82_FR_46436 82 FR 46245 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

82 FR 46245 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

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

Federal Register Volume 82, Issue 191 (October 4, 2017)

Page Range46245-46245
FR Document2017-21249

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 191 (Wednesday, October 4, 2017)
[Federal Register Volume 82, Number 191 (Wednesday, October 4, 2017)]
[Notices]
[Page 46245]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10110]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

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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 (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 a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate 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 on the collection(s) of information must be received by 
the OMB desk officer by November 3, 2017.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-5806 OR Email: 
[email protected].
    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 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: William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-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 that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Manufacturer 
Submission of Average Sales Prices (ASP) Data for Medicare Part B 
Drugs; Use: In accordance with Section 1847A of the Social Security Act 
(the Act), Medicare Part B covered drugs and biologicals not paid on a 
cost or prospective payment basis are paid based on the average sales 
price (ASP) of the drug or biological, beginning in Calendar Year (CY) 
2005. The ASP data reporting requirements are specified in Section 1927 
of the Act. The reported ASP data are used to establish the Medicare 
payment amounts. Form Number: CMS-10110 (OMB control number: 0938-
0921); Frequency: Quarterly; Affected Public: Business or other For-
profits; Number of Respondents: 180; Total Annual Responses: 720; Total 
Annual Hours: 9360. (For policy questions regarding this collection 
contact Felicia Eggleston at 410-786-9287.)

    Dated: September 28, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2017-21249 Filed 10-3-17; 8:45 am]
 BILLING CODE 4120-01-P



                                                                           Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Notices                                                 46245

                                                VOCs that affect outdoor air quality.                   DEPARTMENT OF HEALTH AND                                 2. Email your request, including your
                                                Consistent with the Green Guides, the                   HUMAN SERVICES                                        address, phone number, OMB number,
                                                order defines ‘‘trace level of emissions’’                                                                    and CMS document identifier, to
                                                for claims for a substance to mean that                 Centers for Medicare & Medicaid                       Paperwork@cms.hhs.gov.
                                                (1) emissions of the substance do not                   Services                                                 3. Call the Reports Clearance Office at
                                                result in inhalation concentrations of                  [Document Identifiers: CMS–10110]
                                                                                                                                                              (410) 786–1326.
                                                that substance higher than background                                                                         FOR FURTHER INFORMATION CONTACT:
                                                levels in the typical residential home;                 Agency Information Collection                         William Parham at (410) 786–4669.
                                                (2) emissions of the substance do not                   Activities: Submission for OMB                        SUPPLEMENTARY INFORMATION: Under the
                                                cause material harm that consumers                      Review; Comment Request                               Paperwork Reduction Act of 1995 (PRA)
                                                typically associate with that substance,                                                                      (44 U.S.C. 3501–3520), federal agencies
                                                                                                        AGENCY: Centers for Medicare &
                                                including harm to the environment or                                                                          must obtain approval from the Office of
                                                                                                        Medicaid Services, HHS.
                                                human health; and (3) the substance has                                                                       Management and Budget (OMB) for each
                                                                                                        ACTION: Notice.                                       collection of information they conduct
                                                not been added intentionally to the
                                                                                                        SUMMARY:    The Centers for Medicare &                or sponsor. The term ‘‘collection of
                                                covered product.
                                                                                                        Medicaid Services (CMS) is announcing                 information’’ is defined in 44 U.S.C.
                                                   Part III prohibits respondent from                   an opportunity for the public to                      3502(3) and 5 CFR 1320.3(c) and
                                                mispresenting the results of any tests or               comment on CMS’ intention to collect                  includes agency requests or
                                                studies, or from misrepresenting that                   information from the public. Under the                requirements that members of the public
                                                any product benefit is scientifically or                Paperwork Reduction Act of 1995                       submit reports, keep records, or provide
                                                clinically proven. Parts IV and V                       (PRA), federal agencies are required to               information to a third party. Section
                                                prohibit respondent from                                publish notice in the Federal Register                3506(c)(2)(A) of the PRA (44 U.S.C.
                                                misrepresenting certifications or failing               concerning each proposed collection of                3506(c)(2)(A)) requires federal agencies
                                                to adequately disclose a material                       information, including each proposed                  to publish a 30-day notice in the
                                                connection to a party making a                          extension or reinstatement of an existing             Federal Register concerning each
                                                representation, e.g., an endorser.                      collection of information, and to allow               proposed collection of information,
                                                                                                        a second opportunity for public                       including each proposed extension or
                                                   Parts VI through X are reporting and                                                                       reinstatement of an existing collection
                                                compliance provisions. Part VI                          comment on the notice. Interested
                                                                                                        persons are invited to send comments                  of information, before submitting the
                                                mandates that respondent acknowledge                                                                          collection to OMB for approval. To
                                                                                                        regarding the burden estimate or any
                                                receipt of the order, distribute the order                                                                    comply with this requirement, CMS is
                                                                                                        other aspect of this collection of
                                                to certain employees and agents, and                    information, including the necessity and              publishing this notice that summarizes
                                                secure acknowledgments from                             utility of the proposed information                   the following proposed collection(s) of
                                                recipients of the order. Part VII requires              collection for the proper performance of              information for public comment:
                                                that respondent submit compliance                       the agency’s functions, the accuracy of                  1. Type of Information Collection
                                                reports to the FTC within ninety (90)                   the estimated burden, ways to enhance                 Request: Revision of a currently
                                                days of the order’s issuance and submit                 the quality, utility, and clarity of the              approved collection; Title of
                                                additional reports when certain events                  information to be collected; and the use              Information Collection: Manufacturer
                                                occur. Part VIII requires that respondent               of automated collection techniques or                 Submission of Average Sales Prices
                                                create and retain certain records for five              other forms of information technology to              (ASP) Data for Medicare Part B Drugs;
                                                (5) years. Part IX provides for the FTC’s               minimize the information collection                   Use: In accordance with Section 1847A
                                                continued compliance monitoring of                      burden.                                               of the Social Security Act (the Act),
                                                respondent’s activity during the order’s                                                                      Medicare Part B covered drugs and
                                                                                                        DATES: Comments on the collection(s) of
                                                effective dates. Part X is a provision                                                                        biologicals not paid on a cost or
                                                                                                        information must be received by the                   prospective payment basis are paid
                                                ‘‘sunsetting’’ the order after twenty (20)              OMB desk officer by November 3, 2017.                 based on the average sales price (ASP)
                                                years, with certain exceptions.                         ADDRESSES: When commenting on the                     of the drug or biological, beginning in
                                                   The purpose of the analysis is to aid                proposed information collections,                     Calendar Year (CY) 2005. The ASP data
                                                public comment on the proposed order.                   please reference the document identifier              reporting requirements are specified in
                                                It is not intended to constitute an                     or OMB control number. To be assured                  Section 1927 of the Act. The reported
                                                official interpretation of the proposed                 consideration, comments and                           ASP data are used to establish the
                                                order or to modify its terms in any way.                recommendations must be received by                   Medicare payment amounts. Form
                                                                                                        the OMB desk officer via one of the                   Number: CMS–10110 (OMB control
                                                  By direction of the Commission.                       following transmissions: OMB, Office of               number: 0938–0921); Frequency:
                                                Donald S. Clark,                                        Information and Regulatory Affairs,                   Quarterly; Affected Public: Business or
                                                Secretary.                                              Attention: CMS Desk Officer, Fax                      other For-profits; Number of
                                                [FR Doc. 2017–21289 Filed 10–3–17; 8:45 am]             Number: (202) 395–5806 OR Email:                      Respondents: 180; Total Annual
                                                BILLING CODE 6750–01–P
                                                                                                        OIRA_submission@omb.eop.gov.                          Responses: 720; Total Annual Hours:
                                                                                                           To obtain copies of a supporting
                                                                                                                                                              9360. (For policy questions regarding
                                                                                                        statement and any related forms for the
                                                                                                                                                              this collection contact Felicia Eggleston
                                                                                                        proposed collection(s) summarized in
                                                                                                                                                              at 410–786–9287.)
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                                                                                                        this notice, you may make your request
                                                                                                        using one of following:                                  Dated: September 28, 2017.
                                                                                                           1. Access CMS’ Web site address at                 William N. Parham, III,
                                                                                                        Web site address at https://                          Director, Paperwork Reduction Staff, Office
                                                                                                        www.cms.gov/Regulations-and-                          of Strategic Operations and Regulatory
                                                                                                        Guidance/Legislation/                                 Affairs.
                                                                                                        PaperworkReductionActof1995/PRA-                      [FR Doc. 2017–21249 Filed 10–3–17; 8:45 am]
                                                                                                        Listing.html.                                         BILLING CODE 4120–01–P




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Document Created: 2018-10-25 09:53:29
Document Modified: 2018-10-25 09:53:29
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 on the collection(s) of information must be received by the OMB desk officer by November 3, 2017.
ContactWilliam Parham at (410) 786-4669.
FR Citation82 FR 46245 

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