Agency Information Collection Activities: Submission for OMB Review; Comment Request, 68332-68333 [2020-23890]
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Federal Register / Vol. 85, No. 209 / Wednesday, October 28, 2020 / Notices
applicable GPOs to disclose any
ownership or investment interests in
such entities held by physicians or their
immediate family members, as well as
information on any payments or other
transfers of value provided to such
physician owners or investors. Form
Number: CMS–10495 (OMB control
number: 0938–1237); Frequency: Once;
Affected Public: Private sector; Business
or other for-profits; Number of
Respondents: 34,616; Total Annual
Responses: 78,812; Total Annual Hours:
1,897,790. (For policy questions
regarding this collection contact
Kathleen Ott 410–786–4246.)
Dated: October 23, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–23893 Filed 10–27–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10570 and CMS–
10437]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
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
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:29 Oct 27, 2020
Jkt 253001
for Certain Imaging Services,’’ which
directs the Secretary to establish a
program to promote the use of AUC.
DATES: Comments on the collection(s) of
This program is codified at 42 CFR
information must be received by the
414.94. Evidence-based AUC for
OMB desk officer by November 27,
imaging can assist clinicians in selecting
2020.
the imaging study that is most likely to
ADDRESSES: Written comments and
improve health outcomes for patients
recommendations for the proposed
based on their individual context. A
information collection should be sent
provider-led entity (PLE) as defined in
within 30 days of publication of this
42 CFR 414.94(b) is a national
notice to www.reginfo.gov/public/do/
professional medical specialty society or
PRAMain. Find this particular
other organization that is comprised
information collection by selecting
primarily of providers or practitioners
‘‘Currently under 30-day Review—Open who, either within the organization or
for Public Comments’’ or by using the
outside the organization, predominantly
search function.
provide direct patient care. This
To obtain copies of a supporting
program requires professionals ordering
statement and any related forms for the
applicable imaging services as defined
proposed collection(s) summarized in
in § 414.94(b) to consult with specified
applicable AUC, which are criteria
this notice, you may make your request
developed, endorsed or modified by a
using one of following:
qualified PLE.
1. Access CMS’ website address at
The cornerstone of the PLE
website address at https://www.cms.gov/
qualification process is for PLEs to
Regulations-and-Guidance/Legislation/
demonstrate that they engage in a
PaperworkReductionActof1995/PRArigorous evidence-based process for
Listing.html.
2. Call the Reports Clearance Office at developing, modifying, or endorsing
AUC. Section 1834(q)(2)(B) specifies
(410) 786–1326.
that the Secretary must consider
FOR FURTHER INFORMATION CONTACT:
whether AUC have stakeholder
William Parham at (410) 786–4669.
consensus, are scientifically valid and
SUPPLEMENTARY INFORMATION: Under the
evidence-based, and are based on
Paperwork Reduction Act of 1995 (PRA) studies that are published and
(44 U.S.C. 3501–3520), federal agencies
reviewable by stakeholders. In the 2016
must obtain approval from the Office of
Physician Fee Schedule Final Rule with
Management and Budget (OMB) for each comment period (80 FR 70886,
collection of information they conduct
November 16, 2015; see pages 71102–
or sponsor. The term ‘‘collection of
71116 and pages 71380–71382) we
information’’ is defined in 44 U.S.C.
established a qualification process and
3502(3) and 5 CFR 1320.3(c) and
requirements for qualified PLEs in order
includes agency requests or
to ensure that the AUC development or
requirements that members of the public endorsement processes used by a PLE
submit reports, keep records, or provide result in high quality, evidence-based
information to a third party. Section
AUC in accordance with section
3506(c)(2)(A) of the PRA (44 U.S.C.
1834(q)(2)(B).
3506(c)(2)(A)) requires federal agencies
In order to become and remain a
to publish a 30-day notice in the
qualified PLE, we require PLEs to
Federal Register concerning each
demonstrate adherence to specific
proposed collection of information,
requirements when developing,
including each proposed extension or
modifying or endorsing AUC. To ensure
reinstatement of an existing collection
that these requirements are met, we
of information, before submitting the
require PLEs to submit information
collection to OMB for approval. To
demonstrating their adherence to these
comply with this requirement, CMS is
requirements. CMS qualifies those PLEs
publishing this notice that summarizes
that demonstrate adherence to the
the following proposed collection(s) of
requirements for a period of five years.
information for public comment:
Qualified PLEs are also required, during
1. Type of Information Collection
the 5th year after their most recent
Request: Reinstatement of a previously
approval date, to ensure adherence has
approved collection; Title of
been maintained and to account for any
Information Collection: Appropriate Use changes in the entities’ processes.
Criteria (AUC) for Advanced Diagnostic Qualified PLEs must reapply every five
Imaging Services; Use: Section 218(b) of years and must submit the applications
the Protecting Access to Medicare Act
by January 1 of the 5th year after the
(PAMA) of 2014 amended the Medicare PLE’s most recent approval date. Form
Number: CMS–10570 (OMB control
Part B statute by adding a new section
number: 0938–1288); Frequency:
1834(q) of the Act entitled,
Occasionally; Affected Public: Private:
‘‘Recognizing Appropriate Use Criteria
minimize the information collection
burden.
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jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 209 / Wednesday, October 28, 2020 / Notices
Business or other for-profit and Not forprofit institutions; Number of
Respondents: 10; Number of Responses:
10; Total Annual Hours: 150. (For
policy questions regarding this
collection, contact Heather Hostetler at
410–786–4515.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Generic Social
Marketing & Consumer Testing
Research; Use: The purpose of this
submission is to extend the approval of
the generic clearance for a program of
consumer research aimed at a broad
audience of those affected by CMS
programs including Medicare,
Medicaid, Children’s Health Insurance
Program (CHIP), and health insurance
exchanges. This program extends
strategic efforts to reach and tailor
communications to beneficiaries,
caregivers, providers, stakeholders, and
any other audiences that would support
the Agency in improving the
functioning of the health care system,
improve patient care and outcomes, and
reduce costs without sacrificing quality
of care. The information collected will
be used to create a streamlined and
proactive process for collection of data
and utilizing the feedback on service
delivery for continuous improvement of
communication activities aimed at
diverse CMS audiences.
The generic clearance will allow rapid
response to inform CMS initiatives
using a mixture of qualitative and
quantitative consumer research
strategies (including formative research
studies and methodological tests) to
improve communication with key CMS
audiences. As new information
resources and persuasive technologies
are developed, they can be tested and
evaluated for beneficiary response to the
materials and delivery channels. Results
will inform communication
development and information
architecture as well as allow for
continuous quality improvement. The
overall goal is to maximize the extent to
which consumers have access to useful
sources of CMS program information in
a form that can help them make the
most of their benefits and options
The activities under this clearance
involve social marketing and consumer
research using samples of self-selected
customers, as well as convenience
samples, and quota samples, with
respondents selected either to cover a
broad range of customers or to include
specific characteristics related to certain
products or services. All collection of
information under this clearance will
utilize a subset of items drawn from a
core collection of customizable items
VerDate Sep<11>2014
18:29 Oct 27, 2020
Jkt 253001
referred to as the Social Marketing and
Consumer Testing Item Bank. This item
bank is designed to establish a set of
pre-approved generic question that can
be drawn upon to allow for the rapid
turn-around consumer testing required
for us to communicate more effectively
with our audiences. The questions in
the item bank are divided into two
major categories. One set focuses on
characteristics of individuals and is
intended primarily for participant
screening and for use in structured
quantitative on-line or telephone
surveys. The other set is less structured
and is designed for use in qualitative
one-on-one and small group discussions
or collecting information related to
subjective impressions of test materials.
Results will be compiled and
disseminated so that future
communication can be informed by the
testing results. We will use the findings
to create the greatest possible public
benefit. Form Number: CMS–10437
(OMB control number: 0938–1247);
Frequency: Yearly; Affected Public:
Individuals; Number of Respondents:
7,732; Number of Responses: 61,992;
Total Annual Hours: 26,588. (For policy
questions regarding this collection
contact Sabreet Kang Rajeev at 410–
786–5616.)
Dated: October 23, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–23890 Filed 10–27–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Performance Review Board
Membership
68333
FOR FURTHER INFORMATION CONTACT:
Kathy Vaughn, 410–786–1050 or
katherine.vaughn@cms.hhs.gov
SUPPLEMENTARY INFORMATION: 5 U.S.C.
4314(c)(4) requires the appointment of
board members to be published in the
Federal Register. The following persons
comprise a standing roster to serve as
members of the SES PRB for the Centers
for Medicare & Medicaid Services:
Jennifer Main, Chief Operating Officer
(serves as the Chair)
Kimberly Brandt, Principal Deputy
Administrator for Policy and
Operations
Tia Butler, Director, Office of Human
Capital
Nancy O’Connor, Director, Office of
Program Operations and Local
Engagement
Randy Pate, Deputy Administrator and
Director, Center for Consumer
Information and Insurance Oversight
Elizabeth Richter, Deputy Center
Director, Center for Medicare
Karen Shields, Deputy Center Director,
Center for Medicaid and CHIP
Services
Arrah Tabe-Bedward, Deputy Director,
Center for Medicare and Medicaid
Innovation
Jeffrey Wu, Deputy Director for
Operations, Center for Consumer
Information and Insurance Oversight
The Chief Operating Officer of the
Centers for Medicare & Medicaid
Services (CMS), Jennifer Main, having
reviewed and approved this document,
authorizes Lynette Wilson, who is the
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Dated: October 23, 2020.
Lynette Wilson,
Federal Register Liaison, Department of
Health and Human Services.
[FR Doc. 2020–23891 Filed 10–27–20; 8:45 am]
BILLING CODE 4120–01–P
Centers for Medicare &
Medicaid Services
ACTION: Notice of Performance Review
Board Membership
AGENCY:
In accordance with
regulations prescribed by the Office of
Personnel Management, one or more
Senior Executive Service (SES)
Performance Review Boards (PRBs). The
PRB shall review and evaluate the
initial summary rating of a senior
executive’s performance, the executive’s
response, and the higher-level official’s
comments on the initial summary
rating. In addition, the PRB will review
and recommend executive performance
bonuses and pay increases.
SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1030]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Allergen
Labeling and Reporting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
E:\FR\FM\28OCN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 209 (Wednesday, October 28, 2020)]
[Notices]
[Pages 68332-68333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23890]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10570 and CMS-10437]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
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 November 27, 2020.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
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.
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 of a
previously approved collection; Title of Information Collection:
Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging
Services; Use: Section 218(b) of the Protecting Access to Medicare Act
(PAMA) of 2014 amended the Medicare Part B statute by adding a new
section 1834(q) of the Act entitled, ``Recognizing Appropriate Use
Criteria for Certain Imaging Services,'' which directs the Secretary to
establish a program to promote the use of AUC. This program is codified
at 42 CFR 414.94. Evidence-based AUC for imaging can assist clinicians
in selecting the imaging study that is most likely to improve health
outcomes for patients based on their individual context. A provider-led
entity (PLE) as defined in 42 CFR 414.94(b) is a national professional
medical specialty society or other organization that is comprised
primarily of providers or practitioners who, either within the
organization or outside the organization, predominantly provide direct
patient care. This program requires professionals ordering applicable
imaging services as defined in Sec. 414.94(b) to consult with
specified applicable AUC, which are criteria developed, endorsed or
modified by a qualified PLE.
The cornerstone of the PLE qualification process is for PLEs to
demonstrate that they engage in a rigorous evidence-based process for
developing, modifying, or endorsing AUC. Section 1834(q)(2)(B)
specifies that the Secretary must consider whether AUC have stakeholder
consensus, are scientifically valid and evidence-based, and are based
on studies that are published and reviewable by stakeholders. In the
2016 Physician Fee Schedule Final Rule with comment period (80 FR
70886, November 16, 2015; see pages 71102-71116 and pages 71380-71382)
we established a qualification process and requirements for qualified
PLEs in order to ensure that the AUC development or endorsement
processes used by a PLE result in high quality, evidence-based AUC in
accordance with section 1834(q)(2)(B).
In order to become and remain a qualified PLE, we require PLEs to
demonstrate adherence to specific requirements when developing,
modifying or endorsing AUC. To ensure that these requirements are met,
we require PLEs to submit information demonstrating their adherence to
these requirements. CMS qualifies those PLEs that demonstrate adherence
to the requirements for a period of five years. Qualified PLEs are also
required, during the 5th year after their most recent approval date, to
ensure adherence has been maintained and to account for any changes in
the entities' processes. Qualified PLEs must reapply every five years
and must submit the applications by January 1 of the 5th year after the
PLE's most recent approval date. Form Number: CMS-10570 (OMB control
number: 0938-1288); Frequency: Occasionally; Affected Public: Private:
[[Page 68333]]
Business or other for-profit and Not for-profit institutions; Number of
Respondents: 10; Number of Responses: 10; Total Annual Hours: 150. (For
policy questions regarding this collection, contact Heather Hostetler
at 410-786-4515.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Generic Social
Marketing & Consumer Testing Research; Use: The purpose of this
submission is to extend the approval of the generic clearance for a
program of consumer research aimed at a broad audience of those
affected by CMS programs including Medicare, Medicaid, Children's
Health Insurance Program (CHIP), and health insurance exchanges. This
program extends strategic efforts to reach and tailor communications to
beneficiaries, caregivers, providers, stakeholders, and any other
audiences that would support the Agency in improving the functioning of
the health care system, improve patient care and outcomes, and reduce
costs without sacrificing quality of care. The information collected
will be used to create a streamlined and proactive process for
collection of data and utilizing the feedback on service delivery for
continuous improvement of communication activities aimed at diverse CMS
audiences.
The generic clearance will allow rapid response to inform CMS
initiatives using a mixture of qualitative and quantitative consumer
research strategies (including formative research studies and
methodological tests) to improve communication with key CMS audiences.
As new information resources and persuasive technologies are developed,
they can be tested and evaluated for beneficiary response to the
materials and delivery channels. Results will inform communication
development and information architecture as well as allow for
continuous quality improvement. The overall goal is to maximize the
extent to which consumers have access to useful sources of CMS program
information in a form that can help them make the most of their
benefits and options
The activities under this clearance involve social marketing and
consumer research using samples of self-selected customers, as well as
convenience samples, and quota samples, with respondents selected
either to cover a broad range of customers or to include specific
characteristics related to certain products or services. All collection
of information under this clearance will utilize a subset of items
drawn from a core collection of customizable items referred to as the
Social Marketing and Consumer Testing Item Bank. This item bank is
designed to establish a set of pre-approved generic question that can
be drawn upon to allow for the rapid turn-around consumer testing
required for us to communicate more effectively with our audiences. The
questions in the item bank are divided into two major categories. One
set focuses on characteristics of individuals and is intended primarily
for participant screening and for use in structured quantitative on-
line or telephone surveys. The other set is less structured and is
designed for use in qualitative one-on-one and small group discussions
or collecting information related to subjective impressions of test
materials. Results will be compiled and disseminated so that future
communication can be informed by the testing results. We will use the
findings to create the greatest possible public benefit. Form Number:
CMS-10437 (OMB control number: 0938-1247); Frequency: Yearly; Affected
Public: Individuals; Number of Respondents: 7,732; Number of Responses:
61,992; Total Annual Hours: 26,588. (For policy questions regarding
this collection contact Sabreet Kang Rajeev at 410-786-5616.)
Dated: October 23, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2020-23890 Filed 10-27-20; 8:45 am]
BILLING CODE 4120-01-P
