Oral Dosage Form New Animal Drugs; Neomycin, 68738 [E6-20126]

Download as PDF 68738 Federal Register / Vol. 71, No. 228 / Tuesday, November 28, 2006 / Rules and Regulations Security Officer, HS–1/Forrestal Building’’. I c. Paragraphs (d) and (e) by removing ‘‘DOE Director of Security Affairs’’ and adding in their place ‘‘Chief Health, Safety and Security Officer’’. I d. Paragraph (f) by removing ‘‘DOE Director of Security Affairs’’’ and adding in its place ‘‘Chief Health, Safety and Security Officer’s’’. adding in its place ‘‘National Training Center’’. PART 1049—LIMITED ARREST AUTHORITY AND USE OF FORCE BY PROTECTIVE FORCE OFFICERS OF THE STRATEGIC PETROLEUM RESERVE 149. The authority citation for part 1049 continues to read as follows: I PART 1046—PHYSICAL PROTECTION OF SECURITY INTERESTS Authority: 42 U.S.C. 7101 et seq. § 1049.8 145. The authority citation for part 1046 continues to read as follows: I 150. Section 1049.8(a) is amended by removing ‘‘Department of Energy Office of Safeguards and Security’’ and adding in its place ‘‘Chief Health, Safety and Security Officer’’. I Authority: Sec. 2201, Pub. L. 83–703, 68 Stat. 919 (42 U.S.C. 2201 et seq.); sec. 7151, Pub. L. 95–91, 91 Stat. 565 (42 U.S.C. 7101 et seq.). § 1046.3 [Amended] [Amended] [FR Doc. E6–20104 Filed 11–27–06; 8:45 am] BILLING CODE 6450–01–P 146. Section 1046.3 is amended in the definition of ‘‘Designated physician’’ by removing ‘‘Medical Director, Office of Operational and Environmental Safety, Headquarters’’ and adding in its place ‘‘Director, Office of Health and Safety’’ and by removing ‘‘Medical’’ in the second sentence. I DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Appendix A to Subpart B of Part 1046 [Amended] Oral Dosage Form New Animal Drugs; Neomycin 147. Appendix A is amended in: a. Section B.(9) by removing ‘‘Director of Safeguards and Security, Headquarters,’’ and adding in its place ‘‘Chief Health, Safety and Security Officer’’. I b. Section G.(1)(e) by removing ‘‘Director of Safeguards and Security, DOE Headquarters,’’ and adding in its place ‘‘Chief Health, Safety and Security Officer’’. I c. Section J.(5) by removing ‘‘Director of Safeguards and Security, DOE Headquarters’’ and adding in its place ‘‘Chief Health, Safety and Security Officer’’. AGENCY: I I Appendix B to Subpart B of Part 1046 [Amended] 148. Appendix B is amended in: a. Section B.(1) by removing ‘‘Central Training Academy (CTA)’’ and adding in its place ‘‘National Training Center,’’ and by removing ‘‘Director, Office of Safeguards and Security’’ and adding in its place ‘‘Chief Health, Safety and Security Officer’’. I b. Section B.(9)(b) is amended by removing ‘‘DOE Operations Office’’ and adding in its place ‘‘DOE field office’’. I c. Section B.(9)(g) by removing ‘‘Office of Safeguards and Security (SA–10)’’ and adding in its place ‘‘Chief Health, Safety and Security Officer’’. I d. Section B.(9)(i) by removing ‘‘Central Training Academy’’ and mstockstill on PROD1PC61 with RULES I I VerDate Aug<31>2005 13:50 Nov 27, 2006 Jkt 211001 Food and Drug Administration, HHS. ACTION: List of Subjects in 21 CFR Part 520 Final rule. Animal drugs. 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 Sparhawk Laboratories, Inc. The ANADA provides for use of neomycin sulfate oral solution in livestock for the treatment and control of bacterial enteritis. SUMMARY: This rule is effective November 28, 2006. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215, filed ANADA 200–379 for the use of Neomycin Liquid in cattle, swine, sheep, and goats for the treatment and control of bacterial enteritis. Sparhawk Laboratories, Inc.’s Neomycin Liquid is approved as a generic copy of Pharmacia &Upjohn Co.’s BIOSOL Liquid, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., under ANADA 200–113. The ANADA is approved as of October DATES: PO 00000 24, 2006, and the regulations in 21 CFR 520.1484 are amended 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. Frm 00012 Fmt 4700 Sfmt 4700 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. § 520.1484 [Amended] 2. In paragraph (b)(3) of § 520.1484, add ‘‘058005,’’ in numerical sequence. I Dated: November 16, 2006. Bernadette Dunham, Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6–20126 Filed 11–27–06; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\28NOR1.SGM 28NOR1

Agencies

[Federal Register Volume 71, Number 228 (Tuesday, November 28, 2006)]
[Rules and Regulations]
[Page 68738]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20126]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Neomycin

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 an abbreviated new animal drug 
application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA 
provides for use of neomycin sulfate oral solution in livestock for the 
treatment and control of bacterial enteritis.

DATES: This rule is effective November 28, 2006.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Sparhawk Laboratories, Inc., 12340 Santa Fe 
Trail Dr., Lenexa, KS 66215, filed ANADA 200-379 for the use of 
Neomycin Liquid in cattle, swine, sheep, and goats for the treatment 
and control of bacterial enteritis. Sparhawk Laboratories, Inc.'s 
Neomycin Liquid is approved as a generic copy of Pharmacia &Upjohn 
Co.'s BIOSOL Liquid, sponsored by Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc., under ANADA 200-113. The ANADA is approved as of October 
24, 2006, and the regulations in 21 CFR 520.1484 are amended 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 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.  520.1484  [Amended]

0
2. In paragraph (b)(3) of Sec.  520.1484, add ``058005,'' in numerical 
sequence.

    Dated: November 16, 2006.
Bernadette Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. E6-20126 Filed 11-27-06; 8:45 am]
BILLING CODE 4160-01-S

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