Animal drugs, feeds, and related products: Sponsor name and address changes Merial Ltd.,
[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]
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.
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
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
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]
