Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Paying Benefits, 8649-8651 [2011-3403]
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Federal Register / Vol. 76, No. 31 / Tuesday, February 15, 2011 / Rules and Regulations
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quality systems would include
complaint-handling procedures. FDA’s
QS requirements are flexible and FDA
believes that these manufacturers will
be able to conform their systems to FDA
requirements with little difficulty or
cost. Manufacturers are already required
to report to FDA whenever they learn
that their device may have caused or
contributed to a death or serious injury
to a patient. The costs of complying
with these requirements will be
relatively small, but will vary
depending on the number and nature of
the devices manufactured and the state
of the firm’s existing quality system.
Based on our understanding that the
industry generally has in place
measures to ensure quality, we believe
most firms will be able to adapt their
systems to meet FDA’s QS and MDR
regulations for not more than $20,000.
This cost would not be imposed by this
final rule; it is an existing burden that
manufacturers may not have fully
incurred because of FDA’s exercise of
enforcement discretion with
manufacturers of MDDSs.
Because manufacturers have not been
required to register and list, we cannot
be positive all firms have existing
measures to ensure quality, and we
cannot rule out the possibility that some
manufacturers will face greater costs. If
a manufacturer has no quality system in
place, we estimate that it would cost
less than $20,000 to establish a quality
system plus the annual cost of a fulltime employee to manage such a system.
Comments to the proposed rule
estimated the cost of such an employee,
including benefits, to be $143,000 per
year.
F. Premarket Notification
With the issuance of this final rule
and the classification of MDDSs into
class I, a manufacturer of an MDDS
would not need to comply with the
PMA requirement that applies to class
III devices or submit a premarket
notification. For those MDDSs that
exceed the limitations on 510(k)
exemptions found in § 880.9, the
required premarket notification for an
MDDS will be far less complex than
submission of a PMA. The cost of
preparing and submitting such a
notification would be several thousand
dollars. The user fees for a premarket
notification would be $4,348 for FY
2011, increasing to $4,717 in 2012. In
contrast, the cost of submitting a PMA
can reach $1,000,000, plus user fees of
an additional $236,298 in FY 2011,
increasing to $256,384 in FY 2012.
In summary, this device
reclassification final rule will
substantially reduce an existing legal
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15:22 Feb 14, 2011
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burden on the manufacturers of MDDSs.
The burden of compliance with the
general controls provisions applicable to
the manufacturers of all class I devices
is attributable to statutory requirements
that already apply but in the past have
not been enforced for MDDSs. Because
continued exercise of enforcement
discretion may not be a viable long-term
regulatory alternative, this final rule
reduces the ultimate regulatory burden
for manufacturers of MDDSs.
Considering the cost of submitting a
PMA plus the relevant user fees, the
reduction could be $1,000,000 per
device.
The Regulatory Flexibility Act
requires Agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because reclassification of the
affected devices from class III to class I
will relieve manufacturers of the cost of
complying with the premarket approval
requirements of section 515 of the FD&C
Act (21 U.S.C. 360e), the Agency
certifies that this final rule will not have
a significant economic impact on a
substantial number of small entities.
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 collections
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 880
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 880 is
amended as follows:
PART 880—GENERAL HOSPITAL AND
PERSONAL USE DEVICES
1. The authority citation for 21 CFR
part 880 continues to read as follows:
■
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8649
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Section 880.6310 is added to
subpart G to read as follows:
■
§ 880.6310
Medical device data system.
(a) Identification. (1) A medical
device data system (MDDS) is a device
that is intended to provide one or more
of the following uses, without
controlling or altering the functions or
parameters of any connected medical
devices:
(i) The electronic transfer of medical
device data;
(ii) The electronic storage of medical
device data;
(iii) The electronic conversion of
medical device data from one format to
another format in accordance with a
preset specification; or
(iv) The electronic display of medical
device data.
(2) An MDDS may include software,
electronic or electrical hardware such as
a physical communications medium
(including wireless hardware), modems,
interfaces, and a communications
protocol. This identification does not
include devices intended to be used in
connection with active patient
monitoring.
(b) Classification. Class I (general
controls). The device is exempt from the
premarket notification procedures in
subpart E of part 807 of this chapter,
subject to the limitations in § 880.9.
Dated: February 9, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–3321 Filed 2–14–11; 8:45 am]
BILLING CODE 4160–01–P
PENSION BENEFIT GUARANTY
CORPORATION
29 CFR Part 4022
Benefits Payable in Terminated SingleEmployer Plans; Interest Assumptions
for Paying Benefits
Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
AGENCY:
This final rule amends
Pension Benefit Guaranty Corporation’s
regulation on Benefits Payable in
Terminated Single-Employer Plans to
prescribe interest assumptions under
the regulation for valuation dates in
March 2011. Interest assumptions are
also published on PBGC’s Web site
(https://www.pbgc.gov).
DATES: Effective March 1, 2011.
SUMMARY:
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8650
Federal Register / Vol. 76, No. 31 / Tuesday, February 15, 2011 / Rules and Regulations
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: PBGC’s
regulation on Benefits Payable in
Terminated Single-Employer Plans (29
CFR part 4022) prescribes actuarial
assumptions—including interest
assumptions—for paying plan benefits
under terminating single-employer
plans covered by title IV of the
Employee Retirement Income Security
Act of 1974.
PBGC uses the interest assumptions in
Appendix B to Part 4022 to determine
whether a benefit is payable as a lump
sum and to determine the amount to
pay. Appendix C to Part 4022 contains
interest assumptions for private-sector
pension practitioners to refer to if they
wish to use lump-sum interest rates
determined using PBGC’s historical
methodology. Currently, the rates in
Appendices B and C of the benefit
payment regulation are the same.
The interest assumptions are intended
to reflect current conditions in the
Rate set
For plans with a
valuation date
On or after
*
209
financial and annuity markets.
Assumptions under the benefit
payments regulation are updated
monthly. This final rule updates the
benefit payments interest assumptions
for March 2011.1
The March 2011 interest assumptions
under the benefit payments regulation
will be 2.50 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. In comparison with the interest
assumptions in effect for February 2011,
these interest assumptions are
unchanged.
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 payment of
benefits under plans with valuation
dates during March 2011, PBGC finds
that good cause exists for making the
assumptions set forth in this
amendment effective less than 30 days
after publication.
*
3–1–11
3. In appendix C to part 4022, Rate Set
209, as set forth below, is added to the
table.
On or after
*
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209
*
3–1–11
15:22 Feb 14, 2011
*
*
4–1–11
2.50
1 Appendix B to PBGC’s regulation on Allocation
of Assets in Single-Employer Plans (29 CFR part
4044) prescribes interest assumptions for valuing
VerDate Mar<15>2010
*
Immediate
annuity rate
(percent)
Before
Jkt 223001
In consideration of the foregoing, 29
CFR part 4022 is 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
209, as set forth below, is added to the
table.
■
Appendix B to Part 4022—Lump Sum
Interest Rates for PBGC Payments
*
*
*
*
*
i3
4.00
*
n1
*
4.00
n2
*
7
8
n1
n2
Appendix C to Part 4022—Lump Sum
Interest Rates for Private-Sector
Payments
*
For plans with a
valuation date
Employee benefit plans, Pension
insurance, Pensions, Reporting and
recordkeeping requirements.
i2
*
4.00
2.50
■
Rate set
i1
*
4–1–11
List of Subjects in 29 CFR Part 4022
Deferred annuities
(percent)
Immediate
annuity rate
(percent)
Before
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).
*
*
Deferred annuities
(percent)
i1
i2
*
4.00
i3
4.00
*
benefits under terminating covered single-employer
plans for purposes of allocation of assets under
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*
4.00
*
7
8
ERISA section 4044. Those assumptions are
updated quarterly.
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Federal Register / Vol. 76, No. 31 / Tuesday, February 15, 2011 / Rules and Regulations
Issued in Washington, DC, on this 8th day
of February 2011.
Vincent K. Snowbarger,
Deputy Director for Operations, Pension
Benefit Guaranty Corporation.
[FR Doc. 2011–3403 Filed 2–14–11; 8:45 am]
BILLING CODE 7709–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2010–1093]
RIN 1625–AA08
Special Local Regulation; Mavericks
Surf Competition, Half Moon Bay, CA
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a temporary special local
regulation on certain navigable waters of
Half Moon Bay in support of the
Mavericks Surf Competition. This
special local regulation is necessary to
ensure the safety of participants and
spectators during the event. Entry into
this zone is prohibited unless
authorized by the Captain of the Port
San Francisco, CA.
DATES: This rule is effective from
February 15, 2011 through February 28,
2011.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket USCG–2010–
1093 and are available online by going
to https://www.regulations.gov, inserting
USCG–2010–1093 in the ‘‘Keyword’’
box, and then clicking ‘‘Search.’’ They
are also available for inspection or
copying at the Docket Management
Facility (M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
rule, call Lieutenant Junior Grade Liezl
Nicholas at (415) 399–7436, or
e-mail D11-PF-MarineEvents@uscg.mil.
If you have questions on viewing the
docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone
(202)366–9826.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
Regulatory Information
The Coast Guard is issuing this
temporary final rule without prior
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15:22 Feb 14, 2011
Jkt 223001
notice and opportunity to comment
pursuant to authority under section 4(a)
of the Administrative Procedure Act
(APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b)(B), the Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule because
immediate action is needed to provide
for the safety of life and property on
navigable waters. Because of the dangers
posed by the surf conditions during the
Mavericks Surf Competition, the special
local regulation is necessary to provide
for the safety of event participants,
spectators, spectator craft, and other
vessels transiting the event area. For the
safety concerns noted, it is in the public
interest to have these regulations in
effect during the event.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register. Any delay in the effective date
of this rule would expose mariners to
the dangers posed by the surf conditions
during the Mavericks Surf Competition.
Basis and Purpose
The Mavericks Surf Competition is a
one day ‘‘Big Wave’’ surfing competition
consisting of the top 24 big wave surfers
and only occurs when 15–20 foot waves
are sustained for over 24 hours and are
combined with mild easterly winds of
no more than 5–10 knots. Because
weather conditions are integral to the
occurrence of the Maverick Surf
Competition, the exact date of the event
cannot be determined in advance. The
rock and reef ridges that make up the
sea floor of the Pillar Point area
combined with just the right weather
conditions create the large waves that
Mavericks is known for. Due to the
treacherous terrain and un-navigable
areas surrounding Pillar Point, the Coast
Guard is establishing a special local
regulation within a 1,000 yard radius of
Pillar Point that restricts navigation near
the surf competition area and
neighboring treacherous terrain and
identifies the safest area for spectator
viewing on the water.
Discussion of Rule
The Coast Guard is establishing a
special local regulation within a 1,000
yard radius of Pillar Point in Half Moon
Bay. The Mavericks Surf Competition
will occur in the vicinity of Pillar Point
in the navigable waters of Half Moon
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8651
Bay, and the spectator viewing area will
be located inside the following
coordinates: 37°29.265′ N 122°30.165′
W, 37°29.248′ N 122°29.978′ W, and
37°29.406′ N 122°30.081′ W (NAD 83).
Competitors, participating agencies
(Coast Guard, San Mateo Police Marine
Patrol, Pillar Point Harbor Patrol, San
Mateo Fire Marine Patrol) and the
public (to include but not restricted to:
Commercial sightseeing vessels,
photographer platforms and recreational
boaters) will be given 48 hours notice
prior to the start of the one day
competition. This action is necessary to
ensure the safety of participants and
spectators during the event. During the
enforcement period, unauthorized
persons (persons not classified as
spectators, participants or participating
agencies) or vessels are prohibited from
transiting through, anchoring, blocking,
or loitering in the regulated area without
permission of the Captain of the Port
(COTP) or their designated
representative.
The effect of the temporary special
local regulation will be to regulate
navigation in the vicinity of Pillar Point
while the Mavericks Surf Competition is
taking place. Except for persons or
vessels authorized by the Coast Guard
Patrol Commander (persons classified as
spectators, participants or participating
agencies), no person or vessel may
transit within the bounds of the
regulated area. These regulations are
needed to keep spectators and vessels a
safe distance away from the event
participants and the un-navigable
waters surrounding Pillar Point and to
ensure the safety of participants,
spectators, and transiting vessels.
The Coast Guard will enforce the
temporary special local regulation from
8 a.m. to 3 p.m. on a date to be
determined. Notification of the
enforcement of the special local
regulation will be provided to the public
via broadcast notice to mariners, as well
as through advertising on local media.
Regulatory Analyses
We developed this rule after
considering numerous statutes and
executive orders related to rulemaking.
Below we summarize our analyses
based on 13 of these statutes or
executive orders.
Regulatory Planning and Review
This rule is not a significant
regulatory action under section 3(f) of
Executive Order 12866, Regulatory
Planning and Review, and does not
require an assessment of potential costs
and benefits under section 6(a)(3) of that
Order. The Office of Management and
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15FER1
]]>Agencies
[Federal Register Volume 76, Number 31 (Tuesday, February 15, 2011)]
[Rules and Regulations]
[Pages 8649-8651]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3403]
=======================================================================
-----------------------------------------------------------------------
PENSION BENEFIT GUARANTY CORPORATION
29 CFR Part 4022
Benefits Payable in Terminated Single-Employer Plans; Interest
Assumptions for Paying Benefits
AGENCY: Pension Benefit Guaranty Corporation.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule amends Pension Benefit Guaranty Corporation's
regulation on Benefits Payable in Terminated Single-Employer Plans to
prescribe interest assumptions under the regulation for valuation dates
in March 2011. Interest assumptions are also published on PBGC's Web
site (https://www.pbgc.gov).
DATES: Effective March 1, 2011.
[[Page 8650]]
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: PBGC's regulation on Benefits Payable in
Terminated Single-Employer Plans (29 CFR part 4022) prescribes
actuarial assumptions--including interest assumptions--for paying plan
benefits under terminating single-employer plans covered by title IV of
the Employee Retirement Income Security Act of 1974.
PBGC uses the interest assumptions in Appendix B to Part 4022 to
determine whether a benefit is payable as a lump sum and to determine
the amount to pay. Appendix C to Part 4022 contains interest
assumptions for private-sector pension practitioners to refer to if
they wish to use lump-sum interest rates determined using PBGC's
historical methodology. Currently, the rates in Appendices B and C of
the benefit payment regulation are the same.
The interest assumptions are intended to reflect current conditions
in the financial and annuity markets. Assumptions under the benefit
payments regulation are updated monthly. This final rule updates the
benefit payments interest assumptions for March 2011.\1\
---------------------------------------------------------------------------
\1\ Appendix B to PBGC's regulation on Allocation of Assets in
Single-Employer Plans (29 CFR part 4044) prescribes interest
assumptions for valuing benefits under terminating covered single-
employer plans for purposes of allocation of assets under ERISA
section 4044. Those assumptions are updated quarterly.
---------------------------------------------------------------------------
The March 2011 interest assumptions under the benefit payments
regulation will be 2.50 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. In comparison with the interest
assumptions in effect for February 2011, these interest assumptions are
unchanged.
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 payment
of benefits under plans with valuation dates during March 2011, PBGC
finds that good cause exists for making the assumptions set forth in
this amendment effective less than 30 days after publication.
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 in 29 CFR Part 4022
Employee benefit plans, Pension insurance, Pensions, Reporting and
recordkeeping requirements.
In consideration of the foregoing, 29 CFR part 4022 is amended as
follows:
PART 4022--BENEFITS PAYABLE IN TERMINATED SINGLE-EMPLOYER PLANS
0
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.
0
2. In appendix B to part 4022, Rate Set 209, as set forth below, is
added to the table.
Appendix B to Part 4022--Lump Sum Interest Rates for PBGC Payments
* * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
For plans with a valuation date Immediate Deferred annuities (percent)
Rate set ---------------------------------- annuity rate ------------------------------------------------------------------------------------
On or after Before (percent) i1 i2 i3 n1 n2
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
209 3-1-11 4-1-11 2.50 4.00 4.00 4.00 7 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
0
3. In appendix C to part 4022, Rate Set 209, as set forth below, is
added to the table.
Appendix C to Part 4022--Lump Sum Interest Rates for Private-Sector
Payments
* * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
For plans with a valuation date Immediate Deferred annuities (percent)
Rate set ---------------------------------- annuity rate ------------------------------------------------------------------------------------
On or after Before (percent) i1 i2 i3 n1 n2
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
209 3-1-11 4-1-11 2.50 4.00 4.00 4.00 7 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 8651]]
Issued in Washington, DC, on this 8th day of February 2011.
Vincent K. Snowbarger,
Deputy Director for Operations, Pension Benefit Guaranty Corporation.
[FR Doc. 2011-3403 Filed 2-14-11; 8:45 am]
BILLING CODE 7709-01-P
