[Federal Register Volume 64, Number 133 (Tuesday, July 13, 1999)]
[Rules and Regulations]
[Pages 37672-37673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17761]


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DEPARTMENT OF HEALTH AND HUMAN RESOURCES

Food and Drug Administration

21 CFR Parts 520 and 558


Animal Drugs, Feeds, and Related Products; Chlortetracycline 
Powder, Etc.; Technical Amendments

AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to correct errors concerning the sponsor of oral 
chlortetracycline powder, oral tetracycline powder, and interim use of 
certain medicated feeds. The amendments are required because the 
regulations did not reflect a change of sponsor from Fermenta Animal 
Health to Boehringer Ingelheim Vetmedica.

EFFECTIVE DATE: July 13, 1999.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 30, 1997 (62 
FR 35075 through 35077), FDA published a document reflecting the change 
of sponsor of several new animal drug applications from Fermenta Animal 
Health Co. to Boehringer Ingelheim Vetmedica, Inc. (at that time known 
as Boehringer Ingelheim Animal Health, Inc.). In 21 CFR 
520.445b(d)(4)(iii)(C) and 520.2345d(a)(1) the regulations failed to 
reflect the change from ``054273'' to ``000010''. Also, in 21 CFR 
558.15(g)(1) and (g)(2), the regulation failed to reflect the change 
from ``Fermenta Animal Health'' to ``Boehringer Ingelheim Vetmedica.'' 
At this time, the regulations in 21 CFR parts 520 and 558 are amended 
to reflect the change of sponsor.
    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 520

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner

[[Page 37673]]

of Food and Drugs and redelegated to the Center for Veterinary 
Medicine, 21 CFR parts 520 and 558 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:

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


Sec. 520.445b  [Amended]

    2. Section 520.445b Chlortetracycline powder (chlortetracycline 
hydrochloride or chlortetracycline bisulfate) is amended in paragraph 
(d)(4)(iii)(C) by removing ``012286, 053389, and 054273'' and adding in 
its place ``000010, 012286, and 053389''.


Sec. 520.2345d  [Amended]

    3. Section 520.2345d Tetracycline hydrochloride soluble powder is 
amended in paragraph (a)(1) by removing ``054273,'' and adding 
``000010,'' before ``046573''.

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

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

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


Sec. 558.15  [Amended]

    5. Section 558.15 Antibiotic, nitrofuran, and sulfonamide drugs in 
the feed of animals is amended in paragraphs (g)(1) and (g)(2) by 
removing ``Fermenta Animal Health Co.'' and adding in its place 
``Boehringer Ingelheim Vetmedica, Inc.''

    Dated: June 28, 1999.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 99-17761 Filed 7-12-99; 8:45 am]
BILLING CODE 4160-01-F