82_FR_48714 82 FR 48514 - Agency Information Collection Activities: Proposed Collection; Comment Request

82 FR 48514 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 82, Issue 200 (October 18, 2017)

Page Range48514-48515
FR Document2017-22630

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 200 (Wednesday, October 18, 2017)
[Federal Register Volume 82, Number 200 (Wednesday, October 18, 2017)]
[Notices]
[Pages 48514-48515]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22630]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10054 and CMS-10106]


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 December 18, 2017.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number___, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.

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-10054 New Technology Payments for APCs Under the Outpatient 
Prospective Payment System
CMS-10106 Medicare Authorization to Disclose Personal Health 
Information

    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: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: New Technology Payments for APCs Under the Outpatient 
Prospective Payment System; Use: CMS needs to keep pace with emerging 
new technologies and make them accessible to Medicare beneficiaries in 
a timely manner. It is necessary that we continue to collect 
appropriate information from interested parties such as hospitals, 
medical device manufacturers, pharmaceutical companies and others that 
bring to our attention specific services that they wish us to evaluate 
for New Technology APC payment. We are making no changes to the 
information that we collect. The information that we seek to continue 
to collect is necessary to determine whether certain new services are 
eligible for payment in New Technology APCs, to determine appropriate 
coding and to set an appropriate 4 payment rate for the new technology 
service. The intent of these provisions is to ensure timely beneficiary 
access to new and appropriate technologies Form Number: CMS-10054 (OMB 
control number: 0938-0860); Frequency: Annually; Affected Public: 
Private Sector; Business or Other for-profits; Number of Respondents: 
10; Total Annual Responses: 10; Total Annual Hours: 160. (For policy 
questions regarding this collection contact Joshua McFeeters at 410-
786-9732).
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare 
Authorization to Disclose Personal Health Information; Use: Unless 
permitted or required by law, the Health Insurance Portability and 
Accountability Act (HIPAA) Privacy Rule (Sec.  164.508) prohibits 
Medicare (a HIPAA covered entity) from disclosing an individual's 
protected health information without a valid authorization. In order to 
be valid, an authorization must include specified core elements and 
statements. Medicare will make available to Medicare beneficiaries a 
standard, valid authorization to enable beneficiaries to request the 
disclosure of their protected health information. This standard 
authorization will simplify the process of requesting information 
disclosure for beneficiaries and minimize the response time for 
Medicare. Form CMS-10106, the Medicare Authorization to Disclose 
Personal Health Information, will be used by Medicare beneficiaries to 
authorize Medicare to disclose their protected health information to a 
third party. Form Number: CMS-10106 (OMB control number: 0938-0930); 
Frequency: Occasionally; Affected Public:

[[Page 48515]]

Individuals or Households; Number of Respondents: 2,200,000; Total 
Annual Responses: 2,200,000; Total Annual Hours: 550,000. (For policy 
questions regarding this collection contact Sam Jenkins at 410-786-
3261.)

    Dated: October 13, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2017-22630 Filed 10-17-17; 8:45 am]
 BILLING CODE 4120-01-P



                                               48514                     Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices

                                                 Board of Governors of the Federal Reserve             address: CMS, Office of Strategic                     Technology Payments for APCs Under
                                               System, October 13, 2017.                               Operations and Regulatory Affairs,                    the Outpatient Prospective Payment
                                               Michele Taylor Fennell,                                 Division of Regulations Development,                  System; Use: CMS needs to keep pace
                                               Assistant Secretary of the Board.                       Attention: Document Identifier/OMB                    with emerging new technologies and
                                               [FR Doc. 2017–22621 Filed 10–17–17; 8:45 am]            Control Numberlll, Room C4–26–                        make them accessible to Medicare
                                               BILLING CODE P                                          05, 7500 Security Boulevard, Baltimore,               beneficiaries in a timely manner. It is
                                                                                                       Maryland 21244–1850.                                  necessary that we continue to collect
                                                                                                         To obtain copies of a supporting                    appropriate information from interested
                                               DEPARTMENT OF HEALTH AND                                statement and any related forms for the               parties such as hospitals, medical
                                               HUMAN SERVICES                                          proposed collection(s) summarized in                  device manufacturers, pharmaceutical
                                                                                                       this notice, you may make your request                companies and others that bring to our
                                               Centers for Medicare & Medicaid                         using one of following:                               attention specific services that they
                                               Services                                                  1. Access CMS’ Web site address at                  wish us to evaluate for New Technology
                                                                                                       http://www.cms.hhs.gov/                               APC payment. We are making no
                                               [Document Identifier: CMS–10054 and CMS–
                                               10106]                                                  PaperworkReductionActof1995.                          changes to the information that we
                                                                                                         2. Email your request, including your               collect. The information that we seek to
                                               Agency Information Collection                           address, phone number, OMB number,                    continue to collect is necessary to
                                               Activities: Proposed Collection;                        and CMS document identifier, to                       determine whether certain new services
                                               Comment Request                                         Paperwork@cms.hhs.gov.                                are eligible for payment in New
                                                                                                         3. Call the Reports Clearance Office at             Technology APCs, to determine
                                               AGENCY: Centers for Medicare &                          (410) 786–1326.                                       appropriate coding and to set an
                                               Medicaid Services, HHS.                                 FOR FURTHER INFORMATION CONTACT:                      appropriate 4 payment rate for the new
                                               ACTION: Notice.                                         William Parham at (410) 786–4669.                     technology service. The intent of these
                                               SUMMARY:    The Centers for Medicare &                  SUPPLEMENTARY INFORMATION:                            provisions is to ensure timely
                                               Medicaid Services (CMS) is announcing                                                                         beneficiary access to new and
                                                                                                       Contents                                              appropriate technologies Form Number:
                                               an opportunity for the public to
                                               comment on CMS’ intention to collect                      This notice sets out a summary of the               CMS–10054 (OMB control number:
                                               information from the public. Under the                  use and burden associated with the                    0938–0860); Frequency: Annually;
                                               Paperwork Reduction Act of 1995 (the                    following information collections. More               Affected Public: Private Sector; Business
                                               PRA), federal agencies are required to                  detailed information can be found in                  or Other for-profits; Number of
                                               publish notice in the Federal Register                  each collection’s supporting statement                Respondents: 10; Total Annual
                                               concerning each proposed collection of                  and associated materials (see                         Responses: 10; Total Annual Hours:
                                               information (including each proposed                    ADDRESSES).                                           160. (For policy questions regarding this
                                               extension or reinstatement of an existing               CMS–10054 New Technology                              collection contact Joshua McFeeters at
                                               collection of information) and to allow                   Payments for APCs Under the                         410–786–9732).
                                               60 days for public comment on the                         Outpatient Prospective Payment                         2. Type of Information Collection
                                               proposed action. Interested persons are                   System                                              Request: Extension of a currently
                                               invited to send comments regarding our                  CMS–10106 Medicare Authorization                      approved collection; Title of
                                               burden estimates or any other aspect of                   to Disclose Personal Health                         Information Collection: Medicare
                                               this collection of information, including                 Information                                         Authorization to Disclose Personal
                                               the necessity and utility of the proposed                 Under the PRA (44 U.S.C. 3501–                      Health Information; Use: Unless
                                               information collection for the proper                   3520), federal agencies must obtain                   permitted or required by law, the Health
                                               performance of the agency’s functions,                  approval from the Office of Management                Insurance Portability and
                                               the accuracy of the estimated burden,                   and Budget (OMB) for each collection of               Accountability Act (HIPAA) Privacy
                                               ways to enhance the quality, utility, and               information they conduct or sponsor.                  Rule (§ 164.508) prohibits Medicare (a
                                               clarity of the information to be                        The term ‘‘collection of information’’ is             HIPAA covered entity) from disclosing
                                               collected, and the use of automated                     defined in 44 U.S.C. 3502(3) and 5 CFR                an individual’s protected health
                                               collection techniques or other forms of                 1320.3(c) and includes agency requests                information without a valid
                                               information technology to minimize the                  or requirements that members of the                   authorization. In order to be valid, an
                                               information collection burden.                          public submit reports, keep records, or               authorization must include specified
                                               DATES: Comments must be received by                     provide information to a third party.                 core elements and statements. Medicare
                                               December 18, 2017.                                      Section 3506(c)(2)(A) of the PRA                      will make available to Medicare
                                               ADDRESSES: When commenting, please                      requires federal agencies to publish a                beneficiaries a standard, valid
                                               reference the document identifier or                    60-day notice in the Federal Register                 authorization to enable beneficiaries to
                                               OMB control number. To be assured                       concerning each proposed collection of                request the disclosure of their protected
                                               consideration, comments and                             information, including each proposed                  health information. This standard
                                               recommendations must be submitted in                    extension or reinstatement of an existing             authorization will simplify the process
                                               any one of the following ways:                          collection of information, before                     of requesting information disclosure for
                                                 1. Electronically. You may send your                  submitting the collection to OMB for                  beneficiaries and minimize the response
                                               comments electronically to http://                      approval. To comply with this                         time for Medicare. Form CMS–10106,
                                               www.regulations.gov. Follow the                         requirement, CMS is publishing this                   the Medicare Authorization to Disclose
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                                               instructions for ‘‘Comment or                           notice.                                               Personal Health Information, will be
                                               Submission’’ or ‘‘More Search Options’’                                                                       used by Medicare beneficiaries to
                                               to find the information collection                      Information Collection                                authorize Medicare to disclose their
                                               document(s) that are accepting                            1. Type of Information Collection                   protected health information to a third
                                               comments.                                               Request: Reinstatement without change                 party. Form Number: CMS–10106 (OMB
                                                 2. By regular mail. You may mail                      of a previously approved collection;                  control number: 0938–0930); Frequency:
                                               written comments to the following                       Title of Information Collection: New                  Occasionally; Affected Public:


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                                                                                   Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices                                                                48515

                                               Individuals or Households; Number of                                       Act (the Act), States, Territories, and                       capacities throughout the five-year plan
                                               Respondents: 2,200,000; Total Annual                                       Tribes are required to submit a Child                         period. The CFS–101 has three parts.
                                               Responses: 2,200,000; Total Annual                                         and Family Services Plan (CFSP). The                          Part I is an annual budget request for the
                                               Hours: 550,000. (For policy questions                                      CFSP lays the groundwork for a system                         upcoming fiscal year. Part II includes a
                                               regarding this collection contact Sam                                      of coordinated, integrated, and                               summary of planned expenditures by
                                               Jenkins at 410–786–3261.)                                                  culturally relevant family services for                       program area for the upcoming fiscal
                                                  Dated: October 13, 2017.                                                the subsequent five years (45 CFR                             year, the estimated number of
                                               William N. Parham, III,                                                    1357.15(a)(1)). The CFSP outlines                             individuals or families to be served, and
                                               Director, Paperwork Reduction Staff, Office                                initiatives and activities the State,                         the geographical service area. Part III
                                               of Strategic Operations and Regulatory                                     Territory, and Tribes will carry out in                       includes actual expenditures by
                                               Affairs.                                                                   administering programs and services to                        program area, numbers of families and
                                               [FR Doc. 2017–22630 Filed 10–17–17; 8:45 am]                               promote the safety, permanency, and                           individuals served by program area, and
                                               BILLING CODE 4120–01–P                                                     well-being of children and families,                          the geographic areas served for the last
                                                                                                                          including, as applicable, those activities                    complete fiscal year.
                                                                                                                          conducted under the John H. Chafee
                                               DEPARTMENT OF HEALTH AND                                                                                                                    Respondents: States, Territories, and
                                                                                                                          Foster Care Independence Program
                                               HUMAN SERVICES                                                                                                                           Tribes must complete the CFSP, APSR,
                                                                                                                          (Section 477 of the Act) and the State
                                                                                                                                                                                        and CFS–101. States and Territories
                                                                                                                          grant authorized by the Child Abuse
                                               Administration for Children and                                                                                                          must also report data annually on
                                                                                                                          Prevention and Treatment Act. By June
                                               Families                                                                                                                                 caseworker visits with children in foster
                                                                                                                          30 of each year, States, Territories, and
                                               [OMB No.: 0970–0426]                                                       Tribes are also required to submit an                         care. Tribes are exempted from the
                                                                                                                          Annual Progress and Services Report                           caseworker visits reporting requirement
                                               Submission for OMB Review;                                                 (APSR) and a financial report called the                      of the CFSP/APSR. There are
                                               Comment Request; Child and Family                                          CFS–101. The APSR is a yearly report                          approximately 189 Tribal entities that
                                               Services Plan (CFSP), Annual Progress                                      that discusses progress made by a State,                      currently receive IV–B funding. There
                                               and Services Review (APSR), and                                            Territory or Tribe in accomplishing the                       are 53 States (including Puerto Rico, the
                                               Annual Budget Expenses Request and                                                                                                       District of Columbia, and the U.S. Virgin
                                                                                                                          goals and objectives cited in its CFSP
                                               Estimated Expenditures (CFS–101)                                                                                                         Islands) that must complete the CFSP,
                                                                                                                          (45 CFR 1357.16(a)). The APSR contains
                                                 Description: Under title IV–B,                                           new and updated information about                             APSR, and CFS–101. There are a total of
                                               subparts 1 and 2, of the Social Security                                   service needs and organizational                              242 possible respondents.

                                                                                                                                   ANNUAL BURDEN ESTIMATES
                                                                                                                                                                                        Number of           Average
                                                                                                                                                                       Number of                                         Total burden
                                                                                                Instrument                                                                            responses per       burden hours
                                                                                                                                                                      respondents                                           hours
                                                                                                                                                                                        respondent        per response

                                               APSR ...............................................................................................................             242                1                80         19,360
                                               CFSP ...............................................................................................................            48.4                1            120.25       5,820.10
                                               CFS–101, Parts I, II, and III ............................................................................                       242                1                 5          1,210
                                               Caseworker Visits ............................................................................................                    53                1             99.33       5,264.49



                                                 Estimated Total Annual Burden                                            SUBMISSION@OMB.EOP.GOV, Attn:                                 or Center) is announcing the 2018
                                               Hours: 31,654.59.                                                          Desk Officer for the Administration for                       Experiential Learning Program (ELP).
                                                 Additional Information: Copies of the                                    Children and Families.                                        This training is intended to provide
                                               proposed collection may be obtained by                                                                                                   CDRH and other FDA staff with an
                                                                                                                          Mary Jones,
                                               writing to the Administration for                                                                                                        opportunity to understand laboratory
                                                                                                                          ACF/OPRE Certifying Officer.                                  practices, quality system management,
                                               Children and Families, Office of                                           [FR Doc. 2017–22519 Filed 10–17–17; 8:45 am]
                                               Planning, Research and Evaluation, 330                                                                                                   patient perspective/input, and
                                               C Street SW., Washington, DC 20201,
                                                                                                                          BILLING CODE 4184–25–P                                        challenges that impact the medical
                                               Attn: Reports Clearance Officer. All                                                                                                     device development life cycle. The
                                               requests should be identified by the title                                                                                               purpose of this document is to invite
                                                                                                                          DEPARTMENT OF HEALTH AND                                      medical device industry, academia, and
                                               of the information collection. Email                                       HUMAN SERVICES
                                               address: infocollection@acf.hhs.gov.                                                                                                     health care facilities, and others to
                                                                                                                          Food and Drug Administration                                  participate in this formal training
                                                 OMB Comment: OMB is required to
                                                                                                                                                                                        program for CDRH and other FDA staff,
                                               make a decision concerning the
                                                                                                                          [Docket No. FDA–2017–N–1003]                                  or to contact CDRH for more
                                               collection of information between 30
                                                                                                                                                                                        information regarding the ELP.
                                               and 60 days after publication of this
                                                                                                                          Center for Devices and Radiological                           DATES: Submit electronic proposals for
                                               document in the Federal Register.
                                                                                                                          Health: Experiential Learning Program                         participation in the ELP within the
                                               Therefore, a comment is best assured of
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                                               having its full effect if OMB receives it                                  AGENCY:        Food and Drug Administration,                  dates provided at the ELP Web site at:
                                               within 30 days of publication. Written                                     HHS.                                                          https://www.fda.gov/scienceresearch/
                                               comments and recommendations for the                                                                                                     sciencecareeropportunities/
                                                                                                                          ACTION:       Notice of availability.                         ucm380676.htm.
                                               proposed information collection should
                                               be sent directly to the following: Office                                  SUMMARY:  The Food and Drug                                   ADDRESSES:  For access to the docket to
                                               of Management and Budget, Paperwork                                        Administration’s (FDA) Center for                             read background documents, go to
                                               Reduction Project, Email: OIRA_                                            Devices and Radiological Health (CDRH                         https://www.regulations.gov and insert


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Document Created: 2017-10-18 01:38:06
Document Modified: 2017-10-18 01:38:06
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 December 18, 2017.
ContactWilliam Parham at (410) 786-4669.
FR Citation82 FR 48514 

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