Agency Information Collection Activities: Proposed Collection; Comment Request, 34735-34736 [2020-12285]
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Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Notices
notice (78 FR 48164–69) published on
August 7, 2013 which delineates the
process for making a national coverage
determination (NCD) including
information for external parties to
submit a formal request for a new NCD
or a reconsideration of an existing NCD.
An NCD is defined in 1862(l) of the
Social Security Act (the Act) as ‘‘a
determination by the Secretary with
respect to whether or not a particular
item or service is covered nationally
under this title.’’ This information
collection will assist us in obtaining the
information we require to make a
national coverage determination in a
timely manner and ensuring that the
Medicare program continues to meet the
needs of its beneficiaries. Form Number:
CMS–R–290 (OMB control number:
0938–0776); Frequency: Annual;
Affected Public: Private Sector: Business
or other for-profits; Number of
Respondents: 30; Total Annual
Responses: 30; Total Annual Hours:
1,200. (For policy questions regarding
this collection contact Lori M. Ashby at
410–786–6322.)
Dated: June 2, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–12287 Filed 6–5–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10114, CMS–
10199, CMS–R–52 and CMS–R–26]
Agency Information Collection
Activities: Proposed Collection;
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 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:09 Jun 05, 2020
Jkt 250001
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
August 7, 2020.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to 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 lllll, 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/Paperwork
ReductionActof1995/PRA-Listing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10114 National Provider
Identifier (NPI) Application and
Update Form and Supporting
Regulations in 45 CFR 142.408, 45
CFR 162.406, 45 CFR 162.408
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
34735
CMS–10199 Data Collection for
Medicare Facilities Performing
Carotid Artery Stenting with Embolic
Protection in Patients at High Risk for
Carotid Endarterectomy
CMS–R–52 Conditions for Coverage of
Suppliers of End Stage Renal Disease
(ESRD) Services and Supporting
Regulations
CMS–R–26 Clinical Laboratory
Improvement Amendments (CLIA)
Regulations
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: National
Provider Identifier (NPI) Application
and Update Form and Supporting
Regulations in 45 CFR 142.408, 45 CFR
162.406, 45 CFR 162.408; Use: The
National Provider Identifier Application
and Update Form is used by health care
providers to apply for NPIs and furnish
updates to the information they
supplied on their initial applications.
The form is also used to deactivate their
NPIs if necessary. The form is available
on paper or can be completed via a webbased process. Health care providers can
mail a paper application, complete the
application via the web-based process
via the National Plan and Provider
Enumeration System (NPPES), or have a
trusted organization submit the
application on their behalf via the
Electronic File Interchange (EFI)
process. The Enumerator uses the
NPPES to process the application and
generate the NPI. NPPES is the Medicare
contractor tasked with issuing NPIs, and
maintaining and storing NPI data. Form
Number: CMS–10114 (OMB Control
Number: 0938–0931); Frequency:
Reporting—On occasion; Affected
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khammond on DSKJM1Z7X2PROD with NOTICES
34736
Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Notices
Public: Business or other for-profit, Notfor-profit institutions, and Federal
government; Number of Respondents:
996,042; Total Annual Responses:
996,042; Total Annual Hours: 169,327.
(For policy questions regarding this
collection contact Da’Vona Boyd at 410–
786–7483.)
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: Extension 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
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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 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).
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Dated: June 2, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–12285 Filed 6–5–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0128]
Reauthorization of the Prescription
Drug User Fee Act; Public Meeting;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
hosting a virtual public meeting to
discuss proposed recommendations for
the reauthorization of the Prescription
Drug User Fee Act (PDUFA) for fiscal
years (FYs) 2023 through 2027. PDUFA
authorizes FDA to collect user fees to
support the process for the review of
human drug applications. The current
legislative authority for PDUFA expires
in September 2022. At that time, new
legislation will be required for FDA to
continue collecting prescription drug
user fees in future fiscal years. The
Federal Food, Drug, and Cosmetic Act
(FD&C Act) directs that FDA begin the
PDUFA reauthorization process by
publishing a notice in the Federal
Register requesting public input and
holding a public meeting where the
public may present its views on the
reauthorization. FDA invites public
comment as the Agency begins the
process to reauthorize the program in
FYs 2023 through 2027. These
comments will be published and
available on FDA’s website.
DATES: The public meeting will be held
on July 23, 2020, from 9 a.m. to 2 p.m.,
and will take place virtually and will be
held by webcast only. Submit either
electronic or written comments on this
public meeting by August 23, 2020.
ADDRESSES: Registration to attend the
meeting and other information can be
found at https://pdufaviipublicmeeting.eventbrite.com. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before August 23, 2020. The
SUMMARY:
E:\FR\FM\08JNN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 110 (Monday, June 8, 2020)]
[Notices]
[Pages 34735-34736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12285]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10114, CMS-10199, CMS-R-52 and CMS-R-26]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (the PRA), federal agencies are required to publish notice
in the Federal Register concerning each proposed collection of
information (including each proposed extension or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments must be received by August 7, 2020.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
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-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10114 National Provider Identifier (NPI) Application and Update
Form and Supporting Regulations in 45 CFR 142.408, 45 CFR 162.406, 45
CFR 162.408
CMS-10199 Data Collection for Medicare Facilities Performing Carotid
Artery Stenting with Embolic Protection in Patients at High Risk for
Carotid Endarterectomy
CMS-R-52 Conditions for Coverage of Suppliers of End Stage Renal
Disease (ESRD) Services and Supporting Regulations
CMS-R-26 Clinical Laboratory Improvement Amendments (CLIA) Regulations
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. The term
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA requires federal agencies
to publish a 60-day notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
or reinstatement of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, CMS is publishing this notice.
Information Collection
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: National Provider
Identifier (NPI) Application and Update Form and Supporting Regulations
in 45 CFR 142.408, 45 CFR 162.406, 45 CFR 162.408; Use: The National
Provider Identifier Application and Update Form is used by health care
providers to apply for NPIs and furnish updates to the information they
supplied on their initial applications. The form is also used to
deactivate their NPIs if necessary. The form is available on paper or
can be completed via a web-based process. Health care providers can
mail a paper application, complete the application via the web-based
process via the National Plan and Provider Enumeration System (NPPES),
or have a trusted organization submit the application on their behalf
via the Electronic File Interchange (EFI) process. The Enumerator uses
the NPPES to process the application and generate the NPI. NPPES is the
Medicare contractor tasked with issuing NPIs, and maintaining and
storing NPI data. Form Number: CMS-10114 (OMB Control Number: 0938-
0931); Frequency: Reporting--On occasion; Affected
[[Page 34736]]
Public: Business or other for-profit, Not-for-profit institutions, and
Federal government; Number of Respondents: 996,042; Total Annual
Responses: 996,042; Total Annual Hours: 169,327. (For policy questions
regarding this collection contact Da'Vona Boyd at 410-786-7483.)
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: Extension 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: June 2, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2020-12285 Filed 6-5-20; 8:45 am]
BILLING CODE 4120-01-P
