[Federal Register: February 6, 2007 (Volume 72, Number 24)]
[Rules and Regulations]
[Page 5329-5330]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06fe07-2]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 529
New Animal Drugs; Hydrogen Peroxide
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 a new animal drug application
(NADA) filed by Eka Chemicals, Inc. The NADA provides for immersion use
of hydrogen peroxide solution for control of mortality in certain
freshwater-reared finfish species in several life stages due to various
fungal and bacterial diseases.
DATES: This rule is effective February 6, 2007.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
joan.gotthardt@fda.gov.
SUPPLEMENTARY INFORMATION: Eka Chemicals, Inc., 1775 West Oak Commons
Ct., Marietta, GA 30062-2254, filed NADA 141-255 for 35% PEROX-AID
(hydrogen peroxide) for control of mortality in freshwater-reared
finfish eggs due to saprolegniasis, for control of mortality in
freshwater-reared salmonids due to bacterial gill disease associated
with Flavobacterium branchiophilum, and for control of mortality in
freshwater-reared coolwater finfish and channel catfish due to external
columnaris disease associated with Flavobacterium columnare
(Flexibacter columnaris). The NADA is approved as of January 11, 2007,
and the regulations are amended in part 529 (21 CFR part 529) by adding
Sec. 529.1150 to reflect the approval. The basis of approval is
discussed in the freedom of information summary.
In addition, Eka Chemicals, Inc., has not been previously listed in
the animal drug regulations as a sponsor of an approved application. At
this time, 21 CFR 510.600(c) is being amended to add entries for this
firm.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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 Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
Under section 573(c) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360ccc-2), this approval qualifies for 7 years of
exclusive marketing rights beginning January 11, 2007, because the new
animal drug has been declared a designated new animal drug by FDA under
section 573(a) of the act.
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
[[Page 5330]]
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 Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
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.
0
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
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.
2. In Sec. 510.600, in the table in paragraph (c)(1)
alphabetically add an entry for ``Eka Chemicals, Inc.''; and in the
table in paragraph (c)(2) numerically add an entry for ``061088'' to
read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
Eka Chemicals, Inc., 1775 West Oak Commons Ct., 061088
Marietta, GA 30062-2254.
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
061088.................. Eka Chemicals, Inc., 1775 West Oak Commons
Ct., Marietta, GA 30062-2254
* * * * *
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PART 529--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. Add Sec. 529.1150 to read as follows:
Sec. 529.1150 Hydrogen peroxide.
(a) Specifications. Each milliliter of solution contains 396.1
milligrams (mg) hydrogen peroxide (a 35% w/w solution).
(b) Sponsor. See No. 061088 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in finfish--(1) Amount--(i) Freshwater-reared
finfish eggs: 500 to 1,000 mg per liter (/L) of culture water for 15
minutes in a continuous flow system once per day on consecutive or
alternate days until hatch for all coldwater and coolwater species of
freshwater-reared finfish eggs or 750 to 1,000 mg/L for 15 minutes in a
continuous flow system once per day on consecutive or alternate days
until hatch for all warmwater species of freshwater-reared finfish
eggs.
(ii) Freshwater-reared salmonids: 100 mg/L for 30 minutes or 50 to
100 mg/L for 60 minutes once per day on alternate days for three
treatments in a continuous flow water supply or as a static bath.
(iii) Coolwater species of freshwater-reared finfish fingerlings
and adults (except northern pike & paddlefish) and channel catfish
fingerlings and adults: 50 to 75 mg/L for 60 minutes once per day on
alternate days for three treatments in continuous flow water supply or
as a static bath. Coolwater species of freshwater-reared finfish fry
(except northern pike, pallid sturgeon & paddlefish) and channel
catfish fry: 50 mg/L for 60 minutes once per day on alternate days for
three treatments in continuous flow water supply or as a static bath.
(2) Indications for use. For control of mortality in freshwater-
reared finfish eggs due to saprolegniasis; for control of mortality in
freshwater-reared salmonids due to bacterial gill disease associated
with Flavobacterium branchiophilum; and for control of mortality in
freshwater-reared coolwater finfish and channel catfish due to external
columnaris disease associated with Flavobacterium columnare
(Flexibacter columnaris).
(3) Limitations. Initial bioassay on a small number is recommended
before treating the entire group. Eggs: Some strains of rainbow trout
eggs are sensitive to hydrogen peroxide treatment at a time during
incubation concurrent with blastopore formation through closure, about
70 to 140 Daily Temperature Units, [deg]C. Consider withholding
treatment or using an alternate therapeutant during that sensitive time
to reduce egg mortalities due to drug toxicity. Finfish: Use with
caution on walleye. Preharvest withdrawal time: zero days.
Dated: January 26, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-1848 Filed 2-5-07; 8:45 am]
BILLING CODE 4160-01-S