[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