New Animal Drugs For Use in Animal Feeds; Fenbendazole, 66045-66046 [E7-22987]

Download as PDF Federal Register / Vol. 72, No. 227 / Tuesday, November 27, 2007 / Rules and Regulations 66045 Actions Compliance Procedures (2) Remove any primer and/or paint from the fuel filler adapter surround. Before further flight after the inspection required by paragraph (e)(1) of this AD where primer and/or paint was found on the fuel filler adapter surround. Follow the procedures in Eclipse Aviation Corporation Alert Service Bulletin SB 500–57– 007, Rev B, dated October 23, 2007. Special Flight Permit DEPARTMENT OF TRANSPORTATION (f) Under 14 CFR 39.23, we are limiting the special flight permits for this AD by allowing ‘‘Flight in Day Visual Flight Rules (VFR) Only.’’ Federal Aviation Administration 14 CFR Part 45 Alternative Methods of Compliance (AMOCs) [Docket No. FAA–2007–27173; Amendment No. 45–25] (g) The Manager, Fort Worth Airplane Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Mitchell Soth, Flight Test Engineer, 2601 Meacham Blvd., Fort Worth, Texas 76137; telephone: (817) 222–5104; fax: (817) 222–5960. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. RIN 2120–AJ02 Material Incorporated by Reference pwalker on PROD1PC71 with RULES (h) You must use Eclipse Aviation Corporation Alert Service Bulletin SB 500– 57–007, Rev A, dated October 12, 2007 or Eclipse Aviation Corporation Alert Service Bulletin SB 500–57–007, Rev B, dated October 23, 2007, to do the actions required by this AD, unless the AD specifies otherwise. (1) The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51. (2) For service information identified in this AD, contact Eclipse Aviation Corporation, 4100 Aerospace Parkway, Albuquerque, New Mexico 87121; phone (505) 245–7555; fax: (505) 241–8802; e-mail: customercare@EclipseAviation.com. (3) You may review copies at the FAA, Central Region, Office of the Regional Counsel, 901 Locust, Kansas City, Missouri 64106; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: https://www.archives.gov/federal_register/ code_of_federal_regulations/ ibr_locations.html. Issued in Kansas City, Missouri, on November 20, 2007. Kim Smith, Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E7–23024 Filed 11–26–07; 8:45 am] BILLING CODE 4910–13–P VerDate Aug<31>2005 18:41 Nov 26, 2007 Jkt 214001 Nationality and Registration Marks; Non Fixed-Wing Aircraft Federal Aviation Administration (FAA), DOT. ACTION: Direct final rule confirmation of effective date. AGENCY: SUMMARY: This action confirms the direct final rule issued on September 14, 2007, which became effective on November 13, 2007. The rule changes certain display requirements for nationality and registration marks for powered parachutes and weight-shiftcontrol aircraft. No comments were received on this direct final rule. DATES: The direct final rule published at 72 FR 52467 is confirmed effective November 13, 2007. ADDRESSES: The complete docket for the direct final rule on nationality and registration marks; non fixed-wing aircraft, Docket ID FAA–2007–27173 may be examined at https:// www.regulations.gov at any time or go to Docket Operations in Room W12–140 of the West Building, Ground Floor, at 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Grant Schneemann, AIR–230, Airworthiness Branch, Production and Airworthiness Division, Aircraft Certification Service, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone (202) 267–8473. SUPPLEMENTARY INFORMATION: Background On September 14, 2007, the FAA published a direct final rule (72 FR 52467) that permits operators of U.S. registered powered parachutes and weight-shift-control aircraft to display their nationality and registration marks in other than a horizontal orientation on the fuselage, a structural member, or a PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 component of the aircraft. The direct final rule also clarifies the size requirements for nationality and registration marks on U.S. registered powered parachutes and weight-shiftcontrol aircraft. Discussion of Comments The FAA received no comments on the nationality and registration marks; non fixed-wing aircraft direct final rule. Conclusion In consideration that no comments were submitted in response to the direct final rule, the FAA has determined that no further rulemaking action is necessary. Amendment 45–25 remains in effect as adopted. Issued in Washington, DC, on November 20, 2007. John Hickey, Director, Aircraft Certification Services. [FR Doc. E7–23028 Filed 11–26–07; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs For Use in Animal Feeds; Fenbendazole 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 Intervet Inc. The supplemental NADA provides for a revised food safety warning on labeling for fenbendazole Type A medicated article and Type B and Type C medicated horse feeds. DATES: This rule is effective November 27, 2007. 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: Intervet Inc., P.O. Box 318, 29160 Intervet Lane, E:\FR\FM\27NOR1.SGM 27NOR1 66046 Federal Register / Vol. 72, No. 227 / Tuesday, November 27, 2007 / Rules and Regulations Millsboro, DE 19966, filed a supplement to NADA 131–675 for use of SAFEGUARD (fenbendazole) 20% Type A medicated article to formulate Type B and Type C medicated horse feeds. The supplemental NADA provides for a revised food safety warning on labeling. The supplemental NADA is approved as of November 5, 2007, and the regulations are amended in 21 CFR 558.258 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. FDA 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 558 Animal drugs, Animal feeds. 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 558 is amended as follows: I PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: I Authority: 21 U.S.C. 360b, 371. § 558.258 [Amended] 2. In § 558.258, in the table in paragraph (e)(4)(i), in the ‘‘Limitations’’ column, remove ‘‘Do not use in horses intended for food.’’ and add in its place ‘‘Do not use in horses intended for human consumption.’’. pwalker on PROD1PC71 with RULES I Dated: November 16, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–22987 Filed 11–26–07; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 18:41 Nov 26, 2007 Jkt 214001 DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [CGD08–07–040] RIN 1625–AA09 Drawbridge Operation Regulations; Sabine River (Old Channel) Behind Orange Harbor Island, Orange, TX Coast Guard, DHS. Final rule. AGENCY: ACTION: SUMMARY: The Coast Guard is removing the existing drawbridge operation regulation for the drawbridge across the Sabine River (Old Channel) behind Orange Harbor Island, mile 9.5, at Orange, Texas. The regulation can be removed because the bridge no longer exists. This rule is effective November 27, 2007. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket CGD08–07– 040 and are available for inspection or copying at Eighth Coast Guard District, Bridge Administration Branch, Hale Boggs Federal Building, Room 1313, 500 Poydras Street, New Orleans, Louisiana 70130–3310 between 7 a.m. and 3 p.m., Monday through Friday, except Federal holidays. The telephone number is (504) 671–2128. FOR FURTHER INFORMATION CONTACT: Bart Marcules, Bridge Administration Branch, telephone (504) 671–2128. SUPPLEMENTARY INFORMATION: We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Public comment is not necessary since the bridge that the regulation governed no longer exists. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective in less than 30 days after publication in the Federal Register. There is no need to delay the implementation of this rule because the bridge it governs has been removed in its entirety. DATES: Background and Purpose The entire drawbridge across the Sabine River (Old Channel) behind Orange Harbor Island, mile 9.5, at Orange, Texas has been removed. Since the bridge has been removed, mariners are no longer required to go around the bridge. The regulation governing the PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 operation of the bridge is found in 33 CFR 117.983. The purpose of this rule is to remove 33 CFR 117.983 from the Code of Federal Regulations since it governs a bridge that is no longer across the waterway. Discussion of Rule The Coast Guard is changing the regulation in 33 CFR 117 without publishing an NPRM. The change removes the regulation governing the bridge since the bridge has been removed in its entirety. This change does not affect vessel operators using the waterway. Thus, it is not necessary to publish an NPRM. Regulatory Evaluation This rule is not a ‘‘significant regulatory action’’ under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. The Coast Guard does not consider this rule to be ‘‘significant’’ under that Order because it does not affect the way vessels operate on the waterway. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601–612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term ‘‘small entities’’ comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will have no impact on any small entities because the bridge has been removed in its entirety, and it will not adversely affect the owners and operators of vessels needing to transit the waterway. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to E:\FR\FM\27NOR1.SGM 27NOR1

Agencies

[Federal Register Volume 72, Number 227 (Tuesday, November 27, 2007)]
[Rules and Regulations]
[Pages 66045-66046]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22987]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use in Animal Feeds; Fenbendazole

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 Intervet Inc. The supplemental NADA 
provides for a revised food safety warning on labeling for fenbendazole 
Type A medicated article and Type B and Type C medicated horse feeds.

DATES: This rule is effective November 27, 2007.

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: Intervet Inc., P.O. Box 318, 29160 Intervet 
Lane,

[[Page 66046]]

Millsboro, DE 19966, filed a supplement to NADA 131-675 for use of 
SAFE-GUARD (fenbendazole) 20% Type A medicated article to formulate 
Type B and Type C medicated horse feeds. The supplemental NADA provides 
for a revised food safety warning on labeling. The supplemental NADA is 
approved as of November 5, 2007, and the regulations are amended in 21 
CFR 558.258 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.
    FDA 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 558

    Animal drugs, Animal feeds.

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 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec.  558.258  [Amended]

0
2. In Sec.  558.258, in the table in paragraph (e)(4)(i), in the 
``Limitations'' column, remove ``Do not use in horses intended for 
food.'' and add in its place ``Do not use in horses intended for human 
consumption.''.

    Dated: November 16, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-22987 Filed 11-26-07; 8:45 am]
BILLING CODE 4160-01-S

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