Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Rules and Regulations 69277 

Under these conditions, FDA believes 

that it is appropriate to categorically 

exclude the establishment of a special 

control from the requirement to prepare 

an EA or EIS. 

B. HDE 

FDA is amending § 25.34 to include 

approval of an HDE as a category of 

action that does not individually or 

cumulatively have a significant effect on 

the human environment and for which 

neither an EA nor EIS is required. 

Because humanitarian use devices are 

limited by definition to use for treating 

or diagnosing diseases or conditions 

affecting fewer than 4,000 individuals in 

the United States per year, any 

environmental impact associated with 

use of a humanitarian use device is very 

limited. FDA approves few HDEs, 

further limiting any potential 

environmental impact. FDA’s 

experience in reviewing HDEs has 

shown that no HDE reviewed thus far 

has had a significant environmental 

impact. 

V. Environmental Impact 

The agency has determined that under 

21 CFR 24.30(h) 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. 

VI. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and the Regulatory Flexibility Act (5 

U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4). 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). The agency 

believes that this final rule is not a 

significant regulatory action under the 

Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because this final rule provides 

for an exclusion from the requirement to 

prepare an EA or EIS and, as such, 

relieves a burden, the agency certifies 

that this final rule will not have a 

significant economic impact on 

substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before finalizing ‘‘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 

or more (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 1-year 

expenditure that would meet or exceed 

this amount. 

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, the 

agency 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. Paperwork Reduction Act of 1995 

This final rule contains no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

List of Subjects in 21 CFR Part 25 

Environmental impact statements, 

Foreign relations, Reporting and 

recordkeeping requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of the Food and Drug Administration, 

21 CFR part 25 is amended as follows: 

PART 25—ENVIRONMENTAL IMPACT 

CONSIDERATIONS 

■ 1. The authority citation for 21 CFR 

part 25 continues to read as follows: 

Authority: 21 U.S.C. 321–393; 42 U.S.C. 

262, 263b–264; 42 U.S.C. 4321, 4332; 40 CFR 

parts 1500–1508; E.O. 11514, 35 FR 4247, 3 

CFR, 1971 Comp., p. 531–533 as amended by 

E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., 

p. 123–124 and E.O. 12114, 44 FR 1957, 3 

CFR, 1980 Comp., p. 356–360. 

■ 2. Section 25.34 is amended by 

revising paragraph (b) and adding 

paragraph (i) to read as follows: 

§ 25.34 Devices and electronic products. 

* * * * * 

(b) Classification or reclassification of 

a device under part 860 of this chapter, 

including the establishment of special 

controls, if the action will not result in 

increases in the existing levels of use of 

the device or changes in the intended 

use of the device or its substitutes. 

* * * * * 

(i) Approval of humanitarian device 

exemption under subpart H of part 814 

of this chapter. 

Dated: October 14, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22563 Filed 11–14–05; 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. 

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 December 2005. Interest 

assumptions are also published on the 

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

DATES: Effective December 1, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Catherine B. Klion, Attorney, Legislative 

and Regulatory Department, Pension 

Benefit Guaranty Corporation, 1200 K 

Street, NW., Washington, DC 20005, 

202–326–4024. (TTY/TDD users may 

call the Federal relay service toll-free 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 

69278 Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Rules and Regulations 

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). 

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 December 2005, 

(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 

December 2005, 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 

December 2005. 

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 4.00 

percent for the first 20 years following 

the valuation date and 4.75 percent 

thereafter. These interest assumptions 

represent an increase (from those in 

effect for November 2005) of 0.30 

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 an increase (from those in 

effect for November 2005) 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 December 2005, 

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 

146, as set forth below, is added to the 

table. 

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

* * * * * * * 

146 12–1–05 1–1–06 2.75 4.00 4.00 4.00 7 8 

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

146, as set forth below, is added to the 

table. 

Appendix C to Part 4022—Lump Sum 

Interest Rates For Private-Sector 

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

* * * * * * * 

146 12–1–05 1–1–06 2.75 4.00 4.00 4.00 7 8 

Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Rules and Regulations 69279 

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 for December 2005, as set forth 

below, is added to the table. 

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 = 

* * * * * * * 

December 2005 ................................................................ .0400 1–20 .0475 >20 N/A N/A 

Issued in Washington, DC, on this 9th day 

of November 2005. 

James J. Armbruster, 

Acting Director, Legislative and Regulatory 

Department, Pension Benefit Guaranty 

Corporation. 

[FR Doc. 05–22604 Filed 11–14–05; 8:45 am] 

BILLING CODE 7708–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[CGD05–05–126] 

RIN 1625–AA08 

Special Local Regulations for Marine 

Events; Approaches to Annapolis 

Harbor, Spa Creek and Severn River, 

Annapolis, MD 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

the special local regulations at 33 CFR 

100.511 during the Eastport Yacht Club 

Lights Parade, a marine event to be held 

December 10, 2005, on the waters of Spa 

Creek and the Severn River at 

Annapolis, Maryland. These special 

local regulations are necessary to 

control vessel traffic due to the confined 

nature of the waterway and expected 

vessel congestion during the event. The 

effect will be to restrict general 

navigation in the regulated area for the 

safety of event participants, spectators 

and vessels transiting the event area. 

DATES: 33 CFR 100.511 will be enforced 

from 5:30 p.m. to 8:30 p.m. on 

December 10, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Ronald Houck, Marine Events 

Coordinator, Commander, Coast Guard 

Sector Baltimore, 2401 Hawkins Point 

Road, Baltimore, MD 21226–1971, and 

(410) 576–2674. 

SUPPLEMENTARY INFORMATION: The 

Eastport Yacht Club will sponsor a 

lighted boat parade on the waters of Spa 

Creek and the Severn River at 

Annapolis, Maryland. The event will 

consist of approximately 50 boats 

traveling at slow speed along two 

separate parade routes in Annapolis 

Harbor. The participating boats will 

range in length from 10 to 60 feet, and 

each will be decorated with holiday 

lights. In order to ensure the safety of 

participants, spectators and transiting 

vessels, 33 CFR 100.511 will be 

enforced for the duration of the event. 

Under provisions of 33 CFR 100.511, 

vessels may not enter the regulated area 

without permission from the Coast 

Guard Patrol Commander. Spectator 

vessels may anchor outside the 

regulated area but may not block a 

navigable channel. Because these 

restrictions will be in effect for a limited 

period, they should not result in a 

significant disruption of maritime 

traffic. 

In addition to this notice, the 

maritime community will be provided 

extensive advance notification via the 

Local Notice to Mariners, marine 

information broadcasts, and area 

newspapers, so mariners can adjust 

their plans accordingly. 

Dated: November 2, 2005. 

Larry L. Hereth, 

Rear Admiral, U.S. Coast Guard, Commander, 

Fifth Coast Guard District. 

[FR Doc. 05–22574 Filed 11–14–05; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[CGD05–05–123] 

RIN 1625–AA87 

Security Zone; Cape Fear River, Eagle 

Island, North Carolina State Port 

Authority Terminal, Wilmington, NC 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary security zone 

at the North Carolina State Port 

Authority (NCSPA), Wilmington to 

include the Cape Fear River and Eagle 

Island. Entry into or movement within 

the security zone will be prohibited 

without authorization from the Captain 

of the Port (COTP), Wilmingon, NC. 

This action is necessary to safeguard the 

vessels and the facility from sabotage, 

subversive acts, or other threats. 

DATES: This rule is effective from 

October 1, 2005, until December 31, 

2005. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket CGD05–05–

123 and are available for inspection or 

copying at the Marine Safety Unit 721 

Medical Center Drive, Suite 100, 

Wilmington, North Carolina 28401 

between 7:30 a.m. and 3 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

LTJG Diego Benavides, Branch Chief, 

Port Safety and Security (910) 772–2200 

or toll free (877) 229–0770. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

We did not publish a notice of 

proposed rulemaking (NPRM) for this 

rule. The Coast Guard is promulgating 

this security zone regulation to protect 

NCSPA Wilmington and the