Agency Information Collection Activities: Submission for OMB Review; Comment Request, 49654-49655 [2020-17852]
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Federal Register / Vol. 85, No. 158 / Friday, August 14, 2020 / Notices
minutes, and each speaker may only
speak once per meeting.
Written Public Comment: Written
comments must be received on or before
September 23, 2020. Written public
comments submitted by 72 hours prior
to the ACIP meeting will be provided to
ACIP members before the meeting.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–17765 Filed 8–13–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10418, CMS–
10199, CMS–R–52 and CMS–R–26]
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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:29 Aug 13, 2020
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to the Secretary concerning the amount
the issuer spends each year on claims,
quality improvement expenses, nonDATES: Comments on the collection(s) of
claims costs, Federal and State taxes
information must be received by the
and licensing and regulatory fees, the
OMB desk officer by September 14,
amount of earned premium, and
2020.
beginning with the 2014 reporting year,
ADDRESSES: Written comments and
the amounts related to the transitional
recommendations for the proposed
reinsurance, risk corridors, and risk
information collection should be sent
adjustment programs established under
within 30 days of publication of this
sections 1341, 1342, and 1343,
notice to www.reginfo.gov/public/do/
respectively, of the Affordable Care Act.
PRAMain. Find this particular
An issuer must provide an annual rebate
information collection by selecting
if the amount it spends on certain costs
‘‘Currently under 30-day Review—Open compared to its premium revenue
for Public Comments’’ or by using the
(excluding Federal and States taxes and
search function.
licensing and regulatory fees) does not
To obtain copies of a supporting
meet a certain ratio, referred to as the
statement and any related forms for the
medical loss ratio (MLR). Each issuer is
proposed collection(s) summarized in
required to submit annually MLR data,
this notice, you may make your request
including information about any rebates
using one of following:
it must provide, on a form prescribed by
1. Access CMS’ website address at
CMS, for each State in which the issuer
website address at https://www.cms.gov/ conducts business. Each issuer is also
Regulations-and-Guidance/Legislation/
required to provide a rebate notice to
PaperworkReductionActof1995/PRAeach policyholder that is owed a rebate
Listing.html.
and each subscriber of policyholders
2. Call the Reports Clearance Office at that are owed a rebate for any given
(410) 786–1326.
MLR reporting year. Additionally, each
issuer is required to maintain for a
FOR FURTHER INFORMATION CONTACT:
period of seven years all documents,
William Parham at (410) 786–4669.
records and other evidence that support
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA) the data included in each issuer’s
annual report to the Secretary.
(44 U.S.C. 3501–3520), federal agencies
Based upon CMS’ experience in the
must obtain approval from the Office of
Management and Budget (OMB) for each MLR data collection and evaluation
process, CMS is updating its annual
collection of information they conduct
burden hour estimates to reflect the
or sponsor. The term ‘‘collection of
actual numbers of submissions, rebates
information’’ is defined in 44 U.S.C.
and rebate notices. The 2019 MLR
3502(3) and 5 CFR 1320.3(c) and
Reporting Form and Instructions reflect
includes agency requests or
requirements that members of the public changes for the 2018 reporting year and
submit reports, keep records, or provide beyond. The 2019 MLR Reporting Form
and instructions are also modified to
information to a third party. Section
eliminate the reporting elements that
3506(c)(2)(A) of the PRA (44 U.S.C.
were required under the risk corridors
3506(c)(2)(A)) requires federal agencies
data submission requirements in 45 CFR
to publish a 30-day notice in the
153.530 for the 2014 through 2016
Federal Register concerning each
benefit years. For 2019, it is expected
proposed collection of information,
that issuers will submit fewer reports
including each proposed extension or
and on average, send fewer notices and
reinstatement of an existing collection
rebate checks in the mail to
of information, before submitting the
policyholders and subscribers, which
collection to OMB for approval. To
will reduce burden on issuers. In
comply with this requirement, CMS is
addition, issuers of qualified health
publishing this notice that summarizes
plans will no longer have to submit on
the following proposed collection(s) of
the annual report the data for the risk
information for public comment:
corridors program established under
1. Type of Information Collection
section 1342 of the Patient Protection
Request: Revision of a currently
and Affordable Care Act. Form Number:
approved collection; Title of
CMS–10418 (OMB control number:
Information Collection: Annual MLR
and Rebate Calculation Report and MLR 0938–1164); Frequency: Annually;
Affected Public: Private Sector, Business
Rebate Notices; Use: Under Section
or other for-profit and not-for-profit
2718 of the Affordable Care Act and
implementing regulation at 45 CFR part institutions; Number of Respondents:
494; Number of Responses: 1,896; Total
158, a health insurance issuer (issuer)
Annual Hours: 232,427. For policy
offering group or individual health
insurance coverage must submit a report questions regarding this collection
minimize the information collection
burden.
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 158 / Friday, August 14, 2020 / Notices
contact Stephanie Watson at 301–492–
4238.
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Data Collection
for Medicare Facilities Performing
Carotid Artery Stenting with Embolic
Protection in Patients at High Risk for
Carotid Endarterectomy; Use: CMS
provides coverage for carotid artery
stenting (CAS) with embolic protection
for patients at high risk for carotid
endarterectomy and who also have
symptomatic carotid artery stenosis
between 50 percent and 70 percent or
have asymptomatic carotid artery
stenosis ≥80 percent in accordance with
the Category B IDE clinical trials
regulation (42 CFR 405.201), a trial
under the CMS Clinical Trial Policy
(NCD Manual § 310.1, or in accordance
with the National Coverage
Determination on CAS post approval
studies (Medicare NCD Manual 20.7
CMS also covers CAS with embolic
protection for patients at high risk for
carotid endarterectomy and who also
have symptomatic carotid artery
stenosis ≥70 percent performed in
facilities that have been determined to
be competent in performing the
evaluation, procedure and follow-up
necessary to ensure optimal patient
outcomes. In accordance with this
criteria, we consider coverage for CAS
reasonable and necessary (section 1862
(A)(1)(a) of the Social Security Act).
Form Number: CMS–10199 (OMB
control number: 0938–1011); Frequency:
Yearly; Affected Public: Business or
other for-profit and Not-for-profit
institutions; Number of Respondents:
1,420; Total Annual Responses: 3,313;
Total Annual Hours: 30,057. (For policy
questions regarding this collection
contact Sarah Fulton at 410–786–2749.)
3. Type of Information Collection
Request: Reinstatement of a previously
approved collection; Title of
Information Collection: Conditions for
Coverage of Suppliers of End Stage
Renal Disease (ESRD) Services and
Supporting Regulations; Use: The
information collection requirements
described herein are part of the
Medicare and Medicaid Programs;
Conditions for Coverage for End-Stage
Renal Disease Facilities. The
requirements fall into three categories:
Record keeping, reporting, and
disclosure. With regard to the record
keeping requirements, CMS uses these
conditions for coverage to certify health
care facilities that want to participate in
the Medicare or Medicaid programs. For
the reporting requirements, the
information is needed to assess and
ensure proper distribution and effective
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17:29 Aug 13, 2020
Jkt 250001
utilization of ESRD treatment resources
while maintaining or improving quality
of care. All of the reports specified in
this document are geared toward
ensuring that facilities achieve quality
and cost-effective service provision.
Collection of this information is
authorized by Section 1881 of the Act
and required by 42 CFR 405.2100
through 405.2171 (now at 42 CFR
414.330, 488.60, and 494.100–494.180).
Depending on the outcome of litigation,
disclosures may be required by
Medicare-certified dialysis facilities that
make payments of premiums for
individual market health plans. Form
Number: CMS–R–52 (OMB Control
Number: 0938–0386); Frequency:
Annually; Affected Public: Private
sector—Business or other for-profit;
Number of Respondents: 8,246; Total
Annual Responses: 171,795; Total
Annual Hours: 1,260,491. (For policy
questions regarding this collection
contact Eric Laib at 410–786–9759.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Clinical
Laboratory Improvement Amendments
(CLIA) Regulations; Use: The
information is necessary to determine
an entity’s compliance with the
Congressionally-mandated program
with respect to the regulation of
laboratory testing (CLIA). In addition,
laboratories participating in the
Medicare program must comply with
CLIA requirements as required by
section 6141 of OBRA 89. Medicaid,
under the authority of section
1902(a)(9)(C) of the Social Security Act,
pays for services furnished only by
laboratories that meet Medicare (CLIA)
requirements. Form Number: CMS–R–
26 (OMB Control Number: 0938–0612);
Frequency: Monthly, occasionally;
Affected Public: Business or other forprofits and Not-for-profit institutions,
State, Local or Tribal Governments, and
the Federal government; Number of
Respondents: 34,579; Total Annual
Responses: 74,476,376; Total Annual
Hours: 14,514,802. (For policy questions
regarding this collection contact Raelene
Perfetto at 410–786–6876).
Dated: August 11, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–17852 Filed 8–13–20; 8:45 am]
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49655
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2019–D–1649 and FDA–
2019–D–1651]
Safety and Performance Based
Pathway Device-Specific Guidances;
Guidances for Industry and Food and
Drug Administration Staff; Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of two final
device-specific guidance documents for
the Safety and Performance Based
Pathway—specifically, ‘‘Cutaneous
Electrode for Recording Purposes—
Performance Criteria for Safety and
Performance Based Pathway; Guidance
for Industry and Food and Drug
Administration Staff’’ and
‘‘Conventional Foley Catheters—
Performance Criteria for Safety and
Performance Based Pathway; Guidance
for Industry and Food and Drug
Administration Staff.’’ The devicespecific guidances identified in this
notice were developed in accordance
with the finalized guidance entitled
‘‘Safety and Performance Based
Pathway.’’
DATES: The announcement of the
guidance is published in the Federal
Register on August 14, 2020.
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.
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]]>Agencies
[Federal Register Volume 85, Number 158 (Friday, August 14, 2020)]
[Notices]
[Pages 49654-49655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17852]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10418, CMS-10199, CMS-R-52 and CMS-R-26]
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 September 14, 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: Revision of a currently
approved collection; Title of Information Collection: Annual MLR and
Rebate Calculation Report and MLR Rebate Notices; Use: Under Section
2718 of the Affordable Care Act and implementing regulation at 45 CFR
part 158, a health insurance issuer (issuer) offering group or
individual health insurance coverage must submit a report to the
Secretary concerning the amount the issuer spends each year on claims,
quality improvement expenses, non-claims costs, Federal and State taxes
and licensing and regulatory fees, the amount of earned premium, and
beginning with the 2014 reporting year, the amounts related to the
transitional reinsurance, risk corridors, and risk adjustment programs
established under sections 1341, 1342, and 1343, respectively, of the
Affordable Care Act. An issuer must provide an annual rebate if the
amount it spends on certain costs compared to its premium revenue
(excluding Federal and States taxes and licensing and regulatory fees)
does not meet a certain ratio, referred to as the medical loss ratio
(MLR). Each issuer is required to submit annually MLR data, including
information about any rebates it must provide, on a form prescribed by
CMS, for each State in which the issuer conducts business. Each issuer
is also required to provide a rebate notice to each policyholder that
is owed a rebate and each subscriber of policyholders that are owed a
rebate for any given MLR reporting year. Additionally, each issuer is
required to maintain for a period of seven years all documents, records
and other evidence that support the data included in each issuer's
annual report to the Secretary.
Based upon CMS' experience in the MLR data collection and
evaluation process, CMS is updating its annual burden hour estimates to
reflect the actual numbers of submissions, rebates and rebate notices.
The 2019 MLR Reporting Form and Instructions reflect changes for the
2018 reporting year and beyond. The 2019 MLR Reporting Form and
instructions are also modified to eliminate the reporting elements that
were required under the risk corridors data submission requirements in
45 CFR 153.530 for the 2014 through 2016 benefit years. For 2019, it is
expected that issuers will submit fewer reports and on average, send
fewer notices and rebate checks in the mail to policyholders and
subscribers, which will reduce burden on issuers. In addition, issuers
of qualified health plans will no longer have to submit on the annual
report the data for the risk corridors program established under
section 1342 of the Patient Protection and Affordable Care Act. Form
Number: CMS-10418 (OMB control number: 0938-1164); Frequency: Annually;
Affected Public: Private Sector, Business or other for-profit and not-
for-profit institutions; Number of Respondents: 494; Number of
Responses: 1,896; Total Annual Hours: 232,427. For policy questions
regarding this collection
[[Page 49655]]
contact Stephanie Watson at 301-492-4238.
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Data Collection
for Medicare Facilities Performing Carotid Artery Stenting with Embolic
Protection in Patients at High Risk for Carotid Endarterectomy; Use:
CMS provides coverage for carotid artery stenting (CAS) with embolic
protection for patients at high risk for carotid endarterectomy and who
also have symptomatic carotid artery stenosis between 50 percent and 70
percent or have asymptomatic carotid artery stenosis >=80 percent in
accordance with the Category B IDE clinical trials regulation (42 CFR
405.201), a trial under the CMS Clinical Trial Policy (NCD Manual Sec.
310.1, or in accordance with the National Coverage Determination on CAS
post approval studies (Medicare NCD Manual 20.7 CMS also covers CAS
with embolic protection for patients at high risk for carotid
endarterectomy and who also have symptomatic carotid artery stenosis
>=70 percent performed in facilities that have been determined to be
competent in performing the evaluation, procedure and follow-up
necessary to ensure optimal patient outcomes. In accordance with this
criteria, we consider coverage for CAS reasonable and necessary
(section 1862 (A)(1)(a) of the Social Security Act). Form Number: CMS-
10199 (OMB control number: 0938-1011); Frequency: Yearly; Affected
Public: Business or other for-profit and Not-for-profit institutions;
Number of Respondents: 1,420; Total Annual Responses: 3,313; Total
Annual Hours: 30,057. (For policy questions regarding this collection
contact Sarah Fulton at 410-786-2749.)
3. Type of Information Collection Request: Reinstatement of a
previously approved collection; Title of Information Collection:
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD)
Services and Supporting Regulations; Use: The information collection
requirements described herein are part of the Medicare and Medicaid
Programs; Conditions for Coverage for End-Stage Renal Disease
Facilities. The requirements fall into three categories: Record
keeping, reporting, and disclosure. With regard to the record keeping
requirements, CMS uses these conditions for coverage to certify health
care facilities that want to participate in the Medicare or Medicaid
programs. For the reporting requirements, the information is needed to
assess and ensure proper distribution and effective utilization of ESRD
treatment resources while maintaining or improving quality of care. All
of the reports specified in this document are geared toward ensuring
that facilities achieve quality and cost-effective service provision.
Collection of this information is authorized by Section 1881 of the Act
and required by 42 CFR 405.2100 through 405.2171 (now at 42 CFR
414.330, 488.60, and 494.100-494.180). Depending on the outcome of
litigation, disclosures may be required by Medicare-certified dialysis
facilities that make payments of premiums for individual market health
plans. Form Number: CMS-R-52 (OMB Control Number: 0938-0386);
Frequency: Annually; Affected Public: Private sector--Business or other
for-profit; Number of Respondents: 8,246; Total Annual Responses:
171,795; Total Annual Hours: 1,260,491. (For policy questions regarding
this collection contact Eric Laib at 410-786-9759.)
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Clinical
Laboratory Improvement Amendments (CLIA) Regulations; Use: The
information is necessary to determine an entity's compliance with the
Congressionally-mandated program with respect to the regulation of
laboratory testing (CLIA). In addition, laboratories participating in
the Medicare program must comply with CLIA requirements as required by
section 6141 of OBRA 89. Medicaid, under the authority of section
1902(a)(9)(C) of the Social Security Act, pays for services furnished
only by laboratories that meet Medicare (CLIA) requirements. Form
Number: CMS-R-26 (OMB Control Number: 0938-0612); Frequency: Monthly,
occasionally; Affected Public: Business or other for-profits and Not-
for-profit institutions, State, Local or Tribal Governments, and the
Federal government; Number of Respondents: 34,579; Total Annual
Responses: 74,476,376; Total Annual Hours: 14,514,802. (For policy
questions regarding this collection contact Raelene Perfetto at 410-
786-6876).
Dated: August 11, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2020-17852 Filed 8-13-20; 8:45 am]
BILLING CODE 4120-01-P
