Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Rules and Regulations 68783

Issued in Kansas City, MO, on November 

8, 2004. 

Anthony D. Roetzel, 

Acting Area Director, Western Flight Services 

Operations.

[FR Doc. 04–26100 Filed 11–24–04; 8:45 am] 

BILLING CODE 4910–13–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration 

14 CFR Part 71

[Docket No. FAA–2004–18825; Airspace 

Docket No. 04–ACE–51] 

Modification of Class E Airspace; 

Harrisonville, MO

AGENCY: Federal Aviation 

Administration (FAA), DOT.

ACTION: Direct final rule; confirmation of 

effective date. 

SUMMARY: This document confirms the 

effective date of the direct final rule 

which revises Class E airspace at 

Harrisonville, MO.

EFFECTIVE DATE: 0901 UTC, January 20, 

2005.

FOR FURTHER INFORMATION CONTACT:

Brenda Mumper, Air Traffic Division, 

Airspace Branch, ACE–520A, DOT 

Regional Headquarters Building, Federal 

Aviation Administration, 901 Locust, 

Kansas City, MO 64106; telephone: 

(816) 329–2524.

SUPPLEMENTARY INFORMATION: The FAA 

published this direct final rule with a 

request for comments in the Federal 

Register on October 8, 2004 (69 FR 

60285). The FAA uses the direct final 

rulemaking procedure for a noncontroversial rule where the FAA 

believes that there will be no adverse 

public comment. This direct final rule 

advised the public that no adverse 

comments were anticipated, and that 

unless a written adverse comment, or a 

written notice of intent to submit such 

an adverse comment, were received 

within the comment period, the 

regulation would become effective on 

January 20, 2005. No adverse comments 

were received, and thus this notice 

confirms that this direct final rule will 

become effective on that date.

Issued in Kansas City, MO on November 8, 

2004. 

Anthony D. Roetzel, 

Acting Area Director, Western Flight Services 

Operations.

[FR Doc. 04–26099 Filed 11–24–04; 8:45 am] 

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558

New Animal Drugs; Monensin

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 use of 

monensin Type A medicated articles to 

formulate Type B and Type C medicated 

feeds used for increased milk 

production efficiency in dairy cows.

DATES: This rule is effective November 

26, 2004.

FOR FURTHER INFORMATION CONTACT: Eric 

S. Dubbin, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855; 301–827–0232; email: edubbin@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: Elanco 

Animal Health, A Division of Eli Lilly 

& Co., Lilly Corporate Center, 

Indianapolis, IN 46285, filed a 

supplement to NADA 95 735 that 

provides for the use of RUMENSIN 80 

(monensin sodium) Type A medicated 

article to formulate Type B and Type C 

medicated feeds used for increased milk 

production efficiency (production of 

marketable solids-corrected milk per 

unit of feed intake) in dairy cows. The 

supplemental NADA is approved as of 

October 28, 2004, and the regulations in 

21 CFR 556.420 and 558.355 are 

amended 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. The agency has carefully considered 

the potential environmental impact of 

this action and has concluded that the 

action will not have a significant impact 

on the human environment and that an 

environmental impact statement is not 

required. FDA’s finding of no significant 

impact and the evidence supporting that 

finding, contained in an environmental 

assessment, may be seen in the Division 

of Dockets Management (see previous 

paragraph).

Under section 512(c)(2)(F)(iii) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(iii)), this 

supplemental approval qualifies for 3 

years of marketing exclusivity beginning 

October 28, 2004.

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 556

Animal drugs, Foods.

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 

parts 556 and 558 are amended as 

follows:

PART 556—TOLERANCES FOR 

RESIDUES OF NEW ANIMAL DRUGS 

IN FOOD

■ 1. The authority citation for 21 CFR 

part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

■ 2. Section 556.420 is amended by 

revising paragraph (b) and by adding 

paragraph (c) to read as follows:

§ 556.420 Monensin.

* * * * *

(b) Tolerances. The tolerances for 

residues of monensin are:

(1)Cattle—(i) Edible tissues. 0.05 part 

per million (ppm).

(ii) Milk. Not required.

(2)Goats—(i) Edible tissues. 0.05 ppm.

(ii) [Reserved]

(3) Chickens, turkeys, and quail. A 

tolerance for residues of monensin in 

chickens, turkeys, and quail is not 

required.

(c) Related conditions of use. See 

§§ 520.1448 and 558.355 of this chapter.

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS

■ 3. The authority citation for 21 CFR 

part 558 continues to read as follows:

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

■ 4. Section 558.355 is amended by 

revising paragraph (d)(7)(vi); and by 

adding paragraphs (d)(13) and (f)(3)(xiii) 

to read as follows:

68784 Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Rules and Regulations 

§ 558.355 Monensin.

* * * * *

(d) * * *

(7) * * *

(vi) A withdrawal time has not been 

established for preruminating calves. Do 

not use in calves to be processed for 

veal.

* * * * *

(13) The labeling of Type B and Type 

C (liquid and dry) medicated feeds 

intended for use in dairy cows shall 

bear the following caution statements: 

You may notice: Reduced voluntary 

feed intake in dairy cows fed monensin. 

This reduction increases with higher 

doses of monensin fed. Rule out 

monensin as the cause of reduced feed 

intake before attributing to other causes 

such as illness, feed management, or the 

environment. Reduced milk fat 

percentage in dairy cows fed monensin. 

This reduction increases with higher 

doses of monensin fed. Increased 

incidence of cystic ovaries and metritis 

in dairy cows fed monensin. Reduced 

conception rates, increased services per 

animal, and extended days open and 

corresponding calving intervals in dairy 

cows fed monensin.

* * * * *

(f) * * *

(3) * * *

(xiii) Amount per ton. Monensin, 11 

to 22 grams.

(A) Indications for use. For increased 

milk production efficiency (production 

of marketable solids-corrected milk per 

unit of feed intake) in dairy cows.

(B) Limitations. Feed continuously to 

dry and lactating dairy cows in a total 

mixed ration (‘‘complete feed’’). See 

paragraphs (d)(2), (d)(5), (d)(6), (d)(7)(i), 

(d)(7)(ii), (d)(7)(iii), (d)(7)(vi), (d)(8), and 

(d)(12) of this section.

* * * * *

Dated: November 10, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine.

[FR Doc. 04–26091 Filed 11–24–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Part 203

[Docket No. FR–4835–F–03] 

RIN 2502–AI00

FHA TOTAL Mortgage Scorecard

AGENCY: Office of the Assistant 

Secretary for Housing–Federal Housing 

Commissioner, HUD.

ACTION: Final rule.

SUMMARY: On November 21, 2003, HUD 

published an interim rule to codify the 

procedures that mortgagees and 

automated underwriting system vendors 

must follow if they opt to use the 

‘‘Technology Open to Approved 

Lenders’’ (TOTAL) Mortgage Scorecard 

offered by the Federal Housing 

Administration (FHA). The interim rule 

did not alter the underwriting 

requirements applicable to FHA 

mortgagees. Rather, the interim rule 

defined the acronym TOTAL and 

provided the requirements and 

procedures for use of the TOTAL 

Mortgage Scorecard. This final rule 

follows publication of the November 21, 

2003, interim rule. HUD did not receive 

any public comments on the interim 

rule. Accordingly, HUD is adopting the 

interim rule, as corrected by a technical 

correction published on January 2, 2004, 

without change.

DATES: Effective date: December 27, 

2004.

FOR FURTHER INFORMATION CONTACT:

Vance T. Morris, Director, Office of 

Single Family Program Development, 

Room 9278, Department of Housing and 

Urban Development, 451 Seventh Street, 

SW., Washington, DC 20410–8000; 

telephone (202) 708–2121. (This is not 

a toll-free number.) Hearing- or speechimpaired persons may access this 

number by calling the toll-free Federal 

Information Relay Service number at 1–

800–877–8339.

SUPPLEMENTARY INFORMATION: 

I. Background—HUD’s November 21, 

2003, Interim Rule 

On November 21, 2003 (68 FR 65824), 

HUD published an interim rule 

codifying the procedures that 

mortgagees and automated underwriting 

system vendors must follow if they opt 

to use the ‘‘Technology Open to 

Approved Lenders’’ (TOTAL) Mortgage 

Scorecard offered by the Federal 

Housing Administration (FHA). The 

TOTAL Mortgage Scorecard (or 

Scorecard) developed by HUD assesses 

the credit worthiness of FHA mortgagors 

by evaluating certain mortgage 

application and mortgagor credit 

information that has been statistically 

proven to accurately predict the 

likelihood of mortgagor default. The 

TOTAL Mortgage Scorecard is not an 

automated underwriting system (AUS); 

rather, it is a mathematical equation 

intended for use within an AUS. 

The November 21, 2003, interim rule 

followed a December 6, 2000 (65 FR 

76273) Federal Register notice 

announcing HUD’s intention to deploy 

the FHA TOTAL Mortgage Scorecard. 

The objectives for use of the TOTAL 

Mortgage Scorecard, which were first 

stated in the Notice are (1) to provide an 

improved credit evaluation system for 

FHA loans that has been statistically 

proven to accurately predict the 

likelihood of mortgagor default while 

providing a uniform system protective 

of borrowers; (2) to expand access to 

mortgage credit for low- and moderateincome mortgagors and discourage 

unlawful discrimination against 

mortgagors protected by the Fair 

Housing Act and the Equal Credit 

Opportunity Act; (3) to facilitate access 

to, and reduce the cost and time 

associated with, originating HUD/FHAinsured mortgages; and (4) to encourage 

a standardized, industry-wide capability 

for communication and exchange of 

information among members of the 

mortgage lending community. 

The December 6, 2000, Notice also 

advised that after deployment of the 

TOTAL Mortgage Scorecard, HUD 

would require use of the Scorecard in 

any AUS. The Notice also indicated that 

users of the TOTAL Mortgage Scorecard 

would receive documentation relief and 

credit policy waivers provided by HUD. 

Further, the Notice advised that HUD 

also had developed a Use Agreement 

that established the requirements and 

responsibilities for implementation and 

use of the TOTAL Mortgage Scorecard 

by qualified mortgagees and others that 

purchase, sell, underwrite, or document 

HUD mortgage loans for mortgagees 

under HUD’s Direct Endorsement 

program. 

While HUD could have continued, 

through individual approvals, to 

authorize organizations to use the 

TOTAL Mortgage Scorecard, HUD 

decided that a more efficient course of 

action would be to promulgate 

regulations for the use of the Scorecard 

consistent with the purpose and 

objectives described above instead of 

executing individual approvals that 

establish the requirements and 

responsibilities for use of the Scorecard. 

Accordingly, HUD issued the November 

21, 2003, interim rule.

The interim rule revised HUD’s 

regulation at 24 CFR 203.251 to define 

the acronym ‘‘TOTAL’’ and revised 

§ 203.255 to establish specific 

requirements that mortgagees and 

vendors must abide by when using the 

TOTAL Mortgage Scorecard. The 

interim rule described the Scorecard 

requirements in order to assist the 

mortgagee in expediting the 

endorsement process. While the 

Scorecard is a valuable tool, its value 

depends on approved lenders properly 

using the Scorecard in accordance with 

HUD requirements and procedures. The 

preamble to the November 21, 2003,