[Federal Register Volume 64, Number 42 (Thursday, March 4, 1999)]
[Rules and Regulations]
[Page 10389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5280]
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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 abbreviated new
animal drug application (ANADA) filed by Merial, Ltd. The supplemental
ANADA provides for use of a larger package size of oxytetracycline
hydrochloride soluble powder in the drinking water of chickens,
turkeys, swine, cattle, and sheep for the treatment and control of
various bacterial diseases.
EFFECTIVE DATE: March 4, 1999.
FOR FURTHER INFORMATION CONTACT: Patricia D. Leinbach, Center for
Veterinary Medicine (HFV-142), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6965.
SUPPLEMENTARY INFORMATION: Merial, Ltd., 2100 Ronson Rd., Iselin, NJ
08830-3077, filed supplemental ANADA 200-144 that provides for use of a
larger package size of oxytetracycline hydrochloride soluble powder in
the drinking water of chickens, turkeys, swine, cattle, and sheep for
the treatment and control of various bacterial diseases. The
supplemental ANADA is approved as of December 16, 1998, and the
regulations are amended in 21 CFR 520.1660d(a) and (b) to reflect the
approval.
Furthermore, the regulations had not been previously amended to
reflect the sponsor change from Rhone Merieux Canada, Inc., to Merial,
Ltd. The regulation in Sec. 520.1660d(b) is amended at this time to
reflect the sponsor change.
Approval of this supplemental ANADA does not require additional
safety and effectiveness data. Therefore, a freedom of information
summary for approval of this supplemental application is not required.
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 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 adding paragraphs (a)(9) and
(b)(7), and by revising paragraph (b)(2) to read as follows:
Sec. 520.1660d Oxytetracycline hydrochloride soluble powder.
(a) * * *
(9) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets:
9.87 and 19.75 oz; pails: 5 lb).
(b) * * *
(2) No. 017144 for use of OTC HCl concentration in paragraph (a)(4)
of this section in chickens, turkeys, and swine.
* * * * *
(7) No. 050604 for use of OTC HCl concentration in paragraph (a)(9)
of this section in chickens, turkeys, and swine.
* * * * *
Dated: February 24, 1999.
Woodrow M. Knight,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 99-5280 Filed 3-3-99; 8:45 am]
BILLING CODE 4160-01-F
