Submission to OMB for Review; Federal Acquisition Regulation; Certification of Independent Price Determination and Parent Company and Identifying Data, 38317-38318 [2014-15639]
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Federal Register / Vol. 79, No. 129 / Monday, July 7, 2014 / Notices
FEDERAL RESERVE SYSTEM
DEPARTMENT OF DEFENSE
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
GENERAL SERVICES
ADMINISTRATION
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR Part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than July 31, 2014.
A. Federal Reserve Bank of St. Louis
(Yvonne Sparks, Community
Development Officer) P.O. Box 442, St.
Louis, Missouri 63166–2034:
1. First Light Bancorp, Evansville,
Indiana; to become a bank holding
company by acquiring 100 percent of
the voting shares of Evansville
Commerce Bank, Evansville, Indiana.
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
Board of Governors of the Federal Reserve
System, July 1, 2014.
Michele Taylor Fennell,
Assistant Secretary of the Board.
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[FR Doc. 2014–15746 Filed 7–3–14; 8:45 am]
BILLING CODE 6210–01–P
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[OMB Control No. 9000–0018; Docket 2014–
0055; Sequence 8]
Submission to OMB for Review;
Federal Acquisition Regulation;
Certification of Independent Price
Determination and Parent Company
and Identifying Data
Department of Defense (DOD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Notice of request for public
comments regarding an extension to an
existing OMB clearance.
AGENCY:
Under the provisions of the
Paperwork Reduction Act (44 U.S.C.
chapter 35), the Regulatory Secretariat
Division (MVCB) will be submitting to
the Office of Management and Budget
(OMB) a request to review and approve
an extension of a currently approved
information collection requirement
concerning certification of independent
price determination and parent
company and identifying data. A notice
was published in the Federal Register
on April 14, 2014. No comments were
received.
DATES: Submit comments on or before
August 6, 2014.
ADDRESSES: Submit comments
identified by Information Collection
9000–0018, Certification of Independent
Price Determination and Parent
Company and Identifying Data by any of
the following methods:
• Regulations.gov: https://
www.regulations.gov. Submit comments
via the Federal eRulemaking portal by
searching the OMB control number
9000–0018. Select the link ‘‘Comment
Now’’ that corresponds with
‘‘Information Collection 9000–0018,
Certification of Independent Price
Determination and Parent Company and
Identifying Data.’’ Follow the
instructions provided on the screen.
Please include your name, company
name (if any), and ‘‘Information
Collection 9000–0018, Certification of
Independent Price Determination and
Parent Company and Identifying Data’’
on your attached document.
• Fax: 202–501–4067.
• Mail: General Services
Administration, Regulatory Secretariat
Division (MVCB), 1800 F Street NW.,
Washington, DC 20405. ATTN: Ms.
Flowers/IC 9000–0018.
SUMMARY:
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38317
Instructions: Please submit comments
only and cite Information Collection
9000–0018, in all correspondence
related to this collection. All comments
received will be posted without change
to https://www.regulations.gov, including
any personal and/or business
confidential information provided.
FOR FURTHER INFORMATION CONTACT: Mr.
Edward Chambers, Procurement
Analyst, Federal Acquisition Policy
Division, GSA 202–501–3221 or
Edward.chambers@gsa.gov.
SUPPLEMENTARY INFORMATION:
A. Purpose
As a first step in assuring that
Government contracts are not awarded
to firms violating anti-trust laws,
offerors on Government contracts must
complete the certificate of independent
price determination. The Contracting
Officer will reject certificates where the
offeror has deleted or modified portions
of the certificate and has not furnished
with the certificate a signed statement of
the circumstances of disclosure of
prices. Agencies are required to report
to the Attorney General rejected offers
where the offeror deleted or modified
the certificate or the certificate is
suspected of being false.
The information collection is required
each time an offeror responds to a
solicitation for firm-fixed price contract
or fixed-price economic price
adjustment contract unless the
acquisition is: (1) Made under the
simplified acquisition threshold; (2) at
the request for technical proposals
under two-step sealed bidding
procedures; or (3) for utility services for
which rates are set by law or regulation.
The FAR rule requires a Certificate of
Independent Price Determination so that
contractors certify that the prices in
their offer have been arrived at
independently, have not been or will
not be knowingly disclosed, and have
not been submitted for the purpose of
restricting competition. This clause does
not apply to commercial items.
B. Annual Reporting Burden
A reassessment of FAR 3.103 and FAR
52.203–2 was performed. Based on the
comprehensive reassessment performed,
this information collection resulted in a
slight decrease in the annual number of
responses and an increase in the annual
time burden from the previous
information collection that was
published in the Federal Register at 76
FR 37353 on June 27, 2011. The
decrease in the annual number of
responses was likely a result of updated
Fiscal Year 2013 data obtained from the
Federal Procurement Data System. The
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38318
Federal Register / Vol. 79, No. 129 / Monday, July 7, 2014 / Notices
increase in the annual time burden
resulted from increases in the amount of
time necessary to research and prepares
the certification from .01 hours (less
than one minute) to .25 hours (15
minutes). No public comments were
received in prior years that have
challenged the validity of the
Government’s estimate.
Respondents: 13,486.
Responses per Respondent: 76.
Total Responses: 1,024,936.
Hours per Response: .25.
Total Burden hours: 256,234.
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary for the proper
performance of functions of the FAR,
and whether it will have practical
utility; whether our estimate of the
public burden of this collection of
information is accurate, and based on
valid assumptions and methodology;
ways to enhance the quality, utility, and
clarity of the information to be
collected; and ways in which we can
minimize the burden of the collection of
information on those who are to
respond, through the use of appropriate
technological collection techniques or
other forms of information technology.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405. ATTN: Ms. Flowers/IC 9000–
0018, telephone 202–501–4755.
Please cite OMB Control No. 9000–
0018, Certification of Independent Price
Determination and Parent Company and
Identifying Data, in all correspondence.
Dated: June 27, 2014.
Karlos Morgan,
Acting Director, Federal Acquisition Policy
Division, Office of Government-wide
Acquisition Policy, Office of Acquisition
Policy, Office of Government-wide Policy.
[FR Doc. 2014–15639 Filed 7–3–14; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2011–N–0085]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry: Cooperative Manufacturing
Arrangements for Licensed Biologics
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the proposed extension of the collection
of information concerning cooperative
manufacturing arrangements for
licensed biologics.
DATES: Submit either electronic or
written comments on the collection of
information by September 5, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
SUMMARY:
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the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance for Industry: Cooperative
Manufacturing Arrangements for
Licensed Biologics—(OMB Control
Number 0910–0629)—Extension
The guidance document provides
information concerning cooperative
manufacturing arrangements applicable
to biological products subject to
licensure under section 351 of the
Public Health Service Act (42 U.S.C.
262). The guidance addresses several
types of manufacturing arrangements
(i.e., short supply arrangements, divided
manufacturing arrangements, shared
manufacturing arrangements, and
contract manufacturing arrangements)
and describes certain reporting and
recordkeeping responsibilities,
associated with these arrangements,
including the following: (1) Notification
of all important proposed changes to
production and facilities; (2)
notification of results of tests and
investigations regarding or possibly
impacting the product; (3) notification
of products manufactured in a contract
facility; and (4) standard operating
procedures.
1. Notification of All Important
Proposed Changes to Production and
Facilities
Each licensed manufacturer in a
divided manufacturing arrangement or
shared manufacturing arrangement must
notify the appropriate FDA Center
regarding proposed changes in the
manufacture, testing, or specifications of
its product, in accordance with § 601.12
(21 CFR 601.12). In the guidance, we
recommend that each licensed
manufacturer that proposes such a
change should also inform other
participating licensed manufacturer(s)
of the proposed change.
For contract manufacturing
arrangements, we recommend that the
contract manufacturer should share
with the license manufacturer all
important proposed changes to
production and facilities (including
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]]>Agencies
[Federal Register Volume 79, Number 129 (Monday, July 7, 2014)]
[Notices]
[Pages 38317-38318]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15639]
=======================================================================
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DEPARTMENT OF DEFENSE
GENERAL SERVICES ADMINISTRATION
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
[OMB Control No. 9000-0018; Docket 2014-0055; Sequence 8]
Submission to OMB for Review; Federal Acquisition Regulation;
Certification of Independent Price Determination and Parent Company and
Identifying Data
AGENCY: Department of Defense (DOD), General Services Administration
(GSA), and National Aeronautics and Space Administration (NASA).
ACTION: Notice of request for public comments regarding an extension to
an existing OMB clearance.
-----------------------------------------------------------------------
SUMMARY: Under the provisions of the Paperwork Reduction Act (44 U.S.C.
chapter 35), the Regulatory Secretariat Division (MVCB) will be
submitting to the Office of Management and Budget (OMB) a request to
review and approve an extension of a currently approved information
collection requirement concerning certification of independent price
determination and parent company and identifying data. A notice was
published in the Federal Register on April 14, 2014. No comments were
received.
DATES: Submit comments on or before August 6, 2014.
ADDRESSES: Submit comments identified by Information Collection 9000-
0018, Certification of Independent Price Determination and Parent
Company and Identifying Data by any of the following methods:
Regulations.gov: https://www.regulations.gov. Submit
comments via the Federal eRulemaking portal by searching the OMB
control number 9000-0018. Select the link ``Comment Now'' that
corresponds with ``Information Collection 9000-0018, Certification of
Independent Price Determination and Parent Company and Identifying
Data.'' Follow the instructions provided on the screen. Please include
your name, company name (if any), and ``Information Collection 9000-
0018, Certification of Independent Price Determination and Parent
Company and Identifying Data'' on your attached document.
Fax: 202-501-4067.
Mail: General Services Administration, Regulatory
Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405.
ATTN: Ms. Flowers/IC 9000-0018.
Instructions: Please submit comments only and cite Information
Collection 9000-0018, in all correspondence related to this collection.
All comments received will be posted without change to https://www.regulations.gov, including any personal and/or business
confidential information provided.
FOR FURTHER INFORMATION CONTACT: Mr. Edward Chambers, Procurement
Analyst, Federal Acquisition Policy Division, GSA 202-501-3221 or
Edward.chambers@gsa.gov.
SUPPLEMENTARY INFORMATION:
A. Purpose
As a first step in assuring that Government contracts are not
awarded to firms violating anti-trust laws, offerors on Government
contracts must complete the certificate of independent price
determination. The Contracting Officer will reject certificates where
the offeror has deleted or modified portions of the certificate and has
not furnished with the certificate a signed statement of the
circumstances of disclosure of prices. Agencies are required to report
to the Attorney General rejected offers where the offeror deleted or
modified the certificate or the certificate is suspected of being
false.
The information collection is required each time an offeror
responds to a solicitation for firm-fixed price contract or fixed-price
economic price adjustment contract unless the acquisition is: (1) Made
under the simplified acquisition threshold; (2) at the request for
technical proposals under two-step sealed bidding procedures; or (3)
for utility services for which rates are set by law or regulation. The
FAR rule requires a Certificate of Independent Price Determination so
that contractors certify that the prices in their offer have been
arrived at independently, have not been or will not be knowingly
disclosed, and have not been submitted for the purpose of restricting
competition. This clause does not apply to commercial items.
B. Annual Reporting Burden
A reassessment of FAR 3.103 and FAR 52.203-2 was performed. Based
on the comprehensive reassessment performed, this information
collection resulted in a slight decrease in the annual number of
responses and an increase in the annual time burden from the previous
information collection that was published in the Federal Register at 76
FR 37353 on June 27, 2011. The decrease in the annual number of
responses was likely a result of updated Fiscal Year 2013 data obtained
from the Federal Procurement Data System. The
[[Page 38318]]
increase in the annual time burden resulted from increases in the
amount of time necessary to research and prepares the certification
from .01 hours (less than one minute) to .25 hours (15 minutes). No
public comments were received in prior years that have challenged the
validity of the Government's estimate.
Respondents: 13,486.
Responses per Respondent: 76.
Total Responses: 1,024,936.
Hours per Response: .25.
Total Burden hours: 256,234.
C. Public Comments
Public comments are particularly invited on: Whether this
collection of information is necessary for the proper performance of
functions of the FAR, and whether it will have practical utility;
whether our estimate of the public burden of this collection of
information is accurate, and based on valid assumptions and
methodology; ways to enhance the quality, utility, and clarity of the
information to be collected; and ways in which we can minimize the
burden of the collection of information on those who are to respond,
through the use of appropriate technological collection techniques or
other forms of information technology.
Obtaining Copies of Proposals: Requesters may obtain a copy of the
information collection documents from the General Services
Administration, Regulatory Secretariat Division (MVCB), 1800 F Street
NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 9000-0018, telephone
202-501-4755.
Please cite OMB Control No. 9000-0018, Certification of Independent
Price Determination and Parent Company and Identifying Data, in all
correspondence.
Dated: June 27, 2014.
Karlos Morgan,
Acting Director, Federal Acquisition Policy Division, Office of
Government-wide Acquisition Policy, Office of Acquisition Policy,
Office of Government-wide Policy.
[FR Doc. 2014-15639 Filed 7-3-14; 8:45 am]
BILLING CODE 6820-EP-P
