Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Rules and Regulations 57509 

does not make any changes to existing 

requirements, and thus, does not impose 

any new costs on facilities, the agency 

certifies that this final rule will not have 

a significant impact on a substantial 

number of small entities. Full analysis 

of the effect of the registration 

requirement on small entities is 

provided in the analysis of economic 

impacts set out in the preceding 

analysis of economic impacts and in the 

preamble to the interim final rule at 68 

FR 58894 at 58954. 

V. Unfunded Mandates 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4) requires that agencies 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before proposing 

‘‘any rule that includes any Federal 

mandate that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 (adjusted 

annually for inflation) in any one year.’’

The current threshold after adjustment 

for inflation is $115 million, using the 

most current (2003) Implicit Price 

Deflator for the Gross Domestic Product. 

FDA does not expect this final rule to 

result in any one-year expenditure that 

would meet or exceed this amount. 

VI. Federalism Analysis 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the final rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

agency concludes that the final rule 

does not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

VII. The Paperwork Reduction Act of 

1995 

This final rule contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The title, description, and 

respondent description of the 

information collection provisions and 

an estimate of the annual reporting 

burden were provided in the interim 

final rule issued October 10, 2003 (68 

FR 58894). Included in the estimate was 

the time for reviewing instructions, 

searching existing data sources, 

gathering and maintaining the data 

needed, and completing and reviewing 

each collection of information. The final 

rule requires no new information 

collection. Individuals and 

organizations may submit comments on 

the burden estimates or on any other 

aspect of these information collection 

provisions, including suggestions for 

reducing the burden, and should direct 

them to the contact person identified in 

the FOR FURTHER INFORMATION CONTACT

section of this document. The 

information collection provisions in this 

final rule have been approved under 

OMB control number 0910–0502. This 

approval expires October 31, 2006. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. 

VIII. Analysis of Environmental Impact 

The agency has determined under 21 

CFR 25.30(h) 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. 

List of Subjects 

21 CFR Part 1 

Cosmetics, Drugs, Exports, Food 

labeling, Imports, Labeling, Reporting 

and recordkeeping requirements. 

21 CFR Part 20 

Confidential business information, 

Courts, Freedom of information, 

Government employees. 

PART 1—GENERAL ENFORCEMENT 

REGULATIONS 

PART 20—PUBLIC INFORMATION 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, the interim rule 

amending 21 CFR parts 1 and 20, which 

was published at 68 FR 58894 (October 

10, 2003) and amended at 69 FR 29428 

(May 24, 2004), is adopted as a final rule 

without change. 

Dated: August 28, 2005. 

Michael Chertoff, 

Secretary of Homeland Security. 

Dated: September 20, 2005. 

Michael O. Leavitt, 

Secretary of Health and Human Services. 

[FR Doc. 05–19730 Filed 9–28–05; 1:53 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9226] 

RIN 1545–BD27 

Stock Held by Foreign Insurance 

Companies 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations. 

SUMMARY: This document contains final 

regulations relating to the determination 

of income of foreign insurance 

companies that is effectively connected 

with the conduct of a trade or business 

within the United States. The 

regulations provide that the exception to 

the asset-use test for stock shall not 

apply in determining whether the 

income, gain, or loss from portfolio 

stock held by foreign insurance 

companies constitutes effectively 

connected income. 

DATES: Effective Date: These regulations 

are effective on October 3, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Sheila Ramaswamy, (202) 622–3870 (not 

a toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

On June 25, 2004, a notice of 

proposed rulemaking (REG–117307–04) 

was published in the Federal Register 

(69 FR 35543). No requests for a public 

hearing were received, and no public 

hearing was held. The IRS received one 

written comment in response to the 

notice of proposed rulemaking. After 

consideration of the comment, the 

proposed regulation is adopted without 

change. 

Explanation of Provisions and 

Summary of Comments 

This Treasury decision adopts the 

language of the proposed regulation 

without change. 

The IRS received one comment in 

response to the proposed regulation. 

The commentator requested further 

clarification regarding what constitutes 

57510 Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Rules and Regulations 

an insurance company for federal 

income tax purposes. The IRS believes 

the issue of what constitutes an 

insurance company is outside the scope 

of this regulation, which solely relates 

to the application of the asset-use test to 

stock held by foreign insurance 

companies. 

The commentator also expressed 

concern about the interaction of the 

proposed regulation with § 1.864–5(a), 

which provides, generally, that foreign 

source income, such as a foreign-source 

dividend or gain, cannot constitute U.S. 

effectively connected income in 

circumstances in which a U.S.-source 

dividend or gain would not constitute 

U.S. effectively connected income. 

Accordingly, the commentator is 

concerned that the rule in the 

regulations will also expand the 

category of foreign-source dividends or 

gains that may constitute effectively 

connected income. That is true and the 

Treasury Department and the IRS 

believe this is the appropriate result. 

The IRS invited comments whether 

the 10 percent threshold provided in the 

proposed regulation was an appropriate 

standard for determining whether stock 

is a portfolio investment. The 

commentator stated that it was possible 

for insurance companies to make a 

strategic investment in a corporation at 

a level below 10 percent of the vote or 

value of the corporation, such as by 

purchasing a special class of shares that 

conveyed the power to elect directors. 

The commentator recommended 

creating a rebuttable presumption of 

portfolio status. 

We do not believe that treating the 10 

percent threshold as a rebuttable 

presumption is appropriate. The 10 

percent threshold provides a reasonable 

method for identifying portfolio stock 

held by a branch of a foreign life 

insurance company. 

Special Analyses 

It has been determined that this 

Treasury decision is not a significant 

regulatory action as defined in 

Executive Order 12866. Therefore, a 

regulatory assessment is not required. It 

has also been determined that section 

553(b) of the Administrative Procedure 

Act (5 U.S.C. chapter 5) does not apply 

to these regulations, and because these 

regulations do not impose a collection 

of information on small entities, the 

provisions of the Regulatory Flexibility 

Act (5 U.S.C. chapter 6) do not apply. 

Pursuant to section 7805(f) of the 

Internal Revenue Code, the notice of 

proposed rulemaking preceding this 

regulation was submitted to the Chief 

Counsel for Advocacy of the Small 

Business Administration for comment 

on its impact on small business. 

Drafting Information 

The principal author of this regulation 

is Sheila Ramaswamy, Office of 

Associate Chief Counsel (International). 

However, other personnel from the IRS 

and Treasury Department participated 

in their development. 

List of Subjects in 26 CFR Part 1 

Income taxes, Reporting and 

recordkeeping requirements. 

Proposed Amendment to the 

Regulations 

■ Accordingly, 26 CFR part 1 is 

amended as follows: 

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. In § 1.864–4, paragraph 

(c)(2)(iii)(b) is revised to read as follows: 

§ 1.864–4 U.S. source income effectively 

connected with U.S. business. 

* * * * * 

(c) * * * 

(2) * * * 

(iii) * * * 

(b) Stock held by foreign insurance 

companies. This paragraph (c)(2)(iii) 

shall not apply to stock of a corporation 

(whether domestic or foreign) held by a 

foreign insurance company unless the 

foreign insurance company owns 10 

percent or more of the total voting 

power or value of all classes of stock of 

such corporation. For purposes of this 

section, section 318(a) shall be applied 

in determining ownership, except that 

in applying section 318(a)(2)(C), the 

phrase ‘‘10 percent’’ is used instead of 

the phrase ‘‘50 percent.’’

* * * * * 

Mark E. Matthews, 

Deputy Commissioner for Services and 

Enforcement. 

Approved: August 9, 2005. 

Eric Solomon, 

Acting Deputy Assistant Secretary for Tax 

Policy. 

[FR Doc. 05–19622 Filed 9–30–05; 8:45 am] 

BILLING CODE 4830–01–U 

EQUAL EMPLOYMENT OPPORTUNITY 

COMMISSION 

29 CFR Part 1610 

RIN 3046–AA75 

Freedom of Information Act Fee 

Schedule 

AGENCY: Equal Employment 

Opportunity Commission. 

ACTION: Final rule. 

SUMMARY: The Equal Employment 

Opportunity Commission (EEOC or the 

Commission) is adopting revisions to its 

Freedom of Information Act (FOIA) fee 

schedule. The updated schedule of fees 

reflects increases in the direct costs 

incurred by the Commission in 

responding to requests for records. 

DATES: October 3, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Thomas J. Schlageter, Assistant Legal 

Counsel, or Michelle Zinman, Senior 

General Attorney at (202) 663–4640 

(voice) or (202) 663–7026 (TTY). This 

notice of final rule is also available in 

the following formats: large print, 

Braille, audiotape and electronic file on 

computer disk. Requests for this notice 

of final rule in an alternative format 

should be made to EEOC’s Publication 

Center at 1–800–669–3362. 

SUPPLEMENTARY INFORMATION: On July 1, 

2005, at 70 FR 38060–01, the EEOC 

published a notice of proposed 

rulemaking proposing to amend the 

sections of 29 CFR part 1610 that 

concern the fees assessed to persons 

who seek agency records under the 

FOIA. The changes comply with the 

Office of Management and Budget’s 

Uniform Freedom of Information Act 

Fee Schedule and Guidelines, 52 FR 

10012 (1987). Comments from the 

public were due on or before August 31, 

2005. No comments were received. 

Therefore, EEOC is adopting the 

proposed revisions, without change, as 

its final rule. 

Regulatory Procedures 

Executive Order 12866 

Pursuant to Executive Order 12866, 

EEOC has determined that the 

regulation will not have an annual effect 

on the economy of $100 million or more 

or adversely affect in a material way the 

economy, a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State or local tribal governments or 

communities. Therefore, a detailed costbenefit assessment of the regulation is 

not required.