82_FR_11958 82 FR 11921 - Agency Information Collection Activities: Proposed Collection; Comment Request

82 FR 11921 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 82, Issue 37 (February 27, 2017)

Page Range11921-11923
FR Document2017-03809

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 37 (Monday, February 27, 2017)
[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)]
[Notices]
[Pages 11921-11923]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03809]



[[Page 11921]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-65, CMS-1572, CMS-10175, CMS-10220, CMS-
10471, and CMS-10495]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (the PRA), federal agencies are required to publish notice 
in the Federal Register concerning each proposed collection of 
information (including each proposed extension or reinstatement of an 
existing collection of information) and to allow 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates or any other aspect of this 
collection of information, including the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected, and the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

DATES: Comments must be received by April 28, 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-R-65 Final Peer Review Organizations Sanction Regulations in 42 CFR 
Sections 1004.40, 1004.50, 1004.60, and 1004.70
CMS-1572 Home Health Agency Survey and Deficiencies Report
CMS-10175 Certification Statement for Electronic File Interchange 
Organizations
CMS-10220 Security Consent and Surrogate Authorization Form
CMS-10471 Medicare Prior Authorization of Power Mobility Devices (PMDs) 
Demonstration
CMS-10495 Registration, Attestation, Dispute & Resolution, Assumptions 
Document and Data Retention Requirements for Open Payments

    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: Final Peer Review 
Organizations Sanction Regulations in 42 CFR Sections 1004.40, 1004.50, 
1004.60, and 1004.70; Use: The Peer Review Improvement Act of 1982 
amended Title XI of the Social Security Act (the Act), creating the 
Utilization and Quality Control Peer Review Organization Program. 
Section 1156 of the Act imposes obligations on health care 
practitioners and others who furnish or order services or items under 
Medicare. This section also provides for sanction actions, if the 
Secretary determines that the obligations as stated by this section are 
not met. Quality Improvement Organizations (QIOs) are responsible for 
identifying violations. The QIOs may allow practitioners or other 
entities, opportunities to submit relevant information before 
determining that a violation has occurred. The information collection 
requirements contained in this information collection request are used 
by the QIOs to collect the information necessary to make their 
decision. Form Number: CMS-R-65 (OMB Control Number: 0938-0444); 
Frequency: Occasionally; Affected Public: Private sector--Business or 
other for-profit and Not-for-profit institutions; Number of 
Respondents: 18; Total Annual Responses: 18; Total Annual Hours: 4,716. 
(For policy questions regarding this collection contact Tiffany 
Jackson-Dickey at 410-786-1124.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Home Health 
Agency Survey and Deficiencies Report; Use: In order to participate in 
the Medicare Program as a Home Health Agency (HHA) provider, the HHA 
must meet federal standards. This form is used to record information 
and patients' health and provider compliance with requirements and to 
report the information to the federal government. Form Number: CMS-1572 
(OMB Control Number: 0938-0355); Frequency: Yearly; Affected Public: 
State, Local or Tribal Government; Number of Respondents: 3,830; Total 
Annual Responses: 3,830; Total Annual Hours: 958. (For policy questions 
regarding this collection contact Sarah Fahrendorf at 410-786-3112.)
    3. Type of Information Collection Request: Extension of a currently 
approved information collection; Title of Information Collection: 
Certification Statement for Electronic File Interchange Organizations; 
Use: Health

[[Page 11922]]

care providers can currently obtain a National Provider Identifier 
(NPI) via a paper application or over the Internet through the National 
Plan and Provider Enumeration System (NPPES). These applications must 
be submitted individually, on a per-provider basis. The Electronic File 
Interchange (EFI) process allows provider-designated organizations 
(EFIOs) to capture multiple providers' NPI application information on a 
single electronic file for submission to NPPES. This process is also 
referred to as bulk enumeration. To ensure that the EFIO has the 
authority to act on behalf of each provider and complies with other 
federal requirements, an authorized official of the EFIO must sign a 
certification statement and mail it to us. Form Number: CMS-10175 (OMB 
Control Number: 0938-0984). Frequency: Occasionally. Affected Public: 
Private Sector; Number of Respondents: 25; Total Annual Responses: 25; 
Total Annual Hours: 75. (For policy questions regarding this collection 
contact Kimberly McPhillips at 410-786-5374.)
    4. Type of Information Collection Request: Revision of a currently 
approved information collection; Title of Information Collection: 
Security Consent and Surrogate Authorization Form; Use: The primary 
function of the Medicare enrollment application is to obtain 
information about the Provider or supplier and whether they meet the 
Federal and/or State qualifications to participate in the Medicare 
program. In addition, the Medicare enrollment application gathers 
information regarding the provider or supplier's practice location, the 
identity of the owners of the enrolling organization, and information 
necessary to establish the correct claims payment.
    Enrollees have the option of submitting either a CMS-855 form, or 
submitting information via a Web based process. In establishing a Web 
based application process, we allow providers and suppliers the ability 
to enroll in the Medicare program, revalidate their enrollment and make 
changes to their enrollment information via Internet-based Provider 
Enrollment, Chain and Ownership System (PECOS). Individual providers/
suppliers (hereinafter referred to as ``Individual Providers'') log 
into Internet-based PECOS using their User IDs and passwords 
established when they applied online to the National Plan and Provider 
Enumeration System (NPPES) for their National Provider Identifiers 
(NPIs). Authorized Officials (AOs) of the provider or supplier 
organizations (hereinafter referred to as ``Organizational Providers'') 
must register for a user account and authenticate their identity and 
connection to the organization they represent before being able to log 
into Internet-based PECOS. Once authenticated, AOs for Organizational 
Providers, receive complete access to their enrollment information via 
Internet-based PECOS. Individuals and AOs of Organizational Providers 
are not required to submit a Security Consent and Surrogate 
Authorization Form to enroll, revalidate or make changes to their 
Medicare enrollment information.
    Individual and Organizational Providers may complete their Medicare 
enrollment responsibilities on their own or elect to delegate this task 
to a Surrogate. A Surrogate is an individual or organization identified 
by an Individual or Organizational Provider as someone authorized to 
access CMS computer systems, such as Internet-based PECOS, National 
Provider Plan and Enumeration System (NPPES) and the Medicare and 
Medicaid Electronic Health Records (EHR) Incentive Program Registration 
and Attestation System (HITECH), on their behalf and to modify or view 
any information contained therein that the Individual or Organizational 
Provider may have permission or right to access in accordance with 
Medicare statutes, regulations, policies, and usage guidelines for any 
CMS system. Surrogates may consist of administrative staff, independent 
contractors, 3rd party consulting companies or credentialing 
departments. In order for an Individual or Organizational Provider to 
delegate the Medicare credentialing process to a Surrogate to access 
and update their enrollment information in the above mentioned CMS 
systems on their behalf, it is required that a Security Consent and 
Surrogate Authorization Form be completed, or Individual and 
Organizational Providers use an equivalent online process via the PECOS 
Identity and Access Management (I&A) system. The Security Consent and 
Surrogate Authorization form replicates business service agreements 
between Medicare providers, suppliers or both and Surrogates providing 
enrollment services. The form, once signed, mailed and approved, grants 
a Surrogate access to all current and future enrollment data for the 
Individual or Organization Provider. Form Number: CMS-10220 (OMB 
Control Number: 0938-1035); Frequency: Occasionally; Affected Public: 
Individuals and Private Sector; Number of Respondents: 226,100; Total 
Annual Responses: 226,100; Total Annual Hours: 226,100. (For policy 
questions regarding this collection contact Kimberly McPhillips at 410-
786-5374.)
    5. Type of Information Collection Request: Extension of a currently 
approved collection of information; Title of Information Collection: 
Medicare Prior Authorization of Power Mobility Devices (PMDs) 
Demonstration; Use: The purpose of the Medicare Prior Authorization of 
Power Mobility Devices Demonstration (the Demonstration) is to ensure 
that payments for PMDs are appropriate before the claims are paid, 
thereby preventing the fraud, waste, and abuse in the seven states 
participating in the Demonstration: California, Florida, Illinois, 
Michigan, New York, North Carolina and Texas. Additional benefits of 
the Demonstration include ensuring that a beneficiary's medical 
condition warrants their medical equipment under existing coverage 
guidelines and preserving their ability to receive quality products 
from accredited suppliers. In order to gather qualitative information 
for analysis, the evaluation team will use semi-structured interview 
guides that focus on the direct impact of the Demonstration on 
stakeholder groups. Stakeholders will be drawn from advocacy 
organizations, power mobility device supply companies, state and local 
government, and healthcare practitioners. This information collection 
request explains the research methodology and data collection 
strategies designed to minimize the burden placed on research 
participants, while effectively gathering the data needed for the 
evaluation of the Demonstration. Form Number: CMS-10471 (OMB Control 
Number: 0938-1235); Frequency: Yearly; Affected Public: Private sector 
(business or other for-profit and not-for-profit institutions) and 
State and Local Governments; Number of Respondents: 254; Total Annual 
Responses: 254; Total Annual Hours: 288. (For policy questions 
regarding this collection contact Debbie Skinner at 410-786-7480.)
    6. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Registration, 
Attestation, Dispute & Resolution, Assumptions Document and Data 
Retention Requirements for Open Payments; Use: Section 6002 of the 
Affordable Care Act added section 1128G to the Social Security Act 
(Act), which requires applicable manufacturers and applicable group 
purchasing organizations (GPOs) of covered drugs, devices, biologicals, 
or medical supplies to report annually to CMS certain payments or other 
transfers

[[Page 11923]]

of value to physicians and teaching hospitals, as well as, certain 
information regarding the ownership or investment interests held by 
physicians or their immediate family members in applicable 
manufacturers or applicable GPOs.
    Specifically, applicable manufacturers of covered drugs, devices, 
biologicals, and medical supplies are required to submit on an annual 
basis the information required in section 1128G(a)(1) of the Act about 
certain payments or other transfers of value made to physicians and 
teaching hospitals (collectively called covered recipients) during the 
course of the preceding calendar year. Similarly, section 1128G(a)(2) 
of the Act requires applicable manufacturers and applicable GPOs to 
disclose any ownership or investment interests in such entities held by 
physicians or their immediate family members, as well as information on 
any payments or other transfers of value provided to such physician 
owners or investors. Applicable manufacturers must report the required 
payment and other transfer of value information annually to CMS in an 
electronic format. The statute also provides that applicable 
manufacturers and applicable GPOs must report annually to CMS the 
required information about physician ownership and investment 
interests, including information on any payments or other transfers of 
value provided to physician owners or investors, in an electronic 
format by the same date. Applicable manufacturers and applicable GPOs 
are subject to civil monetary penalties (CMPs) for failing to comply 
with the reporting requirements of the statute. We are required by 
statute to publish the reported data on a public Web site. The data 
must be downloadable, easily searchable, and aggregated. In addition, 
we must submit annual reports to the Congress and each state 
summarizing the data reported. Finally, section 1128G of the Act 
generally preempts state laws that require disclosure of the same type 
of information by manufacturers. Form Number: CMS-10495 (OMB Control 
Number: 0938-1237); Frequency: Once; Affected Public: Private sector--
Business or other for-profits; Number of Respondents: 227,157; Total 
Annual Responses: 457,454; Total Annual Hours: 3,099,297. (For policy 
questions regarding this collection contact Veronika Peleshchuk Fradlin 
at 410-786-3323.)

    Dated: February 22, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2017-03809 Filed 2-24-17; 8:45 am]
 BILLING CODE 4120-01-P



                                                                               Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Notices                                            11921

                                                  DEPARTMENT OF HEALTH AND                                  To obtain copies of a supporting                    Information Collection
                                                  HUMAN SERVICES                                          statement and any related forms for the                 1. Type of Information Collection
                                                                                                          proposed collection(s) summarized in                  Request: Extension of a currently
                                                  Centers for Medicare & Medicaid                         this notice, you may make your request                approved collection; Title of
                                                  Services                                                using one of following:                               Information Collection: Final Peer
                                                  [Document Identifier: CMS–R–65, CMS–                      1. Access CMS’ Web site address at                  Review Organizations Sanction
                                                  1572, CMS–10175, CMS–10220, CMS–10471,                  http://www.cms.hhs.gov/                               Regulations in 42 CFR Sections 1004.40,
                                                  and CMS–10495]                                          PaperworkReductionActof1995.                          1004.50, 1004.60, and 1004.70; Use: The
                                                                                                            2. Email your request, including your               Peer Review Improvement Act of 1982
                                                  Agency Information Collection                           address, phone number, OMB number,                    amended Title XI of the Social Security
                                                  Activities: Proposed Collection;                        and CMS document identifier, to                       Act (the Act), creating the Utilization
                                                  Comment Request                                         Paperwork@cms.hhs.gov.                                and Quality Control Peer Review
                                                  AGENCY: Centers for Medicare &                            3. Call the Reports Clearance Office at             Organization Program. Section 1156 of
                                                  Medicaid Services, HHS.                                 (410) 786–1326.                                       the Act imposes obligations on health
                                                  ACTION: Notice.                                         FOR FURTHER INFORMATION CONTACT:                      care practitioners and others who
                                                                                                          Reports Clearance Office at (410) 786–                furnish or order services or items under
                                                  SUMMARY:    The Centers for Medicare &                  1326.                                                 Medicare. This section also provides for
                                                  Medicaid Services (CMS) is announcing                                                                         sanction actions, if the Secretary
                                                                                                          SUPPLEMENTARY INFORMATION:
                                                  an opportunity for the public to                                                                              determines that the obligations as stated
                                                  comment on CMS’ intention to collect                    Contents                                              by this section are not met. Quality
                                                  information from the public. Under the                                                                        Improvement Organizations (QIOs) are
                                                                                                            This notice sets out a summary of the
                                                  Paperwork Reduction Act of 1995 (the                                                                          responsible for identifying violations.
                                                                                                          use and burden associated with the
                                                  PRA), federal agencies are required to                                                                        The QIOs may allow practitioners or
                                                                                                          following information collections. More
                                                  publish notice in the Federal Register                                                                        other entities, opportunities to submit
                                                                                                          detailed information can be found in
                                                  concerning each proposed collection of                                                                        relevant information before determining
                                                                                                          each collection’s supporting statement
                                                  information (including each proposed                                                                          that a violation has occurred. The
                                                                                                          and associated materials (see
                                                  extension or reinstatement of an existing                                                                     information collection requirements
                                                                                                          ADDRESSES).
                                                  collection of information) and to allow                                                                       contained in this information collection
                                                  60 days for public comment on the                       CMS–R–65 Final Peer Review                            request are used by the QIOs to collect
                                                  proposed action. Interested persons are                   Organizations Sanction Regulations in               the information necessary to make their
                                                  invited to send comments regarding our                    42 CFR Sections 1004.40, 1004.50,                   decision. Form Number: CMS–R–65
                                                  burden estimates or any other aspect of                   1004.60, and 1004.70                                (OMB Control Number: 0938–0444);
                                                  this collection of information, including               CMS–1572 Home Health Agency                           Frequency: Occasionally; Affected
                                                  the necessity and utility of the proposed                 Survey and Deficiencies Report                      Public: Private sector—Business or other
                                                  information collection for the proper                   CMS–10175 Certification Statement                     for-profit and Not-for-profit institutions;
                                                  performance of the agency’s functions,                    for Electronic File Interchange                     Number of Respondents: 18; Total
                                                  the accuracy of the estimated burden,                     Organizations                                       Annual Responses: 18; Total Annual
                                                  ways to enhance the quality, utility, and               CMS–10220 Security Consent and                        Hours: 4,716. (For policy questions
                                                  clarity of the information to be                          Surrogate Authorization Form                        regarding this collection contact Tiffany
                                                  collected, and the use of automated                     CMS–10471 Medicare Prior                              Jackson-Dickey at 410–786–1124.)
                                                  collection techniques or other forms of                   Authorization of Power Mobility                       2. Type of Information Collection
                                                  information technology to minimize the                    Devices (PMDs) Demonstration                        Request: Extension of a currently
                                                  information collection burden.                          CMS–10495 Registration, Attestation,                  approved collection; Title of
                                                  DATES: Comments must be received by                       Dispute & Resolution, Assumptions                   Information Collection: Home Health
                                                  April 28, 2017.                                           Document and Data Retention                         Agency Survey and Deficiencies Report;
                                                  ADDRESSES: When commenting, please
                                                                                                            Requirements for Open Payments                      Use: In order to participate in the
                                                  reference the document identifier or                      Under the PRA (44 U.S.C. 3501–                      Medicare Program as a Home Health
                                                  OMB control number. To be assured                       3520), federal agencies must obtain                   Agency (HHA) provider, the HHA must
                                                  consideration, comments and                             approval from the Office of Management                meet federal standards. This form is
                                                  recommendations must be submitted in                    and Budget (OMB) for each collection of               used to record information and patients’
                                                  any one of the following ways:                          information they conduct or sponsor.                  health and provider compliance with
                                                    1. Electronically. You may send your                  The term ‘‘collection of information’’ is             requirements and to report the
                                                  comments electronically to http://                      defined in 44 U.S.C. 3502(3) and 5 CFR                information to the federal government.
                                                  www.regulations.gov. Follow the                         1320.3(c) and includes agency requests                Form Number: CMS–1572 (OMB
                                                  instructions for ‘‘Comment or                           or requirements that members of the                   Control Number: 0938–0355);
                                                  Submission’’ or ‘‘More Search Options’’                 public submit reports, keep records, or               Frequency: Yearly; Affected Public:
                                                  to find the information collection                      provide information to a third party.                 State, Local or Tribal Government;
                                                  document(s) that are accepting                          Section 3506(c)(2)(A) of the PRA                      Number of Respondents: 3,830; Total
                                                  comments.                                               requires federal agencies to publish a                Annual Responses: 3,830; Total Annual
                                                    2. By regular mail. You may mail                      60-day notice in the Federal Register                 Hours: 958. (For policy questions
                                                  written comments to the following                       concerning each proposed collection of                regarding this collection contact Sarah
mstockstill on DSK3G9T082PROD with NOTICES




                                                  address: CMS, Office of Strategic                       information, including each proposed                  Fahrendorf at 410–786–3112.)
                                                  Operations and Regulatory Affairs,                      extension or reinstatement of an existing               3. Type of Information Collection
                                                  Division of Regulations Development,                    collection of information, before                     Request: Extension of a currently
                                                  Attention: Document Identifier/OMB                      submitting the collection to OMB for                  approved information collection; Title
                                                  Control Number lll, Room C4–26–                         approval. To comply with this                         of Information Collection: Certification
                                                  05, 7500 Security Boulevard, Baltimore,                 requirement, CMS is publishing this                   Statement for Electronic File
                                                  Maryland 21244–1850.                                    notice.                                               Interchange Organizations; Use: Health


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                                                  11922                        Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Notices

                                                  care providers can currently obtain a                   register for a user account and                       questions regarding this collection
                                                  National Provider Identifier (NPI) via a                authenticate their identity and                       contact Kimberly McPhillips at 410–
                                                  paper application or over the Internet                  connection to the organization they                   786–5374.)
                                                  through the National Plan and Provider                  represent before being able to log into                  5. Type of Information Collection
                                                  Enumeration System (NPPES). These                       Internet-based PECOS. Once                            Request: Extension of a currently
                                                  applications must be submitted                          authenticated, AOs for Organizational                 approved collection of information;
                                                  individually, on a per-provider basis.                  Providers, receive complete access to                 Title of Information Collection:
                                                  The Electronic File Interchange (EFI)                   their enrollment information via                      Medicare Prior Authorization of Power
                                                  process allows provider-designated                      Internet-based PECOS. Individuals and                 Mobility Devices (PMDs)
                                                  organizations (EFIOs) to capture                        AOs of Organizational Providers are not               Demonstration; Use: The purpose of the
                                                  multiple providers’ NPI application                     required to submit a Security Consent                 Medicare Prior Authorization of Power
                                                  information on a single electronic file                 and Surrogate Authorization Form to                   Mobility Devices Demonstration (the
                                                  for submission to NPPES. This process                   enroll, revalidate or make changes to                 Demonstration) is to ensure that
                                                  is also referred to as bulk enumeration.                their Medicare enrollment information.                payments for PMDs are appropriate
                                                  To ensure that the EFIO has the                            Individual and Organizational                      before the claims are paid, thereby
                                                  authority to act on behalf of each                      Providers may complete their Medicare                 preventing the fraud, waste, and abuse
                                                  provider and complies with other                        enrollment responsibilities on their own              in the seven states participating in the
                                                  federal requirements, an authorized                     or elect to delegate this task to a                   Demonstration: California, Florida,
                                                  official of the EFIO must sign a                                                                              Illinois, Michigan, New York, North
                                                                                                          Surrogate. A Surrogate is an individual
                                                  certification statement and mail it to us.                                                                    Carolina and Texas. Additional benefits
                                                                                                          or organization identified by an
                                                  Form Number: CMS–10175 (OMB                                                                                   of the Demonstration include ensuring
                                                                                                          Individual or Organizational Provider as
                                                  Control Number: 0938–0984).                                                                                   that a beneficiary’s medical condition
                                                                                                          someone authorized to access CMS
                                                  Frequency: Occasionally. Affected                                                                             warrants their medical equipment under
                                                                                                          computer systems, such as Internet-
                                                  Public: Private Sector; Number of                                                                             existing coverage guidelines and
                                                                                                          based PECOS, National Provider Plan
                                                  Respondents: 25; Total Annual                                                                                 preserving their ability to receive
                                                                                                          and Enumeration System (NPPES) and
                                                  Responses: 25; Total Annual Hours: 75.                                                                        quality products from accredited
                                                                                                          the Medicare and Medicaid Electronic
                                                  (For policy questions regarding this                                                                          suppliers. In order to gather qualitative
                                                                                                          Health Records (EHR) Incentive Program
                                                  collection contact Kimberly McPhillips                                                                        information for analysis, the evaluation
                                                                                                          Registration and Attestation System                   team will use semi-structured interview
                                                  at 410–786–5374.)
                                                     4. Type of Information Collection                    (HITECH), on their behalf and to modify               guides that focus on the direct impact of
                                                  Request: Revision of a currently                        or view any information contained                     the Demonstration on stakeholder
                                                  approved information collection; Title                  therein that the Individual or                        groups. Stakeholders will be drawn
                                                  of Information Collection: Security                     Organizational Provider may have                      from advocacy organizations, power
                                                  Consent and Surrogate Authorization                     permission or right to access in                      mobility device supply companies, state
                                                  Form; Use: The primary function of the                  accordance with Medicare statutes,                    and local government, and healthcare
                                                  Medicare enrollment application is to                   regulations, policies, and usage                      practitioners. This information
                                                  obtain information about the Provider or                guidelines for any CMS system.                        collection request explains the research
                                                  supplier and whether they meet the                      Surrogates may consist of administrative              methodology and data collection
                                                  Federal and/or State qualifications to                  staff, independent contractors, 3rd party             strategies designed to minimize the
                                                  participate in the Medicare program. In                 consulting companies or credentialing                 burden placed on research participants,
                                                  addition, the Medicare enrollment                       departments. In order for an Individual               while effectively gathering the data
                                                  application gathers information                         or Organizational Provider to delegate                needed for the evaluation of the
                                                  regarding the provider or supplier’s                    the Medicare credentialing process to a               Demonstration. Form Number: CMS–
                                                  practice location, the identity of the                  Surrogate to access and update their                  10471 (OMB Control Number: 0938–
                                                  owners of the enrolling organization,                   enrollment information in the above                   1235); Frequency: Yearly; Affected
                                                  and information necessary to establish                  mentioned CMS systems on their behalf,                Public: Private sector (business or other
                                                  the correct claims payment.                             it is required that a Security Consent                for-profit and not-for-profit institutions)
                                                     Enrollees have the option of                         and Surrogate Authorization Form be                   and State and Local Governments;
                                                  submitting either a CMS–855 form, or                    completed, or Individual and                          Number of Respondents: 254; Total
                                                  submitting information via a Web based                  Organizational Providers use an                       Annual Responses: 254; Total Annual
                                                  process. In establishing a Web based                    equivalent online process via the                     Hours: 288. (For policy questions
                                                  application process, we allow providers                 PECOS Identity and Access                             regarding this collection contact Debbie
                                                  and suppliers the ability to enroll in the              Management (I&A) system. The Security                 Skinner at 410–786–7480.)
                                                  Medicare program, revalidate their                      Consent and Surrogate Authorization                      6. Type of Information Collection
                                                  enrollment and make changes to their                    form replicates business service                      Request: Revision of a currently
                                                  enrollment information via Internet-                    agreements between Medicare                           approved collection; Title of
                                                  based Provider Enrollment, Chain and                    providers, suppliers or both and                      Information Collection: Registration,
                                                  Ownership System (PECOS). Individual                    Surrogates providing enrollment                       Attestation, Dispute & Resolution,
                                                  providers/suppliers (hereinafter referred               services. The form, once signed, mailed               Assumptions Document and Data
                                                  to as ‘‘Individual Providers’’) log into                and approved, grants a Surrogate access               Retention Requirements for Open
                                                  Internet-based PECOS using their User                   to all current and future enrollment data             Payments; Use: Section 6002 of the
                                                  IDs and passwords established when                      for the Individual or Organization                    Affordable Care Act added section
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                                                  they applied online to the National Plan                Provider. Form Number: CMS–10220                      1128G to the Social Security Act (Act),
                                                  and Provider Enumeration System                         (OMB Control Number: 0938–1035);                      which requires applicable
                                                  (NPPES) for their National Provider                     Frequency: Occasionally; Affected                     manufacturers and applicable group
                                                  Identifiers (NPIs). Authorized Officials                Public: Individuals and Private Sector;               purchasing organizations (GPOs) of
                                                  (AOs) of the provider or supplier                       Number of Respondents: 226,100; Total                 covered drugs, devices, biologicals, or
                                                  organizations (hereinafter referred to as               Annual Responses: 226,100; Total                      medical supplies to report annually to
                                                  ‘‘Organizational Providers’’) must                      Annual Hours: 226,100. (For policy                    CMS certain payments or other transfers


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                                                                               Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Notices                                          11923

                                                  of value to physicians and teaching                        Dated: February 22, 2017.                          Electronic Submissions
                                                  hospitals, as well as, certain information              William N. Parham, III,                                 Submit electronic comments in the
                                                  regarding the ownership or investment                   Director, Paperwork Reduction Staff, Office           following way:
                                                  interests held by physicians or their                   of Strategic Operations and Regulatory                  • Federal eRulemaking Portal:
                                                  immediate family members in                             Affairs.
                                                                                                                                                                https://www.regulations.gov. Follow the
                                                  applicable manufacturers or applicable                  [FR Doc. 2017–03809 Filed 2–24–17; 8:45 am]
                                                                                                                                                                instructions for submitting comments.
                                                  GPOs.                                                   BILLING CODE 4120–01–P
                                                                                                                                                                Comments submitted electronically,
                                                     Specifically, applicable manufacturers                                                                     including attachments, to https://
                                                  of covered drugs, devices, biologicals,                                                                       www.regulations.gov will be posted to
                                                                                                          DEPARTMENT OF HEALTH AND
                                                  and medical supplies are required to                                                                          the docket unchanged. Because your
                                                                                                          HUMAN SERVICES
                                                  submit on an annual basis the                                                                                 comment will be made public, you are
                                                  information required in section                         Food and Drug Administration                          solely responsible for ensuring that your
                                                  1128G(a)(1) of the Act about certain                                                                          comment does not include any
                                                                                                          [Docket No. FDA–2017–N–0696]                          confidential information that you or a
                                                  payments or other transfers of value
                                                                                                                                                                third party may not wish to be posted,
                                                  made to physicians and teaching                         Current State and Further
                                                                                                                                                                such as medical information, your or
                                                  hospitals (collectively called covered                  Development of Animal Models of
                                                                                                                                                                anyone else’s Social Security number, or
                                                  recipients) during the course of the                    Serious Infections Caused by
                                                                                                                                                                confidential business information, such
                                                  preceding calendar year. Similarly,                     Acinetobacter baumannii and
                                                                                                                                                                as a manufacturing process. Please note
                                                  section 1128G(a)(2) of the Act requires                 Pseudomonas aeruginosa; Public
                                                                                                                                                                that if you include your name, contact
                                                  applicable manufacturers and                            Workshop
                                                                                                                                                                information, or other information that
                                                  applicable GPOs to disclose any                         AGENCY:    Food and Drug Administration,              identifies you in the body of your
                                                  ownership or investment interests in                    HHS.                                                  comments, that information will be
                                                  such entities held by physicians or their               ACTION: Notice of public workshop;                    posted on https://www.regulations.gov.
                                                  immediate family members, as well as                    request for comments.                                   • If you want to submit a comment
                                                  information on any payments or other                                                                          with confidential information that you
                                                  transfers of value provided to such                     SUMMARY:    The Food and Drug                         do not wish to be made available to the
                                                  physician owners or investors.                          Administration (FDA) is announcing a                  public, submit the comment as a
                                                  Applicable manufacturers must report                    public workshop regarding the current                 written/paper submission and in the
                                                  the required payment and other transfer                 state and further development of animal               manner detailed (see ‘‘Written/Paper
                                                  of value information annually to CMS in                 models for serious infections caused by               Submissions’’ and ‘‘Instructions’’).
                                                  an electronic format. The statute also                  Acinetobacter baumannii and
                                                                                                          Pseudomonas aeruginosa. FDA is                        Written/Paper Submissions
                                                  provides that applicable manufacturers
                                                                                                          conducting this workshop in order to                     Submit written/paper submissions as
                                                  and applicable GPOs must report
                                                                                                          facilitate the development of narrow-                 follows:
                                                  annually to CMS the required
                                                  information about physician ownership
                                                                                                          spectrum antibacterial drugs, such as                    • Mail/Hand delivery/Courier (for
                                                                                                          those that are active against only a                  written/paper submissions): Division of
                                                  and investment interests, including                     single species of bacteria that may not               Dockets Management (HFA–305), Food
                                                  information on any payments or other                    occur frequently.                                     and Drug Administration, 5630 Fishers
                                                  transfers of value provided to physician                  This public workshop is intended to                 Lane, Rm. 1061, Rockville, MD 20852.
                                                  owners or investors, in an electronic                   provide information for and gain                         • For written/paper comments
                                                  format by the same date. Applicable                     perspective from health care providers,               submitted to the Division of Dockets
                                                  manufacturers and applicable GPOs are                   other U.S. Government Agencies,                       Management, FDA will post your
                                                  subject to civil monetary penalties                     academic experts, contract research                   comment, as well as any attachments,
                                                  (CMPs) for failing to comply with the                   organizations, and industry on various                except for information submitted,
                                                  reporting requirements of the statute.                  aspects of development efforts                        marked and identified, as confidential,
                                                  We are required by statute to publish                   pertaining to animal models of serious                if submitted as detailed in
                                                  the reported data on a public Web site.                 infections. The input from this public                ‘‘Instructions.’’
                                                  The data must be downloadable, easily                   workshop will also help FDA in                           Instructions: All submissions received
                                                  searchable, and aggregated. In addition,                developing topics for future discussion.              must include the Docket No. FDA–
                                                  we must submit annual reports to the                    DATES: The public workshop will be                    2017–N–0696 for ‘‘Current State and
                                                  Congress and each state summarizing                     held on March 1, 2017, from 8:30 a.m.                 Further Development of Animal Models
                                                  the data reported. Finally, section                     to 5 p.m. Submit either electronic or                 of Serious Infections Caused by
                                                  1128G of the Act generally preempts                     written comments on this public                       Acinetobacter baumannii and
                                                  state laws that require disclosure of the               workshop by March 15, 2017. See the                   Pseudomonas aeruginosa.’’ Received
                                                  same type of information by                             SUPPLEMENTARY INFORMATION section for                 comments will be placed in the docket
                                                  manufacturers. Form Number: CMS–                        registration information. The workshop                and, except for those submitted as
                                                  10495 (OMB Control Number: 0938–                        draft Agenda will be made available at:               ‘‘Confidential Submissions,’’ publicly
                                                  1237); Frequency: Once; Affected                        http://www.fda.gov/Drugs/NewsEvents/                  viewable at https://www.regulations.gov
                                                  Public: Private sector—Business or other                ucm534031.htm prior to the meeting.                   or at the Division of Dockets
                                                                                                          ADDRESSES: The public workshop will                   Management between 9 a.m. and 4 p.m.,
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                                                  for-profits; Number of Respondents:
                                                                                                          be held at the DoubleTree by Hilton                   Monday through Friday.
                                                  227,157; Total Annual Responses:
                                                                                                          Hotel Washington DC-Silver Spring,                       • Confidential Submissions—To
                                                  457,454; Total Annual Hours: 3,099,297.
                                                                                                          8727 Colesville Rd., Silver Spring, MD                submit a comment with confidential
                                                  (For policy questions regarding this                                                                          information that you do not wish to be
                                                                                                          20910. The hotel’s phone number is
                                                  collection contact Veronika Peleshchuk                                                                        made publicly available, submit your
                                                                                                          301–589–5200.
                                                  Fradlin at 410–786–3323.)                                 You may submit comments as                          comments only as a written/paper
                                                                                                          follows:                                              submission. You should submit two


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Document Created: 2017-02-25 01:05:43
Document Modified: 2017-02-25 01:05:43
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 28, 2017.
ContactReports Clearance Office at (410) 786- 1326.
FR Citation82 FR 11921 

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