as 

hazardous materials in transport under 

49 CFR parts 171 through 180. 

(14) Any other item the Administrator 

determines is necessary. 

* * * * * 

Issued in Washington, DC on May 7, 2010. 

Pamela Hamilton-Powell, 

Director, Office of Rulemaking, Aviation 

Safety. 

[FR Doc. 2010–11266 Filed 5–11–10; 8:45 am] 

BILLING CODE 4910–13–P 

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; 

Orbifloxacin 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 

approval of a new animal drug 

application (NADA) filed by Intervet, 

Inc. The NADA provides for the 

veterinary prescription use of an oral 

suspension containing orbifloxacin for 

the treatment of various bacterial 

infections in dogs and cats. 

DATES: This rule is effective May 12, 

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: Intervet, 

Inc., 56 Livingston Ave., Roseland, NJ 

07068, filed NADA 141–305 that 

provides for veterinary prescription use 

of ORBAX (orbifloxacin) Oral 

Suspension for the treatment of various 

bacterial infections in dogs and cats. 

The NADA is approved as of March 25, 

2010, and the regulations are amended 

in 21 CFR part 520 by adding new 

§ 520.1618 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. 

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. 

Under section 512(c)(2)(F)(ii) of the 

Federal Food, Drug, and Cosmetic Act 

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

approval qualifies for 3 years of 

marketing exclusivity beginning on the 

date of approval. 

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 the 

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. 

§ 520.1616 [Amended] 

■ 2. Revise the section heading of 

§ 520.1616 to read ‘‘Orbifloxacin 

tablets.’’. 

■ 3. Add § 520.1618 to read as follows: 

§ 520.1618 Orbifloxacin suspension. 

(a) Specifications. Each milliliter of 

suspension contains 30 milligrams (mg) 

orbifloxacin. 

(b) Sponsor. See No. 000061 in 

510.600(c) of this chapter. 

(c) Special considerations. Federal 

law restricts this drug to use by or on 

the order of a licensed veterinarian. 

Federal law prohibits the extralabel use 

of this drug in food-producing animals. 

(d) Conditions of use—(1) Dogs—(i) 

Amount. 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/ 

kg) of body weight once daily. 

(ii) Indications for use. For the 

treatment of urinary tract infections 

(cystitis) in dogs caused by susceptible 

strains of Staphylococcus 

pseudintermedius, Proteus mirabilis, 

Escherichia coli, and Enterococcus 

faecalis and skin and soft tissue 

infections (wounds and abscesses) in 

dogs caused by susceptible strains of 

Staphylococcus pseudintermedius, 

Staphylococcus aureus, coagulasepositive staphylococci, Pasteurella 

multocida, Proteus mirabilis, 

Pseudomonas spp., Klebsiella 

pneumoniae, E. coli, Enterobacter spp., 

Citrobacter spp., E. faecalis, b-hemolytic 

streptococci (Group G), and 

Streptococcus equisimilis. 

(2) Cats—(i) Amount. 3.4 mg/lb (7.5 

mg/kg) of body weight once daily. 

(ii) Indications for use. For the 

treatment of skin infections (wounds 

and abscesses) in cats caused by 

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