Agency Information Collection Activities: Submission for OMB Review; Comment Request, 19733-19734 [2017-08663]
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Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–304/CMS–304a,
CMS–368/CMS–R–144, and CMS–R–308]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected; and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by May 30, 2017.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
Web site address at https://
www.cms.gov/Regulations-andGuidance/Legislation/
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:38 Apr 27, 2017
Jkt 241001
PaperworkReductionActof1995/PRAListing.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 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.
Comments submitted in response to the
60-day FR Notice have been addressed
in Appendix A of the ICR. 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: Extension of a currently
approved collection; Title of
Information Collection: Reconciliation
of State Invoice and Prior Quarter
Adjustment Statement; Use: Form CMS–
304 (Reconciliation of State Invoice) is
used by manufacturers to respond to the
state’s rebate invoice for current quarter
utilization. Form CMS–304a (Prior
Quarter Adjustment Statement) is
required only in those instances where
a change to the original rebate data
submittal is necessary. Form Number:
CMS–304 and –304a (OMB control
number: 0938–0676); Frequency:
Quarterly; Affected Public: Business or
other for-profits; Number of
Respondents: 1,037; Total Annual
Responses: 4,148; Total Annual Hours:
187,880. (For policy questions regarding
this collection contact Andrea
Wellington at 410–786–3490.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicaid Drug
Rebate Program Forms; Use: We develop
the rebate amount per drug unit from
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Fmt 4703
Sfmt 4703
19733
information supplied by the drug
manufacturers and distributes these data
to the states. States then must report
quarterly to the drug manufacturers and
report to us the total number of units of
each dosage form/strength of their
covered outpatient drugs reimbursed
during a quarter and the rebate amount
to be refunded. This report is due
within 60 days of the end of each
calendar quarter. The information in the
report is based on claims paid by the
state Medicaid agency during a calendar
quarter. Form CMS–R–144 (Quarterly
Report Data) is required from states
quarterly to report utilization for any
drugs paid for during that quarter. Form
CMS–368 (Administrative Data) is
required only in those instances where
a change to the original data submittal
is necessary. Form Number: CMS–368
and –R–144 (OMB control number:
0938–0582); Frequency: Quarterly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 224; Total
Annual Hours: 12,101. (For policy
questions regarding this collection
contact Andrea Wellington at 410–786–
3490.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: State Children’s
Health Insurance Program and
Supporting Regulations; Use: States
must submit title XXI plans and
amendments for approval by the
Secretary. We use the plan and its
subsequent amendments to determine if
the state has met the requirements of
title XXI. Information provided in the
state plan, state plan amendments, and
from the other information we are
collecting will be used by advocacy
groups, beneficiaries, applicants, other
governmental agencies, providers
groups, research organizations, health
care corporations, health care
consultants. States will use the
information collected to assess state
plan performance, health outcomes and
an evaluation of the amount of
substitution of private coverage that
occurs as a result of the subsidies and
the effect of the subsidies on access to
coverage. Form Number: CMS–R–308
(OMB control number: 0938–0841);
Frequency: Yearly, Once, and
Occasionally; Affected Public: State,
Local, or Tribal Governments; Number
of Respondents: 56; Total Annual
Responses: 28,294,596; Total Annual
Hours: 1,473,885. (For policy questions
regarding this collection contact Amy
Lutzky at 410–786–0721).
E:\FR\FM\28APN1.SGM
28APN1
19734
Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices
Dated: April 25, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–08663 Filed 4–27–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10151, CMS–
10199, CMS–R–13, CMS–10279]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected; and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by May 30, 2017.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:38 Apr 27, 2017
Jkt 241001
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’ Web site address at
Web site address at https://
www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.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 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.
Comments submitted in response to the
60-day Federal Register Notice have
been addressed in Appendix A of the
ICR. 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 with change of a
previously approved collection; Title of
Information Collection: Data Collection
for Medicare Beneficiaries Receiving
Implantable Cardioverter-Defibrillators
for Primary Prevention of Sudden
Cardiac Death; Use: We provide
coverage for implantable cardioverterdefibrillators (ICDs) for secondary
prevention of sudden cardiac death
based on extensive evidence showing
that use of ICDs among patients with a
certain set of physiologic conditions are
effective. Accordingly, we consider
coverage for ICDs reasonable and
necessary under Section 1862(a)(1)(A) of
the Social Security Act. However,
evidence for use of ICDs for primary
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
prevention of sudden cardiac death is
less compelling for certain patients.
To encourage responsible and
appropriate use of ICDs, we issued a
‘‘Decision Memo for Implantable
Defibrillators’’ on January 27, 2005,
indicating that ICDs will be covered for
primary prevention of sudden cardiac
death if the beneficiary is enrolled in
either an FDA-approved category B IDE
clinical trial (42 CFR 405.201), a trial
under the CMS Clinical Trial Policy
(NCD Manual § 310.1) or a qualifying
prospective data collection system
(either a practical clinical trial or
prospective systematic data collection,
which is sometimes referred to as a
registry). Form Number: CMS–10151
(OMB control number: 0938–0967);
Frequency: Occasionally; Affected
Public: Business or other for-profits,
Not-for-profit institutions; Number of
Respondents: 1,600; Total Annual
Responses: 80,000; Total Annual Hours:
20,000. (For policy questions regarding
this collection contact JoAnna Baldwin
at 410–786–7205.)
2. Type of Information Collection
Request: Revision 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: We
provide 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).
Accordingly, we consider coverage for
CAS reasonable and necessary (section
1862(A)(1)(a) of the Social Security Act).
However, evidence for use of CAS with
embolic protection for patients with
high risk for carotid endarterectomy and
who also have symptomatic carotid
artery stenosis ≥70 percent who are not
enrolled in a study or trial is less
compelling. To encourage responsible
and appropriate use of CAS with
embolic protection, we issued a
Decision Memo for Carotid Artery
Stenting on March 17, 2005, indicating
that CAS with embolic protection for
symptomatic carotid artery stenosis ≥70
percent will be covered only if
performed in facilities that have been
determined to be competent in
E:\FR\FM\28APN1.SGM
28APN1
]]>Agencies
[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)]
[Notices]
[Pages 19733-19734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08663]
[[Page 19733]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-304/CMS-304a, CMS-368/CMS-R-144, and CMS-R-
308]
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 May 30, 2017.
ADDRESSES: When commenting on the proposed information collections,
please reference the document identifier or OMB control number. To be
assured consideration, comments and recommendations must be received by
the OMB desk officer via one of the following transmissions: OMB,
Office of Information and Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395-5806 OR, Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' Web site address at Web site 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 Paperwork@cms.hhs.gov.
3. 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.
Comments submitted in response to the 60-day FR Notice have been
addressed in Appendix A of the ICR. 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: Extension of a currently
approved collection; Title of Information Collection: Reconciliation of
State Invoice and Prior Quarter Adjustment Statement; Use: Form CMS-304
(Reconciliation of State Invoice) is used by manufacturers to respond
to the state's rebate invoice for current quarter utilization. Form
CMS-304a (Prior Quarter Adjustment Statement) is required only in those
instances where a change to the original rebate data submittal is
necessary. Form Number: CMS-304 and -304a (OMB control number: 0938-
0676); Frequency: Quarterly; Affected Public: Business or other for-
profits; Number of Respondents: 1,037; Total Annual Responses: 4,148;
Total Annual Hours: 187,880. (For policy questions regarding this
collection contact Andrea Wellington at 410-786-3490.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicaid Drug
Rebate Program Forms; Use: We develop the rebate amount per drug unit
from information supplied by the drug manufacturers and distributes
these data to the states. States then must report quarterly to the drug
manufacturers and report to us the total number of units of each dosage
form/strength of their covered outpatient drugs reimbursed during a
quarter and the rebate amount to be refunded. This report is due within
60 days of the end of each calendar quarter. The information in the
report is based on claims paid by the state Medicaid agency during a
calendar quarter. Form CMS-R-144 (Quarterly Report Data) is required
from states quarterly to report utilization for any drugs paid for
during that quarter. Form CMS-368 (Administrative Data) is required
only in those instances where a change to the original data submittal
is necessary. Form Number: CMS-368 and -R-144 (OMB control number:
0938-0582); Frequency: Quarterly; Affected Public: State, Local, or
Tribal Governments; Number of Respondents: 56; Total Annual Responses:
224; Total Annual Hours: 12,101. (For policy questions regarding this
collection contact Andrea Wellington at 410-786-3490.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: State Children's
Health Insurance Program and Supporting Regulations; Use: States must
submit title XXI plans and amendments for approval by the Secretary. We
use the plan and its subsequent amendments to determine if the state
has met the requirements of title XXI. Information provided in the
state plan, state plan amendments, and from the other information we
are collecting will be used by advocacy groups, beneficiaries,
applicants, other governmental agencies, providers groups, research
organizations, health care corporations, health care consultants.
States will use the information collected to assess state plan
performance, health outcomes and an evaluation of the amount of
substitution of private coverage that occurs as a result of the
subsidies and the effect of the subsidies on access to coverage. Form
Number: CMS-R-308 (OMB control number: 0938-0841); Frequency: Yearly,
Once, and Occasionally; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 56; Total Annual Responses:
28,294,596; Total Annual Hours: 1,473,885. (For policy questions
regarding this collection contact Amy Lutzky at 410-786-0721).
[[Page 19734]]
Dated: April 25, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2017-08663 Filed 4-27-17; 8:45 am]
BILLING CODE 4120-01-P
