Food and Drug Administration, HHS.
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 Federal Register, FDA is withdrawing approval of two NADAs sponsored by Abbott Laboratories.
This rule is effective April 30, 2001.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Mohammad I. Sharar, Center for Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0159.End Further Info End Preamble Start Supplemental Information
In a notice published elsewhere in this issue of the Federal Register, 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® (sarafloxacin hydrochloride) WSP and is under § 520.2095 (21 CFR 520.2095) and NADA 141-018 provides for the use of SaraFlox® (sarafloxacin hydrochloride) Injection and is under § 522.2095 (21 CFR 522.2095). Relevant information concerning tolerances for residues of sarafloxacin in edible tissues of poultry is under § 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 §§ 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.Start List of Subjects
List of Subjects
and 522End List of Subjects Start Amendment Part
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,End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part
1. The authority citation for 21 CFR part 520 continues to read as follows:
2. Section 520.2095End Amendment Part Start Part
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part
3. The authority citation for 21 CFR part 522 continues to read as follows:
4. Section 522.2095 Sarafloxacin solution for injection is removed.Start Part
PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOODEnd Part
5. The authority citation for 21 CFR part 556 continues to read as follows:
6. Section 556.594 Sarafloxacin is removed.Start Signature
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