[Federal Register Volume 66, Number 117 (Monday, June 18, 2001)]
[Rules and Regulations]
[Pages 32739-32740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15273]


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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 the change of sponsor for three approved 
new animal drug applications (NADAs) for oxytetracycline premixes from 
Pfizer, Inc., to Phibro Animal Health, Inc. The drug labeler code for 
Phibro Animal Health, Inc., is also being listed.

DATES: This rule is effective June 18, 2001.

FOR FURTHER INFORMATION CONTACT: Norman J. Turner, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0214.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, has informed FDA that it has transferred ownership of, and 
all rights and interests in, NADA 8-804 for Terramycin<Register> 
(oxytetracycline) Type A medicated articles, NADA 38-439 for 
Terramycin<Register> (oxytetracycline) for fish, and NADA 95-143 for 
OXTC<Register> (oxytetracycline) Type A medicated articles to Phibro 
Animal Health, Inc., One Parker Plaza, Fort Lee, NJ 07024. Accordingly, 
the agency is amending the regulations in 21 CFR 558.450 to reflect the 
transfer of ownership.
    In addition, Phibro Animal Health, Inc., has not been previously 
listed in the animal drug regulations as a sponsor of an approved 
application. At this time, 21 CFR 510.600(c)(1) and (c)(2) is being 
amended to add entries for the firm.
    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.
    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding an entry for ``Phibro Animal Health, Inc.'' and 
in the table in paragraph (c)(2) by numerically adding an entry for 
``066104'' 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
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*                  *                  *                  *
                  *                  *                  *
Phibro Animal Health, Inc., One      066104
 Parker Plaza, Fort Lee, NJ 07024

[[Page 32740]]

 
 
*                  *                  *                  *
                  *                  *                  *
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    (2) *  *  *  

------------------------------------------------------------------------
         Drug labeler code                   Firm name and address
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*                  *                  *                  *
                  *                  *                  *
066104                               Phibro Animal Health, Inc., One
                                      Parker Plaza, Fort Lee, NJ 07024
 
*                  *                  *                  *
                  *                  *                  *
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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.


Sec.  558.450  [Amended]

    4. Section 558.450 Oxytetracycline is amended in paragraph (a)(1) 
by removing ``000069'' and by adding in its place ``066104''; and in 
table 1 in paragraphs (d)(1)(i), (d)(1)(v), (d)(1)(vii),
and (d)(1)(viii), under the ``Sponsor'' column, and in table 2 in 
paragraphs (d)(2)(i) through (d)(2)(iii), under the ``Sponsor'' column, 
by removing ``000069'' and by adding in its place ``066104''.

    Dated: June 8, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-15273 Filed 6-15-01; 8:45 am]
BILLING CODE 4160-01-S