Implantation or Injectable Dosage Form New Animal Drugs; Flunixin, 48868 [05-16499]

Download as PDF 48868 Federal Register / Vol. 70, No. 161 / Monday, August 22, 2005 / Rules and Regulations pounds deducted from the possession limit for the additional trip. The Regional Administrator will issue this authorization automatically, without request from the vessel owner. A rebated possession limit may be combined with other additional trips as described in paragraph (c)(5)(ii) of this section. * * * * * [FR Doc. 05–16613 Filed 8–19–05; 8:45 am] BILLING CODE 3510–22–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Flunixin 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 a supplemental abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The supplemental ANADA provides for veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of fever associated with bovine respiratory disease and endotoxemia, and for control of inflammation in endotoxemia. DATES: This rule is effective August 22, 2005. 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: Phoenix Scientific, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed a supplemental ANADA 200 124 that provides for veterinary prescription use of Flunixin Meglumine Injection intravenously in lactating dairy cattle for control of fever associated with bovine respiratory disease and endotoxemia, and for control of inflammation in endotoxemia. The supplemental ANADA is approved as of July 18, 2005, and the regulations are amended in 21 CFR 522.970 to reflect the approval. The basis of approval is discussed in the freedom of information summary. FOR FURTHER INFORMATION CONTACT: VerDate jul<14>2003 16:02 Aug 19, 2005 Jkt 205001 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. DEPARTMENT OF THE TREASURY § 522.970 Roth IRAs and Conversions Internal Revenue Service 26 CFR Part 1 [TD 9220] RIN 1545–BE66 Converting an IRA Annuity to a Roth IRA Internal Revenue Service (IRS), Treasury. ACTION: Temporary Regulations. AGENCY: SUMMARY: This document contains temporary regulations under section 408A of the Internal Revenue Code (Code). These temporary regulations provide guidance concerning the tax consequences of converting a non-Roth IRA annuity to a Roth IRA. These temporary regulations affect individuals establishing Roth IRAs, beneficiaries under Roth IRAs, and trustees, custodians and issuers of Roth IRAs. The text of these temporary regulations List of Subject in 21 CFR Part 522 also serves as the text of proposed Animal drugs. regulations set forth in a notice of I Therefore, under the Federal Food, proposed rulemaking in the Proposed Drug, and Cosmetic Act and under Rules section of this issue of the Federal authority delegated to the Commissioner Register. of Food and Drugs and redelegated to the DATES: Effective Date: These regulations Center for Veterinary Medicine, 21 CFR are effective August 19, 2005. part 522 is amended as follows: Applicability Date: These regulations are applicable to any Roth IRA PART 522—IMPLANTATION OR conversion where an annuity contract is INJECTABLE DOSAGE FORM NEW distributed or treated as distributed ANIMAL DRUGS from a traditional IRA on or after August 19, 2005. I 1. The authority citation for 21 CFR part 522 continues to read as follows: FOR FURTHER INFORMATION CONTACT: Concerning the regulations, Cathy A. Authority: 21 U.S.C. 360b. Vohs, 202–622–6060. I 2. Section 522.970 is amended by SUPPLEMENTARY INFORMATION: revising paragraph (e)(2)(iii) to read as follows: Background Flunixin. * * * * * (e) * * * (2) * * * (iii) Limitations. Do not slaughter for food use within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. For Nos. 000061 and 059130: Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. For Nos. 055529 and 057561: Not for use in lactating or dry dairy cows. Dated: August 10, 2005. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 05–16499 Filed 8–19–05; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 This document contains temporary regulations that amend the Income Tax Regulations (26 CFR part 1) under section 408A of Code relating to Roth IRAs. Section 408A of the Code, which was added by section 302 of the Taxpayer Relief Act of 1997, Public Law 105–34 (111 Stat. 788), establishes the Roth IRA as a type of individual retirement plan, effective for taxable years beginning on or after January 1, 1998. Under Code section 408A, a Roth IRA is treated like a traditional IRA with several significant exceptions. Like amounts held in traditional IRAs, amounts held in Roth IRAs generally are exempt from Federal income tax under Code section 408(e)(1). Likewise, contributions to traditional IRAs and E:\FR\FM\22AUR1.SGM 22AUR1

Agencies

[Federal Register Volume 70, Number 161 (Monday, August 22, 2005)]
[Rules and Regulations]
[Page 48868]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16499]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; Flunixin

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 a supplemental abbreviated new 
animal drug application (ANADA) filed by Phoenix Scientific, Inc. The 
supplemental ANADA provides for veterinary prescription use of flunixin 
meglumine solution by intravenous injection in lactating dairy cattle 
for control of fever associated with bovine respiratory disease and 
endotoxemia, and for control of inflammation in endotoxemia.

DATES: This rule is effective August 22, 2005.

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: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed a supplemental ANADA 200 124 
that provides for veterinary prescription use of Flunixin Meglumine 
Injection intravenously in lactating dairy cattle for control of fever 
associated with bovine respiratory disease and endotoxemia, and for 
control of inflammation in endotoxemia. The supplemental ANADA is 
approved as of July 18, 2005, and the regulations are amended in 21 CFR 
522.970 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 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 Subject in 21 CFR Part 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. Section 522.970 is amended by revising paragraph (e)(2)(iii) to read 
as follows:


Sec.  522.970  Flunixin.

* * * * *
    (e) * * *
    (2) * * *
    (iii) Limitations. Do not slaughter for food use within 4 days of 
last treatment. A withdrawal period has not been established for use in 
preruminating calves. Do not use in calves to be processed for veal. 
For Nos. 000061 and 059130: Do not use in dry dairy cows. Milk that has 
been taken during treatment and for 36 hours after the last treatment 
must not be used for food. For Nos. 055529 and 057561: Not for use in 
lactating or dry dairy cows.

    Dated: August 10, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-16499 Filed 8-19-05; 8:45 am]
BILLING CODE 4160-01-S

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