Implantation or Injectable Dosage Form New Animal Drugs; Flunixin, 13225 [2010-6038]

Download as PDF Federal Register / Vol. 75, No. 53 / Friday, March 19, 2010 / Rules and Regulations 21 CFR Part 522 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. [Docket No. FDA–2010–N–0002] List of Subjects in 21 CFR Part 522 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 Implantation or Injectable Dosage Form New Animal Drugs; Flunixin AGENCY: Animal drugs. Food and Drug Administration, HHS. erowe on DSK5CLS3C1PROD with RULES 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 VerDate Nov<24>2008 14:13 Mar 18, 2010 Jkt 220001 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. * * * * * PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 13225 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 E:\FR\FM\19MRR1.SGM 19MRR1

Agencies

[Federal Register Volume 75, Number 53 (Friday, March 19, 2010)]
[Rules and Regulations]
[Page 13225]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6038]


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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.

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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, e-mail: 
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 Schering-Plough 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.

0
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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. In Sec.  522.970, revise paragraphs (b)(1) and (b)(4) to read as 
follows:


Sec.  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
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