New Animal Drugs; Hydrogen Peroxide, 5329-5330 [E7-1848]

Download as PDF rmajette on PROD1PC67 with RULES Federal Register / Vol. 72, No. 24 / Tuesday, February 6, 2007 / Rules and Regulations This action will not impose any additional reporting or recordkeeping requirements on either small or large tomato handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. The AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. In addition, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule. Further, the Committee’s meeting was widely publicized throughout the Florida tomato industry and all interested persons were invited to attend the meeting and participate in Committee deliberations. Like all Committee meetings, the October 4, 2006, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit information on the regulatory and informational impacts of this action on small businesses. A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: https://www.ams.usda.gov/ fv/moab.html. Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section. This rule invites comments on a change to the container requirements currently prescribed under the Florida tomato marketing order. Any comments received will be considered prior to finalization of this rule. After consideration of all relevant material presented, including the Committee’s recommendation, and other information, it is found that this interim final rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act. Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because: (1) The 2006–07 season has begun, and handlers are currently packing tomatoes; (2) the Committee unanimously recommended this change VerDate Aug<31>2005 14:04 Feb 05, 2007 Jkt 211001 at a public meeting and interested parties had an opportunity to provide input; (3) handlers are aware of this change; and (4) this rule provides a 60day comment period and any comments received will be considered prior to finalization of this rule. List of Subjects in 7 CFR Part 966 Marketing agreements, Reporting and recordkeeping requirements, Tomatoes. I For the reasons set forth in the preamble, 7 CFR part 966 is amended as follows: PART 966—TOMATOES GROWN IN FLORIDA 1. The authority citation for 7 CFR part 966 continues to read as follows: I Authority: 7 U.S.C. 601–674. 2. Section 966.323 paragraph (a)(3)(ii) is revised to read as follows: I § 966.323 Handling regulation. * * * * * (a) * * * (3) * * * (ii) Each container or lid shall be marked to indicate the designated net weight and must show the name and address of the registered handler (as defined in 966.7) in letters at least onefourth (1⁄4) inch high, and such containers must be packed at the registered handler’s facilities. The use of inverted, previously printed container lids is limited to the registered handler identified by the labels or marks that originally appeared on the lid. * * * * * Dated: February 1, 2007. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. 07–502 Filed 2–5–07; 8:45 am] BILLING CODE 3410–02–M 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. 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 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 5329 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, email: 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 § 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 E:\FR\FM\06FER1.SGM 06FER1 5330 Federal Register / Vol. 72, No. 24 / Tuesday, February 6, 2007 / Rules and Regulations rmajette on PROD1PC67 with RULES 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. PART 529—OTHER DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 529 continues to read as follows: I Authority: 21 U.S.C. 360b. I 4. Add § 529.1150 to read as follows: § 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 List of Subjects § 510.600(c) of this chapter. 21 CFR Part 510 (c) Conditions of use in finfish—(1) Administrative practice and Amount—(i) Freshwater-reared finfish procedure, Animal drugs, Labeling, eggs: 500 to 1,000 mg per liter (/L) of Reporting and recordkeeping culture water for 15 minutes in a requirements. continuous flow system once per day on consecutive or alternate days until hatch 21 CFR Part 529 for all coldwater and coolwater species Animal drugs. of freshwater-reared finfish eggs or 750 to 1,000 mg/L for 15 minutes in a I Therefore, under the Federal Food, continuous flow system once per day on Drug, and Cosmetic Act and under authority delegated to the Commissioner consecutive or alternate days until hatch for all warmwater species of freshwaterof Food and Drugs and redelegated to reared finfish eggs. the Center for Veterinary Medicine, 21 (ii) Freshwater-reared salmonids: 100 CFR parts 510 and 529 are amended as mg/L for 30 minutes or 50 to 100 mg/ follows: L for 60 minutes once per day on PART 510—NEW ANIMAL DRUGS alternate days for three treatments in a continuous flow water supply or as a I 1. The authority citation for 21 CFR static bath. part 510 continues to read as follows: (iii) Coolwater species of freshwaterAuthority: 21 U.S.C. 321, 331, 351, 352, reared finfish fingerlings and adults 353, 360b, 371, 379e. (except northern pike & paddlefish) and channel catfish fingerlings and adults: 2. In § 510.600, in the table in 50 to 75 mg/L for 60 minutes once per paragraph (c)(1) alphabetically add an day on alternate days for three entry for ‘‘Eka Chemicals, Inc.’’; and in the table in paragraph (c)(2) numerically treatments in continuous flow water supply or as a static bath. Coolwater add an entry for ‘‘061088’’ to read as species of freshwater-reared finfish fry follows: (except northern pike, pallid sturgeon & § 510.600 Names, addresses, and drug paddlefish) and channel catfish fry: 50 labeler codes of sponsors of approved mg/L for 60 minutes once per day on applications. alternate days for three treatments in * * * * * continuous flow water supply or as a (c) * * * static bath. (1) * * * (2) Indications for use. For control of mortality in freshwater-reared finfish Drug labeler Firm name and address eggs due to saprolegniasis; for control of code mortality in freshwater-reared * * * * * salmonids due to bacterial gill disease Eka Chemicals, Inc., 1775 061088 associated with Flavobacterium West Oak Commons Ct., branchiophilum; and for control of Marietta, GA 30062–2254. mortality in freshwater-reared coolwater * * * * * finfish and channel catfish due to external columnaris disease associated (2) * * * with Flavobacterium columnare (Flexibacter columnaris). Drug labeler Firm name and address (3) Limitations. Initial bioassay on a code small number is recommended before * * * * * treating the entire group. Eggs: Some 061088 ....... Eka Chemicals, Inc., 1775 strains of rainbow trout eggs are West Oak Commons Ct., sensitive to hydrogen peroxide Marietta, GA 30062–2254 treatment at a time during incubation * * * * * concurrent with blastopore formation VerDate Aug<31>2005 14:04 Feb 05, 2007 Jkt 211001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 through closure, about 70 to 140 Daily Temperature Units, °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 DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943 [TX–056–FOR] Texas Abandoned Mine Land Reclamation Plan Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. AGENCY: SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are approving an amendment to the Texas abandoned mine land reclamation plan (Texas plan) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). The Railroad Commission of Texas (RCT or Commission) proposed to assume responsibility of the abandoned mine land reclamation (AML) emergency program in Texas. The Commission also proposed to revise the Texas plan by updating portions to reflect its current practices and by removing references to its old regulations (Texas Coal Mining Regulations (TCMR)) and replacing them with references to its recodified regulations (16 Texas Administrative Code (TAC)). DATES: Effective Date: February 6, 2007. FOR FURTHER INFORMATION CONTACT: Michael C. Wolfrom, Director, Tulsa Field Office. Telephone: (918) 581– 6430. E-mail address: mwolfrom@osmre.gov. SUPPLEMENTARY INFORMATION: I. Background on the Texas Plan II. Submission of the Amendment III. OSM’s Findings IV. Summary and Disposition of Comments V. OSM’s Decision VI. Procedural Determinations E:\FR\FM\06FER1.SGM 06FER1

Agencies

[Federal Register Volume 72, Number 24 (Tuesday, February 6, 2007)]
[Rules and Regulations]
[Pages 5329-5330]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1848]


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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.

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

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.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
061088..................  Eka Chemicals, Inc., 1775 West Oak Commons
                           Ct., Marietta, GA 30062-2254
                                * * * * *
------------------------------------------------------------------------

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

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