[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Rules and Regulations]
[Pages 51820-51821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25904]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
Oral Dosage Form New Animal Drugs; Streptomycin Oral Solution
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 an abbreviated new animal drug
application (ANADA) filed by Contemporary Products, Inc. The ANADA
provides for the use of streptomycin oral solution in drinking water
for the treatment of nonspecific infectious enteritis in chickens and
for the treatment of bacterial enteritis in swine and calves.
EFFECTIVE DATE: September 29, 1998.
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: Contemporary Products, Inc., 3788 Elm
Springs Rd., P.O. Box 6067, Springdale, AR 72766-6067, filed ANADA 200-
197 that provides for the use of streptomycin oral solution in drinking
water for the treatment of nonspecific infectious enteritis in chickens
and for the treatment of bacterial enteritis in swine and calves.
Contemporary Products, Inc.'s ANADA 200-197 is approved as a
generic copy of Veterinary Services, Inc.'s NADA 065-252. ANADA 200-197
is approved as of August 3, 1998, and the regulations are amended in 21
CFR 520.2158a to reflect the approval. The basis for approval is
discussed in the freedom of information summary.
Contemporary Products, Inc., is not currently listed in the animal
drug regulations as the sponsor of an approved application. At this
time, 21 CFR 510.600(c)(1) and (c)(2) are amended by adding a new
listing for the sponsor.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
[[Page 51821]]
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 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
alphabetically adding a new entry for ``Contemporary Products, Inc.''
and in the table in paragraph (c)(2) by numerically adding a new entry
for ``055462'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Firm name and address Drug labeler code
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* * * *
* * *
Contemporary Products, Inc., 3788 Elm Springs Rd.,
Springdale, AR 72764-6067 055462
* * * *
* * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * *
* * *
055462............ Contemporary Products, Inc., 3788 Elm Springs Rd.,
Springdale, AR 72764-6067
* * * *
* * *
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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.
Sec. 520.2158a [Amended]
4. Section 520.2158a Streptomycin sulfate oral solution is amended
in paragraph (b) by removing the phrase ``No. 033008'' and adding in
its place `` Nos. 033008 and 055462''.
Dated: August 27, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-25904 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F
