[Federal Register: December 5, 2002 (Volume 67, Number 234)]
[Rules and Regulations]
[Page 72365-72366]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de02-2]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
New Animal Drugs; Neomycin Sulfate Soluble Powder; Change of
Sponsor's Address
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 approval of a supplemental abbreviated new
animal drug application (ANADA) filed by Bimeda, Inc., and a change of
this sponsor's address. The supplemental ANADA provides for use of
neomycin sulfate soluble powder in the drinking water of growing
turkeys for the control of mortality associated with Escherichia coli
organisms susceptible to neomycin.
DATES: This rule is effective December 5, 2002.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail:
lluther@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Bimeda, Inc., 288 County Rd. 28, LeSueur, MN
56058-9322, filed a supplement to ANADA 200-050 that provides for use
of Neomycin 325 Soluble Powder for making medicated drinking water for
administration to cattle (excluding veal calves), swine, sheep, and
goats for the treatment and control of colibacillosis (bacterial
enteritis) caused by E. coli susceptible to neomycin. The supplemental
ANADA provides for use of neomycin in the drinking water of growing
turkeys for the control of mortality associated with E. coli organisms
susceptible to neomycin. The supplemental application is approved as of
July 10, 2002, and the regulations are amended in 21 CFR 520.1484 to
reflect the approval. The basis of approval is discussed in the freedom
of information summary.
In addition, Bimeda, Inc., has informed FDA of a change of sponsor
address to 291 Forest Prairie Rd., LeSueur, MN 56058. Accordingly, the
agency is amending the regulations in 21 CFR 510.600 to reflect the
change of sponsor address.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
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 520
Animal drugs.
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
[[Page 72366]]
CFR parts 510 and 520 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
revising the entry for ``Bimeda, Inc.'' and in the table in paragraph
(c)(2) by revising the entry for ``061133'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Drug labeler
Firm name and address code
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* * * * * * *
Bimeda, Inc., 291 Forest Prairie Rd., LeSueur, MN 56058... 061133
* * * * * * *
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(2) * * *
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Drug labeler
code Firm name and address
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* * * * * * *
061133 Bimeda, Inc., 291 Forest Prairie Rd., LeSueur, MN 56058
* * * * * * *
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
4. Section 520.1484 is amended by revising paragraphs (a) and (b)
to read as follows:
Sec. 520.1484 Neomycin sulfate soluble powder.
(a) Specifications. Each ounce of powder contains 20.3 grams of
neomycin sulfate (equivalent to 14.2 grams of neomycin base).
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section.
(1) Nos. 000069, 046573, and 051259 for use as in paragraph (d)(1)
of this section.
(2) Nos. 000009 and 061133 for use as in paragraphs (d)(1) and
(d)(2) of this section.
* * * * *
Dated: November 19, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 02-30785 Filed 12-4-02; 8:45 am]
BILLING CODE 4160-01-S