Agency Information Collection Activities: Submission for OMB Review; Comment Request, 37303-37304 [2019-16224]
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Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices
II. Approval of Deeming Organizations
Section 1865(a)(2) of the Act and our
regulations at 42 CFR 488.5 require that
our findings concerning review and
approval of a national accrediting
organization’s requirements consider,
among other factors, the applying
accrediting organization’s requirements
for accreditation; survey procedures;
resources for conducting required
surveys; capacity to furnish information
for use in enforcement activities;
monitoring procedures for provider
entities found not in compliance with
the conditions or requirements; and
ability to provide CMS with the
necessary data for validation.
Section 1865(a)(3)(A) of the Act
further requires that we publish, within
60 days of receipt of an organization’s
complete application, a notice
identifying the national accrediting
body making the request, describing the
nature of the request, and providing at
least a 30-day public comment period.
We have 210 days from the receipt of a
complete application to publish notice
of approval or denial of the application.
The purpose of this proposed notice
is to inform the public of AAHHS–
HFAP’s request for continued CMS
approval of its CAH accreditation
program. This notice also solicits public
comment on whether AAHHS–HFAP’s
requirements meet or exceed the
Medicare conditions of participation for
CAHs.
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III. Evaluation of Deeming Authority
Request
AAHHS–HFAP submitted all the
necessary materials to enable us to make
a determination concerning its request
for continued approval of its CAH
accreditation program. This application
was determined to be complete on May
31, 2019. Under Section 1865(a)(2) of
the Act and our regulations at 42 CFR
488.5 (Application and re-application
procedures for national accrediting
organizations), our review and
evaluation of AAHHS–HFAP will be
conducted in accordance with, but not
necessarily limited to, the following
factors:
• The equivalency of AAHHS–
HFAP’s standards for CAHs as
compared with CMS’ CAH conditions of
participation.
• AAHHS–HFAP’s survey process to
determine the following:
++ The composition of the survey
team, surveyor qualifications, and the
ability of the organization to provide
continuing surveyor training.
++ The comparability of AAHHS–
HFAP’s processes to those of State
agencies, including survey frequency,
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and the ability to investigate and
respond appropriately to complaints
against accredited facilities.
++ AAHHS–HFAP’s processes and
procedures for monitoring a CAH found
out of compliance with AAHHS–
HFAP’s program requirements. These
monitoring procedures are used only
when AAHHS–HFAP identifies
noncompliance. If noncompliance is
identified through validation reviews or
complaint surveys conducted by the
State survey agency, the State survey
agency monitors corrections as specified
at 42 CFR 488.9.
++ AAHHS–HFAP’s capacity to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ AAHHS–HFAP’s capacity to
provide CMS with electronic data and
reports necessary for effective validation
and assessment of the organization’s
survey process.
++ The adequacy of AAHHS–HFAP’s
staff and other resources, and its
financial viability.
++ AAHHS–HFAP’s capacity to
adequately fund required surveys.
++ AAHHS–HFAP’s policies with
respect to whether surveys are
announced or unannounced, to assure
that surveys are unannounced.
++ AAHHS–HFAP’s agreement to
provide CMS with a copy of the most
current accreditation survey together
with any other information related to
the survey as CMS may require
(including corrective action plans).
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or third
party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35).
V. Response to Public Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Upon completion of our evaluation,
including evaluation of comments
received as a result of this notice, we
will publish a final notice in the Federal
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37303
Register announcing the result of our
evaluation.
Dated: July 24, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–16371 Filed 7–30–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–643 and CMS–
10052]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
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
(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
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate 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.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by August 30, 2019.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
DATES:
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37304
Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices
Number: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov.
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
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
1. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
2. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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 (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-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 that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Reinstatement without change
of a currently approved collection; Title
of Information Collection: Hospice
Survey and Deficiencies Report Form
and Supporting Regulations; Use: We
use the information collected as the
basis for certification decisions for
hospices that wish to obtain or retain
participation in the Medicare and
Medicaid programs. The information is
used by CMS regional offices, which
have the delegated authority to certify
Medicare facilities for participation, and
by State Medicaid agencies, which have
comparable authority under Medicaid.
The information on the Hospice Survey
and Deficiencies Report Form is coded
for entry into the OSCAR system. The
data is analyzed by the CMS regional
offices and by the CMS central office
components for program evaluation and
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20:09 Jul 30, 2019
Jkt 247001
monitoring purposes. The information is
also available to the public upon
request. Form Number: CMS–643 (OMB
control number: 0938–0379); Frequency:
Yearly; Affected Public: State, Local, or
Tribal Governments; Number of
Respondents: 4,801; Total Annual
Responses: 1,600; Total Annual Hours:
1,600. (For policy questions regarding
this collection contact Thomas Pryor at
410–786–1132.)
2. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: Recognition of
pass-through payment for additional
(new) categories of devices under the
Outpatient Prospective Payment System
and Supporting Regulations; Use:
Section 402 of the Benefits
Improvement and Protection Act of
2000 (BIPA), enacted on December 21,
2000, made changes in the provision for
transitional pass-through payment for
devices under the hospital OPPS.
Section 402 of BIPA amended section
1833(t)(6) of the Act to require that we
abandon the item-specific approach in
determining the eligibility of medical
devices for transitional pass-through
payments. This provision mandated that
we adopt a category approach for
making such payments. In accordance
with this requirement, we would pay for
any device that falls in categories we
establish for this purpose. This
provision required us to establish the
initial set of categories, to include
devices previously determined eligible
for transitional pass-through payments,
effective April 1, 2001.
The law made clear that application
and approval processes are no longer
required as the basis for determining an
individual medical device’s eligibility
for transitional pass-through payments.
However, we must assemble certain
crucial information to be able to
determine the appropriateness of
establishing an additional (new)
category. The information that we seek
to collect is essential to determine
whether additional categories of
medical devices are appropriate for
transitional pass-through payments. The
intent of these provisions is to ensure
that timely beneficiary access to new
technologies is not jeopardized by
inadequate payment levels.
Interested parties such as hospitals,
device manufacturers, pharmaceutical
companies, and physicians apply for
transitional pass-through payment for
certain items used with services covered
in the outpatient PPS. After we receive
all requested information, we evaluate
the information to determine if the
creation of an additional category of
medical devices for transitional pass-
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through payments is justified. We may
request additional information related to
the proposed new device category, as
needed. We advise the applicant of our
decision, and update the outpatient PPS
during its next scheduled quarterly
payment update cycle to reflect any
newly approved device categories. Form
Number: CMS–10052 (OMB control
number 0938–0857); Frequency:
Occasionally; Affected Public: State,
Local, and Tribal Governments; Number
of Respondents: 10; Total Annual
Responses: 10; Total Annual Hours:
160. (For policy questions regarding this
collection contact AuSha Washington at
410–786–3736.)
Dated: July 25, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–16224 Filed 7–30–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3505]
Medical Device User Fee Rates for
Fiscal Year 2020
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fee rates and payment procedures for
medical device user fees for fiscal year
(FY) 2020. The Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended
by the Medical Device User Fee
Amendments of 2017 (MDUFA IV),
authorizes FDA to collect user fees for
certain medical device submissions and
annual fees both for certain periodic
reports and for establishments subject to
registration. This notice establishes the
fee rates for FY 2020, which apply from
October 1, 2019, through September 30,
2020. To avoid delay in the review of
your application, you should pay the
application fee before or at the time you
submit your application to FDA. The fee
you must pay is the fee that is in effect
on the later of the date that your
application is received by FDA or the
date your fee payment is recognized by
the U.S. Treasury. If you want to pay a
reduced small business fee, you must
qualify as a small business before
making your submission to FDA; if you
do not qualify as a small business before
making your submission to FDA, you
will have to pay the higher standard fee.
SUMMARY:
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]]>Agencies
[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37303-37304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16224]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-643 and CMS-10052]
Agency Information Collection Activities: Submission for OMB
Review; 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 (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 a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate 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 on the collection(s) of information must be received by
the OMB desk officer by August 30, 2019.
ADDRESSES: When commenting on the proposed information collections,
please reference the document identifier or OMB control number. To be
assured consideration, comments and recommendations must be received by
the OMB desk officer via one of the following transmissions: OMB,
Office of Information and Regulatory Affairs, Attention: CMS Desk
Officer, Fax
[[Page 37304]]
Number: (202) 395-5806 OR, Email: [email protected].
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 website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
1. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
2. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(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 (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-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 that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Reinstatement without
change of a currently approved collection; Title of Information
Collection: Hospice Survey and Deficiencies Report Form and Supporting
Regulations; Use: We use the information collected as the basis for
certification decisions for hospices that wish to obtain or retain
participation in the Medicare and Medicaid programs. The information is
used by CMS regional offices, which have the delegated authority to
certify Medicare facilities for participation, and by State Medicaid
agencies, which have comparable authority under Medicaid. The
information on the Hospice Survey and Deficiencies Report Form is coded
for entry into the OSCAR system. The data is analyzed by the CMS
regional offices and by the CMS central office components for program
evaluation and monitoring purposes. The information is also available
to the public upon request. Form Number: CMS-643 (OMB control number:
0938-0379); Frequency: Yearly; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 4,801; Total Annual Responses:
1,600; Total Annual Hours: 1,600. (For policy questions regarding this
collection contact Thomas Pryor at 410-786-1132.)
2. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Recognition of pass-through payment for additional (new)
categories of devices under the Outpatient Prospective Payment System
and Supporting Regulations; Use: Section 402 of the Benefits
Improvement and Protection Act of 2000 (BIPA), enacted on December 21,
2000, made changes in the provision for transitional pass-through
payment for devices under the hospital OPPS. Section 402 of BIPA
amended section 1833(t)(6) of the Act to require that we abandon the
item-specific approach in determining the eligibility of medical
devices for transitional pass-through payments. This provision mandated
that we adopt a category approach for making such payments. In
accordance with this requirement, we would pay for any device that
falls in categories we establish for this purpose. This provision
required us to establish the initial set of categories, to include
devices previously determined eligible for transitional pass-through
payments, effective April 1, 2001.
The law made clear that application and approval processes are no
longer required as the basis for determining an individual medical
device's eligibility for transitional pass-through payments. However,
we must assemble certain crucial information to be able to determine
the appropriateness of establishing an additional (new) category. The
information that we seek to collect is essential to determine whether
additional categories of medical devices are appropriate for
transitional pass-through payments. The intent of these provisions is
to ensure that timely beneficiary access to new technologies is not
jeopardized by inadequate payment levels.
Interested parties such as hospitals, device manufacturers,
pharmaceutical companies, and physicians apply for transitional pass-
through payment for certain items used with services covered in the
outpatient PPS. After we receive all requested information, we evaluate
the information to determine if the creation of an additional category
of medical devices for transitional pass-through payments is justified.
We may request additional information related to the proposed new
device category, as needed. We advise the applicant of our decision,
and update the outpatient PPS during its next scheduled quarterly
payment update cycle to reflect any newly approved device categories.
Form Number: CMS-10052 (OMB control number 0938-0857); Frequency:
Occasionally; Affected Public: State, Local, and Tribal Governments;
Number of Respondents: 10; Total Annual Responses: 10; Total Annual
Hours: 160. (For policy questions regarding this collection contact
AuSha Washington at 410-786-3736.)
Dated: July 25, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2019-16224 Filed 7-30-19; 8:45 am]
BILLING CODE 4120-01-P
