Oral Dosage Form New Animal Drugs; Deracoxib, 33691-33692 [E8-13353]

Download as PDF 33691 Federal Register / Vol. 73, No. 115 / Friday, June 13, 2008 / Rules and Regulations Agreement Implementation Act (see also General Note 29, HTSUS) that are entered, or withdrawn from warehouse for consumption, on or after January 1, 2005. I 8. The authority citation for part 163 continues to read as follows: Appendix to Part 163—Interim (a)(1)(A) List * 9. Section 163.1(a)(2) is amended by redesignating paragraphs (a)(2)(x) and (a)(2)(xi) as paragraphs (a)(2)(xi) and (a)(2)(xii), and adding a new paragraph (a)(2)(x) to read as follows: § 10.585 CAFTA–DR records that the importer may have in support of a CAFTA– DR claim for preferential tariff treatment, including an importer’s certification. § 163.1 6. The authority citation for part 162 continues to read in part as follows: I PART 163—RECORDKEEPING 10. The Appendix to part 163 is amended by adding a new listing under section IV in numerical order to read as follows: Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1484, 1508, 1509, 1510, 1624. PART 162—INSPECTION, SEARCH, AND SEIZURE PART 178—APPROVAL OF INFORMATION COLLECTION REQUIREMENTS I I Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1592, 1593a, 1624. * * * * * 7. Section 162.0 is amended by revising the last sentence to read as follows: I § 162.0 Part 10, Subparts H, I, J, and M of this chapter, respectively. Definitions. * Scope. * * * Additional provisions concerning records maintenance and examination applicable to U.S. importers, exporters and producers under the U.S.-Chile Free Trade Agreement, the U.S.-Singapore Free Trade Agreement, the Dominican Republic-Central America-U.S. Free Trade Agreement, and the U.S.-Morocco Free Trade Agreement are contained in * * * * (a) * * * (2) * * * (x) The maintenance of any documentation that the importer may have in support of a claim for preferential tariff treatment under the Dominican Republic-Central AmericaUnited States Free Trade Agreement (CAFTA–DR), including an CAFTA–DR importer’s certification. * * * * * * * IV. * * * * * * * * * * 11. The authority citation for part 178 continues to read as follows: I Authority: 5 U.S.C. 301; 19 U.S.C. 1624; 44 U.S.C. 3501 et seq. 12. Section 178.2 is amended by adding new listings for ‘‘§§ 10.583 and 10.584’’ to the table in numerical order to read as follows: I § 178.2 Listing of OMB control numbers. 19 CFR Section Description * * §§ 10.583 and 10.584. ............................. * * * * Claim for preferential tariff treatment under the Dominican Republic-Central America-US Free Trade Agreement.. * * * * * * * * W. Ralph Basham, Commissioner, U.S. Customs and Border Protection. Approved: June 9, 2008. Timothy E. Skud, Deputy Assistant Secretary of the Treasury. [FR Doc. E8–13252 Filed 6–12–08; 8:45 am] BILLING CODE 9111–14–P * OMB control No. * drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for the addition of a 50-milligram size deracoxib tablet which is used for the control of pain and inflammation in dogs. DATES: This rule is effective June 13, 2008. 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. 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, mstockstill on PROD1PC66 with RULES 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 VerDate Aug<31>2005 16:26 Jun 12, 2008 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 50milligram size of DERAMAXX (deracoxib) Chewable Tablets, used for the control of pain and inflammation in dogs. The supplemental NADA is approved as of May 16, 2008, and 21 CFR 520.538 is amended to reflect the approval. SUPPLEMENTARY INFORMATION: Jkt 214001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 * * 1651–0125 * 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 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. E:\FR\FM\13JNR1.SGM 13JNR1 33692 Federal Register / Vol. 73, No. 115 / Friday, June 13, 2008 / Rules and Regulations 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: I PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. § 520.538 [Amended] 2. In paragraph (a) of § 520.538, remove ‘‘25, 75, or 100 milligrams’’ and in its place add ‘‘25, 50, 75, or 100 milligrams’’. I Dated: June 4, 2008. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E8–13353 Filed 6–12–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Ivermectin, Fenbendazole, and Praziquantel Tablets AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. 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 Intervet, Inc. The NADA provides for the veterinary prescription use of chewable tablets containing ivermectin, fenbendazole, and praziquantel for the treatment and control of various internal parasites and for the prevention of canine heartworm disease in adult dogs. DATES: This rule is effective June 13, 2008. SUMMARY: mstockstill on PROD1PC66 with RULES FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV–110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, DE 19966, filed NADA 141– 286 that provides for the veterinary prescription use of PANACUR Plus (ivermectin, fenbendazole, and praziquantel) Soft Chews for the VerDate Aug<31>2005 16:26 Jun 12, 2008 Jkt 214001 treatment and control of various internal parasites and for the prevention of canine heartworm disease in adult dogs. The NADA is approved as of May 9, 2008, and the regulations are amended in 21 CFR part 520 by adding § 520.1200 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. 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 on the date of approval. The agency 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 Subjects in 21 CFR Part 520 Animal drugs. 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 520 is amended as follows: I PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. I 2. Add § 520.1200 to read as follows: § 520.1200 Ivermectin, fenbendazole, and praziquantel tablets. (a) Specifications. Each chewable tablet contains either: (1) 68 micrograms (µg) ivermectin, 1.134 grams fenbendazole, and 57 milligrams (mg) praziquantel; or (2) 27 µg ivermectin, 454 mg fenbendazole, and 23 mg praziquantel. (b) Sponsor. See No. 057926 in § 510.600(c) of this chapter. PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 (c) Conditions of use in dogs—(1) Amount. Administer tablets to provide 6 µg per kilogram (/kg) ivermectin, 100 mg/kg fenbendazole, and 5 mg/kg praziquantel. (2) Indications for use. For the treatment and control of adult Toxocara canis (roundworm), Ancylostoma caninum (hookworm), Trichuris vulpis (whipworm), and Dipylidium caninum (tapeworm), and for the prevention of heartworm disease caused by Dirofilaria immitis in adult dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: June 4, 2008. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E8–13354 Filed 6–12–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 803 [Docket No. FDA–2008–N–0310] Medical Devices; Medical Device Reporting; Baseline Reports AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule. SUMMARY: The Food and Drug Administration (FDA) is amending its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is removing the requirement for baseline reports. The removal of this requirement will eliminate unnecessary duplication and reduce the manufacturer’s reporting burden. FDA is amending the regulation in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA’s usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event we receive a significant adverse comment and withdraw this direct final rule. DATES: This rule is effective October 27, 2008. Submit written or electronic E:\FR\FM\13JNR1.SGM 13JNR1

Agencies

[Federal Register Volume 73, Number 115 (Friday, June 13, 2008)]
[Rules and Regulations]
[Pages 33691-33692]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13353]


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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 50-milligram size 
deracoxib tablet which is used for the control of pain and inflammation 
in dogs.

DATES: This rule is effective June 13, 2008.

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 50-milligram size of 
DERAMAXX (deracoxib) Chewable Tablets, used for the control of pain and 
inflammation in dogs. The supplemental NADA is approved as of May 16, 
2008, and 21 CFR 520.538 is amended 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 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.

[[Page 33692]]


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, 75, or 100 
milligrams'' and in its place add ``25, 50, 75, or 100 milligrams''.

    Dated: June 4, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-13353 Filed 6-12-08; 8:45 am]
BILLING CODE 4160-01-S

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