Proposed Information Collection Activity; ORR Data Collection for the Annual Survey of Refugees (OMB #0907-0033), 34395-34396 [2019-15274]
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34395
Federal Register / Vol. 84, No. 138 / Thursday, July 18, 2019 / Notices
which protects from disclosure ‘‘trade
secrets and commercial or financial
information obtained from a person
[that is] privileged or confidential.’’
Current actions: On April 17, 2019,
the Board published a notice in the
Federal Register (84 FR 16015)
requesting public comment for 60 days
on the extension, without revision, of
the FR 2436. The comment period for
this notice expired on June 17, 2019.
The Board did not receive any
comments.
Board of Governors of the Federal Reserve
System, July 15, 2019.
Michele Taylor Fennell,
Assistant Secretary of the Board.
[FR Doc. 2019–15312 Filed 7–17–19; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL RESERVE SYSTEM
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
indicated or the offices of the Board of
Governors not later than August 12,
2019.
A. Federal Reserve Bank of New York
(Ivan Hurwitz, Senior Vice President) 33
Liberty Street, New York, New York
10045–0001. Comments can also be sent
electronically to
Comments.applications@ny.frb.org:
1. Banco Bradesco, S.A., Lecce
Holdings S.A., Fundac
¸a˜o Bradesco, BBD
Participac¸o˜es S.A., Nova Cidade de
Deus Participac¸o˜es S.A., and Cidade de
Deus Cia. Comercial de Participac
¸o˜es,
all of Osasco, Sa˜o Paulo, Brazil; to
become bank holding companies by
acquiring substantially all of the shares
of BAC Florida Bank, Coral Gables,
Florida.
B. Federal Reserve Bank of Chicago
(Colette A. Fried, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690–1414:
1. Brodhead Bancshares, Inc.,
Brodhead, Wisconsin; to acquire 100
percent of the voting shares of Farmers
and Merchants Bank of Orfordville,
Orfordville, Wisconsin.
Board of Governors of the Federal Reserve
System, July 12, 2019.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2019–15250 Filed 7–17–19; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; ORR Data Collection for the
Annual Survey of Refugees (OMB
#0907–0033)
Office of Refugee Resettlement;
Administration for Children and
Families; HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF) within the
U.S. Department of Health and Human
Services (HHS) seeks an update to the
SUMMARY:
existing data collection for the Annual
Survey of Refugees. The Annual Survey
of Refugees is a yearly sample survey of
refugee households entering the U.S. in
the previous five fiscal years. The
requested update is based upon results
of a multi-year effort in instrument
redesign and field testing. ACF
estimates the proposed changes will
increase response burden from 30 to 45
minutes per respondent.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
the Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing
OPREinfocollection@acf.hhs.gov.
Alternatively, copies can also be
obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests,
emailed or written should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: Data from the Annual
Survey of Refugees are used to meet the
Office of Refugee Resettlement’s
Congressional reporting requirements,
as set forth in the Refugee Act of 1980
(Section 413(a) of the Immigration and
Nationality Act). The Office of Refugee
Resettlement makes survey findings
available to the general public and uses
findings for the purposes of program
planning, policy-making, and budgeting.
The requested update reflects changes
to the survey instrument to: Enhance
ORR’s understanding of refugees’
resettlement experiences; streamline the
collection of household-level
information; and improve data
reliability and validity.
Respondents: The Annual Survey of
Refugees secures a nationally
representative sample of refugee
households arriving in the United States
in the previous five fiscal years.
khammond on DSKBBV9HB2PROD with NOTICES
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
ORR–9 (Annual Survey of Refugees) .................................
Pre-Survey Information Form ..............................................
VerDate Sep<11>2014
17:56 Jul 17, 2019
Jkt 247001
PO 00000
Frm 00064
Annual
number of
respondents
6000
6000
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
2000
2000
E:\FR\FM\18JYN1.SGM
1
1
18JYN1
Average
burden hours
per response
.75
.05
Annual
burden hours
1500
100
34396
Federal Register / Vol. 84, No. 138 / Thursday, July 18, 2019 / Notices
Estimated Total Annual Burden
Hours: 1,600
Comments: The Department
specifically requests comments 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) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Sec. 413. [8 U.S.C. 1523]
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–15274 Filed 7–17–19; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0976]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance:
Emergency Use Authorization of
Medical Products and Related
Authorities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 19,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0595. Also
include the FDA docket number found
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:56 Jul 17, 2019
Jkt 247001
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867 PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Guidance: Emergency Use
Authorization of Medical Products and
Related Authorities
OMB Control Number 0910–0595—
Extension
The guidance describes the Agency’s
policies applicable to the authorization
of the emergency use of certain medical
products under sections 564, 564A, and
564B of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360bbb–3, 360bbb–3a, and 360bbb–3b),
as amended or added by the Project
BioShield Act of 2004 (Pub. L. 108–
276), the Pandemic and All-Hazards
Preparedness Reauthorization Act of
2013 (Pub. L. 113–5), 21st Century
Cures Act (Pub. L. 114–255), and Public
Law 115–92 (2017). The FD&C Act
permits the FDA Commissioner (the
Commissioner) to authorize the use of
unapproved medical products or
unapproved uses of approved medical
products during an emergency declared
under section 564 of the FD&C Act. The
data to support issuance of an
emergency use authorization (EUA)
must demonstrate that, based on the
totality of the scientific evidence
available to the Commissioner,
including data from adequate and wellcontrolled clinical trials (if available), it
is reasonable to believe that the product
may be effective in diagnosing, treating,
or preventing a serious or lifethreatening disease or condition (21
U.S.C. 360bbb–3(c)). Although the exact
type and amount of data needed to
support an EUA may vary depending on
the nature of the declared emergency
and the nature of the candidate product,
FDA recommends that a request for
consideration for an EUA include
scientific evidence evaluating the
product’s safety and effectiveness,
including the adverse event profile for
diagnosis, treatment, or prevention of
the serious or life-threatening disease or
condition, as well as data and other
information on safety, effectiveness,
risks and benefits, and (to the extent
available) alternatives.
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
Under section 564 of the FD&C Act,
the Commissioner may establish
conditions on the authorization. Section
564(e) requires the Commissioner (to the
extent practicable given the
circumstances of the emergency) to
establish certain conditions on an
authorization that the Commissioner
finds necessary or appropriate to protect
the public health and permits the
Commissioner to establish other
conditions that he or she finds
necessary or appropriate to protect the
public health. Conditions authorized by
section 564(e) of the FD&C Act include,
for example: Requirements for
information dissemination to healthcare
providers or authorized dispensers and
product recipients; adverse event
monitoring and reporting; data
collection and analysis; recordkeeping
and records access; restrictions on
product advertising, distribution, and
administration; and limitations on good
manufacturing practices requirements.
Some conditions, the statute specifies,
are mandatory to the extent practicable
for authorizations of unapproved
products and discretionary for
authorizations of unapproved uses of
approved products. Moreover, some
conditions may apply to manufacturers
of an EUA product, while other
conditions may apply to any person
who carries out any activity for which
the authorization is issued. Section 564
of the FD&C Act also gives the
Commissioner authority to establish
other conditions on an authorization
that he or she finds to be necessary or
appropriate to protect the public health.
Additionally, sections 564A and 564B
established streamlined mechanisms to
facilitate preparedness and response
activities involving certain FDAapproved products without requiring
FDA to issue an EUA, including
expiration date extension authority.
For purposes of estimating the annual
burden of reporting (table 1), FDA has
established four categories of
respondents: (1) Those who file a
request for FDA to issue an EUA or a
substantive amendment to an EUA that
has previously been issued, assuming
that a requisite declaration under
section 564 of the FD&C Act has been
made and criteria for issuance have
been met; (2) those who submit a
request for FDA to review information/
data (i.e., a pre-EUA package) for a
candidate EUA product or a substantive
amendment to an existing pre-EUA
package for preparedness purposes; (3)
manufacturers who carry out an activity
related to an unapproved EUA product
(e.g., administering product,
disseminating information) who must
E:\FR\FM\18JYN1.SGM
18JYN1
]]>Agencies
[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Notices]
[Pages 34395-34396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15274]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; ORR Data Collection for
the Annual Survey of Refugees (OMB #0907-0033)
AGENCY: Office of Refugee Resettlement; Administration for Children
and Families; HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF) within the
U.S. Department of Health and Human Services (HHS) seeks an update to
the existing data collection for the Annual Survey of Refugees. The
Annual Survey of Refugees is a yearly sample survey of refugee
households entering the U.S. in the previous five fiscal years. The
requested update is based upon results of a multi-year effort in
instrument redesign and field testing. ACF estimates the proposed
changes will increase response burden from 30 to 45 minutes per
respondent.
DATES: Comments due within 60 days of publication. In compliance with
the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995, the Administration for Children and Families is soliciting
public comment on the specific aspects of the information collection
described above.
ADDRESSES: Copies of the proposed collection of information can be
obtained and comments may be forwarded by emailing
[email protected]. Alternatively, copies can also be
obtained by writing to the Administration for Children and Families,
Office of Planning, Research, and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE Reports Clearance Officer. All
requests, emailed or written should be identified by the title of the
information collection.
SUPPLEMENTARY INFORMATION:
Description: Data from the Annual Survey of Refugees are used to
meet the Office of Refugee Resettlement's Congressional reporting
requirements, as set forth in the Refugee Act of 1980 (Section 413(a)
of the Immigration and Nationality Act). The Office of Refugee
Resettlement makes survey findings available to the general public and
uses findings for the purposes of program planning, policy-making, and
budgeting.
The requested update reflects changes to the survey instrument to:
Enhance ORR's understanding of refugees' resettlement experiences;
streamline the collection of household-level information; and improve
data reliability and validity.
Respondents: The Annual Survey of Refugees secures a nationally
representative sample of refugee households arriving in the United
States in the previous five fiscal years.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Total number Annual number responses per hours per Annual burden
of respondents of respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ORR-9 (Annual Survey of 6000 2000 1 .75 1500
Refugees)......................
Pre-Survey Information Form..... 6000 2000 1 .05 100
----------------------------------------------------------------------------------------------------------------
[[Page 34396]]
Estimated Total Annual Burden Hours: 1,600
Comments: The Department specifically requests comments 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) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Authority: Sec. 413. [8 U.S.C. 1523]
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-15274 Filed 7-17-19; 8:45 am]
BILLING CODE 4184-45-P
