[Federal Register Volume 60, Number 108 (Tuesday, June 6, 1995)]
[Rules and Regulations]
[Pages 29754-29756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13707]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522


Animal Drugs, Feeds, and Related Products; Oxytetracycline 
Injection

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 hybrid new animal drug 
application (NADA) filed by Cross Vetpharm Group Ltd. The NADA 
[[Page 29755]] provides for the use of oxytetracycline injection in 
cattle and swine for the treatment of diseases caused by 
oxytetracycline susceptible organisms.

EFFECTIVE DATE: June 6, 1995.
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: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, has filed ANADA 200-117 (hybrid 
application) which provides for use of oxytetracycline injection as 
follows: (1) Intramuscular or intravenous use in beef and nonlactating 
dairy cattle for the treatment of pneumonia and shipping fever 
associated with -Pasteurella spp. and Hemophilus spp.; infectious 
bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis; foot 
rot and diphtheria caused by Fusobacterium necrophorum; bacterial 
enteritis (scours) caused by Escherichia coli; wooden tongue caused by 
Actinobacillus lignieresi; leptospirosis caused by Leptospira pomona; 
and wound infections and acute metritis caused by strains of 
staphylococci and streptococci organisms sensitive to oxytetracycline; 
(2) intramuscular use in swine for treatment of bacterial enteritis 
(scours, colibacillosis) caused by E. coli; pneumonia caused by P. 
multocida; and leptospirosis caused by L. pomona; and (3) intramuscular 
use in sows for control of infectious enteritis (baby pig scours, 
colibacillosis) in suckling pigs caused by E. coli.
    The data submitted in support of this hybrid NADA satisfy the 
requirements of section 512(b)(1) and (b)(2) of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 360b(b)(1) and (b)(2)) and 21 CFR 
part 514 of the regulations. The hybrid NADA has been defined in the 
Center's Seventh Generic Animal Drug Policy Letter, dated March 20, 
1991. The hybrid application relies on the approval of a listed 
(pioneer) animal drug and contains additional data needed to support 
the change in the generic product. The hybrid applicant is thus relying 
on the approval of the listed animal drug to the extent that such 
reliance is allowed under section 512(n) of the act, to establish the 
safety and effectiveness of the active ingredient. An application that 
relies in part on the approval of a listed animal drug is, for this 
purpose, considered an application described in section 512(b)(2).
    Cross Vetpharm Group Ltd.'s ANADA 200-117 for oxytetracycline 
injection (Oxy-ShotTM LA) is approved as a generic copy of 
Pfizer's NADA 113-232 for oxytetracycline injection 
(Liquamycin LA-200). The ANADA is approved as of April 13, 
1995, and the regulations are amended in 21 CFR 522.1660(b) and 
(c)(2)(iii) to reflect the approval. The basis for approval is 
discussed in the freedom of information summary.
     Additionally, the regulations are amended in 21 CFR 510.600(c) to 
add Cross Vetpharm Group Ltd. to the list of sponsors of approved 
applications.
    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 (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.
    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 (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.
    Because this hybrid NADA is reviewed in part as an application 
under section 512(b)(1) of the act, the hybrid application is eligible 
for 3 years of exclusivity under section 512(c)(2)(F)(iii) of the act. 
Under section 512(c)(2)(F)(iii) of the act, this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning on April 13, 1995, because the supplemental application 
contains reports of new clinical or field investigations (other than 
bioequivalence or residue studies) essential to the approval of the 
application and conducted or sponsored by the applicant.
     Under the center's supplemental approval policy (21 CFR 
514.106(b)(2)(ii)), this is a Category II change. The approval of this 
change is not expected to have any adverse effect on the safety or 
effectiveness of this new animal drug.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 522

    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 parts 510 and 
522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:
    Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).
    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding a new entry for ``Cross Vetpharm Group Ltd.'' and 
in the table in paragraph (c)(2) by numerically adding a new entry for 
``061623'' to read as follows:


Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

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       Firm name and address                  Drug labeler code         
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                  *        *        *        *        *                 
Cross Vetpharm Group Ltd.,           061623                             
 Broomhill Rd., Tallaght, Dublin                                        
 24, Ireland.                                                           
                  *        *        *        *        *                 
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     (2) * * *

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         Drug labeler code                  Firm name and address       
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                  *        *        *        *        *                 
 061623............................  Cross Vetpharm Group Ltd.,         
                                      Broomhill Rd., Tallaght, Dublin   
                                      24, Ireland.                      
                  *        *        *        *        *                 
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PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 522 continues to read as 
follows:
     Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).


Sec. 522.1660  [Amended]

    4. Section 522.1660 Oxytetracycline injection is amended in 
paragraph (b) by removing the phrase ``000010, 000069, and 059130'' and 
adding in its place [[Page 29756]] ``000010, 000069, 059130, and 
061623'', and in paragraph (c)(2)(iii) by revising the last sentence to 
read ``Discontinue treatment at least 42 days prior to slaughter when 
provided by 000010 and 28 days prior to slaughter when provided by 
000069, 059130, or 061623.''

    Dated: May 26, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-13707 Filed 6-5-95; 8:45 am]
BILLING CODE 4160-01-F