[Federal Register Volume 63, Number 160 (Wednesday, August 19, 1998)]
[Rules and Regulations]
[Pages 44383-44384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22266]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride
Soluble Powder
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 new animal drug
application (NADA) filed by Pfizer Inc. The supplemental NADA provides
for added package sizes of oxytetracycline hydrochloride (OTC HCI)
soluble powder to be used in the drinking water of poultry for control
of specific diseases, in the drinking water of cattle, swine, and sheep
for control and treatment of specific diseases, and for control of
specific diseases of bees.
EFFECTIVE DATE: August 19, 1998.
FOR FURTHER INFORMATION CONTACT: William G. Marnane, Center for
Veterinary Medicine (HFV-140), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-0678.
SUPPLEMENTARY INFORMATION: Pfizer Inc., 235 East 42d St., New York, NY
10017, filed supplemental NADA 8-622 that provides for use of 2.25
pound jars and 4.5 pound pails of Terramycin-343
(oxytetracycline hydrochloride) soluble powder for making drinking
water for poultry for control of specific OTC-susceptible diseases,
drinking water for cattle, swine, and sheep for control and treatment
of specific OTC-susceptible diseases, and for control of specific OTC-
susceptible diseases of bees. The supplemental NADA is approved as of
June 19, 1998, and 21 CFR 520.1660d(a)(3) is amended to reflect the
approval.
Approval of this supplemental NADA does not require additional
safety or effectiveness data. A freedom of information summary as
provided under 21 CFR part 20 and 514.11(e)(2)(ii) is not required.
The agency has determined under 21 CFR 25.33(a)(4) 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 in 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 part 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 520.1660d is amended by revising paragraph (a)(3) to
read as follows:
[[Page 44384]]
Sec. 520.1660d Oxytetracycline hydrochloride soluble powder.
(a) * * *
(3) Each 1.32 grams of powder contains 1 gram of OTC HCl (packets:
2.39, 4.78, and 9.55 oz.; jars: 2.25 lbs.; and pails: 4.5 lbs.).
* * * * *
Dated: July 29, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-22266 Filed 8-18-98; 8:45 am]
BILLING CODE 4160-01-F
