New Animal Drugs; Change of Sponsor's Address, 11120-11121 [05-4480]

Download as PDF 11120 Federal Register / Vol. 70, No. 44 / Tuesday, March 8, 2005 / Rules and Regulations available to each date handler in Riverside County. (e) Each approved manufacturer of date products is required to renew their approved manufacturer status with the committee by submitting an updated CDAC Form No. 3 at the end of a crop year, but no later than October 10 of the new crop year. In addition, the approved manufacturer must continue to meet the other approved manufacturer qualification requirements. (f) In the event an approved date product manufacturer who is also a regulated date handler within the area of production does not remain in compliance with the order, or fails or refuses to submit reports or to pay assessments required by the committee, such date product manufacturer shall become ineligible to continue as an approved date product manufacturer. Prior to making a determination to remove a date product manufacturer from the approved date product manufacturer list, the committee shall notify such manufacturer in writing of its intention and the reasons for removal. The committee shall allow the date product manufacturer an opportunity to respond. In the event that a date product manufacturer’s name has been removed from the list of approved date product manufacturers, a new application must be submitted to the committee and the applicant must await approval. Dated: March 2, 2005. Kenneth C. Clayton, Acting Administrator, Agricultural Marketing Service. [FR Doc. 05–4448 Filed 3–7–05; 8:45 am] BILLING CODE 3410–02–P DEPARTMENT OF HEALTH AND HUMAN SERVICES List of Subjects in 21 CFR Part 510 Food and Drug Administration 21 CFR Part 510 New Animal Drugs; Change of Sponsor’s Address AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor’s address for Wellmark International. DATES: This rule is effective March 8, 2005. FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.gov. SUPPLEMENTARY INFORMATION: Wellmark International, 1100 East Woodfield Rd., suite 500, Schaumburg, IL 60173 has informed FDA of a change of address to 1501 East Woodfield Rd., suite 200 West, Schaumburg, IL 60173. * * * Wellmark International, 1501 East Woodfield Rd., suite 200 West, Schaumburg, IL 60173 * * Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. I 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 510 is amended as follows: PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: I 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 ‘‘Wellmark International’’; and in the table in paragraph (c)(2) by revising the entry for ‘‘011536’’ to read as follows: I § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * (c) * * * (1) * * * Drug labeler code Firm name and address * Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect the change. 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. * * 011536 * * (2) * * * Drug labeler code * Firm name and address * * 011536 * VerDate jul<14>2003 11:16 Mar 07, 2005 Jkt 205001 PO 00000 Frm 00010 * * Wellmark International, 1501 East Woodfield Rd., suite 200 West, Schaumburg, IL 60173 * Fmt 4700 * Sfmt 4700 * * E:\FR\FM\08MRR1.SGM 08MRR1 * * Federal Register / Vol. 70, No. 44 / Tuesday, March 8, 2005 / Rules and Regulations Dated: February 16, 2005. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 05–4480 Filed 3–7–05; 8:45 am] BILLING CODE 4160–01–S § 1.411(d)–4 11121 Authority: 26 U.S.C. 7805 * * *. [Corrected] Section 1.411(d)–4, A–2, paragraph § 1.409(p)–1T [Corrected] (e)(3), Example (i) and (ii), in each location the year ‘‘2004’’ is removed, and I Section 1.409(p)–1T(d)(2)(iv), is removed. the year ‘‘2005’’ is added in its place. I Cynthia E. Grigsby, Acting Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedures and Administration). [FR Doc. 05–4502 Filed 3–7–05; 8:45 am] Cynthia E. Grigsby, Acting Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedures and Administration). [FR Doc. 05–4506 Filed 3–7–05; 8:45 am] BILLING CODE 4830–01–P BILLING CODE 4830–01–P [TD 9176] DEPARTMENT OF THE TREASURY DEPARTMENT OF THE INTERIOR RIN 1545–BC35 Internal Revenue Service Office of Surface Mining Reclamation and Enforcement Elimination of Forms of Distribution in Defined Contribution Plans; Correction 26 CFR Part 1 [TD 9164] 30 CFR Part 917 Internal Revenue Service (IRS), Treasury. ACTION: Correcting amendment. RIN 1545–BC33 Kentucky Regulatory Program Prohibited Allocations of Securities in an S Corporation; Correction AGENCY: DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 AGENCY: SUMMARY: This document contains corrections to (TD 9176), which were published in the Federal Register on Tuesday, January 25, 2005 (70 FR 3475). These final regulations would modify the circumstances under which certain forms of distribution previously available are permitted to be eliminated from qualified defined contribution plans. This correction is effective January 25, 2005. DATES: FOR FURTHER INFORMATION CONTACT: Vernon S. Carter at (202) 622–6060 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background The final regulations (TD 9176) that are the subject of these corrections are under section 411(d)(6) of the Internal Revenue Code. Need for Correction As published, TD 9176 contains errors that may prove to be misleading and are in need of clarification. List of Subjects in 26 CFR Part 1 Income taxes, Reporting and recordkeeping requirements. Correction of Publication Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments: PART 1—INCOME TAXES Paragraph 1. The authority citation for part 1 continues to read in part as follows: Authority: 26 U.S.C. 7805 * * *. VerDate jul<14>2003 11:16 Mar 07, 2005 Jkt 205001 SUMMARY: This document corrects temporary regulations (TD 9164) that were published in the Federal Register on Friday, December 17, 2004 (69 FR 75455) concerning requirements for employee stock ownership plans (ESOPs) holding stock of Subchapter S corporations. DATES: This document is effective on December 17, 2004. FOR FURTHER INFORMATION CONTACT: John T. Ricotta, (202) 622–6060 (not a tollfree number). SUPPLEMENTARY INFORMATION: Background The temporary regulations (TD 9164) that is the subject of this correction are under section 409(p). Need for Correction As published, the temporary regulations (TD 9164) contain errors that may prove to be misleading and are in need of clarification. List of Subjects in 26 CFR Parts 1 Income Taxes, Reporting and recordkeeping requirements. I I Internal Revenue Service (IRS), Treasury. ACTION: Correcting amendment. AGENCY: Correction of Publication Accordingly, 26 CFR part 1 is corrected by making the following correcting amendment: I PART 1—INCOME TAXES Paragraph 1. The authority citation for part 1 and continues to read in part as follows: I PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 Office of Surface Mining Reclamation and Enforcement (OSM), Interior. ACTION: Final rule. SUMMARY: This final rule removes a suspension notation from our regulations pertaining to the Kentucky regulatory program (the ‘‘Kentucky program’’). The suspension prohibited the issuance of new financial guarantees by the Kentucky Bond Pool because of insufficient funds that had resulted from the transfer of funds out of the bond pool. Kentucky has reimbursed its bond pool and the suspension notation concerning that issue is being removed because it is no longer necessary. EFFECTIVE DATE: March 8, 2005. FOR FURTHER INFORMATION CONTACT: William J. Kovacic, Telephone: (859) 260–8400. Telefax number: (859) 260– 8410. SUPPLEMENTARY INFORMATION: I. Background on the Kentucky Program II. Submission Information III. OSM’s Findings IV. Procedural Determinations I. Background on the Kentucky Program Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, ‘‘a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of the Act * * *; and rules and regulations consistent with regulations issued by the Secretary pursuant to the Act.’’ See 30 U.S.C. E:\FR\FM\08MRR1.SGM 08MRR1

Agencies

[Federal Register Volume 70, Number 44 (Tuesday, March 8, 2005)]
[Rules and Regulations]
[Pages 11120-11121]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4480]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510


New Animal Drugs; Change of Sponsor's Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor's address for Wellmark 
International.

DATES: This rule is effective March 8, 2005.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
david.newkirk@fda.gov.

SUPPLEMENTARY INFORMATION: Wellmark International, 1100 East Woodfield 
Rd., suite 500, Schaumburg, IL 60173 has informed FDA of a change of 
address to 1501 East Woodfield Rd., suite 200 West, Schaumburg, IL 
60173. Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c) to reflect the change.
    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 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

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 510 is 
amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. Section 510.600 is amended in the table in paragraph (c)(1) by 
revising the entry for ``Wellmark International''; and in the table in 
paragraph (c)(2) by revising the entry for ``011536'' to read as 
follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
             Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------
Wellmark International, 1501 East Woodfield      011536
 Rd., suite 200 West, Schaumburg, IL 60173
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------
011536                   Wellmark International, 1501 East Woodfield
                          Rd., suite 200 West, Schaumburg, IL 60173
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------



[[Page 11121]]

    Dated: February 16, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-4480 Filed 3-7-05; 8:45 am]
BILLING CODE 4160-01-S
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