83_FR_49283 83 FR 49094 - Agency Information Collection Activities: Proposed Collection; Comment Request

83 FR 49094 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 83, Issue 189 (September 28, 2018)

Page Range49094-49095
FR Document2018-21171

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 83 Issue 189 (Friday, September 28, 2018)
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49094-49095]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-21171]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10464]


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 November 27, 2018.

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

[[Page 49095]]

proposed collection(s) summarized in this notice, you may make your 
request using one of following:
    1. Access CMS' website address at website 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 Paperwork@cms.hhs.gov.
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: William Parham 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-10464 Agent/Broker Data Collection in Federally Facilitated Health 
Insurance Exchanges

    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. Title of Information Collection: Agent/Broker Data Collection in 
Federally Facilitated Health Insurance Exchanges; Type of Information 
Collection Request: Revision of a currently approved collection; Use: 
The Patient Protection and Affordable Care Act, Public Law 111-148, 
enacted on March 23, 2010, and the Health Care and Education 
Reconciliation Act, Public Law 111-152, enacted on March 30, 2010 
(collectively, ``Affordable Care Act''), expands access to health 
insurance for individuals and employees of small businesses through the 
establishment of new Affordable Insurance Exchanges (Exchanges), also 
called Marketplaces, including the Small Business Health Options 
Program (SHOP). Revised requirements pertaining to agents/brokers 
completing Federally-facilitated Exchange (FFE) registration are 
discussed in the final rule published on February 27, 2015 for the 
Patient Protection and Affordable Care Act; HHS Notice of Benefit and 
Payment Parameters for 2016 (CMS-9944-F). These updated requirements 
direct agents/brokers to submit additional fields related to basic 
contact information and National Producer Number (NPN). Current state 
licensure and relevant health lines of authority (LOA) are then 
validated using the National Insurance Producer Registry (NIPR) 
database. This ICR serves as the formal request for renewal and also 
includes some of the information collection requirements from the 
previously approved final rule. Form Number: CMS-10464 (OMB control 
number: 0938-1204); Frequency: Annually; Affected Public: Private 
Sector (Business or other for-profits); Number of Respondents: 52,000; 
Number of Responses: 52,000; Total Annual Hours: 12,480. (For questions 
regarding this collection contact Madeline Pellish at 301-492-4390.)

    Dated: September 25, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-21171 Filed 9-27-18; 8:45 am]
 BILLING CODE 4120-01-P



                                              49094                       Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices

                                              vendor into the Board’s contract writing                the Board’s subcontracting goals. Lastly,             DEPARTMENT OF HEALTH AND
                                              and invoice payment system. As a result                 the Board proposes to discontinue the                 HUMAN SERVICES
                                              of the criteria used by the Board to                    use of the Request for Price Quotation
                                              evaluate proposals, the Solicitation                    Form (RFP/RFPQ). The purpose of the                   Centers for Medicare & Medicaid
                                              Package may also include the Past                       RFPQ form will be absorbed into the FR                Services
                                              Performance Data Sheet and Past                         1400B.                                                [Document Identifiers: CMS–10464]
                                              Performance Questionnaire (Attachment
                                              I of FR 1400B) if past performance is an                  Legal authorization and
                                                                                                                                                            Agency Information Collection
                                              evaluation factor. Typically, if past                   confidentiality: The FR 1400A is
                                                                                                                                                            Activities: Proposed Collection;
                                              performance is considered an evaluation                 voluntary. For prospective vendors that
                                                                                                                                                            Comment Request
                                              factor, the vendor is asked to submit                   decide to submit proposals to the Board,
                                              information on up to three previous                     the FR 1400B, 1400C, and 1400D are                    AGENCY: Centers for Medicare &
                                              contracts whose effort is recent and                    required to obtain a benefit, in order to             Medicaid Services, HHS.
                                              relevant to the effort required by the                  be eligible for the award of a contract.              ACTION: Notice.
                                              solicitation.                                             The FR 1400 is authorized pursuant to               SUMMARY:    The Centers for Medicare &
                                                 Solicitations that require the vendor                sections 10 and 11 of the Federal                     Medicaid Services (CMS) is announcing
                                              to process, store, or transmit data from                Reserve Act (‘‘FRA’’), and section 342(c)             an opportunity for the public to
                                              the Board will contain the Vendor Risk                  of the Dodd-Frank Wall Street Reform                  comment on CMS’ intention to collect
                                              Management Offeror Questionnaire (FR
                                                                                                      and Consumer Protection Act (‘‘Dodd-                  information from the public. Under the
                                              1400C). The questionnaire will be
                                                                                                      Frank’’). Sections 10(3) and 11 of the                Paperwork Reduction Act of 1995 (the
                                              specific to the security controls
                                                                                                      FRA (12 U.S.C. 243 and 248(l)) grant the              PRA), federal agencies are required to
                                              surrounding the vendor’s proposed
                                                                                                      Board full authority to manage its                    publish notice in the Federal Register
                                              application that will be used to process,
                                                                                                      buildings and its staff. Section 10(4) of             concerning each proposed collection of
                                              store, or transmit the data. Security
                                                                                                      the FRA (12 U.S.C. 244) authorizes the                information (including each proposed
                                              controls will be defined and prioritized
                                                                                                      Board to determine and prescribe the                  extension or reinstatement of an existing
                                              based on the Federal Information
                                                                                                      manner in which its obligations shall be              collection of information) and to allow
                                              Security Modernization Act of 2014
                                                                                                      incurred and its disbursements and                    60 days for public comment on the
                                              (FISMA) and the National Institute of
                                              Standards and Technology (NIST)                         expenses allowed and paid. Therefore,                 proposed action. Interested persons are
                                              Special Publication 800–53 (Security                    the Board can solicit proposals and seek              invited to send comments regarding our
                                              Controls and Assessment Procedures for                                                                        burden estimates or any other aspect of
                                                                                                      the information in FR 1400 from
                                              Federal Information Systems and                                                                               this collection of information, including
                                                                                                      prospective vendors.
                                              Organizations). In addition, for                                                                              the necessity and utility of the proposed
                                                                                                        Additionally, the FR 1400 is                        information collection for the proper
                                              solicitations that have subcontracting
                                                                                                      authorized by section 342(c) of Dodd-                 performance of the agency’s functions,
                                              opportunities and are expected to
                                              exceed $100,000 ($300,000 for                           Frank (12 U.S.C. 5452(c)), which                      the accuracy of the estimated burden,
                                              construction), a non-covered company                    requires the Board to develop and                     ways to enhance the quality, utility, and
                                              vendor is required to submit a                          implement standards and procedures for                clarity of the information to be
                                              subcontracting plan in its own format,                  the review and evaluation of contract                 collected, and the use of automated
                                              with its proposal. Then, if the vendor is               proposals and for hiring service                      collection techniques or other forms of
                                              the chosen vendor and awarded a                         providers that include a component that               information technology to minimize the
                                              contract, the vendor is required to                     gives consideration to the diversity of a             information collection burden.
                                              provide the quarterly Subcontracting                    prospective vendor and the fair                       DATES: Comments must be received by
                                              Reports (FR 1400D) to the Board, which                  inclusion of women and minorities in                  November 27, 2018.
                                              shall document the vendor’s                             the workforce of such vendor and any                  ADDRESSES: When commenting, please
                                              participation achievement on a                          subcontractor.                                        reference the document identifier or
                                              cumulative basis. Information from the                    A vendor generally may request                      OMB control number. To be assured
                                              Subcontracting Report is used to assist                                                                       consideration, comments and
                                                                                                      confidential treatment for information
                                              the Board in fulfilling the requirement                                                                       recommendations must be submitted in
                                                                                                      submitted during the solicitation
                                              in Section 342(e) of the Dodd-Frank Act                                                                       any one of the following ways:
                                                                                                      process, and the Board will review the                  1. Electronically. You may send your
                                              that requires the Board to submit to
                                              Congress an annual report regarding the                 request to determine if the data may be               comments electronically to http://
                                              fair inclusion of minorities and women                  kept confidential under exemption 4 of                www.regulations.gov. Follow the
                                              in contracting.                                         the Freedom of Information Act, which                 instructions for ‘‘Comment or
                                                 Proposed revisions: To assist the                    protects from disclosure trade secrets                Submission’’ or ‘‘More Search Options’’
                                              Board’s competitive vendor solicitation                 and commercial or financial information               to find the information collection
                                              process, the Board is proposing to revise               (5 U.S.C. 552(b)(4)).                                 document(s) that are accepting
                                              the FR 1400 by (1) reformatting and                       Board of Governors of the Federal Reserve           comments.
                                              updating the Solicitation Package,                      System, September 24, 2018.                             2. By regular mail. You may mail
                                              including the Solicitation, Offer, and                                                                        written comments to the following
                                                                                                      Michele Taylor Fennell,
                                              Award Form (SOA), Supplier                                                                                    address: CMS, Office of Strategic
                                              Information Form, Past Performance                      Assistant Secretary of the Board.                     Operations and Regulatory Affairs,
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                                              Data Sheet, and Past Performance                        [FR Doc. 2018–21126 Filed 9–27–18; 8:45 am]           Division of Regulations Development,
                                              Questionnaire (FR 1400B); (2) adding                    BILLING CODE 6210–01–P                                Attention: Document Identifier/OMB
                                              the Vendor Risk Management Offeror                                                                            Control Number ll, Room C4–26–05,
                                              Questionnaire (FR 1400C); and (3)                                                                             7500 Security Boulevard, Baltimore,
                                              revising the Subcontracting Report (FR                                                                        Maryland 21244–1850.
                                              1400D) to improve clarity and gather                                                                            To obtain copies of a supporting
                                              specific information in accordance with                                                                       statement and any related forms for the


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                                                                          Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices                                          49095

                                              proposed collection(s) summarized in                    the establishment of new Affordable                   involved fraud. Additionally, Fleming
                                              this notice, you may make your request                  Insurance Exchanges (Exchanges), also                 has demonstrated a pattern of conduct
                                              using one of following:                                 called Marketplaces, including the                    sufficient to find that there is reason to
                                                1. Access CMS’ website address at                     Small Business Health Options Program                 believe that he may violate requirements
                                              website address at https://www.cms.gov/                 (SHOP). Revised requirements                          under the FD&C Act relating to drug
                                              Regulations-and-Guidance/Legislation/                   pertaining to agents/brokers completing               products. In determining the
                                              PaperworkReductionActof1995/PRA-                        Federally-facilitated Exchange (FFE)                  appropriateness and period of Fleming’s
                                              Listing.html.                                           registration are discussed in the final               debarment, FDA considered the relevant
                                                2. Email your request, including your                 rule published on February 27, 2015 for               factors listed in the FD&C Act. Fleming
                                              address, phone number, OMB number,                      the Patient Protection and Affordable                 failed to file with the Agency
                                              and CMS document identifier, to                         Care Act; HHS Notice of Benefit and                   information and analyses sufficient to
                                              Paperwork@cms.hhs.gov.                                  Payment Parameters for 2016 (CMS–                     create a basis for a hearing concerning
                                                3. Call the Reports Clearance Office at               9944–F). These updated requirements                   this action.
                                              (410) 786–1326.                                         direct agents/brokers to submit                       DATES: The order is applicable
                                              FOR FURTHER INFORMATION CONTACT:                        additional fields related to basic contact            September 28, 2018.
                                              William Parham at (410) 786–1326.                       information and National Producer                     ADDRESSES: Any application for
                                              SUPPLEMENTARY INFORMATION:                              Number (NPN). Current state licensure                 termination of debarment by Fleming
                                                                                                      and relevant health lines of authority                under section 306(d) of the FD&C Act
                                              Contents                                                (LOA) are then validated using the                    (application) may be submitted as
                                                This notice sets out a summary of the                 National Insurance Producer Registry                  follows:
                                              use and burden associated with the                      (NIPR) database. This ICR serves as the
                                              following information collections. More                 formal request for renewal and also                   Electronic Submissions
                                              detailed information can be found in                    includes some of the information                         • Federal eRulemaking Portal:
                                              each collection’s supporting statement                  collection requirements from the                      https://www.regulations.gov. Follow the
                                              and associated materials (see                           previously approved final rule. Form                  instructions for submitting comments.
                                              ADDRESSES).                                             Number: CMS–10464 (OMB control                        An application submitted electronically,
                                              CMS–10464 Agent/Broker Data                             number: 0938–1204); Frequency:                        including attachments, to https://
                                              Collection in Federally Facilitated                     Annually; Affected Public: Private                    www.regulations.gov will be posted to
                                              Health Insurance Exchanges                              Sector (Business or other for-profits);               the docket unchanged. Because your
                                                                                                      Number of Respondents: 52,000;                        application will be made public, you are
                                                Under the PRA (44 U.S.C. 3501–                        Number of Responses: 52,000; Total                    solely responsible for ensuring that your
                                              3520), federal agencies must obtain                     Annual Hours: 12,480. (For questions                  application does not include any
                                              approval from the Office of Management                  regarding this collection contact                     confidential information that you or a
                                              and Budget (OMB) for each collection of                 Madeline Pellish at 301–492–4390.)                    third party may not wish to be posted,
                                              information they conduct or sponsor.                                                                          such as medical information, your or
                                                                                                         Dated: September 25, 2018.
                                              The term ‘‘collection of information’’ is                                                                     anyone else’s Social Security number, or
                                              defined in 44 U.S.C. 3502(3) and 5 CFR                  William N. Parham, III,
                                                                                                      Director, Paperwork Reduction Staff, Office
                                                                                                                                                            confidential business information, such
                                              1320.3(c) and includes agency requests                                                                        as a manufacturing process. Please note
                                              or requirements that members of the                     of Strategic Operations and Regulatory
                                                                                                      Affairs.                                              that if you include your name, contact
                                              public submit reports, keep records, or                                                                       information, or other information that
                                                                                                      [FR Doc. 2018–21171 Filed 9–27–18; 8:45 am]
                                              provide information to a third party.                                                                         identifies you in the body of your
                                              Section 3506(c)(2)(A) of the PRA                        BILLING CODE 4120–01–P
                                                                                                                                                            application, that information will be
                                              requires federal agencies to publish a                                                                        posted on https://www.regulations.gov.
                                              60-day notice in the Federal Register                                                                            • If you want to submit an
                                                                                                      DEPARTMENT OF HEALTH AND
                                              concerning each proposed collection of                                                                        application with confidential
                                                                                                      HUMAN SERVICES
                                              information, including each proposed                                                                          information that you do not wish to be
                                              extension or reinstatement of an existing               Food and Drug Administration                          made available to the public, submit the
                                              collection of information, before                                                                             application as a written/paper
                                              submitting the collection to OMB for                    [Docket No. FDA–2013–N–0333]
                                                                                                                                                            submission and in the manner detailed
                                              approval. To comply with this                                                                                 (see ‘‘Written/Paper Submissions’’ and
                                                                                                      Richard M. Fleming; Denial of Hearing;
                                              requirement, CMS is publishing this                                                                           ’’Instructions’’).
                                                                                                      Final Debarment Order
                                              notice.
                                                                                                      AGENCY:    Food and Drug Administration,              Written/Paper Submissions
                                              Information Collection
                                                                                                      HHS.                                                    Submit written/paper submissions as
                                                1. Title of Information Collection:                   ACTION:   Notice.                                     follows:
                                              Agent/Broker Data Collection in                                                                                 • Mail/Hand delivery/Courier (for
                                              Federally Facilitated Health Insurance                  SUMMARY:   The Food and Drug                          written/paper submissions): Dockets
                                              Exchanges; Type of Information                          Administration (FDA or the Agency) is                 Management Staff (HFA–305), Food and
                                              Collection Request: Revision of a                       denying a request for a hearing                       Drug Administration, 5630 Fishers
                                              currently approved collection; Use: The                 submitted by Richard M. Fleming                       Lane, Rm. 1061, Rockville, MD 20852.
                                              Patient Protection and Affordable Care                  (Fleming) and is issuing an order under                 • For a written/paper application
                                              Act, Public Law 111–148, enacted on                     the Federal Food, Drug, and Cosmetic                  submitted to the Dockets Management
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                                              March 23, 2010, and the Health Care                     Act (FD&C Act) debarring Fleming for                  Staff, FDA will post your application, as
                                              and Education Reconciliation Act,                       10 years from providing services in any               well as any attachments, except for
                                              Public Law 111–152, enacted on March                    capacity to a person that has an                      information submitted, marked and
                                              30, 2010 (collectively, ‘‘Affordable Care               approved or pending drug product                      identified, as confidential, if submitted
                                              Act’’), expands access to health                        application. FDA bases this order on a                as detailed in ‘‘Instructions.’’
                                              insurance for individuals and                           finding that Fleming was convicted of                   Instructions: Your application must
                                              employees of small businesses through                   two felonies under Federal law that                   include the Docket No. FDA–2013–N–


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Document Created: 2018-09-28 01:22:38
Document Modified: 2018-09-28 01:22:38
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 November 27, 2018.
ContactWilliam Parham at (410) 786-1326.
FR Citation83 FR 49094 

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