Federal Register / Vol. 75, No. 53 / Friday, March 19, 2010 / Rules and Regulations 13225 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2009–0452; Directorate 

Identifier 2007–NM–326–AD; Amendment 

39–16223; AD 2010–05–13] 

RIN 2120–AA64 

Airworthiness Directives; The Boeing 

Company Model 737–100, –200, –200C, 

–300, –400, and –500 Series Airplanes 

Correction 

In rule document 2010–4511 

beginning on page 10658 in the issue of 

Tuesday, March 9, 2010, make the 

following correction: 

On page 10660, in the table, under the 

heading ‘‘Number of U.S.–registered 

airplanes’’, the second entry ‘‘87’’ should 

read ‘‘787’’. 

[FR Doc. C1–2010–4511 Filed 3–18–10; 8:45 am] 

BILLING CODE 1505–01–D 

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; Flunixin 

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 an original abbreviated new 

animal drug application (ANADA) filed 

by Cross Vetpharm Group Ltd. The 

ANADA provides for the use of flunixin 

meglumine injectable solution in swine. 

DATES: This rule is effective March 19, 

2010. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–170), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Cross 

Vetpharm Group Ltd., Broomhill Rd., 

Tallaght, Dublin 24, Ireland, filed 

ANADA 200–489 that provides for use 

of FLUNAZINE–S (flunixin meglumine) 

Injectable Solution in swine for control 

of pyrexia associated with swine 

respiratory disease. Cross Vetpharm 

Group Ltd.’s FLUNAZINE–S is 

approved as a generic copy of 

BANAMINE–S, sponsored by ScheringPlough Animal Health Corp. under 

NADA 101–479. The ANADA is 

approved as of March 1, 2010, and the 

regulations are amended in 21 CFR 

522.970 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. 

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 

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 § 522.970, revise paragraphs 

(b)(1) and (b)(4) to read as follows: 

§ 522.970 Flunixin. 

* * * * * 

(b) * * * 

(1) See Nos. 000061, 055529, and 

061623 for use as in paragraph (e) of this 

section. 

* * * * * 

(4) See No. 059130 for use as in 

paragraphs (e)(1) and (e)(2) of this 

section. 

* * * * * 

Dated: March 12, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–6038 Filed 3–18–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1140 

[Docket No. FDA–1995–N–0259] (formerly 

Docket No. 1995N–0253) 

RIN 0910–AG33 

Regulations Restricting the Sale and 

Distribution of Cigarettes and 

Smokeless Tobacco To Protect 

Children and Adolescents 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is reissuing a 

final rule restricting the sale, 

distribution, and use of cigarettes and 

smokeless tobacco. As required by the 

Family Smoking Prevention and 

Tobacco Control Act (Tobacco Control 

Act), FDA is issuing a final rule that is 

identical to the provisions of the final 

rule on cigarettes and smokeless tobacco 

published by FDA in 1996, with certain 

required exceptions. The rule prohibits 

the sale of cigarettes and smokeless 

tobacco to individuals under the age of 

18 and imposes specific marketing, 

labeling, and advertising requirements. 

Elsewhere in this issue of the Federal 

Register, FDA is issuing an advance 

notice of proposed rulemaking to obtain 

information related to the regulation of 

outdoor advertising of cigarettes and 

smokeless tobacco. 

DATES: This rule is effective June 22, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Annette Marthaler, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850–3229, 877–287– 

1373, annette.marthaler@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

II. Overview of the Final Rule 

III. Scientific Information That Has Become 

Available Since the Publication of the 1996 

Final Rule 

A. Access 

B. Marketing 

IV. Legal Authority 

V. Executive Order 12866 


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