[Federal Register Volume 68, Number 71 (Monday, April 14, 2003)]
[Rules and Regulations]
[Pages 17881-17883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9028]


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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 seven approved new 
animal drug applications (NADAs) for clopidol Type A medicated articles 
and combination drug medicated chicken and turkey feeds from Aventis 
Animal Nutrition, Inc., to Merial Ltd.

DATES: This rule is effective April 14, 2003.

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.

SUPPLEMENTARY INFORMATION: Aventis Animal Nutrition, Inc., 3480 Preston 
Ridge Rd., suite 650, Alpharetta, GA 30005-8891, has informed FDA that 
it has transferred ownership of, and all rights and interest in, NADA 
34-393, 40-264, 41-541, 44-016, 46-209, 49-934, and 99-150 for clopidol 
Type A medicated articles and certain combination clearances for use in 
medicated feeds for chickens and turkeys to Merial Ltd., 3239 Satellite 
Blvd., Bldg. 500, Duluth, GA 30096-4640. Accordingly, the agency is 
amending the regulations in Sec.  558.175 (21 CFR 558.175) to reflect 
the transfer of ownership. Section 558.175 is also being changed to a 
table format.
    Following the change of sponsor of these NADAs, Aventis Animal 
Nutrition, Inc., is no longer the sponsor of any approved applications. 
Therefore, 21 CFR 510.600(c) is being amended to remove the entries for 
this sponsor.
    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.

[[Page 17882]]

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.

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 
558 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 Names, addresses, and drug labeler codes of sponsors 
of approved applications is amended in the table in paragraph (c)(1) by 
removing the entry for ``Aventis Animal Nutrition, Inc.'' and in the 
table in paragraph (c)(2) by removing the entry for ``011526''.

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

0
3. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.
0
4. Section 558.175 is revised to read as follows:


Sec.  558.175  Clopidol.

    (a) Specifications. Type A medicated article containing 25 percent 
clopidol.
    (b) Approvals. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
0
(d) Conditions of use. It is used as follows:

----------------------------------------------------------------------------------------------------------------
 Clopidol in grams  Combination in grams
      per ton              per ton           Indications for use           Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 113.5           ....................  Broiler chickens and re-  Do not feed to chickens              050604
                                           placement chickens        over 16 weeks of age.
                                           intended for use as
                                           caged layers: As an aid
                                           in the prevention of
                                           coccidiosis caused by
                                           E. tenella, E.
                                           necatrix, E.
                                           acervulina, E. maxima,
                                           E. brunetti, and E.
                                           mivati.
(2) 113.5           Bacitracin methylene  Broiler chickens: As in   Feed continuously as the             050604
                     disalicylate 4 to     paragraph (d)(1) of       sole ration from the
                     50                    this section; for         time chicks are placed
                                           increased rate of         in floor pens until
                                           weight gain.              slaughter. Do not feed
                                                                     to chickens over 16
                                                                     weeks of age;
                                                                     bacitracin methylene
                                                                     disalicylate as
                                                                     provided by No. 046573
                                                                     in Sec.   510.600(c) of
                                                                     this chapter.
(3) 113.5           Bacitracin 4 to 25    Broiler chickens: As in   Do not feed to chickens              046573
                     plus roxarsone 45.4   paragraph (d)(1) of       over 16 weeks of age;               050604
                                           this section; for         withdraw 5 days before
                                           growth promotion, feed    slaughter; as sole
                                           efficiency; improved      source of organic
                                           pigmentation, and         arsenic; as bacitracin
                                           increased rate of         methylene disalicylate
                                           weight gain.              or bacitracin zinc
                                                                     provided by No. 046573
                                                                     in Sec.   510.600(c) of
                                                                     this chapter.
(4) 113.5           Bacitracin zinc 5 to  Broiler chickens: As in   Feed continuously as                 046573
                     25                    paragraph (d)(1) of       sole ration; bacitracin             050604
                                           this section; for         zinc as provided by No.
                                           increased rate of         046573 in Sec.
                                           weight gain and           510.600(c) of this
                                           improved feed             chapter.
                                           efficiency.
(5) 113.5           Chlortetracycline     Broiler and replacement   Feed continuously as                 050604
                     100 to 200            chickens: As in           sole ration from the
                                           paragraph (d)(1) of       time chicks are placed
                                           this section; for         in floor pens for 7 to
                                           control of infectious     14 days.
                                           synovitis caused by
                                           Mycoplasma synoviae
                                           susceptible to
                                           chlortetracycline.
(6) 113.5           Lincomycin 2 to 4     Broiler chickens: As in   Do not feed to chickens              000009
                                           paragraph (d)(1) of       over 16 weeks of age;
                                           this section; for         as lincomycin
                                           increased rate of         hydrochloride
                                           weight gain and           monohydrate.
                                           improved feed
                                           efficiency.
(7) 113.5           Roxarsone 45.4        Broiler and replacement   Do not feed to chickens              050604
                                           chickens intended for     over 16 weeks of age;
                                           use as caged layers: As   withdraw 5 days before
                                           in paragraph (d)(1) of    slaughter; as sole
                                           this section; for         source of organic
                                           growth promotion, feed    arsenic.
                                           efficiency; and
                                           improved pigmentation.

[[Page 17883]]

 
(8) 227             ....................  Broiler and replacement   Feed continuously as the             050604
                                           chickens intended for     sole ration; feed up to
                                           use as caged layers: As   16 weeks of age if
                                           in paragraph (d)(1) of    intended for use as
                                           this section.             caged layers; withdraw
                                                                     5 days before slaughter
                                                                     if given at the level
                                                                     of 0.025 percent in
                                                                     feed or reduce level to
                                                                     0.0125 percent 5 days
                                                                     before slaughter.
(9) 113.5 or 227    ....................  Turkeys: As an aid in     For turkeys grown for                050604
                                           the prevention of         meat purposes only;
                                           leucocytozoonosis         feed continuously as
                                           caused by Leucocytozoon   the sole ration at
                                           smithi.                   0.0125 or 0.025 percent
                                                                     clopidol depending on
                                                                     management practices,
                                                                     degree of exposure, and
                                                                     amount of feed eaten;
                                                                     withdraw 5 days before
                                                                     slaughter.
----------------------------------------------------------------------------------------------------------------


    Dated: March 25, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-9028 Filed 4-11-03; 8:45 am]
BILLING CO DE 4160-01-S