[Federal Register Volume 59, Number 157 (Tuesday, August 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19935]
[[Page Unknown]]
[Federal Register: August 16, 1994]
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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; Tiamulin
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 the approval of a supplemental new animal
drug application (NADA) filed by Fermenta Animal Health Co. The
supplemental NADA provides for the use of tiamulin (Denagard)
Type A medicated article to make a Type C medicated feed used for the
treatment of swine dysentery.
EFFECTIVE DATE: August 16, 1994.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1644.
SUPPLEMENTARY INFORMATION: Fermenta Animal Health Co., 10150 North
Executive Hills Blvd., Kansas City, MO 64153, is the sponsor of NADA
139-472, which was approved on July 17, 1987 (52 FR 26955), for the use
of tiamulin Type A medicated articles in the preparation of Type C
medicated swine feeds. As first approved, the Type C medicated feed
containing 35 grams per ton (g/t) of tiamulin could be used to control
swine dysentery. The Type C medicated feed containing 10 g of tiamulin
per ton could be used for increased rate of weight gain from weaning to
56.70 kilograms (kg) (125 pounds (lb)), which was later approved to
113.40 kg (250 lb) on October 6, 1988 (53 FR 39257). The sponsor has
submitted a supplemental application providing for the use of tiamulin
Type A medicated article containing 5, 10, or 113.4 g/lb of tiamulin
hydrogen fumarate to make a Type C medicated swine feed containing 200
g/t of tiamulin for the treatment of swine dysentery.
The supplemental NADA is approved as of July 7, 1994, and the
regulations are amended by modifying Sec. 558.600 (21 CFR 558.600) to
reflect the approval. The basis for approval is discussed in the
freedom of information summary. In addition, the regulation is amended
by modifying the genera ``Treponema'' to include the currently
scientifically accepted genera name ``Serpulina.''
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 qualifies
for 3 years exclusivity beginning July 7, 1994, because the
supplemental application contains reports of new clinical or field
investigations (other than bioequivalence or residue studies) essential
to the approval of the application and conducted by the applicant. The
3 years of marketing exclusivity applies only to the new claim ``for
treatment of swine dysentery'' for which the supplemental application
was approved.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
2. Section 558.600 Tiamulin is amended in paragraph (c)(1)(i) by
removing the word ``Treponema'' and adding in its place the words
``Serpulina (Treponema)'' and by adding new paragraph (c)(3) to read as
follows:
Sec. 558.600 Tiamulin.
* * * * *
(c) * * *
(3) Amount. 200 grams of tiamulin per ton.
(i) Indications for use. Treatment of swine dysentery associated
with Serpulina (Treponema) hyodysenteriae susceptible to tiamulin.
(ii) Limitations. Feed continuously as the sole feed for 14
consecutive days. Withdraw feed 7 days before slaughter. Not for use in
swine over 113.40 kilograms (250 pounds) body weight. Use as the only
source of tiamulin. Swine being treated with tiamulin should not have
access to feeds containing polyether ionophores (e.g., monensin,
lasalocid, narasin, semduramicin, or salinomycin) as adverse reactions
may occur.
Dated: August 8, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 94-19935 Filed 8-15-94; 8:45 am]
BILLING CODE 4160-01-F
