[Federal Register: April 14, 2003 (Volume 68, Number 71)]
[Rules and Regulations]
[Page 17881-17883]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap03-5]
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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
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3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
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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:
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Clopidol in grams Combination in grams
per ton per ton Indications for use Limitations Sponsor
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(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.
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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]