[Federal Register Volume 66, Number 83 (Monday, April 30, 2001)]
[Notices]
[Pages 21400-21401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10067]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0170]


Abbott Laboratories' Sarafloxacin for Poultry; Withdrawal of 
Approval of NADAs

<BD>AGENCY: <RM>Food and Drug Administration, HHS.

<BD>ACTION: <RM>Notice.

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<BD>SUMMARY: <RM>The Food and Drug Administration (FDA) is withdrawing 
approval of two new animal drug applications (NADAs) sponsored by 
Abbott Laboratories. The NADAs provide for use of sarafloxacin to treat 
poultry. In a final rule published elsewhere in this issue of the 
<CS>Federal Register<RM>, FDA is amending the animal drug regulations 
by removing the portions reflecting approval of these NADAs.

<BD>DATES: <RM>Withdrawal of approval is effective April 30, 2001.

<BD>FOR FURTHER INFORMATION CONTACT:  <RM>Mohammad I. Sharar, Center 
for Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0159.

<BD>SUPPLEMENTARY INFORMATION: <RM>Abbott Laboratories, North Chicago, 
IL 60064, is sponsor of the following NADAs: (1) NADA 141-017 
SaraFlox<IT><Register> <RM>(sarafloxacin hydrochloride) WSP, a water-
soluble powder used in the drinking water of broiler chickens and 
growing turkeys for control of mortality associated with 
<IT>Escherichia coli <RM>in (21 CFR 520.2095); and (2) NADA 141-018 
SaraFlox<IT><Register> <RM>(sarafloxacin hydrochloride) Injection, an 
injectable solution used in 18-day embryonated broiler eggs and day-old 
broiler chickens for control of early chick mortality associated with 
<IT>E. coli <RM>(21 CFR 522.2095).
    The sponsor was informed by FDA that, on the basis of new data and 
information before it, there is a question of human food safety, due to 
the use of fluoroquinolones such as sarafloxacin in poultry. After 
being informed by FDA of this question, Abbott Laboratories requested 
voluntary withdrawal of approval of NADAs 141-017 and 141-018. By doing 
so, the firm waived its opportunity for hearing.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10), redelegated to the Center for Veterinary 
Medicine (21 CFR 5.84),

[[Page 21401]]

and in accordance with Sec. 514.115 <IT>Withdrawal of approval of 
applications <RM>(21 CFR 514.115), notice is given that approval of 
NADAs 141-017 and 141-018, and all supplements and amendments thereto 
is hereby withdrawn effective April 30, 2001. Any new animal drug 
product that is not the subject of an approved application is subject 
to regulatory action at any time.
    In a final rule published elsewhere in this issue of the 
<CS>Federal Register<RM>, FDA is amending the animal drug regulations 
to reflect the withdrawal of approval of these NADAs.

    Dated: April 17, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-10067 Filed 4-27-01; 8:45 am]
BILLING CODE 4160-01-S