[Federal Register Volume 59, Number 59 (Monday, March 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7202]
[Federal Register: March 28, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510 and 522
Animal Drugs, Feeds, and Related Products; EuthasolTM
Euthanasia Solution
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 an abbreviated new animal drug
application (ANADA) filed by Delmarva Laboratories, Inc. The ANADA
provides for intravenous or intracardiac use of EuthasolTM, a
generic euthanasia solution containing pentobarbital sodium 390
milligrams per milliliter (mg/mL) and phenytoin sodium 50 mg/mL, for
canine euthanasia.
EFFECTIVE DATE: March 28, 1994.
FOR FURTHER INFORMATION CONTACT: Larry D. Rollins, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1612.
SUPPLEMENTARY INFORMATION: Delmarva Laboratories, Inc., P.O. Box 525,
Midlothian, VA 23113, is sponsor of ANADA 200-071 which provides for
the use of EuthasolTM, a generic euthanasia solution containing
pentobarbital sodium 390 mg/mL and phenytoin sodium 50 mg/mL, for
intravenous or intracardiac use for humane, painless, and rapid
euthanasia of dogs.
Approval of Delmarva Laboratories' ANADA 200-071 for
EuthasolTM Euthanasia Solution (pentobarbital sodium 390 mg/mL and
phenytoin sodium 50 mg/mL) is as a generic copy of Schering's NADA 119-
807 for Beuthanasia-D Special Solution (pentobarbital sodium
390 mg/mL and phenytoin sodium 50 mg/mL). The ANADA is approved as of
February 24, 1994, and the regulations in 21 CFR 522.900 are amended to
reflect the approval. The basis for approval is discussed in the
freedom of information summary.
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, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, from
9 a.m. to 4 p.m., Monday through Friday.
In addition, Delmarva Laboratories, Inc., has not been previously
listed in 21 CFR 510.600(c)(1) and (c)(2) as sponsor of an approved
application. That section is amended to add entries for the sponsor.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 parts 510 and
522 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).
2. Section 510.600 is amended in the table in paragraph (c)(1) by
alphabetically adding a new entry for Delmarva Laboratories, Inc., and
in the table in paragraph (c)(2) by numerically adding a new entry
``059079'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Drug
Firm name and address labeler
code
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*****
Delmarva Laboratories, Inc., 2200 Wadebridge Rd., P.O. Box 525,
Midlothian, VA 23113.......................................... 059079
*****
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(2) * * *
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Drug
labeler Firm name and address
code
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*****
059079. Delmarva Laboratories, Inc., 2200 Wadebridge Rd., P.O. Box 525,
Midlothian, VA 23113
*****
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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).
Sec. 522.900 [Amended]
4. Section 522.900 Euthanasia solution is amended in paragraph
(b)(2) by removing the phrase ``No. 000061'' and adding in its place
``Nos. 000061 and 059079.''
Dated: March 21, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-7202 Filed 3-25-94; 8:45 am]
BILLING CODE 4160-01-F
