1460 Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 807, 868, 870, 872, 874, 

876, 878, 880, 882, 884, 886, and 892 

[Docket No. 2006N–0335] 

Medical Devices; Reprocessed SingleUse Devices; Requirement for 

Submission of Validation Data; 

Withdrawal 

ACTION: Direct final rule; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) published a 

direct final rule that appeared in the 

Federal Register of September 25, 2006 

(71 FR 55729), that would have 

amended certain classification 

regulations for reprocessed single-use 

devices (SUDs) whose exemption from 

premarket notification (510(k)) 

requirements have been terminated and 

other reprocessed SUDs already subject 

to premarket notification for which 

validation data, as specified under the 

Medical Device User Fee and 

Modernization Act of 2002, are 

necessary in a 510(k). FDA stated in the 

direct final rule that, if it received a 

significant adverse comment by 

December 11, 2006, FDA would publish 

a notice of withdrawal. FDA received 

two comments and considers at least 

one of these comments a significant 

adverse comment and, therefore, is 

withdrawing the direct final rule. 

Accordingly, the agency will consider 

the comments received under our usual 

procedures for notice and comment in 

connection with the notice of proposed 

rulemaking that was published in the 

Federal Register of September 25, 2006 

(71 FR 55748) as a companion to the 

direct final rule. 

DATES: The direct final rule published at 

71 FR 55729 on September 25, 2006, is 

withdrawn as of January 12, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Heather S. Rosecrans, Center for Devices 

and Radiological Health (HFZ–404), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–4040. 

Authority: Therefore, under the 

Federal Food, Drug, and Cosmetic Act 

and under authority delegated to the 

Commissioner of Food and Drugs, the 

direct final rule published on September 

25, 2006 (71 FR 55729), is withdrawn. 

Dated: January 9, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–105 Filed 1–9–07; 2:49 pm] 

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 February 2007. Interest 

assumptions are also published on the 

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

DATES: Effective February 1, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Catherine B. Klion, Manager, Regulatory 

and Policy Division, 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 

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 February 2007, 

(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 

February 2007, 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 

February 2007. 

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 5.13 

percent for the first 20 years following 

the valuation date and 4.80 percent 

thereafter. These interest assumptions 

represent an increase (from those in 

effect for January 2007) of 0.25 percent 

for the first 20 years following the 

valuation date and 0.25 percent for all 

years thereafter. 

The interest assumptions that the 

PBGC will use for its own lump-sum 

payments (set forth in Appendix B to 

part 4022) will be 3.00 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 January 2007) of 0.25 percent 

in the immediate annuity rate 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 current 

market conditions as accurately as 

possible. 

Because of the need to provide 

immediate guidance for the valuation 

and payment of benefits in plans with 

valuation dates during February 2007, 

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). 


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