76892 Federal Register / Vol. 76, No. 237 / Friday, December 9, 2011 / Rules and Regulations 

The FAA subsequently published a rule 

in the Federal Register of June 16, 2011 

that delayed the effective date until 

further notice. An amendment, 

published in the Federal Register of 

October 20, 2011, further modified the 

rule. This action is the result of 

satisfactory flight inspections for the 

Federal airways affected by the 

relocation of the Anchorage VHF 

Omnidirectional Range (VOR). 

DATES: Effective date 0901 UTC. This 

announcement is effective February 9, 

2012. The effective date of FR Doc. 

2011–10240, published on April 28, 

2011 (FR 76 23687), delayed by FR Doc. 

2011–14711, published on June 16, 

2011, and amended by FR Doc. 2011– 

27118, published October 20, 2011 (FR 

76 65106) is February 9, 2012. The 

Director of the Federal Register 

approves this incorporation by reference 

action under 1 CFR part 51, subject to 

the annual revision of FAA Order 

7400.9 and publication of conforming 

amendments. 

FOR FURTHER INFORMATION CONTACT: 

Colby Abbott, Airspace, Regulations and 

ATC Procedures Group, Office of 

Mission Support Services, Federal 

Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone: (202) 

267–8783. 

SUPPLEMENTARY INFORMATION: 

Background 

Federal Register Document FAA– 

2011–0010, Airspace Docket No. 11– 

AAL–1, published on April 28, 2011 (76 

FR 23687), amends all Federal airways 

affected by the relocation of the 

Anchorage VOR navigation aid effective 

June 30, 2011. Due to a failed flight 

inspection, the FAA subsequently 

published in the Federal Register of 

June 16, 2011 a rule delaying the 

effective date from June 30, 2011, until 

further notice (76 FR 35097). Upon 

further inspection, the FAA removed 

two Federal airways in an amendment 

published in the Federal Register of 

October 20, (76 FR 65106). Two Federal 

airways were removed to be reworked as 

a separate rulemaking action. 

Satisfactory flight inspection results for 

the remaining Federal airways 

contained in the rule, as delayed and 

amended, have been accomplished the 

effective date is now established. 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. Therefore, this regulation (1) Is 

not a significant regulatory action under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

Regulatory Evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that will only affect air 

traffic procedures and air navigation, it 

is certified that this rule will not have 

a significant economic impact on a 

substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the United States Code. 

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. 

This rulemaking is promulgated 

under the authority described in subtitle 

VII, part A, subpart I, section 40103. 

Under that section, the FAA is charged 

with prescribing regulations to assign 

the use of the airspace necessary to 

ensure the safety of aircraft and the 

efficient use of airspace. This regulation 

is within the scope of that authority as 

it modifies federal airways in Alaska. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

PART 71—AMENDED 

Announcement of Effective Date 

■ The effective date of Airspace Docket 

No. 11–AAL–1, published on April 28, 

2011 (76 FR 23687), delayed on June 16, 

2011 (76 FR 35097), and amended on 

October 20, 2011 (76 FR 65106) is 

hereby established as February 9, 2012. 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 

1963 Comp., p. 389. 

Issued in Washington, DC, on November 

30, 2011. 

Gary A. Norek, 

Acting Manager, Airspace, Regulations and 

ATC Procedures Group. 

[FR Doc. 2011–31461 Filed 12–8–11; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Parts 730, 734, 736, 742, 744, 

and 745 

[Docket No. 111031662–1691–01] 

RIN 0694–AF44 

Updated Statements of Legal Authority 

To Reflect Continuation of Emergency 

Declared in Executive Order 12938 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Final rule. 

SUMMARY: This rule updates the Code of 

Federal Regulations (CFR) legal 

authority citations for the Export 

Administration Regulations (EAR) to 

replace citations to the President’s 

Notice of November 4, 2010, 

Continuation of Emergency Regarding 

Weapons of Mass Destruction, with 

citations to the President’s Notice of 

November 9, 2011 on the same subject. 

BIS is making these changes to keep the 

CFR’s legal authority citations for the 

EAR current. 

DATES: Effective Date: December 9, 2011. 

ADDRESSES: Comments concerning this 

rule should be sent to 

publiccomments@bis.doc.gov, or to 

Regulatory Policy Division, Bureau of 

Industry and Security, Room H2099B, 

U.S. Department of Commerce, 

Washington, DC 20230. Please refer to 

regulatory identification number (RIN) 

0694–AF44 in all comments, and in the 

subject line of email comments. 

FOR FURTHER INFORMATION CONTACT: 

William Arvin, Regulatory Policy 

Division, Bureau of Industry and 

Security, telephone: (202) 482–2440. 

SUPPLEMENTARY INFORMATION: 

Background 

In Executive Order 12938 of 

November 14, 1994 (59 FR 59099, 3 

CFR, 1994 Comp., p. 950), the President 

declared a national emergency with 

respect to the unusual and extraordinary 

threat to the national security, foreign 

policy and economy of the United States 

posed by the proliferation of nuclear, 

biological and chemical weapons and 

the means of delivering such weapons. 

That emergency has been continued in 

effect through successive annual 

presidential notices. The authority for 

parts 730, 734, 736, 742, 744 and 745 of 

the EAR (15 CFR parts 730, 734, 736, 

742, 744 and 745) rests in part on E.O. 

12938, as amended, and on the 

successive annual notices continuing 

the emergency. This rule revises the 

authority citations in those parts of the 


sroberts on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 76, No. 237 / Friday, December 9, 2011 / Rules and Regulations 76893 

CFR to cite the notice of November 9, 

2011, which is the most recent such 

annual Presidential notice, and to 

remove the citation to the notice of 

November 4, 2010 on the same topic. 

BIS is making these revisions so that 

title 15 of the CFR will cite the current 

authority for the parts mentioned above. 

This rule is purely procedural, and 

makes no changes other than to revise 

CFR authority citations paragraphs. It 

does not change the text of any section 

of the EAR, nor does it alter any right, 

obligation or prohibition that applies to 

any person under the EAR. 

Rulemaking Requirements 

1. Executive Orders 13563 and 12866 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). This rule does not impose any 

regulatory burden on the public and is 

consistent with the goals of Executive 

Order 13563. This rule has been 

determined not to be a significant rule 

for purposes of Executive Order 12866. 

2. Notwithstanding any other 

provision of law, no person is required 

to respond to, nor shall any person be 

subject to a penalty for failure to comply 

with, a collection of information subject 

to the requirements of the Paperwork 

Reduction Act of 1995 (PRA), 44 U.S.C. 

3501 et seq., unless that collection of 

information displays a currently valid 

Office of Management and Budget 

(OMB) Control Number. This rule does 

not involve any collection of 

information. 

3. This rule does not contain policies 

with Federalism implications as that 

term is defined under Executive Order 

13132. 

4. The Department finds that there is 

good cause under 5 U.S.C. 553(b)(3)(B) 

to waive the provisions of the 

Administrative Procedure Act requiring 

prior notice and the opportunity for 

public comment because they are 

unnecessary. This rule only updates 

legal authority citations and is 

nondiscretionary. This rule does not 

alter any right, obligation or prohibition 

that applies to any person under the 

EAR. Because these revisions are not 

substantive changes, it is unnecessary to 

provide notice and opportunity for 

public comment. In addition, the 30-day 

delay in effectiveness required by 5 

U.S.C. 553(d) is not applicable because 

this rule is not a substantive rule. 

Because neither the Administrative 

Procedure Act nor any other law 

requires that notice of proposed 

rulemaking and an opportunity for 

public comment be given for this rule, 

the analytical requirements of the 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.) are not applicable. 

List of Subjects 

15 CFR Part 730 

Administrative practice and 

procedure, Advisory committees, 

Exports, Reporting and recordkeeping 

requirements, Strategic and critical 

materials. 

15 CFR Part 734 

Administrative practice and 

procedure, Exports, Inventions and 

patents, Research, Science and 

technology. 

15 CFR Part 736 

Exports. 

15 CFR Part 742 

Exports, Terrorism. 

15 CFR Part 744 

Exports, Reporting and recordkeeping 

requirements, Terrorism. 

15 CFR Part 745 

Administrative practice and 

procedure, Chemicals, Exports, Foreign 

trade, Reporting and recordkeeping 

requirements. 

Accordingly, the EAR (15 CFR parts 

730–774) is amended as follows: 

PART 730—[AMENDED] 

■ 1. The authority citation for 15 CFR 

part 730 is revised to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 

7430(e); 22 U.S.C. 287c; 22 U.S.C. 2151 note; 

22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 30 

U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42 

U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; 

50 U.S.C. app. 5; 22 U.S.C. 7201 et seq.; 22 

U.S.C. 7210; E.O. 11912, 41 FR 15825, 3 CFR, 

1976 Comp., p. 114; E.O. 12002, 42 FR 35623, 

3 CFR, 1977 Comp., p. 133; E.O. 12058, 43 

FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 

12214, 45 FR 29783, 3 CFR, 1980 Comp., p. 

256; E.O. 12851, 58 FR 33181, 3 CFR, 1993 

Comp., p. 608; E.O. 12854, 58 FR 36587, 3 

CFR, 1993 Comp., p. 179; E.O. 12918, 59 FR 

28205, 3 CFR, 1994 Comp., p. 899; E.O. 

12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 

950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 

Comp., p. 356; E.O. 12981, 60 FR 62981, 3 

CFR, 1995 Comp., p. 419; E.O. 13020, 61 FR 

54079, 3 CFR, 1996 Comp., p. 219; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 

Comp., p. 208; E.O. 13222, 66 FR 44025, 3 

CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 

49079, 3 CFR, 2001 Comp., p. 786; E.O. 

13338, 69 FR 26751, 3 CFR, 2004 Comp., p. 

168; Notice of January 13, 2011, 76 FR 3009 

(January 18, 2011); Notice of August 12, 

2011, 76 FR 50661 (August 16, 2011); Notice 

of November 9, 2011, 76 FR 70319 

(November 10, 2011). 

PART 734—[AMENDED] 

■ 2. The authority citation for 15 CFR 

part 734 is revised to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 

3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 

FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; Notice of August 12, 2011, 76 

FR 50661 (August 16, 2011); Notice of 

November 9, 2011, 76 FR 70319 (November 

10, 2011). 

PART 736—[AMENDED] 

■ 3. The authority citation for 15 CFR 

part 736 is revised to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 22 U.S.C. 2151 note; E.O. 

12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 

950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 

Comp., p. 219; E.O. 13026, 61 FR 58767, 3 

CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 

44025, 3 CFR, 2001 Comp., p. 783; E.O. 

13338, 69 FR 26751, 3 CFR, 2004 Comp., p. 

168; Notice of August 12, 2011, 76 FR 50661 

(August 16, 2011); Notice of November 9, 

2011, 76 FR 70319 (November 10, 2011). 

PART 742—[AMENDED] 

■ 4. The authority citation for 15 CFR 

part 742 is revised to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 

42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 

U.S.C. 7210; Sec. 1503, Pub. L. 108–11, 117 

Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 

1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 

3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 

FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; Presidential Determination 

2003–23 of May 7, 2003, 68 FR 26459, May 

16, 2003; Notice of August 12, 2011, 76 FR 

50661 (August 16, 2011); Notice of November 

9, 2011, 76 FR 70319 (November 10, 2011). 

PART 744—[AMENDED] 

■ 5. The authority citation for 15 CFR 

part 744 is revised to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 

42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 

U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 

1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 

3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 

FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 

12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 

356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 

Comp., p. 228; E.O. 13099, 63 FR 45167, 3 

CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 

44025, 3 CFR, 2001 Comp., p. 783; E.O. 

13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 

786; Notice of January 13, 2011, 76 FR 3009 


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76894 Federal Register / Vol. 76, No. 237 / Friday, December 9, 2011 / Rules and Regulations 

(January 18, 2011); Notice of August 12, 

2011, 76 FR 50661 (August 16, 2011); Notice 

of November 9, 2011, 76 FR 70319 

(November 10, 2011). 

PART 745—[AMENDED] 

■ 6. The authority citation for 15 CFR 

part 745 is revised to read as follows: 

Authority: 50 U.S.C. 1701 et seq.; E.O. 

12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 

950; Notice of November 9, 2011, 76 FR 

70319 (November 10, 2011). 

Dated: December 5, 2011. 

Kevin J. Wolf, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2011–31687 Filed 12–8–11; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2011–N–0003] 

New Animal Drugs for Use in Animal 

Feeds; Tilmicosin 

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 supplemental new animal 

drug application (NADA) filed by 

Elanco Animal Health, a division of Eli 

Lilly & Co. The supplemental NADA 

provides for use of tilmicosin Type C 

medicated feeds by veterinary feed 

directive for the control of bovine 

respiratory disease in groups of beef and 

nonlactating dairy cattle. 

DATES: This rule is effective December 9, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Cindy L. Burnsteel, Center for 

Veterinary Medicine (HFV–130), Food 

and Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, (240) 276– 

8341, email: 

cindy.burnsteel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Elanco 

Animal Health, a division of Eli Lilly & 

Co., Lilly Corporate Center, 

Indianapolis, IN 46285, filed a 

supplement to NADA 141–064 for 

PULMOTIL 90 (tilmicosin phosphate) 

Type A medicated article. The 

supplemental NADA provides for the 

use of tilmicosin Type C medicated 

feeds by veterinary feed directive for the 

control of bovine respiratory disease 

(BRD) associated with Mannheimia 

haemolytica, Pasteurella multocida, and 

Histophilus somni in groups of beef and 

nonlactating dairy cattle where active 

BRD has been diagnosed in at least 10 

percent of the animals in the group. The 

supplemental NADA is approved as of 

August 19, 2011, and 21 CFR 558.4 and 

558.618 are amended 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. 

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

Federal Food, Drug, and Cosmetic Act 

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

supplemental approval qualifies for 

3 years of marketing exclusivity 

beginning on the date of approval. 

The Agency has carefully considered 

the potential environmental impact of 

this action and has concluded that the 

action will not have a significant impact 

on the human environment and that an 

environmental impact statement is not 

required. FDA’s finding of no significant 

impact and the evidence supporting that 

finding, contained in an environmental 

assessment, may be seen in the Division 

of Dockets Management (address above) 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

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 558 

Animal drugs, Animal feeds. 

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 part 558 is amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

§ 558.4 [Amended] 

■ 2. In paragraph (d) of § 558.4, in the 

‘‘Category II’’ table, in the ‘‘Type B 

maximum (100x)’’ column, in the entry 

for ‘‘Tilmicosin’’, remove ‘‘18.2 g/lb 

(4.0%)’’ and in its place add ‘‘37.9 g/lb 

(8.35%)’’. 

■ 3. In § 558.618, revise paragraphs (a), 

(c), and (e) to read as follows: 

§ 558.618 Tilmicosin. 

(a) Specifications. Type A medicated 

article containing 90.7 grams (g) per 

pound tilmicosin as tilmicosin 

phosphate (200 g per kilogram). 

* * * * * 

(c) Special considerations—(1) 

Tilmicosin medicated feeds are 

restricted to use under a veterinary feed 

directive (VFD). See § 558.6 of this 

chapter for required label statements 

and other limitations. 

(2) VFDs for tilmicosin phosphate 

shall not be refilled. 

(3) Labeling of tilmicosin Type B or 

Type C medicated feeds must bear the 

following warnings: 

(i) Do not allow horses or other 

equines access to feeds containing 

tilmicosin. 

(ii) Use of antibacterial drugs in the 

absence of a susceptible bacterial 

infection is unlikely to provide benefit 

to treated animals and may increase the 

risk of the development of drug-resistant 

pathogenic bacteria. 

(4) Special considerations for use of 

tilmicosin medicated swine feeds 

include the following: 

(i) The expiration date of VFDs for 

tilmicosin must not exceed 90 days from 

the time of issuance. 

(ii) Labeling of tilmicosin Type B or 

Type C medicated feeds for swine must 

bear the following warning: ‘‘Do not use 

in any feeds containing bentonite. 

Bentonite in feeds may affect the 

efficacy of tilmicosin.’’ 

(iii) Feed containing tilmicosin shall 

not be fed to pigs for more than 21 days 

during each phase of production 

without ceasing administration for 

reevaluation of antimicrobial use by a 

licensed veterinarian before reinitiating 

a further course of therapy with an 

appropriate antimicrobial. 

(5) Special consideration for use of 

tilmicosin medicated cattle feeds 

include the following: 

(i) The expiration date of VFDs for 

cattle must not exceed 45 days from the 

time of issuance. 

(ii) Labeling of tilmicosin Type B or 

Type C medicated feeds for cattle must 

bear the following warning: ‘‘Do not use 

in any feeds containing bentonite, 

cottonseed meal, or cottonseed hulls. 

Bentonite, cottonseed meal, or 

cottonseed hulls in feeds may affect the 

efficacy of tilmicosin.’’ 

(iii) To assure both food safety and 

responsible use in cattle, administration 

of feed containing tilmicosin to cattle 


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