[Federal Register Volume 66, Number 158 (Wednesday, August 15, 2001)]
[Rules and Regulations]
[Pages 42730-42731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; 
Chloramphenicol, etc.; Withdrawal of Approval of NADAs

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 remove those portions that reflect approval of two 
new animal drug applications (NADAs) held by EVSCO Pharmaceuticals, an 
Affiliate of IGI, Inc. In a notice published elsewhere in this issue of 
the Federal Register, FDA is withdrawing approval of these NADAs.

DATES: This rule is effective August 27, 2001.

FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-210), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-5593.

SUPPLEMENTARY INFORMATION: EVSCO Pharmaceuticals, an Affiliate of IGI, 
Inc., Box 209, Harding Hwy., Buena, NJ 08310, has requested that FDA 
withdraw approval of NADA 32-984 for Cerumite (chloramphenicol, 
prednisolone, tetracaine, and squalane)

[[Page 42731]]

topical suspension, and NADA 55-005 for Liquichlor with Cerumene 
(squalane, pyrethrins, and piperonyl butoxide) topical suspension 
because the products are no longer manufactured or marketed. As 
provided below, the animal drug regulations are amended to reflect the 
withdrawal of approval of these NADAs by removing 21 CFR 524.390c and 
524.2140.
    In a notice published elsewhere in this issue of the Federal 
Register, FDA is withdrawing approval of these NADAs.
    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 in 21 CFR Part 524

    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 part 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec. 524.390c  [Removed]

    2. Section 524.390c Chloramphenicol-prednisolone-tetracaine-
squalane topical suspension is removed.


Sec. 524.2140  [Removed]

    3. Section 524.2140 Squalane, pyrethrins and piperonyl butoxide is 
removed.

    Dated: August 6, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-20573 Filed 8-14-01; 8:45 am]
BILLING CODE 4160-01-S