60 Day FRN

Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Notices
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
11, 2015.
A. Federal Reserve Bank of Dallas
(Robert L. Triplett III, Senior Vice
President) 2200 North Pearl Street,
Dallas, Texas 75201–2272:
1. Happy Bancshares, Inc., Employee
Stock Ownership Plan with 401(k)
Provisions, Vicki Wilmarth, Trustee,
Amarillo, Texas; to acquire voting
shares of Happy Bancshares, Inc.,
Canyon, Texas, and thereby indirectly
acquire voting shares of Happy State
Bank, Happy, Texas.
Board of Governors of the Federal Reserve
System, July 22, 2015.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2015–18310 Filed 7–24–15; 8:45 am]
BILLING CODE 6210–01–P

FEDERAL RESERVE SYSTEM

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Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
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

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indicated or the offices of the Board of
Governors not later than August 21,
2015.
A. Federal Reserve Bank of Chicago
(Colette A. Fried, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690–1414:
1. Heartland Financial USA, Inc.,
Dubuque, Iowa; to acquire 100 percent
of the voting shares of Premier Valley
Bank, Fresno, California.
B. Federal Reserve Bank of
Minneapolis (Jacquelyn K. Brunmeier,
Assistant Vice President) 90 Hennepin
Avenue, Minneapolis, Minnesota
55480–0291:
1. Stearns Financial Services, Inc.,
Employee Stock Ownership Plan, Saint
Cloud, Minnesota, to retain and acquire
additional voting shares, for a total up
to 32.48 percent of the voting shares of
Stearns Financial Services, Inc., Saint
Cloud, Minnesota, and thereby
indirectly increase its control of Stearns
Bank National Association, Saint Cloud,
Minnesota, Stearns Bank of Upsala,
National Association, Upsala,
Minnesota, and Stearns Bank of
Holdingford, National Association,
Holdingford, Minnesota.
Board of Governors of the Federal Reserve
System, July 22, 2015.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2015–18312 Filed 7–24–15; 8:45 am]
BILLING CODE 6210–01–P

FEDERAL RESERVE SYSTEM
Notice of Proposals To Engage in or
To Acquire Companies Engaged in
Permissible Nonbanking Activities
The companies listed in this notice
have given notice under section 4 of the
Bank Holding Company Act (12 U.S.C.
1843) (BHC Act) and Regulation Y, (12
CFR part 225) to engage de novo, or to
acquire or control voting securities or
assets of a company, including the
companies listed below, that engages
either directly or through a subsidiary or
other company, in a nonbanking activity
that is listed in § 225.28 of Regulation Y
(12 CFR 225.28) or that the Board has
determined by Order to be closely
related to banking and permissible for
bank holding companies. Unless
otherwise noted, these activities will be
conducted throughout the United States.
Each notice is available for inspection
at the Federal Reserve Bank indicated.
The notice also will be available for
inspection at the offices of the Board of
Governors. Interested persons may
express their views in writing on the
question whether the proposal complies

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with the standards of section 4 of the
BHC Act.
Unless otherwise noted, comments
regarding the notices must be received
at the Reserve Bank indicated or the
offices of the Board of Governors not
later than August 21, 2015.
A. Federal Reserve Bank of Boston
(Prabal Chakrabarti, Senior Vice
President) 600 Atlantic Avenue, Boston,
Massachusetts 02210–2204:
1. South Shore Mutual Holding
Company, Weymouth, Massachusetts; to
acquire Satuit MHC, and indirectly
acquire Scituate Federal Savings Bank,
both in Scituate, Massachusetts, and
thereby engage in operating a savings
and loan association, pursuant to
section 225.28(b)(4)(ii).
Board of Governors of the Federal Reserve
System, July 22, 2015.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2015–18311 Filed 7–24–15; 8:45 am]
BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–15–15AWV; Docket No. CDC–2015–
0060]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on an information collection
pertaining to the collection of
tuberculosis-related information from
United States Panel Physicians.
DATES: Written comments must be
received on or before September 25,
2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0060 by any of the following methods:
• Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
SUMMARY:

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44356

Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Notices

• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.

To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
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FOR FURTHER INFORMATION CONTACT:

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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.
Burden means the total time, effort, or
financial resources expended by persons
to generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Information Collection for
Tuberculosis Data from Panel
Physicians—An Existing Collection in
Use Without an OMB Control Number—
National Center for Emerging and
Zoonotic Infections Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention’s (CDC), National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Division of Global
Migration and Quarantine (DGMQ),
Immigrant, Refugee, and Migrant Health
Branch (IRMH), requests approval for a
new information collection to request
quarterly reports on certain tuberculosis
data from U.S. panel physicians.
The respondents are panel physicians.
More than 760 panel physicians perform
overseas pre-departure medical
examinations in accordance with
requirements, referred to as technical
instructions, provided by the Centers for
Disease Control and Prevention’s
Division of Global Migration and
Quarantine, Quality Assessment
Program (QAP). The role of QAP is to
assist and guide panel physicians in the
implementation of the Technical
Instructions; evaluate the quality of the
overseas medical examination for U.S.bound immigrants and refugees; assess
potential panel physician sites; and

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provide recommendations to the U.S.
Department of State in matters of
immigrant medical screening.
To achieve DGMQ’s mission, the
Immigrant, Refugee and Migrant Health
branch (IRMH) works with domestic
and international programs to improve
the health of U.S.-bound immigrants
and refugees to protect the U.S. public
by preventing the importation of
infectious disease. These goals are
accomplished through IRMH’s oversight
of medical exams required for all U.S.bound immigrants and refugees who
seek permanent residence in the U.S.
IRMH is responsible for assisting and
training the international panel
physicians with the implementation of
medical exam Technical Instructions
(TI). Technical Instructions are detailed
requirements and national policies
regarding the medical screening and
treatment of all U.S.-bound immigrants
and refugees.
Screening for tuberculosis (TB) is a
particularly important component of the
immigration medical exam and allows
panel physicians to diagnose active TB
disease prior to arrival in the United
States. As part of the Technical
Instructions requirements, panel
physicians perform chest x-rays and
laboratory tests that aid in the
identification of tuberculosis infection
(Class B1 applicants) and diagnosis of
active tuberculosis disease (Class A,
inadmissible applicants). CDC uses
these classifications to report new
immigrant and refugee arrivals with a
higher risk of developing TB disease to
U.S. state and local health departments
for further follow-up. Some information
that panel physicians collect as part of
the medical exam is not reported on the
standard Department of State forms (DSforms), thereby preventing CDC from
evaluating TB trends in globally mobile
populations and monitoring program
effectiveness.
Currently, CDC is requesting this data
to be sent by panel physicians once per
year. The consequences of reducing this
frequency would be the loss of
monitoring program impact and TB
burdens in mobile populations and
immigrants and refugees coming to the
United States on an annual basis. There
is no cost to the respondents other than
their time.

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Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Notices

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ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Number of
respondents

TB Indicators Excel Spreadsheet.

353

..............................................

..............................

Type of respondents

International Panel Physicians (All sites).
TOTAL ..........................

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–18301 Filed 7–24–15; 8:45 am]
BILLING CODE 4163–18–P

Number of
responses per
respondent

................................

0910–0796. The approval expires on
June 30, 2018. A copy of the supporting
statement for this information collection
is available on the Internet at http://
www.reginfo.gov/public/do/PRAMain.
Dated: July 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P

Food and Drug Administration

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[Docket No. FDA–2014–N–0987]

Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Generic Clearance for the Collection of
Qualitative Data on Tobacco Products
and Communications
AGENCY:

Food and Drug Administration,

ACTION:

[Docket No. FDA–2014–D–0103]

Analytical Procedures and Methods
Validation for Drugs and Biologics;
Guidance for Industry; Availability
AGENCY:
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘Generic Clearance for the Collection of
Qualitative Data on Tobacco Products
and Communications’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
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: On
December 10, 2014, the Agency
submitted a proposed collection of
information entitled, ‘‘Generic
Clearance for the Collection of
Qualitative Data on Tobacco Products
and Communications’’ to OMB for
review and clearance under 44 U.S.C.
3507. An Agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. OMB has now
approved the information collection and
has assigned OMB control number
SUMMARY:

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Food and Drug Administration

Food and Drug Administration,

HHS.

HHS.

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Notice.

The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Analytical Procedures and
Methods Validation for Drugs and
Biologics.’’ This guidance supersedes
the draft of the same name that
published on February 19, 2014, and
replaces the 2000 draft guidance for
industry on ‘‘Analytical Procedures and
Methods Validation’’ and the 1987 FDA
guidance for industry on ‘‘Submitting
Samples and Analytical Data for
Methods Validation.’’ This guidance
discusses how to submit analytical
procedures and methods validation data
to support the documentation of the
identity, strength, quality, purity, and
potency of drug substances and drug
products.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Office of Communications, Division of
Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Bldg., 4th
SUMMARY:

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Total burden
hours

7.5

2,648

..............................

2,648

1

[FR Doc. 2015–18295 Filed 7–24–15; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Average
burden
per response
(in hours)

Floor, Silver Spring, MD 20993, or to
the Office of Communication, Outreach
and Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at
1–800–835–4709 or 240–402–7800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
guidance to http://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Room 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Lucinda Buhse, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2130,
Silver Spring, MD 20993–0002, 240–
402–4595, or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Analytical Procedures and Methods
Validation for Drugs and Biologics.’’
This guidance supersedes the draft of
the same name that published on
February 19, 2014, and replaces the
2000 draft guidance for industry on
‘‘Analytical Procedures and Methods
Validation’’ and the 1987 FDA guidance
for industry on ‘‘Submitting Samples
and Analytical Data for Methods
Validation.’’ It discusses how to submit
analytical procedures and methods
validation data to support the
documentation of the identity, strength,
quality, purity, and potency of drug
substances and drug products, and how
to assemble information and present

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