Oral Dosage Form New Animal Drugs; Phenylbutazone Powder, 875-876 [06-90]

Download as PDF 875 Federal Register / Vol. 71, No. 4 / Friday, January 6, 2006 / Rules and Regulations 32–064, dated January 26, 2005, as an additional source of service information for doing the modification. At the end of the modification: The HCB part number (P/N) C24856000–9 will become P/N C24856000– 11, and the HCB P/N C24856001–7 will become P/N C24856001–9. (g) After the effective date of this AD, no person may install on any airplane an HCB having P/N C24856000–9 or C24856001–7. Alternative Methods of Compliance (AMOCs) (h)(1) The Manager, ANM–116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19. (2) Before using any AMOC approved in accordance with § 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. Related Information (i) French airworthiness directive F–2005– 016, dated January 19, 2005, also addresses the subject of this AD. Material Incorporated by Reference cprice-sewell on PROD1PC66 with RULES (j) You must use Airbus Service Bulletin A330–32–3156, dated December 22, 2004; or Airbus Service Bulletin A340–32–4194, dated December 22, 2004; as applicable; to perform the actions that are required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approved the incorporation by reference of these documents in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France, for a copy of this service information. You may review copies at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street SW., room PL–401, Nassif Building, Washington, DC; on the Internet at https:// dms.dot.gov; or at the National Archives and Records Administration (NARA). For information on the availability of this material at the NARA, call (202) 741–6030, or go to https://www.archives.gov/ federal_register/code_of_federal_regulations/ ibr_locations.html. Issued in Renton, Washington, on December 27, 2005. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 06–62 Filed 1–5–06; 8:45 am] BILLING CODE 4910–13–P 14:16 Jan 05, 2006 Food and Drug Administration 21 CFR Parts 510 and 520 Oral Dosage Form New Animal Drugs; Phenylbutazone Powder Parts Installation VerDate Aug<31>2005 DEPARTMENT OF HEALTH AND HUMAN SERVICES Jkt 208001 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 A & G Pharmaceuticals, Inc. The ANADA provides for the veterinary prescription use of phenylbutazone powder administered to horses in feed for the relief of inflammatory conditions associated with the musculoskeletal system. DATES: This rule is effective January 6, 2006. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–9808, email: john.harshman@fda.gov. SUPPLEMENTARY INFORMATION: A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527, filed ANADA 200–334 that provides for the veterinary prescription use of EQUIZONE 100 (phenylbutazone), a powder administered to horses in feed for the relief of inflammatory conditions associated with the musculoskeletal system. A & G Pharmaceuticals, Inc.’s, EQUIZONE 100 is approved as a generic copy of Phoenix Scientific, Inc.’s, Phenylbutazone Tablets, USP, approved under NADA 91–818. The ANADA is approved as of November 18, 2005, and the regulations are amended in 21 CFR part 520 by adding new § 520.1720e. The basis of approval is discussed in the freedom of information summary. In addition, A & G Pharmaceuticals, Inc., has not been previously listed in the animal drug regulations as a sponsor of an approved application. At this time, 21 CFR 510.600(c) is being amended to add entries for the firm. 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 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 a.m. and 4 p.m., Monday through Friday. 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 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 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 parts 510 and 520 are amended as follows: PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: I Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. Section 510.600 is amended in the table in paragraph (c)(1) by alphabetically adding a new entry for ‘‘A & G Pharmaceuticals, Inc.’’ and in the table in paragraph (c)(2) by numerically adding a new entry for ‘‘057699’’ to read as follows: I § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * (c) * * * (1) * * * * * Firm name and address * * * A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527. * * * Drug labeler code * 057699 * * * (2) * * * Drug labeler code * E:\FR\FM\06JAR1.SGM * 06JAR1 Firm name and address * * * 876 Federal Register / Vol. 71, No. 4 / Friday, January 6, 2006 / Rules and Regulations Drug labeler code 057699 * ACTION: Firm name and address A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd., Jackson, NJ 08527 * * * * PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. 4. Section 520.1720e is added to read as follows: I § 520.1720e Phenylbutazone powder. (a) Specifications. Each 10 grams (g) of powder contains 1 g phenylbutazone. (b) Sponsor. See No. 057699 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 1 to 2 g (1 to 2 level scoops, using the scoop provided) per 500 pounds of body weight on a small amount of palatable feed. (2) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system. (3) Limitations. Do not exceed 4 g per animal daily. Administer at a relatively high dosage level for the first 48 hours, then reduce gradually to a maintenance dosage level with the lowest dosage maintained at the level capable of producing the desired clinical response. Do not use in horses intended for human consumption. Federal law prohibits the extralabel use of this product in female cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: December 21, 2005. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 06–90 Filed 1–5–06; 8:45 am] BILLING CODE 4160–01–S GENERAL SERVICES ADMINISTRATION 41 CFR Part 301–10 [FTR Amendment 2005–07; FTR Case 2005– 308 ] cprice-sewell on PROD1PC66 with RULES RIN 3090–AI21 Federal Travel Regulation; 2006 Privately Owned Vehicle Mileage Reimbursement Office of Governmentwide Policy, General Services Administration (GSA). AGENCY: VerDate Aug<31>2005 14:16 Jan 05, 2006 Jkt 208001 Final rule. SUMMARY: This final rule amends the mileage reimbursement rate for use of a privately owned automobile (POA) on official travel to reflect the decrease in the single standard mileage rate established by the Internal Revenue Service (IRS). 5 U.S.C. 5704(a)(1) prohibits GSA from exceeding the single standard mileage rate established by the IRS. Accordingly, the FTR is revised to decrease the reimbursement of operating a POA from $0.485 to $0.445 per mile. DATES: Effective date: This final rule is effective January 6, 2006. Applicability date: This final rule is effective for travel performed on and after January 1, 2006. FOR FURTHER INFORMATION CONTACT: The Regulatory Secretariat, Room 4035, GS Building, Washington, DC, 20405, (202) 208–7312, for information pertaining to status or publication schedules. For clarification of content, contact Umeki Thorne, Office of Governmentwide Policy, email umeki.thorne@gsa.gov or by telephone at (202) 208–7636. Please cite FTR Amendment 2005–07, FTR case 2005–308. SUPPLEMENTARY INFORMATION: A. Background Pursuant to 5 U.S.C 5707(b), the Administrator of General Services has the responsibility to prescribe the privately owned vehicle (POV) mileage reimbursement rates to which Federal employees are entitled when using their privately owned airplanes, automobiles, and motorcycles while engaged on official business. As provided for in 5 U.S.C. 5704(a)(1), the automobile reimbursement rate established by the Administrator of General Services cannot exceed the single standard mileage rate established by the Internal Revenue Service (IRS) for purposes of calculating the deductible costs of operating an automobile for business purposes. The IRS issued Revenue Procedure 2005–78 announcing the new single standard mileage rate for automobiles would be $0.445 per mile effective on January 1, 2006. At this time, this change only affects the mileage reimbursement for privately owned automobiles. GSA is obtaining data from industry sources to determine if an increase or decrease in the mileage reimbursement allowances is warranted for motorcycles and airplanes. B. Executive Order 12886 This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 final rule is not a major rule under 5 U.S.C. 804. C. Regulatory Flexibility Act This final rule is not required to be published in the Federal Register for notice and comment; therefore, the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., does not apply. D. Paperwork Reduction Act The Paperwork Reduction Act does not apply because the changes to the FTR do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public which require the approval of the Office of Management and Budget (OMB) under 44 U.S.C. 3501, et seq. E. Small Business Regulatory Enforcement Fairness Act This final rule is also exempt from congressional review prescribed under 5 U.S.C. 801 since it relates solely to agency management and personnel. List of Subjects in 41 CFR Part 301–10 Government employees, Travel and transportation expenses. Dated: December 21, 2005. David L. Bibb, Acting Administrator of General Services. For the reasons set forth in the preamble, under 5 U.S.C. 5701–5709, the General Services Administration (GSA) amends 41 CFR part 301–10 as set forth below: I PART 301–10—TRANSPORTATION EXPENSES 1. The authority citation for 41 CFR part 301–10 is added to read as follows: I Authority: 5 U. S.C. 5707; 40 U.S.C. 121(c), 49 U.S.C. 40118, Office of Management and Budget Circular No. A–126, ‘‘Improving the Management and Use of Government Aircraft.’’ Revised May 22, 1992. § 301–10.303 [Amended] I 2. In § 301–10.303, in the table, in the second column, in the third entry under the heading ‘‘Your reimbursement is’’, add ‘‘$0.445’’. [FR Doc. 06–86 Filed 1–5–06; 8:45 am] BILLING CODE 6820–14–S E:\FR\FM\06JAR1.SGM 06JAR1

Agencies

[Federal Register Volume 71, Number 4 (Friday, January 6, 2006)]
[Rules and Regulations]
[Pages 875-876]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-90]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Oral Dosage Form New Animal Drugs; Phenylbutazone Powder

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 A & G Pharmaceuticals, Inc. The ANADA 
provides for the veterinary prescription use of phenylbutazone powder 
administered to horses in feed for the relief of inflammatory 
conditions associated with the musculoskeletal system.

DATES: This rule is effective January 6, 2006.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail: 
john.harshman@fda.gov.

SUPPLEMENTARY INFORMATION: A & G Pharmaceuticals, Inc., 1030 West 
Commodore Blvd., Jackson, NJ 08527, filed ANADA 200-334 that provides 
for the veterinary prescription use of EQUIZONE 100 (phenylbutazone), a 
powder administered to horses in feed for the relief of inflammatory 
conditions associated with the musculoskeletal system. A & G 
Pharmaceuticals, Inc.'s, EQUIZONE 100 is approved as a generic copy of 
Phoenix Scientific, Inc.'s, Phenylbutazone Tablets, USP, approved under 
NADA 91-818. The ANADA is approved as of November 18, 2005, and the 
regulations are amended in 21 CFR part 520 by adding new Sec.  
520.1720e. The basis of approval is discussed in the freedom of 
information summary.
    In addition, A & G Pharmaceuticals, Inc., has not been previously 
listed in the animal drug regulations as a sponsor of an approved 
application. At this time, 21 CFR 510.600(c) is being amended to add 
entries for the firm.
    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.
    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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

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 parts 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding a new entry for ``A & G Pharmaceuticals, Inc.'' 
and in the table in paragraph (c)(2) by numerically adding a new entry 
for ``057699'' to read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
A & G Pharmaceuticals, Inc., 1030 West        057699
 Commodore Blvd., Jackson, NJ 08527.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *

[[Page 876]]

 
057699                       A & G Pharmaceuticals, Inc., 1030 West
                              Commodore Blvd., Jackson, NJ 08527
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
4. Section 520.1720e is added to read as follows:


Sec.  520.1720e  Phenylbutazone powder.

    (a) Specifications. Each 10 grams (g) of powder contains 1 g 
phenylbutazone.
    (b) Sponsor. See No. 057699 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 1 to 2 g (1 
to 2 level scoops, using the scoop provided) per 500 pounds of body 
weight on a small amount of palatable feed.
    (2) Indications for use. For the relief of inflammatory conditions 
associated with the musculoskeletal system.
    (3) Limitations. Do not exceed 4 g per animal daily. Administer at 
a relatively high dosage level for the first 48 hours, then reduce 
gradually to a maintenance dosage level with the lowest dosage 
maintained at the level capable of producing the desired clinical 
response. Do not use in horses intended for human consumption. Federal 
law prohibits the extralabel use of this product in female cattle 20 
months of age or older. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: December 21, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06-90 Filed 1-5-06; 8:45 am]
BILLING CODE 4160-01-S
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