Document ID: FDA-2013-N-0002-0047
Agency: fda
Document Type: Rule
Title: Withdrawal of Approval of New Animal Drug Applications; Argent
Laboratories; Formalin; Tricaine Methanesulfonate
Posted Date: 2014-01-16T05:00Z

[Federal Register Volume 79, Number 11 (Thursday, January 16, 2014)]
[Rules and Regulations]
[Pages 2785-2786]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00721]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 529

[Docket No. FDA-2013-N-0002]

Withdrawal of Approval of New Animal Drug Applications; Argent 
Laboratories; Formalin; Tricaine Methanesulfonate

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 withdrawal of approval of two new 
animal drug applications (NADAs) held by Argent Laboratories. 
Withdrawal of approval of these NADAs was at the sponsor's request 
because the products are no longer manufactured or marketed.

DATES: This final rule is effective January 27, 2014.

FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6843 david.alterman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Argent Laboratories, 8702 152d Ave. NE., 
Redmond, WA 98052 has requested that FDA withdraw approval of the 
following two NADAs because the products are no longer manufactured or 
marketed: NADA 042-427 for FINQUEL (tricaine methanesulfonate) and NADA 
140-831 for PARACIDE-F (formalin).
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 042-427 and 140-831, and all supplements and 
amendments thereto, is withdrawn. As provided in the regulatory text of 
this document, the

[[Page 2786]]

animal drug regulations are amended to reflect these voluntary 
withdrawals of approval.
    Following these withdrawals of approval, Argent Laboratories will 
no longer be the sponsor of an approved application. Accordingly, 21 
CFR 510.600(c) is being amended to remove the entries for this firm.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 529

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and 
529 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``Argent Laboratories''; and in the table in paragraph (c)(2), 
remove the entry for ``051212''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 529 continues to read as 
follows:

    Authority:  21 U.S.C. 360b.

0
4. In Sec.  529.1030:
0
a. Revise paragraph (b);
0
b. Remove paragraphs (d)(1)(i) and (d)(1)(ii), and redesignate 
paragraphs (d)(1)(iii), (d)(1)(iv), and (d)(1)(v) as paragraphs 
(d)(1)(i), (d)(1)(ii), and (d)(1)(iii);
0
c. Remove paragraphs (d)(2)(i) and (d)(2)(ii), and redesignate 
paragraphs (d)(2)(iii), (d)(2)(iv), and (d)(2)(v) as paragraphs 
(d)(2)(i), (d)(2)(ii), and (d)(2)(iii); and
0
d. Revise the introductory text in newly designated paragraph 
(d)(2)(ii), and revise paragraph (d)(2)(iii).
    The revisions read as follows:

Sec.  529.1030  Formalin.

* * * * *
    (b) Sponsors. See Nos. 049968, 050378, and 067188 in Sec.  
510.600(c) of this chapter.
* * * * *
    (d) * * *
    (2) * * *
    (ii) For control of external parasites on finfish:
* * * * *
    (iii) For control of fungi of the family Saprolegniaceae on finfish 
eggs: Eggs of all finfish except Acipenseriformes, 1,000 to 2,000 
[micro]L/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to 1,500 
[mu]L/L (ppm) for 15 minutes.
* * * * *

0
5. Revise Sec.  529.2503 to read as follows:

Sec.  529.2503  Tricaine methanesulfonate.

    (a) Specifications. Ethyl-m-amino-benzoate methanesulfonate.
    (b) Sponsor. See No. 050378 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. It is used as follows:
    (1) Amount--(i) For fish the drug is added to ambient water at a 
concentration of from 15 to 330 milligrams per liter depending upon the 
degree of anesthetization or sedation desired, the species and size of 
the fish, and the temperature and softness of the water. Preliminary 
tests of solutions must be made with small numbers of fish to determine 
the desired rates of sedation or anesthesia and the appropriate 
exposure times for the specific lots of fish under prevailing 
conditions.
    (ii) For amphibians and other aquatic coldblooded animals, the drug 
is added to ambient water in concentrations of from 1:1000 to 1:20,000 
depending upon species and stage of development.
    (2) Indications for use. It is used for the temporary 
immobilization of fish, amphibians, and other aquatic coldblooded 
animals (poikilotherms) as an aid in handling during manual spawning 
(fish stripping), weighing, measuring, marking, surgical operations, 
transport, photography, and research.
    (3) Limitations. Do not use within 21 days of harvesting fish for 
food. Use in fish intended for food should be restricted to 
Ictaluridae, Salmonidae, Esocidae, and Percidae, and water temperature 
should exceed 10 [deg]C. (50 [deg]F). In other fish and in cold-blooded 
animals, the drug should be limited to hatchery or laboratory use.

    Dated: January 10, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-00721 Filed 1-15-14; 8:45 am]
BILLING CODE 4160-01-P