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

1 This 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 lightingconditions 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 increaseworkload. 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


### 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