[Federal Register Volume 66, Number 133 (Wednesday, July 11, 2001)]
[Rules and Regulations]
[Page 36162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17407]


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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; Tylosin; 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) listed below. In a notice 
published elsewhere in this issue of the Federal Register, FDA is 
withdrawing approval of the NADAs.

DATES: This rule is effective July 23, 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: Heinold Feeds, Inc., P.O. Box 377, Kouts, IN 
46347, has requested that FDA withdraw approval of NADA 95-628 for 
Tylosin Antibiotic Premix and NADA 127-506 for 
Tylan Sulfa-G Premixes because the products are no longer 
manufactured or marketed.
    Following the withdrawal of approval of these NADAs, Heinold Feeds, 
Inc., is no longer the sponsor of any approved applications. Therefore, 
21 CFR 510.600(c) is amended to remove entries for this sponsor.
    As provided below, the animal drug regulations are amended to 
reflect the withdrawal of approvals.
    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, 
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 entry for ``Heinold Feeds, Inc.,'' and in the 
table in paragraph (c)(2) by removing the entry for ``043727''.

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. 558.625  [Amended]

    4. Section 558.625 Tylosin is amended by removing and reserving 
paragraph (b)(9).


Sec. 558.630  [Amended]

    5. Section 558.630 Tylosin and sulfamethazine is amended in 
paragraph (b)(10) by removing ``043727,''; and by removing ``and 
051359, 053389'' and by adding in its place ``051359, and 053389''.

    Dated: July 2, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-17407 Filed 7-10-01; 8:45 am]
BILLING CODE 4160-01-S