Oral Dosage Form New Animal Drugs; Oxibendazole Paste, 33236-33237 [E6-8894]

Download as PDF 33236 Federal Register / Vol. 71, No. 110 / Thursday, June 8, 2006 / Rules and Regulations the closure by the Canadian Customs and Revenue Agency of the Port of Emerson, Manitoba, Canada, which is located north of the Port of Noyes, and the close proximity of the Port of Noyes to the Port of Pembina. DATES: Effective July 10, 2006. FOR FURTHER INFORMATION CONTACT: Dennis Dore, Office of Field Operations, 202–344–2776. SUPPLEMENTARY INFORMATION: cprice-sewell on PROD1PC66 with RULES Background On August 12, 2005, the Bureau of Customs and Border Protection (CBP) published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (70 FR 47151) proposing to close the Port of Noyes, Minnesota, and extend the limits of the Port of Pembina, North Dakota, to include the rail facilities located at Noyes. The reason for the proposed rulemaking was that on June 8, 2003, the Canadian Customs and Revenue Agency closed the East Port of Emerson, Manitoba, Canada, which is located north of the Port of Noyes. The factors influencing their decision to close the Port of Emerson included the age of the facility, the close proximity of a port at Emerson West, declining workload, and resource considerations. The Port of Noyes, which is located two miles from the CBP Port of Pembina, processes on average three trucks, 50 vehicles, 154 passengers and three trains per day. CBP did not receive any comments on the NPRM. As part of a continuing program to utilize more efficiently its personnel, facilities, and resources, and to provide better service to carriers, importers, and the public, CBP is closing the Port of Noyes and extending the limits of the Port of Pembina as proposed. CBP is extending the limits of the Port of Pembina to encompass the railroad yard located at Noyes, Minnesota, owned by the Canadian Pacific Railway and the Burlington Northern Santa Fe Railway. The Port of Pembina will assume responsibility for processing trains as they arrive at Noyes. However, other traffic must utilize the border crossing within the City of Pembina and will no longer be processed at Noyes. The office facility at Noyes will continue to be used to support the needs of several Border Patrol agents and Immigration and Customs Enforcement (ICE) agents. Security gates and surveillance cameras have also been installed at the Port of Noyes to ensure continued remote monitoring of that location by the Port of Pembina. VerDate Aug<31>2005 15:35 Jun 07, 2006 Jkt 208001 New Port Limits of the Port of Pembina, North Dakota Accordingly, CBP is amending 19 CFR 101.3(b)(1) to reflect that the new limits of the port of entry of Pembina, North Dakota, are as follows: City of Pembina, North Dakota, and the rail facilities located at Noyes, Minnesota. Authority These changes are being made pursuant to 5 U.S.C. 301 and 19 U.S.C. 2, 66 and 1624, and the Homeland Security Act of 2002, Pub. L. 107–296 (November 25, 2002). Congressional Notification On September 15, 2003, the Commissioner of CBP notified Congress of CBP’s intention to close the Port of Noyes, Minnesota, fulfilling the congressional notification requirements of 19 U.S.C. 2075(g)(2) and section 417 of the Homeland Security Act (6 U.S.C. 217). The Regulatory Flexibility Act and Executive Order 12866 With DHS approval, CBP establishes, expands and consolidates CBP ports of entry throughout the United States to accommodate the volume of CBP-related activity in various parts of the country. This regulatory action will not have a significant economic impact on a substantial number of small entities. Accordingly, it is certified that this document is not subject to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). In addition, DHS and the Office of Management and Budget have determined that this final rule does not constitute a significant regulatory action as defined under Executive Order 12866. Signing Authority The signing authority for this document falls under 19 CFR 0.2(a). Accordingly, the final rule is signed by the Secretary of Homeland Security. List of Subjects in 19 CFR Part 101 Customs ports of entry, Exports, Imports, Organization and functions (Government agencies). Amendment to the Regulations For the reasons set forth above, 19 CFR part 101 is amended as set forth below. I 1. The general authority citation for part 101 continues to read and the specific authority citation for § 101.3 is revised to read as follows: I Authority: 5 U.S.C. 301; 19 U.S.C. 2, 66, 1202 (General Note 3(i), Harmonized Tariff PO 00000 Frm 00090 Fmt 4700 Sfmt 4700 Schedule of the United States), 1623, 1624, 1646a. Sections 101.3 and 101.4 also issued under 19 U.S.C. 1 and 58b; * * * * * § 101.3 [Amended] 2. Amend § 101.3(b)(1) as follows: a. Under the state of Minnesota, remove the entry ‘‘Noyes’’ from the ‘‘Ports of entry’’ column and the corresponding entry ‘‘E.O. 5835, Apr. 13, 1932.’’ from the ‘‘Limits of port’’ column; and I b. Under the state of North Dakota, adjacent to Pembina, add in the ‘‘Limits of port’’ column the citation ‘‘CBP Dec. 06–15’’. I I Dated: June 2, 2006. Michael Chertoff, Secretary. [FR Doc. E6–8960 Filed 6–7–06; 8:45 am] BILLING CODE 9111–14–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Oxibendazole Paste 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 Pfizer, Inc. The supplemental NADA provides for revised food safety labeling for oxibendazole paste 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, email: melanie.berson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 10017–5755, filed a supplement to NADA 121–042 for use of ANTHELCIDE EQ (oxibendazole) Paste administered orally to horses as an antiparasitic. The supplemental NADA provides for revised food safety labeling. The supplemental NADA is approved as of April 12, 2006, and the regulations are amended in 21 CFR 520.1638 to reflect the approval. E:\FR\FM\08JNR1.SGM 08JNR1 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]
[Pages 33236-33237]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8894]


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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 Paste

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 paste 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 121-042 for use of ANTHELCIDE EQ 
(oxibendazole) Paste administered orally to horses as an antiparasitic. 
The supplemental NADA provides for revised food safety labeling. The 
supplemental NADA is approved as of April 12, 2006, and the regulations 
are amended in 21 CFR 520.1638 to reflect the approval.

[[Page 33237]]

    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.  520.1638  [Amended]

0
2. In paragraph (c)(3) of Sec.  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.''

    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

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