Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Rules and Regulations 54019 

■ 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 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 2. In § 522.956, revise paragraph (d)(2) 

to read as follows: 

§ 522.956 Florfenicol and flunixin. 

* * * * * 

(d) * * * 

(2) Indications for use. For treatment 

of bovine respiratory disease (BRD) 

associated with Mannheimia 

haemolytica, Pasteurella multocida, 

Histophilus somni, and Mycoplasma 

bovis, and control of BRD-associated 

pyrexia in beef and non-lactating dairy 

cattle. 

* * * * * 

Dated: August 31, 2010. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–22039 Filed 9–2–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2010–N–0002] 

New Animal Drugs for Use in Animal 

Feed; Ractopamine 

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 two supplemental new 

animal drug applications (NADAs) filed 

by Elanco Animal Health, A Division of 

Eli Lilly & Co. The supplemental 

NADAs provide for administering a 

Type C medicated feed containing 

ractopamine hydrochloride as a top 

dress on Type C medicated feeds 

containing monensin, USP, or 

monensin, USP, and tylosin phosphate 

to cattle fed in confinement for 

slaughter. 

DATES: This rule is effective September 

3, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Suzanne J. Sechen, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8105, email: suzanne.sechen@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 141–225 that 

provides for use of OPTAFLEXX 

(ractopamine hydrochloride) and 

RUMENSIN (monensin, USP) Type A 

medicated articles to formulate two-way 

combination drug Type C medicated 

feeds for cattle fed in confinement for 

slaughter. Elanco Animal Health also 

filed a supplement to NADA 141–224 

that provides for use of OPTAFLEXX 

(ractopamine hydrochloride), 

RUMENSIN (monensin, USP), and 

TYLAN (tylosin phosphate) Type A 

medicated articles to formulate threeway combination drug Type C 

medicated feeds for cattle fed in 

confinement for slaughter. 

The supplemental NADAs provide for 

administering ractopamine 

hydrochloride Type C medicated feeds 

as a top dress on Type C medicated 

feeds containing monensin, USP, or 

monensin, USP, and tylosin phosphate 

to cattle fed in confinement for 

slaughter as the means by which the 

two-way or three-way combinations will 

be created. Supplemental NADA 141– 

224 is approved as of June 7, 2010; 

supplemental NADA 141–225 is 

approved as of June 17, 2010; and the 

regulations in 21 CFR 558.500 are 

amended to reflect the approvals. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summaries of safety and effectiveness 

data and information submitted to 

support approval of these applications 

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 that these actions are of a 

type that do 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 558 

Animal drugs, Animal feeds. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under the 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 558 is amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

■ 2. In § 558.500, add paragraphs 

(e)(2)(xii) and (e)(2)(xiii) to read as 

follows: 

§ 558.500 Ractopamine. 

* * * * * 

(e) * * * 

(2) * * * 

Ractopamine in 

grams/ton 

Combination in 

grams/ton Indications for use Limitations Sponsor 

*******

(xii) Not to exceed 800; to 

provide 70 to 400 mg/ 

head/day.

Monensin 10 to 40 to 

provide 0.14 to 0.42 

mg monensin/lb of 

body weight, depending on severity of 

coccidiosis challenge, 

up to 480 mg/head/ 

day. 

Cattle fed in confinement for 

slaughter: As in paragraph 

(e)(2)(i) of this section; for prevention and control of coccidiosis 

due to Eimeria bovis and E. 

zuernii. 

Top dress ractopamine in a minimum of 1.0 lb of medicated feed 

during the last 28 to 42 days on 

feed. Not for animals intended for 

breeding. See § 558.355(d). 

000986 


erowe on DSK5CLS3C1PROD with RULES
54020 Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Rules and Regulations 

1On November 13, 2009, HUD released an 

independent actuarial study that reported that FHA 

will likely sustain significant losses from mortgage 

loans made prior to 2009, due to the high 

concentration of seller-financed downpayment 

assistance mortgage loans and declining real estate 

values nationwide, and that the MMIF capital 

reserve relative to the amount of outstanding 

insurance in force had fallen below the statutorily 

mandated 2 percent ratio. The capital reserve 

account serves as a back-up fund, where FHA holds 

additional capital to cover unexpected losses. The 

capital ratio generally reflects the reserves available 

(net of expected claims and expenses), as a 

percentage of the current portfolio, to address 

unexpected losses. The report can be found at: 

http://www.hud.gov/offices/hsg/ 

fhafy09annualmanagementreport.pdf. 

2While the Federal Credit Reform Act of 1990 

requires that FHA (and all other government credit 

agencies) estimate and budget for the anticipated 

cost of mortgage loan guarantees, the National 

Ractopamine in 

grams/ton 

Combination in 

grams/ton Indications for use Limitations Sponsor 

(xiii) Not to exceed 800; to 

provide 70 to 400 mg/ 

head/day.

Monensin 10 to 40 to 

provide 0.14 to 0.42 

mg monensin/lb of 

body weight, depending on severity of 

coccidiosis challenge, 

up to 480 mg/head/ 

day, plus tylosin 8 to 

10. 

Cattle fed in confinement for 

slaughter: As in paragraph 

(e)(2)(i) of this section; for prevention and control of coccidiosis 

due to Eimeria bovis and E. 

zuernii; and for reduction of incidence of liver abscesses caused 

by Fusobacterium necrophorum 

and Arcanobacterium 

(Actinomyces) pyogenes. 

Top dress ractopamine in a minimum of 1.0 lb of medicated feed 

during the last 28 to 42 days on 

feed. Not for animals intended for 

breeding. See §§ 558.355(d) and 

558.625(c). 

000986 

* * * * * 

Dated: August 31, 2010. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–22071 Filed 9–2–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Ch. II 

[Docket No. FR–5404–N–02] 

Federal Housing Administration Risk 

Management Initiatives: New Loan-toValue and Credit Score Requirements 

AGENCY: Office of the Assistant 

Secretary for Housing—Federal Housing 

Commissioner, HUD. 

ACTION: Final rule. 

SUMMARY: On July 15, 2010, HUD issued 

a notice seeking comment on three 

initiatives that HUD proposed would 

contribute to the restoration of the 

Mutual Mortgage Insurance Fund 

(MMIF) capital reserve account. This 

document is limited to implementation 

of HUD’s proposal to introduce a 

minimum credit score threshold and 

reduce the maximum LTV. At the end 

of the public comment period on August 

16, 2010, HUD received 902 comments. 

The overwhelming majority of these 

comments focused on HUD’s proposal 

to cap seller concessions. HUD is 

continuing to review and consider the 

issues raised by commenters on capping 

seller concessions as well as those 

pertaining to HUD’s proposal to tighten 

manual underwriting guidelines. HUD’s 

final decision on these two proposals 

will be addressed separately. 

DATES: Effective Date: October 4, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Karin Hill, Director, Office of Single 

Family Program Development, Office of 

Housing, Department of Housing and 

Urban Development, 451 7th Street, 

SW., Room 9278, Washington, DC 

20410; telephone number 202–708–2121 

(this is not a toll-free number). Persons 

with hearing or speech impairments 

may access this number through TTY by 

calling the toll-free Federal Information 

Relay Service at 800–877–8339. 

SUPPLEMENTARY INFORMATION: 

I. Background—HUD’s July 15, 2010 

Notice 

On July 15, 2010, at 75 FR 41217, 

HUD issued a proposed rule seeking 

comment on three initiatives that HUD 

proposed would contribute to the 

restoration of the Mutual Mortgage 

Insurance Fund (MMIF) capital reserve 

account. The proposed changes were 

developed to preserve both the 

historical role of the Federal Housing 

Administration (FHA) in providing a 

home financing vehicle during periods 

of economic volatility and HUD’s social 

mission of helping underserved 

borrowers. In the July 15, 2010, notice, 

HUD proposed the following: To reduce 

the amount of closing costs a seller may 

pay on behalf of a homebuyer 

purchasing a home with FHA-insured 

mortgage financing for the purposes of 

calculating the maximum mortgage 

amount; to introduce a credit score 

threshold as well as reduce the 

maximum loan-to-value (LTV) for 

borrowers with lower credit scores who 

represent a higher risk of default and 

mortgage insurance claim; and to 

tighten underwriting standards for 

mortgage loan transactions that are 

manually underwritten. 

A recently issued independent 

actuarial study shows that the MMIF 

capital ratio has fallen below its 

statutorily mandated threshold.1

Consistent with HUD’s responsibility 

under the National Housing Act to 

ensure that the MMIF remains 

financially sound, HUD published the 

July 15, 2010 document and sought 

public comment on the three proposals 

described above designed to address 

features of FHA mortgage insurance that 

have resulted in high mortgage 

insurance claim rates and present an 

unacceptable risk of loss to FHA. 

Over the past two years, the volume 

of FHA insurance has increased rapidly 

as private sources of mortgage finance 

retreated from the market. FHA’s share 

of the single-family mortgage market 

today is approximately 30 percent—up 

from 3 percent in 2007, and the dollar 

volume of insurance written has jumped 

from the $56 billion issued in that year 

to more than $300 billion in 2009. The 

growth in the MMIF portfolio over such 

a short period of time coincided with 

worsening economic conditions that 

have seen high levels of defaults and 

foreclosures, and consequently 

unacceptable risks of loss to the MMIF. 

Given these conditions and concerns, 

FHA, in managing the MMIF, must be 

especially vigilant in monitoring the 

performance of the portfolio, enhancing 

risk controls, and tightening standards 

to address portions of the business that 

expose homeowners to excessive 

financial risks. FHA’s authorizing 

statute, the National Housing Act (12 

U.S.C. 1701 et seq.), envisions that FHA 

will adjust program standards and 

practices, as necessary, to operate the 

MMIF, with reasonable expectations of 

financial loss. Within the past year, 

FHA has adjusted several program 

standards and practices so that the 

MMIF is preserved and FHA is 

operating the MMIF with acceptable 

risks of financial loss, not unacceptable 

risks.2


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