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

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new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

55411 

Vol. 77, No. 175 

Monday, September 10, 2012 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2012–0046; Directorate 

Identifier 2011–CE–040–AD; Amendment 

39–17186; AD 2012–15–07 R1] 

RIN 2120–AA64 

Airworthiness Directives; Glasflugel 

Gliders 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Final rule; request for 

comments. 

SUMMARY: We are revising an existing 

airworthiness directive (AD) for 

Glasflugel Models Standard Libelle201B, Club Libelle 205, Mosquito, and 

Kestrel gliders. That AD currently 

requires actions to address the unsafe 

condition on these products. This new 

AD includes clarification that the 

replacement control rod has an 

additional drain hole at the rod bottom 

between the forks and is the acceptable 

configuration for compliance. This AD 

results from mandatory continuing 

airworthiness information (MCAI) 

issued by an aviation authority of 

another country to identify and correct 

an unsafe condition on an aviation 

product. The MCAI describes the unsafe 

condition as corrosion damage to the 

elevator control rod that could lead to 

failure of the elevator control rod, 

possibly resulting in loss of control of 

the glider. We are issuing this AD to 

require actions to address the unsafe 

condition on these products. 

DATES: This AD is effective September 

25, 2012. 

The Director of the Federal Register 

approved the incorporation by reference 

of a certain publication listed in the AD 

as of September 11, 2012. 

We must receive any comments on 

this AD by October 25, 2012. 

ADDRESSES: You may examine the AD 

docket on the Internet at http://www.

regulations.gov or in person at 

Document Management Facility, U.S. 

Department of Transportation, Docket 

Operations, M–30, West Building 

Ground Floor, Room W12–140, 1200 

New Jersey Avenue SE., Washington, 

DC 20590. 

For service information identified in 

this AD, contact Glasfaser FlugzeugService Hansjo ̈rg Streifeneder GmbH, D– 

72582 Grabenstetten, Germany; phone: 

+49(0)73821032, fax: +49(0)73821629; 

email: info@streifly.de; Internet: 

www.streifly.de/. You may review 

copies of the referenced service 

information at the FAA, Small Airplane 

Directorate, 901 Locust, Kansas City, 

Missouri 64106. For information on the 

availability of this material at the FAA, 

call (816) 329–4148. 

FOR FURTHER INFORMATION CONTACT: Jim 

Rutherford, Aerospace Engineer, FAA, 

Small Airplane Directorate, 901 Locust, 

Room 301, Kansas City, Missouri 64106; 

telephone: (816) 329–4165; fax: (816) 

329–4090; email: jim.rutherford@faa.

gov. 

SUPPLEMENTARY INFORMATION: 

Discussion 

On July 18, 2012, we issued AD 2012– 

15–07, amendment 39–17136 (77 FR 

46940, August 7, 2012) for Glasflugel 

Models Standard Libelle-201B, Club 

Libelle 205, Mosquito, and Kestrel 

gliders. That AD resulted from 

mandatory continuing airworthiness 

information (MCAI) issued by an 

aviation authority of another country to 

identify and correct an unsafe condition 

on an aviation product. We issued that 

AD to require actions to address the 

unsafe condition on these products. 

Actions Since AD Was Issued 

Since we issued AD 2012–15–07, 

amendment 39–17136 (77 FR 46940, 

August 7, 2012), compliance with the 

existing AD required operators to not 

install an elevator control rod with a 

control bore hole. An operator reported 

that the improved replacement rods, as 

expected, have no control bore hole on 

the side at the top of the rod where there 

had previously been a hole. However, 

the improved replacement rods do have 

a new drain hole at the bottom of the 

rod between the forks. The operator 

expressed confusion as to whether this 

drain hole would cause the new rod to 

not be in compliance since there was no 

clarification of ‘‘on the side.’’ 

Relevant Service Information 

Glasfaser Flugzeug-Service GmbH has 

issued Technical Note TN 201–40, TN 

205–27, TN 206–26, TN 303–25, TN 

304–12, TN 401–30, TN 501–10, and TN 

604–11, Revision 1, dated July 14, 2011 

(EASA translation approval dated 

September 9, 2011). The actions 

described in this service information are 

intended to correct the unsafe condition 

identified in the MCAI. 

FAA’s Determination 

We are issuing this AD because we 

evaluated all the relevant information 

and determined the unsafe condition 

described previously is likely to exist or 

develop in other products of the same 

type design. 

AD Requirements 

This AD retains the actions from AD 

2012–15–07 but adds the language of 

‘‘on the side’’ to assure that the 

replacement control rod, which has an 

additional drain hole at the rod bottom 

between the forks, is an acceptable 

configuration for compliance. 

FAA’s Justification and Determination 

of the Effective Date 

This action incorporates clarification 

that the additional drain hole at the rod 

bottom between the forks on the 

replacement control rods is the 

acceptable configuration for compliance 

and does not require any additional 

work for those airplanes. Therefore, we 

find that notice and opportunity for 

prior public comment are unnecessary 

and that good cause exists for making 

this amendment effective in less than 30 

days. 

Comments Invited 

This AD is a final rule that involves 

requirements affecting flight safety, and 

we did not provide you with notice and 

an opportunity to provide your 

comments before it becomes effective. 

However, we invite you to send any 

written data, views, or arguments about 

this AD. Send your comments to an 

address listed under the ADDRESSES

section. Include the docket number 

FAA–2012–0046 and directorate 

identifier 2011–CE–040–AD at the 

beginning of your comments. We 


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55412 Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Rules and Regulations 

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. 

Costs of Compliance 

We estimate that this AD will affect 

54 products of U.S. registry. We also 

estimate that it would take about 6 

work-hours per product to comply with 

the basic requirements of this AD. The 

average labor rate is $85 per work-hour. 

Required parts would cost about $333 

per product. 

Based on these figures, we estimate 

the cost of the AD on U.S. operators to 

be $45,522, or $843 per product. 

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 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. 

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 the NPRM, 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. 

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 adding 

the following new AD: 

2012–15–07 R1 Glasflugel: Amendment 39– 

17186; Docket No. FAA–2012–0046; 

Directorate Identifier 2011–CE–040–AD. 

(a) Effective Date 

This airworthiness directive (AD) becomes 

effective September 25, 2012. 

(b) Affected ADs 

This AD revises AD 2012–15–07, 

amendment 39–17136 (77 FR 46940, August 

7, 2012). 

(c) Applicability 

This AD applies to the following Glasflugel 

models and serial number (S/N) gliders, 

certificated in any category: 

(1) Club Libelle 205, all S/Ns. 

(2) Kestrel, all S/Ns, except S/N 85, 110, 

and 125. 

(3) Mosquito, all S/Ns. 

(4) Standard Libelle-201B, S/N 169. 

(d) Subject 

Air Transport Association of America 

(ATA) Code 27: Flight Controls. 

(e) Reason 

This AD was prompted by mandatory 

continuing airworthiness information (MCAI) 

originated by an aviation authority of another 

country to identify and correct an unsafe 

condition on an aviation product. The MCAI 

describes the unsafe condition as corrosion 

damage to the elevator control rod that could 

lead to failure of the elevator control rod, 

possibly resulting in loss of control of the 

glider. We are issuing this AD to require 

actions to address the unsafe condition on 

these products. 

(f) Actions and Compliance 

Unless already done, do the following 

actions: 

(1) Within 30 days after September 11, 

2012 (the effective date of AD 2012–15–07), 

inspect the elevator control rod in the 

vertical fin following Glasfaser FlugzeugService GmbH Technical Note TN 201–40, 

TN 205–27, TN 206–26, TN 303–25, TN 304– 

12, TN 401–30, TN 501–10, and TN 604–11, 

Revision 1, dated July 14, 2011 (EASA 

translation approval dated September 9, 

2011), as applicable to glider model. 

(2) If you find any discrepancy in the 

inspection required by paragraph (f)(1) of this 

AD, before further flight, replace the elevator 

control rod with an elevator control rod that 

does not have a control bore hole on the side 

following Glasfaser Flugzeug-Service GmbH 

Technical Note TN 201–40, TN 205–27, TN 

206–26, TN 303–25, TN 304–12, TN 401–30, 

TN 501–10, and TN 604–11, Revision 1, 

dated July 14, 2011 (EASA translation 

approval dated September 9, 2011), as 

applicable to glider model. 

(3) Within 9 months after September 11, 

2012 (the effective date of AD 2012–15–07), 

unless already done as required by paragraph 

(f)(2) of this AD, replace the elevator control 

rod in the vertical fin with an elevator 

control rod that does not have a control bore 

hole on the side following Glasfaser 

Flugzeug-Service GmbH Technical Note TN 

201–40, TN 205–27, TN 206–26, TN 303–25, 

TN 304–12, TN 401–30, TN 501–10, and TN 

604–11, Revision 1, dated July 14, 2011 

(EASA translation approval dated September 

9, 2011), as applicable to glider model. 

(4) As of September 11, 2012 (the effective 

date of AD 2012–15–07), do not install an 

elevator control rod with a control bore hole 

on the side. 

Note to paragraphs (f)(2), (f)(3), and (f)(4) 

of this AD: The replacement control rod has 

an additional drain hole at the rod bottom 

between the forks and is an acceptable 

configuration for compliance. 

(5) The actions mandated by this AD may 

be accomplished by persons authorized to 

perform maintenance in accordance with 14 

CFR 43.3 and by persons authorized to 

approve aircraft for return to service after 

maintenance in accordance with 14 CFR 

43.7. 

(g) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, Standards Office, 

FAA, has the authority to approve AMOCs 

for this AD, if requested using the procedures 


wreier-aviles on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Rules and Regulations 55413 

found in 14 CFR 39.19. Send information to 

ATTN: Jim Rutherford, Aerospace Engineer, 

FAA, Small Airplane Directorate, 901 Locust, 

Room 301, Kansas City, Missouri 64106; 

telephone: (816) 329–4165; fax: (816) 329– 

4090; email: jim.rutherford@faa.gov. Before 

using any approved AMOC on any airplane 

to which the AMOC applies, notify your 

appropriate principal inspector (PI) in the 

FAA Flight Standards District Office (FSDO), 

or lacking a PI, your local FSDO. 

(2) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 

(3) Reporting Requirements: For any 

reporting requirement in this AD, a federal 

agency may not conduct or sponsor, and a 

person is not required to respond to, nor 

shall a person be subject to a penalty for 

failure to comply with a collection of 

information subject to the requirements of 

the Paperwork Reduction Act unless that 

collection of information displays a current 

valid OMB Control Number. The OMB 

Control Number for this information 

collection is 2120–0056. Public reporting for 

this collection of information is estimated to 

be approximately 5 minutes per response, 

including the time for reviewing instructions, 

completing and reviewing the collection of 

information. All responses to this collection 

of information are mandatory. Comments 

concerning the accuracy of this burden and 

suggestions for reducing the burden should 

be directed to the FAA at: 800 Independence 

Ave. SW., Washington, DC 20591, Attn: 

Information Collection Clearance Officer, 

AES–200. 

(h) Related Information 

Refer to MCAI European Aviation Safety 

Agency (EASA) AD No.: 2011–0213R1, dated 

November 8, 2011; and Glasfaser FlugzeugService GmbH Technical Note TN 201–40, 

TN 205–27, TN 206–26, TN 303–25, TN 304– 

12, TN 401–30, TN 501–10, and TN 604–11, 

Revision 1, dated July 14, 2011 (EASA 

translation approval dated September 9, 

2011), for related information. For service 

information related to this AD, contact 

Glasfaser Flugzeug-Service Hansjo ̈rg 

Streifeneder GmbH, D–72582 Grabenstetten, 

Germany; phone: +49(0)73821032, fax: 

+49(0)73821629; email: info@streifly.de; 

Internet: www.streifly.de/. You may review 

copies of the referenced service information 

at the FAA, Small Airplane Directorate, 901 

Locust, Kansas City, Missouri 64106. For 

information on the availability of this 

material at the FAA, call (816) 329–4148. 

(i) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless the AD specifies otherwise. 

(3) The following information was 

approved for IBR on September 11, 2012. 

(i) Glasfaser Flugzeug Service GmbH 

Technical Note TN 201–40, TN 205–27, TN 

206–26, TN 303–25, TN 304–12, TN 401–30, 

TN 501–10, and TN 604–11, Revision 1, 

dated July 14, 2011. 

(ii) Reserved. 

(4) For Glasflugel service information 

identified in this AD, contact Glasfaser 

Flugzeug-Service Hansjo ̈rg Streifeneder 

GmbH, D–72582 Grabenstetten, Germany; 

phone: +49(0)73821032, fax: +49(0)73821629; 

email: info@streifly.de; Internet: www.streifly.

de/. 

(5) You may view this service information 

at FAA, Small Airplane Directorate, 901 

Locust, Kansas City, Missouri 64106. For 

information on the availability of this 

material at the FAA, call (816) 329–4148. 

(6) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

202–741–6030, or go to: http://www.archives.

gov/federal-register/cfr/index.html. 

Issued in Kansas City, Missouri, on August 

31, 2012. 

Earl Lawrence, 

Manager, Small Airplane Directorate, Aircraft 

Certification Service. 

[FR Doc. 2012–22039 Filed 9–7–12; 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–2012–N–0902] 

New Animal Drugs; Chorionic 

Gonadotropin; Naloxone; 

Oxymorphone; Oxytocin 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect the 

withdrawal of approval of four new 

animal drug applications (NADAs) at 

the sponsor’s request because the 

products are no longer manufactured or 

marketed. 

DATES: This rule is effective September 

20, 2012. 

FOR FURTHER INFORMATION CONTACT: 

David Alterman, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855; 240–453–6843; 

email: david.alterman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

sponsors of the four approved NADAs 

listed in table 1 of this document have 

requested that FDA withdraw approval 

because the products are no longer 

manufactured or marketed: 

TABLE 1—WITHDRAWAL OF APPROVAL REQUESTS

NADA No. Trade name (drug) Applicant Citation in 21 CFR 

030–525 ............ NUMORPHAN (oxymorphone hydrochloride) Injection.Endo Pharmaceuticals Inc., 100 Painters Dr., Chadds Ford, PA 

19317.

522.1642 

035–825 ............ NARCAN (naloxone hydrochloride) Injection.Endo Pharmaceuticals Inc., 100 Painters Dr., Chadds Ford, PA 

19317.

522.1462 

046–822 ............ VETOCIN (oxytocin) Injection ...... United Vaccines, A Harlan Sprague Dawley, Inc., Co., P.O. Box 

4220, Madison, WI 53711.

522.1680 

103–090 ............ CHORTROPIN (chorionic 

gonadotropin) Injection.

United Vaccines, A Harlan Sprague Dawley, Inc., Co., P.O. Box 

4220, Madison, WI 53711.

522.1081 

Elsewhere in this issue of the Federal 

Register, FDA gave notice that approval 

of NADAs 030–525, 035–825, 046–822, 

and 103–090, and all supplements and 

amendments thereto, is withdrawn, 

effective September 20, 2012. As 

provided in the regulatory text of this 

document, the animal drug regulations 

are amended to reflect these voluntary 

withdrawals of approval. 

Following these withdrawals of 

approval, Endo Pharmaceuticals Inc. 

and United Vaccines, A Harlan Sprague 

Dawley, Inc., Co., will no longer be the 

sponsor of an approved application. 

Accordingly, 21 CFR 510.600(c) is being 

amended to remove the entries for these 

firms. 


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