[Federal Register Volume 59, Number 14 (Friday, January 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1421]
[[Page Unknown]]
[Federal Register: January 21, 1994]
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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 I.D. Russell Co. Laboratories under the
National Academy of Sciences/National Research Council, Drug Efficacy
Study Implementation Program. The supplemental NADA provides for
expanding the ``me-too'' use of oxytetracycline hydrochloride (OTC HCl)
soluble powder to the drinking water of swine for the control and
treatment of bacterial enteritis, bacterial pneumonia and
leptospirosis.
EFFECTIVE DATE: January 21, 1994.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1623.
SUPPLEMENTARY INFORMATION: I.D. Russell Co. Laboratories, 1301 Iowa
Ave., Longmont, CO 80501, is the sponsor of NADA 130-435 which provides
for use of OTC HCl soluble powder in the drinking water of chickens and
turkeys for the control of specific diseases caused by certain bacteria
susceptible to oxytetracycline (OTC). I.D. Russel Co. Laboratories has
filed a supplemental application providing for expanding the ``me-too''
use of OTC HCl soluble powder to the drinking water of swine for the
control and treatment of bacterial enteritis and bacterial pneumonia
and to the drinking water of breeding swine for control and treatment
of leptospirosis all caused by bacteria susceptible to OTC. The
supplemental NADA is approved as of December 10, 1993, and 21 CFR
520.1660d is amended to reflect the approval. The basis for approval is
discussed in the freedom of information summary. The agency is further
amending this section by adding an additional I.D. Russell drug product
(i.e., 3.09-ounce pail) to Sec. 520.1660d (a)(4).
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval does not
qualify for an exclusivity period because the supplemental application
does not contain reports of new clinical or field investigations (other
than bioequivalence or residue studies) and, in the case of food-
producing animals, human food safety studies (other than bioequivalence
or residue studies) essential to the approval and conducted or
sponsored by the applicant.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. Section 520.1660d is amended by revising paragraphs (a)(4),
(b)(2), and (e)(1)(iii)(C) to read as follows:
Sec. 520.1660d Oxytetracycline hydrochloride soluble powder.
(a) * * *
(4) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets:
2.46 and 9.87 oz; pail: 3.09 lb).
* * * * *
(b) * * *
(2) No. 017144 for use of OTC HCl concentration in paragraph (a)(4)
of this section in chickens, turkeys, and swine.
* * * * *
(e) * * *
(1) * * *
(iii) * * *
(C) Limitations. Prepare a fresh solution daily. Use as sole source
of OTC. Administer up to 14 days; do not use for more than 14
consecutive days; withdraw 5 days prior to slaughter those products
sponsored by No. 000069. Administer up to 5 days; do not use for more
than 5 consecutive days; withdraw 13 days prior to slaughter those
products sponsored by No. 017144.
* * * * *
Dated: January 15, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 94-1421 Filed 1-19-94; 4:15 pm]
BILLING CODE 4160-01-F
