Agency Information Collection Activities; Proposed Collection; Comment Request; Senior Legal Helplines Operating Within Model Approaches to Statewide Legal Assistance Systems Demonstrations, 45446-45447 [2014-18463]
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Federal Register / Vol. 79, No. 150 / Tuesday, August 5, 2014 / Notices
participate in the Refugee Resettlement
program.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ORR–1, Cash and Medical Assistance Program Estimates ...........................
46
1
0.60
27.60
Estimated Total Annual Burden
Hours: 27.60.
In compliance with the requirements
of Section 506(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.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–18468 Filed 8–4–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Senior Legal
Helplines Operating Within Model
Approaches to Statewide Legal
Assistance Systems Demonstrations
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) 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
proposed information collection
requirements relating to Senior Legal
Helplines (SLHs) operating within
Model Approaches to Statewide Legal
Assistance Systems Demonstrations.
DATES: Submit written or electronic
comments on the collection of
information by October 6, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to: Omar.Valverde@acl.gov
Submit written comments on the
collection of information to
Administration on Aging, Washington,
DC 20201, attention Omar Valverde.
FOR FURTHER INFORMATION CONTACT:
Omar Valverde, Aging Services Program
Specialist, Administration for
Community Living, Administration on
Aging, Washington, DC 20201, (202)
357–3514.
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.
SUMMARY:
PO 00000
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‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency request
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, ACL is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the anticipated
collection of information, ACL invites
comments on: (1) Whether the proposed
collection of information is necessary
for the proper performance of ACL’s
functions, including whether the
information will have practical utility;
(2) the accuracy of ACL’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.
Senior Legal Helplines (SLHs) funded
by Title IV of the Older Americans, and
operating as part of Model Approaches
to Statewide Legal Assistance Systems
(Model Approaches) demonstration
Grants play an important role within
statewide legal service delivery systems
and are designed to provide a limited
scope of assistance on a wide range of
legal issues such as consumer
protection, housing, income security,
healthcare financing, and elder abuse
prevention. It is important to capture
information that accurately illustrates
the range and type of legal assistance
being provided by the SLHs to older
persons in the most social or economic
need, without being overly burdensome
to providers responsible for collecting
the data. The anticipate data collected
E:\FR\FM\05AUN1.SGM
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Federal Register / Vol. 79, No. 150 / Tuesday, August 5, 2014 / Notices
and reported by SLHs participating in
ACL-funded Model Approaches projects
will be comparable from one SLH to
another and apply standard/uniform
terminology consistently across Model
Approaches projects. The consistent and
uniform data will be used to illustrate
the effectiveness of Model Approaches
states in reaching key target populations
under the OAA with much needed
‘‘priority’’ legal assistance through
SLHs. The data collected will also
inform and drive ongoing ACL policy
related to increasing the number of
states that have a SLH as a sustained,
and permanent feature of integrated and
cost effective legal service delivery
systems targeted to those most in need.
Anticipated data collection and
reporting requirements would apply to
SLHs operating as lead partners in 2014
Model Approaches Phase I and Phase II,
with a total of 11 SLHs operational
during the 3 year project period.
ACL estimates the burden of this
collection of information as follows: 11
SLHs would be asked to respond
annually pursuant to data collection
tools that should require an average
burden of 2.5 hours per SLH per year or
a total 27.5 hours for all complying
SLHs operating under Model
Approaches projects. The proposed data
collection tools may be found on the
CERA Web site for review at: https://
www.legalhotlines.org/uploads/1/6/9/1/
16912868/reportingguidelinesforsenior
legalhelplines.pdf.
Dated: July 31, 2014.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2014–18463 Filed 8–4–14; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–1161]
Design Considerations for Devices
Intended for Home Use; Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Design Considerations for Devices
Intended for Home Use.’’ This
document is intended to assist
manufacturers in designing and
developing home use medical devices
SUMMARY:
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that comply with applicable standards
of safety and effectiveness and other
regulatory requirements. Devices used
in the home or other non-clinical
environments are associated with
unique risks created by the interactions
among the user (often a layperson), the
use environment, and the device. This
document identifies several factors that
manufacturers should consider,
especially during device design and
development, and provides
recommendations for minimizing these
unique risks.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Design
Considerations for Devices Intended for
Home Use’’ to the Office of the Center
Director, Guidance and Policy
Development, Center for Devices and
Radiological Health (CDRH), Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993–0002.
Alternatively, you may submit written
requests for single copies of the
guidance 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 the
office that you are ordering from to
assist that office in processing your
request.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: For
information concerning the guidance as
it relates to devices regulated by CDRH:
Mary Brady, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5426, Silver Spring,
MD 20993–0002, 301–796–6089.
For information concerning the
guidance as it relates to devices
regulated by CBER: Stephen Ripley,
PO 00000
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45447
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
For a variety of reasons, use of devices
outside professional healthcare facilities
is on the rise. First, the U.S. population
is aging, and the elderly are more likely
to live with chronic diseases that
require daily medical care at home.
Second, due to medical advancements,
many individuals with chronic diseases
are living longer but are dependent on
home medical care. Finally, an
increasing focus on reducing healthcare
costs for patients of all ages has spurred
the growth of the home health care
market. Integral to the home health care
market are home use devices. Although
home use devices provide significant
benefits to patients and families,
including quality of life improvements
and cost savings, they are also
associated with unique risks.
Minimizing the risks posed by home use
devices can greatly improve the public
health.
This guidance provides
recommendations for designing and
developing medical devices intended
for home use through considerations
involving the physical environment, the
user, the device or system, the labeling,
and human factors. This should result
in a safe and easier-to-use device,
minimize use error, and reduce the
likelihood that adverse events will
occur. The recommendations in the
guidance apply to both prescription and
over-the-counter medical devices that
are intended for use in the home or
other non-clinical environments.
In the Federal Register of December
13, 2012 (77 FR 74195), FDA announced
the availability of the draft guidance
document. Interested persons were
invited to comment by March 13, 2013.
FDA reviewed the comments and
revised the guidance as appropriate.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on design
considerations for devices intended for
home use. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
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]]>Agencies
[Federal Register Volume 79, Number 150 (Tuesday, August 5, 2014)]
[Notices]
[Pages 45446-45447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18463]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Proposed Collection;
Comment Request; Senior Legal Helplines Operating Within Model
Approaches to Statewide Legal Assistance Systems Demonstrations
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living (ACL) 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 proposed information
collection requirements relating to Senior Legal Helplines (SLHs)
operating within Model Approaches to Statewide Legal Assistance Systems
Demonstrations.
DATES: Submit written or electronic comments on the collection of
information by October 6, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to: Omar.Valverde@acl.gov
Submit written comments on the collection of information to
Administration on Aging, Washington, DC 20201, attention Omar Valverde.
FOR FURTHER INFORMATION CONTACT: Omar Valverde, Aging Services Program
Specialist, Administration for Community Living, Administration on
Aging, Washington, DC 20201, (202) 357-3514.
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 request 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, ACL is publishing notice of the proposed collection
of information set forth in this document.
With respect to the anticipated collection of information, ACL
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of ACL's functions, including
whether the information will have practical utility; (2) the accuracy
of ACL'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.
Senior Legal Helplines (SLHs) funded by Title IV of the Older
Americans, and operating as part of Model Approaches to Statewide Legal
Assistance Systems (Model Approaches) demonstration
Grants play an important role within statewide legal service
delivery systems and are designed to provide a limited scope of
assistance on a wide range of legal issues such as consumer protection,
housing, income security, healthcare financing, and elder abuse
prevention. It is important to capture information that accurately
illustrates the range and type of legal assistance being provided by
the SLHs to older persons in the most social or economic need, without
being overly burdensome to providers responsible for collecting the
data. The anticipate data collected
[[Page 45447]]
and reported by SLHs participating in ACL-funded Model Approaches
projects will be comparable from one SLH to another and apply standard/
uniform terminology consistently across Model Approaches projects. The
consistent and uniform data will be used to illustrate the
effectiveness of Model Approaches states in reaching key target
populations under the OAA with much needed ``priority'' legal
assistance through SLHs. The data collected will also inform and drive
ongoing ACL policy related to increasing the number of states that have
a SLH as a sustained, and permanent feature of integrated and cost
effective legal service delivery systems targeted to those most in
need. Anticipated data collection and reporting requirements would
apply to SLHs operating as lead partners in 2014 Model Approaches Phase
I and Phase II, with a total of 11 SLHs operational during the 3 year
project period.
ACL estimates the burden of this collection of information as
follows: 11 SLHs would be asked to respond annually pursuant to data
collection tools that should require an average burden of 2.5 hours per
SLH per year or a total 27.5 hours for all complying SLHs operating
under Model Approaches projects. The proposed data collection tools may
be found on the CERA Web site for review at: https://www.legalhotlines.org/uploads/1/6/9/1/16912868/reportingguidelinesforseniorlegalhelplines.pdf.
Dated: July 31, 2014.
Kathy Greenlee,
Administrator and Assistant Secretary for Aging.
[FR Doc. 2014-18463 Filed 8-4-14; 8:45 am]
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