Oral Dosage Form New Animal Drugs; Oxibendazole Suspension, 33237 [E6-8953]

Download as PDF Federal Register / Vol. 71, No. 110 / Thursday, June 8, 2006 / Rules and Regulations 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. The agency has determined under 21 CFR 25.33(d)(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 520 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 520 is amended as follows: I PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. § 520.1638 [Amended] 2. In paragraph (c)(3) of § 520.1638, remove ‘‘Not for use in horses intended for food.’’ and add in its place ‘‘Not for use in horses intended for human consumption.’’ I Dated: May 26, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6–8894 Filed 6–7–06; 8:45 am] BILLING CODE 4160–01–S Food and Drug Administration Melanie R. Berson, Center for Veterinary Medicine (HFV–110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 10017–5755, filed a supplement to NADA 109–722 for use of ANTHELCIDE EQ (oxibendazole) Suspension administered orally to horses as an antiparasitic. The supplemental NADA provides for revised food safety labeling. The supplemental application is approved as of April 17, 2006, and the regulations are amended in 21 CFR 520.1640 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. The agency has determined under 21 CFR 25.33(d)(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 520 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 520 is amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Oxibendazole Suspension Food and Drug Administration, 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. cprice-sewell on PROD1PC66 with RULES HHS. ACTION: Final rule. § 520.1640 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 Pfizer, VerDate Aug<31>2005 15:35 Jun 07, 2006 Jkt 208001 Dated: May 26, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6–8953 Filed 6–7–06; 8:45 am] BILLING CODE 4160–01–S FOR FURTHER INFORMATION CONTACT: I DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Inc. The supplemental NADA provides for revised food safety labeling for oxibendazole suspension administered orally to horses as an antiparasitic. DATES: This rule is effective June 8, 2006. 33237 [Amended] 2. Amend paragraph (c)(3) of § 520.1640 by removing ‘‘Not for use in horses intended for food.’’ and adding in its place ‘‘Not for use in horses intended for human consumption.’’. I PO 00000 Frm 00091 Fmt 4700 Sfmt 4700 DEPARTMENT OF STATE 22 CFR Part 62 [Public Notice 5437] RIN 1400–AC16 Au Pair Exchange Programs State Department. Final rule. AGENCY: ACTION: SUMMARY: The Department of State (Department) adopts as final certain proposed amendments to existing au pair regulations. These changes will permit au pair sponsors to request a one-time extension of six, nine, or 12 months beyond an au pair participant’s original 12-month period of program participation). Effective Date: This rule is effective July 10, 2006. DATES: FOR FURTHER INFORMATION CONTACT: Stanley S. Colvin, Director, Office of Exchange Coordination and Designation, U.S. Department of State, SA–44, 301 4th Street, SW., Room 734, Washington, DC 20547; or email at jexchanges@state.gov. In February 2004, the Department of State announced a pilot program whereby Department designated au pair sponsors could request the extension of program participation beyond the original 12month maximum period afforded au pair participants. The Department has completed its review of the Au Pair Pilot Extension Program and has determined that au pair extensions enhance the overall success of this program. Both host families and au pair participants have enthusiastically embraced the extension concept. Accordingly, the Department is adopting the amendment of program regulations to permit designated sponsors of the au pair program to submit requests to the Department for consideration of program extensions for six, nine, or 12 month durations for first-year au pair participants beyond the maximum duration of participation allowed under Section 62.31(c)(1). SUPPLEMENTARY INFORMATION: Analysis of Comments The Department received a total of 1 comment on the proposed rule for Au Pair extension requests. However, the E:\FR\FM\08JNR1.SGM 08JNR1

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[Federal Register Volume 71, Number 110 (Thursday, June 8, 2006)]
[Rules and Regulations]
[Page 33237]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8953]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Oxibendazole Suspension

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 new animal drug 
application (NADA) filed by Pfizer, Inc. The supplemental NADA provides 
for revised food safety labeling for oxibendazole suspension 
administered orally to horses as an antiparasitic.

DATES: This rule is effective June 8, 2006.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed a supplement to NADA 109-722 for use of ANTHELCIDE EQ 
(oxibendazole) Suspension administered orally to horses as an 
antiparasitic. The supplemental NADA provides for revised food safety 
labeling. The supplemental application is approved as of April 17, 
2006, and the regulations are amended in 21 CFR 520.1640 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.
    The agency has determined under 21 CFR 25.33(d)(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 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.1640  [Amended]

0
2. Amend paragraph (c)(3) of Sec.  520.1640 by removing ``Not for use 
in horses intended for food.'' and adding in its place ``Not for use in 
horses intended for human consumption.''.

    Dated: May 26, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-8953 Filed 6-7-06; 8:45 am]
BILLING CODE 4160-01-S
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