Implantation or Injectable Dosage Form New Animal Drugs; Tylosin, 11643-11644 [E9-6009]

Download as PDF Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Rules and Regulations 11643 Dated: March 11, 2009. Carol Waller Pope, Acting Chairman. [FR Doc. E9–5694 Filed 3–18–09; 8:45 am] comply with a requirement of FCIC. The term ‘‘requirement of this title’’ is confusing and provides no reference to a specific requirement. DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 6727–01–P List of Subjects in 7 CFR Parts 407 and 457 21 CFR Part 522 DEPARTMENT OF AGRICULTURE Federal Crop Insurance Corporation Administrative practice and procedures; Administrative remedies for non-compliance. Implantation or Injectable Dosage Form New Animal Drugs; Tylosin 7 CFR Parts 400, 407, 457 ■ RIN 0563–AB73 General Administrative Regulations; Administrative Remedies for NonCompliance; Correcting Amendments AGENCY: Federal Crop Insurance Corporation, USDA. ACTION: Final rule; correcting amendment. 2. In § 407.9 amend item 22 by revising paragraph (a)(1) to read as follows: ■ This document contains correcting amendments to the final regulations that were published December 18, 2008 (73 FR 76868– 76891). These regulations pertain to Administrative Remedies for NonCompliance and provide clarification of existing remedies. DATES: Effective Date: March 19, 2009. FOR FURTHER INFORMATION CONTACT: Cynthia Simpson, Director, Appeals, Litigation and Legal Liaison Staff, Risk Management Agency, United States Department of Agriculture, 1400 Independence Avenue, SW., Room 6603, Stop 0806, Washington, DC 20250, telephone (202) 720–0642. SUPPLEMENTARY INFORMATION: § 407.9 Group risk plan common policy. * * * * * 22. Remedial Sanctions * * * * * (a) * * * (1) The amount of the pecuniary gain obtained as a result of the false or inaccurate information provided or the noncompliance with a requirement of FCIC; or * * * * * PART 457—COMMON CROP INSURANCE REGULATIONS 3. In § 457.8 amend item 27 by revising paragraph (e)(1)(i) to read as follows: ■ Background The final regulation that is the subject of these correcting amendments was intended to add additional administrative remedies that are available as a result of the enactment of section 515(h) of the Federal Crop Insurance Act (Act) (7 U.S.C. 1515(h)), make such other changes as are necessary to implement the provisions of section 515(h) of the Act, and to clarify existing administrative remedies. Need for Corrections mstockstill on PROD1PC66 with RULES Authority: 7 U.S.C. 1506(l) and 1506(o). PART 407—GROUP RISK PLAN OF INSURANCE REGULATIONS SUMMARY: As published, the final regulation contained an error that may prove to be misleading and needs to be clarified. On page 73 FR 76891 in § 407.9 item 22(a)(1) and § 457.8 item 27(e)(1)(i) the term ‘‘requirement of this title’’ is incorrect and should read ‘‘requirement of FCIC.’’ Section 515(h) of the Act authorizes disqualification and the assessment of civil fine of persons who willfully and intentionally provide false or inaccurate information or fails to VerDate Nov<24>2008 Accordingly, the 7 CFR part 407 and 457 is amended as follows: ■ 1. The authority citation for 7 CFR part 407 and 457 is revised to read as follows: 18:17 Mar 18, 2009 Jkt 217001 § 457.8 The application and policy. * * * * * 27. Concealment, Misrepresentation or Fraud. * * * * * (e) * * * (1) * * * (i) The amount of the pecuniary gain obtained as a result of the false or inaccurate information provided or the noncompliance with a requirement of FCIC; or * * * * * Signed in Washington, DC, on March 11, 2009. William J. Murphy, Acting Manager, Federal Crop Insurance Corporation. [FR Doc. E9–5793 Filed 3–18–09; 8:45 am] BILLING CODE 3410–08–P PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 Food and Drug Administration [Docket No. FDA–2009–N–0665] 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 new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for changing scientific nomenclature for a bovine pathogen on labeling for tylosin injectable solution. DATES: This rule is effective March 19, 2009. FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276– 8341, e-mail: cindy.burnsteel@fda.hhs.gov. Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 12–965 for TYLAN (tylosin) Injection, an injectable solution used for the treatment of animal diseases associated with several bacterial pathogens. The supplemental NADA provides for changing a bovine pathogen name on product labeling. The supplemental NADA is approved as of February 24, 2009, and the regulations in 21 CFR 522.2640 and 522.2640a are amended to reflect the approval. 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. 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. SUPPLEMENTARY INFORMATION: E:\FR\FM\19MRR1.SGM 19MRR1 11644 Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Rules and Regulations List of Subjects in 21 CFR Part 522 Animal drugs. ■ 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 FOR FURTHER INFORMATION CONTACT: Kenneth P. Christman, (202) 435–5265 (not a toll-free number). SUPPLEMENTARY INFORMATION: 1. The authority citation for 21 CFR part 522 continues to read as follows: ■ Background Authority: 21 U.S.C. 360b. § 522.2640 ■ The final and temporary regulations that are the subject of this document are under sections 367 and 482 of the Internal Revenue Code. [Removed] 2. Remove § 522.2640. § 522.2640a [Redesignated as § 522.2640] 3. Redesignate § 522.2640a as § 522.2640. ■ § 522.2640 address issues that have arisen in administering the current regulations. The temporary regulations affect domestic and foreign entities that enter into cost sharing arrangements described in the temporary regulations. DATES: This correction is effective March 19, 2009, and is applicable on January 5, 2009. [Amended] 4. In the newly redesignated § 522.2640, remove ‘‘injection’’ from the section heading; remove and reserve paragraph (c); and in paragraph (e)(1)(ii), remove ‘‘Corynebacterium pyogenes’’ both times it appears and in its place add ‘‘Arcanobacterium pyogenes’’. ■ Dated: March 13, 2009. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E9–6009 Filed 3–18–09; 8:45 am] BILLING CODE 4160–01–S Need for Correction As published, final and temporary regulations (TD 9441) contains an error that may prove to be misleading and is in need of clarification. List of Subjects in 26 CFR Part 1 Income taxes, Reporting and recordkeeping requirements. Correction of Publication Accordingly, 26 CFR part 1 is corrected by making the following correcting amendment: ■ PART 1—INCOME TAXES ■ Paragraph 1. The authority citation for part 1 continues to read in part as follows: Authority: 26 U.S.C. 7805 * * * ■ Par. 2. Section 1.482–0T is amended by removing and reserving the entry of § 1.482–7T(h)(3)(vi)(B) and revising the entry of § 1.482–7T(i)(6)(vi)(B) to read as follows: DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9441] § 1.482–0T Outline of regulations under section 482 (temporary). RIN 1545–BI46 * Section 482: Methods To Determine Taxable Income in Connection With a Cost Sharing Arrangement; Correction mstockstill on PROD1PC66 with RULES AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Correcting amendment. SUMMARY: This document contains a correction to a correcting amendment for final and temporary regulations (TD 9441) that were published in the Federal Register on Thursday, March 5, 2009 (74 FR 9570) providing further guidance and clarification regarding methods under section 482 to determine taxable income in connection with a cost sharing arrangement in order to VerDate Nov<24>2008 18:17 Mar 18, 2009 Jkt 217001 * * * * DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Parts 1 and 54 [TD 9447] RIN 1545–BG80 Automatic Contribution Arrangements; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Correction to final regulations. SUMMARY: This document contains a correction to final regulations (TD 9447) that were published in the Federal Register on Tuesday, February 24, 2009 (74 FR 8200) relating to automatic contribution arrangements. These regulations affect administrators of, employers maintaining, participants in, and beneficiaries of section 401(k) plans and other eligible plans that include an automatic contribution arrangement. DATES: This correction is effective on March 19, 2009, and is applicable on February 24, 2009. FOR FURTHER INFORMATION CONTACT: R. Lisa Mojiri-Azad, Dana Barry, or William D. Gibbs at (202) 622–3860 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background The final regulations that are the subject of this document are under sections 401, 402, 411, 414, and 4979 of the Internal Revenue Code. Need for Correction As published, final regulations (TD 9447) contains an error that may prove to be misleading and is in need of clarification. Correction of Publication * * * * (i) * * * (6) * * * (vi) * * * (B) Circumstances in which Periodic Trigger deemed not to occur. * * * * * Accordingly, the publication of the final regulations (TD 9447), which was the subject of FR Doc. E9–3716, is corrected as follows: On page 8206, column 1, in the preamble, under the paragraph heading ‘‘D. Permissible Withdrawal’’, fourth paragraph of the column, last line of the paragraph, the language ‘‘section 3405(a).’’ is corrected to read ‘‘section 3405(b).’’. LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. E9–5950 Filed 3–18–09; 8:45 am] LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. E9–5952 Filed 3–18–09; 8:45 am] BILLING CODE 4830–01–P BILLING CODE 4830–01–P § 1.482–7T Methods to determine taxable income in connection with a cost sharing arrangement (temporary). * PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\19MRR1.SGM 19MRR1

Agencies

[Federal Register Volume 74, Number 52 (Thursday, March 19, 2009)]
[Rules and Regulations]
[Pages 11643-11644]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-6009]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2009-N-0665]


Implantation or Injectable Dosage Form New Animal Drugs; Tylosin

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 new animal drug 
application (NADA) filed by Elanco Animal Health. The supplemental NADA 
provides for changing scientific nomenclature for a bovine pathogen on 
labeling for tylosin injectable solution.

DATES: This rule is effective March 19, 2009.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 12-965 for TYLAN (tylosin) Injection, an injectable 
solution used for the treatment of animal diseases associated with 
several bacterial pathogens. The supplemental NADA provides for 
changing a bovine pathogen name on product labeling. The supplemental 
NADA is approved as of February 24, 2009, and the regulations in 21 CFR 
522.2640 and 522.2640a are amended to reflect the approval.
    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.
    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.

[[Page 11644]]

List of Subjects 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.


Sec.  522.2640  [Removed]

0
2. Remove Sec.  522.2640.


Sec.  522.2640a  [Redesignated as Sec.  522.2640]

0
3. Redesignate Sec.  522.2640a as Sec.  522.2640.


Sec.  522.2640  [Amended]

0
4. In the newly redesignated Sec.  522.2640, remove ``injection'' from 
the section heading; remove and reserve paragraph (c); and in paragraph 
(e)(1)(ii), remove ``Corynebacterium pyogenes'' both times it appears 
and in its place add ``Arcanobacterium pyogenes''.

    Dated: March 13, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-6009 Filed 3-18-09; 8:45 am]
BILLING CODE 4160-01-S
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