This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

53685 

Vol. 73, No. 181 

Wednesday, September 17, 2008 

FEDERAL RESERVE SYSTEM 

12 CFR Part 202 

[Regulation B; Docket No. R–1327] 

Equal Credit Opportunity 

AGENCY: Board of Governors of the 

Federal Reserve System. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Board is publishing 

amendments to Regulation B (Equal 

Credit Opportunity Act) to update the 

address where questions should be 

directed concerning creditors for which 

the Office of Thrift Supervision 

administers compliance with the 

regulation. 

DATES: Effective Date: October 17, 2008. 

Compliance is optional until September 

17, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Jamie Z. Goodson, Attorney, Division of 

Consumer and Community Affairs, 

Board of Governors of the Federal 

Reserve System, at (202) 452–3667. For 

the users of Telecommunications Device 

for the Deaf (‘‘TDD’’) only, contact (202) 

263–4869. 

SUPPLEMENTARY INFORMATION: The Equal 

Credit Opportunity Act (ECOA), 15 

U.S.C. 1691–1691f, makes it unlawful 

for a creditor to discriminate against an 

applicant in any aspect of a credit 

transaction on the basis of the 

applicant’s national origin, marital 

status, religion, sex, color, race, age 

(provided the applicant has the capacity 

to contract), receipt of public assistance 

benefits, or the good faith exercise of a 

right under the Consumer Credit 

Protection Act, 15 U.S.C. 1601 et seq. 

The ECOA is implemented by the 

Board’s Regulation B. 

In addition to the general prohibition 

against discrimination, Regulation B 

contains specific rules concerning the 

taking and evaluation of credit 

applications, including procedures and 

notices for credit denials and other 

adverse actions. Under section 202.9 of 

Regulation B, notification given to an 

applicant when adverse action is taken 

must contain the name and address of 

the federal agency that administers 

compliance with respect to the creditor. 

Appendix A of Regulation B contains 

the names and addresses of the 

enforcement agencies where questions 

concerning a particular creditor shall be 

directed. This amendment updates the 

address for the Office of Thrift 

Supervision. Creditors for which the 

Office of Thrift Supervision administers 

compliance with Regulation B must 

include this new address on their 

adverse action notices starting 

September 17, 2009. 

List of Subjects in 12 CFR Part 202 

Aged, Banks, Banking, Civil rights, 

Consumer protections, Credit, 

Discrimination, Federal Reserve System, 

Marital status discrimination, Penalties, 

Religious discrimination, Sex 

discrimination. 

Authority and Issuance 

■ For the reasons set forth in the 

preamble, the Board amends 12 CFR 

part 202 to read as follows: 

PART 202—EQUAL CREDIT 

OPPORTUNITY ACT (REGULATION B) 

■ 1. The authority citation for part 202 

continues to read as follows: 

Authority: Section 15 U.S.C. 1691–1691f. 

■ 2. Appendix A is amended by 

removing the fifth and sixth paragraphs 

and adding a new paragraph in their 

place to read as follows: 

APPENDIX A TO PART 202—FEDERAL 

ENFORCEMENT AGENCIES 

* * * * * 

Savings institutions under the Savings 

Association Insurance Fund of the FDIC and 

federally chartered savings banks insured 

under the Bank Insurance Fund of the FDIC 

(but not including state-chartered savings 

banks insured under the Bank Insurance 

Fund): Office of Thrift Supervision, 

Consumer Response Unit, 1700 G Street, 

NW., Washington, DC 20552. 

* * * * * 

By order of the Board of Governors of the 

Federal Reserve System, acting through the 

Secretary of the Board under delegated 

authority, September 11, 2008. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. E8–21629 Filed 9–16–08; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2008–N–0039] 

Oral Dosage Form New Animal Drugs; 

Sulfadiazine/Pyrimethamine 

Suspension 

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 

Animal Health Pharmaceuticals, LLC. 

The supplemental NADA provides for a 

revised human food safety warning on 

labeling for an oral suspension of 

sulfadiazine and pyrimethamine used 

for the treatment of equine protozoal 

myeloencephalitis (EPM). 

DATES: This rule is effective September 

17, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Animal 

Health Pharmaceuticals, LLC, 1805 Oak 

Ridge Circle, suite 101, St. Joseph, MO 

64506, filed a supplement to NADA 

141–240 for use of REBALANCE 

(sulfadiazine/pyrimethamine) 

Antiprotozoal Oral Suspension for the 

treatment of EPM caused by Sarcocystis 

neurona. The supplement provides for a 

revised human food safety warning on 

labeling. The supplemental NADA is 

approved as of August 27, 2008, and 21 

CFR 520.2215 is amended to reflect the 

approval. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

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53686 Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 

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. 

List of Subjects in 21 CFR Part 520 

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 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

■ 2. In 520.2215, revise paragraph (c)(3) 

to read as follows: 

§ 520.2215 Sulfadiazine/pyrimethamine 

suspension. 

* * * * * 

(c) * * * 

(3) Limitations. Do not use in horses 

intended for human consumption. 

Federal law restricts this drug to use by 

or on the order of a licensed 

veterinarian. 

Dated: September 5, 2008. 

William T. Flynn, 

Acting Director, Center for Veterinary 

Medicine. 

[FR Doc. E8–21625 Filed 9–16–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 803 

[Docket No. FDA–2008–N–0310] 

Medical Devices; Medical Device 

Reporting; Baseline Reports; 

Confirmation of Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule; confirmation of 

effective date. 

SUMMARY: The Food and Drug 

Administration (FDA) is confirming the 

effective date of October 27, 2008, for 

the final rule that appeared in the 

Federal Register of June 13, 2008 (73 FR 

33692). The direct final rule amends the 

Medical Device Reporting regulation by 

removing the requirement for baseline 

reports. This document confirms the 

effective date of the direct final rule. 

DATES: Effective date confirmed: 

October 27, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Howard A. Press, Center for Devices and 

Radiological Health (HFZ–531), Food 

and Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20850, 240–276– 

3457. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 13, 2008 (73 FR 

33692), FDA solicited comments 

concerning the direct final rule for a 75- 

day period ending August 27, 2008. 

FDA stated that the effective date of the 

direct final rule would be on October 

27, 2008, 60 days after the end of the 

comment period, unless any significant 

adverse comment was submitted to FDA 

during the comment period. FDA did 

not receive any significant adverse 

comments. 

Authority: Therefore, under the Federal 

Food, Drug, and Cosmetic Act and the Public 

Health Service Act, and under authority 

delegated to the Commissioner of Food and 

Drugs, the amendments issued thereby 

become effective on October 27, 2008. 

Dated: September 11, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21756 Filed 9–16–08; 8:45 am] 

BILLING CODE 4160–01–S 

MILLENNIUM CHALLENGE 

CORPORATION 

22 CFR Part 1304 

Regulations Implementing the 

Freedom of Information Act 

AGENCY: Millennium Challenge 

Corporation. 

ACTION: Final rule. 

SUMMARY: The Millennium Challenge 

Corporation is issuing a final rule to 

update its Freedom of Information Act 

regulations. The purpose of this final 

rule is to outline the procedures by 

which the Millennium Challenge 

Corporation proposes to implement the 

relevant provisions of the Freedom of 

Information Act as required under that 

statute. This document will assist 

interested parties in obtaining access to 

Millennium Challenge Corporation 

public records. 

DATES: This final rule is effective on 

September 17, 2008. 

ADDRESSES: Send comments to John 

Mantini, FOIA Officer, Office of the 

General Counsel, Millennium Challenge 

Corporation, 875 Fifteenth Street, NW., 

Washington, DC 20005–2221. 

FOR FURTHER INFORMATION CONTACT: John 

Mantini, FOIA Officer, 202–521–3863. 

SUPPLEMENTARY INFORMATION: The 

Millennium Challenge Act (MCA) of 

2003 established a new federal agency 

called the Millennium Challenge 

Corporation. Congress enacted the 

Freedom of Information Act (FOIA) in 

1966 and last modified it with the 

Electronic Freedom of Information Act 

amendments of 1996. On August 28, 

2007, the Millennium Challenge 

Corporation published a proposed rule 

in the Federal Register, 72 FR 49238, 

Aug. 28, 2007 to outline its procedures 

to implement the FOIA regulations and 

requested public comments. The 

Millennium Challenge Corporation 

received no comments during the 60- 

day comment period. The Millennium 

Challenge Corporation’s final 

regulations are identical to those in the 

proposed rule. 

This final rule addresses 

electronically available documents, 

procedures for making requests, agency 

handling of requests, records not 

disclosed, changes in fees, and public 

reading rooms as well as other related 

provisions. 

List of Subjects in 22 Part 1304 

Freedom of Information Act 

Procedures. 

■ For the reasons set forth in the 

preamble, the Millennium Challenge 

Corporation adds 22 CFR part 1304 as 

follows: 

PART 1304—FREEDOM OF 

INFORMATION ACT PROCEDURES 

Sec. 

1304.1 General Provisions. 

1304.2 Definitions. 

1304.3 Records available to the public. 

1304.4 Requests for records. 

1304.5 Responsibility for responding to 

requests. 

1304.6 Records not disclosed. 

1304.7 Confidential commercial 

information. 

1304.8 Appeals. 

1304.9 Fees. 

Authority: 5 U.S.C. 552, as amended. 

§ 1304.1 General Provisions. 

This part contains the regulations the 

Millennium Challenge Corporation 

(MCC) follows in implementing the 

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