Allocation of Assets in Single-Employer Plans; Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Valuing and Paying Benefits, 14274-14275 [2012-5786]
Download as PDF
<![CDATA[
14274
Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Rules and Regulations
reasonable assurance of the safety and
effectiveness of the device. For this type
of device, FDA has determined because
of the risks of false positives and false
negatives that premarket notification is
necessary to provide reasonable
assurance of the safety and effectiveness
of the device and, therefore, this type of
device is not exempt from premarket
notification requirements. Persons who
intend to market this type of device
must submit to FDA a premarket
notification, prior to marketing the
device, which contains information
about the norovirus serological reagents
they intend to market.
erowe on DSK2VPTVN1PROD with RULES
V. Environmental Impact
The Agency has determined under
21 CFR 25.34(b) that this action is of
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,
Executive Order 13563, the Regulatory
Flexibility Act (Pub. L. 96–354)
(5 U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4). Executive Orders 12866 and
13563 direct 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 proposed rule is not a
significant regulatory action as defined
by Executive Order 12866.
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 is
deregulatory and imposes no new
burdens, the Agency proposes to certify
that the final rule will not have a
significant economic impact on a
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 proposing ‘‘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
VerDate Mar<15>2010
15:10 Mar 08, 2012
Jkt 226001
after adjustment for inflation is $136
million, using the most current (2010)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this proposed 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. Section 4(a)
of the Executive Order requires
Agencies to ‘‘construe * * * a Federal
statute to preempt State law only where
the statute contains an express
preemption provision or there is some
other clear evidence that the Congress
intended preemption of State law, or
where the exercise of State authority
conflicts with the exercise of Federal
authority under the Federal statute.’’
Federal law includes an express
preemption provision that preempts
certain state requirements ‘‘different or
in addition to’’ certain federal
requirements applicable to devices.
21 U.S.C. 360k; See Medtronic v. Lohr,
518 U.S. 470 (1996); Riegel v.
Medtronic, Inc., 552 U.S. 312 (2008).
The special controls established by this
rulemaking create ‘‘requirements’’ to
address each identified risk to health
presented by these specific medical
devices under 21 U.S.C. 360k, even
though product sponsors may have
flexibility in how they meet those
requirements. Cf. Papike v. Tambrands,
Inc., 107 F.3d 737, 740–42 (9th Cir.
1997).
VIII. Paperwork Reduction Act of 1995
This final rule establishes as special
controls a guidance document that
refers to previously approved
collections of information found in
other FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520).
Elsewhere in this issue of the Federal
Register, FDA is publishing a notice
announcing the availability of the
guidance document entitled ‘‘Class II
Special Controls Guidance Document:
Norovirus Serological Reagents.’’ The
notice contains an analysis of the
paperwork burden for the guidance.
IX. References
The following reference has been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
1. Petition from R-Biopharm AG, c/o
Lehnus and Associates, dated February
15, 2011.
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, 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 866 is
amended as follows:
PART 866—IMMUNOLOGY AND
MICROBIOLOGY DEVICES
1. The authority citation for 21 CFR
part 866 continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Section 866.3395 is added to
subpart D to read as follows:
■
§ 866.3395
Norovirus serological reagents.
(a) Identification. Norovirus
serological reagents are devices that
consist of antigens and antisera used in
serological tests to detect the presence
of norovirus antigens in fecal samples.
These devices aid in the diagnosis of
norovirus infection in the setting of an
individual patient with symptoms of
acute gastroenteritis when the
individual patient is epidemiologically
linked to other patients with symptoms
of acute gastroenteritis and/or aid in the
identification of norovirus as the
etiology of an outbreak of acute
gastroenteritis in the setting of
epidemiologically linked patients with
symptoms of acute gastroenteritis.
(b) Classification. Class II (special
controls). The special control is FDA’s
guidance document entitled ‘‘Class II
Special Controls Guidance Document:
Norovirus Serological Reagents.’’ See
§ 866.1(e) for the availability of this
guidance document.
Dated: March 5, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2012–5675 Filed 3–8–12; 8:45 am]
BILLING CODE 4160–01–P
PENSION BENEFIT GUARANTY
CORPORATION
29 CFR Part 4044
Allocation of Assets in SingleEmployer Plans; Benefits Payable in
Terminated Single-Employer Plans;
Interest Assumptions for Valuing and
Paying Benefits
Pension Benefit Guaranty
Corporation.
AGENCY:
E:\FR\FM\09MRR1.SGM
09MRR1
14275
Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Rules and Regulations
ACTION:
Correcting amendments.
The Pension Benefit Guaranty
Corporation published a final rule
document in the Federal Register on
September 15, 2011 (at 76 FR 56973),
amending its regulations on Benefits
Payable in Terminated Single-Employer
Plans and Allocation of Assets in
Single-Employer Plans to prescribe
interest assumptions under those
regulations. This document corrects an
inadvertent error in that final rule
relating to the prescribed interest
assumption under the allocation
regulation, applicable to plans with
valuation dates during the fourth
quarter of 2011.
DATES: Effective March 9, 2012.
FOR FURTHER INFORMATION CONTACT:
Catherine B. Klion
(Klion.Catherine@PBGC.gov), 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
SUMMARY:
free at 1–800–877–8339 and ask to be
connected to 202–326–4024.)
SUPPLEMENTARY INFORMATION: The
Pension Benefit Guaranty Corporation
published a final rule document in the
Federal Register of September 15, 2011
(at 76 FR 56973), amending its
regulations on Benefits Payable in
Terminated Single-Employer Plans and
Allocation of Assets in Single-Employer
Plans to prescribe interest assumptions
under those regulations. The rule
inadvertently misstated the prescribed
interest assumptions under the
allocation regulation, applicable to
plans with valuation dates during the
fourth quarter of 2011. The errors
appeared both in the preamble and in
the amendatory instructions.
In the preamble, the first full
paragraph in the second column on p.
56974 should have read as follows:
The fourth quarter 2011 interest
assumptions under the allocation regulation
will be 4.09 percent for the first 20 years
following the valuation date and 4.30 percent
thereafter. In comparison with the interest
assumptions in effect for the third quarter of
2011, these interest assumptions represent no
change in the select period (the period during
which the select rate (the initial rate)
applies), a decrease of 0.13 percent in the
select rate, and a decrease of 0.04 percent in
the ultimate rate (the final rate).
List of Subjects in 29 CFR Part 4044
Employee benefit plans, Pension
insurance, Pensions.
In consideration of the foregoing,
29 CFR part 4044 is corrected by making
the following correcting amendment:
PART 4044—ALLOCATION OF
ASSETS IN SINGLE-EMPLOYER
PLANS
1. The authority citation for part 4044
continues to read as follows:
■
Authority: 29 U.S.C. 1301(a), 1302(b)(3),
1341, 1344, 1362.
2. In appendix B to part 4044, the
entry for October–December 2011 is
corrected to read as follows:
■
Appendix B to Part 4044—Interest
Rates Used To Value Benefits
*
*
*
*
*
The values of it are:
For valuation dates occurring in the months—
it
*
*
*
October–December 2011 .................................................
*
*
[FR Doc. 2012–5786 Filed 3–8–12; 8:45 am]
BILLING CODE 7709–01–P
PENSION BENEFIT GUARANTY
CORPORATION
29 CFR Part 4044
Allocation of Assets in SingleEmployer Plans; Benefits Payable in
Terminated Single-Employer Plans;
Interest Assumptions for Valuing and
Paying Benefits
Pension Benefit Guaranty
Corporation.
ACTION: Correcting amendments.
erowe on DSK2VPTVN1PROD with RULES
AGENCY:
The Pension Benefit Guaranty
Corporation published a final rule
document in the Federal Register on
June 15, 2011 (at 76 FR 34847),
amending its regulations on Benefits
Payable in Terminated Single-Employer
SUMMARY:
VerDate Mar<15>2010
15:10 Mar 08, 2012
Jkt 226001
it
for t =
1–20
*
0.0430
>20
*
0.0409
*
Issued in Washington, DC, on this 6th day
of March 2012.
Laricke Blanchard,
Deputy Director for Policy, Pension Benefit
Guaranty Corporation.
for t =
*
PO 00000
Frm 00007
Fmt 4700
*
*
Plans and Allocation of Assets in
Single-Employer Plans to prescribe
interest assumptions under those
regulations. This document corrects an
inadvertent error in that final rule
relating to the prescribed interest
assumption under the allocation
regulation, applicable to plans with
valuation dates during the third quarter
of 2011.
DATES: Effective March 9, 2012.
FOR FURTHER INFORMATION CONTACT:
Catherine B. Klion
(Klion.Catherine@PBGC.gov), 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
Pension Benefit Guaranty Corporation
published a final rule document in the
Federal Register of June 15, 2011 (at 76
FR 34847), amending its regulations on
Benefits Payable in Terminated Single-
Sfmt 4700
it
for t =
*
N/A
*
N/A
*
Employer Plans and Allocation of
Assets in Single-Employer Plans to
prescribe interest assumptions under
those regulations. The rule
inadvertently misstated the prescribed
interest assumptions under the
allocation regulation, applicable to
plans with valuation dates during the
third quarter of 2011. The errors
appeared both in the preamble and in
the amendatory instructions.
In the preamble, the third full
paragraph in the second column on p.
34847 should have read as follows:
The third quarter 2011 interest
assumptions under the allocation regulation
will be 4.22 percent for the first 20 years
following the valuation date and 4.34 percent
thereafter. In comparison with the interest
assumptions in effect for the second quarter
of 2011, these interest assumptions represent
no change in the select period (the period
during which the select rate (the initial rate)
applies), an increase of 0.26 percent in the
select rate, and an increase of 0.02 percent in
the ultimate rate (the final rate).
List of Subjects in 29 CFR Part 4044
Employee benefit plans, Pension
insurance, Pensions.
E:\FR\FM\09MRR1.SGM
09MRR1
]]>Agencies
[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Rules and Regulations]
[Pages 14274-14275]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5786]
=======================================================================
-----------------------------------------------------------------------
PENSION BENEFIT GUARANTY CORPORATION
29 CFR Part 4044
Allocation of Assets in Single-Employer Plans; Benefits Payable
in Terminated Single-Employer Plans; Interest Assumptions for Valuing
and Paying Benefits
AGENCY: Pension Benefit Guaranty Corporation.
[[Page 14275]]
ACTION: Correcting amendments.
-----------------------------------------------------------------------
SUMMARY: The Pension Benefit Guaranty Corporation published a final
rule document in the Federal Register on September 15, 2011 (at 76 FR
56973), amending its regulations on Benefits Payable in Terminated
Single-Employer Plans and Allocation of Assets in Single-Employer Plans
to prescribe interest assumptions under those regulations. This
document corrects an inadvertent error in that final rule relating to
the prescribed interest assumption under the allocation regulation,
applicable to plans with valuation dates during the fourth quarter of
2011.
DATES: Effective March 9, 2012.
FOR FURTHER INFORMATION CONTACT: Catherine B. Klion
(Klion.Catherine@PBGC.gov), 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 Pension Benefit Guaranty Corporation
published a final rule document in the Federal Register of September
15, 2011 (at 76 FR 56973), amending its regulations on Benefits Payable
in Terminated Single-Employer Plans and Allocation of Assets in Single-
Employer Plans to prescribe interest assumptions under those
regulations. The rule inadvertently misstated the prescribed interest
assumptions under the allocation regulation, applicable to plans with
valuation dates during the fourth quarter of 2011. The errors appeared
both in the preamble and in the amendatory instructions.
In the preamble, the first full paragraph in the second column on
p. 56974 should have read as follows:
The fourth quarter 2011 interest assumptions under the
allocation regulation will be 4.09 percent for the first 20 years
following the valuation date and 4.30 percent thereafter. In
comparison with the interest assumptions in effect for the third
quarter of 2011, these interest assumptions represent no change in
the select period (the period during which the select rate (the
initial rate) applies), a decrease of 0.13 percent in the select
rate, and a decrease of 0.04 percent in the ultimate rate (the final
rate).
List of Subjects in 29 CFR Part 4044
Employee benefit plans, Pension insurance, Pensions.
In consideration of the foregoing, 29 CFR part 4044 is corrected by
making the following correcting amendment:
PART 4044--ALLOCATION OF ASSETS IN SINGLE-EMPLOYER PLANS
0
1. The authority citation for part 4044 continues to read as follows:
Authority: 29 U.S.C. 1301(a), 1302(b)(3), 1341, 1344, 1362.
0
2. In appendix B to part 4044, the entry for October-December 2011 is
corrected to read as follows:
Appendix B to Part 4044--Interest Rates Used To Value Benefits
* * * * *
----------------------------------------------------------------------------------------------------------------
The values of it are:
For valuation dates -----------------------------------------------------------------------------------
occurring in the months-- it for t = it for t = it for t =
----------------------------------------------------------------------------------------------------------------
* * * * * * *
October-December 2011....... 0.0409 1-20 0.0430 >20 N/A N/A
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Issued in Washington, DC, on this 6th day of March 2012.
Laricke Blanchard,
Deputy Director for Policy, Pension Benefit Guaranty Corporation.
[FR Doc. 2012-5786 Filed 3-8-12; 8:45 am]
BILLING CODE 7709-01-P
