Agency Information Collection Activities: Submission for OMB Review; Comment Request, 70166-70167 [2020-24442]
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70166
Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–24475 Filed 11–3–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10744]
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
minimize the information collection
burden.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by December 4, 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
khammond on DSKJM1Z7X2PROD with NOTICES
DATES:
VerDate Sep<11>2014
18:16 Nov 03, 2020
Jkt 253001
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.
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: New collection (Request for a
new OMB control number); Title of
Information Collection: Medicare
Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
(DMEPOS) Competitive Bidding
Program—Contracting Forms; Use: The
Medicare Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
(DMEPOS) Competitive Bidding
Program was established by the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (‘‘Medicare Modernization Act’’ or
‘‘MMA’’). Section 302 of the MMA
amended Section 1847 of the Social
Security Act (the Act) to establish the
competitive acquisition program and
define program requirements.
Under the MMA, the DMEPOS
Competitive Bidding Program was to be
phased in so that competition under the
program would first occur in 10 areas in
2007. The Centers for Medicare &
Medicaid Services (CMS) completed the
rulemaking process for the competitive
acquisition of DMEPOS items and
services in 42 CFR parts 411 and 414
published in the Federal Register
Volume 72 on April 10, 2007. CMS
PO 00000
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Fmt 4703
Sfmt 4703
conducted the Round 1 competition in
10 areas and for 10 DMEPOS product
categories, and implemented the
program on July 1, 2008. The Medicare
Improvements for Patients and
Providers Act of 2008 (MIPPA), enacted
on July 15, 2008, made limited changes
to the Competitive Bidding Program,
including termination of existing
contracts that were in effect and a
requirement to re-bid Round 1.
As required by MIPPA, CMS
conducted the competition for the
Round 1 Rebid in 2009. The Round 1
Rebid contracts and prices became
effective on January 1, 2011. The
Affordable Care Act (ACA), enacted on
March 23, 2010, expanded the Round 2
competition by adding an additional 21
metropolitan statistical areas (MSAs),
bringing the total MSAs for Round 2 to
91. The competition for Round 2 began
in December 2011. CMS also began a
competition for National Mail Order
(NMO) of diabetes testing supplies at
the same time as Round 2. The Round
2 and NMO contracts and prices were
implemented on July 1, 2013.
The MMA requires the Secretary to
recompete contracts not less often than
once every three years. The Round 1
Rebid contract period for all product
categories except mail-order diabetes
testing supplies expired on December
31, 2013. (Round 1 Rebid contracts for
mail-order diabetes testing supplies
ended on December 31, 2012.) The
competition for the Round 1 Recompete
began in August of 2012 and contracts
and prices became effective on January
1, 2014. The Round 1 Recompete
contract period expires on December 31,
2016. Round 1 2017 contracts will
become effective on January 1, 2017
through December 31, 2018. Round 2
and NMO contracts and prices expired
on June 30, 2016. Round 2 Recompete
and the NMO Recompete contracts
became effective on July 1, 2016, and
expired on December 31, 2018. CMS
will be implementing a consolidated
round of competition to include all
Round 1 2017 and Round 2 Recompete
competitive bidding areas, referred to as
Round 2021. Round 2021 will not
include NMO, which will be competed
again in future rounds of the program.
The forms included in this ICR were
previously included in the ICR currently
approved under 0938–1016. Due to the
temporary gap in the DMEPOS
Competitive Bidding Program, which
started on January 1, 2019, we do not
currently have any active PRA package
for this specific collection of
information (Form C, Subcontracting,
Change of Ownerships, and
Grandfathering). We are now seeking
approval of a PRA package based on
E:\FR\FM\04NON1.SGM
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Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
estimates from previous rounds of the
program (specifically Round 2
Recompete and Round 1 2017) and
without reference to changes in burden.
Form Number: CMS–10744 (OMB
control number: 0938–New); Frequency:
Occasionally (varies by form); Affected
Public: Private Sector, Business or other
for-profits; Number of Respondents:
2,984; Total Annual Responses:
271,597; Total Annual Hours: 31,121.
(For policy questions regarding this
collection contact Julia Howard at 410–
786–8645.)
Dated: October 30, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–24442 Filed 11–3–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10757]
Emergency Clearance: Public
Information Collection Requirements
Submitted to the Office of Management
and Budget (OMB)
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
On March 13, 2020, the
President declared a national emergency
in response to the public health
emergency (PHE) caused by the SARS–
CoV–2 virus, otherwise known as
COVID–19. The CARES Act was
published in response to the PHE that
requires ‘‘every laboratory that performs
or analyzes a test that is intended to
detect SARS–CoV–2 or to diagnose a
possible case of COVID–19 shall report
the results from each such test.’’ The
September 2, 2020 interim final rule
with comment (CMS–3401–IFC)
requires laboratories to report SARS–
CoV–2 test results in a manner and
frequency specified by the Secretary.
Consistent with the CARES Act
laboratory reporting requirements, CMS
made modifications to the CLIA
regulations to meet the SARS–CoV–2
test result reporting provisions related
to the Secretary’s Public Health
Emergency declaration with respect to
COVID–19.
DATES: Comments must be received by
November 19, 2020.
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SUMMARY:
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Jkt 253001
When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted
within 15 days in any one of the
following ways:
1. Electronically. You may send your
comments electronically to https://
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’ website address at
https://www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
Under the
PRA, Federal agencies are required to
publish notice in the Federal Register
concerning each proposed ICR.
Interested persons are invited to send
comments regarding our burden
estimates or any other aspect of this ICR
including the necessity and utility of the
proposed ICR 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.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following ICR. More detailed
information can be found in the
collection’s supporting statement and
associated materials (see ADDRESSES).
CMS–10757 CLIA Collection of
Information Requirements Related to
SARS–CoV–2 Test Results Reporting
Under the PRA (44 U.S.C. 3501–
3520), Federal agencies must obtain
approval from the Office of Management
PO 00000
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70167
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. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
Information Collection
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: CLIA Collection
of Information Requirements Related to
SARS–CoV–2 Test Results Reporting;
Use: In order to be in compliance with
the new CLIA mandatory SARS–CoV–2
test results reporting requirements,
laboratories will need to develop a
mechanism to track, collect, and report
test results as well as update policies
and procedures. In addition,
Accreditation Organizations (AOs) and
Exempt States (ESs) will need to update
laboratory standards to reflect the
reporting requirements and update
policies and procedures related to
reporting laboratories that do not report
test results as required.
The CDC has an information
collection request (OMB Control
Number 0920–1299) in order to collect
laboratory data related to the COVID–19
Pandemic Response. The CMS package
(ICR) is for laboratory implementation
and CMS monitoring of compliance
with the CMS–3401–IFC CLIA-certified
laboratory reporting requirements.
The information collected by the
Centers for Medicare and Medicaid
Services (CMS) or its designee, such as
a CMS agent or CMS approved
laboratory accreditation organization,
when conducting inspections will be
used to determine a laboratory’s
compliance with the CLIA SARS–CoV–
2 test result reporting requirements.
During an on-site survey, the Conditionlevel laboratory requirement at 42 CFR
493.41 and 493.1100(a) are assessed for
compliance. The information is used by
CMS in determining appropriate Civil
Money Penalties (CMPs) when
laboratories fail to report as required.
Form Number: CMS–10757 (OMB
control number: 0938–NEW);
Frequency: Daily; Affected Public:
Private Sector Not-for-profit institutions
and State, Local and Tribal
Governments; Number of Respondents:
77,033; Total Annual Responses:
308,114; Total Annual Hours: 1,386,873
(For policy questions regarding this
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]]>Agencies
[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Pages 70166-70167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24442]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10744]
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 December 4, 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: New collection (Request
for a new OMB control number); Title of Information Collection:
Medicare Durable Medical Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Competitive Bidding Program--Contracting Forms; Use:
The Medicare Durable Medical Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Competitive Bidding Program was established by the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(``Medicare Modernization Act'' or ``MMA''). Section 302 of the MMA
amended Section 1847 of the Social Security Act (the Act) to establish
the competitive acquisition program and define program requirements.
Under the MMA, the DMEPOS Competitive Bidding Program was to be
phased in so that competition under the program would first occur in 10
areas in 2007. The Centers for Medicare & Medicaid Services (CMS)
completed the rulemaking process for the competitive acquisition of
DMEPOS items and services in 42 CFR parts 411 and 414 published in the
Federal Register Volume 72 on April 10, 2007. CMS conducted the Round 1
competition in 10 areas and for 10 DMEPOS product categories, and
implemented the program on July 1, 2008. The Medicare Improvements for
Patients and Providers Act of 2008 (MIPPA), enacted on July 15, 2008,
made limited changes to the Competitive Bidding Program, including
termination of existing contracts that were in effect and a requirement
to re-bid Round 1.
As required by MIPPA, CMS conducted the competition for the Round 1
Rebid in 2009. The Round 1 Rebid contracts and prices became effective
on January 1, 2011. The Affordable Care Act (ACA), enacted on March 23,
2010, expanded the Round 2 competition by adding an additional 21
metropolitan statistical areas (MSAs), bringing the total MSAs for
Round 2 to 91. The competition for Round 2 began in December 2011. CMS
also began a competition for National Mail Order (NMO) of diabetes
testing supplies at the same time as Round 2. The Round 2 and NMO
contracts and prices were implemented on July 1, 2013.
The MMA requires the Secretary to recompete contracts not less
often than once every three years. The Round 1 Rebid contract period
for all product categories except mail-order diabetes testing supplies
expired on December 31, 2013. (Round 1 Rebid contracts for mail-order
diabetes testing supplies ended on December 31, 2012.) The competition
for the Round 1 Recompete began in August of 2012 and contracts and
prices became effective on January 1, 2014. The Round 1 Recompete
contract period expires on December 31, 2016. Round 1 2017 contracts
will become effective on January 1, 2017 through December 31, 2018.
Round 2 and NMO contracts and prices expired on June 30, 2016. Round 2
Recompete and the NMO Recompete contracts became effective on July 1,
2016, and expired on December 31, 2018. CMS will be implementing a
consolidated round of competition to include all Round 1 2017 and Round
2 Recompete competitive bidding areas, referred to as Round 2021. Round
2021 will not include NMO, which will be competed again in future
rounds of the program.
The forms included in this ICR were previously included in the ICR
currently approved under 0938-1016. Due to the temporary gap in the
DMEPOS Competitive Bidding Program, which started on January 1, 2019,
we do not currently have any active PRA package for this specific
collection of information (Form C, Subcontracting, Change of
Ownerships, and Grandfathering). We are now seeking approval of a PRA
package based on
[[Page 70167]]
estimates from previous rounds of the program (specifically Round 2
Recompete and Round 1 2017) and without reference to changes in burden.
Form Number: CMS-10744 (OMB control number: 0938-New); Frequency:
Occasionally (varies by form); Affected Public: Private Sector,
Business or other for-profits; Number of Respondents: 2,984; Total
Annual Responses: 271,597; Total Annual Hours: 31,121. (For policy
questions regarding this collection contact Julia Howard at 410-786-
8645.)
Dated: October 30, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2020-24442 Filed 11-3-20; 8:45 am]
BILLING CODE 4120-01-P
