[Federal Register Volume 62, Number 56 (Monday, March 24, 1997)]
[Rules and Regulations]
[Page 13825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7277]
[[Page 13825]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Oxytetracycline Injection; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a final
rule that was published in the Federal Register of July 10, 1996 (61 FR
36290), that amended the animal drug regulations to reflect approval of
a supplemental abbreviated new animal drug application (ANADA) held by
Boehringer Ingelheim Animal Health, Inc. The regulation inadvertently
failed to specify that only Boehringer Ingelheim's oxytetracycline
injection is approved for subcutaneous use in cattle. In addition, the
preamble failed to provide that the supplemental approval was granted 3
years marketing exclusivity for the new use. This document corrects
these errors.
EFFECTIVE DATE: July 10, 1996.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 10, 1996 (61
FR 36290), FDA published the approval of Boehringer Ingelheim Animal
Health, Inc.'s supplemental ANADA 200-008 that provides for
subcutaneous use of oxytetracycline injection in addition to the
approved intravenous and intramuscular use in beef and nonlactating
dairy cattle. The approval document inadvertently failed to specify
that only Boehringer Ingelheim's oxytetracycline injection is approved
for subcutaneous use in cattle. Accordingly, the agency is correcting
21 CFR 522.1660(c)(1)(iii) as set forth below.
In addition, the document did not state that under section
512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360b(c)(2)(F)(iii)), as in effect on May 22, 1996, the date of
approval, this approval for food-producing animals qualifies for 3
years of marketing exclusivity beginning May 22, 1996, because the
supplement contains 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 of the supplement and
conducted or sponsored by the applicant.
Sec. 522.1660 [Corrected]
2. In FR Doc. 96-17541, appearing on page 36290 in the Federal
Register of Wednesday, July 10, 1996, the following correction is made.
On page 36291, in the first column, in line 2, amendment ``2.'' is
corrected to read as follows:
2. Section 522.1660 Oxytetracycline injection is amended in
paragraph (c)(1)(iii) by removing the first sentence and adding two
sentences in its place, to read as follows:
Sec. 522.1660 Oxytetracycline injection.
* * * * *
(c) * * *
(1) * * *
(iii) Administer intramuscularly or intravenously at the 3 to 5
milligrams level, intramuscularly at the 9 milligrams level. Sponsor
000010, may also administer subcutaneously at the 3 to 5 milligrams and
9 milligrams levels. * * *
* * * * *
Dated: March 13, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation Center for Veterinary
Medicine
[FR Doc. 97-7277 Filed 3-21-97; 8:45 am]
BILLING CODE 4160-01-F
