[Federal Register Volume 61, Number 95 (Wednesday, May 15, 1996)]
[Rules and Regulations]
[Pages 24440-24441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12154]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 522, and 556
Animal Drugs, Feeds, and Related Products; Gentamicin 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 the following actions on two new animal
drug applications (NADA's) held by Schering-Plough Animal Health: The
combination of two NADA's into one and the withdrawal of the other, the
codification of a supplemental NADA approved by letter, the approval of
a supplemental NADA that provides for the use of two higher product -
concentrations at the same dosage and for the same indications, and the
addition of a tolerance for residues of gentamicin in chickens.
The approved, combined, and supplemented NADA provides for use of
gentamicin sulfate injection for the prevention of early mortality of
day-old chickens and 1- to 3-day-old turkeys due to certain infections
susceptible to gentamicin.
EFFECTIVE DATE: May 15, 1996
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-133), Food and Drug
[[Page 24441]]
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1644.
SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health, Schering-
Plough Corp., P.O. Box 529, Kenilworth, NJ 07033, has requested that
NADA 47-486 Garasol Injection (5 milligrams gentamicin per
milliliter (mg/mL) for turkeys) be included in NADA 101-862
Garasol Injection (50 and 100 mg/mL for chickens). The NADA's
are combined as NADA 101-862. NADA 47-486 is withdrawn. Schering-Plough
also filed supplemental NADA 101-862 providing for the use of 50 and
100 mg/mL gentamicin sulfate injection for turkeys at the same dosage
and for the same indications as currently approved. The supplement is
approved as of March 28, 1996. In addition, supplemental NADA 101-862
was approved on July 27, 1983, for the use of a 100 mg/mL injection in
day-old chickens. However, this approval was not codified. At this time
the regulation in Sec. 522.1044 (21 CFR 522.1044) is amended to codify
use of the 100 mg/mL injection in day-old chickens. Although the use
was approved in chickens as well as turkeys, the regulations were not
amended to provide for a tolerance for gentamicin residues in chickens.
The regulations in 21 CFR 556.300 are amended to provide for tolerances
for gentamicin residues in chickens as well as turkeys.
The approved, combined, and supplemented NADA 101-862 provides for
use of Garasol Injection (50 and 100 mg/mL gentamicin sulfate
injection) in day-old chickens for the prevention of early mortality
caused by Escherichia coli, Salmonella typhimurium, and Pseudomonas
aeruginosa susceptible to gentamicin, and for use of Garasol
Injection (5, 50, and 100 mg/mL gentamicin sulfate injection) in 1- to
3-day-old turkeys for the prevention of early mortality due to Arizona
paracolon infections susceptible to gentamicin.
In Sec. 522.1044(d)(2)(i), the regulation is editorially amended to
reflect the language used in Sec. 522.1044(d)(3)(i).
Also, American Scientific Laboratories, A Division of Schering
Corp., has been incorporated into Schering-Plough Animal Health,
Schering-Plough Corp. Therefore, 21 CFR 510.600(c) is amended to remove
the entries for American Scientific Laboratories, drug label code
000138.
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.
The agency has determined under 21 CFR 25.24(d)(1)(iii) 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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 510,
522, and 556 are amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
-Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e).
Sec. 510.600 [Amended]
-2. Section 510.600 Names, addresses, and drug labeler codes of
sponsors of approved applications is amended in the table in paragraph
(c)(1) by removing the entry for ``American Scientific Laboratories''
and in the table in paragraph (c)(2) by removing the entry for
``000138''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
3. 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).
4. Section 522.1044 is amended by revising paragraphs (b),
(d)(2)(i), and (d)(3)(i) to read as follows:
Sec. 522.1044 Gentamicin sulfate injection.
(b) Sponsors. (1) See No. 000061 in Sec. 510.600(c) of this chapter
for use of: 5-milligrams-per-milliliter solution in swine as in
paragraph (d)(4) of this section, 50-milligrams-per-milliliter solution
in dogs and cats as in paragraph (d)(1) of this section, 50- and 100-
milligrams-per-milliliter solution in chickens and turkeys as in
paragraphs (d)(2) and (d)(3) of this section.
(2) [Reserved]
* * * * *
(d) * * *
(2) Turkeys--(i) Amount. One milligram of gentamicin per 0.2
milliliter dose, using the 50- or 100-milligrams-per-milliliter product
diluted with sterile saline to a concentration of 5 milligrams-per-
milliliter.
* * * * *
(3) Chickens--(i) Amount. 0.2 milligram of gentamicin per 0.2
milliliter dose, using the 50- or 100-milligrams-per-milliliter product
diluted with sterile saline to a concentration of 1.0 milligram-per-
milliliter.
* * * * *
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
-5. 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).
Sec. 556.300 [Amended]
6. Section 556.300 Gentamicin sulfate is amended in paragraph (a)
by adding the phrase ``chickens and'' after ``tissues of''.
Dated: April 26, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-12154 Filed 5-14-96; 8:45 am]
BILLING CODE 4160-01-F