This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. Prices of new books are listed in the first FEDERAL REGISTER issue of each week. 

# Rules and Regulations Federal Register 

### 17865

Vol. 78, No. 57

Monday, March 25, 2013

**DEPARTMENT OF TRANSPORTATION**

**Federal Aviation Administration**

**14 CFR Part 39**

**[Docket No. FAA–2008–0070; Directorate Identifier 2007–CE–098–AD; Amendment**  **39–17398; AD 2008–07–11 R1]**

**RIN 2120–AA64**

**Airworthiness Directives; PILATUS AIRCRAFT LTD. Airplanes** 

**AGENCY :**  Federal Aviation Administration (FAA), DOT.

**ACTION :**  Final rule; rescission; request for comments

**SUMMARY :**  We are rescinding an airworthiness directive (AD) for all PILATUS AIRCRAFT LTD. Models PC– 12, PC–12/45, and PC–12/47 airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. We issued that AD to mandate new life limits for the pitch trim actuator and pitch trim actuator attachment parts. If these new limitations were not mandated, the pitch trim actuator and the pitch trim actuator components could fail. This failure could lead to an unsafe flying configuration. Since we issued that AD, we have determined that the unsafe condition addressed in that AD is now addressed in another AD.

**DATES :**  This AD is effective March 25,
2013.

We must receive comments on this AD by May 9, 2013.

**ADDRESSES :**  You may send comments by any of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.

• Fax: (202) 493–2251.

• Mail: U.S. Department of Transportation, Docket Operations, M– 30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590.

• Hand Delivery: U.S. Department of Transportation, Docket Operations, M– 30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Examining the AD Docket

You may examine the AD docket on the Internet at http:// www.regulations.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647– 5527) is in the **ADDRESSES** section. Comments will be available in the AD docket shortly after receipt.

**FOR FURTHER INFORMATION CONTACT :**  Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329– 4059; fax: (816) 329–4090; email: doug.rudolph@faa.gov.

**SUPPLEMENTARY INFORMATION :** 

Discussion

On March 27, 2008, we issued AD 2008–07–11, Amendment 39–15452 (73 FR 18433, April 4, 2008). That AD required actions intended to address an unsafe condition on the products listed above.

AD 2008–07–11, Amendment 39– 15452 (73 FR 18433, April 4, 2008) was based on results of a full-scale fatigue test of the pitch trim actuator on PILATUS AIRCRAFT LTD. Models PC– 12, PC–12/45, and PC–12/47 airplanes. The life-limit was extended and the time between overhaul (TBO) was reduced. In addition, based on the results of the fatigue test, a life-limit of the pitch trim actuator attachment had been established.

These new limitations were incorporated into the airworthiness limitations section of the Pilatus PC–12 Airplane Maintenance Manual (AMM) 12–A/AMP–04, chapter 4, revision 10, dated October 26, 2007.

The new limitations for the pitch trim actuator TBO were moved from Chapter 5: Time Limits/Maintenance Checks, to Chapter 4: Structural, Component and Miscellaneous—Airworthiness Limitations. Since both chapter 4 and chapter 5 are mandatory within the European and Swiss airworthiness systems, it was not necessary for the European Aviation Safety Agency (EASA) and the Federal Office of Civil Aviation (FOCA) to issue an AD to mandate these new limitations.

The only way the FAA can mandate the implementation of changes to the airworthiness limitations section of an FAA-approved maintenance program is by AD action.

On February 8, 2013, we issued AD 2012–26–16, Amendment 39–17311 (78 FR 11572, February 19, 2013). AD 2012– 26–16 also requires incorporating new revisions into the Limitations section, Chapter 4, of the Pilatus PC–12 AMM. The limitations were revised to include an inspection of the wing main spar fastener holes at rib 6 for cracks.

After issuing AD 2012–26–16, Amendment 39–17311 (78 FR 11572, February 19, 2013), we determined that AD 2008–07–11 should have been superseded by AD 2012–26–16. Since AD 2008–07–11 requires incorporating an earlier version of the airworthiness limitations section of the AMM, it could cause confusion for the owners/ operators and could result in missed inspections and replacements required by AD 2012–26–16. Therefore, the need to continue to address this subject as an unsafe condition through AD 2008–07– 11 is no longer necessary.

FAA’s Determination

We are issuing this AD because we evaluated all available information and determined the existing AD is no longer
necessary. AD Requirements

This AD would rescind AD 2008–07– 11, Amendment 39–15452 (73 FR 18433, April 4, 2008).

FAA’s Determination of the Effective Date

An unsafe condition exists or could develop that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because the unsafe condition addressed in AD 2008–07–11, Amendment 39–15452 (73 FR 18433, April 4, 2008) is currently addressed in AD 2012–26–16, Amendment 39–17311


### 17866 Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Rules and Regulations

(78 FR 11572, February 19, 2013). Allowing the airworthiness limitation section (ALS) required by AD 2008–07– 11 to remain valid could cause confusion as to what is required and this could introduce an unsafe condition if certain areas were not inspected. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.

Comments Invited

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the **ADDRESSES** section. Include ‘‘Docket No. FAA–2008–0070; Directorate Identifier 2007–CE–098– AD’’ at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those
comments.

We will post all comments we receive, without change, to http:// www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD. Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA’s authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. ‘‘Subtitle VII: 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 products 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.

For the reasons discussed above, I certify that 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),

(3) Will not affect intrastate aviation in Alaska, and

(4) 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. List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation safety, Incorporation by reference, 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 removing AD 2008–07–11, Amendment 39–15452 (73 FR 18433, April 4, 2008), and adding the following new AD:

2008–07–11 R1 PILATUS AIRCRAFT LTD.: Amendment 39–17398; Docket No. FAA–2008–0070; Directorate Identifier 2007–CE–098–AD.
(a) Effective Date

This airworthiness directive (AD) becomes effective April 15, 2013.

(b) Affected ADs

This AD rescinds AD 2008–07–11, Amendment 39–15452 (73 FR 18433, April 4, 2008).
(c) Applicability

This AD applies to PILATUS AIRCRAFT LTD. Models PC–12, PC–12/45, and PC–12/ 47 airplanes, all serial numbers, certificated in any category.
(d) Subject

Air Transport Association of America (ATA) Code 27: Flight Controls. Issued in Kansas City, Missouri on March 11, 2013. Earl Lawrence, Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2013–06169 Filed 3–22–13; 8:45 am]

**BILLING CODE 4910–13–P**

**DEPARTMENT OF HEALTH AND HUMAN SERVICES** 

**Food and Drug Administration**

**21 CFR Parts 510, 522, 524, and 529**

**[Docket No. FDA–2013–N–0002]**

**New Animal Drug Approvals; Change of Sponsor; Change of Sponsor’s Drug**  **Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol;**  **Sevoflurane; Triamcinolone Acetonide**

**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 actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship for an NADA and ANADA, and a change of a sponsor’s drug labeler code.

**DATES :**  This rule is effective March 25,
2013.

**FOR FURTHER INFORMATION CONTACT :**  George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9019, email: george.haibel@fda.hhs.gov.

**SUPPLEMENTARY INFORMATION :**  FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January 2013, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630