Agency Information Collection Activities; Proposed Collection; Comment Request; National Adult Maltreatment Reporting System; [OMB# 0985-0054], 11088-11089 [2020-03842]
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11088
Federal Register / Vol. 85, No. 38 / Wednesday, February 26, 2020 / Notices
• Aid hospices with their internal
quality improvement efforts and
external benchmarking with other
facilities; and
• Provide CMS with information for
monitoring the care provided.
CAHPS is a standardized family of
surveys developed by the Agency for
Healthcare Research and Quality
(AHRQ) for patients to assess and report
the quality of care they receive from
their health care providers and health
care delivery systems.
CMS announced its intention to
implement the CAHPS® Hospice Survey
in the FY 2014 Hospice Wage Index and
Payment Rate Update; Hospice Quality
Reporting Requirements; and Updates
on Payment Reform. National
implementation of the survey launched
on January 1, 2015 with hospices
administering the survey for a ‘‘dry run’’
for at least one month in the first quarter
of 2015. Starting April 1, 2015 (second
quarter), hospices were required to
participate on a monthly basis in order
to receive the full Annual Payment
Update (APU). Implementation is
ongoing and there have been no changes
to the questionnaire.
Publicly reporting comparative survey
results related to patients’ perspectives
of the care they receive from providers
and plans collected through the
Consumer Assessment of Healthcare
Providers and Systems (CAHPS®)
Surveys support CMS’s efforts to put
patients first and improve the
beneficiary experience. Form Number:
CMS–10537 (OMB control number:
0938–1257); Frequency: Yearly; Affected
Public: Individuals and Households;
Number of Respondents: 1,032,004;
Total Annual Responses: 1,032,004;
Total Annual Hours: 180,004. (For
policy questions regarding this
collection contact Debra Dean-Whittaker
at 410–786–0848.)
Dated: February 20, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–03746 Filed 2–25–20; 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; National Adult
Maltreatment Reporting System;
[OMB# 0985–0054]
Administration for Community
Living (ACL), HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living is announcing that
the proposed collection of information
listed above has been submitted to the
Office of Management and Budget
(OMB) for review and clearance as
required under the Paperwork
Reduction Act of 1995. This 30-Day
notice collects comments on the
information collection requirements
related to an extension without change
and solicits comments on the
information collection requirements
relating to the National Adult
Maltreatment Reporting System
(NAMRS).
SUMMARY:
Submit written comments on the
collection of information by March 27,
2020.
ADDRESSES: Submit written comments
on the collection of information by:
(a) Email to: OIRA_submission@
omb.eop.gov, Attn: OMB Desk Officer
for ACL;
(b) fax to 202.395.5806, Attn: OMB
Desk Officer for ACL; or
(c) by mail to the Office of
Information and Regulatory Affairs,
OMB, New Executive Office Bldg., 725
17th St. NW, Rm. 10235, Washington,
DC 20503, Attn: OMB Desk Officer for
ACL.
FOR FURTHER INFORMATION CONTACT:
Stephanie Whittier Eliason,
Administration for Community Living,
Washington, DC 20201, at 202–795–
7467 or Stephanie.WhittierEliason@
acl.hhs.gov.
DATES:
In
compliance with 44 U.S.C. 3507, ACL
has submitted the following proposed
collection of information to OMB for
review and clearance. The National
Adult Maltreatment Reporting System
authorized under the Elder Justice Act
of 2009, which amends Title XX of the
Social Security Act [42.U.S.C. 13976 et
seq.], requires that the Secretary of the
U.S. Department of Health and Human
Services ‘‘collects and disseminates data
annually relating to the abuse,
exploitation, and neglect of elders in
coordination with the Department of
SUPPLEMENTARY INFORMATION:
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Justice’’ [Sec. 2041 (a)(1)(B)] and
‘‘conducts research related to the
provision of adult protective services’’
[Sec. 2041 (a)(1)(D)].
The Elder Justice Coordinating
Council (EJCC) recommended
development of ‘‘a national adult
protective services (APS) system based
upon standardized data collection and a
core set of service provision standards
and best practices.’’
NAMRS is a voluntary system that has
been annually collecting since FFY2016
both summary and de-identified caselevel data on APS investigations
submitted by states. NAMRS consists of
three components:
(1) ACL proposes to collect
descriptive data on state agency and
practices from all states through the
‘‘Agency Component,’’ and
(2) Case-level, non-identifiable data
on persons who receive an investigation
by APS in response to an allegation of
abuse, neglect, or exploitation through
‘‘Case Component’’, or
(3) For states that are unable to submit
a case-level file through the ‘‘Case
Component,’’ a ‘‘Key Indicators
Component’’ will be available for them
to submit data on a smaller set of core
items.
ACL provides technical assistance to
states to assist in the preparation of their
data submissions. Respondents are state
APS agencies and APS agencies in the
District of Columbia, Puerto Rico,
Guam, Northern Mariana Islands, Virgin
Islands, and American Samoa (states,
hereafter). No personally identifiable
information is collected. The proposed
form(s) may be found on the ACL
website at https://www.acl.gov/aboutacl/public-input.
Estimated Program Burden
ACL estimates the burden associated
with this collection of information as
follows: 56 States will respond every
year. It will take approximately 4 hours
for all 56 states to respond to the
Agency Component, 20 hours for 17
states to respond to the Key Indicator
Component, and 100 hours for 35 states
to respond to the Case Component. The
total annual burden is estimated to be
4,164 hours. The estimates are based on
the amount of time States have
previously reported in completing the
data collection instruments; continued
increase in the number of states
reporting on Case Component and Key
Indicator Component data; and
assumption of modest incremental
efficiencies by States in reporting data
to NAMRS every year, including, most
significantly, minimal need to recode to
extract data after the initial year.
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Federal Register / Vol. 85, No. 38 / Wednesday, February 26, 2020 / Notices
Hours per
response
Annual burden
hours
Agency Component .........................................................................................
Key Indicators Component ..............................................................................
Case Component .............................................................................................
56
17
36
1
1
1
4
20
100
224
340
3,600
Total ..........................................................................................................
........................
........................
........................
4,164
Dated: February 19, 2020.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2020–03842 Filed 2–25–20; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–5625]
Recommendations for Dual 510(k) and
Clinical Laboratory Improvement
Amendments Waiver by Application
Studies; Guidance for Industry and
Food and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Recommendations
for Dual 510(k) and CLIA Waiver by
Application Studies.’’ It describes study
designs for generating data that may
support both 510(k) clearance and
Clinical Laboratory Improvement
Amendments (CLIA) waiver. Use of the
Dual 510(k) and CLIA Waiver by
Application pathway is optional;
however, FDA believes this pathway is
in many instances the least burdensome
and fastest approach for manufacturers
to obtain a CLIA waiver at the same time
as 510(k) clearance for new in vitro
diagnostic (IVD) tests. FDA believes
increased use of this pathway will speed
up the process of bringing simple and
accurate IVD tests to CLIA-waived
settings, which will better serve patients
and providers.
DATES: The announcement of the
guidance is published in the Federal
Register on February 26, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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Responses
per
respondent
Number of
respondents
Respondent/data collection activity
Electronic Submissions
Submit electronic comments in the
following way:
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• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–D–5625 for ‘‘Recommendations
for Dual 510(k) and CLIA Waiver by
Application Studies.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
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information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
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 ‘‘Recommendations
for Dual 510(k) and CLIA Waiver by
Application Studies’’ to the Office of
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]]>Agencies
[Federal Register Volume 85, Number 38 (Wednesday, February 26, 2020)]
[Notices]
[Pages 11088-11089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03842]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Proposed Collection;
Comment Request; National Adult Maltreatment Reporting System; [OMB#
0985-0054]
AGENCY: Administration for Community Living (ACL), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living is announcing that the
proposed collection of information listed above has been submitted to
the Office of Management and Budget (OMB) for review and clearance as
required under the Paperwork Reduction Act of 1995. This 30-Day notice
collects comments on the information collection requirements related to
an extension without change and solicits comments on the information
collection requirements relating to the National Adult Maltreatment
Reporting System (NAMRS).
DATES: Submit written comments on the collection of information by
March 27, 2020.
ADDRESSES: Submit written comments on the collection of information by:
(a) Email to: [email protected], Attn: OMB Desk Officer
for ACL;
(b) fax to 202.395.5806, Attn: OMB Desk Officer for ACL; or
(c) by mail to the Office of Information and Regulatory Affairs,
OMB, New Executive Office Bldg., 725 17th St. NW, Rm. 10235,
Washington, DC 20503, Attn: OMB Desk Officer for ACL.
FOR FURTHER INFORMATION CONTACT: Stephanie Whittier Eliason,
Administration for Community Living, Washington, DC 20201, at 202-795-
7467 or [email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, ACL has
submitted the following proposed collection of information to OMB for
review and clearance. The National Adult Maltreatment Reporting System
authorized under the Elder Justice Act of 2009, which amends Title XX
of the Social Security Act [42.U.S.C. 13976 et seq.], requires that the
Secretary of the U.S. Department of Health and Human Services
``collects and disseminates data annually relating to the abuse,
exploitation, and neglect of elders in coordination with the Department
of Justice'' [Sec. 2041 (a)(1)(B)] and ``conducts research related to
the provision of adult protective services'' [Sec. 2041 (a)(1)(D)].
The Elder Justice Coordinating Council (EJCC) recommended
development of ``a national adult protective services (APS) system
based upon standardized data collection and a core set of service
provision standards and best practices.''
NAMRS is a voluntary system that has been annually collecting since
FFY2016 both summary and de-identified case-level data on APS
investigations submitted by states. NAMRS consists of three components:
(1) ACL proposes to collect descriptive data on state agency and
practices from all states through the ``Agency Component,'' and
(2) Case-level, non-identifiable data on persons who receive an
investigation by APS in response to an allegation of abuse, neglect, or
exploitation through ``Case Component'', or
(3) For states that are unable to submit a case-level file through
the ``Case Component,'' a ``Key Indicators Component'' will be
available for them to submit data on a smaller set of core items.
ACL provides technical assistance to states to assist in the
preparation of their data submissions. Respondents are state APS
agencies and APS agencies in the District of Columbia, Puerto Rico,
Guam, Northern Mariana Islands, Virgin Islands, and American Samoa
(states, hereafter). No personally identifiable information is
collected. The proposed form(s) may be found on the ACL website at
https://www.acl.gov/about-acl/public-input.
Estimated Program Burden
ACL estimates the burden associated with this collection of
information as follows: 56 States will respond every year. It will take
approximately 4 hours for all 56 states to respond to the Agency
Component, 20 hours for 17 states to respond to the Key Indicator
Component, and 100 hours for 35 states to respond to the Case
Component. The total annual burden is estimated to be 4,164 hours. The
estimates are based on the amount of time States have previously
reported in completing the data collection instruments; continued
increase in the number of states reporting on Case Component and Key
Indicator Component data; and assumption of modest incremental
efficiencies by States in reporting data to NAMRS every year,
including, most significantly, minimal need to recode to extract data
after the initial year.
[[Page 11089]]
----------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Annual burden
Respondent/data collection activity respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Agency Component................................ 56 1 4 224
Key Indicators Component........................ 17 1 20 340
Case Component.................................. 36 1 100 3,600
---------------------------------------------------------------
Total....................................... .............. .............. .............. 4,164
----------------------------------------------------------------------------------------------------------------
Dated: February 19, 2020.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2020-03842 Filed 2-25-20; 8:45 am]
BILLING CODE 4154-01-P
