Oral Dosage Form New Animal Drugs; Carprofen, 30625-30626 [05-10627]

Download as PDF Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Rules and Regulations part 71) establishes Class E airspace designated as a surface area for an airport at Chillicothe, MO. Controlled airspace extending upward from the surface of the earth is needed to contain aircraft executing instrument approach procedures to Chillicothe Municipal Airport. Weather observations will be provided by an automatic Weather Observing/Reporting System (AWOS) and communications will be direct with Columbia Automated Flight Service Station. This rule also revises the Class E airspace area extending upward from 700 feet above the surface at Chillicothe, MO. An examination of this Class E airspace area for Chillicothe, MO revealed noncompliance with FAA directives. This corrects identified discrepancies by increasing the area from a 6.4-mile to a 6.9-mile radius of Chillicothe Municipal Airport, defining the extension to the airspace area in terms of the Chillicothe nondirectional radio beacon (NDB), modifying the bearing of the extension, correcting errors in the identified location of the Chillicothe NDB and defining airspace of appropriate dimensions to protect aircraft departing and executing instrument approach procedures to Chillicothe Municipal Airport. The airspace area is brought into compliance with FAA directives. Both areas will be depicted on appropriate aeronautical charts. Class E airspace areas designated as surface areas are published in Paragraph 6002 of FAA Order 7400.9M, Airspace Designations and Reporting points, dated August 30, 2004, and effective September 16, 2004, which is incorporated by reference in 14 CFR 71.1. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of the same Order. The Class E airspace designations listed in this document will be published subsequently in the Order. The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation—(1) is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant VerDate jul<14>2003 19:56 May 26, 2005 Jkt 205001 economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority since it contains aircraft executing instrument approach procedures to Chillicothe Municipal Airport. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (Air). Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: I PART 71—DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND CLASS E AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: I Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9M, dated August 30, 2004, and effective September 16, 2004, is amended as follows: I Paragraph 6002 Class E Airspace Designated as Surface Areas. * * * * * ACE MO E2 Chillicothe, MO Chillicothe Municipal Airport, MO (Lat. 39°46′56″ N., long. 93°29′44″ W.) Chillicothe NDB (Lat. 39°46′38″ N., long. 93°29′39″ W.) Within a 4.4-mile radius of Chillicothe Municipal Airport and within 2.5 miles each side of the 335° bearing from the Chillicothe NDB extending from the 4.4-mile radius of the airport to 7 miles northwest of the NDB. * * * * * Paragraph 6005 Class E airspace areas extending upward from 700 feet or more above the surface of the earth. * * * * * ACE MO E5 Chillicothe, MO Chillicothe Municipal Airport, MO (Lat. 39°46′56″ N., long. 93°29′44″ W.) Chillicothe NDB (Lat. 39°46′38″ N., long. 93°29′39″ W.) PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 30625 That airspace extending upward from 700 feet above the surface within a 6.9-mile radius of Chillicothe Municipal Airport and within 2.5 miles each side of the 335° bearing from the Chillicothe NDB extending from the 6.9-mile radius of the airport to 7 miles northwest of the NDB. * * * * * Issued in Kansas City, MO, on May 17, 2005. Elizabeth S. Wallis, Acting Area Director, Western Flight Services Operations. [FR Doc. 05–10600 Filed 5–26–05; 8:45 am] BILLING CODE 4910–13–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Carprofen 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 IMPAX Laboratories, Inc. The ANADA provides for veterinary prescription use of carprofen caplets in dogs for the relief of pain and inflammation associated with osteoarthritis. DATES: This rule is effective May 27, 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: IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544, filed ANADA 200–366 for veterinary prescription use of Carprofen Caplets in dogs for the relief of pain and inflammation associated with osteoarthritis. IMPAX Laboratories, Inc.’s Carprofen Caplets is approved as a generic copy of Pfizer, Inc.’s RIMADYL Caplets, approved under NADA 141–053. ANADA 200– 366 is approved as of April 27, 2005, and 21 CFR 520.309 is amended 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 E:\FR\FM\27MYR1.SGM 27MYR1 30626 Federal Register / Vol. 70, No. 102 / Friday, May 27, 2005 / Rules and Regulations 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.’’ 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. Dated: May 13, 2005. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 05–10627 Filed 5–26–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms, and Explosives 27 CFR Part 555 [Docket No. ATF 5F; AG Order No. 2766– 2005] RIN 1140–AA02 Identification Markings Placed on Imported Explosive Materials and Miscellaneous Amendments (2000R– 238P) Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF), Department of Justice. ACTION: Final rule. AGENCY: SUMMARY: The Department of Justice is amending the current regulations of the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) to require licensed importers to identify by marking all explosive materials they import for sale or distribution. Licensed PART 520—ORAL DOSAGE FORM manufacturers currently are required to NEW ANIMAL DRUGS place identification markings on explosive materials manufactured in the I 1. The authority citation for 21 CFR United States. Similar marking part 520 continues to read as follows: requirements, however, do not currently exist for imported explosive materials. Authority: 21 U.S.C. 360b. Identification markings are needed on I 2. Section 520.309 is amended by explosives to help ensure that these revising paragraphs (b) and (d)(2) to read materials can be effectively traced for as follows: criminal enforcement purposes. Although ATF does not have regulatory § 520.309 Carprofen. oversight over foreign manufacturers, it * * * * * does have authority over licensed (b) Sponsors. See sponsors in importers of explosive materials. This § 510.600(c) of this chapter for uses as rule will impose identification in paragraph (d) of this section. requirements on licensed importers of (1) No. 000069 for use of products explosive materials that are described in paragraph (a) of this substantially similar to the marking section as in paragraph (d) of this requirements imposed on domestic section. manufacturers. In addition, the final rule incorporates (2) No. 000115 for use of product into the regulations the provisions of described in paragraph (a)(1) of this ATF Ruling 75–35, relating to methods section as in paragraphs (d)(1), (d)(2)(i), of marking containers of explosive and (d)(3) of this section. materials. This final rule also amends * * * * * the regulations to remove the (d) * * * requirement that a licensee or permittee (2) Indications for use—(i) For the file for an amended license or permit in relief of pain and inflammation order to change the class of explosive associated with osteoarthritis. materials described in their license or permit from a lower to a higher (ii) For the control of postoperative classification. pain associated with soft tissue and orthopedic surgery. DATES: This rule is effective July 26, * * * * * 2005. 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 VerDate jul<14>2003 19:56 May 26, 2005 Jkt 205001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 FOR FURTHER INFORMATION CONTACT: James P. Ficaretta; Enforcement Programs and Services; Bureau of Alcohol, Tobacco, Firearms, and Explosives; U.S. Department of Justice; 650 Massachusetts Avenue, NW., Washington, DC 20226, telephone (202) 927–8203. SUPPLEMENTARY INFORMATION: I. Background The Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) is responsible for implementing Title XI, Regulation of Explosives (18 United States Code (U.S.C.) Chapter 40), of the Organized Crime Control Act of 1970. One of the stated purposes of the Act is to reduce the hazards to persons and property arising from the misuse of explosive materials. Under section 847 of title 18, U.S.C., the Attorney General ‘‘may prescribe such rules and regulations as he deems reasonably necessary to carry out the provisions of this chapter.’’ Regulations that implement the provisions of chapter 40 are contained in title 27, Code of Federal Regulations (CFR), part 555 (‘‘Commerce in Explosives’’). The term ‘‘explosive materials,’’ as defined in 27 CFR 555.11, means explosives, blasting agents, water gels, and detonators. The term includes, but is not limited to, all items in the ‘‘List of Explosive Materials’’ provided for in § 555.23. Section 555.202 provides for three classes of explosive materials: (1) High explosives (e.g., dynamite, flash powders, and bulk salutes), (2) low explosives (e.g., black powder, safety fuses, igniters, igniter cords, fuse lighters, and display fireworks (except bulk salutes)), and (3) blasting agents (e.g., ammonium nitrate-fuel oil and certain water gels). Section 555.109 requires licensed manufacturers of explosive materials to legibly identify by marking all explosive materials manufactured for sale or distribution. The marks required by this section include the identity of the manufacturer and the location, date, and shift of manufacture. This section also provides that licensed manufacturers must place the required marks on each cartridge, bag, or other immediate container of explosive materials for sale or distribution, as well as on the outside container, if any, used for their packaging. Exceptions to the marking requirements are set forth in § 555.109(b). This section provides that (1) licensed manufacturers of blasting caps are only required to place the required identification marks on the containers used for the packaging of blasting caps, (2) the Director may E:\FR\FM\27MYR1.SGM 27MYR1

Agencies

[Federal Register Volume 70, Number 102 (Friday, May 27, 2005)]
[Rules and Regulations]
[Pages 30625-30626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10627]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Carprofen

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 IMPAX Laboratories, Inc. The ANADA 
provides for veterinary prescription use of carprofen caplets in dogs 
for the relief of pain and inflammation associated with osteoarthritis.

DATES: This rule is effective May 27, 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: IMPAX Laboratories, Inc., 30831 Huntwood 
Ave., Hayward, CA 94544, filed ANADA 200-366 for veterinary 
prescription use of Carprofen Caplets in dogs for the relief of pain 
and inflammation associated with osteoarthritis. IMPAX Laboratories, 
Inc.'s Carprofen Caplets is approved as a generic copy of Pfizer, 
Inc.'s RIMADYL Caplets, approved under NADA 141-053. ANADA 200-366 is 
approved as of April 27, 2005, and 21 CFR 520.309 is amended 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

[[Page 30626]]

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.'' 
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.

0
2. Section 520.309 is amended by revising paragraphs (b) and (d)(2) to 
read as follows:


Sec.  520.309  Carprofen.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
uses as in paragraph (d) of this section.
    (1) No. 000069 for use of products described in paragraph (a) of 
this section as in paragraph (d) of this section.
    (2) No. 000115 for use of product described in paragraph (a)(1) of 
this section as in paragraphs (d)(1), (d)(2)(i), and (d)(3) of this 
section.
* * * * *
    (d) * * *
    (2) Indications for use--(i) For the relief of pain and 
inflammation associated with osteoarthritis.
    (ii) For the control of postoperative pain associated with soft 
tissue and orthopedic surgery.
* * * * *

    Dated: May 13, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-10627 Filed 5-26-05; 8:45 am]
BILLING CODE 4160-01-S

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