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] 

BILLING CODE 6727–01–P 

DEPARTMENT OF AGRICULTURE 

Federal Crop Insurance Corporation 

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. 

SUMMARY: 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: 

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 

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 

comply with a requirement of FCIC. The 

term ‘‘requirement of this title’’ is 

confusing and provides no reference to 

a specific requirement. 

List of Subjects in 7 CFR Parts 407 and 

457 

Administrative practice and 

procedures; Administrative remedies for 

non-compliance. 

■ 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: 

Authority: 7 U.S.C. 1506(l) and 1506(o). 

PART 407—GROUP RISK PLAN OF 

INSURANCE REGULATIONS 

■ 2. In § 407.9 amend item 22 by 

revising paragraph (a)(1) to read as 

follows: 

§ 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: 

§ 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 

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. 

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