[Federal Register Volume 62, Number 19 (Wednesday, January 29, 1997)]
[Rules and Regulations]
[Pages 4163-4164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2140]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 556
Animal Drugs, Feeds, and Related Products; Tripelennamine
Hydrochloride Injection
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 more clearly reflect the currently approved
conditions of use of a new animal drug application (NADA) held by
Solvay Animal Health, Inc. The NADA provides for use of tripelennamine
hydrochloride injection for antihistaminic therapy in horses and
cattle. The amendment provides for tolerances for drug residues in
edible cattle tissues and in milk and the corresponding drug withdrawal
and milk discard periods. When the NADA was reviewed under the National
Academy of Sciences/National Research Council Drug Study Implementation
Program and the results of the review finalized in 1983, this
information was inadvertently omitted from the regulations.
[[Page 4164]]
EFFECTIVE DATE: January 29, 1997.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1623.
SUPPLEMENTARY INFORMATION: Solvay Animal Health, Inc., 1201 Northland
Dr., Mendota Heights, MN 55120, is sponsor of NADA 6-417. The
application provides for intravenous or intramuscular use of
tripelennamine hydrochloride injection in cattle and intramuscular use
in horses for treating conditions in which antihistaminic therapy may
be expected to lead to alleviation of some signs of disease. FDA is
amending the regulations to reflect additional limitations currently in
the approved drug labeling and publishing tolerances for drug residues
in cattle tissues and in milk. The product is for veterinary
prescription use only. The regulations are amended in 21 CFR
522.2615(c) to reflect the required withdrawal period and milk discard
time and in 21 CFR part 556 to reflect the tolerance for residues in
cattle tissues and in milk.
List of Subjects
21 CFR Part 522
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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 522 and
556 are amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. Section 522.2615 is amended by redesignating paragraph (c) as
paragraph (d), adding new paragraph (c), and revising newly
redesignated paragraph (d)(3) to read as follows:
Sec. 522.2615 Tripelennamine hydrochloride injection.
* * * * *
(c) Related tolerances. See Sec. 556.741 of this chapter.
(d) * * *
(3) Limitations. Do not use in horses intended for food purposes.
Treated cattle must not be slaughtered for food during treatment and
for 4 days following the last treatment. Milk that has been taken
during treatment and for 24 hours (two milkings) after the last
treatment must not be used for food. A withdrawal period has not been
established for this product in preruminating calves. Do not use in
calves to be processed for veal. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
3. 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).
4. New Sec. 556.741 is added to read as follows:
Sec. 556.741 Tripelennamine.
A tolerance of 200 parts per billion (ppb) is established for
residues of tripelennamine in uncooked edible tissues of cattle and 20
ppb in milk.
Dated: January 7, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-2140 Filed 1-28-97; 8:45 am]
BILLING CODE 4160-01-F
