Federal Register / Vol. 75, No. 40 / Tuesday, March 2, 2010 / Rules and Regulations 9333 

absence of extraordinary circumstances. 

The FAA has determined this 

rulemaking action qualifies for the 

categorical exclusion identified in 

paragraph 312f and involves no 

extraordinary circumstances. 

Regulations That Significantly Affect 

Energy, Supply, Distribution, or Use 

The FAA has analyzed this NPRM 

under Executive Order 13211, Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use (May 18, 2001). We 

have determined that it is not a 

‘‘significant energy action’’ under the 

executive order because it is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866, and it is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. 

Availability of Rulemaking Documents 

You can get an electronic copy of 

rulemaking documents using the 

Internet by— 

1. Searching the Federal eRulemaking 

Portal (http://www.regulations.gov); 

2. Visiting the FAA’s Regulations and 

Policies Web page at http:// 

www.faa.gov/regulations_policies/ or 

3. Accessing the Government Printing 

Office’s Web page at http:// 

www.gpoaccess.gov/fr/index.html. 

You can also get a copy by sending a 

request to the Federal Aviation 

Administration, Office of Rulemaking, 

ARM–1, 800 Independence Avenue, 

SW., Washington, DC 20591, or by 

calling (202) 267–9680. Make sure to 

identify the amendment number or 

docket number of this rulemaking. 

You may search the electronic form of 

all comments received into any of our 

dockets by the name of the individual 

submitting the comment (or signing the 

comment, if submitted on behalf of an 

association, business, labor union, etc.). 

You may review DOT’s complete 

Privacy Act statement in the Federal 

Register published on April 11, 2000 

(Volume 65, Number 70; Pages 19477– 

78) or you may visit http:// 

DocketsInfo.dot.gov. 

Small Business Regulatory Enforcement 

Fairness Act 

The Small Business Regulatory 

Enforcement Fairness Act (SBREFA) of 

1996 requires FAA to comply with 

small entity requests for information or 

advice about compliance with statutes 

and regulations within its jurisdiction. If 

you are a small entity and you have a 

question regarding this document, you 

may contact your local FAA official, or 

the person listed under the FOR FURTHER

INFORMATION CONTACT heading at the 

beginning of the preamble. You can find 

out more about SBREFA on the Internet 

at http://www.faa.gov/ 

regulations_policies/rulemaking/ 

sbre_act/. 

List of Subjects in 14 CFR part 91 

Aircraft, Noise control, Reporting and 

recordkeeping requirements. 

The Amendment 

■ In consideration of the foregoing, the 

Federal Aviation Administration 

amends Chapter 1 of Title 14, Code of 

Federal Regulations, as follows: 

PART 91—GENERAL OPERATING AND 

FLIGHT RULES 

■ 1. The authority citation for part 91 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 1155, 40103, 

40113, 40120, 44101, 44111, 44701, 44709, 

44711, 44712, 44715, 44716, 44717, 44722, 

46306, 46315, 46316, 46504, 46506, 46507, 

47122, 47508, 47528–47531, articles 12 and 

29 of the Convention on International Civil 

Aviation (61 stat 1180). 

■ 2. Amend § 91.703 by adding 

paragraph (a)(5) to read as follows: 

§ 91.703 Operations of civil aircraft of U.S. 

registry outside of the United States. 

(a) * * * 

(5) For aircraft subject to ICAO Annex 

16, carry on board the aircraft 

documents that summarize the noise 

operating characteristics and 

certifications of the aircraft that 

demonstrate compliance with this part 

and part 36 of this chapter. 

* * * * * 

Issued in Washington, DC, on February 18, 

2010. 

J. Randolph Babbitt, 

Administrator. 

[FR Doc. 2010–4316 Filed 3–1–10; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2010–N–0002] 

Implantation or Injectable Dosage 

Form New Animal Drugs; 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 a dose range for use of an 

injectable solution of tilmicosin 

phosphate for treatment of respiratory 

disease in cattle and additional 

pathogens for which this therapy is 

effective. 

DATES: This rule is effective March 2, 

2010. 

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, e-mail: 

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 140–929 for 

MICOTIL 300 (tilmicosin injection, 

USP) Injection, available by veterinary 

prescription for use in the treatment and 

control of respiratory disease in cattle 

and the treatment of respiratory disease 

in sheep. The supplemental NADA 

establishes a dose range and adds 

pathogens for which this therapy is 

effective in the management of bovine 

respiratory disease. As a consequence of 

revising the dosage, the preslaughter 

withdrawal period has been 

recalculated. The supplemental NADA 

is approved as of December 30, 2009, 

and the regulations in 21 CFR 522.2471 

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 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. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

WReier-Aviles on DSKGBLS3C1PROD with RULES

9334 Federal Register / Vol. 75, No. 40 / Tuesday, March 2, 2010 / Rules and Regulations 

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 522 

Animal drugs. 

■ 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 522 is amended as follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 2. In § 522.2471, revise paragraphs 

(e)(1)(i), (e)(1)(ii), and (e)(1)(iii) to read 

as follows: 

§ 522.2471 Tilmicosin. 

* * * * * 

(e) * * * 

(1) * * * 

(i) Amount. 10 to 20 milligrams per 

kilograms (mg/kg) of body weight as a 

single subcutaneous injection. 

(ii) Indications for use. For the 

treatment of bovine respiratory disease 

(BRD) associated with Mannheimia 

haemolytica, Pasteurella multocida, and 

Histophilus somni. For the control of 

respiratory disease in cattle at high risk 

of developing BRD associated with M. 

haemolytica. 

(iii) Limitations. Do not use in female 

dairy cattle 20 months of age or older. 

Use of this antibiotic in this class of 

cattle may cause milk residues. Do not 

slaughter within 42 days of last 

treatment. 

* * * * * 

Dated: February 16, 2010. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–4206 Filed 3–1–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2010–N–0002] 

New Animal Drugs for Use in Animal 

Feeds; Chlortetracycline 

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 ADM 

Alliance Nutrition, Inc. The 

supplemental NADA provides for use of 

a higher concentration chlortetracycline 

Type A medicated article for the 

manufacture of medicated feeds for 

livestock and poultry. 

DATES: This rule is effective March 2, 

2010. 

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, e-mail: 

cindy.burnsteel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: ADM 

Alliance Nutrition, Inc., 1000 North 

30th St., Quincy, IL 62305–3115, filed a 

supplement to NADA 48–480 that 

provides for the use of CHLORATET 50 

(chlortetracycline), a Type A medicated 

article containing 50 grams of 

chlortetracycline per pound, for the 

manufacture of medicated feeds for 

livestock and poultry. The supplement 

provides for use of Type A medicated 

articles containing 90 or 100 grams of 

chlortetracycline per pound. The 

supplemental NADA is approved as of 

January 7, 2010, and the regulations are 

amended in 21 CFR 558.128 to reflect 

the approval. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

information. Therefore, a freedom of 

information summary is not required. 

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. 

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 Subject 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. 

■ 2. In § 558.128, revise paragraph (b)(2) 

to read as follows: 

§ 558.128 Chlortetracycline. 

* * * * * 

(b) * * * 

(2) No. 012286: 50, 90, or 100 grams 

per pound of Type A medicated article. 

* * * * * 

Dated: February 16, 2010. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–4205 Filed 3–1–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2520 

RIN 1210–AB21 

Multiemployer Pension Plan 

Information Made Available on 

Request 

AGENCY: Employee Benefits Security 

Administration, Labor. 

ACTION: Final rule. 

SUMMARY: This document contains a 

final rule implementing section 101(k) 

of the Employee Retirement Income 

Security Act of 1974, as amended by the 

Pension Protection Act of 2006. Section 

101(k) requires the administrator of a 

multiemployer plan to provide copies of 

certain actuarial and financial 

documents about the plan to 

participants, beneficiaries, employee 

representatives and contributing 

employers upon request. The final rule 

affects plan administrators, participants 

and beneficiaries and contributing 

employers of multiemployer plans. 

DATES: This final rule is effective on 

April 1, 2010. 

FOR FURTHER INFORMATION CONTACT: June 

Solonsky or Stephanie L. Ward, Office 

of Regulations and Interpretations, 

Employee Benefits Security 

Administration, (202) 693–8500. This is 

not a toll-free number. 

SUPPLEMENTARY INFORMATION: 

A. Background 

Section 101(k) of the Employee 

Retirement Income Security Act 

WReier-Aviles on DSKGBLS3C1PROD with RULES