[Federal Register Volume 63, Number 139 (Tuesday, July 21, 1998)]
[Rules and Regulations]
[Pages 39028-39029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19315]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene 
Disalicylate and Nitarsone

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 reflect approval of a new animal drug application 
(NADA) filed by Alpharma Inc. The NADA provides for using approved 
bacitracin methylene disalicylate and nitarsone Type A medicated 
articles to make combination drug Type C medicated turkey feeds used as 
an aid in the prevention of blackhead, and for increased rate of weight 
gain and improved feed efficiency.

EFFECTIVE DATE: July 21, 1998.
FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1600.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, is sponsor of NADA 141-088 that provides for 
combining approved BMD (10, 25, 30, 40, 50, 60, or 75 grams 
per pound (g/lb) bacitracin methylene disalicylate) and 
Histostat (227 g/lb nitarsone) Type A medicated articles to 
make Type C medicated feeds for growing turkeys containing 4 to 50 g 
per ton bacitracin methylene disalicylate and 0.01875 percent 
nitarsone. The Type C medicated turkey feed is used as an aid in the 
prevention of blackhead, and for increased rate of weight gain and 
improved feed efficiency in growing turkeys. The NADA is approved as of 
June 17, 1998, and Secs. 558.76(d)(3) and 558.369(d) (21 CFR 
558.76(d)(3) and 558.369(d)) are amended to add new entries to reflect 
the approval. The basis for approval is discussed in the freedom of 
information summary.
    Also, due to enactment of the Generic Animal Drug and Patent Term 
Restoration Act in 1988, National Academy of Science/National Research 
Council (NAS/NRC) NADA's are no longer approved. Therefore, the text of 
Sec. 558.369(c) NAS/NRC status is removed and the paragraph reserved.
    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 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.
    This approval is for use of single ingredient Type A medicated 
articles to make combination drug Type C medicated feeds. One 
ingredient, nitarsone, is a Category II drug as defined in 21 CFR 
558.3(b)(1)(ii). Prior to enactment of the Animal Drug Availability Act 
of 1996 (Pub. L. 104-250) (ADAA), an approved medicated feed 
application (MFA) was required for feed mills to make Type C medicated 
feeds from Category II drugs. The ADAA revised the Federal Food, Drug, 
and Cosmetic Act to replace the requirement for MFA's with that for 
feed mill licenses. Use of Type A medicated articles to make Type C 
medicated feeds as in this NADA is limited to licensed feed mills.
    FDA has determined under 21 CFR 25.33(a)(2) 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.

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:

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 558.76 is amended by adding paragraph (d)(3)(xvi) to 
read as follows:

Sec. 558.76   Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (3) * * *
    (xvi) Nitarsone alone or in combination as in Sec. 558.369.
    3. Section 558.369 is amended by removing paragraph (c) and 
reserving it, by revising the introductory text of paragraph (d), by 
redesignating paragraphs (d)(1), (d)(2), and (d)(3) as paragraphs 
(d)(1)(i), (d)(1)(ii), and (d)(1)(iii), respectively, by adding a 
heading to paragraph (d)(1), and by adding new paragraph (d)(2), to 
read as follows:

Sec. 558.369   Nitarsone.

* * * * *
    (c) [Reserved]
    (d) Conditions of use. It is used as follows:
    (1) Chickens and turkeys.
* * * * *
    (2) Turkeys--(i) Amount. Nitarsone 0.01875 percent, plus bacitracin 
methylene disalicylate 4 to 50 grams per ton.
    (ii) Indications for use. As an aid in the prevention of blackhead, 
and for increased rate of weight gain and improved feed efficiency.
    (iii) Limitations. For growing turkeys. Feed continuously as sole 
ration. Early medication is essential to prevent spread of disease. 
Adequate drinking water must be provided near feeders at all times. 
Overdosage or lack of water may result in leg weakness or paralysis. 
The drug is not effective in preventing

[[Page 39029]]

blackhead in birds infected more than 4 or 5 days. Discontinue use 5 
days before slaughtering animals for human consumption to allow 
elimination of the drug from edible tissues. The drug is dangerous for 
ducks, geese, and dogs. Use as sole source of arsenic.

    Dated: July 9, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-19315 Filed 7-20-98; 8:45 am]
BILLING CODE 4160-01-F