[Federal Register Volume 63, Number 160 (Wednesday, August 19, 1998)]
[Rules and Regulations]
[Pages 44385-44386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22227]
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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 Chlortetracycline
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 supplemental new animal drug
application (NADA) filed by Alpharma Inc. The supplemental NADA
provides for using approved single ingredient bacitracin methylene
disalicylate (BMD) and chlortetracycline (CTC) Type A medicated
articles to make Type B medicated feeds used to make Type C medicated
swine feeds.
EFFECTIVE DATE: August 19, 1998.
FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1652.
SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, filed supplemental NADA 141-059 that provides
for combining approved BMD (10, 25, 30, 40, 50, 60, or 75
grams per pound (g/lb) BMD) and CTC (50, 65, or 70 g/lb CTC)
Type A medicated articles to make Type B medicated feed. The Type B
medicated feed containing 1 to 3 g/lb BMD and 40 g/lb CTC is used to
make Type C medicated swine feed containing 10 to 30 g per ton (g/t)
BMD and 400 g/t CTC. The Type C medicated swine feeds are used for
treatment of bacterial enteritis caused by Escherichia coli and
Salmonella choleraesuis, and bacterial pneumonia caused by Pasteurella
multocida susceptible to CTC, and for increased rate of weight gain and
improved feed efficiency. The supplemental NADA is approved as of June
24, 1998, and the regulations are amended in the table in 21 CFR
558.76(d)(1) to reflect the approval. The basis for 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 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.
The agency has determined under 21 CFR 25.33(a)(3) 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
the 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 in the table in paragraph (d)(1) by
revising entry (iv) to read as follows:
Sec. 558.76 Bacitracin methylene disalicylate.
* * * * *
(d) * * *
(1) * * *
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Bacitracin methylene Combination in Indications for
disalicylate in grams per ton grams per ton use Limitations Sponsor
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* * * * * *
*
(iv) 10 to 30................... ................ Swine: for For growing and 000004 and 046573
increased rate of finishing swine.
weight gain and
improved feed
efficiency.
[[Page 44386]]
Chlortetracycline Swine; for Feed for not more 000004 and 046573
approximately increased rate of than 14 days to
400, varying with weight gain and provide 10
body weight and improved feed milligrams of
food consumption efficiency; for chlortetracycline
to provide 10 treatment of per pound of body
milligrams per bacterial weight per day;
pound of body enteritis caused as
weight per day. by Escherichia chlortetracycline
coli and provided by Nos.
Salmonella 000004 and 046573
choleraesuis and in Sec.
bacterial 510.600(c) of
pneumonia caused this chapter.
by Pasteurella Type C feed may
multocida be prepared from
susceptible to Type B feed
chlortetracycline. containing 1 to 3
grams per pound
BMD with 400
grams per pound
CTC, to 046573 in
Sec. 510.600(c).
* * * * * *
*
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* * * * *
Dated: August 1, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-22227 Filed 8-18-98; 8:45 am]
BILLING CODE 4160-01-F
