Agency Information Collection Activities: Proposed Collection; Comment Request, 51630-51631 [2017-24134]
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the accomplishments of the committee’s
objectives. The Administrator is seeking
nominations for members fulfilling the
following categories:
• Environmental medicine or
Environmental health specialist;
• Epidemiologist;
• Occupational physician who has
experience treating WTC rescue and
recovery workers;
• Occupational physician;
• Representative of WTC responders;
and
• Toxicologist.
Candidates should submit the
following items:
D Current curriculum vitae, including
complete contact information
(telephone numbers, mailing address,
email address);
D The category of membership
(environmental medicine or
environmental health specialist,
occupational physician, pulmonary
physician, representative of WTC
responders, certified-eligible WTC
survivor representative, industrial
hygienist, toxicologist, epidemiologist,
or mental health professional) that the
candidate is qualified to represent);
D A summary of the background,
experience, and qualifications that
demonstrates the nominee’s suitability
for the nominated membership category;
and
D At least one letter of
recommendation from person(s) not
employed by the U.S. Department of
Health and Human Services.
(Candidates may submit letter(s) from
current HHS employees if they wish,
but at least one letter must be submitted
by a person not employed by an HHS
agency (e.g., CDC, NIH, FDA, etc.).
Nominations may be submitted by the
candidate him- or herself, or by the
person/organization recommending the
candidate.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both CDC and
the Agency for Toxic Substances and
Disease Registry.
Elaine L. Baker
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2017–24155 Filed 11–6–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10656 and CMS–
10455]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. 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 or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
January 8, 2018.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number _________, Room C4–
26–05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
SUMMARY:
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To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10656 Evaluation of the
Partnership for Patients (PfP) 3.0
CMS–10455 Report of a Hospital Death
Associated with Restraint or
Seclusion
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.
The term ‘‘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
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: New collection of information
request; Title of Information Collection:
Evaluation of the Partnership for
Patients (PfP) 3.0; Use: In the summer of
2015, the Centers for Medicare &
Medicaid Services (CMS) Administrator
approved the plans for integration of the
Partnership for Patients (PfP) Hospital
Engagement Network (HEN) model test
with the Quality Improvement NetworkQuality Improvement Organization
(QIN–QIO) program. This is consistent
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ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices
with the Agency’s intention for further
integration to maximize the strengths of
the QIO program and PfP HENs to
sustain and expand current national
reductions in in-patient harm and 30day readmissions. The alignment of the
two programs permits the systematic
use of innovative patient safety
practices at a national scale.
Under this initiative, CMS has
awarded multiple contracts to Hospital
Improvement Innovation Networks
(HIINs), formerly known as HENs, to
engage the hospital, provider, and
broader caregiver communities to
implement well-tested and measured
best practices. The end result of the
overall initiative is the anticipated
reduction in preventable hospital-based
harm and readmissions for patients.
The PfP initiative is a public-private
partnership dedicated to the
improvement of health care quality,
safety, and affordability. CMS, working
with hospitals, providers, and the
broader caregiver community, aims to
implement and disseminate best
practices on a national scale to reduce
hospital acquired conditions (HACs)
and all-cause readmissions. Through the
PfP model, which was initiated in April
2011, CMS fostered rapid learning
among a nationwide community of
practice, resulting in major strides in
patient safety and engagement by
patients and families.
A mixed methods approach to
answering the PfP HIIN evaluation
questions includes three primary data
collection activities, as follows: Hospital
Survey on Prevention of Adverse Events
and Reduction of Readmissions, HIIN
Data Quality Assurance (QA) Survey
and Qualitative Discussions with HIIN
leaders and Other Support Contractors.
The data collected will provide us
feedback to focus efforts to improve the
effectiveness and efficiency of the HIIN
initiative. As we draft future HIIN and
QIO contracts, information from
hospitals about HIIN influence on their
care processes will be used together
with follow-up input from stakeholders
about the survey results. Form Number:
CMS–10656 (OMB Control Number:
0938–NEW); Frequency: Annually;
Affected Public: Private Sector: Business
or other for-profits and Not-for-profit
institutions; Number of Respondents:
835; Total Annual Responses: 854; Total
Annual Hours: 392. (For policy
questions regarding this collection
contact Israel Cross at 410–786–0619.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Report of a
Hospital Death Associated with
Restraint or Seclusion; Use: The
VerDate Sep<11>2014
17:29 Nov 06, 2017
Jkt 244001
regulation that was published on May,
16, 2012 (77 FR 29074) included a
reduction in the reporting requirement
related to hospital deaths associated
with the use of restraint or seclusion,
§ 482.13(g). Hospitals must use Form
CMS–10455 to report those deaths
associated with restraint and/or
seclusion directly to the Centers for
Medicare & Medicaid Services (CMS)
Regional Office (RO). This requirement
also applies to rehabilitation or
psychiatric distinct part units (DPUs) in
Critical Access Hospitals (CAHs). The
RO must provide hospitals with
instructions for submitting the form fax
and/or email, based on RO preference.
Hospitals are no longer required to
report to CMS those deaths where there
was no use of seclusion and the only
restraint was 2-point soft wrist restraints
beginning in May 9, 2014. This
reporting requirement change resulted
in no necessary edits to the form CMS–
10455 as soft wrist restraints may be
used in combination with other types of
restraints. It was estimated that this
would reduce the volume of reports that
must be submitted by 90 percent for
hospitals. In addition, the final rule
replaced the previous requirement for
reporting via telephone to CMS, which
proved to be cumbersome for both CMS
and hospitals, with a requirement that
allows submission of reports via
telephone, facsimile or electronically, as
determined by CMS.
Form CMS–10455 is being revised in
order to obtain the necessary
information for the ROs to make a
determination whether or not to
authorize an on-site investigation
related to the details surrounding the
death of individuals associated with
restraint and/or seclusion. Form
Number: CMS–10455 (OMB control
number: 0938–1210); Frequency:
Occasionally; Affected Public: Private
Sector; Number of Respondents: 6,389;
Number of Responses: 6,389; Total
Annual Hours: 2,619. (For policy
questions regarding this collection
contact Karina Meushaw at 410–786–
1000.)
Dated: November 1, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–24134 Filed 11–6–17; 8:45 am]
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51631
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0529]
Recommended Statement for Over-theCounter Aspirin-Containing Drug
Products Labeled With CardiovascularRelated Imagery; Guidance for
Industry; 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
guidance for industry entitled
‘‘Recommended Statement for Over-theCounter Aspirin-Containing Drug
Products Labeled With CardiovascularRelated Imagery.’’ The guidance is
intended to promote the safe use of
nonprescription (also referred to as
over-the-counter or OTC) aspirin drug
products by encouraging drug
manufacturers, packagers, and labelers
marketing aspirin drug products with
cardiovascular-related imagery to
include a statement that reminds
consumers to talk to their health care
provider before using aspirin for their
heart.
DATES: The announcement of the
guidance is published in the Federal
Register on November 7, 2017.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• 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
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Agencies
[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Pages 51630-51631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24134]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier CMS-10656 and CMS-10455]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. 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 or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments must be received by January 8, 2018.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number _________, Room C4-26-05, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10656 Evaluation of the Partnership for Patients (PfP) 3.0
CMS-10455 Report of a Hospital Death Associated with Restraint or
Seclusion
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. The term
``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 requires federal agencies
to publish a 60-day notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
or reinstatement of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, CMS is publishing this notice.
Information Collection
1. Type of Information Collection Request: New collection of
information request; Title of Information Collection: Evaluation of the
Partnership for Patients (PfP) 3.0; Use: In the summer of 2015, the
Centers for Medicare & Medicaid Services (CMS) Administrator approved
the plans for integration of the Partnership for Patients (PfP)
Hospital Engagement Network (HEN) model test with the Quality
Improvement Network-Quality Improvement Organization (QIN-QIO) program.
This is consistent
[[Page 51631]]
with the Agency's intention for further integration to maximize the
strengths of the QIO program and PfP HENs to sustain and expand current
national reductions in in-patient harm and 30-day readmissions. The
alignment of the two programs permits the systematic use of innovative
patient safety practices at a national scale.
Under this initiative, CMS has awarded multiple contracts to
Hospital Improvement Innovation Networks (HIINs), formerly known as
HENs, to engage the hospital, provider, and broader caregiver
communities to implement well-tested and measured best practices. The
end result of the overall initiative is the anticipated reduction in
preventable hospital-based harm and readmissions for patients.
The PfP initiative is a public-private partnership dedicated to the
improvement of health care quality, safety, and affordability. CMS,
working with hospitals, providers, and the broader caregiver community,
aims to implement and disseminate best practices on a national scale to
reduce hospital acquired conditions (HACs) and all-cause readmissions.
Through the PfP model, which was initiated in April 2011, CMS fostered
rapid learning among a nationwide community of practice, resulting in
major strides in patient safety and engagement by patients and
families.
A mixed methods approach to answering the PfP HIIN evaluation
questions includes three primary data collection activities, as
follows: Hospital Survey on Prevention of Adverse Events and Reduction
of Readmissions, HIIN Data Quality Assurance (QA) Survey and
Qualitative Discussions with HIIN leaders and Other Support
Contractors. The data collected will provide us feedback to focus
efforts to improve the effectiveness and efficiency of the HIIN
initiative. As we draft future HIIN and QIO contracts, information from
hospitals about HIIN influence on their care processes will be used
together with follow-up input from stakeholders about the survey
results. Form Number: CMS-10656 (OMB Control Number: 0938-NEW);
Frequency: Annually; Affected Public: Private Sector: Business or other
for-profits and Not-for-profit institutions; Number of Respondents:
835; Total Annual Responses: 854; Total Annual Hours: 392. (For policy
questions regarding this collection contact Israel Cross at 410-786-
0619.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Report of a
Hospital Death Associated with Restraint or Seclusion; Use: The
regulation that was published on May, 16, 2012 (77 FR 29074) included a
reduction in the reporting requirement related to hospital deaths
associated with the use of restraint or seclusion, Sec. 482.13(g).
Hospitals must use Form CMS-10455 to report those deaths associated
with restraint and/or seclusion directly to the Centers for Medicare &
Medicaid Services (CMS) Regional Office (RO). This requirement also
applies to rehabilitation or psychiatric distinct part units (DPUs) in
Critical Access Hospitals (CAHs). The RO must provide hospitals with
instructions for submitting the form fax and/or email, based on RO
preference. Hospitals are no longer required to report to CMS those
deaths where there was no use of seclusion and the only restraint was
2-point soft wrist restraints beginning in May 9, 2014. This reporting
requirement change resulted in no necessary edits to the form CMS-10455
as soft wrist restraints may be used in combination with other types of
restraints. It was estimated that this would reduce the volume of
reports that must be submitted by 90 percent for hospitals. In
addition, the final rule replaced the previous requirement for
reporting via telephone to CMS, which proved to be cumbersome for both
CMS and hospitals, with a requirement that allows submission of reports
via telephone, facsimile or electronically, as determined by CMS.
Form CMS-10455 is being revised in order to obtain the necessary
information for the ROs to make a determination whether or not to
authorize an on-site investigation related to the details surrounding
the death of individuals associated with restraint and/or seclusion.
Form Number: CMS-10455 (OMB control number: 0938-1210); Frequency:
Occasionally; Affected Public: Private Sector; Number of Respondents:
6,389; Number of Responses: 6,389; Total Annual Hours: 2,619. (For
policy questions regarding this collection contact Karina Meushaw at
410-786-1000.)
Dated: November 1, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2017-24134 Filed 11-6-17; 8:45 am]
BILLING CODE 4120-01-P