[Federal Register: July 26, 2000 (Volume 65, Number 144)]
[Rules and Regulations]               
[Page 45881-45882]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jy00-25]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

 
New Animal Drugs for Use in Animal Feeds; Chlortetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Alpharma, Inc. The supplemental NADA 
provides for use of approved chlortetracycline (CTC) Type A medicated 
articles to make Type C medicated feeds used for control of porcine 
proliferative enteropathies (ileitis) in swine.

DATES: This rule is effective July 26, 2000.

FOR FURTHER INFORMATION CONTACT: Diane D. Jeang, Center for Veterinary 
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-7574.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., PO Box 
1399, Fort Lee, NJ 07024, filed a supplement to approved NADA 046-699 
that provides for use of CHLORMAX<SUP>TM</SUP> (50, 65, or 70 grams per 
pound (g/lb) chlortetracycline as chlortetracycline hydrochloride) Type 
A medicated articles to make Type C medicated feeds for use in growing 
and finishing swine. The Type C medicated feeds contain approximately 
400 g per ton CTC (to provide 10 milligrams/lb body weight) and are 
used for the control of porcine proliferative enteropathies (ileitis) 
caused by Lawsonia intracellularis susceptible to chlortetracycline. 
The supplemental NADA is approved as of July 7, 2000, and the 
regulations are amended in 21 CFR 558.128 to reflect the approval. The 
basis of approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this supplemental 
application may be seen in the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning on July 7, 2000, because the application contains substantial 
evidence of the effectiveness of the drug involved, any studies of 
animal safety, or in the case of food-producing animals, human food 
safety studies (other than bioequivalence or residue studies) required 
for the approval of the application and conducted or sponsored by the 
applicant. The 3 years of marketing exclusivity applies only to the new 
claim for which the supplemental application was approved.
    The agency has determined under 21 CFR 25.33(a)(1) 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.

List of Subjects in 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 part 558 is 
amended as follows:

[[Page 45882]]

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

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

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


    2. Section 558.128 is amended in the table in paragraph (d)(1)(xii) 
by adding an entry ``4.'' to read as follows:


Sec. 558.128  Chlortetracycline.

* * * * *
    (d) * * *
    (1) * * *


------------------------------------------------------------------------
 Chlortetracycline                  Indications
      amount         Combination      for use      Limitations   Sponsor
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
(xii) 10 mg/lb of                 * * *
 body weight
                                  4. Swine; for   Feed for not  046573
                                   control of      more than
                                   porcine         14 d.
                                   proliferative
                                   enteropathies
                                   (ileitis)
                                   caused by
                                   Lawsonia
                                   intracellular
                                   is
                                   susceptible
                                   to
                                   chlortetracyc
                                   line.
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------

* * * * *

    Dated: July 18, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-18823 Filed 7-25-00; 8:45 am]
BILLING CODE 4160-01-F