New Animal Drugs For Use in Animal Feeds; Withdrawal of Approval of a New Animal Drug Application; Bacitracin Zinc, 49191-49192 [E7-16984]

Download as PDF Federal Register / Vol. 72, No. 166 / Tuesday, August 28, 2007 / Rules and Regulations edition to the Director of the Federal Register for approval for incorporation by reference in section 71.1. The FAA has determined that this action (1) is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. This action neither places any new restrictions or requirements on the public, nor changes the dimensions or operation requirements of the airspace listings incorporated by reference in part 71. Consequently, notice and public procedure under 5 U.S.C. 553(b) are unnecessary. Because this action will continue to update the changes to the airspace designations, which are depicted on aeronautical charts, and to avoid any unnecessary pilot confusion, I find that good cause exists, under 5 U.S.C. 553(d), for making this amendment effective in less than 30 days. points will be published in full text as proposed rule documents in the Federal Register. Amendments to the listings of Class A, B, C, D, and E airspace areas; air traffic service routes; and reporting points will be published in full text as final rules in the Federal Register. Periodically, the final rule amendments will be integrated into a revised edition of the Order and submitted to the Director of the Federal Register for approval for incorporation by reference in this section. Copies of FAA Order 7400.9R may be obtained from Airspace and Rules Group, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591, (202) 267–8783. An electronic version of the Order is available on the FAA Web site at https://www.faa.gov/ airports_airtraffic/air_traffic/ publications/. Copies of FAA Order 7400.9R may be inspected in Docket No. 29334 on the Federal Register Web site at www.regulations.gov. § 71.71 § 71.5 21 CFR Part 558 [Amended] List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). 3. Section 71.5 is amended by removing the words ‘‘FAA Order 7400.9P’’ and adding, in their place, the words ‘‘FAA Order 7400.9R.’’ Adoption of the Amendment § 71.15 In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: I I PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: I Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389. I [Amended] § 71.31 [Amended] 5. Section 71.31 is amended by removing the words ‘‘FAA Order 7400.9P’’ and adding, in their place, the words ‘‘FAA Order 7400.9R.’’ I § 71.33 [Amended] 2. Section 71.1 is revised to read as follows: § 71.1 § 71.41 pwalker on PROD1PC71 with NOTICES Applicability. A listing for Class A, B, C, D, and E airspace areas; air traffic service routes; and reporting points can be found in FAA Order 7400.9R, Airspace Designations and Reporting Points, dated August 15, 2007. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552 (a) and 1 CFR part 51. The approval to incorporate by reference FAA Order 7400.9R is effective September 15, 2007, through September 15, 2008. During the incorporation by reference period, proposed changes to the listings of Class A, B, C, D, and E airspace areas; air traffic service routes; and reporting VerDate Aug<31>2005 16:51 Aug 27, 2007 Jkt 211001 [Amended] 10. Paragraphs (b), (c), (d), (e), and (f) of section 71.71 are amended by removing the words ‘‘FAA Order 7400.9P’’ and adding, in their place, the words ‘‘FAA Order 7400.9R.’’ I § 71.901 [Amended] 11. Paragraph (a) of section 71.901 is amended by removing the words ‘‘FAA Order 7400.9P’’ and adding, in their place, the words ‘‘FAA Order 7400.9R.’’ I Issued in Washington, DC on August 17, 2007. Edith V. Parish, Manager, Airspace and Rules Group. [FR Doc. E7–16639 Filed 8–27–07; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration New Animal Drugs For Use in Animal Feeds; Withdrawal of Approval of a New Animal Drug Application; Bacitracin Zinc AGENCY: 4. Section 71.15 is amended by removing the words ‘‘FAA Order 7400.9P’’ and adding, in their place, the words ‘‘FAA Order 7400.9R.’’ 6. Paragraph (c) of section 71.33 is amended by removing the words ‘‘FAA Order 7400.9P’’ and adding, in their place, the words ‘‘FAA Order 7400.9R.’’ I 49191 I Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of a new animal drug application (NADA) for a bacitracin zinc Type A medicated article. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of this NADA. DATES: This rule is effective August 28, 2007. 7. Section 71.41 is amended by removing the words ‘‘FAA Order 7400.9P’’ and adding, in their place, the words ‘‘FAA Order 7400.9R.’’ FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301–827– 7818; e-mail: pamela.esposito@fda.hhs.gov. § 71.51 SUPPLEMENTARY INFORMATION: [Amended] I [Amended] 8. Section 71.51 is amended by removing the words ‘‘FAA Order 7400.9P’’ and adding, in their place, the words ‘‘FAA Order 7400.9R.’’ I § 71.61 [Amended] 9. Section 71.61 is amended by removing the words ‘‘FAA Order 7400.9P’’ and adding, in their place, the words ‘‘FAA Order 7400.9R.’’ I PO 00000 Frm 00065 Fmt 4700 Sfmt 4700 Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, has requested that FDA withdraw approval of NADA 128–550 for ANCHOR Zinc Bacitracin Type A medicated article because the product is not manufactured or marketed. In a notice published elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 128– 550 and all supplements and amendments thereto, are withdrawn, E:\FR\FM\28AUR1.SGM 28AUR1 49192 Federal Register / Vol. 72, No. 166 / Tuesday, August 28, 2007 / Rules and Regulations effective August 28, 2007. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect the withdrawal of approval. 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. 2. In § 558.78, in paragraph (a), remove ‘‘5,’’; in the table in paragraph (d)(1)(i), in the ‘‘Sponsor’’ column, remove ‘‘048164’’; and revise paragraph (b) to read as follows: I § 558.78 Bacitracin zinc. * * * * * (b) Approvals. See No. 046573 in § 510.600(c) of this chapter. * * * * * Office of the General Counsel, Millennium Challenge Corporation, 875 Fifteenth Street, NW., Washington, DC 20005–2221. ADDRESSES: The Millennium Challenge Corporation establishes a new Chapter XIII in Title 22 of the Code of Federal Regulations to read ‘‘Chapter XIII—Millennium Challenge Corporation’’. This interim final rule informs the public about the structure, function, operations, and quorum requirements of the Millennium Challenge Corporation. SUPPLEMENTARY INFORMATION: Regulatory Impact 1. Administrative Procedures Act In promulgating this rule, the Millennium Challenge Corporation finds that notice and public comment are not necessary. Section 553(b)(3)(A) of Title 5, United States Code, provides that when regulations involve matters of agency organization, procedure, or practice, the agency may publish regulations in final form. In addition, the Millennium Challenge Corporation finds, in accordance with 5 U.S.C. 553(d), that a delayed effective date is unnecessary. Accordingly, these regulations are effective upon publication. 2. Paperwork Reduction Act Dated: August 20, 2007. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E7–16984 Filed 8–27–07; 8:45 am] BILLING CODE 4160–01–S This interim final rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) 3. Unfunded Mandates Reform Act of 1995 MILLENNIUM CHALLENGE CORPORATION 22 CFR Part 1300 Organization and Functions of the Millennium Challenge Corporation Millennium Challenge Corporation. ACTION: Interim final rule. pwalker on PROD1PC71 with NOTICES AGENCY: SUMMARY: This document establishes a new chapter in the Code of Federal Regulations for the Millennium Challenge Corporation and provides information on the Millennium Challenge Corporation’s organization, functions and operations. DATES: Effective August 28, 2007. FOR FURTHER INFORMATION CONTACT: John C. Mantini, Assistant General Counsel for Administration. VerDate Aug<31>2005 16:51 Aug 27, 2007 Jkt 211001 This interim final rule does not require the preparation of an assessment statement in accordance with the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531. This rule does not include a Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. List of Subjects in 22 CFR Part 1300 Organization and functions (Government agencies). For the reasons stated in the preamble, the Millennium Challenge Corporation establishes a new Chapter XIII, consisting of part 1300, in title 22 to read as follows: I PO 00000 Frm 00066 Fmt 4700 Sfmt 4700 CHAPTER XIII—MILLENNIUM CHALLENGE CORPORATION PART 1300—ORGANIZATION AND FUNCTIONS OF THE MILLENNIUM CHALLENGE CORPORATION Sec. 1300.1 1300.2 1300.3 1300.4 1300.5 1300.6 Purpose. Organization. Functions. Operations. Quorum and voting requirements. Office location. Authority: 5 U.S.C. 552, as amended. § 1300.1 Purpose. This part describes the organization, functions and operation of the Millennium Challenge Corporation (MCC). MCC is a government corporation (as defined in 5 U.S.C. 103) established by the Millennium Challenge Act of 2003 (Pub. L. 108–199, 118 Stat. 211.) Information about MCC is available from its Web site, https:// www.mcc.gov. § 1300.2 Organization. (a) MCC’s Board consists of: (1) The Secretary of State, the Secretary of the Treasury, the Administrator of the United States Agency for International Development, the United States Trade Representative; and the Chief Executive Officer of the Corporation; and (2) four other individuals with relevant international experience from the private sector; appointed by the President with the advice and consent of the Senate. (b) MCC’s staff is comprised of the following administrative units: (1) The Office of the Chief Executive Officer; (2) The Department of Accountability; (3) The Department of Administration and Finance; (4) The Department of Congressional and Public Affairs; (5) The Department of Operations; (6) The Department of Policy and International Relations; and (7) The Office of the General Counsel. § 1300.3 Functions. (a) MCC provides United States assistance for global development; and (b) Provides such assistance in a manner that promotes economic growth and the elimination of extreme poverty and strengthens good governance, economic freedom, and investments in people. § 1300.4 Operations. In exercising its functions, duties, and responsibilities, MCC utilizes: (a) MCC staff, consisting of specialized offices performing E:\FR\FM\28AUR1.SGM 28AUR1

Agencies

[Federal Register Volume 72, Number 166 (Tuesday, August 28, 2007)]
[Rules and Regulations]
[Pages 49191-49192]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16984]


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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; Withdrawal of Approval 
of a New Animal Drug Application; Bacitracin Zinc

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations by removing those portions that reflect approval of a 
new animal drug application (NADA) for a bacitracin zinc Type A 
medicated article. In a notice published elsewhere in this issue of the 
Federal Register, FDA is withdrawing approval of this NADA.

DATES: This rule is effective August 28, 2007.

FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-7818; e-mail: 
pamela.esposito@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd., 
Omaha, NE 68144, has requested that FDA withdraw approval of NADA 128-
550 for ANCHOR Zinc Bacitracin Type A medicated article because the 
product is not manufactured or marketed.
    In a notice published elsewhere in this issue of the Federal 
Register, FDA gave notice that approval of NADA 128-550 and all 
supplements and amendments thereto, are withdrawn,

[[Page 49192]]

effective August 28, 2007. As provided in the regulatory text of this 
document, the animal drug regulations are amended to reflect the 
withdrawal of approval.
    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.

0
2. In Sec.  558.78, in paragraph (a), remove ``5,''; in the table in 
paragraph (d)(1)(i), in the ``Sponsor'' column, remove ``048164''; and 
revise paragraph (b) to read as follows:


Sec.  558.78  Bacitracin zinc.

* * * * *
    (b) Approvals. See No. 046573 in Sec.  510.600(c) of this chapter.
* * * * *

    Dated: August 20, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-16984 Filed 8-27-07; 8:45 am]
BILLING CODE 4160-01-S

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