Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin, 9049 [E9-4304]

Download as PDF Federal Register / Vol. 74, No. 39 / Monday, March 2, 2009 / Rules and Regulations Request for Referendum will be conducted in accordance with the Act and applicable regulations. Pursuant to 5 U.S.C. 553, good cause is found for not postponing the effective date of the action until 30 days after publication in the Federal Register in order to conduct the Request for Referendum within the timeframes that appear in the Act. List of Subjects in 7 CFR Part 1220 Administrative practice and procedure, Advertising, Agricultural research, Marketing agreements, Reporting and recordkeeping requirements, Soybeans and soybean products. ■ For the reasons set forth in the preamble, 7 CFR part 1220 is amended as follows: PART 1220—SOYBEAN PROMOTION, RESEARCH, AND CONSUMER INFORMATION 1. The authority citation for part 1220 continues to read as follows: ■ Authority: 7 U.S.C. 6301–6311 and 7 U.S.C. 7401. 21 CFR Part 522 [Docket No. FDA–2009–N–0665] Food and Drug Administration, Final rule. The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a 1-percent ivermectin solution by subcutaneous injection. DATES: This rule is effective March 2, 2009. SUMMARY: * * * * * (d) For purposes of paragraphs (b) and (c) of this section, the number of soybean producers in the United States is determined to be 589,182. [Amended] 3. In § 1220.622, paragraph (b) the Web site ‘‘https://www.ams.usda.gov/lsg/ mpb/rp-soy.htm’’ is removed and a new Web site ‘‘https://www.ams.usda.gov/ lsmarketing programs’’ is added in its place. ■ 4. In § 1220.628, paragraph (a) is revised to read as follows: ■ § 1220.628 Results of the request for referendum. (a) The Administrator, FSA, shall submit to the Administrator, AMS, the reports from all State FSA offices. The Administrator, AMS shall tabulate the results of the Request for Referendum. USDA will issue an official press release announcing the results of the Request for Referendum and publish the same results in the Federal Register. In addition, USDA will post the official erowe on PROD1PC63 with RULES Food and Drug Administration ACTION: General. 12:24 Feb 27, 2009 DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: 2. In § 1220.616, paragraph (d) is revised to read as follows: VerDate Nov<24>2008 BILLING CODE 3410–02–P HHS. ■ § 1220.622 Dated: February 24, 2009. Robert C. Keeney, Acting Associate Administrator. [FR Doc. E9–4292 Filed 2–27–09; 8:45 am] Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin Subpart F—Procedures to Request a Referendum § 1220.616 results at the following Web site: ‘‘https://www.ams.usda.gov/ lsmarketingprograms’’. Subsequently, State reports and related papers shall be available for public inspection upon request during normal business hours in the Marketing Programs Branch office, Livestock and Seed Program, AMS, USDA, Room 2628–S, STOP 0251, 1400 Independence Avenue, SW., Washington, DC. * * * * * Jkt 217001 FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8197, e-mail: john.harshman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200–228 that provides for use of PHOENECTIN (ivermectin) Injection 1% for the treatment and control of parasites in cattle. The supplemental ANADA adds PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 9049 claims for persistent effectiveness against various species of external and internal parasites of cattle. The supplemental ANADA is approved as of January 23, 2009, and the regulations are amended in 21 CFR 522.1192 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(a)(1) 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. § 522.1192 [Amended] 2. In § 522.1192, in paragraph (b)(2), remove ‘‘No. 055529’’ and in its place add ‘‘Nos. 055529 and 059130’’; and remove paragraph (b)(3). ■ Dated: February 18, 2009. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E9–4304 Filed 2–27–09; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\02MRR1.SGM 02MRR1

Agencies

[Federal Register Volume 74, Number 39 (Monday, March 2, 2009)]
[Rules and Regulations]
[Page 9049]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4304]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2009-N-0665]


Implantation or Injectable Dosage Form New Animal Drugs; 
Ivermectin

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 a supplemental abbreviated new 
animal drug application (ANADA) filed by IVX Animal Health, Inc. The 
supplemental ANADA adds claims for persistent effectiveness against 
various species of external and internal parasites when cattle are 
treated with a 1-percent ivermectin solution by subcutaneous injection.

DATES:  This rule is effective March 2, 2009.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-228 
that provides for use of PHOENECTIN (ivermectin) Injection 1% for the 
treatment and control of parasites in cattle. The supplemental ANADA 
adds claims for persistent effectiveness against various species of 
external and internal parasites of cattle. The supplemental ANADA is 
approved as of January 23, 2009, and the regulations are amended in 21 
CFR 522.1192 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(a)(1) 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.


Sec.  522.1192  [Amended]

0
2. In Sec.  522.1192, in paragraph (b)(2), remove ``No. 055529'' and in 
its place add ``Nos. 055529 and 059130''; and remove paragraph (b)(3).

    Dated: February 18, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-4304 Filed 2-27-09; 8:45 am]
BILLING CODE 4160-01-S

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