81_FR_44999 81 FR 44867 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

81 FR 44867 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

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

Federal Register Volume 81, Issue 132 (July 11, 2016)

Page Range44867-44867
FR Document2016-16221

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 a 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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Federal Register, Volume 81 Issue 132 (Monday, July 11, 2016)
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Page 44867]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16221]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-367]


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

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 (PRA), federal agencies are required to publish a 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 any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) 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 August 10, 2016:

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 http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.

SUPPLEMENTARY INFORMATION: 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: Medicaid Drug 
Program--Monthly and Quarterly Drug Reporting Format; Use: Labelers 
transmit drug product and pricing data to CMS within 30 days after the 
end of each calendar month and quarter. CMS calculates the unit rebate 
amount (URA) and the unit rebate offset amount (UROA) for each new drug 
application (NDC) and distributes to all State Medicaid agencies. 
States use the URA to invoice the labeler for rebates and the UROA to 
report onto the CMS-64. The monthly data is used to calculate Federal 
Upper Limit (FUL) prices for applicable drugs and for states that opt 
to use this data to establish their pharmacy reimbursement methodology. 
Form Number: CMS-367 (OMB control number: 0938-0578); Frequency: 
Monthly and Quarterly; Affected Public: Private sector (Business or 
other for-profits); Number of Respondents: 610; Total Annual Responses: 
12,810; Total Annual Hours: 3,618,703. (For policy questions regarding 
this collection contact Samone Angel at 410-786-1123.)

    Dated: July 5, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-16221 Filed 7-8-16; 8:45 am]
 BILLING CODE 4120-01-P



                                                                                   Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices                                                                    44867

                                                Potential products include scientific                              There are no costs to the respondents
                                                abstracts and manuscripts,                                       other than their time. The total
                                                presentations, and guidance documents.                           estimated annual burden hours are 134.

                                                                                                                ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                         Average
                                                                                                                                                                                                     Number of
                                                                                                                                                                                    Number of                          burden per
                                                      Type of respondents                                                    Form name                                                             responses per
                                                                                                                                                                                   respondents                          response
                                                                                                                                                                                                     respondent         (in hours)

                                                General Public ........................    Introductory Survey ................................................................             250                  1               20/60
                                                                                           Follow-up survey ....................................................................            250                 12                1/60



                                                Jeffrey M. Zirger,                                               ADDRESSES:   When commenting on the                                the following proposed collection(s) of
                                                Health Scientist, Acting Chief, Information                      proposed information collections,                                  information for public comment:
                                                Collection Review Office, Office of Scientific                   please reference the document identifier
                                                Integrity, Office of the Associate Director for
                                                                                                                                                                                       1. Type of Information Collection
                                                                                                                 or OMB control number. To be assured                               Request: Revision of a currently
                                                Science, Office of the Director, Centers for                     consideration, comments and
                                                Disease Control and Prevention.                                                                                                     approved collection; Title of
                                                                                                                 recommendations must be received by
                                                [FR Doc. 2016–16298 Filed 7–8–16; 8:45 am]                                                                                          Information Collection: Medicaid Drug
                                                                                                                 the OMB desk officer via one of the
                                                                                                                                                                                    Program—Monthly and Quarterly Drug
                                                BILLING CODE 4163–18–P                                           following transmissions: OMB, Office of
                                                                                                                 Information and Regulatory Affairs,                                Reporting Format; Use: Labelers
                                                                                                                 Attention: CMS Desk Officer, Fax                                   transmit drug product and pricing data
                                                DEPARTMENT OF HEALTH AND                                         Number: (202) 395–5806 or, Email:                                  to CMS within 30 days after the end of
                                                HUMAN SERVICES                                                   OIRA_submission@omb.eop.gov.                                       each calendar month and quarter. CMS
                                                                                                                   To obtain copies of a supporting                                 calculates the unit rebate amount (URA)
                                                Centers for Medicare & Medicaid                                                                                                     and the unit rebate offset amount
                                                Services                                                         statement and any related forms for the
                                                                                                                 proposed collection(s) summarized in                               (UROA) for each new drug application
                                                [Document Identifier: CMS–367]                                   this notice, you may make your request                             (NDC) and distributes to all State
                                                                                                                 using one of following:                                            Medicaid agencies. States use the URA
                                                Agency Information Collection                                                                                                       to invoice the labeler for rebates and the
                                                                                                                   1. Access CMS’ Web site address at
                                                Activities: Submission for OMB                                                                                                      UROA to report onto the CMS–64. The
                                                                                                                 http://www.cms.hhs.gov/Paperwork
                                                Review; Comment Request                                                                                                             monthly data is used to calculate
                                                                                                                 ReductionActof1995.
                                                ACTION:    Notice.                                                 2. Email your request, including your                            Federal Upper Limit (FUL) prices for
                                                                                                                 address, phone number, OMB number,                                 applicable drugs and for states that opt
                                                SUMMARY:    The Centers for Medicare &                           and CMS document identifier, to                                    to use this data to establish their
                                                Medicaid Services (CMS) is announcing                            Paperwork@cms.hhs.gov.                                             pharmacy reimbursement methodology.
                                                an opportunity for the public to                                   3. Call the Reports Clearance Office at                          Form Number: CMS–367 (OMB control
                                                comment on CMS’ intention to collect                             (410) 786–1326.                                                    number: 0938–0578); Frequency:
                                                information from the public. Under the                                                                                              Monthly and Quarterly; Affected Public:
                                                Paperwork Reduction Act of 1995                                  FOR FURTHER INFORMATION CONTACT:
                                                                                                                 Reports Clearance Office at (410) 786–                             Private sector (Business or other for-
                                                (PRA), federal agencies are required to                                                                                             profits); Number of Respondents: 610;
                                                publish a notice in the Federal Register                         1326.
                                                                                                                                                                                    Total Annual Responses: 12,810; Total
                                                concerning each proposed collection of                           SUPPLEMENTARY INFORMATION:     Under the                           Annual Hours: 3,618,703. (For policy
                                                information, including each proposed                             Paperwork Reduction Act of 1995 (PRA)                              questions regarding this collection
                                                extension or reinstatement of an existing                        (44 U.S.C. 3501–3520), federal agencies                            contact Samone Angel at 410–786–
                                                collection of information, and to allow                          must obtain approval from the Office of                            1123.)
                                                a second opportunity for public                                  Management and Budget (OMB) for each
                                                comment on the notice. Interested                                collection of information they conduct                                Dated: July 5, 2016.
                                                persons are invited to send comments                             or sponsor. The term ‘‘collection of                               William N. Parham, III,
                                                regarding the burden estimate or any                             information’’ is defined in 44 U.S.C.                              Director, Paperwork Reduction Staff, Office
                                                other aspect of this collection of                               3502(3) and 5 CFR 1320.3(c) and                                    of Strategic Operations and Regulatory
                                                information, including any of the                                includes agency requests or                                        Affairs.
                                                following subjects: (1) The necessity and                        requirements that members of the public                            [FR Doc. 2016–16221 Filed 7–8–16; 8:45 am]
                                                utility of the proposed information                              submit reports, keep records, or provide                           BILLING CODE 4120–01–P
                                                collection for the proper performance of                         information to a third party. Section
                                                the agency’s functions; (2) the accuracy                         3506(c)(2)(A) of the PRA (44 U.S.C.
                                                of the estimated burden; (3) ways to                             3506(c)(2)(A)) requires federal agencies
                                                enhance the quality, utility, and clarity                        to publish a 30-day notice in the
                                                of the information to be collected; and                          Federal Register concerning each
sradovich on DSK3GDR082PROD with NOTICES




                                                (4) the use of automated collection                              proposed collection of information,
                                                techniques or other forms of information                         including each proposed extension or
                                                technology to minimize the information                           reinstatement of an existing collection
                                                collection burden.                                               of information, before submitting the
                                                DATES: Comments on the collection(s) of                          collection to OMB for approval. To
                                                information must be received by the                              comply with this requirement, CMS is
                                                OMB desk officer by August 10, 2016:                             publishing this notice that summarizes


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Document Created: 2016-07-09 00:21:34
Document Modified: 2016-07-09 00:21:34
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 August 10, 2016:
ContactReports Clearance Office at (410) 786- 1326.
FR Citation81 FR 44867 

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