[Federal Register Volume 62, Number 50 (Friday, March 14, 1997)]
[Rules and Regulations]
[Pages 12085-12087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6476]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 556 and 558
Animal Drugs, Feeds, and Related Products; Chlortetracycline and
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 approval of a new animal drug application
(NADA) filed by Fermenta Animal Health Co. The NADA provides for the
use of separately approved Type A medicated articles containing
chlortetracycline and tiamulin in making Type C combination medicated
feed. The feed is used in swine for treatment of bacterial enteritis
and bacterial pneumonia and for control of swine dysentery. The
regulations are also amended to increase the tolerance for tiamulin
residue in swine liver.
EFFECTIVE DATE: March 14, 1997
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 64153-2314, filed NADA 141-011,
[[Page 12086]]
which provides for using separately approved Type A medicated articles
containing chlortetracycline calcium complex equivalent to 50 to 100
grams per pound (g/lb) of chlortetracycline hydrochloride (CTC HCl) and
5 or 10 g/lb of tiamulin in making a Type C medicated swine feed. The
feed contains a specific level of each animal drug as follows:
Chlortetracycline calcium complex equivalent to approximately 400 g of
CTC HCl per ton (g/t), varying with body weight and feed consumption to
provide 10 milligrams of chlortetracycline/lb of body weight daily, and
tiamulin (as tiamulin hydrogen fumarate) 35 g/t. The feed is indicated
for use in swine for treatment of swine bacterial enteritis and
bacterial pneumonia caused by certain bacteria susceptible to CTC and
for control of swine dysentery caused by certain bacteria susceptible
to tiamulin. The NADA is approved as of August 20, 1996, and the
regulations are amended in Secs. 558.128 and 558.600 (21 CFR 558.128
and 558.600) to reflect the approval. The basis for approval is
discussed in the freedom of information summary.
These are new animal drugs used in Type A medicated articles to
make Type B and C medicated feeds. Chlortetracycline and tiamulin are
Category I drugs, which as provided in 21 CFR 558.4, do not require a
licensed feed mill for making a Type B or C medicated feed from a Type
A medicated article. Therefore, a licensed feed mill is not required
for making a Type B or C medicated feed containing chlortetracycline in
combination with tiamulin as in the approved subject NADA and in
amended Sec. 558.600.
Additionally, the safe concentrations and tolerances for tiamulin
and chlortetracycline have been revised based on the new food
consumption factors described in FDA's document entitled ``General
Principles for Evaluating the Safety of Compounds Used in Food-
Producing Animals'' (59 FR 37499, July 22, 1994). The revised
tolerances for chlortetracycline were published in the Federal Register
of December 23, 1996. The revised safe concentrations for total
residues of tiamulin in edible swine tissues are 5 parts per million
(ppm) in muscle, 15 ppm in liver, and 30 ppm in kidney and fat. These
new safe concentrations for tiamulin residues in edible tissues
correspond to a revised tolerance for tiamulin of 0.6 ppm for 8-alpha-
hydroxymutilin (marker compound) in swine liver (target tissue).
Accordingly, 21 CFR 556.738 is revised to increase the tolerance for
the marker compound from 0.4 to 0.6 ppm.
The sponsor has demonstrated via residue depletion studies, using
approved regulatory methods, that the depletion characteristics of the
marker residues for each drug in the combination are not significantly
modified and that the existing regulatory method for each drug in the
combination is not interfered with by residues of the other drug.
Therefore, the Center for Veterinary Medicine (CVM) concludes that the
composition of each drug's residue is unchanged while in the
combination. Accordingly, CVM is establishing a pre-slaughter
withdrawal period of 2 days for use of this combination.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
a 3-year period of marketing exclusivity beginning on August 20, 1996,
because new clinical or field investigations (other than bioequivalence
or residue studies), or human food safety studies (other than
bioequivalence or residue studies) essential to the approval were
conducted or sponsored by the applicant.
The agency has determined under 21 CFR 25.24(d)(1)(ii) 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
21 CFR Part 556
Animal drugs, Foods.
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 parts 556 and
558 are amended as follows:
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
1. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: Secs. 402, 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342, 360b, 371).
2. Section 556.738 is revised to read as follows:
Sec. 556.738 Tiamulin.
A tolerance of 0.6 part per million is established for 8-alpha-
hydroxymutilin (marker compound) in liver (target tissue) of swine.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
3. 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).
4. Section 558.128 is amended by adding new paragraph (c)(3)(xiii)
to read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(c) * * *
(3) * * *
(xiii) Tiamulin in accordance with Sec. 558.600.
5. Section 558.600 is amended by adding new paragraph (c)(4) to
read as follows:
Sec. 558.600 Tiamulin.
* * * * *
(c) * * *
(4) Amount per ton. 35 grams of tiamulin (as tiamulin hydrogen
fumarate), plus the equivalent of approximately 400 grams of
chlortetracycline hydrochloride varying with body weight and feed
consumption to provide 10 milligrams of chlortetracycline per pound of
body weight daily.
(i) Indications for use. Treatment of swine bacterial enteritis
caused by Escherichia coli and Salmonella choleraesuis and bacterial
pneumonia caused by Pasteurella multocida susceptible to
chlortetracycline, and control of swine dysentery associated with
Serpulina (Treponema) hyodysenteriae susceptible to tiamulin.
(ii) Limitations. Feed continuously as sole ration for 14 days. Not
for use in swine weighing over 250 pounds. Use as only source of
chlortetracycline and tiamulin. Swine being treated with tiamulin
should not have access to feeds containing polyether ionophores (e.g.,
[[Page 12087]]
monensin, salinomycin, narasin, semduramicin, and lasalocid) as adverse
reactions may occur. If signs of toxicity occur, discontinue use.
Withdraw 2 days before slaughter. As chlortetracycline calcium complex,
Type A medicated articles containing the equivalent of 50 to 100 grams
per pound of chlortetracycline hydrochloride provided by 000004 and
046573 in Sec. 510.600(c) of this chapter.
Dated: February 6, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-6476 Filed 3-13-97; 8:45 am]
BILLING CODE 4160-01-F