Animal drugs, feeds, and related products: New drug applications Chlortetracycline,
[Federal Register: October 27, 1998 (Volume 63, Number 207)]
[Rules and Regulations]
[Page 57245-57248]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc98-7]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 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) filedby Roche Vitamins, Inc. The supplemental NADA provides for use of a chlortetracycline (CTC) Type A medicated article in Type C medicated feeds for chickens producing eggs for human consumption, a tolerance for residues in eggs, and an acceptable daily intake (ADI) for total tetracycline residues in humans.
EFFECTIVE DATE: October 27, 1998.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0212.
SUPPLEMENTARY INFORMATION: Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 07054-1298, filedsupplemental NADA 48-761 that provides for use of Aureomycin‹Register› (50, 90, and 100 grams per pound CTC) Type A medicated article in Type C medicated feeds for chickens laying eggs for human consumption. The supplemental NADA is approved as of July 31, 1998, and the regulations are amended in 21 CFR 558.128(d)(1) to reflect the approval. The basis of approval is discussed in the freedom of information summary.
In approving the use of chlortetracycline Type C medicated feeds for chickens laying eggs for human consumption, a tolerance is established for chlortetracycline residues in eggs. At this time, FDA is also establishing the ADI for total tetracycline residues (the total drug residues from chlortetracycline, oxytetracycline, and tetracycline, that can safely be
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consumed each day by humans). The regulations in 21 CFR 556.150, 556.500, and 556.720 are amended to establish a tetracycline ADI, and in Sec. 556.150 to provide for a tolerance for chlortetracycline residues in eggs.
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.
Under 21 U.S.C. 360b(c)(2)(F)(iii), this supplemental NADA for food-producing animals qualifies for 3 years of marketing exclusivity beginning July 31, 1998, because the supplement contains substantial evidence of the effectiveness of the drug involved, studies of animal safety or, in the case of food-producing animals, human food safety studies (other than bioequivalence or residue studies) required for approval of the supplement and conducted or sponsored by the applicant. The 3 years marketing exclusivity is limited to use of this drug in the feed of chickens producing eggs for human consumption.
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
Animal drugs, Foods.
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: 21 U.S.C. 342, 360b, 371.
2. Section 556.150 is amended by revising paragraph (b) to read as follows:
Sec. 556.150 Chlortetracycline.
(a) * * *
(b) Tolerances. (1) Tolerances are established for the sum of tetracycline residues in tissues of beef cattle, nonlactating dairy cows, calves, swine, sheep, chickens, turkeys, and ducks, of 2 parts per million (ppm) in muscle, 6 ppm in liver, and 12 ppm in fat and kidney.
(2) A tolerance is established for residues of chlortetracycline in eggs of 0.4 ppm.
3. Section 556.500 is revised to read as follows:
Sec. 556.500 Oxytetracycline.
(a) Acceptable daily intake (ADI). The ADI for total tetracycline residues (chlortetracycline, oxytetracycline, and tetracycline) is 25 micrograms per kilogram of body weight per day.
(b) Tolerances. Tolerances are established for the sum of tetracycline residues in tissues of beef cattle, beef calves, nonlactating dairy cattle, dairy calves, swine, sheep, chickens, turkeys, catfish, lobsters, and salmonids, of 2 parts per million (ppm) in muscle, 6 ppm in liver, and 12 ppm in fat and kidney.
4. Section 556.720 is revised to read as follows:
Sec. 556.720 Tetracycline.
(a) Acceptable daily intake (ADI). The ADI for total tetracycline residues (chlortetracycline, oxytetracycline, and tetracycline) is 25 micrograms per kilogram of body weight per day.
(b) Tolerances. Tolerances are established for the sum of tetracycline residues in tissues of calves, swine, sheep, chickens, and turkeys, of 2 parts per million (ppm) in muscle, 6 ppm in liver, and 12 ppm in fat and kidney.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
5. The authority citation for 21 CFR part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
6. Section 558.128 is amended in paragraph (d)(1) in the table by revising entries (i) through (viii) to read as follows:
Sec. 558.128 Chlortetracycline.
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(d)(1) * * *
Chlortetracycline amount
Combination
Indications for use
Limitations
Sponsor
(i) 10 to 50 g/t
1. Chickens;
.................... 063238. increased rate of weight gain and improved feed efficiency. Do not feed to 000069, 017519, chickens producing 046573, 053389. eggs for human consumption. 2. Growing turkeys; Do not feed to
000069, 017519, increased rate of turkeys producing 046573, 053389, weight gain and
eggs for human
063238. improved feed
consumption. efficiency. 3. Growing swine;
Do. increased rate of weight gain and improved feed efficiency. (ii) 20 to 50 g/t
Growing sheep;
000069, 046573, increased rate of
053389, 063238. weight gain and improved feed efficiency.
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(iii) 50 to 100 g/t
Swine; reducing the
000069, 017519, incidence of
046573, 053389, cervical
063238. lymphadenitis (jowl abscesses) caused by Group E. Streptococci susceptible to chlortetracycline. (iv) 100 to 200 g/t
Chickens; control of 1. Feed continuously 063238. infectious synovitis for 7 to 14 d. caused by Mycoplasma synoviae susceptible to chlortetracycline. 2. Feed continuously 000069, 017519, for 7 to 14 d; do 046573, 053389. not feed to chickens producing eggs for human consumption. (v) 200 g/t
Turkeys; control of Feed continuously 000069, 017519, infectious synovitis for 7 to 14 d; do 046573, 053389, caused by M.
not feed to turkeys 063238. synoviae susceptible producing eggs for to
human consumption. chlortetracycline. (vi) 200 to 400 g/t
1. Chickens; control 1. Feed continuously 063238. of chronic
for 7 to 14 d. respiratory disease (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracycline. 2. Feed continuously 000069, 017519, for 7 to 14 d; do 046573, 053389. not feed to chickens producing eggs for human consumption. 2. Ducks; control and Feed in complete 063238. treatment of fowl ration to provide cholera caused by from 8 to 28 Pasteurella
milligrams per multocida
pound of body susceptible to
weight per day chlortetracycline. depending upon age and severity of disease, for not more than 21 d. Do not feed to ducks producing eggs for human consumption. (vii) 400 g/t
1. Turkeys; control Feed continuously 000069, 017519, of hexamitiasis
for 7 to 14 d; do 046573, 053389, caused by Hexamita not feed to turkeys 063238. meleagrides
producing eggs for susceptible to
human consumption. chlortetracycline. 2. Turkey poults not
Do. over 4 weeks of age; reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline. 3. Breeding swine; Feed continuously Do. control of
for not more than leptospirosis
14 d. (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline. (viii) 500 g/t
Chickens; reduction 1. Feed for 5 d; 063238. of mortality due to withdraw 24 h prior E. coli infections to slaughter. susceptible to chlortetracycline. 2. Feed for 5 d; do 000069, 017519, not feed to
046573, 053389. chickens producing eggs for human consumption; withdraw 24 h prior to slaughter.
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Dated: October 19, 1998. Margaret Ann Miller, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 98-28635Filed10-26-98; 8:45 am]
BILLING CODE 4160-01-F
