82_FR_11072 82 FR 11040 - Agency Information Collection Activities: Proposed Collection; Comment Request

82 FR 11040 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 82, Issue 32 (February 17, 2017)

Page Range11040-11043
FR Document2017-03234

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.

Federal Register, Volume 82 Issue 32 (Friday, February 17, 2017)
[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)]
[Notices]
[Pages 11040-11043]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03234]


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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

[[Page 11041]]

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 
http://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 http://www.cms.hhs.gov/PaperworkReductionActof1995.
    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: 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).

------------------------------------------------------------------------
 
------------------------------------------------------------------------
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);

[[Page 11042]]

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.)


[[Page 11043]]


    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



                                                  11040                         Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices

                                                  approved collection; Title of                           law on the basic aspects of the program.              Improvement Organizations and our
                                                  Information Collection: PACE State Plan                 Form Number: CMS–416 (OMB control                     contractors use HEDIS® data in
                                                  Amendment Preprint; Use: If a state                     number 0938–0354); Frequency: Yearly                  conjunction with their statutory
                                                  elects to offer PACE as an optional                     and on occasion; Affected Public: State,              authority to improve quality of care.
                                                  Medicaid benefit, it must complete a                    Local, or Tribal Governments; Number                  Consumers use the information to help
                                                  state plan amendment preprint packet                    of Respondents: 56; Total Annual                      make informed health care choices. In
                                                  described as ‘‘Enclosures 3, 4, 5, 6, and               Responses: 168; Total Annual Hours:                   addition, the data is made available to
                                                  7.’’ CMS will review the information                    1,624. (For policy questions regarding                researchers and others as public use
                                                  provided in order to determine if the                   this collection contact Kimberly Perrault             files at www.cms.hhs.gov. Form
                                                  state has properly elected to cover PACE                at 410–786–2482.)                                     Number: CMS–10219 (OMB control
                                                  services as a state plan option. In the                    15. Type of Information Collection                 number: 0938–1028); Frequency: Yearly;
                                                  event that the state changes something                  Request: Revision of a currently                      Affected Public: Business or other for-
                                                  in the state plan, only the affected page               approved collection; Title of                         profit and Not-for-profit institutions;
                                                  must be updated. Form Number: CMS–                      Information Collection: Programs for                  Number of Respondents: 576; Total
                                                  10227 (OMB control number: 0938–                        All-inclusive Care of the Elderly (PACE)              Annual Responses: 576; Total Annual
                                                  1027); Frequency: Once and                              and Supporting Regulations in 42 CFR                  Hours: 184,320. (For policy questions
                                                  occasionally; Affected Public: State,                   part 460; Use: This information                       regarding this collection contact Lori
                                                  Local, or Tribal Governments; Number                    collection addresses all operational                  Teichman at 410–786–6684.)
                                                  of Respondents: 7; Total Annual                         components of the PACE program (as
                                                                                                                                                                   Dated: February 14, 2017.
                                                  Responses: 2; Total Annual Hours: 140.                  defined in 42 CFR part 460) with the
                                                                                                          exception of the application process                  William N. Parham, III,
                                                  (For policy questions regarding this
                                                  collection contact Angela Cimino at                     (§ 460.12). We are removing the                       Director, Paperwork Reduction Staff, Office
                                                                                                          application requirements and burden                   of Strategic Operations and Regulatory
                                                  410–786–2638.)
                                                                                                                                                                Affairs.
                                                     13. Type of Information Collection                   since this CMS–R–244 package is
                                                  Request: Extension of a currently                       lengthy and we recognize that it can be               [FR Doc. 2017–03235 Filed 2–16–17; 8:45 am]
                                                  approved collection; Title of                           somewhat time consuming to review.                    BILLING CODE 4120–01–P

                                                  Information Collection: Elimination of                  We believe the change will help
                                                  Cost-Sharing for Full Benefit Dual-                     streamline the public and OMB’s review
                                                  Eligible Individuals Receiving Home                     of the application as well as the                     DEPARTMENT OF HEALTH AND
                                                  and Community-Based Services; Use:                      remaining requirements and burden                     HUMAN SERVICES
                                                  This collection eliminates Part D cost-                 under the CMS–R–244 package.                          Centers for Medicare & Medicaid
                                                  sharing for full benefit dual-eligible                     The application is being moved under
                                                                                                                                                                Services
                                                  beneficiaries who are receiving home                    a new information collection request
                                                  and community based services. In this                   with a new CMS identification number                  [Document Identifiers: CMS–304/304a,
                                                  regard, states are required to identify the             (CMS–10631). An OMB control number                    CMS–368/CMS–R–144, CMS–R–308, CMS–
                                                  affected beneficiaries in their monthly                 specific to the application process is                10151, CMS–10199, CMS–R–13, and CMS–
                                                                                                          pending. The CMS–10631 information                    10279]
                                                  Medicare Modernization Act Phase
                                                  Down reports. Form Number: CMS–                         collection request was submitted to                   Agency Information Collection
                                                  10344 (OMB control number: 0938–                        OMB on October 6, 2016, under ICR                     Activities: Proposed Collection;
                                                  1127); Frequency: Monthly; Affected                     Reference No: 201610–0938–001. When
                                                                                                                                                                Comment Request
                                                  Public: Business or other for-profits and               approved, the control number can be
                                                  Not-for-profit institutions; Number of                  found on www.reginfo.gov/public/.                     AGENCY: Centers for Medicare &
                                                  Respondents: 51; Total Annual                              Form Number: CMS–R–244 (OMB                        Medicaid Services.
                                                  Responses: 612; Total Annual Hours:                     control number: 0938–0790); Frequency:                ACTION: Notice.
                                                  612. (For policy questions regarding this               Once and occasionally; Affected Public:
                                                  collection contact Roland Herrera at                    Private sector (Business or other for-                SUMMARY:    The Centers for Medicare &
                                                  410–786–0668.)                                          profits and Not-for-profit institutions);             Medicaid Services (CMS) is announcing
                                                     14. Type of Information Collection                   Number of Respondents: 130; Total                     an opportunity for the public to
                                                  Request: Revision of a currently                        Annual Responses: 145,455; Total                      comment on CMS’ intention to collect
                                                  approved collection; Title of                           Annual Hours: 61,350. (For policy                     information from the public. Under the
                                                  Information Collection: Annual Early                    questions regarding this collection                   Paperwork Reduction Act of 1995 (the
                                                  and Periodic Screening, Diagnostic and                  contact Debbie Van Hoven at 410–786–                  PRA), federal agencies are required to
                                                  Treatment (EPSDT) Participation                         6625).                                                publish notice in the Federal Register
                                                  Report; Use: The collected baseline data                   16. Type of Information Collection                 concerning each proposed collection of
                                                  is used to assess the effectiveness of                  Request: Extension of a currently                     information (including each proposed
                                                  state early and periodic screening,                     approved collection; Title of                         extension or reinstatement of an existing
                                                  diagnostic and treatment (EPSDT)                        Information Collection: Healthcare                    collection of information) and to allow
                                                  programs in reaching eligible children                  Effectiveness Data and Information Set                60 days for public comment on the
                                                  (by age group and basis of Medicaid                     (HEDIS®) Data Collection for Medicare                 proposed action. Interested persons are
                                                  eligibility) who are provided initial and               Advantage; Use: We use the collected                  invited to send comments regarding our
                                                  periodic child health screening services,               data to: monitor Medicare Advantage                   burden estimates or any other aspect of
                                                  referred for corrective treatment, and                  organization performance, inform audit                this collection of information, including
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                                                  receiving dental, hearing, and vision                   strategies, and inform beneficiary choice             the necessity and utility of the proposed
                                                  services. This assessment is coupled                    through their display in our consumer-                information collection for the proper
                                                  with the state’s results in attaining the               oriented public compare tools and Web                 performance of the agency’s functions,
                                                  participation goals set for the state. The              sites. Medicare Advantage organizations               the accuracy of the estimated burden,
                                                  information gathered from this report,                  use the data for quality assessment and               ways to enhance the quality, utility, and
                                                  permits federal and state managers to                   as part of their quality improvement                  clarity of the information to be
                                                  evaluate the effectiveness of the EPSDT                 programs and activities. Quality                      collected, and the use of automated


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                                                                                     Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices                                          11041

                                                  collection techniques or other forms of                        2. By regular mail. You may mail                    and CMS document identifier, to
                                                  information technology to minimize the                       written comments to the following                     Paperwork@cms.hhs.gov.
                                                  information collection burden.                               address: CMS, Office of Strategic                       3. Call the Reports Clearance Office at
                                                  DATES: Comments must be received by                          Operations and Regulatory Affairs,                    (410) 786–1326.
                                                  April 18, 2017.                                              Division of Regulations Development,
                                                  ADDRESSES: When commenting, please                           Attention: Document Identifier/OMB                    FOR FURTHER INFORMATION CONTACT:
                                                  reference the document identifier or                         Control Number ll, Room C4–26–05,                     Reports Clearance Office at (410) 786–
                                                  OMB control number. To be assured                            7500 Security Boulevard, Baltimore,                   1326.
                                                  consideration, comments and                                  Maryland 21244–1850.
                                                                                                                 To obtain copies of a supporting                    SUPPLEMENTARY INFORMATION:
                                                  recommendations must be submitted in
                                                  any one of the following ways:                               statement and any related forms for the               Contents
                                                    1. Electronically. You may send your                       proposed collection(s) summarized in
                                                  comments electronically to http://                           this notice, you may make your request                  This notice sets out a summary of the
                                                  www.regulations.gov. Follow the                              using one of following:                               use and burden associated with the
                                                  instructions for ‘‘Comment or                                  1. Access CMS’ Web site address at                  following information collections. More
                                                  Submission’’ or ‘‘More Search Options’’                      http://www.cms.hhs.gov/                               detailed information can be found in
                                                  to find the information collection                           PaperworkReductionActof1995.                          each collection’s supporting statement
                                                  document(s) that are accepting                                 2. Email your request, including your               and associated materials (see
                                                  comments.                                                    address, phone number, OMB number,                    ADDRESSES).

                                                  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 Pa-
                                                                                                      tients 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–                             submittal is necessary. Form Number:                  and –R–144 (OMB control number:
                                                  3520), federal agencies must obtain                          CMS–304 and –304a (OMB control                        0938–0582); Frequency: Quarterly;
                                                  approval from the Office of Management                       number: 0938–0676); Frequency:                        Affected Public: State, Local, or Tribal
                                                  and Budget (OMB) for each collection of                      Quarterly; Affected Public: Business or               Governments; Number of Respondents:
                                                  information they conduct or sponsor.                         other for-profits; Number of                          56; Total Annual Responses: 224; Total
                                                  The term ‘‘collection of information’’ is                    Respondents: 1,037; Total Annual                      Annual Hours: 12,101. (For policy
                                                  defined in 44 U.S.C. 3502(3) and 5 CFR                       Responses: 4,148; Total Annual Hours:                 questions regarding this collection
                                                  1320.3(c) and includes agency requests                       187,880. (For policy questions regarding              contact Andrea Wellington at 410–786–
                                                  or requirements that members of the                          this collection contact Andrea                        3490.)
                                                  public submit reports, keep records, or                      Wellington at 410–786–3490.)                             3. Type of Information Collection
                                                  provide information to a third party.                           2. Type of Information Collection                  Request: Extension of a currently
                                                  Section 3506(c)(2)(A) of the PRA                             Request: Extension of a currently                     approved collection; Title of
                                                  requires federal agencies to publish a                       approved collection; Title of                         Information Collection: State Children’s
                                                  60-day notice in the Federal Register                        Information Collection: Medicaid Drug                 Health Insurance Program and
                                                  concerning each proposed collection of                       Rebate Program Forms; Use: We develop                 Supporting Regulations; Use: States
                                                  information, including each proposed                         the rebate amount per drug unit from                  must submit title XXI plans and
                                                  extension or reinstatement of an existing                    information supplied by the drug                      amendments for approval by the
                                                  collection of information, before                            manufacturers and distributes these data              Secretary. We use the plan and its
                                                  submitting the collection to OMB for                         to the states. States then must report                subsequent amendments to determine if
                                                  approval. To comply with this                                quarterly to the drug manufacturers and               the state has met the requirements of
                                                  requirement, CMS is publishing this                          report to us the total number of units of             title XXI. Information provided in the
                                                  notice.                                                      each dosage form/strength of their                    state plan, state plan amendments, and
                                                                                                               covered outpatient drugs reimbursed                   from the other information we are
                                                  Information Collection                                       during a quarter and the rebate amount                collecting will be used by advocacy
                                                    1. Type of Information Collection                          to be refunded. This report is due                    groups, beneficiaries, applicants, other
                                                  Request: Extension of a currently                            within 60 days of the end of each                     governmental agencies, providers
                                                  approved collection; Title of                                calendar quarter. The information in the              groups, research organizations, health
                                                  Information Collection: Reconciliation                       report is based on claims paid by the                 care corporations, health care
                                                  of State Invoice and Prior Quarter                           state Medicaid agency during a calendar               consultants. States will use the
                                                  Adjustment Statement; Use: Form CMS–                         quarter. Form CMS–R–144 (Quarterly                    information collected to assess state
mstockstill on DSK3G9T082PROD with NOTICES




                                                  304 (Reconciliation of State Invoice) is                     Report Data) is required from states                  plan performance, health outcomes and
                                                  used by manufacturers to respond to the                      quarterly to report utilization for any               an evaluation of the amount of
                                                  state’s rebate invoice for current quarter                   drugs paid for during that quarter. Form              substitution of private coverage that
                                                  utilization. Form CMS–304a (Prior                            CMS–368 (Administrative Data) is                      occurs as a result of the subsidies and
                                                  Quarter Adjustment Statement) is                             required only in those instances where                the effect of the subsidies on access to
                                                  required only in those instances where                       a change to the original data submittal               coverage. Form Number: CMS–R–308
                                                  a change to the original rebate data                         is necessary. Form Number: CMS–368                    (OMB control number: 0938–0841);


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                                                  11042                         Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices

                                                  Frequency: Yearly, Once, and                            stenosis ≥ 80 percent in accordance with              G (Requirements for Certification and
                                                  Occasionally; Affected Public: State,                   the Category B IDE clinical trials                    Designation and Conditions for
                                                  Local, or Tribal Governments; Number                    regulation (42 CFR 405.201), a trial                  Coverage: Organ Procurement
                                                  of Respondents: 56; Total Annual                        under the CMS Clinical Trial Policy                   Organizations).
                                                  Responses: 28,294,596; Total Annual                     (NCD Manual § 310.1, or in accordance                   Since each OPO has a monopoly on
                                                  Hours: 1,473,885. (For policy questions                 with the National Coverage
                                                                                                                                                                organ procurement within its designated
                                                  regarding this collection contact Amy                   Determination on CAS post approval
                                                  Lutzky at 410–786–0721).                                                                                      service area (DSA), we must hold OPOs
                                                                                                          studies (Medicare NCD Manual 20.7).
                                                     4. Type of Information Collection                    Accordingly, we consider coverage for                 to high standards. Collection of this
                                                  Request: Reinstatement with change of a                 CAS reasonable and necessary (section                 information is necessary for us to assess
                                                  previously approved collection; Title of                1862 (A)(1)(a) of the Social Security                 the effectiveness of each OPO and
                                                  Information Collection: Data Collection                 Act). However, evidence for use of CAS                determine whether it should continue to
                                                  for Medicare Beneficiaries Receiving                    with embolic protection for patients                  be certified as an OPO and designated
                                                  Implantable Cardioverter-Defibrillators                 with high risk for carotid                            for a particular donation service area by
                                                  for Primary Prevention of Sudden                        endarterectomy and who also have                      the Secretary or replaced by an OPO
                                                  Cardiac Death; Use: We provide                          symptomatic carotid artery stenosis ≥ 70              that can more effectively procure organs
                                                  coverage for implantable cardioverter-                  percent who are not enrolled in a study               within that DSA. Form Number: CMS–
                                                  defibrillators (ICDs) for secondary                     or trial is less compelling. To encourage             R–13 (OMB control number: 0938–
                                                  prevention of sudden cardiac death                      responsible and appropriate use of CAS                0688); Frequency: Occasionally;
                                                  based on extensive evidence showing                     with embolic protection, we issued a                  Affected Public: Not-for-profit
                                                  that use of ICDs among patients with a                  Decision Memo for Carotid Artery                      institutions; Number of Respondents:
                                                  certain set of physiologic conditions are               Stenting on March 17, 2005, indicating                58; Total Annual Responses: 58; Total
                                                  effective. Accordingly, we consider                     that CAS with embolic protection for                  Annual Hours: 13,546. (For policy
                                                  coverage for ICDs reasonable and                        symptomatic carotid artery stenosis ≥ 70              questions regarding this collection
                                                  necessary under Section 1862(a)(1)(A) of                percent will be covered only if                       contact Diane Corning at 410–786–
                                                  the Social Security Act. However,                       performed in facilities that have been
                                                  evidence for use of ICDs for primary                                                                          8486.)
                                                                                                          determined to be competent in
                                                  prevention of sudden cardiac death is                   performing the evaluation, procedure                    7. Type of Information Collection
                                                  less compelling for certain patients.                   and follow-up necessary to ensure                     Request: Extension of a currently
                                                     To encourage responsible and                         optimal patient outcomes. In accordance               approved collection; Title of
                                                  appropriate use of ICDs, we issued a                    with this criteria, we consider coverage              Information Collection: Ambulatory
                                                  ‘‘Decision Memo for Implantable                         for CAS reasonable and necessary                      Surgical Center Conditions for Coverage;
                                                  Defibrillators’’ on January 27, 2005,                                                                         Use: The Ambulatory Surgical Center
                                                                                                          (section 1862 (A)(1)(a) of the Social
                                                  indicating that ICDs will be covered for                                                                      (ASC) Conditions for Coverage (CfCs)
                                                                                                          Security Act). Form Number: CMS–
                                                  primary prevention of sudden cardiac                                                                          focus on a patient-centered, outcome-
                                                                                                          10199 (OMB control number: 0938–
                                                  death if the beneficiary is enrolled in                                                                       oriented, and transparent processes that
                                                                                                          1011); Frequency: Yearly; Affected
                                                  either an FDA-approved category B IDE                                                                         promote quality patient care. The CfCs
                                                                                                          Public: Business or other for-profit and
                                                  clinical trial (42 CFR 405.201), a trial
                                                                                                          Not-for-profit institutions; Number of                are designed to ensure that each facility
                                                  under the CMS Clinical Trial Policy
                                                                                                          Respondents: 1,000; Total Annual                      has properly trained staff to provide the
                                                  (NCD Manual § 310.1) or a qualifying
                                                                                                          Responses: 1,000; Total Annual Hours:                 appropriate type and level of care for
                                                  prospective data collection system
                                                                                                          500. (For policy questions regarding this             that facility and provide a safe physical
                                                  (either a practical clinical trial or
                                                  prospective systematic data collection,                 collection contact Sarah Fulton at 410–               environment for patients. The CfCs are
                                                  which is sometimes referred to as a                     786–2749.)                                            used by Federal or state surveyors as a
                                                  registry). Form Number: CMS–10151                          6. Type of Information Collection                  basis for determining whether an ASC
                                                  (OMB control number: 0938–0967);                        Request: Extension of a currently                     qualifies for approval or re-approval
                                                  Frequency: Occasionally; Affected                       approved collection; Title of                         under Medicare. We, along with the
                                                  Public: Business or other for-profits,                  Information Collection: Conditions of                 healthcare industry, believe that the
                                                  Not-for-profit institutions; Number of                  Coverage for Organ Procurement                        availability to the facility of the type of
                                                  Respondents: 1,600; Total Annual                        Organizations and Supporting                          records and general content of records,
                                                  Responses: 80,000; Total Annual Hours:                  Regulations; Use: Section 1138(b) of the              which this regulation specifies, is
                                                  20,000. (For policy questions regarding                 Social Security Act, as added by section              standard medical practice and is
                                                  this collection contact JoAnna Baldwin                  9318 of the Omnibus Budget                            necessary in order to ensure the well-
                                                  at 410–786–7205.)                                       Reconciliation Act of 1986 (Pub. L. 99–               being and safety of patients and
                                                     5. Type of Information Collection                    509), sets forth the statutory                        professional treatment accountability.
                                                  Request: Extension of a currently                       qualifications and requirements that                  Form Number: CMS–10279 (OMB
                                                  approved collection; Title of                           organ procurement organizations
                                                                                                                                                                control number: 0938–1071); Frequency:
                                                  Information Collection: Data Collection                 (OPOs) must meet in order for the costs
                                                                                                                                                                Annual; Affected Public: Business or
                                                  for Medicare Facilities Performing                      of their services in procuring organs for
                                                  Carotid Artery Stenting with Embolic                    transplant centers to be reimbursable                 other for-profit and Not-for-profit
                                                  Protection in Patients at High Risk for                 under the Medicare and Medicaid                       institutions; Number of Respondents:
                                                  Carotid Endarterectomy; Use: We                         programs. An OPO must be certified and                5,500; Total Annual Responses: 5,500;
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                                                  provide coverage for carotid artery                     designated by the Secretary as an OPO                 Total Annual Hours: 209,000. (For
                                                  stenting (CAS) with embolic protection                  and must meet performance-related                     policy questions regarding this
                                                  for patients at high risk for carotid                   standards prescribed by the Secretary.                collection contact Jacqueline Leach at
                                                  endarterectomy and who also have                        The corresponding regulations are                     410–786–4282.)
                                                  symptomatic carotid artery stenosis                     found at 42 CFR part 486 (Conditions
                                                  between 50 percent and 70 percent or                    for Coverage of Specialized Services
                                                  have asymptomatic carotid artery                        Furnished by Suppliers) under subpart


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                                                                                Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices                                                           11043

                                                     Dated: February 14, 2017.                            Services’ and FDA’s important mission                   • Maximizing Post-Merger Success.
                                                  William N. Parham, III,                                 to protect the public health. The most                  • Your Company Bought a New
                                                  Director, Paperwork Reduction Staff, Office             pressing challenges of the global                     Business—Now What?
                                                  of Strategic Operations and Regulatory                  pharmaceutical industry require                         • Supply Chains in China—Strategies
                                                  Affairs.                                                solutions which are inspired by                       for Regulatory Success.
                                                  [FR Doc. 2017–03234 Filed 2–16–17; 8:45 am]             collaboration to ensure the on-going                    • Top 3 Challenges for Successful
                                                  BILLING CODE 4120–01–P                                  health and safety of patients. These                  Serialization Implementation Across
                                                                                                          challenges include designing products                 Your Supply Chain.
                                                                                                          with the patient in mind, building
                                                  DEPARTMENT OF HEALTH AND                                quality into the product from the                       • Strategic Direction of the Food &
                                                  HUMAN SERVICES                                          starting point, selecting the right                   Drug Administration, Center for Drug
                                                                                                          suppliers, and considering total product              Evaluation and Research (CDER), Office
                                                  Food and Drug Administration                            lifecycle systems. Meeting these                      of Manufacturing Quality.
                                                  [Docket No. FDA–2017–N–0001]                            challenges requires vigilance,                          • Office of Regulatory Affairs Key
                                                                                                          innovation, supply chain strategy,                    Initiatives.
                                                  Food and Drug Administration/Xavier                     relationship management, proactive                      • FDA Investigator Case Study
                                                  University PharmaLink Conference—                       change management, and a commitment                   Insights.
                                                  Leadership in a Global Supply Chain                     to doing the job right the first time. FDA            III. Registration for the Public
                                                  AGENCY:    Food and Drug Administration,                has made education of the drug and                    Conference
                                                  HHS.                                                    device manufacturing community a high
                                                                                                          priority to help ensure the quality of                   Registration: To register online for the
                                                  ACTION:   Notice of public conference.                                                                        public conference, please visit the
                                                                                                          FDA-regulated drugs and devices.
                                                  SUMMARY:    The Food and Drug                              The conference helps to achieve                    ‘‘Registration’’ link on the conference
                                                  Administration (FDA) Cincinnati                         objectives set forth in section 406 of the            Web site at http://
                                                  District, in co-sponsorship with Xavier                 Food and Drug Administration                          www.XavierPharmaLink.com. Please
                                                  University, is announcing a public                      Modernization Act of 1997 (21 U.S.C.                  provide complete contact information
                                                  conference entitled ‘‘FDA/Xavier                        393), which includes working closely                  for each attendee, including name, title,
                                                  University PharmaLink Conference:                       with stakeholders and maximizing the                  affiliation, address, email, and
                                                  Leadership in a Global Supply Chain.’’                  availability and clarity of information to            telephone. FDA has verified the Web
                                                  The PharmaLink conference seeks                         stakeholders and the public. The                      site address in this document, as of the
                                                  solutions to important and complicated                  conference also is consistent with the                date this document publishes in the
                                                  issues by aligning with the strategic                   Small Business Regulatory Enforcement                 Federal Register, but Web sites are
                                                  priorities of FDA, and includes                         Fairness Act of 1996 (Pub. L. 104–121)                subject to change over time.
                                                  presentations from key FDA officials                    by providing outreach activities by                      To register by mail, please send your
                                                  and industry experts.                                   Government Agencies to small                          name, title, firm name, address,
                                                  DATES: The public conference will be                    businesses.                                           telephone and fax numbers, email, and
                                                  held on March 15, 2017, from 8:30 a.m.                     The conference includes the                        payment information for the fee to
                                                  to 5 p.m.; March 16, 2017, from 8:30                    following:                                            Xavier University, Attention: Marla
                                                  a.m. to 5 p.m.; and March 17, 2017, from                   • Welcome Reception at the Hilton                  Phillips, 3800 Victory Pkwy.,
                                                  8:30 a.m. to 12:20 p.m. The conference                  Netherland Plaza.                                     Cincinnati, OH 45207–5471. An email
                                                  is preceded by a Welcome Reception on                      • Lunch Networking by Topic.                       will be sent confirming your
                                                  March 14, 2017, from 5 p.m. to 7 p.m.                      • The Solution ‘‘Xchange’’.                        registration.
                                                  See the SUPPLEMENTARY INFORMATION                          • Case Studies and Small Group                        If you need special accommodations
                                                  section for registration date and                       Discussions.                                          due to a disability, please contact Marla
                                                  information.                                               • Action Plans.
                                                                                                                                                                Phillips (see FOR FURTHER INFORMATION
                                                  ADDRESSES: The public conference will                   II. Topics for Discussion at the Public               CONTACT) at least 7 days in advance of
                                                  be held on the campus of Xavier                         Conference                                            the conference.
                                                  University, 3800 Victory Pkwy.,                           The public conference will engage                      There is a registration fee. The
                                                  Cincinnati, OH 45207, 513–745–3073 or                   those involved in FDA-regulated global                conference registration fees cover the
                                                  513–745–3483.                                           supply chain quality and management                   cost of the presentations, training
                                                  FOR FURTHER INFORMATION CONTACT:                        through the following topics:                         materials, receptions, breakfasts,
                                                     For information regarding this notice:                 • FDA Metrics Program—Path                          lunches, and dinners for the 2.5 days of
                                                  Nicholas Paulin, Food and Drug                          Forward to Reduce Risks Within FDA                    the conference, including the Welcome
                                                  Administration, Cincinnati South                        and Across Industry.                                  Reception that precedes the conference.
                                                  Office, 36 East 7th St., Cincinnati, OH                   • Predictive Capabilities Through a                 There will be onsite registration if space
                                                  45202, 513–246–4134, email:                             Living Metrics Model.                                 is available. The cost of registration is as
                                                  nicholas.paulin@fda.hhs.gov.                              • How Big Data and Artificial                       follows:
                                                     For information regarding the                        Intelligence Can Enhance Your
                                                  conference and registration: Marla                      Proactive Risk Monitoring Programs.                        TABLE 1—REGISTRATION FEES 1
                                                  Phillips, Xavier University, 3800                         • Connecting Culture to Performance.
                                                  Victory Pkwy., Cincinnati, OH 45207–                      • Data Integrity—Detection and                                                                       Standard
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                                                                                                                                                                            Attendee type
                                                  5471, 513–745–3073, email:                              Successful Practices.                                                                                    rate
                                                  phillipsm4@xavier.edu.                                    • Building a Bridge Across                          Industry .....................................      $1,895
                                                  SUPPLEMENTARY INFORMATION:                              Generations.                                          Small Business (<100 employ-
                                                                                                            • Good Supply Practices (GSPs)—                       ees) .......................................       1,295
                                                  I. Background                                           Paradigm Shifting Solutions.                          Start-up Manufacturer ...............                  300
                                                     The public conference helps fulfill the                • How to Develop and Execute a                      Academic ..................................            300
                                                  Department of Health and Human                          Robust Risk-Based Due Diligence Plan.                 Media ........................................        Free



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Document Created: 2017-02-17 00:28:50
Document Modified: 2017-02-17 00:28:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments must be received by April 18, 2017.
ContactReports Clearance Office at (410) 786- 1326.
FR Citation82 FR 11040 

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