[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]


-----------------------------------------------------------------------


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.

-----------------------------------------------------------------------

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) * * *

------------------------------------------------------------------------
                                                                   Drug 
                     Firm name and address                       labeler
                                                                   code 
------------------------------------------------------------------------
                                                                        
                                  *****                                 
Delmarva Laboratories, Inc., 2200 Wadebridge Rd., P.O. Box 525,         
 Midlothian, VA 23113..........................................   059079
                                                                        
                                  *****                                 
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
  Drug                                                                  
labeler                       Firm name and address                     
 code                                                                   
------------------------------------------------------------------------
                                                                        
                                  *****                                 
059079.  Delmarva Laboratories, Inc., 2200 Wadebridge Rd., P.O. Box 525,
          Midlothian, VA 23113                                          
                                                                        
                                  *****                                 
------------------------------------------------------------------------

 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