Agency Information Collection Activities: Proposed Collection; Comment Request, 11040-11043 [2017-03234]
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approved collection; Title of
Information Collection: PACE State Plan
Amendment Preprint; Use: If a state
elects to offer PACE as an optional
Medicaid benefit, it must complete a
state plan amendment preprint packet
described as ‘‘Enclosures 3, 4, 5, 6, and
7.’’ CMS will review the information
provided in order to determine if the
state has properly elected to cover PACE
services as a state plan option. In the
event that the state changes something
in the state plan, only the affected page
must be updated. Form Number: CMS–
10227 (OMB control number: 0938–
1027); Frequency: Once and
occasionally; Affected Public: State,
Local, or Tribal Governments; Number
of Respondents: 7; Total Annual
Responses: 2; Total Annual Hours: 140.
(For policy questions regarding this
collection contact Angela Cimino at
410–786–2638.)
13. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Elimination of
Cost-Sharing for Full Benefit DualEligible Individuals Receiving Home
and Community-Based Services; Use:
This collection eliminates Part D costsharing for full benefit dual-eligible
beneficiaries who are receiving home
and community based services. In this
regard, states are required to identify the
affected beneficiaries in their monthly
Medicare Modernization Act Phase
Down reports. Form Number: CMS–
10344 (OMB control number: 0938–
1127); Frequency: Monthly; Affected
Public: Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 51; Total Annual
Responses: 612; Total Annual Hours:
612. (For policy questions regarding this
collection contact Roland Herrera at
410–786–0668.)
14. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Annual Early
and Periodic Screening, Diagnostic and
Treatment (EPSDT) Participation
Report; Use: The collected baseline data
is used to assess the effectiveness of
state early and periodic screening,
diagnostic and treatment (EPSDT)
programs in reaching eligible children
(by age group and basis of Medicaid
eligibility) who are provided initial and
periodic child health screening services,
referred for corrective treatment, and
receiving dental, hearing, and vision
services. This assessment is coupled
with the state’s results in attaining the
participation goals set for the state. The
information gathered from this report,
permits federal and state managers to
evaluate the effectiveness of the EPSDT
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law on the basic aspects of the program.
Form Number: CMS–416 (OMB control
number 0938–0354); Frequency: Yearly
and on occasion; Affected Public: State,
Local, or Tribal Governments; Number
of Respondents: 56; Total Annual
Responses: 168; Total Annual Hours:
1,624. (For policy questions regarding
this collection contact Kimberly Perrault
at 410–786–2482.)
15. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Programs for
All-inclusive Care of the Elderly (PACE)
and Supporting Regulations in 42 CFR
part 460; Use: This information
collection addresses all operational
components of the PACE program (as
defined in 42 CFR part 460) with the
exception of the application process
(§ 460.12). We are removing the
application requirements and burden
since this CMS–R–244 package is
lengthy and we recognize that it can be
somewhat time consuming to review.
We believe the change will help
streamline the public and OMB’s review
of the application as well as the
remaining requirements and burden
under the CMS–R–244 package.
The application is being moved under
a new information collection request
with a new CMS identification number
(CMS–10631). An OMB control number
specific to the application process is
pending. The CMS–10631 information
collection request was submitted to
OMB on October 6, 2016, under ICR
Reference No: 201610–0938–001. When
approved, the control number can be
found on www.reginfo.gov/public/.
Form Number: CMS–R–244 (OMB
control number: 0938–0790); Frequency:
Once and occasionally; Affected Public:
Private sector (Business or other forprofits and Not-for-profit institutions);
Number of Respondents: 130; Total
Annual Responses: 145,455; Total
Annual Hours: 61,350. (For policy
questions regarding this collection
contact Debbie Van Hoven at 410–786–
6625).
16. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Healthcare
Effectiveness Data and Information Set
(HEDIS®) Data Collection for Medicare
Advantage; Use: We use the collected
data to: monitor Medicare Advantage
organization performance, inform audit
strategies, and inform beneficiary choice
through their display in our consumeroriented public compare tools and Web
sites. Medicare Advantage organizations
use the data for quality assessment and
as part of their quality improvement
programs and activities. Quality
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Improvement Organizations and our
contractors use HEDIS® data in
conjunction with their statutory
authority to improve quality of care.
Consumers use the information to help
make informed health care choices. In
addition, the data is made available to
researchers and others as public use
files at www.cms.hhs.gov. Form
Number: CMS–10219 (OMB control
number: 0938–1028); Frequency: Yearly;
Affected Public: Business or other forprofit and Not-for-profit institutions;
Number of Respondents: 576; Total
Annual Responses: 576; Total Annual
Hours: 184,320. (For policy questions
regarding this collection contact Lori
Teichman at 410–786–6684.)
Dated: February 14, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–03235 Filed 2–16–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–304/304a,
CMS–368/CMS–R–144, CMS–R–308, CMS–
10151, CMS–10199, CMS–R–13, and CMS–
10279]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
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
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
SUMMARY:
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Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
April 18, 2017.
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.
CMS–304/304a ...............................
CMS–368/CMS–R–144 ...................
CMS–R–308 ....................................
CMS–10151 ....................................
CMS–10199 ....................................
CMS–R–13 ......................................
CMS–10279 ....................................
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Information Collection
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
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and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
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).
Reconciliation of State Invoice and Prior Quarter Adjustment Statement.
Medicaid Drug Rebate Program Forms.
State Children’s Health Insurance Program and Supporting Regulations.
Data Collection for Medicare Beneficiaries Receiving Implantable Cardioverter-Defibrillators for Primary
Prevention of Sudden Cardiac Death.
Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy.
Conditions of Coverage for Organ Procurement Organizations and Supporting Regulations ate Children’s
Health Insurance Program and Supporting Regulations.
Ambulatory Surgical Center Conditions for Coverage.
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.
VerDate Sep<11>2014
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 ll, 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’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
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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
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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);
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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).
4. 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
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.)
5. 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: 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
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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
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: 1,000; Total Annual
Responses: 1,000; Total Annual Hours:
500. (For policy questions regarding this
collection contact Sarah Fulton at 410–
786–2749.)
6. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Conditions of
Coverage for Organ Procurement
Organizations and Supporting
Regulations; Use: Section 1138(b) of the
Social Security Act, as added by section
9318 of the Omnibus Budget
Reconciliation Act of 1986 (Pub. L. 99–
509), sets forth the statutory
qualifications and requirements that
organ procurement organizations
(OPOs) must meet in order for the costs
of their services in procuring organs for
transplant centers to be reimbursable
under the Medicare and Medicaid
programs. An OPO must be certified and
designated by the Secretary as an OPO
and must meet performance-related
standards prescribed by the Secretary.
The corresponding regulations are
found at 42 CFR part 486 (Conditions
for Coverage of Specialized Services
Furnished by Suppliers) under subpart
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G (Requirements for Certification and
Designation and Conditions for
Coverage: Organ Procurement
Organizations).
Since each OPO has a monopoly on
organ procurement within its designated
service area (DSA), we must hold OPOs
to high standards. Collection of this
information is necessary for us to assess
the effectiveness of each OPO and
determine whether it should continue to
be certified as an OPO and designated
for a particular donation service area by
the Secretary or replaced by an OPO
that can more effectively procure organs
within that DSA. Form Number: CMS–
R–13 (OMB control number: 0938–
0688); Frequency: Occasionally;
Affected Public: Not-for-profit
institutions; Number of Respondents:
58; Total Annual Responses: 58; Total
Annual Hours: 13,546. (For policy
questions regarding this collection
contact Diane Corning at 410–786–
8486.)
7. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Ambulatory
Surgical Center Conditions for Coverage;
Use: The Ambulatory Surgical Center
(ASC) Conditions for Coverage (CfCs)
focus on a patient-centered, outcomeoriented, and transparent processes that
promote quality patient care. The CfCs
are designed to ensure that each facility
has properly trained staff to provide the
appropriate type and level of care for
that facility and provide a safe physical
environment for patients. The CfCs are
used by Federal or state surveyors as a
basis for determining whether an ASC
qualifies for approval or re-approval
under Medicare. We, along with the
healthcare industry, believe that the
availability to the facility of the type of
records and general content of records,
which this regulation specifies, is
standard medical practice and is
necessary in order to ensure the wellbeing and safety of patients and
professional treatment accountability.
Form Number: CMS–10279 (OMB
control number: 0938–1071); Frequency:
Annual; Affected Public: Business or
other for-profit and Not-for-profit
institutions; Number of Respondents:
5,500; Total Annual Responses: 5,500;
Total Annual Hours: 209,000. (For
policy questions regarding this
collection contact Jacqueline Leach at
410–786–4282.)
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Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices
Dated: February 14, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–03234 Filed 2–16–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
Food and Drug Administration/Xavier
University PharmaLink Conference—
Leadership in a Global Supply Chain
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug
Administration (FDA) Cincinnati
District, in co-sponsorship with Xavier
University, is announcing a public
conference entitled ‘‘FDA/Xavier
University PharmaLink Conference:
Leadership in a Global Supply Chain.’’
The PharmaLink conference seeks
solutions to important and complicated
issues by aligning with the strategic
priorities of FDA, and includes
presentations from key FDA officials
and industry experts.
DATES: The public conference will be
held on March 15, 2017, from 8:30 a.m.
to 5 p.m.; March 16, 2017, from 8:30
a.m. to 5 p.m.; and March 17, 2017, from
8:30 a.m. to 12:20 p.m. The conference
is preceded by a Welcome Reception on
March 14, 2017, from 5 p.m. to 7 p.m.
See the SUPPLEMENTARY INFORMATION
section for registration date and
information.
ADDRESSES: The public conference will
be held on the campus of Xavier
University, 3800 Victory Pkwy.,
Cincinnati, OH 45207, 513–745–3073 or
513–745–3483.
FOR FURTHER INFORMATION CONTACT:
For information regarding this notice:
Nicholas Paulin, Food and Drug
Administration, Cincinnati South
Office, 36 East 7th St., Cincinnati, OH
45202, 513–246–4134, email:
nicholas.paulin@fda.hhs.gov.
For information regarding the
conference and registration: Marla
Phillips, Xavier University, 3800
Victory Pkwy., Cincinnati, OH 45207–
5471, 513–745–3073, email:
phillipsm4@xavier.edu.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
The public conference helps fulfill the
Department of Health and Human
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17:38 Feb 16, 2017
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Services’ and FDA’s important mission
to protect the public health. The most
pressing challenges of the global
pharmaceutical industry require
solutions which are inspired by
collaboration to ensure the on-going
health and safety of patients. These
challenges include designing products
with the patient in mind, building
quality into the product from the
starting point, selecting the right
suppliers, and considering total product
lifecycle systems. Meeting these
challenges requires vigilance,
innovation, supply chain strategy,
relationship management, proactive
change management, and a commitment
to doing the job right the first time. FDA
has made education of the drug and
device manufacturing community a high
priority to help ensure the quality of
FDA-regulated drugs and devices.
The conference helps to achieve
objectives set forth in section 406 of the
Food and Drug Administration
Modernization Act of 1997 (21 U.S.C.
393), which includes working closely
with stakeholders and maximizing the
availability and clarity of information to
stakeholders and the public. The
conference also is consistent with the
Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121)
by providing outreach activities by
Government Agencies to small
businesses.
The conference includes the
following:
• Welcome Reception at the Hilton
Netherland Plaza.
• Lunch Networking by Topic.
• The Solution ‘‘Xchange’’.
• Case Studies and Small Group
Discussions.
• Action Plans.
II. Topics for Discussion at the Public
Conference
The public conference will engage
those involved in FDA-regulated global
supply chain quality and management
through the following topics:
• FDA Metrics Program—Path
Forward to Reduce Risks Within FDA
and Across Industry.
• Predictive Capabilities Through a
Living Metrics Model.
• How Big Data and Artificial
Intelligence Can Enhance Your
Proactive Risk Monitoring Programs.
• Connecting Culture to Performance.
• Data Integrity—Detection and
Successful Practices.
• Building a Bridge Across
Generations.
• Good Supply Practices (GSPs)—
Paradigm Shifting Solutions.
• How to Develop and Execute a
Robust Risk-Based Due Diligence Plan.
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• Maximizing Post-Merger Success.
• Your Company Bought a New
Business—Now What?
• Supply Chains in China—Strategies
for Regulatory Success.
• Top 3 Challenges for Successful
Serialization Implementation Across
Your Supply Chain.
• Strategic Direction of the Food &
Drug Administration, Center for Drug
Evaluation and Research (CDER), Office
of Manufacturing Quality.
• Office of Regulatory Affairs Key
Initiatives.
• FDA Investigator Case Study
Insights.
III. Registration for the Public
Conference
Registration: To register online for the
public conference, please visit the
‘‘Registration’’ link on the conference
Web site at https://
www.XavierPharmaLink.com. Please
provide complete contact information
for each attendee, including name, title,
affiliation, address, email, and
telephone. FDA has verified the Web
site address in this document, as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.
To register by mail, please send your
name, title, firm name, address,
telephone and fax numbers, email, and
payment information for the fee to
Xavier University, Attention: Marla
Phillips, 3800 Victory Pkwy.,
Cincinnati, OH 45207–5471. An email
will be sent confirming your
registration.
If you need special accommodations
due to a disability, please contact Marla
Phillips (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance of
the conference.
There is a registration fee. The
conference registration fees cover the
cost of the presentations, training
materials, receptions, breakfasts,
lunches, and dinners for the 2.5 days of
the conference, including the Welcome
Reception that precedes the conference.
There will be onsite registration if space
is available. The cost of registration is as
follows:
TABLE 1—REGISTRATION FEES 1
Attendee type
Industry .....................................
Small Business (<100 employees) .......................................
Start-up Manufacturer ...............
Academic ..................................
Media ........................................
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Standard
rate
$1,895
1,295
300
300
Free
]]>Agencies
[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)]
[Notices]
[Pages 11040-11043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03234]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-304/304a, CMS-368/CMS-R-144, CMS-R-308, CMS-
10151, CMS-10199, CMS-R-13, and CMS-10279]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
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
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collection techniques or other forms of information technology to
minimize the information collection burden.
DATES: Comments must be received by April 18, 2017.
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' Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995.
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: Reports Clearance Office at (410) 786-
1326.
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).
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CMS-304/304a...................... Reconciliation of State Invoice and
Prior Quarter Adjustment Statement.
CMS-368/CMS-R-144................. Medicaid Drug Rebate Program Forms.
CMS-R-308......................... State Children's Health Insurance
Program and Supporting Regulations.
CMS-10151......................... Data Collection for Medicare
Beneficiaries Receiving Implantable
Cardioverter-Defibrillators for
Primary Prevention of Sudden
Cardiac Death.
CMS-10199......................... Data Collection for Medicare
Facilities Performing Carotid
Artery Stenting with Embolic
Protection in Patients at High Risk
for Carotid Endarterectomy.
CMS-R-13.......................... Conditions of Coverage for Organ
Procurement Organizations and
Supporting Regulations ate
Children's Health Insurance Program
and Supporting Regulations.
CMS-10279......................... Ambulatory Surgical Center
Conditions for Coverage.
------------------------------------------------------------------------
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: 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);
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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).
4. 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
cardioverter-defibrillators (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 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 Sec. 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.)
5. 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: 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 Sec.
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
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: 1,000;
Total Annual Responses: 1,000; Total Annual Hours: 500. (For policy
questions regarding this collection contact Sarah Fulton at 410-786-
2749.)
6. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Conditions of
Coverage for Organ Procurement Organizations and Supporting
Regulations; Use: Section 1138(b) of the Social Security Act, as added
by section 9318 of the Omnibus Budget Reconciliation Act of 1986 (Pub.
L. 99-509), sets forth the statutory qualifications and requirements
that organ procurement organizations (OPOs) must meet in order for the
costs of their services in procuring organs for transplant centers to
be reimbursable under the Medicare and Medicaid programs. An OPO must
be certified and designated by the Secretary as an OPO and must meet
performance-related standards prescribed by the Secretary. The
corresponding regulations are found at 42 CFR part 486 (Conditions for
Coverage of Specialized Services Furnished by Suppliers) under subpart
G (Requirements for Certification and Designation and Conditions for
Coverage: Organ Procurement Organizations).
Since each OPO has a monopoly on organ procurement within its
designated service area (DSA), we must hold OPOs to high standards.
Collection of this information is necessary for us to assess the
effectiveness of each OPO and determine whether it should continue to
be certified as an OPO and designated for a particular donation service
area by the Secretary or replaced by an OPO that can more effectively
procure organs within that DSA. Form Number: CMS-R-13 (OMB control
number: 0938-0688); Frequency: Occasionally; Affected Public: Not-for-
profit institutions; Number of Respondents: 58; Total Annual Responses:
58; Total Annual Hours: 13,546. (For policy questions regarding this
collection contact Diane Corning at 410-786-8486.)
7. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Ambulatory
Surgical Center Conditions for Coverage; Use: The Ambulatory Surgical
Center (ASC) Conditions for Coverage (CfCs) focus on a patient-
centered, outcome-oriented, and transparent processes that promote
quality patient care. The CfCs are designed to ensure that each
facility has properly trained staff to provide the appropriate type and
level of care for that facility and provide a safe physical environment
for patients. The CfCs are used by Federal or state surveyors as a
basis for determining whether an ASC qualifies for approval or re-
approval under Medicare. We, along with the healthcare industry,
believe that the availability to the facility of the type of records
and general content of records, which this regulation specifies, is
standard medical practice and is necessary in order to ensure the well-
being and safety of patients and professional treatment accountability.
Form Number: CMS-10279 (OMB control number: 0938-1071); Frequency:
Annual; Affected Public: Business or other for-profit and Not-for-
profit institutions; Number of Respondents: 5,500; Total Annual
Responses: 5,500; Total Annual Hours: 209,000. (For policy questions
regarding this collection contact Jacqueline Leach at 410-786-4282.)
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Dated: February 14, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2017-03234 Filed 2-16-17; 8:45 am]
BILLING CODE 4120-01-P
