Oral Dosage Form New Animal Drugs; Levamisole Powder for Oral Solution, 2352-2353 [05-675]

Download as PDF 2352 Federal Register / Vol. 70, No. 9 / Thursday, January 13, 2005 / Rules and Regulations regulated organizations will not be compromised. After considering these factors, the Commission has determined to amend Part 171, as set forth below. List of Subjects in 17 CFR Part 171 DEPARTMENT OF HEALTH AND HUMAN SERVICES § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. Food and Drug Administration * 21 CFR Part 510 New Animal Drugs; Change of Sponsor’s Address Administrative practice and procedure, Commodity exchanges, Commodity futures. AGENCY: Food and Drug Administration, HHS. In consideration of the following, the Commission hereby amends chapter I of title 17 of the Code of Federal Regulations as follows: I ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a PART 171—RULES RELATING TO change of sponsor’s address for Alstoe, REVIEW OF NATIONAL FUTURES Ltd. ASSOCIATION DECISIONS IN DATES: This rule is effective January 13, DISCIPLINARY, MEMBERSHIP DENIAL, 2005. REGISTRATION AND MEMBER FOR FURTHER INFORMATION CONTACT: RESPONSIBILITY ACTIONS David R. Newkirk, Center for Veterinary Medicine (HFV–100), Food and Drug I 1. The authority citation for part 171 Administration, 7500 Standish Pl., continues to read as follows: Rockville, MD 20855, 301–827–6967, eAuthority: 7 U.S.C. 4a, 12a, and 21. mail: david.newkirk@fda.gov. I 2. Section 171.1(b) is amended in SUPPLEMENTARY INFORMATION: Alstoe, paragraph (b)(4) by adding ‘‘, Hearing Ltd., Animal Health, Granary Chambers, Committee’’ between ‘‘Business Conduct 37–39 Burton St., Melton Mowbray, Committees’’ and ‘‘or arbitration Leicestershire LE13 1AF, England has panels’’; and replacing ‘‘.’’ with ‘‘;’’ at the informed FDA of a change of address to Pera Innovation Park, Nottingham Rd., end of (b)(4); and by adding new Melton Mowbray, Leicestershire, paragraph (b)(5): England LE13 0PB. Accordingly, the § 171.1 Scope of rules. agency is amending the regulations in 21 CFR 510.600(c) to reflect the change. * * * * * This rule does not meet the definition (b) * * * of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because (5) Suspension of a member or a it is a rule of ‘‘particular applicability.’’ person associated with a member based Therefore, it is not subject to the solely on that person’s failure to pay an congressional review requirements in 5 arbitration award or a settlement U.S.C. 801–808. agreement resulting from an arbitration List of Subjects in 21 CFR Part 510 action brought pursuant to section 17(b)(10) of the Act or rules and Administrative practice and regulations of the National Futures procedure, Animal drugs, Labeling, Association, or a settlement agreement Reporting and recordkeeping resulting from a mediation proceeding requirements. sponsored by the National Futures I Therefore, under the Federal Food, Association, unless there are Drug, and Cosmetic Act and under extraordinary circumstances that authority delegated to the Commissioner involve something more than the of Food and Drugs and redelegated to the ministerial application of a Center for Veterinary Medicine, 21 CFR predetermined sanction, or raise a part 510 is amended as follows: colorable claim that the National PART 510—NEW ANIMAL DRUGS Futures Assocaition has acted arbitrarily. I 1. The authority citation for 21 CFR * * * * * part 510 continues to read as follows: Issued in Washington, DC on the 10th day of January 2005, by the Commission. Jean A. Webb, Secretary of the Commission. [FR Doc. 05–709 Filed 1–12–05; 8:45 am] BILLING CODE 6351–01–M VerDate jul<14>2003 14:42 Jan 12, 2005 Jkt 205001 * * (c) * * * (1) * * * Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. Section 510.600 is amended in the table in paragraph (c)(1) by revising the entry for ‘‘Alstoe, Ltd.’’; and in the table in paragraph (c)(2) by revising the entry for ‘‘062408’’ to read as follows. I PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 * * Firm name and address * * * Drug labeler code * Alstoe, Ltd., Animal Health, Pera Innovation Park, Nottingham Rd., Melton Mowbray, Leicestershire, England LE13 0PB * * * * 062408 * * (2) * * * Drug labeler code * Firm name and address * 062408 * * * Alstoe, Ltd., Animal Health, Pera Innovation Park, Nottingham Rd., Melton Mowbray, Leicestershire, England LE13 0PB * * * * * Dated: January 3, 2005. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 05–697 Filed 1–12–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Levamisole Powder for Oral Solution 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 an abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The ANADA provides for use of levamisole hydrochloride soluble powder to make a drench solution for oral administration to cattle and sheep which is effective against various internal parasites. DATES: This rule is effective January 13, 2005. E:\FR\FM\13JAR1.SGM 13JAR1 Federal Register / Vol. 70, No. 9 / Thursday, January 13, 2005 / Rules and Regulations 2. Section 520.1242a is amended by revising paragraphs (a) and (b)(4) to read as follows: I FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for Veterinary Medicine (HFV 104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301–827–8549, email: lonnie.luther@fda.gov. SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th St. Terrace, St. Joseph, MO 64503, filed ANADA 200–386 for Levamisole Hydrochloride Soluble Drench Powder used to make a drench solution for oral administration to cattle and sheep which is effective against various internal parasites. Phoenix Scientific’s Levamisole Hydrochloride Soluble Drench Powder is approved as a generic copy of Schering-Plough Animal Health Corp.’s, LEVASOL (levamisole hydrochloride) Soluble Drench Powder, approved under NADA 112–051. The ANADA is approved as of December 17, 2004, and the regulations are amended in 21 CFR 520.1242a to reflect the approval. The basis of approval is discussed in the freedom of information summary. 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. 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. § 520.1242a solution. Levamisole powder for oral (a) Specifications. Each package of powder contains 9.075, 11.7, 18.15, 46.8, 362.7, or 544.5 grams (g) levamisole hydrochloride. (b) * * * (4) No. 059130 for use of 46.8-, 362.7, and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section; and for use of an 18.15-g package as in paragraph (e)(3) of this section. * * * * * Dated: January 6, 2005. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 05–675 Filed 1–12–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 110 [CGD01–04–004] 1625–AA01 Anchorage Grounds; Buzzards Bay, MA Coast Guard, DHS. Final rule. AGENCY: ACTION: SUMMARY: The Coast Guard hereby establishes anchorage regulations for Buzzards Bay, Nantucket Sound, and adjacent waters of Massachusetts by relocating anchorage ground ‘‘L’’ in Buzzards Bay to an area near Naushon Island, MA. This action is intended to increase the safety of life and property on Buzzards Bay, improve the safety of anchored vessels in anchorage ‘‘L’’, and provide for the overall safe and efficient flow of vessel traffic and commerce along the newly established List of Subject in 21 CFR Part 520 Recommended Traffic Route for Deep Animal drugs. Draft Vessels. This regulation will I Therefore, under the Federal Food, maintain the original shape and Drug, and Cosmetic Act and under dimension of anchorage ‘‘L’’ but move authority delegated to the Commissioner the anchorage to a new location within of Food and Drugs and redelegated to the Buzzards Bay. Center for Veterinary Medicine, 21 CFR DATES: This rule is effective February part 520 is amended as follows: 14, 2005. ADDRESSES: Comments and material PART 520—ORAL DOSAGE FORM received from the public, as well as NEW ANIMAL DRUGS documents indicated in this preamble as I 1. The authority citation for 21 CFR being available in the docket, are part of part 520 continues to read as follows: docket [CGD01–02–027] and are available for inspection or copying at Authority: 21 U.S.C. 360b. VerDate jul<14>2003 14:42 Jan 12, 2005 Jkt 205001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 2353 First Coast Guard District, 408 Atlantic Ave., Boston, Massachusetts 02110 between 8 a.m. and 3 p.m., Monday through Friday, except Federal holidays. Mr. John J. Mauro, Commander (oan), First Coast Guard District, 408 Atlantic Ave., Boston, MA 02110, Telephone (617) 223–8355, e-mail: jmauro@d1.uscg.mil. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Regulatory Information On April 16, 2004, we published a notice of proposed rulemaking (NPRM) entitled Anchorage Grounds; Buzzards Bay, MA in the Federal Register (69 FR 20568). We received one comment on the proposed rule. No public hearing was requested and none was held. Background and Purpose In light of significant oil spills in Rhode Island Sound in 1996 and Buzzards Bay in 2003, the Coast Guard investigated methods of improving navigational safety in Buzzards Bay. The Coast Guard conducted a Port and Waterways Safety Assessment (PAWSA) to collect input on potential navigational safety improvements in Buzzards Bay from the local maritime community. After studying the issue and collecting mariner input, the Coast Guard concluded that a Recommended Traffic Route for Deep Draft vessels in Buzzards Bay should be implemented to improve navigation safety in this area. Presently, there are two designated anchorage grounds in Buzzards Bay; anchorage ‘‘L’’ and anchorage ‘‘M’’, whose locations are described in 33 CFR 110.140(b)(3) and 33 CFR 110.140(b)(4), respectively. The present location of anchorage ‘‘L’’ puts it directly in the path of the Recommended Route for Deep Draft vessels entering or leaving the Cape Cod Canal via Cleveland Ledge Channel depicted on current versions of NOAA nautical charts in the area. Thus, this rule is needed to move anchorage ‘‘L’’ to a new and safer location. Although the location of anchorage ‘‘L’’ will change, its size and shape will remain the same. The Coast Guard has defined the anchorage areas contained herein with the advice and consent of the Army Corps of Engineers, New England District, located at 696 Virginia Rd., Concord, MA 01742. This regulation will not exclude fishing activity or the transit of vessels in the anchorage grounds. The Coast Guard expects no increase in the amount of vessels utilizing anchorage ‘‘L’’ as a result of this change in its location. E:\FR\FM\13JAR1.SGM 13JAR1

Agencies

[Federal Register Volume 70, Number 9 (Thursday, January 13, 2005)]
[Rules and Regulations]
[Pages 2352-2353]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-675]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Levamisole Powder for Oral 
Solution

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 an abbreviated new animal drug 
application (ANADA) filed by Phoenix Scientific, Inc. The ANADA 
provides for use of levamisole hydrochloride soluble powder to make a 
drench solution for oral administration to cattle and sheep which is 
effective against various internal parasites.

DATES: This rule is effective January 13, 2005.

[[Page 2353]]


FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV 104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
lonnie.luther@fda.gov.

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, St. Joseph, MO 64503, filed ANADA 200-386 for Levamisole 
Hydrochloride Soluble Drench Powder used to make a drench solution for 
oral administration to cattle and sheep which is effective against 
various internal parasites. Phoenix Scientific's Levamisole 
Hydrochloride Soluble Drench Powder is approved as a generic copy of 
Schering-Plough Animal Health Corp.'s, LEVASOL (levamisole 
hydrochloride) Soluble Drench Powder, approved under NADA 112-051. The 
ANADA is approved as of December 17, 2004, and the regulations are 
amended in 21 CFR 520.1242a to reflect the approval. The basis of 
approval is discussed in the freedom of information summary.
    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.
    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 Subject 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.
0
2. Section 520.1242a is amended by revising paragraphs (a) and (b)(4) 
to read as follows:


Sec.  520.1242a  Levamisole powder for oral solution.

    (a) Specifications. Each package of powder contains 9.075, 11.7, 
18.15, 46.8, 362.7, or 544.5 grams (g) levamisole hydrochloride.
    (b) * * *
    (4) No. 059130 for use of 46.8-, 362.7-, and 544.5-g packages as in 
paragraphs (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), 
(e)(2)(ii)(B), and (e)(2)(iii) of this section; and for use of an 
18.15-g package as in paragraph (e)(3) of this section.
* * * * *

    Dated: January 6, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-675 Filed 1-12-05; 8:45 am]
BILLING CODE 4160-01-S

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