[Federal Register Volume 62, Number 223 (Wednesday, November 19, 1997)]
[Rules and Regulations]
[Pages 61627-61628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30405]
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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; 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 changing the withdrawal time to zero following
certain uses of chlortetracycline (CTC) in Type C cattle feeds
(including free-choice feeds).
EFFECTIVE DATE: November 19, 1997.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1638.
SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., 340 Kingsland St.,
Nutley, NJ 07110-1199, filed supplemental NADA 48-761 that provides for
decreasing the withdrawal times for all National Academy of Sciences/
National Research Council drug efficacy study implementation (NAS/NRC
DESI) approved uses of CTC Type C medicated feeds (including free-
choice feeds) for beef and nonlactating dairy cattle and for control of
anaplasmosis and other claims to a zero withdrawal time. The
supplemental NADA is approved as of September 23, 1997, and the
regulations are amended in Sec. 558.128(d)(1) and (d)(2) (21 CFR
558.128(d)(1) and (d)(2)) to reflect the approval. The basis of
approval is discussed in the freedom of information summary.
Also, in the revision of Sec. 558.128 published in the Federal
Register of
[[Page 61628]]
July 9, 1996 (61 FR 35949), FDA provided for approval of five
supplemental NADA's to reflect compliance with the results of the NAS/
NRC DESI review of the products and FDA's conclusions based on that
study. In that document, FDA failed to reflect that Hoffmann-La Roche
is the sponsor of the product codified in Sec. 558.128(d)(2) (see 53 FR
31316, August 18, 1988). The sponsor was the subject of a change of
sponsor from American Cyanamid published in the Federal Register of
April 24, 1996 (61 FR 18081). At this time, the paragraph is amended to
reflect the correct sponsor.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 514.11(e)(2)(ii), a summary of human food safety data and
information submitted to support approval of this supplement 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.
FDA has determined under 21 CFR 25.33(a)(1) 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
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.
Sec. 558.128 [Amended]
2. Section 558.128 Chlortetracycline is amended in the table in
paragraph (d)(1) in entry (xi) in the column ``Limitations'' by adding
after the existing text the sentence ``For sponsor 000004 zero
withdrawal time.'', in entry (xii) for indication 1., in the column
``Limitations'' by adding after the phrase ``for sponsor 048573;'' the
phrase ``zero withdrawal for sponsor 000004;'', in entry (xvii) for
indication 1., in the column ``Limitations'' by adding after the
existing text the sentence ``For sponsor 000004 zero withdrawal
time.'', and in paragraph (d)(2) by adding after the number ``(2)'' the
phrase ``For sponsor 000004:'' and removing the phrase ``discontinue
use 4 days prior to slaughter''.
Dated: November 3, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-30405 Filed 11-18-97; 8:45 am]
BILLING CODE 4160-01-F
