Oral Dosage Form New Animal Drugs; Deracoxib, 37436-37437 [E7-13372]

Download as PDF 37436 Federal Register / Vol. 72, No. 131 / Tuesday, July 10, 2007 / Rules and Regulations List of Subjects in 18 CFR Part 157 § 157.207 Administrative practice and procedure, Natural gas, Reporting and recordkeeping requirements. * By the Commission. Kimberly D. Bose, Secretary. In consideration of the foregoing, the Commission amends part 157, Chapter I, Title 18, Code of Federal Regulations, as follows: I PART 157—APPLICATIONS FOR CERTIFICATES OF PUBLIC CONVENIENCE AND NECESSITY AND FOR ORDERS PERMITTING AND APPROVING ABANDONMENT UNDER SECTION 7 OF THE NATURAL GAS ACT 1. The authority citation for part 157 continues to read as follows: I Authority: 15 U.S.C. 717–717w. § 157.203 [Amended] 2. In § 157.203: a. In paragraph (d)(1), immediately after the phrase ‘‘unless the company makes a good faith effort to notify,’’ the phrase ‘‘in writing’’ is added; I b. In paragraph (d)(1)(iii)(C), ‘‘should’’ is removed and the word ‘‘may’’ is inserted in its place; I c. In paragraph (d)(1)(iii)(D), ‘‘should’’ is removed and the word ‘‘may’’ is inserted in its place; I d. In paragraph (d)(1)(iii)(D), immediately before the period that concludes the sentence, the phrase ‘‘at the current telephone number and email address, which is to be provided in the notification’’ is added; and I e. In paragraph (d)(2), immediately after the phrase ‘‘the company shall make a good faith effort to notify,’’ the phrase ‘‘in writing’’ is added. I 3. In § 157.206, paragraph (b)(5)(i) is revised to read as follows: I I § 157.206 Standard conditions. rmajette on PROD1PC64 with RULES * * * * * (b) * * * (5)(i) The noise attributable to any new compressor station, compression added to an existing station, or any modification, upgrade or update of an existing station, must not exceed a daynight level (Ldn) of 55 dBA at any preexisting noise-sensitive area (such as schools, hospitals, or residences). * * * * * I 4. In § 157.207: Paragraph (c) is removed; paragraphs (d), (e), (f), (g), (h), and (i) are redesignated, respectively, as paragraphs (c), (d), (e), (f), (g), and (h); and paragraph (a) is revised to read as follows: VerDate Aug<31>2005 15:13 Jul 09, 2007 Jkt 211001 General reporting requirements. * * * * (a) For each new facility authorized by §§ 157.208, 157.210, 157.212, or 157.213, the information specified in § 157.208(e); * * * * * § 157.208 [Amended] 6. In § 157.213, paragraph (b) and the introductory text of paragraph (c) are revised to read as follows: I Underground storage field * * * * * (b) Prior Notice. Subject to the notice requirements of §§ 157.205(b) and 157.208(c), the certificate holder is authorized to acquire, construct, modify, replace, and operate natural gas underground storage facilities, provided the storage facility’s certificated physical parameters—including total inventory, reservoir pressure, reservoir and buffer boundaries, and certificated capacity remain unchanged—and provided compliance with environmental and safety provisions is not affected. The cost of a project may not exceed the cost limitation provided in column 2 of Table I in § 157.208(d). the certificate holder must not segment projects in order to meet this cost limitation. (c) Contents of request. In addition to the requirements of §§ 157.206(b) and 157.208(c), requests for activities authorized under paragraph (b) of this section must contain, to the extent necessary to demonstrate that the proposed project will not alter a storage reservoir’s total inventory, reservoir pressure, reservoir or buffer boundaries, or certificated capacity: * * * * * [FR Doc. E7–12560 Filed 7–9–07; 8:45 am] BILLING CODE 6717–01–P PO 00000 Frm 00014 Fmt 4700 Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Deracoxib AGENCY: 5. In § 157.208: I a. In paragraph (e), in the first sentence, after the phrase ‘‘pursuant to paragraph (a) of this section,’’ the phrase ‘‘and § 157.213(a),’’ is added; and I b. In paragraph (e), in the second sentence, after the phrase ‘‘pursuant to paragraph (b) of this section,’’ the phrase ‘‘and §§ 157.210, 157.212, and 157.213(b),’’ is added. I § 157.213 facilities. DEPARTMENT OF HEALTH AND HUMAN SERVICES Sfmt 4700 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 supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for the addition of a 75-milligram size deracoxib tablet which is used for the control of pain and inflammation in dogs. DATES: This rule is effective July 10, 2007. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV–110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408, filed a supplement to NADA 141–203 that provides for the addition of a 75milligram size of DERAMAXX (deracoxib) Chewable Tablets, used for the control of pain and inflammation in dogs. The supplemental NADA is approved as of June 13, 2007, and the regulations are amended in 21 CFR 520.538 to reflect the approval. 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. 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.’’ E:\FR\FM\10JYR1.SGM 10JYR1 Federal Register / Vol. 72, No. 131 / Tuesday, July 10, 2007 / Rules and Regulations 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. I 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 1. The authority citation for 21 CFR part 520 continues to read as follows: I [Amended] 2. In paragraph (a) of § 520.538, remove ‘‘25 or 100 milligrams’’ and in its place add ‘‘25, 75, or 100 milligrams’’. I Dated: June 24, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–13372 Filed 7–9–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs For Use in Animal Feeds; Ivermectin AGENCY: Food and Drug Administration, HHS. Ivermectin in g/ton of feed rmajette on PROD1PC64 with RULES VerDate Aug<31>2005 SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA revises the approved concentration of ivermectin in Type C medicated feed administered as a top dress to adult and breeding swine for the treatment and control of various internal and external parasites. DATES: This rule is effective July 10, 2007. 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.hhs.gov. SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096–4640, filed a supplement to NADA 140–974 that provides for use of IVOMEC (ivermectin) Premix for Swine, a Type A medicated article, for the treatment and control of various internal and external parasites. The supplement revises the approved concentration of ivermectin in Type C medicated feed administered as a top dress to adult and breeding swine. The supplemental NADA is approved as of June 15, 2007, and the regulations in 21 CFR 558.300 are amended to reflect the approval and a current format. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. Combination in g/ton of feed FDA 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 558 Animal drugs, Animal feeds. 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 part 558 is amended as follows: I PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: I Authority: 21 U.S.C. 360b, 371. I 2. Revise § 558.300 to read as follows: § 558.300 Ivermectin. (a) Specifications. Type A medicated article containing 2.72 grams ivermectin per pound (g/lb). (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.344 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use in swine. It is used in feed as follows: Bacitracin methylene disalicylate, 10 to 30 15:13 Jul 09, 2007 Jkt 211001 Indications for use Limitations Weaned, growing-finishing swine: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). (1) 1.8 (to provide 0.1 milligram per kilogram (mg/kg) of body weight per day) (2) 1.8 (to provide 0.1 mg/kg of body weight per day) Final rule. FOR FURTHER INFORMATION CONTACT: Authority: 21 U.S.C. 360b. § 520.538 ACTION: 37437 Feed as the only feed for 7 consecutive days. Withdraw 5 days before slaughter. 050604 Weaned, growing-finishing swine: As in paragraph (e)(1) of this section; and for increased rate of weight gain and improved feed efficiency. For use in swine feed only. Feed as the only feed for 7 consecutive days. Withdraw 5 days before slaughter. 050604 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\10JYR1.SGM 10JYR1 Sponsor

Agencies

[Federal Register Volume 72, Number 131 (Tuesday, July 10, 2007)]
[Rules and Regulations]
[Pages 37436-37437]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13372]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Deracoxib

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 supplemental new animal drug 
application (NADA) filed by Novartis Animal Health US, Inc. The 
supplemental NADA provides for the addition of a 75-milligram size 
deracoxib tablet which is used for the control of pain and inflammation 
in dogs.

DATES: This rule is effective July 10, 2007.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., 3200 
Northline Ave., suite 300, Greensboro, NC 27408, filed a supplement to 
NADA 141-203 that provides for the addition of a 75-milligram size of 
DERAMAXX (deracoxib) Chewable Tablets, used for the control of pain and 
inflammation in dogs. The supplemental NADA is approved as of June 13, 
2007, and the regulations are amended in 21 CFR 520.538 to reflect the 
approval.
    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.
    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.''

[[Page 37437]]

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.  520.538  [Amended]

0
2. In paragraph (a) of Sec.  520.538, remove ``25 or 100 milligrams'' 
and in its place add ``25, 75, or 100 milligrams''.

    Dated: June 24, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-13372 Filed 7-9-07; 8:45 am]
BILLING CODE 4160-01-S

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