[Federal Register Volume 66, Number 236 (Friday, December 7, 2001)]
[Rules and Regulations]
[Pages 63499-63500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558


New Animal Drugs; Change of Sponsor

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 a change of sponsor for six approved new 
animal drug applications (NADAs) from Koffolk, Inc., to Phibro Animal 
Health.

DATES: This rule is effective December 7, 2001.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Koffolk, Inc., P.O. Box 675935, 14735 Las 
Quintas, Rancho Santa Fe, CA 92067, has informed FDA that it has 
transferred ownership of, and all rights and interest in, the following 
NADAs to Phibro Animal Health, 710 Rte. 46 East, suite 401, Fairfield, 
NJ 07004.

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            NADA Number               Established Names of Ingredients
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9-476.............................  Nicarbazin
98-378............................  Nicarbazin/Bacitracin Methylene
                                     Disalicylate
107-997...........................  Nicarbazin/Lincomycin/Roxarsone
108-115...........................  Nicarbazin/Roxarsone
108-116...........................  Nicarbazin/Lincomycin
141-146...........................  Nicarbazin/Bacitracin Zinc
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
558.366 to reflect the transfer of ownership.
    Following the change of sponsor of these NADAs, Koffolk, Inc., is 
no longer the sponsor of any approved applications. Therefore, 21 CFR 
510.600(c) is amended to remove the entries for this sponsor.

[[Page 63500]]

    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 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 parts 510 and 
558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    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]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) by removing the entry ``Koffolk, Inc.,'' and in the table in 
paragraph (c)(2) by removing the entry ``063271''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    3. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.
    4. Section 558.366 is amended by redesignating paragraphs (b) and 
(c) as paragraphs (c) and (d), respectively; by revising paragraph (a); 
by adding a new paragraph (b); and in the newly redesignated paragraph 
(d), in the table, under the headings ``Limitations'' and ``Sponsor'' 
by removing ``063271'' wherever it appears and by adding in its place 
``066104'' to read as follows:


Sec.  558.366  Nicarbazin.

    (a) Specifications. Type A medicated articles containing 25 percent 
nicarbazin.
    (b) Approvals. See Nos. 000986, 060728, and 066104 in 
Sec. 510.600(c) of this chapter for use as in paragraph (d) of this 
section.
* * * * *

    Dated: November 15, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-30299 Filed 12-6-01; 8:45 am]
BILLING CODE 4160-01-S