Revocation of Status of Specific Products; Group A Streptococcus; Confirmation of Effective Date, 20533-20534 [06-3790]

Download as PDF Federal Register / Vol. 71, No. 77 / Friday, April 21, 2006 / Rules and Regulations copies at the Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL–401, Washington, DC 20590–0001, on the Internet at https://dms.dot.gov; 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/cfr/ibrlocations.html. Issued in Burlington, Massachusetts, on April 14, 2006. Robert G. Mann, Acting Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. 06–3765 Filed 4–20–06; 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; Melengestrol and Monensin 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 Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol and monensin to make two-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter. DATES: This rule is effective April 21, 2006. wwhite on PROD1PC61 with RULES FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–0223, email: daniel.benz@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200–422 for use of HEIFERMAX 500 (melengestrol acetate) Liquid Premix and RUMENSIN (monensin sodium) single-ingredient Type A medicated articles to make, two-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter. Ivy Laboratories’ ANADA 200–422 is approved as a generic copy of Pharmacia and Upjohn’s NADA 125– VerDate Aug<31>2005 16:06 Apr 20, 2006 Jkt 208001 476 for combination use of MGA 500 (melengestrol acetate) Liquid Premix and RUMENSIN in cattle feed. The application is approved as of March 22, 2006, and the regulations are amended in 21 CFR 558.342 to reflect the approval. The basis of approval is discussed in 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. The agency has determined under 21 CFR 25.33(a)(2) 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. § 558.342 [Amended] 2. In § 558.342, amend the table in paragraphs (e)(1)(v) and (e)(1)(vi) in the ‘‘Sponsor’’ column by adding in numerical sequence ‘‘021641’’. I Dated: April 7, 2006. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 06–3820 Filed 4–20–06; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 20533 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 610 [Docket No. 2005N–0355] RIN 0910–AF20 Revocation of Status of Specific Products; Group A Streptococcus; Confirmation of Effective Date AGENCY: Food and Drug Administration, HHS. Direct final rule; confirmation of effective date. ACTION: SUMMARY: The Food and Drug Administration (FDA) is confirming the effective date of June 2, 2006, for the direct final rule that appeared in the Federal Register of December 2, 2005 (70 FR 72197). The direct final rule removes the regulation applicable to the status of specific products; Group A streptococcus. FDA is removing the regulation because the existing requirement for Group A streptococcus organisms and derivatives is both obsolete and a perceived impediment to the development of Group A streptococcus vaccines. This document confirms the effective date of the direct final rule. DATES: Effective date confirmed: June 2, 2006. FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: In the Federal Register of December 2, 2005 (70 FR 72197), FDA solicited comments concerning the direct final rule for a 75day period ending February 15, 2006. FDA stated that the effective date of the direct final rule would be on June 2, 2006, 6 months after the date of publication in the Federal Register, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments. Therefore, FDA is removing from the regulation 21 CFR 610.19 because this provision is obsolete and a perceived impediment to the development of Group A streptococcus vaccines. Authority: Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and under authority delegated to the Commissioner of Food and Drugs, the amendment issued thereby becomes effective on June 2, 2006. E:\FR\FM\21APR1.SGM 21APR1 20534 Federal Register / Vol. 71, No. 77 / Friday, April 21, 2006 / Rules and Regulations Dated: April 14, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06–3790 Filed 4–20–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF STATE 22 CFR Parts 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, and 130 [Public Notice: 5345] Amendments to the International Traffic in Arms Regulations: Office Names, Corrected Cross-Referencing, Reference to Wassenaar Arrangement, and Other Corrections/Administrative Changes Department of State. Final rule. AGENCY: ACTION: SUMMARY: The Department of State is amending the International Traffic in Arms Regulations (ITAR) to reflect current office names, correct crossreferences, update the reference to the Wassenaar Arrangement, and make other corrections and administrative changes. Effective Date: This rule is effective April 21, 2006. ADDRESSES: Interested parties may submit comments at any time by any of the following methods: • E-mail: DDTCResponseTeam@state.gov with an appropriate subject line. • Mail: Department of State, Directorate of Defense Trade Controls, Office of Defense Trade Controls Management, ATTN: Regulatory Change, 12th Floor, SA–1, Washington, DC 20522–0112. • Fax: 202–261–8199. • Hand Delivery or Courier (regular work hours only): Department of State, Directorate of Defense Trade Controls, Office of Defense Trade Controls Management, ATTENTION: Regulatory Change, SA–1, 12th Floor, 2401 E Street, NW., Washington, DC 20037. Persons with access to the Internet may also view this notice by going to the regulations.gov Web site at: https:// www.regulations.gov/index.cfm. FOR FURTHER INFORMATION CONTACT: Mary Sweeney, Office of Defense Trade Controls Management, Department of State, 12th Floor, SA–1, Washington, DC 20522–0112; Telephone 202–663–2865 or FAX 202–261–8199; e-mail: DDTCResponseTeam@state.gov. ATTN: Regulatory Change. SUPPLEMENTARY INFORMATION: References to the ‘‘Office of Defense Trade wwhite on PROD1PC61 with RULES DATES: VerDate Aug<31>2005 16:06 Apr 20, 2006 Jkt 208001 Controls’’ have been amended to the ‘‘Directorate of Defense Trade Controls’’ (§§ 120.1(c), 120.4(a), 120.4(b), 120.12, 120.20, 120.28(a), 121.1 Category XXI(a), 121.16, 122.1(a), 122.4(a), 122.4(b), 122.4(c), 122.4(c)(4). 122.4(d), 123.1(a), 123.1(c), 123.3(a), 123.8(a), 123.8(b), 123.9(a), 123.9(d), 123.9(e), 123.9(e)(3), 123.9(e)(4), 123.10(b), 123.10(c), 123.11(a), 123.14(b), 123.25(a), 123.27(a), 123.27(a)(2), 123.27(a)(5), 123.27(a)(6), 123.27(b), 123.27(c), 124.1(a), 124.1(b), 124.1(c), 124.1(d), 124.4(a), 124.4(b), 124.5, 124.6, 124.10(a), 124.10(b)(1), 124.10 Note, 124.12(1), 124.12(a)(1), 124.13(d), 124.13(e), 124.14(a), 124.14(b), 124.14(b)(4), 124.14(c)(5), 124.14(e), 124.14(e)(1), 125.1(b), 125.2(a), 125.2(b), 125.3(a), 125.3(b), 125.3(c), 125.4(a), 125.4(b)(10)(iii), 125.4(b)(11), 125.5(a), 125.5(b), 125.7(a), 125.7(b), 125.9, 126.1(e), 126.2, 126.7(b), 126.7(c), 126.8(a), 126.8(a)(1), 126.8(a)(2), 126.8(a)(3), 126.8(c)(1)(i), 126.8(c)(2), 126.9(a), 126.9(b), 126.10(a), 126.14(a), 126.14(a)(1), 126.14(a)(2), 126.14(a)(3)(i), 126.14(b), 127.1(a)(1), 127.1(a)(2), 127.1(a)(3), 127.1(c), 127.7(b)(2), 127.8(a), 127.9, 127.10, 127.11, 127.12(a), 127.12(b)(1), 127.12(b)(2), 127.12(b)(3), 127.12(c), 127.12(d)(iii), 128.3(a), 128.5(c), 128.6(a), 128.6(b), 128.6(d), 128.10, 128.11(a), 128.13(d), 128.15(a), 128.15(b)(3), 129.3(a), 129.4(b), 129.5(b), 129.5(c), 129.5(e), 129.6(a), 129.7(a), 129.7(b)(2), 129.7(c), 129.8(a), 129.8(b), 129.9(a), 130.2, 130.8(a)(1), 130.9(a)(1), 130.9(a)(1)(ii), 130.9(a)(2), 130.9(b), 130.9(b)(2), 130.9(d), 130.10(a), 130.11(a)(3), 130.11(b), 130.11(b)(2), 130.12(c), 130.12(d)(1), and 130.12(d)(2)). ‘‘COCOM’’ has been amended to the ‘‘Wassenaar Arrangement’’ (§§ 120.4(d)(3)(ii), 120.4(d)(3)(iii), and 126.10(d)(2)). ‘‘Center for Defense Trade’’ has been amended to the ‘‘Directorate of Defense Trade Controls’’ (§§ 120.4(g) and 121.1(a)). ‘‘Center for Defense Trade’’ has been amended to ‘‘Office of Defense Trade Controls Policy’’ (§ 120.4(e)). Also, references to the ‘‘Bureau of Politico-Military Affairs’’ have been amended to the ‘‘Bureau of Political-Military Affairs’’ (§§ 120.4(g), 120.12, 120.28(a), 127.7(a), 127.9 and 127.11(b)). Grammatical changes have been made to the definition of ‘‘U.S. person’’ at § 120.15, to § 124.1(a) by deleting ‘‘either,’’ and to ‘‘Voluntary Disclosures’’ at § 127.12(b)(4). The ‘‘Defense Security Assistance Agency’’ has been amended to the ‘‘Defense Security Cooperation Agency’’ (§ 120.28(b)(3)). Certain references to the Treasury Department have been amended to the PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 Attorney General, and other references to Treasury have been amended to the Department of Justice, as appropriate, because the Bureau of Alcohol, Tobacco and Firearms (ATF) was transferred to the Department of Justice and ATF’s name was changed to Bureau of Alcohol, Tobacco, Firearms and Explosives (§§ 120.5, 120.18, 123.2 and 126.11). Also, the reference to 31 CFR part 505 has been changed to 27 CFR part 447 and 15 CFR parts 768–799 have been changed to 15 CFR parts 730–799 at § 120.5. References to 27 CFR parts 47, 178 and 179 have been changed to 27 CFR parts 447, 478, 479, and 555 at §§ 120.18 and 123.2. Reference to 27 CFR 178.115(d) has been changed to 27 CFR 478.115(d) at § 123.17(d). Numerous typographical errors are being corrected in the United States Munitions List, § 121.1, Categories V and XV. References to ‘‘technical data’’ and ‘‘defense service’’ have been corrected in § 121.1, Categories IV, V, XI, XII, XIV, XVII, XX, and XXI. Cross references have been corrected (§§ 120.1(c), 120.10(a)(1), 120.16, 121.1(b), 121.1 Category V(g)(2), 121.1 Category V(g)(5), 121.1 Category V(g)(6), 121.1 Category V(g)(7), 121.1 Category V(g)(8), 124.2(c)(5)(ix), 126.7(a), 127.8(a), 127.9 and 127.11(c)). Typographical mistakes have been corrected in § 121.1, Category V(a)(1); § 121.1, Category V(a)(5); § 121.1, Category V(a)(9); § 121.1, Category V(a)(15)(i); § 121.1, Category V(a)(20)(i); § 121.1, Category V(a)(24)(ii); § 121.1, Category V(a)(29); § 121.1, Category V(a)(31)(i); § 121.1, Category V(a)(31)(ii); § 121.1, Category V(a)(31)(iv); § 121.1, Category V(c)(8); § 121.1, Category V(c)(9); § 121.1, Category V(e)(2); § 121.1, Category V(e)(9); § 121.1, Category V(e)(13); § 121.1, Category V(e)(14); § 121.1, Category V(f)(3)(iv); § 121.1, Category V(f)(14); § 121.1, Category V(f)(15); § 121.1, Category V(f)(17); § 121.1, Category XV(d)(1); § 121.1, Category XV(d)(2); § 121.1, Category XV(d)(3); § 121.1, Category XV(d)(5); § 121.16, Item 1–Category 1; § 121.16, Item 4– Category II; § 121.16, Item 9–Category II; § 121.16, Item 12–Category II; § 121.16, Note to Item 18(a); and in §§ 123.16(b)(2)(v), 126.5(c)(4)(v), 126.14(a)(3)(iv), 127.3(b), 128.7(a)(1)(ii), and 130.5(b)(1). CAS numbers were added in § 121.1, Category V(a)(2); § 121.1, Category V(a)(31)(vii); § 121.1, Category V(a)(34); § 121.1, Category V(e)(11); § 121.1, Category V(e)(13); and § 121.1, Category V(e)(15). The ‘‘Director of the Office of Defense Trade Controls’’ has been changed to the ‘‘Director, Office of Defense Trade Controls Policy’’ E:\FR\FM\21APR1.SGM 21APR1

Agencies

[Federal Register Volume 71, Number 77 (Friday, April 21, 2006)]
[Rules and Regulations]
[Pages 20533-20534]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3790]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 610

[Docket No. 2005N-0355]
RIN 0910-AF20


Revocation of Status of Specific Products; Group A Streptococcus; 
Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of June 2, 2006, for the direct final rule that appeared 
in the Federal Register of December 2, 2005 (70 FR 72197). The direct 
final rule removes the regulation applicable to the status of specific 
products; Group A streptococcus. FDA is removing the regulation because 
the existing requirement for Group A streptococcus organisms and 
derivatives is both obsolete and a perceived impediment to the 
development of Group A streptococcus vaccines. This document confirms 
the effective date of the direct final rule.

DATES: Effective date confirmed: June 2, 2006.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 2, 2005 
(70 FR 72197), FDA solicited comments concerning the direct final rule 
for a 75-day period ending February 15, 2006. FDA stated that the 
effective date of the direct final rule would be on June 2, 2006, 6 
months after the date of publication in the Federal Register, unless 
any significant adverse comment was submitted to FDA during the comment 
period. FDA did not receive any significant adverse comments. 
Therefore, FDA is removing from the regulation 21 CFR 610.19 because 
this provision is obsolete and a perceived impediment to the 
development of Group A streptococcus vaccines.

    Authority: Therefore, under the Federal Food, Drug, and Cosmetic 
Act and the Public Health Service Act and under authority delegated 
to the Commissioner of Food and Drugs, the amendment issued thereby 
becomes effective on June 2, 2006.


[[Page 20534]]


    Dated: April 14, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-3790 Filed 4-20-06; 8:45 am]
BILLING CODE 4160-01-S

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