82 FR 51630 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 82, Issue 214 (November 7, 2017)
Centers for Medicare & Medicaid Services
Federal Register Volume 82, Issue 214 (November 7, 2017)
| Page Range | 51630-51631 | |
| FR Document | 2017-24134 |
[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)] [Notices] [Pages 51630-51631] From the Federal Register Online [www.thefederalregister.org] [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 http://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 http://www.cms.hhs.gov/PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]. 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
![51630 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices
the accomplishments of the committee’s DEPARTMENT OF HEALTH AND To obtain copies of a supporting
objectives. The Administrator is seeking HUMAN SERVICES statement and any related forms for the
nominations for members fulfilling the proposed collection(s) summarized in
following categories: Centers for Medicare & Medicaid this notice, you may make your request
Services using one of following:
• Environmental medicine or
1. Access CMS’ Web site address at
Environmental health specialist; [Document Identifier CMS–10656 and CMS– http://www.cms.hhs.gov/
• Epidemiologist; 10455]
PaperworkReductionActof1995.
• Occupational physician who has Agency Information Collection 2. Email your request, including your
experience treating WTC rescue and Activities: Proposed Collection; address, phone number, OMB number,
recovery workers; Comment Request and CMS document identifier, to
Paperwork@cms.hhs.gov.
• Occupational physician; AGENCY: Centers for Medicare & 3. Call the Reports Clearance Office at
• Representative of WTC responders; Medicaid Services. (410) 786–1326.
and ACTION: Notice. FOR FURTHER INFORMATION CONTACT:
• Toxicologist. William Parham at (410) 786–4669.
SUMMARY: The Centers for Medicare & SUPPLEMENTARY INFORMATION:
Candidates should submit the Medicaid Services (CMS) is announcing
following items: an opportunity for the public to Contents
D Current curriculum vitae, including comment on CMS’ intention to collect This notice sets out a summary of the
complete contact information information from the public. Under the use and burden associated with the
(telephone numbers, mailing address, Paperwork Reduction Act of 1995 (the following information collections. More
email address); PRA), federal agencies are required to detailed information can be found in
D The category of membership publish notice in the Federal Register each collection’s supporting statement
(environmental medicine or concerning each proposed collection of and associated materials (see
information (including each proposed ADDRESSES).
environmental health specialist,
extension or reinstatement of an existing CMS–10656 Evaluation of the
occupational physician, pulmonary
collection of information) and to allow Partnership for Patients (PfP) 3.0
physician, representative of WTC
60 days for public comment on the CMS–10455 Report of a Hospital Death
responders, certified-eligible WTC proposed action. Interested persons are
survivor representative, industrial Associated with Restraint or
invited to send comments regarding our Seclusion
hygienist, toxicologist, epidemiologist, burden estimates or any other aspect of
or mental health professional) that the this collection of information, including Under the PRA (44 U.S.C. 3501–
candidate is qualified to represent); the necessity and utility of the proposed 3520), federal agencies must obtain
D A summary of the background, information collection for the proper approval from the Office of Management
performance of the agency’s functions, and Budget (OMB) for each collection of
experience, and qualifications that
the accuracy of the estimated burden, information they conduct or sponsor.
demonstrates the nominee’s suitability
ways to enhance the quality, utility, and The term ‘‘collection of information’’ is
for the nominated membership category;
clarity of the information to be defined in 44 U.S.C. 3502(3) and 5 CFR
and 1320.3(c) and includes agency requests
D At least one letter of collected, and the use of automated
collection techniques or other forms of or requirements that members of the
recommendation from person(s) not public submit reports, keep records, or
information technology to minimize the
employed by the U.S. Department of provide information to a third party.
information collection burden.
Health and Human Services. Section 3506(c)(2)(A) of the PRA
(Candidates may submit letter(s) from DATES: Comments must be received by requires federal agencies to publish a
current HHS employees if they wish, January 8, 2018. 60-day notice in the Federal Register
but at least one letter must be submitted ADDRESSES: When commenting, please concerning each proposed collection of
by a person not employed by an HHS reference the document identifier or information, including each proposed
agency (e.g., CDC, NIH, FDA, etc.). OMB control number. To be assured extension or reinstatement of an existing
consideration, comments and collection of information, before
Nominations may be submitted by the recommendations must be submitted in submitting the collection to OMB for
candidate him- or herself, or by the any one of the following ways: approval. To comply with this
person/organization recommending the 1. Electronically. You may send your requirement, CMS is publishing this
candidate. comments electronically to http:// notice.
The Director, Management Analysis www.regulations.gov. Follow the
and Services Office, has been delegated instructions for ‘‘Comment or Information Collection
the authority to sign Federal Register Submission’’ or ‘‘More Search Options’’ 1. Type of Information Collection
notices pertaining to announcements of to find the information collection Request: New collection of information
meetings and other committee document(s) that are accepting request; Title of Information Collection:
management activities for both CDC and comments. Evaluation of the Partnership for
the Agency for Toxic Substances and 2. By regular mail. You may mail Patients (PfP) 3.0; Use: In the summer of
Disease Registry. written comments to the following 2015, the Centers for Medicare &
ethrower on DSK3G9T082PROD with NOTICES
address: CMS, Office of Strategic Medicaid Services (CMS) Administrator
Elaine L. Baker Operations and Regulatory Affairs, approved the plans for integration of the
Director, Management Analysis and Services Division of Regulations Development, Partnership for Patients (PfP) Hospital
Office, Centers for Disease Control and Attention: Document Identifier/OMB Engagement Network (HEN) model test
Prevention. Control Number _________, Room C4– with the Quality Improvement Network-
[FR Doc. 2017–24155 Filed 11–6–17; 8:45 am] 26–05, 7500 Security Boulevard, Quality Improvement Organization
BILLING CODE 4163–18–P Baltimore, Maryland 21244–1850. (QIN–QIO) program. This is consistent
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![Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51631
with the Agency’s intention for further regulation that was published on May, DEPARTMENT OF HEALTH AND
integration to maximize the strengths of 16, 2012 (77 FR 29074) included a HUMAN SERVICES
the QIO program and PfP HENs to reduction in the reporting requirement
sustain and expand current national related to hospital deaths associated Food and Drug Administration
reductions in in-patient harm and 30- with the use of restraint or seclusion, [Docket No. FDA–2012–D–0529]
day readmissions. The alignment of the § 482.13(g). Hospitals must use Form
two programs permits the systematic CMS–10455 to report those deaths Recommended Statement for Over-the-
use of innovative patient safety associated with restraint and/or Counter Aspirin-Containing Drug
practices at a national scale. seclusion directly to the Centers for Products Labeled With Cardiovascular-
Under this initiative, CMS has Related Imagery; Guidance for
Medicare & Medicaid Services (CMS)
awarded multiple contracts to Hospital Industry; Availability
Improvement Innovation Networks Regional Office (RO). This requirement
(HIINs), formerly known as HENs, to also applies to rehabilitation or AGENCY: Food and Drug Administration,
engage the hospital, provider, and psychiatric distinct part units (DPUs) in HHS.
broader caregiver communities to Critical Access Hospitals (CAHs). The ACTION: Notice of availability.
implement well-tested and measured RO must provide hospitals with
instructions for submitting the form fax SUMMARY: The Food and Drug
best practices. The end result of the
and/or email, based on RO preference. Administration (FDA or Agency) is
overall initiative is the anticipated
Hospitals are no longer required to announcing the availability of a
reduction in preventable hospital-based
report to CMS those deaths where there guidance for industry entitled
harm and readmissions for patients.
The PfP initiative is a public-private ‘‘Recommended Statement for Over-the-
was no use of seclusion and the only
partnership dedicated to the Counter Aspirin-Containing Drug
restraint was 2-point soft wrist restraints Products Labeled With Cardiovascular-
improvement of health care quality, beginning in May 9, 2014. This
safety, and affordability. CMS, working Related Imagery.’’ The guidance is
reporting requirement change resulted intended to promote the safe use of
with hospitals, providers, and the in no necessary edits to the form CMS–
broader caregiver community, aims to nonprescription (also referred to as
10455 as soft wrist restraints may be over-the-counter or OTC) aspirin drug
implement and disseminate best used in combination with other types of
practices on a national scale to reduce products by encouraging drug
restraints. It was estimated that this manufacturers, packagers, and labelers
hospital acquired conditions (HACs)
would reduce the volume of reports that marketing aspirin drug products with
and all-cause readmissions. Through the
PfP model, which was initiated in April must be submitted by 90 percent for cardiovascular-related imagery to
2011, CMS fostered rapid learning hospitals. In addition, the final rule include a statement that reminds
among a nationwide community of replaced the previous requirement for consumers to talk to their health care
practice, resulting in major strides in reporting via telephone to CMS, which provider before using aspirin for their
patient safety and engagement by proved to be cumbersome for both CMS heart.
patients and families. and hospitals, with a requirement that DATES: The announcement of the
A mixed methods approach to allows submission of reports via guidance is published in the Federal
answering the PfP HIIN evaluation telephone, facsimile or electronically, as Register on November 7, 2017.
questions includes three primary data determined by CMS. ADDRESSES: You may submit either
collection activities, as follows: Hospital Form CMS–10455 is being revised in electronic or written comments on
Survey on Prevention of Adverse Events order to obtain the necessary Agency guidances at any time as
and Reduction of Readmissions, HIIN follows:
information for the ROs to make a
Data Quality Assurance (QA) Survey
determination whether or not to Electronic Submissions
and Qualitative Discussions with HIIN
leaders and Other Support Contractors. authorize an on-site investigation Submit electronic comments in the
The data collected will provide us related to the details surrounding the following way:
feedback to focus efforts to improve the death of individuals associated with • Federal eRulemaking Portal:
effectiveness and efficiency of the HIIN restraint and/or seclusion. Form https://www.regulations.gov. Follow the
initiative. As we draft future HIIN and Number: CMS–10455 (OMB control instructions for submitting comments.
QIO contracts, information from number: 0938–1210); Frequency: Comments submitted electronically,
hospitals about HIIN influence on their Occasionally; Affected Public: Private including attachments, to https://
care processes will be used together Sector; Number of Respondents: 6,389; www.regulations.gov will be posted to
with follow-up input from stakeholders Number of Responses: 6,389; Total the docket unchanged. Because your
about the survey results. Form Number: Annual Hours: 2,619. (For policy comment will be made public, you are
CMS–10656 (OMB Control Number: questions regarding this collection solely responsible for ensuring that your
0938–NEW); Frequency: Annually; contact Karina Meushaw at 410–786– comment does not include any
Affected Public: Private Sector: Business 1000.) confidential information that you or a
or other for-profits and Not-for-profit third party may not wish to be posted,
Dated: November 1, 2017.
institutions; Number of Respondents: such as medical information, your or
835; Total Annual Responses: 854; Total William N. Parham, III, anyone else’s Social Security number, or
Annual Hours: 392. (For policy Director, Paperwork Reduction Staff, Office confidential business information, such
questions regarding this collection of Strategic Operations and Regulatory as a manufacturing process. Please note
ethrower on DSK3G9T082PROD with NOTICES
contact Israel Cross at 410–786–0619.) Affairs. that if you include your name, contact
2. Type of Information Collection [FR Doc. 2017–24134 Filed 11–6–17; 8:45 am] information, or other information that
Request: Revision of a currently BILLING CODE 4120–01–P identifies you in the body of your
approved collection; Title of comments, that information will be
Information Collection: Report of a posted on https://www.regulations.gov.
Hospital Death Associated with • If you want to submit a comment
Restraint or Seclusion; Use: The with confidential information that you
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Document Created: 2018-10-25 10:26:44
Document Modified: 2018-10-25 10:26:44
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by January 8, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 82 FR 51630 |
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