Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; Withdrawal, 1460 [07-105]
Download as PDF
<![CDATA[
1460
Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PENSION BENEFIT GUARANTY
CORPORATION
Food and Drug Administration
29 CFR Parts 4022 and 4044
21 CFR Parts 807, 868, 870, 872, 874,
876, 878, 880, 882, 884, 886, and 892
Benefits Payable in Terminated SingleEmployer Plans; Allocation of Assets
in Single-Employer Plans; Interest
Assumptions for Valuing and Paying
Benefits
[Docket No. 2006N–0335]
Medical Devices; Reprocessed SingleUse Devices; Requirement for
Submission of Validation Data;
Withdrawal
ACTION:
Direct final rule; withdrawal.
rmajette on PROD1PC67 with RULES
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withdrawn as of January 12, 2007.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25, 2006 (71 FR 55729), is withdrawn.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
VerDate Aug<31>2005
15:29 Jan 11, 2007
Jkt 211001
Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
AGENCY:
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 (https://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
PO 00000
Frm 00046
Fmt 4700
Sfmt 4700
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).
E:\FR\FM\12JAR1.SGM
12JAR1
]]>Agencies
[Federal Register Volume 72, Number 8 (Friday, January 12, 2007)]
[Rules and Regulations]
[Page 1460]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-105]
[[Page 1460]]
-----------------------------------------------------------------------
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 Single-Use 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
