[Federal Register Volume 63, Number 61 (Tuesday, March 31, 1998)]
[Rules and Regulations]
[Pages 15291-15292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-8126]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


Hoffmann-La Roche, Inc.; Chlortetracycline; Approval

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is approving two 
supplemental new animal drug applications (NADA's) filed by Hoffmann-La 
Roche, Inc. The supplemental NADA's provide for use of 
chlortetracycline (CTC) Type A medicated articles to make a Type C 
medicated feed and a calf milk replacer in compliance with the 
conclusions of the National Academy of Sciences/National Research 
Council (NAS/NRC) Drug Efficacy Study Implementation (DESI) review of 
the effectiveness of the drugs and FDA's conclusions based on that 
review. Approval of these supplemental NADA's does not require 
amendment of animal drug regulations.

EFFECTIVE DATE: March 31, 1998.
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: Hoffmann-La Roche, Inc., Nutley, NJ 07110-
1199, is sponsor of NADA 49-287 that provides for use of 
PfiChlor 50, 70, and 100 (CTC) Type A medicated articles to 
make Type C medicated feeds for chickens, turkeys, sheep, calves, 
cattle, and swine; and NADA 100-901 that provides for use of 
PfiChlor 100S (CTC) Type A medicated articles to make calf 
milk replacers. The firm filed supplemental applications to reflect 
concurrence with the conclusions of the NAS/NRC DESI review of the 
applications and FDA's conclusions based on that review.
    CTC was the subject of a NAS/NRC DESI review published in the 
Federal Register of July 21, 1970 (35 FR 11646). The NAS/NRC review 
concluded, and FDA concurred, that the products were probably effective 
for growth promotion and feed efficiency and the treatment of animal 
diseases caused by pathogens sensitive to CTC. FDA reviewed the 
available data concerning effectiveness of the products and concluded 
that the data supported claims for control and treatment of certain 
bacterial diseases susceptible to CTC in chickens, turkeys, ducks, 
psittacine birds, cattle, sheep, and swine as well as increased rate of 
weight gain and improved feed efficiency in most of the same species. 
The sponsor provided revised labeling that complied with the 
conclusions of the NAS/NRC review.
    The firm filed supplemental applications to reflect concurrence 
with the conclusions of the NAS/NRC DESI review of the applications and 
FDA's conclusions based on that review.
    The supplemental NADA's are approved as of January 21, 1998. The 
basis of approval is discussed in the freedom of information summaries.
    In the Federal Register of October 21, 1977 (42 FR 56264), the then 
Bureau of Veterinary Medicine issued a notice of opportunity for a 
hearing (NOOH) on a proposal to withdraw approval of certain NADA's 
listed in 21 CFR 558.15, for most subtherapeutic uses of tetracycline 
(CTC and oxytetracycline) in animal feed. The NOOH was issued in 
response to scientific research suggesting that subtherapeutic use of 
such drugs has contributed to the pool of antibiotic-resistant 
pathogenic microorganisms in food animals.

[[Page 15292]]

 Furthermore, research indicated that the drug resistance could be 
transferred to pathogenic organisms in humans. The NOOH is still 
pending and approval of these supplements to finalize the DESI review 
process for CTC Type A medicated articles does not constitute a bar to 
subsequent action to withdraw approval on the grounds cited in the 
outstanding NOOH.
    The NAS/NRC DESI evaluation concerns only the drug's effectiveness 
and safety to the treated animal. It does not take into account the 
safety for food use of food derived from drug-treated animals. Nothing 
herein will constitute a bar to further proceedings with respect to the 
safety of the drugs or its metabolites in food products derived from 
treated animals.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), summaries of safety and effectiveness 
data and information submitted to support approval of these 
applications may be seen in the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) that these 
actions are of a type that do not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    Because the animal drug regulations in 21 CFR 558.128(a)(1) reflect 
that Hoffmann-La Roche, Inc., is the sponsor of other NADA's providing 
for use of the same or similar CTC products, amendment of the animal 
drug regulations is not required.

    Dated: March 17, 1998.
Andrew J. Beaulieau,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-8126 Filed 3-30-98; 8:45 am]
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