Protecting the Privacy of Workers: Labor Standards Provisions Applicable to Contracts Covering Federally Financed and Assisted Construction, Effectiveness of Information Collection Requirements, 2862 [E9-675]
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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
Agencies
[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Rules and Regulations]
[Page 2862]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-675]
=======================================================================
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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
AGENCY: Department of Labor, Employment Standards Administration, Wage
and Hour Division.
ACTION: OMB approval of information collection requirements.
-----------------------------------------------------------------------
SUMMARY: 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 effectiveness of information
collection requirements contained in a final rule.
DATES: The amendments to Sec. Sec. 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 Davis-Bacon 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 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 PRA-required 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