Federal Register / Vol. 66, No. 221 / Thursday, November 15, 2001 / Rules and Regulations 57369

Device Exemptions From Premarket

Notification, Guidance for Industry and

CDRH Staff.’’ That guidance can be

obtained through the Internet on the

CDRH home page at http://

www.fda.gov/cdrh or by facsimile

through CDRH Facts-on-Demand at 1–

800–899–0381 or 301–827–0111.

Specify ‘‘159’’ when prompted for the

document shelf number.

III. Petition

On March 25, 2001, FDA received a

petition requesting an exemption from

premarket notification for the F-Spoon,

a manual compression device that

allows a radiologist to press on the

abdomen during a fluoroscopic

procedure without exposing his or her

hand to the x-ray beam. In the Federal

Register of June 18, 2001 (66 FR 32828),

FDA published a notice announcing that

this petition had been received and

provided an opportunity for interested

persons to submit comments on the

petition by July 18, 2001. FDA also

announced that it intended to expand

the exemption to include all

fluoroscopic compression devices of

this generic type, subject to limitations

in 21 CFR 892.9. FDA received no

comments. FDA has reviewed the

petition and has determined that this

device meets the criteria for exemption

described previously and is, therefore,

issuing this order exempting the device

from the requirements of premarket

notification. The fluoroscopic

compression device is an accessory to

the image-intensified fluoroscopic x-ray

system classified under 21 CFR

892.1650.

IV. 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.

V. 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) (as amended by subtitle

D of the Small Business Regulatory

Fairness Act of 1996 (Public Law 104–

121)), 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

consistent with the regulatory

philosophy and principles identified in

the Executive order. In addition, 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.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because this rule will relieve a

burden and simplify the marketing of

these devices, the agency certifies that

the 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.

VI. Paperwork Reduction Act of 1995

FDA concludes that 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.

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 order and, consequently, a

federalism summary impact statement is

not required.

List of Subjects in 21 CFR Part 892

Medical devices, Radiation

protection, X-rays.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 892 is

amended as follows:

PART 892—RADIOLOGY DEVICES

1. The authority citation for 21 CFR

part 892 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,

360j, 371.

2. Section 892.1650 is amended by

revising paragraph (b) to read as follows:

§ 892.1650 Image-intensified fluoroscopic

x-ray system.

* * * * *

(b) Classification. Class II. When

intended as an accessory to the device

described in paragraph (a) of this

section, the fluoroscopic compression

device is exempt from the premarket

notification procedures in subpart E of

part 807 of this chapter subject to

§ 892.9.

Dated: October 25, 2001.

Linda S. Kahan,

Deputy Director, Center for Devices and

Radiological Health.

[FR Doc. 01–28563 Filed 11–14–01; 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 2001. Interest

assumptions are also published on the

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

EFFECTIVE DATE: December 1, 2001.

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.

57370 Federal Register / Vol. 66, No. 221 / Thursday, November 15, 2001 / Rules and Regulations

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 December 2001,

(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 2001, 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 2001.

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 6.10

percent for the first 20 years following

the valuation date and 6.25 percent

thereafter. These interest assumptions

represent a decrease (from those in

effect for November 2001) of 0.40

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 4.50 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 November 2001) 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 2001,

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

98, 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

*******

98 12–1–01 1–1–02 4.50 4.00 4.00 4.00 7 8

3. In appendix C to part 4022, Rate Set 98, 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

* * * * * * *

Rate set

For plans with a valuation

date Immediate

annuities rate

(percent)

Deferred annuity (percent)

On or after Before i1 i2 i3 n1 n2

*******

98 12–1–01 1–1–02 4.50 4.00 4.00 4.00 7 8

Federal Register / Vol. 66, No. 221 / Thursday, November 15, 2001 / Rules and Regulations 57371

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 =

*******

December 2001 ................................................. .0610 1–20 .0625 >20 N/A N/A

Issued in Washington, DC, on this 7th day

of November 2001.

John Seal,

Acting Executive Director, Pension Benefit

Guaranty Corporation.

[FR Doc. 01–28623 Filed 11–14–01; 8:45 am]

BILLING CODE 7708–01–P

DEPARTMENT OF THE TREASURY

Office of Foreign Assets Control

31 CFR Chapter V and Part 539

Additional Designations and Removal

of Persons Listed in Appendix A to 31

CFR Chapter V and Appendix I to 31

CFR Part 539, Weapons of Mass

Destruction Trade Control Regulations

AGENCY: Office of Foreign Assets

Control, Treasury.

ACTION: Amendment of final rule.

SUMMARY: The Treasury Department is

amending appendix A to 31 CFR

chapter V to add or remove, as

appropriate, the names of individuals

and entities designated as specially

designated narcotics traffickers, a

foreign terrorist organization, or blocked

persons or specially designated

nationals designated pursuant to

Executive Orders 13088, 13192, or

13219; amending the notes to the

appendices to 31 CFR chapter V to

reflect the revisions to appendix A and

the publication of the Taliban

(Afghanistan) Sanctions Regulations, 31

CFR part 545; and amending appendix

I to 31 CFR part 539 to remove two

entities previously designated as

designated foreign persons.

EFFECTIVE DATE: November 9, 2001.

FOR FURTHER INFORMATION CONTACT:

Office of Foreign Assets Control,

Department of the Treasury,

Washington, D.C. 20220, tel.: 202/622–

2520.

SUPPLEMENTARY INFORMATION:

Electronic and Facsimile Availability

This document is available as an

electronic file on The Federal Bulletin

Board the day of publication in the

Federal Register. By modem, dial 202/

512–1387 and type ‘‘/GO FAC,’’ or call

202/512–1530 for disk or paper copies.

This file is available for downloading

without charge in ASCII and Adobe

Acrobat7 readable (*.PDF) formats. For

Internet access, the address for use with

the World Wide Web (Home Page),

Telnet, or FTP protocol is:

fedbbs.access.gpo.gov. This document

and additional information concerning

the programs of the Office of Foreign

Assets Control are available for

downloading from the Office’s Internet

Home Page: http://www.treas.gov/ofac,

or in fax form through the Office’s 24-

hour fax-on-demand service: call 202/

622–0077 using a fax machine, fax

modem, or (within the United States) a

touch-tone telephone.

Background

A. Amendments to Appendix A and the

Notes to the Appendices to 31 CFR

Chapter V

Appendix A to 31 CFR chapter V lists

the names of blocked persons, specially

designated nationals, specially

designated terrorists, foreign terrorist

organizations, and specially designated

narcotics traffickers with respect to

whom transactions are subject to the

various economic sanctions programs

administered by the Treasury

Department’s Office of Foreign Assets

Control (‘‘OFAC’’). OFAC, acting under

authority delegated by the Secretary of

the Treasury, is amending appendix A

to add or remove, as appropriate, the

names of individuals and entities

designated as specially designated

narcotics traffickers, a foreign terrorist

organization, or blocked persons or

specially designated nationals

designated pursuant to Executive Orders

13088, 13192, or 13219. OFAC is also

amending notes 4 and 6 to the notes to

the appendices to 31 CFR chapter V to

reflect the revisions to appendix A and

the publication of the Taliban

(Afghanistan) Sanctions Regulations, 31

CFR part 545.

Specially Designated Narcotics

Traffickers. On June 1, 2001, President

Bush identified twelve individuals as

significant foreign narcotics traffickers

pursuant to section 804(b) of the Foreign

Narcotics Kingpin Designation Act, 21

U.S.C. 1903(b). In accordance with

§ 598.314 of the Foreign Narcotics

Kingpin Sanctions Regulations, 31 CFR

part 598, those twelve individuals and

their known aliases are added to

appendix A as specially designated

narcotics traffickers identified by the

term ‘‘[SDNTK].’’

As of June 1, 2001, all property and

interests in property, including but not

limited to all accounts, that are or come

within the United States or that are or

come within the possession or control of

U.S. persons, including their overseas

branches, that are owned or controlled

by any of those twelve persons are with

limited exceptions blocked and may not

be transferred, paid, exported,

withdrawn, or otherwise dealt in. All

transactions or dealings by U.S. persons

or within the United States in property

or interests in property of any of those

twelve persons are prohibited unless

licensed by OFAC or otherwise

authorized.

Foreign Terrorist Organization. On

May 16, 2001, the Secretary of State in

a notice published in the Federal

Register (66 FR 27442) designated the

‘‘Real IRA’’ a foreign terrorist

organization pursuant to section 302 of

the Antiterrorism and Effective Death

Penalty Act of 1996, 8 U.S.C. 1189

(‘‘AEDPA’’). In furtherance of section

303 of AEDPA, 18 U.S.C. 2339B,

implemented in part by the Foreign

Terrorist Organizations Sanctions

Regulations, 31 CFR part 597 (the ‘‘FTO

Regulations’’), the ‘‘Real IRA’’ and its

known aliases are added to appendix A

as a foreign terrorist organization

identified by the term ‘‘[FTO].’’