Submission for OMB Review; Comment Request, 46762-46763 [2012-19141]
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46762
Federal Register / Vol. 77, No. 151 / Monday, August 6, 2012 / Notices
b. The accuracy of the agencies’
estimate of the burden of the proposed
information collection, including the
validity of the methodology and
assumptions used;
c. Ways to enhance the quality,
utility, and clarity of the information to
be collected;
d. Ways to minimize the burden of
information collection on respondents,
including through the use of automated
collection techniques or other forms of
information technology; and
e. Estimates of capital or start up costs
and costs of operation, maintenance,
and purchase of services to provide
information.
Comments submitted in response to
this notice will be shared among the
agencies. All comments will become a
matter of public record.
Proposal To Extend for Three Years,
Without Revision, the Following
Currently Approved Collection of
Information
Report Title: Country Exposure Report
for U.S. Branches and Agencies of
Foreign Banks.
Form Number: FFIEC 019.
OMB Number: 7100–0213.
Frequency of Response: Quarterly.
Affected Public: U.S. branches and
agencies of foreign banks.
Estimated Number of Respondents:
168.
Estimated Average Time per
Response: 10 hours.
Estimated Total Annual Burden:
6,720 hours.
General Description of Report: This
information collection is mandatory: 12
U.S.C. 3906 for all agencies; 12 U.S.C.
3105 and 3108 for the Board; sections 7
and 10 of the Federal Deposit Insurance
Act (12 U.S.C. 1817, 1820) for the FDIC;
and the National Bank Act (12 U.S.C.
161) for the OCC. This information
collection is given confidential
treatment under the Freedom of
Information Act (5 U.S.C. 552(b)(8)).
Abstract: All individual U.S. branches
and agencies of foreign banks that have
more than $30 million in direct claims
on residents of foreign countries must
file the FFIEC 019 report quarterly.
Currently, all respondents report
adjusted exposure amounts to the five
largest countries having at least $20
million in total adjusted exposure. The
agencies collect this data to monitor the
extent to which such branches and
agencies are pursuing prudent country
risk diversification policies and limiting
potential liquidity pressures. No
changes are proposed to the FFIEC 019
reporting form or instructions.
Board of Governors of the Federal Reserve
System, July 31, 2012.
Robert deV. Frierson,
Deputy Secretary of the Board.
Middlefield, Ohio, and Emerald Bank,
Dublin; Ohio.
B. Federal Reserve Bank of Atlanta
(Chapelle Davis, Assistant Vice
President) 1000 Peachtree Street NE.,
Atlanta, Georgia 30309:
1. Moishe Gubin, Hillside, Illinois; to
acquire voting shares of OptimumBank
Holdings, Inc., Ft. Lauderdale, Florida,
and thereby indirectly acquire voting
shares of OptimumBank, Plantation,
Florida.
[FR Doc. 2012–19059 Filed 8–3–12; 8:45 am]
Board of Governors of the Federal Reserve
System, August 1, 2012.
Michael J. Lewandowski,
Assistant Secretary of the Board.
BILLING CODE 6210–01–P
[FR Doc. 2012–19092 Filed 8–3–12; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL RESERVE SYSTEM
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
The notificants listed below have
applied under the Change in Bank
Control Act (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire shares of a bank
or bank holding company. The factors
that are considered in acting on the
notices are set forth in paragraph 7 of
the Act (12 U.S.C. 1817(j)(7)).
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
the offices of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices
of the Board of Governors. Comments
must be received not later than August
21, 2012.
A. Federal Reserve Bank of Cleveland
(Nadine Wallman, Vice President) 1455
East Sixth Street, Cleveland, Ohio
44101–2566:
1. Opportunity Fund, LLC; Bank
Opportunity Advisors LLC; and Bank
Acquisitions LLC, all in Washington,
DC; to acquire voting shares of
Middlefield Banc Corp., and thereby
indirectly acquire voting shares of The
Middlefield Banking Company, both in
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Extension to HS Transportation
Requirement.
OMB No.: 0970–0260.
Description: The Office of Head Start
is proposing to renew authority to
collect information regarding the Head
Start transportation requirement
without changes. The transportation
requirement provides the requirement
that each child be seated in a child
restraint system while the vehicle is in
motion, and the requirement that each
bus have at least one bus monitor on
board at all times. Waivers would be
granted when the Head Start or Early
Head Start grantee demonstrates that
compliance with the requirement(s) for
which the waiver is being sought will
result in a significant disruption to the
Head Start program or the Early Head
Start program and that waiving the
requirement(s) is in the best interest of
the children involved.
Respondents: Head Start and Early
Head Start program grants recipients.
ANNUAL BURDEN ESTIMATES
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
Burden Hours
per Response
Total Burden
Hours
Form .................................................................................................................
275
1
1
275
Estimated Total Annual Burden
Hours: 275.
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Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
E:\FR\FM\06AUN1.SGM
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Federal Register / Vol. 77, No. 151 / Monday, August 6, 2012 / Notices
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email:
OIRA_SUBMISSION@OMB.EOP.GOV
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–19141 Filed 8–3–12; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0724]
Documents to Support Submission of
an Electronic Common Technical
Document; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the following final
versions of documents that support
making regulatory submissions in
electronic format using the electronic
Common Technical Document (eCTD)
specifications: ‘‘The eCTD Backbone
Files Specification for Module 1,
version 2.0’’ (which includes the U.S.
regional document type definition
(DTD), version 3.0) and
‘‘Comprehensive Table of Contents
Headings and Hierarchy, version 2.0.’’
Supporting technical files are also being
made available on the Agency Web site.
These documents represent FDA’s major
updates to Module 1 of the eCTD, which
contains regional information. FDA is
not prepared at present to accept
submissions utilizing this new version
because eCTD software vendors need
time to update their software to
accommodate this information and
because its use will require software
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:11 Aug 03, 2012
Jkt 226001
upgrades within the Agency. FDA
estimates it will be able to receive
submissions utilizing Module 1
Specifications 2.0 by September 2013,
but this is not a firm date and we will
give 30 days advance notice to industry.
ADDRESSES: Submit written requests for
single copies of the documents to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm 2201,
Silver Spring, MD 20993–0002; or Office
of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the documents.
FOR FURTHER INFORMATION CONTACT:
Virginia Hussong, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm 1161,
Silver Spring, MD 20993, email:
Esub@fda.hhs.gov; or Mary Padgett,
Center for Biologics Evaluation and
Research (HFM–25), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852, 301–
827–0373, email:
mary.padgett@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The eCTD is an International
Conference on Harmonisation (ICH)
standard based on specifications
developed by ICH and its member
parties. FDA’s Center for Drug
Evaluation and Research (CDER) and
Center for Biologics Evaluation and
Research (CBER) have been receiving
submissions in the eCTD format since
2003, and the eCTD has been the
standard for electronic submissions to
CDER and CBER since January 1, 2008.
The majority of new electronic
submissions are now received in eCTD
format. Since adoption of the eCTD
standard, it has become necessary to
update the administrative portion of the
eCTD (Module 1) to reflect regulatory
changes, to provide clarification of
business rules for submission
processing and review, to refine the
characterization of promotional
marketing and advertising material, and
to facilitate automated processing of
submissions. In preparation for the
Module 1 update, FDA made available
draft technical documentation for public
comment in a Federal Register notice
dated October 26, 2011 (Docket No.
PO 00000
Frm 00083
Fmt 4703
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46763
FDA–2011–N–0724). After considering
comments submitted, FDA revised the
draft documentation and is making
available final versions of the following
documents:
• ‘‘The eCTD Backbone Files
Specification for Module 1, version
2.0,’’ which provides specifications for
creating the eCTD backbone file for
Module 1 for submission to CDER and
CBER. It should be used in conjunction
with the guidance for industry
‘‘Providing Regulatory Submissions in
Electronic Format—Human
Pharmaceutical Product Applications
and Related Submissions Using the
eCTD Specifications,’’ which can be
found online (https://www.fda.gov/
downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
UCM072349.pdf), and which will be
revised as part of the implementation of
the updated eCTD backbone files
specification.
• ‘‘Comprehensive Table of Contents
Headings and Hierarchy, version 2.0,’’
which reflects updated headings that are
specified in the draft document entitled
‘‘The eCTD Backbone Files
Specification for Module 1, version
2.0,’’ as well as mappings to regulations
and legislation.
Supporting technical files are also
being made available on the Agency
Web site. The documents include
changes that:
• Allow submission of promotional
label and advertising materials to CDER
in eCTD format;
• Provide for processing of grouped
submissions (e.g., a supplement that can
be applied to more than one new drug
application or biologics license
application);
• Provide detailed contact
information so that companies can
specify points of contact to discuss
technical matters that may arise with a
submission;
• Clarify headings;
• Use attributes in place of certain
headings to provide flexibility for future
changes without revising the
specification itself.
FDA is not prepared at present to
accept submissions utilizing this new
version because eCTD software vendors
need time to update their software to
accommodate this information and
because its use will require software
upgrades within the Agency. FDA
estimates it will be able to receive
submissions utilizing Module 1
Specifications 2.0 by September 2013,
but this is not a firm date and we will
give 30 days advance notice to industry.
E:\FR\FM\06AUN1.SGM
06AUN1
]]>Agencies
[Federal Register Volume 77, Number 151 (Monday, August 6, 2012)]
[Notices]
[Pages 46762-46763]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19141]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Extension to HS Transportation Requirement.
OMB No.: 0970-0260.
Description: The Office of Head Start is proposing to renew
authority to collect information regarding the Head Start
transportation requirement without changes. The transportation
requirement provides the requirement that each child be seated in a
child restraint system while the vehicle is in motion, and the
requirement that each bus have at least one bus monitor on board at all
times. Waivers would be granted when the Head Start or Early Head Start
grantee demonstrates that compliance with the requirement(s) for which
the waiver is being sought will result in a significant disruption to
the Head Start program or the Early Head Start program and that waiving
the requirement(s) is in the best interest of the children involved.
Respondents: Head Start and Early Head Start program grants
recipients.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average Burden
Instrument Number of responses per Hours per Total Burden
respondents respondent Response Hours
----------------------------------------------------------------------------------------------------------------
Form........................................ 275 1 1 275
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 275.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 370 L'Enfant Promenade
SW., Washington,
[[Page 46763]]
DC 20447, Attn: ACF Reports Clearance Officer. All requests should be
identified by the title of the information collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Fax: 202-395-
7285, Email: OIRA_SUBMISSION@OMB.EOP.GOV Attn: Desk Officer for the
Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012-19141 Filed 8-3-12; 8:45 am]
BILLING CODE 4184-01-P
