82_FR_21906 82 FR 21817 - Agency Information Collection Activities: Proposed Collection; Comment Request

82 FR 21817 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 82, Issue 89 (May 10, 2017)

Page Range21817-21818
FR Document2017-09478

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 89 (Wednesday, May 10, 2017)
[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)]
[Notices]
[Pages 21817-21818]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-09478]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10225]


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 July 10, 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 https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: 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).

[[Page 21818]]

CMS-10225 Disclosures Required of Certain Hospitals and Critical Access 
Hospitals Regarding Physician Ownership

    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: Disclosures 
Required of Certain Hospitals and Critical Access Hospitals Regarding 
Physician Ownership; Use: This information collection relates to the 
required third party disclosures by certain Medicare-participating 
hospitals and Critical Access Hospitals (CAHs) and physicians to their 
patients. The intent of the disclosure notice is to assist the patient 
in making an informed decision regarding their care. The disclosure 
requires hospitals and CAHs to disclose to its patients whether the 
hospitals/CAHs are physician-owned and, if so, the names of the 
physician-owners. The second disclosure requires all hospitals and CAHs 
that do not have a Doctor of Medicine (MD) or a Doctor of Osteopathic 
Medicine (DO) on the premises at all times to disclose this to patients 
upon admission or registration for both inpatient and specified 
outpatient services. Form Number: CMS-10225 (OMB Control Number: 0938-
1034); Frequency: Occasionally; Affected Public: Private sector--
Business or other for-profits and Not-for-profit institutions; Number 
of Respondents: 2,556; Total Annual Responses: 162,993; Total Annual 
Hours: 6,435. (For policy questions regarding this collection contact 
Natalie Clybourn at 410-786-5642).

    Dated: May 5, 2017
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2017-09478 Filed 5-9-17; 8:45 am]
BILLING CODE 4120-01-P



                                                                               Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Notices                                            21817

                                                  please reference the document identifier                Program. Section 1156 of the Act                      the necessity and utility of the proposed
                                                  or OMB control number. To be assured                    imposes obligations on health care                    information collection for the proper
                                                  consideration, comments and                             practitioners and others who furnish or               performance of the agency’s functions,
                                                  recommendations must be received by                     order services or items under Medicare.               the accuracy of the estimated burden,
                                                  the OMB desk officer via one of the                     This section also provides for sanction               ways to enhance the quality, utility, and
                                                  following transmissions: OMB, Office of                 actions, if the Secretary determines that             clarity of the information to be
                                                  Information and Regulatory Affairs,                     the obligations as stated by this section             collected, and the use of automated
                                                  Attention: CMS Desk Officer, Fax                        are not met. Quality Improvement                      collection techniques or other forms of
                                                  Number: (202) 395–5806 OR, Email:                       Organizations (QIOs) are responsible for              information technology to minimize the
                                                  OIRA_submission@omb.eop.gov.                            identifying violations. The QIOs may                  information collection burden.
                                                    To obtain copies of a supporting                      allow practitioners or other entities,
                                                                                                          opportunities to submit relevant                      DATES: Comments must be received by
                                                  statement and any related forms for the
                                                                                                          information before determining that a                 July 10, 2017.
                                                  proposed collection(s) summarized in
                                                  this notice, you may make your request                  violation has occurred. The information               ADDRESSES:   When commenting, please
                                                  using one of following:                                 collection requirements contained in                  reference the document identifier or
                                                    1. Access CMS’ Web site address at                    this information collection request are               OMB control number. To be assured
                                                  Web site address at https://                            used by the QIOs to collect the                       consideration, comments and
                                                  www.cms.gov/Regulations-and-                            information necessary to make their                   recommendations must be submitted in
                                                  Guidance/Legislation/                                   decision. Form Number: CMS–R–65                       any one of the following ways:
                                                  PaperworkReductionActof1995/PRA-                        (OMB control number: 0938–0444);
                                                                                                                                                                  1. Electronically. You may send your
                                                  Listing.html                                            Frequency: Occasionally; Affected
                                                                                                                                                                comments electronically to http://
                                                    2. Email your request, including your                 Public: Private sector—Business or other
                                                                                                                                                                www.regulations.gov. Follow the
                                                  address, phone number, OMB number,                      for-profit and Not-for-profit institutions;
                                                                                                                                                                instructions for ‘‘Comment or
                                                  and CMS document identifier, to                         Number of Respondents: 18; Total
                                                                                                                                                                Submission’’ or ‘‘More Search Options’’
                                                  Paperwork@cms.hhs.gov.                                  Annual Responses: 18; Total Annual
                                                                                                          Hours: 4,716. (For policy questions                   to find the information collection
                                                    3. Call the Reports Clearance Office at                                                                     document(s) that are accepting
                                                  (410) 786–1326.                                         regarding this collection contact Tiffany
                                                                                                          Jackson-Dickey at 410–786–1124.)                      comments.
                                                  FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                  2. By regular mail. You may mail
                                                  William Parham at (410) 786–4669.                          Dated: May 5, 2017.
                                                                                                                                                                written comments to the following
                                                  SUPPLEMENTARY INFORMATION: Under the                    William N. Parham, III,
                                                                                                                                                                address: CMS, Office of Strategic
                                                  Paperwork Reduction Act of 1995 (PRA)                   Director, Paperwork Reduction Staff, Office
                                                                                                                                                                Operations and Regulatory Affairs,
                                                  (44 U.S.C. 3501–3520), federal agencies                 of Strategic Operations and Regulatory
                                                                                                          Affairs.                                              Division of Regulations Development,
                                                  must obtain approval from the Office of                                                                       Attention: Document Identifier/OMB
                                                  Management and Budget (OMB) for each                    [FR Doc. 2017–09482 Filed 5–9–17; 8:45 am]
                                                                                                                                                                Control Number llll, Room C4–26–
                                                  collection of information they conduct                  BILLING CODE 4120–01–P
                                                                                                                                                                05, 7500 Security Boulevard, Baltimore,
                                                  or sponsor. The term ‘‘collection of                                                                          Maryland 21244–1850.
                                                  information’’ is defined in 44 U.S.C.
                                                  3502(3) and 5 CFR 1320.3(c) and                         DEPARTMENT OF HEALTH AND                                To obtain copies of a supporting
                                                  includes agency requests or                             HUMAN SERVICES                                        statement and any related forms for the
                                                  requirements that members of the public                                                                       proposed collection(s) summarized in
                                                                                                          Centers for Medicare & Medicaid                       this notice, you may make your request
                                                  submit reports, keep records, or provide
                                                                                                          Services                                              using one of following:
                                                  information to a third party. Section
                                                  3506(c)(2)(A) of the PRA (44 U.S.C.                     [Document Identifier CMS–10225]                         1. Access CMS’ Web site address at
                                                  3506(c)(2)(A)) requires federal agencies                                                                      https://www.cms.gov/Regulations-and-
                                                  to publish a 30-day notice in the                       Agency Information Collection                         Guidance/Legislation/
                                                  Federal Register concerning each                        Activities: Proposed Collection;                      PaperworkReductionActof1995/PRA-
                                                  proposed collection of information,                     Comment Request                                       Listing.html
                                                  including each proposed extension or                    AGENCY: Centers for Medicare &                          2. Email your request, including your
                                                  reinstatement of an existing collection                 Medicaid Services, HHS.                               address, phone number, OMB number,
                                                  of information, before submitting the                   ACTION: Notice.                                       and CMS document identifier, to
                                                  collection to OMB for approval.                                                                               Paperwork@cms.hhs.gov.
                                                  Comments submitted in response to the                   SUMMARY:   The Centers for Medicare &
                                                  60-day FR Notice have been addressed                    Medicaid Services (CMS) is announcing                   3. Call the Reports Clearance Office at
                                                  in Appendix A of the ICR. To comply                     an opportunity for the public to                      (410) 786–1326.
                                                  with this requirement, CMS is                           comment on CMS’ intention to collect                  FOR FURTHER INFORMATION CONTACT:
                                                  publishing this notice that summarizes                  information from the public. Under the                Reports Clearance Office at (410) 786–
                                                  the following proposed collection(s) of                 Paperwork Reduction Act of 1995 (the                  1326.
                                                  information for public comment:                         PRA), federal agencies are required to
                                                    1. Type of Information Collection                     publish notice in the Federal Register                SUPPLEMENTARY INFORMATION:
                                                  Request: Reinstatement with change of a                 concerning each proposed collection of                Contents
                                                  previously collection; Title of                         information (including each proposed
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                                                  Information Collection: Final Peer                      extension or reinstatement of an existing               This notice sets out a summary of the
                                                  Review Organizations Sanction                           collection of information) and to allow               use and burden associated with the
                                                  Regulations; Use: The Peer Review                       60 days for public comment on the                     following information collections. More
                                                  Improvement Act of 1982 amended Title                   proposed action. Interested persons are               detailed information can be found in
                                                  XI of the Social Security Act (the Act),                invited to send comments regarding our                each collection’s supporting statement
                                                  creating the Utilization and Quality                    burden estimates or any other aspect of               and associated materials (see
                                                  Control Peer Review Organization                        this collection of information, including             ADDRESSES).



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                                                  21818                        Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Notices

                                                  CMS–10225 Disclosures Required of                          Dated: May 5, 2017                                 third party may not wish to be posted,
                                                  Certain Hospitals and Critical Access                   William N. Parham, III,                               such as medical information, your or
                                                  Hospitals Regarding Physician                           Director, Paperwork Reduction Staff, Office           anyone else’s Social Security number, or
                                                  Ownership                                               of Strategic Operations and Regulatory                confidential business information, such
                                                                                                          Affairs.                                              as a manufacturing process. Please note
                                                    Under the PRA (44 U.S.C. 3501–                        [FR Doc. 2017–09478 Filed 5–9–17; 8:45 am]            that if you include your name, contact
                                                  3520), federal agencies must obtain                     BILLING CODE 4120–01–P                                information, or other information that
                                                  approval from the Office of Management                                                                        identifies you in the body of your
                                                  and Budget (OMB) for each collection of                                                                       comments, that information will be
                                                  information they conduct or sponsor.                    DEPARTMENT OF HEALTH AND                              posted on https://www.regulations.gov.
                                                  The term ‘‘collection of information’’ is               HUMAN SERVICES                                          • If you want to submit a comment
                                                  defined in 44 U.S.C. 3502(3) and 5 CFR                                                                        with confidential information that you
                                                  1320.3(c) and includes agency requests                  Food and Drug Administration                          do not wish to be made available to the
                                                  or requirements that members of the                     [Docket No. FDA–2017–D–2497]                          public, submit the comment as a
                                                  public submit reports, keep records, or                                                                       written/paper submission and in the
                                                                                                          Draft Revisions to the Food and Drug                  manner detailed (see ‘‘Written/Paper
                                                  provide information to a third party.
                                                                                                          Administration Blueprint for Prescriber               Submissions’’ and ‘‘Instructions’’).
                                                  Section 3506(c)(2)(A) of the PRA
                                                  requires federal agencies to publish a                  Education for Extended-Release and                    Written/Paper Submissions
                                                  60-day notice in the Federal Register                   Long-Acting Opioids; Availability
                                                                                                                                                                   Submit written/paper submissions as
                                                  concerning each proposed collection of                  AGENCY:    Food and Drug Administration,              follows:
                                                  information, including each proposed                    HHS.                                                     • Mail/Hand delivery/Courier (for
                                                  extension or reinstatement of an existing               ACTION:Notice of availability; request                written/paper submissions): Division of
                                                  collection of information, before                       for comments.                                         Dockets Management (HFA–305), Food
                                                  submitting the collection to OMB for                                                                          and Drug Administration, 5630 Fishers
                                                  approval. To comply with this                           SUMMARY:    The Food and Drug                         Lane, Rm. 1061, Rockville, MD 20852.
                                                  requirement, CMS is publishing this                     Administration (FDA or Agency) is                        • For written/paper comments
                                                  notice.                                                 announcing the availability of draft                  submitted to the Division of Dockets
                                                                                                          revisions to the ‘‘FDA Blueprint for                  Management, FDA will post your
                                                  Information Collection                                  Prescriber Education for Extended-                    comment, as well as any attachments,
                                                                                                          Release and Long-Acting Opioid                        except for information submitted,
                                                     1. Type of Information Collection                    Analgesics’’ (Blueprint). The Blueprint               marked and identified, as confidential,
                                                  Request: Extension of a currently                       is part of the FDA-approved risk                      if submitted as detailed in
                                                  approved collection; Title of                           evaluation and mitigation strategy                    ‘‘Instructions.’’
                                                  Information Collection: Disclosures                     (REMS) for extended release (ER) and                     Instructions: All submissions received
                                                  Required of Certain Hospitals and                       long-acting (LA) opioid analgesic                     must include the Docket No. FDA–
                                                  Critical Access Hospitals Regarding                     medications (ER/LA Opioid Analgesics                  2017–D–2497 for ‘‘Draft Revisions to
                                                  Physician Ownership; Use: This                          REMS).                                                FDA Blueprint for Prescriber Education
                                                  information collection relates to the                      FDA is seeking comment on the draft                for Extended-Release and Long-Acting
                                                  required third party disclosures by                     revisions to the Blueprint and has added              Opioids; Request for Comments.’’
                                                  certain Medicare-participating hospitals                sections of draft revised Blueprint to the            Received comments will be placed in
                                                  and Critical Access Hospitals (CAHs)                    background materials for the public                   the docket and, except for those
                                                  and physicians to their patients. The                   workshop scheduled for May 9–10,                      submitted as ‘‘Confidential
                                                  intent of the disclosure notice is to                   2017. Although the draft revisions to the             Submissions,’’ publicly viewable at
                                                  assist the patient in making an informed                Blueprint will not be a discussion topic              https://www.regulations.gov or at the
                                                  decision regarding their care. The                      at the workshop, FDA expects the draft                Division of Dockets Management
                                                  disclosure requires hospitals and CAHs                  revisions to provide important context                between 9 a.m. and 4 p.m., Monday
                                                  to disclose to its patients whether the                 for discussions during the workshop.                  through Friday.
                                                  hospitals/CAHs are physician-owned                      DATES: To ensure that FDA considers                      • Confidential Submissions—To
                                                                                                          your comments on the draft revisions to               submit a comment with confidential
                                                  and, if so, the names of the physician-
                                                                                                          the Blueprint, submit either electronic               information that you do not wish to be
                                                  owners. The second disclosure requires
                                                                                                          or written comments by July 10, 2017.                 made publicly available, submit your
                                                  all hospitals and CAHs that do not have
                                                                                                          ADDRESSES: You may submit comments                    comments only as a written/paper
                                                  a Doctor of Medicine (MD) or a Doctor                                                                         submission. You should submit two
                                                  of Osteopathic Medicine (DO) on the                     as follows:
                                                                                                                                                                copies total. One copy will include the
                                                  premises at all times to disclose this to               Electronic Submissions                                information you claim to be confidential
                                                  patients upon admission or registration                   Submit electronic comments in the                   with a heading or cover note that states
                                                  for both inpatient and specified                        following way:                                        ‘‘THIS DOCUMENT CONTAINS
                                                  outpatient services. Form Number:                         • Federal eRulemaking Portal:                       CONFIDENTIAL INFORMATION.’’ The
                                                  CMS–10225 (OMB Control Number:                          https://www.regulations.gov. Follow the               Agency will review this copy, including
                                                  0938–1034); Frequency: Occasionally;                    instructions for submitting comments.                 the claimed confidential information, in
                                                  Affected Public: Private sector—                        Comments submitted electronically,                    its consideration of comments. The
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                                                  Business or other for-profits and Not-                  including attachments, to https://                    second copy, which will have the
                                                  for-profit institutions; Number of                      www.regulations.gov will be posted to                 claimed confidential information
                                                  Respondents: 2,556; Total Annual                        the docket unchanged. Because your                    redacted/blacked out, will be available
                                                  Responses: 162,993; Total Annual                        comment will be made public, you are                  for public viewing and posted on
                                                  Hours: 6,435. (For policy questions                     solely responsible for ensuring that your             https://www.regulations.gov. Submit
                                                  regarding this collection contact Natalie               comment does not include any                          both copies to the Division of Dockets
                                                  Clybourn at 410–786–5642).                              confidential information that you or a                Management. If you do not wish your


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Document Created: 2017-05-10 00:00:46
Document Modified: 2017-05-10 00:00:46
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 July 10, 2017.
ContactReports Clearance Office at (410) 786- 1326.
FR Citation82 FR 21817 

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