Withdrawal of Approval of New Animal Drug Applications; Argent Laboratories; Formalin; Tricaine Methanesulfonate, 2785-2786 [2014-00721]
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2785
Federal Register / Vol. 79, No. 11 / Thursday, January 16, 2014 / Rules and Regulations
‘‘codex’’ and are written or painted on
animal skins (cattle, sheep/goat, camel)
known as parchment.
I. Painting
1. Wall paintings—On various kinds
of plaster and which generally portray
religious images and scenes of Biblical
events. Surrounding paintings may
contain animal, floral, or geometric
designs, including borders and bands.
2. Panel Paintings (Icons)—Smaller
versions of the scenes on wall paintings,
and may be partially covered with gold
or silver, sometimes encrusted with
semi-precious or precious stones and
are usually painted on a wooden panel,
often for inclusion in a wooden screen
(iconastasis). May also be painted on
ceramic.
J. Mosaics—Wall mosaics generally
portray religious images and scenes of
Biblical events.
Surrounding panels may contain
animal, floral, or geometric designs.
They are made from stone and glass cut
into small bits (tesserae) and laid into a
plaster matrix.
Inapplicability of Notice and Delayed
Effective Date
Amendment to CBP Regulations
This amendment involves a foreign
affairs function of the United States and
is, therefore, being made without notice
or public procedure (5 U.S.C. 553(a)(1)).
For the same reason, a delayed effective
date is not required under 5 U.S.C.
553(d)(3).
Regulatory Flexibility Act
Because no notice of proposed
rulemaking is required, the provisions
of the Regulatory Flexibility Act (5
U.S.C. 601 et seq.) do not apply.
Executive Order 12866
Because this rule involves a foreign
affairs function of the United States, it
is not subject to Executive Order 12866.
Signing Authority
For the reasons set forth above, part
12 of Title 19 of the Code of Federal
Regulations (19 CFR Part 12), is
amended as set forth below:
PART 12—SPECIAL CLASSES OF
MERCHANDISE
1. The general authority citation for
part 12 and the specific authority
citation for § 12.104g continue to read as
follows:
■
Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202
(General Note 3(i), Harmonized Tariff
Schedule of the United States (HTSUS)),
1624.
*
*
*
*
*
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*
This regulation is being issued in
accordance with 19 CFR 0.1(a)(1).
List of Subjects in 19 CFR Part 12
Cultural property, Customs duties and
inspection, Imports, Prohibited
merchandise, Reporting and
recordkeeping requirements.
§ 12.104g Specific items or categories
designated by agreements or emergency
actions.
(a) * * *
*
*
Bulgaria ..........................................
*
*
*
Archaeological material representing Bulgaria’s cultural heritage from
Neolithic period (7500 B.C.) through approximately 1750 A. D. and
ecclesiastical ethnological material representing Bulgaria’s Middle
Ages (681 A. D.) through approximately 1750 A. D.
*
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Thomas S. Winkowski,
Acting Commissioner, U.S. Customs and
Border Protection.
Approved: January 8, 2014.
Timothy E. Skud,
Deputy Assistant Secretary of the Treasury.
[FR Doc. 2014–00615 Filed 1–15–14; 8:45 am]
BILLING CODE 9111–14–P
Decision No.
*
Food and Drug Administration
[Docket No. FDA–2013–N–0002]
Withdrawal of Approval of New Animal
Drug Applications; Argent
Laboratories; Formalin; Tricaine
Methanesulfonate
Food and Drug Administration,
HHS.
Final rule.
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
SUMMARY:
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14:19 Jan 15, 2014
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*
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*
are no longer manufactured or
marketed.
This final rule is effective
January 27, 2014.
DATES:
FOR FURTHER INFORMATION CONTACT:
21 CFR Parts 510 and 529
ACTION:
*
CBP Dec. 14–01
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
*
2. In § 12.104g, paragraph (a), the table
is amended by adding the Republic of
Bulgaria to the list in appropriate
alphabetical order as follows:
Cultural property
*
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■
State party
ehiers on DSK2VPTVN1PROD with RULES
*
Sections 12.104 through 12.104i also
issued under 19 U.S.C. 2612;
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
E:\FR\FM\16JAR1.SGM
16JAR1
2786
Federal Register / Vol. 79, No. 11 / Thursday, January 16, 2014 / Rules and Regulations
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
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.
§ 510.600
[Amended]
2. In § 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
3. The authority citation for 21 CFR
part 529 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
4. In § 529.1030:
a. Revise paragraph (b);
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);
■ 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
■ d. Revise the introductory text in
newly designated paragraph (d)(2)(ii),
and revise paragraph (d)(2)(iii).
ehiers on DSK2VPTVN1PROD with RULES
■
■
■
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The revisions read as follows:
§ 529.1030
Formalin.
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*
*
(b) Sponsors. See Nos. 049968,
050378, and 067188 in § 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 mL/L (ppm) for 15
minutes; eggs of Acipenseriformes, up
to 1,500 mL/L (ppm) for 15 minutes.
*
*
*
*
*
■ 5. Revise § 529.2503 to read as
follows:
§ 529.2503
Tricaine methanesulfonate.
(a) Specifications. Ethyl-m-aminobenzoate methanesulfonate.
(b) Sponsor. See No. 050378 in
§ 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 °C. (50
°F). In other fish and in cold-blooded
animals, the drug should be limited to
hatchery or laboratory use.
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
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
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:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
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.
SUMMARY:
Withdrawal of approval is
effective January 27, 2014.
DATES:
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.
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).
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of NADAs 042–427 and 140–831, and
all supplements and amendments
thereto, is hereby withdrawn.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\16JAR1.SGM
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
