[Federal Register Volume 66, Number 83 (Monday, April 30, 2001)]
[Rules and Regulations]
[Page 21282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, and 556


Animal Drugs, Feeds, and Related Products; Sarafloxacin for 
Poultry; Withdrawal of Approval of NADAs

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

<BD>ACTION: <RM>Final rule.

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

<BD>DATES: <RM>This rule 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>In a notice published elsewhere in 
this issue of the <CS>Federal Register<RM>, FDA is withdrawing approval 
of two NADAs held by Abbott Laboratories, North Chicago, IL 60064. The 
NADAs provide for use of sarafloxacin to treat poultry. NADA 141-017 
provides for the use of SaraFlox<IT><Register> <RM>(sarafloxacin 
hydrochloride) WSP and is under Sec. 520.2095 (21 CFR 520.2095) and 
NADA 141-018 provides for the use of SaraFlox<IT><Register> 
<RM>(sarafloxacin hydrochloride) Injection and is under Sec. 522.2095 
(21 CFR 522.2095). Relevant information concerning tolerances for 
residues of sarafloxacin in edible tissues of poultry is under 
Sec. 556.594 (21 CFR 556.594).
    Abbott Laboratories requested withdrawal of approval in response to 
safety questions raised by FDA regarding the products.
    No other NADAs for use of sarafloxacin have been approved. 
Therefore, in accordance with the notice of withdrawal of approvals, 
FDA is amending the regulations to remove Sec. Sec. 520.2095, 522.2095, 
and 556.594 effective April 30, 2001.
    The agency has determined under 21 CFR 25.33(g) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Parts 520 and 522

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Food and Drug Administration and redelegated 
to the Center for Veterinary Medicine, 21 CFR parts 520, 522, and 556 
are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    <CS>Authority: <RM>21 U.S.C. 360b.


Sec.  520.2095  [Removed]

    2. Section 520.2095 <IT>Sarafloxacin soluble powder <RM>is removed.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 522 continues to read as 
follows:

    <CS>Authority: <RM>21 U.S.C. 360b.


Sec.  522.2095  [Removed]

    4. Section 522.2095 <IT>Sarafloxacin solution for injection <RM>is 
removed.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

    5. The authority citation for 21 CFR part 556 continues to read as 
follows:

    <CS>Authority: <RM>21 U.S.C. 342, 360b, 371.


Sec.  556.594  [Removed]

    6. Section 556.594 <IT>Sarafloxacin <RM>is removed.

    Dated: April 17, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-10069 Filed 4-27-01; 8:45 am]
BILLING CODE 4160-01-S