Implantation or Injectable Dosage Form New Animal Drugs; Embutramide, Chloroquine, and Lidocaine Solution, 36336-36337 [05-12422]

Download as PDF 36336 Federal Register / Vol. 70, No. 120 / Thursday, June 23, 2005 / Rules and Regulations Fort Huachuca-Sierra Vista, AZ, Sierra Vista Muni-Libby AAF, GPS RWY 8, Orig-B, CANCELLED Fort Huachuca-Sierra Vista, AZ, Sierra Vista Muni-Libby AAF, GPS RWY 26, Orig-A, CANCELLED Yuma, AZ, Yuma MCAS-Yuma Intl, VOR RWY 17, Amdt 5A, CANCELLED Yuma, AZ, Yuma MCAS-Yuma Intl, VOR/ DME OR TACAN–1 RWY 17, Amdt 1B, CANCELLED Yuma, AZ, Yuma MCAS-Yuma Intl, VOR/ DME RNAV RWY 21R, Amdt 4A, CANCELLED Yuma, AZ, Yuma MCAS-Yuma Intl, ILS RWY 21R, Amdt 5A, CANCELLED Yuma, AZ, Yuma MCAS-Yuma Intl, GPS RWY 17, Orig-B, CANCELLED Yuma, AZ, Yuma MCAS-Yuma Intl, GPS RWY 21R, Orig-A, CANCELLED Yuma, AZ, Yuma MCAS-Yuma Intl, Takeoff Minimums and Textual DP, Amdt 2, CANCELLED Los Angeles, CA, Los Angeles Intl, Takeoff Minimums and Textual DP, Amdt 11 Visalia, CA, Visalia Muni, NDB RWY 30, Amdt 3B, CANCELLED Aspen, CO, Aspen-Pitkin County/Sardy Field, LOC/DME–E, Orig Washington, DC, Washington Dulles Intl, ILS OR LOC RWY 1R, ILS RWY 1R (CAT II), ILS RWY 1R (CAT III), Amdt 23 Washington, DC, Washington Dulles Intl, ILS OR LOC RWY 19L, Amdt 12 Washington, DC, Washington Dulles Intl, CONVERGING ILS RWY 19L, Amdt 6 Caldwell, ID, Caldwell Industrial, NDB RWY 30, Amdt 1 Caldwell, ID, Caldwell Industrial, RNAV (GPS) RWY 12, Orig Caldwell, ID, Caldwell Industrial, RNAV (GPS) RWY 30, Orig Caldwell, ID, Caldwell Industrial, GPS RWY 12, Orig-A, CANCELLED Caldwell, ID, Caldwell Industrial, GPS RWY 30, Orig-A, CANCELLED Caldwell, ID, Caldwell Industrial, Takeoff Minimums and Textual DP, Amdt 5 Terre Haute, IN, Terre Haute InternationalHulman Field, RNAV (GPS) RWY 14, Orig Terre Haute, IN, Terre Haute InternationalHulman Field, RNAV (GPS) RWY 32, Orig Terre Haute, IN, Terre Haute InternationalHulman Field, GPS RWY 32, Orig, CANCELLED Terre Haute, IN, Terre Haute InternationalHulman Field, VOR/DME RNAV RWY 32, Amdt 8, CANCELLED Slidell, LA, Slidell, RNAV (GPS) RWY 36, Orig-A Jefferson City, MO, Jefferson City Meml, LOC BC RWY 12, Amdt 6D, CANCELLED Joplin, MO, Joplin Regional, RNAV (GPS) RWY 13, Orig Joplin, MO, Joplin Regional, RNAV (GPS) RWY 18, Orig Joplin, MO, Joplin Regional, RNAV (GPS) RWY 31, Orig Joplin, MO, Joplin Regional, RNAV (GPS) RWY 36, Orig Joplin, MO, Joplin Regional, ILS OR LOC/ DME RWY 18, Amdt 2 Joplin, MO, Joplin Regional, ILS OR LOC/ NDB RWY 13, Orig Joplin, MO, Joplin Regional, ILS RWY 13, Amdt 23B, CANCELLED VerDate jul<14>2003 19:30 Jun 22, 2005 Jkt 205001 Joplin, MO, Joplin Regional, LOC BC RWY 31, Amdt 21 Joplin, MO, Joplin Regional, GPS RWY 13, Orig, CANCELLED Joplin, MO, Joplin Regional, GPS RWY 18, Orig, CANCELLED Joplin, MO, Joplin Regional, GPS RWY 36, Orig-A, CANCELLED Joplin, MO, Joplin Regional, NDB RWY 13, Amdt 25 Joplin, MO, Joplin Regional, Takeoff Minimums and Textual DP, Amdt 4 Billings, MT, Billings Logan Intl, RNAV (GPS) RWY 10L, Amdt 1 Billings, MT, Billings Logan Intl, RNAV (GPS) RWY 28R, Amdt 1 Berlin, NH, Berlin Muni, NDB RWY 18, OrigC, CANCELLED Blairstown, NJ, Blairstown, VOR RWY 25, Amdt 2 Blairstown, NJ, Blairstown, RNAV (GPS) RWY 7, Orig Blairstown, NJ, Blairstown, RNAV (GPS) RWY 25, Orig Blairstown, NJ, Blairstown, GPS RWY 7, Orig, CANCELLED Middletown, NY, Randall, RNAV (GPS) RWY 8, Orig Middletown, NY, Randall, RNAV (GPS) RWY 26, Orig Middletown, NY, Randall, GPS RWY 8, Orig, CANCELLED Middletown, NY, Randall, GPS RWY 26, Orig, CANCELLED Tulsa, OK, Richard Lloyd Jones Jr, RNAV (GPS) RWY 1L, Orig Tulsa, OK, Richard Lloyd Jones Jr, ILS OR LOC RWY 1L, Amdt 1 Tulsa, OK, Richard Lloyd Jones Jr, GPS RWY 1L, Orig-A, CANCELLED Eugene, OR, Mahlon Sweet Field, VOR/DME OR TACAN RWY 34L, Amdt 4D Eugene, OR, Mahlon Sweet Field, VOR/DME OR TACAN RWY 16R, Amdt 4C Eugene, OR, Mahlon Sweet Field, NDB RWY 16R, Amdt 29D Eugene, OR, Mahlon Sweet Field, ILS OR LOC RWY 16R, ILS RWY 16R (CAT II), Amdt 34C St. Marys, PA, St. Marys Muni, RNAV (GPS) RWY 10, Orig St. Marys, PA, St. Marys Muni, VOR/DME RNAV RWY 10, Amdt 5B, CANCELLED Rapid City, SD, Rapid City Regional, RNAV (GPS) RWY 14, Amdt 1 Millington, TN, Millington Muni, GPS RWY 4, Orig-A, CANCELLED Millington, TN, Millington Muni, RNAV (GPS) RWY 4, Orig The FAA published an Amendment in Docket No. 30447, Amdt No. 3124 to Part 97 of the Federal Aviation Regulations (Vol 70, FR No. 115, pages 34992–34993; dated June 16, 2005) under section 97.33 effective 7 JUL 2005, which is hereby rescinded: Castroville, TX, Castroville Muni, RNAV (GPS) RWY 15, Orig Raton, NM, Raton Municipal/Crews Field, NDB RWY 2, Amdt 5 [FR Doc. 05–12362 Filed 6–22–05; 8:45 am] BILLING CODE 4910–13–P PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Embutramide, Chloroquine, and Lidocaine 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 original new animal drug application (NADA) filed by Phoenix Scientific, Inc. The NADA provides for veterinary prescription use of a solution containing embutramide, chloroquine phosphate, and lidocaine by intravenous injection for euthanasia of dogs. DATES: This rule is effective June 23, 2005. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV–110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7543, email: melanie.berson@fda.gov. SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed NADA 141 245 that provides for veterinary prescription use of TRIBUTAME Euthanasia Solution (embutramide; chloroquine phosphate, U.S.P.; and lidocaine, USP) by intravenous injection for euthanasia of dogs. The NADA is approved as of May 20, 2005, and the regulations are amended in 21 CFR part 522 by adding § 522.810 to reflect the approval. The basis of approval is discussed in the freedom of information summary. 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 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning May 20, 2005. E:\FR\FM\23JNR1.SGM 23JNR1 Federal Register / Vol. 70, No. 120 / Thursday, June 23, 2005 / Rules and Regulations FDA has determined under 21 CFR 25.33(d)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 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. 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 Fort Dodge Animal Health. The NADA provides for use of an injectable moxidectin solution for the treatment and control of various internal and external parasites of cattle. DATES: This rule is effective June 23, 2005. Joan C. Gotthardt, Center for Veterinary Medicine (HFV–130), Food and Drug Animal drugs. Administration, 7500 Standish Pl., I Therefore, under the Federal Food, Rockville, MD 20855, 301–827–7571, eDrug, and Cosmetic Act and under mail: jgotthar@cvm.fda.gov. authority delegated to the Commissioner SUPPLEMENTARY INFORMATION: Fort of Food and Drugs and redelegated to the Dodge Animal Health, Division of Center for Veterinary Medicine, 21 CFR Wyeth, 800 Fifth St. NW., Fort Dodge, part 522 is amended as follows: IA 50501, filed NADA 141–220 that provides for use of CYDECTIN PART 522—IMPLANTATION OR (moxidectin) Injectable Solution for Beef INJECTABLE DOSAGE FORM NEW and Nonlactating Dairy Cattle for the ANIMAL DRUGS treatment and control of various internal and external parasites. The NADA is I 1. The authority citation for 21 CFR approved as of May 20, 2005, and the part 522 continues to read as follows: regulations are amended in part 522 (21 Authority: 21 U.S.C. 360b. CFR part 522) by adding § 522.1450 and I 2. Section 522.810 is added to read as in part 556 (21 CFR part 556) by revising follows: § 556.426 to reflect the approval. The basis of approval is discussed in the § 522.810 Embutramide, chloroquine, and freedom of information summary. lidocaine solution. In accordance with the freedom of (a) Specifications. Each milliliter (mL) of solution contains 135 milligrams (mg) information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a embutramide; 45 mg chloroquine phosphate, U.S.P.; and 1.9 mg lidocaine, summary of safety and effectiveness data and information submitted to U.S.P. support approval of this application (b) Sponsor. See No. 059130 in may be seen in the Division of Dockets § 510.600(c) of this chapter. Management (HFA–305), Food and Drug (c) Conditions of use in dogs—(1) Administration, 5630 Fishers Lane, rm. Amount. One mL per 5 pounds of body 1061, Rockville, MD 20852, between 9 weight. (2) Indications for use. For euthanasia. a.m. and 4 p.m., Monday through (3) Limitations. Not for use in animals Friday. Under section 512(c)(2)(F)(ii) of the intended for food. Federal law restricts Federal Food, Drug, and Cosmetic Act this drug to use by or on the order of (21 U.S.C. 360b(c)(2)(F)(ii)), this a licensed veterinarian. approval qualifies for 3 years of Dated: June 10, 2005. marketing exclusivity beginning May Stephen F. Sundlof, 20, 2005. Director, Center for Veterinary Medicine. The agency has carefully considered [FR Doc. 05–12422 Filed 6–22–05; 8:45 am] the potential environmental impact of BILLING CODE 4160–01–S this action and has concluded that the action will not have a significant impact on the human environment and that an DEPARTMENT OF HEALTH AND environmental impact statement is not HUMAN SERVICES required. FDA’s finding of no significant impact and the evidence supporting that Food and Drug Administration finding, contained in an environmental assessment, may be seen in the Division 21 CFR Parts 522 and 556 of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. New Animal Drugs; Moxidectin This rule does not meet the definition AGENCY: Food and Drug Administration, of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because it is a rule of ‘‘particular applicability.’’ HHS. FOR FURTHER INFORMATION CONTACT: List of Subject in 21 CFR Part 522 VerDate jul<14>2003 19:30 Jun 22, 2005 Jkt 205001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 36337 Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808. List of Subjects 21 CFR Part 522 Animal drugs. 21 CFR Part 556 Animal drugs, Foods. I 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 522 and 556 are amended as follows: PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: I Authority: 21 U.S.C. 360b. 2. Section 522.1450 is added to read as follows: I § 522.1450 Moxidectin solution. (a) Specifications. Each milliliter of solution contains 10 milligrams (mg) moxidectin. (b) Sponsor. See No. 000856 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.426 of this chapter. (d) Conditions of use in beef and nonlactating dairy cattle.—(1) Amount. 0.2 mg/kilogram body weight (0.2 mg/ 2.2 pound) as a single subcutaneous injection. (2) Indications for use. For treatment and control of gastrointestinal roundworms: Ostertagia ostertagi (adults and inhibited fourth-stage larvae), Haemonchus placei (adults), Trichostrongylus axei (adults), T. colubriformis (fourth-stage larvae), Cooperia oncophora (adults), C. punctata (adults and fourth-stage larvae), C. surnabada (adults and fourthstage larvae), Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris spp. (adults); lungworms: Dictyocaulus viviparus (adults and fourth-stage larvae); grubs: Hypoderma bovis and H. lineatum; mites: Psoroptes ovis (P. communis var. bovis); lice: Linognathus vituli and Solenopotes capillatus; for protection of cattle from reinfection with D. viviparus and O. radiatum for 42 days after treatment, with H. placei for 35 days after treatment, and with O. ostertagi and T. axei for 14 days after treatment. (3) Limitations. Do not slaughter cattle within 21 days of treatment. Because a withholding time for milk has not been established, do not use in female dairy E:\FR\FM\23JNR1.SGM 23JNR1

Agencies

[Federal Register Volume 70, Number 120 (Thursday, June 23, 2005)]
[Rules and Regulations]
[Pages 36336-36337]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12422]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Embutramide, Chloroquine, and Lidocaine 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 original new animal drug 
application (NADA) filed by Phoenix Scientific, Inc. The NADA provides 
for veterinary prescription use of a solution containing embutramide, 
chloroquine phosphate, and lidocaine by intravenous injection for 
euthanasia of dogs.

DATES: This rule is effective June 23, 2005.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
melanie.berson@fda.gov.

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed NADA 141 245 that provides for 
veterinary prescription use of TRIBUTAME Euthanasia Solution 
(embutramide; chloroquine phosphate, U.S.P.; and lidocaine, USP) by 
intravenous injection for euthanasia of dogs. The NADA is approved as 
of May 20, 2005, and the regulations are amended in 21 CFR part 522 by 
adding Sec.  522.810 to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    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 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning May 20, 2005.

[[Page 36337]]

    FDA has determined under 21 CFR 25.33(d)(1) that this action is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    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 Subject in 21 CFR Part 522

    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 part 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. Section 522.810 is added to read as follows:


Sec.  522.810  Embutramide, chloroquine, and lidocaine solution.

    (a) Specifications. Each milliliter (mL) of solution contains 135 
milligrams (mg) embutramide; 45 mg chloroquine phosphate, U.S.P.; and 
1.9 mg lidocaine, U.S.P.
    (b) Sponsor. See No. 059130 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. One mL per 5 pounds of 
body weight.
    (2) Indications for use. For euthanasia.
    (3) Limitations. Not for use in animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: June 10, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-12422 Filed 6-22-05; 8:45 am]
BILLING CODE 4160-01-S

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