[Federal Register Volume 62, Number 98 (Wednesday, May 21, 1997)]
[Rules and Regulations]
[Pages 27692-27693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13268]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation and Injectable Dosage Form New Animal Drugs;
Oxytetracycline 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 reflect approval of a supplemental new animal drug
application (NADA) filed by Pfizer Animal Health. The supplemental NADA
provides for subcutaneous use of oxytetracycline injection in addition
to intramuscular and intravenous use in beef cattle and nonlactating
dairy cattle, and calves including preruminating (veal) calves.
EFFECTIVE DATE: May 21, 1997.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1644.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, filed supplemental NADA 113-232 that provides for use of
Liquamycin LA-200 (oxytetracycline injection) for
subcutaneous in addition to intramuscular and intravenous treatment of
beef cattle, nonlactating dairy cattle, and calves including
preruminating (veal) calves. The supplemental NADA is approved as of
April 23, 1997, and the regulations are amended in Sec. 522.1660 (21
CFR 522.1660) to reflect the approval. The basis of approval is
discussed in the freedom of information summary.
Section 522.1660(c) is redesignated as paragraph (d) and new
paragraph (c) is added to provide for more uniform regulations and
future expansion.
Also Sec. 522.1660 is amended in new paragraph (d)(1) to add the
phrase ``and calves including preruminating (veal) calves'' after the
phrase ``nonlactating cattle'' in the title and an additional sentence
following the text of newly redesignated paragraph (d)(1)(iii) to
provide for subcutaneous use for this sponsor.
Furthermore, Sec. 522.1660 is amended to correct several
typographical errors. The errors are: In Sec. 522.1660(d)(1)(ii),
Haemophilis is misspelled, Staphylococcus is not capitalized, and in
Sec. 522.1660(d)(2)(ii), multocida is misspelled.
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, 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
for food-producing animals qualifies for 3 years of marketing
exclusivity beginning April 23, 1997, because the supplement contains
substantial evidence of effectiveness of the drug involved, any 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. Exclusivity applies only to the subcutaneous route of
administration.
The agency has determined under 21 CFR 25.24(d)(1)(i) 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 522
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 522 is
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 522.1660 is amended by redesignating paragraph (c) as
(d) and reserving paragraph (c), in newly redesignated paragraph (d)(1)
by revising the heading, in newly redesignated paragraph (d)(1)(ii) by
removing the word ``Hemophilis'' and adding in its place
``Haemophilis'' and by removing the word ``staphylococcus'' and adding
in its place ``Staphylococcus'', in newly redesignated paragraph
(d)(2)(ii) by removing the word ``multicida'' and adding in its place
``multocida'', and by adding a new sentence at the end of newly
redesignated paragraph (d)(1)(iii) to read as follows:
Sec. 522.1660 Oxytetracycline injection.
* * * * *
(c) [Reserved]
(d) * * *
(1) Beef cattle, nonlactating dairy cattle and calves including
preruminating (veal) calves. * * *
(iii) * * * For sponsor 000069, use subcutaneously with a maximum
of 10 milliliters per injection site in adult cattle as well as
intramuscularly and intravenously.
* * * * *
[[Page 27693]]
Dated: May 7, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-13268 Filed 5-20-97; 8:45 am]
BILLING CODE 4160-01-F
