Oral Dosage Form New Animal Drugs; Tiamulin Liquid Concentrate, 43045-43046 [05-14696]

Download as PDF Federal Register / Vol. 70, No. 142 / Tuesday, July 26, 2005 / Rules and Regulations which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents are to be submitted and are to be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will publish notice of the objections that the agency has received or lack thereof in the Federal Register. List of Subjects in 21 CFR Part 73 Color additives, Cosmetics, Drugs, Incorporation by reference, Medical devices. I Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 73 is amended as follows: PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION 1. The authority citation for 21 CFR part 73 continues to read as follows: I Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e. 2. Section 73.585 is added to subpart A to read as follows: I § 73.585 Tomato lycopene extract; tomato lycopene concentrate. (a) Identity. (1) The color additive tomato lycopene extract is a red to dark brown viscous oleoresin extracted with ethyl acetate from tomato pulp followed by removal of the solvent by evaporation. The pulp is produced from fresh, edible varieties of the tomato by removing the liquid. The main coloring component is lycopene. (2) The color additive tomato lycopene concentrate is a powder prepared from tomato lycopene extract by removing most of the tomato lipids with ethyl acetate and then evaporating off the solvent. (3) Color additive mixtures made with tomato lycopene extract or tomato lycopene concentrate may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring food. (b) Specifications. (1) Tomato lycopene extract shall conform to the following specification: Lycopene, not VerDate jul<14>2003 23:50 Jul 25, 2005 Jkt 205001 less than 5.5 percent of oleoresin as determined by the method entitled ‘‘Qualitative Analysis of Lycopene, Its Isomers and Other Carotenoids in Different Concentrations of Lyc-OMato (Tomato Oleoresin) and in Tomato Pulp by High Performance Liquid Chromatography (HPLC),’’ S.O.P. number : Lab/119/01, Revision 01, dated May 30, 2001, published by LycoRed Natural Products Industries, which is incorporated by reference, or an equivalent method. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of the method from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. You may inspect a copy at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch Pkwy., College Park, MD, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: https://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html (2) Tomato lycopene concentrate shall conform to the following specification: Lycopene, not less than 60 percent of oleoresin as determined by the method identified in paragraph (b)(1) of this section. (c) Uses and restrictions. Tomato lycopene extract and tomato lycopene concentrate may be safely used for coloring foods generally in amounts consistent with good manufacturing practice, except that they may not be used to color foods for which standards of identity have been issued under section 401 of the act, unless the use of added color is authorized by such standards. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. Dated: July 15, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–14631 Filed 7–25–05; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 43045 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Tiamulin Liquid Concentrate 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 abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The ANADA provides for use of tiamulin concentrate solution to prepare medicated drinking water for the treatment of swine dysentery and swine pneumonia. DATES: This rule is effective July 26, 2005. FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–0223, email: daniel.benz@fda.gov. SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed ANADA 200–360 that provides for use of Tiamulin Liquid Concentrate to prepare medicated drinking water for the treatment of swine dysentery and swine pneumonia. Phoenix Scientific, Inc.’s Tiamulin Liquid Concentrate is approved as a generic copy of Boehringer Ingelheim Vetmedica, Inc.’s DENAGARD (tiamulin) Liquid Concentrate approved under NADA 140–916. The ANADA is approved as of June 24, 2005, and the regulations are amended in § 520.2456 (21 CFR 520.2456) to reflect the approval. The basis of approval is discussed in the freedom of information summary. The regulations are also amended in § 520.2456 to reflect a more recent genus name for the causative pathogen for swine dysentery. This action is being taken to improve the accuracy of the regulations. 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. E:\FR\FM\26JYR1.SGM 26JYR1 43046 Federal Register / Vol. 70, No. 142 / Tuesday, July 26, 2005 / Rules and Regulations external parasites following topical administration of doramectin solution on cattle. DATES: This rule is effective July 26, 2006. 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: Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement to NADA List of Subjects in 21 CFR Part 520 141–095 for DECTOMAX (doramectin) Pour-On Solution for Cattle. The Animal drugs. supplemental application provides for a I Therefore, under the Federal Food, period of protection from reinfestation Drug, and Cosmetic Act and under authority delegated to the Commissioner with two species of external parasites of Food and Drugs and redelegated to the following topical administration of doramectin solution on cattle. Center for Veterinary Medicine, 21 CFR Specifically, the period of persistent part 520 is amended as follows: effectiveness is 42 days for Linognathus vituli and 77 days for Bovicola PART 520—ORAL DOSAGE FORM (Damalinia) bovis. The supplemental NEW ANIMAL DRUGS NADA is approved as of June 23, 2005, I 1. The authority citation for 21 CFR and 21 CFR 524.770 is amended to part 520 continues to read as follows: reflect the approval. The basis of approval is discussed in the freedom of Authority: 21 U.S.C. 360b. information summary. § 520.2456 [Amended] In accordance with the freedom of information provisions of 21 CFR part I 2. Section 520.2456 is amended in paragraph (b) by removing ‘‘Sponsor. See 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness 000010’’ and by adding in its place data and information submitted to ‘‘Sponsors. See Nos. 000010 and support approval of this application 059130’’, and in paragraph (d)(2) by may be seen in the Division of Dockets removing ‘‘Treponema’’ and by adding Management (HFA–305), Food and Drug in its place ‘‘Brachyspira’’. Administration, 5630 Fishers Lane, rm. Dated: July 11, 2005. 1061, Rockville, MD 20852, between 9 Linda Tollefson, a.m. and 4 p.m., Monday through Acting Director, Center for Veterinary Friday. Medicine. Under section 512(c)(2)(F)(iii) of the [FR Doc. 05–14696 Filed 7–25–05; 8:45 am] Federal Food, Drug, and Cosmetic Act BILLING CODE 4160–01–S (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing exclusivity beginning June DEPARTMENT OF HEALTH AND 23, 2005. Exclusivity applies only to the HUMAN SERVICES persistent effectiveness claims for the two species of external parasites listed Food and Drug Administration previously in this document. FDA has determined under 21 CFR 21 CFR Part 524 25.33(a)(1) that this action is of a type that does not individually or Ophthalmic and Topical Dosage Form cumulatively have a significant effect on New Animal Drugs; Doramectin the human environment. Therefore, AGENCY: Food and Drug Administration, neither an environmental assessment HHS. nor an environmental impact statement is required. ACTION: Final rule. This rule does not meet the definition SUMMARY: The Food and Drug of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because Administration (FDA) is amending the it is a rule of ‘‘particular applicability.’’ animal drug regulations to reflect Therefore, it is not subject to the approval of a supplemental new animal congressional review requirements in 5 drug application (NADA) filed by Pfizer, U.S.C. 801–808. Inc. The supplemental NADA provides List of Subjects in 21 CFR Part 524 for a period of protection from Animal drugs. reinfestation with two species of The agency has determined under 21 CFR 25.33(a)(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. VerDate jul<14>2003 23:50 Jul 25, 2005 Jkt 205001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 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 524 is amended as follows: I PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 524 continues to read as follows: I Authority: 21 U.S.C. 360b. 2. Section 524.770 is amended by revising paragraph (e)(2) to read as follows: I § 524.770 * Doramectin. * * * * (e) * * * (2) Indications for use. For treatment and control of gastrointestinal roundworms: Ostertagia ostertagi (adults and fourth-stage larvae), Ostertagia ostertagi (inhibited fourthstage larvae), Ostertagia lyrata (adults), Haemonchus placei (adults and fourthstage larvae), Trichostrongylus axei (adults and fourth-stage larvae), Trichostrongylus colubriformis (adults and fourth-stage larvae), Cooperia oncophora (adults and fourth-stage larvae), Cooperia punctata (adults and fourth-stage larvae), Cooperia pectinata (adults), Cooperia surnabada (adults), Bunostomum phlebotomum (adults), Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris spp. (adults); lungworms: Dictyocaulus viviparus (adults and fourth-stage larvae); eyeworms: Thelazia gulosa (adults), Thelazia skrjabini (adults); grubs: Hypoderma bovis and Hypoderma lineatum; sucking lice: Linognathus vituli, Haematopinus eurysternus, and Solenopotes capillatus; biting lice: Bovicola (Damalinia) bovis; mange mites: Chorioptes bovis and Sarcoptes scabiei; horn flies: Haematobia irritans; and to control infections and to protect from reinfection with Cooperia oncophora, Dictyocaulus viviparus, Ostertagia ostertagi, and Oesophagostomum radiatum for 28 days; and with Cooperia punctata and Haemonchus placei for 35 days after treatment; and to control infestations and to protect from reinfestation with Linognathus vituli for 42 days and with Bovicola (Damalinia) bovis for 77 days after treatment. * * * * * E:\FR\FM\26JYR1.SGM 26JYR1

Agencies

[Federal Register Volume 70, Number 142 (Tuesday, July 26, 2005)]
[Rules and Regulations]
[Pages 43045-43046]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14696]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Tiamulin Liquid Concentrate

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 an abbreviated new animal drug 
application (ANADA) filed by Phoenix Scientific, Inc. The ANADA 
provides for use of tiamulin concentrate solution to prepare medicated 
drinking water for the treatment of swine dysentery and swine 
pneumonia.

DATES: This rule is effective July 26, 2005.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: daniel.benz@fda.gov.

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed ANADA 200-360 that provides 
for use of Tiamulin Liquid Concentrate to prepare medicated drinking 
water for the treatment of swine dysentery and swine pneumonia. Phoenix 
Scientific, Inc.'s Tiamulin Liquid Concentrate is approved as a generic 
copy of Boehringer Ingelheim Vetmedica, Inc.'s DENAGARD (tiamulin) 
Liquid Concentrate approved under NADA 140-916. The ANADA is approved 
as of June 24, 2005, and the regulations are amended in Sec.  520.2456 
(21 CFR 520.2456) to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    The regulations are also amended in Sec.  520.2456 to reflect a 
more recent genus name for the causative pathogen for swine dysentery. 
This action is being taken to improve the accuracy of the regulations.
    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.

[[Page 43046]]

    The agency has determined under 21 CFR 25.33(a)(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 Subjects in 21 CFR Part 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.2456  [Amended]

0
2. Section 520.2456 is amended in paragraph (b) by removing ``Sponsor. 
See 000010'' and by adding in its place ``Sponsors. See Nos. 000010 and 
059130'', and in paragraph (d)(2) by removing ``Treponema'' and by 
adding in its place ``Brachyspira''.

    Dated: July 11, 2005.
Linda Tollefson,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-14696 Filed 7-25-05; 8:45 am]
BILLING CODE 4160-01-S
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