61150 Federal Register / Vol. 69, No. 199 / Friday, October 15, 2004 / Rules and Regulations 

than 24 hours (one day), additional or 

alternative labeling may be necessary. 

FDA would like comments regarding 

labeling, such as the following:

• How often to apply the product,

• The effect of bathing or showering 

before the duration of effect period 

ends, and

• Whether any other special labeling 

should apply to products with a 

duration of effect greater than 24 hours.

FDA also requests comments on 

whether there should be any limit on 

the enhanced duration claim and 

whether there are any potential safety 

issues if a product with enhanced 

duration of action is reapplied more 

frequently than directed (e.g., an 

antiperspirant labeled as providing 48 

hours of sweat protection applied every 

24 hours).

IV. Analysis of Impacts

The economic impact of the FM was 

discussed in the final rule (68 FR 34273 

at 34289). This partial stay of the 

labeling claims for enhanced duration in 

§ 350.50(b)(3) and (b)(5) does not change 

the economic impact on industry 

described in the final rule.

FDA has examined the impacts of this 

final rule under Executive Order 12866, 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (2 U.S.C. 1501 et 

seq.). Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). Under 

the Regulatory Flexibility Act, if a rule 

has a significant economic impact on a 

substantial number of small entities, an 

agency must analyze regulatory options 

that would minimize any significant 

impact of the rule on small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act requires that 

agencies prepare a written statement of 

anticipated costs and benefits before 

proposing any rule that may result in an 

expenditure in any one year by State, 

local, and tribal governments, in the 

aggregate, or by the private sector, of 

$100 million (adjusted annually for 

inflation). The current inflation adjusted 

statutory threshold is about $110 

million.

FDA concludes that this final rule is 

consistent with the regulatory 

philosophy and principles identified in 

the Executive order and in these two 

statutes. The final rule is not a 

significant regulatory action as defined 

by the Executive order and so is not 

subject to review under the Executive 

order. FDA has determined that the final 

rule does not have a significant 

economic impact on a substantial 

number of small entities. The Unfunded 

Mandates Reform Act does not require 

FDA to prepare a statement of costs and 

benefits for this final rule, because this 

final rule is not expected to result in any 

1-year expenditure that would exceed 

$100 million adjusted for inflation.

The purpose of this final rule is to 

stay the effective date of one part of the 

antiperspirant FM: The limitation of the 

enhanced duration claim to 24 hours 

(§ 350.50(b)(3) and (b)(5)). The partial 

stay will allow manufacturers who have 

supporting data to include greater than 

24 hour duration claims in the labeling 

of OTC antiperspirant drug products 

while FDA evaluates data to support 

such claims using FDA’s effectiveness 

test. FDA has learned that one 

manufacturer has approximately 40 

stockkeeping units (SKUs) and another 

manufacturer has several SKUs with 

labels indicating effectiveness for more 

than 24 hours. These manufacturers will 

not have to revise the existing 

‘‘enhanced duration’’ portion of their 

labeling when the FM becomes effective 

on December 9, 2004. Accordingly, FDA 

certifies that this final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Therefore, under the Regulatory 

Flexibility Act, no further analysis is 

required.

V. Paperwork Reduction

This final rule contains no collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required.

VI. Environmental Impact

FDA has determined under 21 CFR 

25.31(a) 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.

VII. Federalism

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the 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, FDA 

has concluded that the 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.

VIII. Request for Comments

Interested persons may submit written 

or electronic comments regarding this 

rule to the Division of Dockets 

Management (see ADDRESSES). Three 

copies of all written comments are to be 

submitted. Individuals submitting 

written comments or anyone submitting 

electronic comments may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document and may be accompanied by 

a supporting memorandum or brief. 

Received comments may be seen in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday.

IX. References

The following references are on 

display in the Division of Dockets 

Management (see ADDRESSES) under 

Docket No. 1978N–0064 and may be 

seen by interested persons between 9 

a.m. and 4 p.m., Monday through 

Friday.

1. Comment No. PRC1.

2. Comment No. PRC2.

3. Comment No. SUP4.

4. Comment No. C54.

X. Authority

This final rule (partial stay) is issued 

under sections 201, 501, 502, 503, 505, 

510, and 701 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 321, 351, 

352, 353, 355, 360, and 371) and under 

authority delegated to the Commissioner 

of Food and Drugs.

Dated: October 6, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–23106 Filed 10–14–04; 8:45 am]

BILLING CODE 4160–01–S

PENSION BENEFIT GUARANTY 

CORPORATION 

29 CFR Parts 4022 and 4044 

Benefits Payable in Terminated SingleEmployer Plans; Allocation of Assets 

in Single-Employer Plans; Interest 

Assumptions for Valuing and Paying 

Benefits

AGENCY: Pension Benefit Guaranty 

Corporation.

ACTION: Final rule.

Federal Register / Vol. 69, No. 199 / Friday, October 15, 2004 / Rules and Regulations 61151

SUMMARY: The Pension Benefit Guaranty 

Corporation’s regulations on Benefits 

Payable in Terminated Single-Employer 

Plans and Allocation of Assets in 

Single-Employer Plans prescribe interest 

assumptions for valuing and paying 

benefits under terminating singleemployer plans. This final rule amends 

the regulations to adopt interest 

assumptions for plans with valuation 

dates in November 2004. Interest 

assumptions are also published on the 

PBGC’s Web site (http://www.pbgc.gov).

DATES: November 1, 2004.

FOR FURTHER INFORMATION CONTACT:

Harold J. Ashner, Assistant General 

Counsel, Office of the General Counsel, 

Pension Benefit Guaranty Corporation, 

1200 K Street, NW., Washington, DC 

20005, 202–326–4024. (TTY/TDD users 

may call the Federal relay service tollfree at 1–800–877–8339 and ask to be 

connected to 202–326–4024.)

SUPPLEMENTARY INFORMATION: The 

PBGC’s regulations prescribe actuarial 

assumptions—including interest 

assumptions—for valuing and paying 

plan benefits of terminating singleemployer plans covered by title IV of 

the Employee Retirement Income 

Security Act of 1974. The interest 

assumptions are intended to reflect 

current conditions in the financial and 

annuity markets. 

Three sets of interest assumptions are 

prescribed: (1) A set for the valuation of 

benefits for allocation purposes under 

section 4044 (found in Appendix B to 

part 4044), (2) a set for the PBGC to use 

to determine whether a benefit is 

payable as a lump sum and to determine 

lump-sum amounts to be paid by the 

PBGC (found in Appendix B to part 

4022), and (3) a set for private-sector 

pension practitioners to refer to if they 

wish to use lump-sum interest rates 

determined using the PBGC’s historical 

methodology (found in Appendix C to 

part 4022). 

Accordingly, this amendment (1) adds 

to Appendix B to part 4044 the interest 

assumptions for valuing benefits for 

allocation purposes in plans with 

valuation dates during November 2004, 

(2) adds to Appendix B to part 4022 the 

interest assumptions for the PBGC to 

use for its own lump-sum payments in 

plans with valuation dates during 

November 2004, and (3) adds to 

Appendix C to part 4022 the interest 

assumptions for private-sector pension 

practitioners to refer to if they wish to 

use lump-sum interest rates determined 

using the PBGC’s historical 

methodology for valuation dates during 

November 2004. 

For valuation of benefits for allocation 

purposes, the interest assumptions that 

the PBGC will use (set forth in 

Appendix B to part 4044) will be 3.80 

percent for the first 20 years following 

the valuation date and 5.00 percent 

thereafter. These interest assumptions 

represent a decrease (from those in 

effect for October 2004) of 0.20 percent 

for the first 20 years following the 

valuation date and are otherwise 

unchanged. 

The interest assumptions that the 

PBGC will use for its own lump-sum 

payments (set forth in Appendix B to 

part 4022) will be 2.75 percent for the 

period during which a benefit is in pay 

status and 4.00 percent during any years 

preceding the benefit’s placement in pay 

status. These interest assumptions 

represent a decrease (from those in 

effect for October 2004) of 0.25 percent 

for the period during which a benefit is 

in pay status and are otherwise 

unchanged. 

For private-sector payments, the 

interest assumptions (set forth in 

Appendix C to part 4022) will be the 

same as those used by the PBGC for 

determining and paying lump sums (set 

forth in Appendix B to part 4022). 

The PBGC has determined that notice 

and public comment on this amendment 

are impracticable and contrary to the 

public interest. This finding is based on 

the need to determine and issue new 

interest assumptions promptly so that 

the assumptions can reflect, as 

accurately as possible, current market 

conditions.

Because of the need to provide 

immediate guidance for the valuation 

and payment of benefits in plans with 

valuation dates during November 2004, 

the PBGC finds that good cause exists 

for making the assumptions set forth in 

this amendment effective less than 30 

days after publication. 

The PBGC has determined that this 

action is not a ‘‘significant regulatory 

action’’ under the criteria set forth in 

Executive Order 12866. 

Because no general notice of proposed 

rulemaking is required for this 

amendment, the Regulatory Flexibility 

Act of 1980 does not apply. See 5 U.S.C. 

601(2).

List of Subjects 

29 CFR Part 4022 

Employee benefit plans, Pension 

insurance, Pensions, Reporting and 

recordkeeping requirements. 

29 CFR Part 4044 

Employee benefit plans, Pension 

insurance, Pensions.

■ In consideration of the foregoing, 29 

CFR parts 4022 and 4044 are amended as 

follows:

PART 4022—BENEFITS PAYABLE IN 

TERMINATED SINGLE-EMPLOYER 

PLANS

■ 1. The authority citation for part 4022 

continues to read as follows:

Authority: 29 U.S.C. 1302, 1322, 1322b, 

1341(c)(3)(D), and 1344.

■ 2. In appendix B to part 4022, Rate Set 

133, as set forth below, is added to the 

table. (The introductory text of the table 

is omitted.) 

Appendix B to Part 4022—Lump Sum 

Interest Rates for PBGC Payments

* * * * *

Rate set 

For plans with a

valuation date Immediate

annuity rate

(percent) 

Deferred annuities

(percent) 

On or after Before i1 i2 i3 n1 n2

*******

133 11–1–04 12–1–04 2.75 4.00 4.00 4.00 7 8 

■ 3. In appendix C to part 4022, Rate Set 

133, as set forth below, is added to the 

table. (The introductory text of the table 

is omitted.)

Appendix C to Part 4022—Lump Sum 

Interest Rates for Private-Sector 

Payments

* * * * *

61152 Federal Register / Vol. 69, No. 199 / Friday, October 15, 2004 / Rules and Regulations 

Rate set 

For plans with a

valuation date Immediate

annuity rate

(percent) 

Deferred annuities

(percent) 

On or after Before i1 i2 i3 n1 n2

*******

133 11–1–04 12–1–04 2.75 4.00 4.00 4.00 7 8 

PART 4044—ALLOCATION OF 

ASSETS IN SINGLE-EMPLOYER 

PLANS

■ 4. The authority citation for part 4044 

continues to read as follows:

Authority: 29 U.S.C. 1301(a), 1302(b)(3), 

1341, 1344, 1362.

■ 5. In appendix B to part 4044, a new 

entry, as set forth below, is added to the 

table. (The introductory text of the table 

is omitted.) 

Appendix B to Part 4044—Interest 

Rates Used To Value Benefits

* * * * *

For valuation dates occurring in the month—

The values of it are: 

it for t = it for t = it for t = 

*******

November 2004 ................................................................ .0380 1–20 .0500 >20 N/A N/A 

Issued in Washington, DC, on this 12th day 

of October 2004. 

Joseph H. Grant, 

Deputy Executive Director and Chief 

Operating Officer, Pension Benefit Guaranty 

Corporation.

[FR Doc. 04–23180 Filed 10–14–04; 8:45 am] 

BILLING CODE 7708–01–P

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 64 

[CC Docket No. 96–146; RM–8783; ENF–95–

20; FCC 04–162] 

Policies and Rules Governing 

Interstate Pay-Per-Call and Other 

Information Services, and Toll-free 

Number Usage; Truth-in-Billing and 

Billing Format

AGENCY: Federal Communications 

Commission.

ACTION: Final rules.

SUMMARY: In this document, the 

Commission closes CC Docket 96–146, a 

rulemaking initiated in 1996 to 

implement portions of the 

Telecommunications Act of 1996 (1996 

Act) governing pay-per-call and related 

information services. This docket was 

opened specifically for the purpose of 

implementing section 228 as amended 

by the 1996 Act. In 1996, the 

Commission released an Order and 

Notice of Proposed Rulemaking that 

adopted new rules, incorporating much 

of the statute verbatim, and completed 

implementation of the new provision of 

section 228. In the years since the rules 

took effect, the shape of the pay-per-call 

industry, technology in general, and 

regulatory perspectives have changed 

considerably. For reasons of 

administrative efficiency, the 

Commission now closes that docket. 

Furthermore, in this document, the 

Commission denies a related 

application for review, dismisses a 

petition to initiate a rulemaking, and 

corrects a word error in the existing 

rules.

DATES: Effective July 16, 2004.

ADDRESSES: Federal Communications 

Commission, 445 12th Street, SW., 

Washington, DC 20554.

FOR FURTHER INFORMATION CONTACT:

Ruth Yodaiken, of the Consumer & 

Government Affairs Bureau at (202) 

418–2512 (voice), or e-mail 

ruth.yodaiken@fcc.gov.

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s 

Memorandum Opinion and Order 

(MO&O), Policies and Rules Governing 

Interstate Pay-Per-Call and Other 

Information Services Pursuant to the 

Telecommunications Act of 1996, 

Policies and Rules Implementing the 

Telephone Disclosure and Dispute 

Resolution Act, Florida Public Service 

Commission Petition to Initiate 

Rulemaking to Adopt Additional 

Safeguards; Application for Review of 

Advisory Ruling Regarding Directly 

Dialed Calls to International 

Information Services, CC Docket No. 

96–146, RM 8783, ENF–95–20; FCC 04–

162, adopted July 1, 2004, and released 

July 16, 2004. This MO&O document 

does not contain new or modified 

information collection requirements 

subject to the Paperwork Reduction Act 

of 1995 (PRA), Public Law 104–13. In 

addition, therefore, it does not contain 

any new or modified ‘‘information 

collection burden for small business 

concerns with fewer than 25 

employees,’’ pursuant to the Small 

Business Paperwork Relief Act of 2002, 

Public Law 107–198, see 44 U.S.C. 

3506(c)(4). On July 16, 2004, the 

Commission also released a Notice of 

Proposed Rulemaking (NPRM), Policies 

and Rules Governing Interstate Pay-PerCall and Other Information Services 

Pursuant to the Telecommunications 

Act of 1996; Policies and Rules 

Governing Interstate Pay-Per-Call and 

Other Information Services, and Tollfree Number Usage; Truth-in-Billing and 

Billing Format, CC Docket Nos. 96–146 

and 98–170, CG Docket No. 04–244; 

FCC 04–162, that contains proposed 

information requirements. The full text 

of this document is available on the 

Commission’s website Electronic 

Comment Filing System and for public 

inspection during regular business 

hours in the FCC Reference Center, 

Room CY–A257, 445 12th Street, SW., 

Washington, DC 20554. To request 

materials in accessible formats for 

people with disabilities (Braille, large 

print, electronic files, audio format), 

send an e-mail to fcc504@fcc.gov, or call 

the Consumer & Governmental Affairs