[Federal Register Volume 64, Number 62 (Thursday, April 1, 1999)]
[Rules and Regulations]
[Pages 15684-15685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7924]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Sulfadimethoxine Tablets and
Boluses; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to codify an approved new animal drug application
(NADA) held by Pfizer, Inc. The NADA provides for use of
sulfadimethoxine (SDM) tablets to treat bacterial infections of dogs
and cats.
EFFECTIVE DATE: April 1, 1999.
FOR FURTHER INFORMATION CONTACT: Diane T. McRae, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0212.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, is sponsor of NADA 15-102 that provides for oral use of SDM
tablets for the treatment of SDM-susceptible bacterial infections of
dogs and cats. The NADA was approved on December 14, 1964, for Hoffmann
LaRoche, Inc. After several changes of sponsors, the current sponsor of
the NADA, Pfizer, Inc., has filed a supplement to NADA 15-102 providing
information supporting prior approval of their NADA and has requested
codification. FDA concurs that NADA 15-102 was approved for use in dogs
and cats on December 14, 1964, and therefore, amends 21 CFR 520.2220b
to reflect the approval. Also, FDA is amending the regulation to add
several editorial changes by removing paragraph (a), by redesignating
paragraphs (b), (d), and (e) as paragraphs (a), (b), and (d),
respectively, and by revising new paragraphs (a) and (d)(2) to reflect
the codification.
Approval of this supplemental NADA does not require additional
safety and effectiveness data. Therefore, a freedom of information
summary is not required.
The agency 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 Subject 21 CFR Part 520
Animal drugs.
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 520.2220b is amended by removing paragraph (a), by
redesignating paragraphs (b), (d), and (e) as paragraphs (a), (b), and
(d), respectively, and by revising newly redesignated paragraphs (a)
and (d)(2) to read as follows:
Sec. 520.2220b Sulfadimethoxine tablets and boluses.
(a) Sponsors. Approval to firms identified in Sec. 510.600(c) of
this chapter as follows:
(1) To 000069, approval for use as in paragraphs (d)(1), (d)(2),
and (d)(3) of this section.
[[Page 15685]]
(2) To 000061, approval for use as in paragraph (d)(2).
* * * * *
(d) * * *
(2) Dogs and cats. (i) Amount. 12.5 to 25 milligrams per pound of
body weight.
(ii) Indications for use. Treatment of sulfadimethoxine-susceptible
bacterial infections.
(iii) Limitations. Administer 25 milligrams per pound of body
weight on the first day followed by 12.5 milligrams per pound of body
weight per day until the animal is free of symptoms for 48 hours.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
* * * * *
Dated: March 17, 1999.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 99-7924 Filed 3-31-99; 8:45 am]
BILLING CODE 4160-01-F