83 FR 21296 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 90 (May 9, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 90 (May 9, 2018)
| Page Range | 21296-21297 | |
| FR Document | 2018-09686 |
[Federal Register Volume 83, Number 90 (Wednesday, May 9, 2018)] [Notices] [Pages 21296-21297] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-09686] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10102] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. 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 July 9, 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. [[Page 21297]] 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' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html. 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-10102 National Implementation of the Hospital CAHPS Survey 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: Extension of a currently approved collection; Title of Information Collection: National Implementation of the Hospital CAHPS Survey; Use: The HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) Survey, also known as the CAHPS[supreg] Hospital Survey or Hospital CAHPS[supreg], is a standardized survey instrument and data collection methodology that has been in use since 2006 to measure patients' perspectives of hospital care. While many hospitals collect information on patient satisfaction, HCAHPS created a national standard for the collection and public reporting of information that enables valid comparisons to be made across all hospitals to support consumer choice. Form Number: CMS- 10102 (OMB control number 0938-0981); Frequency: Occasionally; Affected Public: Private sector (Business or other for-profits and Not-for- profit institutions); Number of Respondents: 4,200; Total Annual Responses: 3,100,000; Total Annual Hours: 413,230. (For policy questions regarding this collection contact William Lehrman at 410-786- 1037.) Dated: May 2, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018-09686 Filed 5-8-18; 8:45 am] BILLING CODE 4120-01-P
![21296 Federal Register / Vol. 83, No. 90 / Wednesday, May 9, 2018 / Notices
Improvement and Patient Safety, AHRQ, major health agencies within HHS as DEPARTMENT OF HEALTH AND
5600 Fishers Lane, Rockville, MD well as the Departments of Defense and HUMAN SERVICES
20857; Telephone (toll free): (866) 403– Veterans Affairs. The PSWG helps
3697; Telephone (local): (301) 427– assure the consistency of definitions/ Centers for Medicare & Medicaid
1111; TTY (toll free): (866) 438–7231; formats with those of relevant Services
TTY (local): (301) 427–1130; Email: government agencies. In addition, [Document Identifier: CMS–10102]
pso@ahrq.hhs.gov. AHRQ has solicited comments from the
SUPPLEMENTARY INFORMATION: private and public sectors regarding Agency Information Collection
Background on Common Formats proposed versions of the Common Activities: Proposed Collection;
Development Formats through a contract, since 2008, Comment Request
The Patient Safety and Quality with the National Quality Forum (NQF), AGENCY: Centers for Medicare &
Improvement Act of 2005, 42 U.S.C. which is a non-profit organization Medicaid Services, HHS.
299b–21 to b–26, (Patient Safety Act) focused on health care quality. After ACTION: Notice.
and the related Patient Safety and receiving comments, the NQF solicits
Quality Improvement Final Rule, 42 review of the formats by its Common SUMMARY: The Centers for Medicare &
CFR part 3 (Patient Safety Rule), Formats Expert Panel. Subsequently, Medicaid Services (CMS) is announcing
published in the Federal Register on NQF provides this input to AHRQ who an opportunity for the public to
November 21, 2008, 73 FR 70731– then uses it to refine the Common comment on CMS’ intention to collect
70814, provide for the formation of Formats before issuing as a production information from the public. Under the
Patient Safety Organizations (PSOs), version. Paperwork Reduction Act of 1995 (the
which collect, aggregate, and analyze Previously, AHRQ’s primary focus PRA), federal agencies are required to
confidential information regarding the publish notice in the Federal Register
with the Common Formats has been to
quality and safety of health care concerning each proposed collection of
support traditional event reporting. For
delivery. The collection of patient safety information (including each proposed
the Common Formats, it should be extension or reinstatement of an existing
work product allows for the aggregation
noted that AHRQ uses the term collection of information) and to allow
of data that help to identify and address
underlying causal factors of patient ‘‘surveillance’’ to refer to the improved 60 days for public comment on the
safety and quality issues. detection of events and calculation of proposed action. Interested persons are
The Patient Safety Act provides for adverse event rates in populations invited to send comments regarding our
AHRQ to develop standardized reviewed that will allow for collection burden estimates or any other aspect of
reporting formats using common of comparable performance data over this collection of information, including
language and definitions (Common time and across settings. These formats the necessity and utility of the proposed
Formats) for reporting on health care are designed to provide, through information collection for the proper
quality and patient safety that will retrospective review of medical records, performance of the agency’s functions,
ensure that data collected by PSOs and information that is complementary to the accuracy of the estimated burden,
other entities have comparable clinical that derived from event reporting ways to enhance the quality, utility, and
meaning. The Common Formats systems. For more information on clarity of the information to be
facilitate aggregation of comparable data AHRQ’s efforts measuring patient safety collected, and the use of automated
at local, PSO, regional and national in this area, please go to: https:// collection techniques or other forms of
levels. In addition, the Common www.ahrq.gov/news/blog/ahrqviews/ information technology to minimize the
Formats are intended to enhance the new-system-aims-to-improve-patient- information collection burden.
reporting of information that is safety-monitoring.html. DATES: Comments must be received by
standardized both clinically and July 9, 2018.
electronically. Commenting on Common Formats:
AHRQ has developed Common ADDRESSES: When commenting, please
Common Formats for Surveillance—
Formats for three settings of care—acute reference the document identifier or
Hospital Version 0.2 Beta
care hospitals, skilled nursing facilities, OMB control number. To be assured
and community pharmacies—for use by AHRQ is specifically interested in consideration, comments and
health care providers and PSOs. AHRQ- receiving feedback in order to guide the recommendations must be submitted in
listed PSOs are required to collect improvement of the Common Formats. any one of the following ways:
patient safety work product in a Information on how to comment on the 1. Electronically. You may send your
standardized manner to the extent Common Formats for Surveillance— comments electronically to http://
practical and appropriate; a requirement www.regulations.gov. Follow the
Hospital Version 0.2 Beta is available at:
the PSO can meet by collecting such instructions for ‘‘Comment or
http://www.qualityforum.org/Project_
information using Common Formats. Submission’’ or ‘‘More Search Options’’
Pages/Common_Formats_for_Patient_
Additionally, providers and other to find the information collection
Safety_Data.aspx. document(s) that are accepting
organizations not working with an
AHRQ-listed PSO can use the Common Additional information about the comments.
Formats in their work to improve Common Formats can be obtained 2. By regular mail. You may mail
quality and safety; however, they cannot through AHRQ’s PSO website: https:// written comments to the following
benefit from the federal confidentiality pso.ahrq.gov/. address:
amozie on DSK3GDR082PROD with NOTICES
and privilege protections of the Patient Francis D. Chesley, Jr.,
CMS, Office of Strategic Operations and
Safety Act. Regulatory Affairs, Division of
Acting Deputy Director.
Since February 2005, AHRQ has Regulations Development, Attention:
convened the Federal Patient Safety [FR Doc. 2018–09870 Filed 5–8–18; 8:45 am] Document Identifier/OMB Control
Work Group (PSWG) to assist AHRQ in BILLING CODE 4160–90–P Number ____, Room C4–26–05, 7500
developing and maintaining the Security Boulevard, Baltimore,
Common Formats. The PSWG includes Maryland 21244–1850.
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![Federal Register / Vol. 83, No. 90 / Wednesday, May 9, 2018 / Notices 21297
To obtain copies of a supporting collect information on patient ADDRESSES: You may submit comments
statement and any related forms for the satisfaction, HCAHPS created a national on any guidance at any time as follows:
proposed collection(s) summarized in standard for the collection and public
Electronic Submissions
this notice, you may make your request reporting of information that enables
using one of following: valid comparisons to be made across all Submit electronic comments in the
1. Access CMS’ website address at hospitals to support consumer choice. following way:
https://www.cms.gov/Regulations-and- Form Number: CMS–10102 (OMB • Federal eRulemaking Portal:
Guidance/Legislation/ control number 0938–0981); Frequency: https://www.regulations.gov. Follow the
PaperworkReductionActof1995/PRA- Occasionally; Affected Public: Private instructions for submitting comments.
Listing.html. sector (Business or other for-profits and Comments submitted electronically,
2. Email your request, including your Not-for-profit institutions); Number of including attachments, to https://
address, phone number, OMB number, Respondents: 4,200; Total Annual www.regulations.gov will be posted to
and CMS document identifier, to Responses: 3,100,000; Total Annual the docket unchanged. Because your
Paperwork@cms.hhs.gov. Hours: 413,230. (For policy questions comment will be made public, you are
3. Call the Reports Clearance Office at regarding this collection contact solely responsible for ensuring that your
(410) 786–1326. William Lehrman at 410–786–1037.) comment does not include any
FOR FURTHER INFORMATION CONTACT: confidential information that you or a
Dated: May 2, 2018.
William Parham at (410) 786–4669. third party may not wish to be posted,
William N. Parham, III, such as medical information, your or
SUPPLEMENTARY INFORMATION:
Director, Paperwork Reduction Staff, Office anyone else’s Social Security number, or
Contents of Strategic Operations and Regulatory confidential business information, such
This notice sets out a summary of the Affairs.
as a manufacturing process. Please note
use and burden associated with the [FR Doc. 2018–09686 Filed 5–8–18; 8:45 am] that if you include your name, contact
following information collections. More BILLING CODE 4120–01–P information, or other information that
detailed information can be found in identifies you in the body of your
each collection’s supporting statement comments, that information will be
and associated materials (see DEPARTMENT OF HEALTH AND posted on https://www.regulations.gov.
ADDRESSES). HUMAN SERVICES • If you want to submit a comment
CMS–10102 National Implementation with confidential information that you
Food and Drug Administration
of the Hospital CAHPS Survey do not wish to be made available to the
[Docket No. FDA–2018–D–1434] public, submit the comment as a
Under the PRA (44 U.S.C. 3501– written/paper submission and in the
3520), federal agencies must obtain Waivers, Exceptions, and Exemptions manner detailed (see ‘‘Written/Paper
approval from the Office of Management From the Requirements of Section 582 Submissions’’ and ‘‘Instructions’’).
and Budget (OMB) for each collection of of the Federal Food, Drug, and
information they conduct or sponsor. Cosmetic Act; Draft Guidance for Written/Paper Submissions
The term ‘‘collection of information’’ is Industry; Availability Submit written/paper submissions as
defined in 44 U.S.C. 3502(3) and 5 CFR follows:
1320.3(c) and includes agency requests AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
or requirements that members of the HHS. written/paper submissions): Dockets
public submit reports, keep records, or ACTION: Notice of availability. Management Staff (HFA–305), Food and
provide information to a third party. Drug Administration, 5630 Fishers
Section 3506(c)(2)(A) of the PRA SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
requires federal agencies to publish a Administration (FDA or Agency) is • For written/paper comments
60-day notice in the Federal Register announcing the availability of a draft submitted to the Dockets Management
concerning each proposed collection of guidance for industry entitled ‘‘Waivers, Staff, FDA will post your comment, as
information, including each proposed Exceptions, and Exemptions from the well as any attachments, except for
extension or reinstatement of an existing Requirements of Section 582 of the information submitted, marked and
collection of information, before Federal Food, Drug, and Cosmetic Act.’’ identified, as confidential, if submitted
submitting the collection to OMB for When finalized, this draft guidance will as detailed in ‘‘Instructions.’’
approval. To comply with this describe the process that trading Instructions: All submissions received
requirement, CMS is publishing this partners and stakeholders should use to must include the Docket No. FDA–
notice. request a waiver, exception, or 2018–D–1434 for ‘‘Waivers, Exceptions,
exemption from certain requirements of and Exemptions from the Requirements
Information Collection the Federal Food, Drug, and Cosmetic of Section 582 of the Federal Food,
1. Type of Information Collection Act (FD&C Act), and describe how FDA Drug, and Cosmetic Act; Draft Guidance
Request: Extension of a currently intends to review and decide such for Industry.’’ Received comments will
approved collection; Title of requests and determine FDA-initiated be placed in the docket and, except for
Information Collection: National exceptions and exemptions. those submitted as ‘‘Confidential
Implementation of the Hospital CAHPS Additionally, when finalized, this draft Submissions,’’ publicly viewable at
Survey; Use: The HCAHPS (Hospital guidance will describe how FDA https://www.regulations.gov or at the
Consumer Assessment of Healthcare intends to biennially review and renew Dockets Management Staff between 9
amozie on DSK3GDR082PROD with NOTICES
Providers and Systems) Survey, also waivers, exceptions, and exemptions. a.m. and 4 p.m., Monday through
known as the CAHPS® Hospital Survey DATES: Submit either electronic or Friday.
or Hospital CAHPS®, is a standardized written comments on the draft guidance • Confidential Submissions—To
survey instrument and data collection by July 9, 2018 to ensure that the submit a comment with confidential
methodology that has been in use since Agency considers your comment on this information that you do not wish to be
2006 to measure patients’ perspectives draft guidance before it begins work on made publicly available, submit your
of hospital care. While many hospitals the final version of the guidance. comments only as a written/paper
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Document Created: 2018-05-09 03:18:14
Document Modified: 2018-05-09 03:18:14
| 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 July 9, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 21296 |
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