[Federal Register Volume 66, Number 173 (Thursday, September 6, 2001)]
[Rules and Regulations]
[Pages 46518-46519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22381]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558


Animal Drugs, Feeds, and Related Products; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is updating the animal 
drug regulations to reflect changes to previously approved new animal 
drug applications (NADAs). Several sponsors currently listed as 
sponsors of approved applications and specified in the animal drug 
approval regulations are incorrect. This action is being taken to 
improve the accuracy of the regulations.

DATES: This rule is effective September 6, 2001.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-4567.

SUPPLEMENTARY INFORMATION: FDA has found several errors in the agency's 
regulations concerning sponsors of approved applications of medicated 
animal feeds. To correct those errors, FDA is amending 21 CFR 
510.600(c)(1) and (c)(2) to remove names and corresponding drug labeler 
codes for Carnation Co., Illini Feeds, and Tevcon Ind., Inc., because 
these firms are no longer the holders of any approved NADAs. The agency 
is also amending the animal drug approval regulations by removing the 
entry associated with Carnation Co.'s NADA 104-424 in 21 CFR 558.58, 
which is no longer an approved NADA.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). Notice 
and public procedure are unnecessary because FDA is merely correcting 
nonsubstantive errors.
    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 Part 510

    Administrative practice and procedure, Animal drugs, Labeling,

[[Page 46519]]

Reporting and recordkeeping requirements.

21 CFR Part 558

    Animal drugs, Animal feeds.

    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 parts 510 and 
558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec. 510.600  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) by removing the entries for ``Carnation Co.'', ``Illini Feeds'', 
and ``Tevcon Ind., Inc.'' and in the table in paragraph (c)(2) by 
removing the entries for ``047019 and 037310''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    3. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec. 558.58  [Amended]

    4. Section 558.58 Amprolium and ethopabate is amended in the table 
in paragraph (d)(1) by removing paragraph (d)(1)(v).

    Dated: August 29, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-22381 Filed 9-5-01; 8:45 am]
BILLING CODE 4160-01-S