[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Page 36291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17315]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; 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 Hoffmann-La Roche, Inc. The supplemental
NADA provides for use of a free-choice, mineral, Type C cattle feed
containing chlortetracycline (CTC) for grazing beef cattle weighing
over 700 pounds (lb) for control of active anaplasmosis infections.
EFFECTIVE DATE: July 10, 1996.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0217.
SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., 340 Kingsland St.,
Nutley, NJ 07110, filed a supplement to NADA 48-761,
Aureomycin (chlortetracycline) mineral, Type C cattle feed
containing 4 grams CTC per lb. The supplement provides for free-choice
feeding to grazing beef cattle weighing over 700 lb at 0.0125 to 0.05
lb of Type C feed per 100 lb of body weight per day (0.5 to 2.0
milligrams (mg) CTC per lb of body weight per day) for control of
active infections of anaplasmosis caused by Anaplasma marginale
susceptible to chlortetracycline. The supplement is approved as of July
10, 1996, and the regulations are amended in 21 CFR 558.128(c)(4) to
reflect the approval. The basis of approval is discussed in the freedom
of information summary.
With approval of this supplement, cattle may be fed 0.5 to 2.0 mg
CTC per head per day. To provide for safe use at the upper limit, a
withdrawal time of 4 days prior to slaughter is provided.
Use of Type A medicated articles to make free-choice CTC Type C
medicated feeds requires an approved Form FDA 1900 as in 21 CFR
510.455.
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, 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)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning July 10, 1996,
because the supplemental application contains reports of 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 and conducted or sponsored by the
applicant. The 3 years of marketing exclusivity applies only to the new
claim for which the supplement was approved.
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).
Sec. 558.128 [Amended]
2. Section 558.128 Chlortetracycline is amended in paragraph (c)(4)
by removing the phrase ``daily minimum intake of 0.5 milligram of
chlortetracycline per pound of body weight to aid in the prevention of
anaplasmosis'' and adding in its place ``daily intake of 0.5 to 2.0
milligrams of chlortetracycline per pound of body weight to aid in the
control of active infection of anaplasmosis caused by Anaplasma
marginale susceptible to chlortetracycline; discontinue use 4 days
prior to slaughter''.
Dated: May 31, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-17315 Filed 7-9-96; 8:45 am]
BILLING CODE 4160-01-F
