The Family and Medical Leave Act of 1993, Effectiveness of Information Collection Requirements, 2862-2863 [E9-674]
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Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations
manufacture from the formulation
submitted for approval, but are similar
enough to be relevant to the agency’s
determination of bioequivalence.
■ 6. Amend § 320.21 by revising the
section heading and paragraph (b)(1) to
read as follows:
§ 320.21 Requirements for submission of
bioavailability and bioequivalence data.
*
*
*
*
*
(b) * * *
(1) Evidence demonstrating that the
drug product that is the subject of the
abbreviated new drug application is
bioequivalent to the reference listed
drug (defined in § 314.3(b) of this
chapter). A complete study report must
be submitted for the bioequivalence
study upon which the applicant relies
for approval. For all other
bioequivalence studies conducted on
the same drug product formulation, the
applicant must submit either a complete
or summary report. If a summary report
of a bioequivalence study is submitted
and FDA determines that there may be
bioequivalence issues or concerns with
the product, FDA may require that the
applicant submit a complete report of
the bioequivalence study to FDA; or
*
*
*
*
*
Dated: January 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–884 Filed 1–15–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF LABOR
Wage and Hour Division
29 CFR Parts 3 and 5
Protecting the Privacy of Workers:
Labor Standards Provisions Applicable
to Contracts Covering Federally
Financed and Assisted Construction,
Effectiveness of Information Collection
Requirements
Department of Labor,
Employment Standards Administration,
Wage and Hour Division.
ACTION: OMB approval of information
collection requirements.
AGENCY:
The Office of Management
and Budget (OMB) has approved under
the Paperwork Reduction Act (PRA)
information collection requirements
contained in recently revised final
regulations published by the
Department of Labor in the Federal
Register on December 19, 2008. The
PRA requires this notice to set forth the
sroberts on PROD1PC70 with RULES
SUMMARY:
VerDate Nov<24>2008
16:34 Jan 15, 2009
Jkt 217001
effectiveness of information collection
requirements contained in a final rule.
DATES: The amendments to §§ 3.3(b) and
5.5(a)(3)(ii)(A) and (B)(1) published in
the Federal Register on December 19,
2008 (73 FR 77504) have been approved
by OMB and are effective January 18,
2009.
ADDRESSES: Written comments
regarding the burden-hour estimates or
other aspects of the information
collection requirements contained in 29
CFR parts 3 and 5 may be submitted to:
Administrator, Wage and Hour Division,
Room S3502, 200 Constitution Avenue,
NW., Washington DC 20210.
FOR FURTHER INFORMATION CONTACT:
Richard M. Brennan, Director, Division
of Interpretations and Regulatory
Analysis, Wage and Hour Division,
Employment Standards Administration,
U.S. Department of Labor, Room S–
3506, 200 Constitution Avenue, NW.,
Washington, DC 20210; telephone: (202)
693–0051.
Questions of interpretation and/or
enforcement of regulations referenced in
this notice may be directed to the
nearest Wage and Hour Division (WHD)
District Office. Locate the nearest office
by calling the WHD toll-free help line at
(866) 4US–WAGE ((866) 487–9243)
between 8 a.m. and 5 p.m. in your local
time zone, or log onto the WHD’s Web
site for a nationwide listing of WHD
District and Area Offices at: https://
www.dol.gov/esa/whd/america2.htm.
This notice is available through the
printed Federal Register and
electronically via the https://
www.gpoaccess.gov/fr/ Web
site.
Copies of this notice may be obtained
in alternative formats (Large Print,
Braille, Audio Tape or Disc), upon
request, by calling (202) 693–0023.
TTY/TDD callers may dial toll-free (877)
889–5627 to obtain information or
request materials in alternative formats.
SUPPLEMENTARY INFORMATION: On
December 30, 2008, the Office of
Management and Budget (OMB)
approved under the PRA the
Department of Labor’s information
collection request for requirements in 29
CFR 5.5(a)(3)(ii)(A), and
5.5(a)(3)(ii)(B)(1), as published in the
Federal Register on December 19, 2008.
See 73 FR 77504. The current expiration
date for OMB authorization for this
information collection is December 31,
2011. The regulations implement DavisBacon and Related Acts and the
Copeland Anti-Kickback Act
requirements, and the regulatory
changes reduce respondent burden and
improve privacy protections for laborers
and mechanics employed on federally
PO 00000
Frm 00106
Fmt 4700
Sfmt 4700
financed or assisted construction
contracts by lessening the transmission
of personal information regarding
individuals who work on contracts
subject to Davis-Bacon Act labor
standards. The preamble to the new
regulations stated a general effective
date of January 18, 2009; however, the
OMB had not yet provided a PRArequired approval for the revised
information collection requirements
contained in 29 CFR 3.3, 5.5(a)(3)(ii)(A),
and 5.5(a)(3)(ii)(B)(1) at the time of their
publication. 44 U.S.C. 3507(a)(2). An
agency may not conduct an information
collection unless it has a currently valid
OMB approval; therefore, in accordance
with the PRA, the effective date of the
information collection requirements in
the revised regulations was delayed
until the OMB approved them under the
PRA. 44 U.S.C. 3506(c)(1)(B)(iii)(V). On
December 30, 2008, the OMB approved
the Department’s information collection
request under Control Number 1215–
0149; thus, giving effect to the
requirements, as announced and
published in the Federal Register on
December 18, 2008, under the PRA. The
current expiration date for OMB
authorization for this information
collection is December 31, 2011.
Dated: January 9, 2009.
Victoria A. Lipnic,
Assistant Secretary, Employment Standards
Administration.
Alexander J. Passantino,
Acting Administrator, Wage and Hour
Division.
[FR Doc. E9–675 Filed 1–15–09; 8:45 am]
BILLING CODE 4510–27–P
DEPARTMENT OF LABOR
Wage and Hour Division
29 CFR Part 825
The Family and Medical Leave Act of
1993, Effectiveness of Information
Collection Requirements
AGENCY: Department of Labor,
Employment Standards Administration,
Wage and Hour Division.
ACTION: OMB approval of information
collection requirements.
SUMMARY: On December 14, 2008, the
Office of Management and Budget
(OMB) approved under the Paperwork
Reduction Act (PRA) the Department of
Labor’s information collection request
for requirements regarding Family and
Medical Leave Act regulations, as
published in the Federal Register on
November 17, 2008. The PRA requires
this notice to set forth the effectiveness
E:\FR\FM\16JAR1.SGM
16JAR1
sroberts on PROD1PC70 with RULES
Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations
of information collection requirements
contained in a final rule.
DATES: The final rule published in the
Federal Register on November 17, 2008
(73 FR 67934) has been approved by
OMB and is effective January 16, 2009.
The current expiration date for OMB
authorization for this information
collection is December 31, 2011.
ADDRESSES: Written comments
regarding the burden-hour estimates or
other aspects of the information
collection requirements contained in 29
CFR part 825 may be submitted to:
Administrator, Wage and Hour Division,
Room S3502, 200 Constitution Avenue,
NW., Washington DC 20210.
FOR FURTHER INFORMATION CONTACT:
Richard M. Brennan, Director, Division
of Interpretations and Regulatory
Analysis, Wage and Hour Division,
Employment Standards Administration,
U.S. Department of Labor, Room S–
3506, 200 Constitution Avenue, NW.,
Washington, DC 20210; telephone: (202)
693–0051 (this is not a toll-free
number).
Questions of interpretation and/or
enforcement of regulations referenced in
this notice may be directed to the
nearest Wage and Hour Division (WHD)
District Office. Locate the nearest office
by calling the WHD toll-free help line at
(866) 4US–WAGE ((866) 487–9243)
between 8 a.m. and 5 p.m. in your local
time zone, or log onto the WHD’s Web
site for a nationwide listing of WHD
District and Area Offices at: https://
www.dol.gov/esa/whd/america2.htm.
This notice is available through the
printed Federal Register and
electronically via the https://
www.gpoaccess.gov/fr/ Web
site.
Copies of this notice may be obtained
in alternative formats (Large Print,
Braille, Audio Tape or Disc), upon
request, by calling (202) 693–0023 (not
a toll-free number). TTY/TDD callers
may dial toll-free (877) 889–5627 to
obtain information or request materials
in alternative formats.
SUPPLEMENTARY INFORMATION: The Office
of Management and Budget (OMB) has
approved under the PRA information
collection requirements contained in
recently revised final regulations under
the Family and Medical Leave Act
published by the Department of Labor in
the Federal Register on November 17,
2008. See 73 FR 67934. The preamble to
the new regulations stated an effective
date of January 18, 2009; however, the
OMB had not yet provided a PRArequired approval for the revised
information collection requirements
contained in the revised FMLA rules at
the time of their publication. 44 U.S.C.
VerDate Nov<24>2008
16:34 Jan 15, 2009
Jkt 217001
3507(a)(2). An agency may not conduct
an information collection unless it has
a currently valid OMB approval;
therefore, in accordance with the PRA,
the effective date of the information
collection requirements in the revised
regulations was delayed until the OMB
approved them under the PRA. 44
U.S.C. 3506(c)(1)(B)(iii)(V). On
December 14, 2008, the OMB approved
the Department’s information collection
request under Control Number 1215–
0181; thus, giving effect to the
requirements, as announced and
published in the Federal Register on
November 17, 2008, under the PRA. The
current expiration date for OMB
authorization for this information
collection is December 31, 2011.
Dated: January 9, 2009.
Victoria A. Lipnic,
Assistant Secretary, Employment Standards
Administration.
Alexander J. Passantino,
Acting Administrator, Wage and Hour
Division.
[FR Doc. E9–674 Filed 1–15–09; 8:45 am]
BILLING CODE 4510–27–P
PENSION BENEFIT GUARANTY
CORPORATION
29 CFR Part 4022
Benefits Payable in Terminated SingleEmployer Plans; Interest Assumptions
for Valuing and Paying Benefits
AGENCY: Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
SUMMARY: Pension Benefit Guaranty
Corporation’s regulation on Benefits
Payable in Terminated Single-Employer
Plans prescribes interest assumptions
for valuing and paying certain benefits
under terminating single-employer
plans. This final rule amends the benefit
payments regulation to adopt interest
assumptions for plans with valuation
dates in February 2009. As discussed
below, this final rule does not address
the interest assumptions under PBGC’s
regulation on Allocation of Assets in
Single-Employer Plans. Interest
assumptions are also published on
PBGC’s Web site (https://www.pbgc.gov).
DATES: Effective February 1, 2009.
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–
PO 00000
Frm 00107
Fmt 4700
Sfmt 4700
2863
877–8339 and ask to be connected to
202–326–4024.)
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.
These interest assumptions are found
in two PBGC regulations: the regulation
on Benefits Payable in Terminated
Single-Employer Plans (29 CFR Part
4022) and the regulation on Allocation
of Assets in Single-Employer Plans (29
CFR Part 4044). Before 2009, PBGC
updated the assumptions under the two
regulations each month in a single
rulemaking document. In a final rule
published in the Federal Register on
December 29, 2008 (at 73 FR 79362),
PBGC announced a change in its
practice for determining the interest
assumptions for use under the asset
allocation regulation. As explained in
the preamble to that final rule (73 FR
79362 at 79363), the new practice leads
to assumptions that remain unchanged
within a calendar quarter. Accordingly,
the assumptions published December
29, 2008, remain in effect for January,
February, and March 2009, and need not
be updated for February 2009. Thus this
final rule document updates the benefit
payments regulation only. Similarly,
future updates to the asset allocation
regulation will be made quarterly rather
than monthly; between quarterly
updates of the asset allocation
regulation, only the benefit payment
regulation will be updated each month.
Two sets of interest assumptions are
prescribed under the benefit payments
regulation: (1) A set for PBGC to use to
determine whether a benefit is payable
as a lump sum and to determine lumpsum amounts to be paid by PBGC (found
in Appendix B to Part 4022), and (2) a
set for private-sector pension
practitioners to refer to if they wish to
use lump-sum interest rates determined
using PBGC’s historical methodology
(found in Appendix C to Part 4022).
This amendment (1) adds to
Appendix B to Part 4022 the interest
assumptions for PBGC to use for its own
lump-sum payments in plans with
valuation dates during February 2009,
and (2) adds to Appendix C to Part 4022
the interest assumptions for privatesector pension practitioners to refer to if
they wish to use lump-sum interest rates
determined using PBGC’s historical
SUPPLEMENTARY INFORMATION:
E:\FR\FM\16JAR1.SGM
16JAR1
Agencies
[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Rules and Regulations]
[Pages 2862-2863]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-674]
-----------------------------------------------------------------------
DEPARTMENT OF LABOR
Wage and Hour Division
29 CFR Part 825
The Family and Medical Leave Act of 1993, Effectiveness of
Information Collection Requirements
AGENCY: Department of Labor, Employment Standards Administration, Wage
and Hour Division.
ACTION: OMB approval of information collection requirements.
-----------------------------------------------------------------------
SUMMARY: On December 14, 2008, the Office of Management and Budget
(OMB) approved under the Paperwork Reduction Act (PRA) the Department
of Labor's information collection request for requirements regarding
Family and Medical Leave Act regulations, as published in the Federal
Register on November 17, 2008. The PRA requires this notice to set
forth the effectiveness
[[Page 2863]]
of information collection requirements contained in a final rule.
DATES: The final rule published in the Federal Register on November 17,
2008 (73 FR 67934) has been approved by OMB and is effective January
16, 2009. The current expiration date for OMB authorization for this
information collection is December 31, 2011.
ADDRESSES: Written comments regarding the burden-hour estimates or
other aspects of the information collection requirements contained in
29 CFR part 825 may be submitted to: Administrator, Wage and Hour
Division, Room S3502, 200 Constitution Avenue, NW., Washington DC
20210.
FOR FURTHER INFORMATION CONTACT: Richard M. Brennan, Director, Division
of Interpretations and Regulatory Analysis, Wage and Hour Division,
Employment Standards Administration, U.S. Department of Labor, Room S-
3506, 200 Constitution Avenue, NW., Washington, DC 20210; telephone:
(202) 693-0051 (this is not a toll-free number).
Questions of interpretation and/or enforcement of regulations
referenced in this notice may be directed to the nearest Wage and Hour
Division (WHD) District Office. Locate the nearest office by calling
the WHD toll-free help line at (866) 4US-WAGE ((866) 487-9243) between
8 a.m. and 5 p.m. in your local time zone, or log onto the WHD's Web
site for a nationwide listing of WHD District and Area Offices at:
https://www.dol.gov/esa/whd/america2.htm.
This notice is available through the printed Federal Register and
electronically via the https://www.gpoaccess.gov/fr/ Web site.
Copies of this notice may be obtained in alternative formats (Large
Print, Braille, Audio Tape or Disc), upon request, by calling (202)
693-0023 (not a toll-free number). TTY/TDD callers may dial toll-free
(877) 889-5627 to obtain information or request materials in
alternative formats.
SUPPLEMENTARY INFORMATION: The Office of Management and Budget (OMB)
has approved under the PRA information collection requirements
contained in recently revised final regulations under the Family and
Medical Leave Act published by the Department of Labor in the Federal
Register on November 17, 2008. See 73 FR 67934. The preamble to the new
regulations stated an effective date of January 18, 2009; however, the
OMB had not yet provided a PRA-required approval for the revised
information collection requirements contained in the revised FMLA rules
at the time of their publication. 44 U.S.C. 3507(a)(2). An agency may
not conduct an information collection unless it has a currently valid
OMB approval; therefore, in accordance with the PRA, the effective date
of the information collection requirements in the revised regulations
was delayed until the OMB approved them under the PRA. 44 U.S.C.
3506(c)(1)(B)(iii)(V). On December 14, 2008, the OMB approved the
Department's information collection request under Control Number 1215-
0181; thus, giving effect to the requirements, as announced and
published in the Federal Register on November 17, 2008, under the PRA.
The current expiration date for OMB authorization for this information
collection is December 31, 2011.
Dated: January 9, 2009.
Victoria A. Lipnic,
Assistant Secretary, Employment Standards Administration.
Alexander J. Passantino,
Acting Administrator, Wage and Hour Division.
[FR Doc. E9-674 Filed 1-15-09; 8:45 am]
BILLING CODE 4510-27-P