New Animal Drugs; Change of Sponsor, 17319 [05-6721]

Download as PDF Federal Register / Vol. 70, No. 65 / Wednesday, April 6, 2005 / Rules and Regulations PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: I Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721–44722. 2. Part 97 is amended to read as follows: I * * * Effective 12 May 2005 Sylacauga, AL, Merkel Field Sylacauga Muni, NDB–A, Amdt 3 Sylacauga, AL, Merkel Field Sylacauga Muni, RNAV (GPS) RWY 9, Orig Sylacauga, AL, Merkel Field Sylacauga Muni, RNAV (GPS) RWY 27, Orig Dallas-Fort Worth, TX, Dallas/Fort Worth International, VOR RWY 31L, Orig Lancaster, PA, Lancaster, LOC RWY 8 Orig Lancaster, PA, Lancaster, ILS OR LOC RWY 8, Amdt 15, CANCELLED Newport News, VA, Newport News/ Williamsburg Intl, ILS OR LOC RWY 25, Orig * * * Effective 07 July 2005 Savannah, GA, Savannah/Hilton Head Intl, VOR/DME OR TACAN RWY 36, Orig Savannah, GA, Savannah/Hilton Head Intl, VOR/DME OR TACAN RWY 18, Orig Savannah, GA, Savannah/Hilton Head Intl, VOR/DME–A, Orig Pulaski, TN, Abernathy Field, VOR/ DME RWY 33, Amdt 2 Pulaski, TN, Abernathy Field, RNAV (GPS) RWY 15, Amdt 1 Pulaski, TN, Abernathy Field, RNAV (GPS) RWY 33, Amdt 1 [FR Doc. 05–6656 Filed 4–5–05; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 520 New Animal Drugs; Change of Sponsor 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 for a new animal drug application (NADA) from Akzo Nobel Surface Chemistry AB (Azko Nobel) to Virbac AH, Inc. DATES: This rule is effective April 6, 2005. VerDate jul<14>2003 15:41 Apr 05, 2005 Jkt 205001 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: Akzo Nobel, Box 851, S–44485 Stenungsund, Sweden, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 10–886 for Purina Liquid Wormer to Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137. Following this change of sponsorship, Akzo Nobel is no longer the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for Akzo Nobel. Purina Liquid Wormer (NADA 10– 886) is labeled for use in chickens, turkeys, and swine. The drug was the subject of a National Academy of Sciences/National Research Council evaluation of effectiveness under FDA’s drug efficacy study implementation (DESI) program (DESI 10–005V). The findings of the evaluation were published in the Federal Register of February 14, 1969 (34 FR 2213). A separate entry in part 520 (21 CFR part 520) (§ 520.1807) was created (64 FR 23017, April 29, 1999) to accommodate oral piperazine products approved for use in chickens, turkeys, and swine consistent with DESI findings and human food safety requirements (DESI finalization). However to date, NADA 10–886 has not been DESI finalized. Accordingly, § 520.1807 will not be amended to reflect the approval of NADA 10–886 until the current sponsor of that NADA submits a supplemental NADA adequate for DESI finalization. In addition, § 520.1806 has been found to inaccurately list Akzo Nobel as the sponsor of an oral piperazine product approved for use in dogs. This error occurred during the codification of a previous change of sponsor for NADA 10–886 (59 FR 28763, June 3, 1994). Accordingly, the agency is amending the regulations in § 520.1806 to remove Akzo Nobel’s drug labeler code and to reflect the current format. 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 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 17319 21 CFR Part 520 Animal drugs. 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 parts 510 and 520 are amended as follows: I 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. § 510.600 [Amended] 2. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entry for ‘‘Akzo Nobel Surface Chemistry AB’’ and in the table in paragraph (c)(2) by removing the entry for ‘‘063765’’. I PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. 4. Section 520.1806 is revised to read as follows: I § 520.1806 Piperazine suspension. (a) Specifications. Each milliliter of suspension contains piperazine monohydrochloride equivalent to 33.5 milligrams (mg) piperazine base. (b) Sponsor. See No. 017135 in § 510.600(c) of this chapter. (c) Special considerations. See § 500.25(c) of this chapter. (d) Conditions of use in dogs—(1) Indications for use. For the removal of roundworms (Toxocara canisand Toxascaris leonina). (2) Dosage. Administer 20 to 30 mg piperazine base per pound body weight as a single dose. (3) Limitations. Administer by mixing into the animal’s ration to be consumed at one feeding. For animals in heavily contaminated areas, reworm at monthly intervals. Not for use in unweaned pups or animals less than 3 weeks of age. Dated: December 10, 2004. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 05–6721 Filed 4–5–05; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\06APR1.SGM 06APR1

Agencies

[Federal Register Volume 70, Number 65 (Wednesday, April 6, 2005)]
[Rules and Regulations]
[Page 17319]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


New Animal Drugs; Change of Sponsor

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 for a new animal drug 
application (NADA) from Akzo Nobel Surface Chemistry AB (Azko Nobel) to 
Virbac AH, Inc.

DATES: This rule is effective April 6, 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: Akzo Nobel, Box 851, S-44485 Stenungsund, 
Sweden, has informed FDA that it has transferred ownership of, and all 
rights and interest in, NADA 10-886 for Purina Liquid Wormer to Virbac 
AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137.
    Following this change of sponsorship, Akzo Nobel is no longer the 
sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is 
being amended to remove the entries for Akzo Nobel.
    Purina Liquid Wormer (NADA 10-886) is labeled for use in chickens, 
turkeys, and swine. The drug was the subject of a National Academy of 
Sciences/National Research Council evaluation of effectiveness under 
FDA's drug efficacy study implementation (DESI) program (DESI 10-005V). 
The findings of the evaluation were published in the Federal Register 
of February 14, 1969 (34 FR 2213). A separate entry in part 520 (21 CFR 
part 520) (Sec.  520.1807) was created (64 FR 23017, April 29, 1999) to 
accommodate oral piperazine products approved for use in chickens, 
turkeys, and swine consistent with DESI findings and human food safety 
requirements (DESI finalization). However to date, NADA 10-886 has not 
been DESI finalized. Accordingly, Sec.  520.1807 will not be amended to 
reflect the approval of NADA 10-886 until the current sponsor of that 
NADA submits a supplemental NADA adequate for DESI finalization.
    In addition, Sec.  520.1806 has been found to inaccurately list 
Akzo Nobel as the sponsor of an oral piperazine product approved for 
use in dogs. This error occurred during the codification of a previous 
change of sponsor for NADA 10-886 (59 FR 28763, June 3, 1994). 
Accordingly, the agency is amending the regulations in Sec.  520.1806 
to remove Akzo Nobel's drug labeler code and to reflect the current 
format.
    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

21 CFR Part 510

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

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 parts 510 and 
520 are 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.


Sec.  510.600  [Amended]

0
2. Section 510.600 is amended in the table in paragraph (c)(1) by 
removing the entry for ``Akzo Nobel Surface Chemistry AB'' and in the 
table in paragraph (c)(2) by removing the entry for ``063765''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


0
4. Section 520.1806 is revised to read as follows:


Sec.  520.1806  Piperazine suspension.

    (a) Specifications. Each milliliter of suspension contains 
piperazine monohydrochloride equivalent to 33.5 milligrams (mg) 
piperazine base.
    (b) Sponsor. See No. 017135 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. See Sec.  500.25(c) of this chapter.
    (d) Conditions of use in dogs--(1) Indications for use. For the 
removal of roundworms (Toxocara canisand Toxascaris leonina).
    (2) Dosage. Administer 20 to 30 mg piperazine base per pound body 
weight as a single dose.
    (3) Limitations. Administer by mixing into the animal's ration to 
be consumed at one feeding. For animals in heavily contaminated areas, 
reworm at monthly intervals. Not for use in unweaned pups or animals 
less than 3 weeks of age.

    Dated: December 10, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-6721 Filed 4-5-05; 8:45 am]
BILLING CODE 4160-01-S

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