80_FR_25019 80 FR 24935 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

80 FR 24935 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

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

Federal Register Volume 80, Issue 84 (May 1, 2015)

Page Range24935-24936
FR Document2015-10207

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 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 80 Issue 84 (Friday, May 1, 2015)
[Federal Register Volume 80, Number 84 (Friday, May 1, 2015)]
[Notices]
[Pages 24935-24936]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10207]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10500 and CMS-R-306]


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 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 June 1, 2015.

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: Consumer 
Assessment of Healthcare Providers and Systems Outpatient and 
Ambulatory Surgery (OAS CAHPS) Survey; Use: The information collected 
in the national implementation of Outpatient/Ambulatory Surgery Patient 
Experience of Care Survey (A/ASPECS) will be used to: (1) Provide a 
source of information from which selected measures can be publicly 
reported to beneficiaries to help them make informed decisions for 
outpatient surgery facility selection; (2) aid facilities with their 
internal quality improvement efforts and external benchmarking with 
other facilities; and (3) provide us with information for monitoring 
and public reporting purposes. The package has been revised subsequent 
to the publication of the 60-day Federal Register notice (January 16, 
2015; 80 FR 2430). Previously, the package was entitled, ``Outpatient/
Ambulatory Surgery Patient Experience of Care Survey (O/ASPECS).'' Form 
Number: CMS-10500 (OMB Control Number: 0938-1240); Frequency: Once; 
Affected Public: Individuals and households; Number of Respondents: 
2,813,610; Total Annual Responses: 2,813,610; Total Annual Hours: 
365,769. (For policy questions regarding this

[[Page 24936]]

collection contact Memuna Ifedirah at 410-786-6849).
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Use of Restraint 
and Seclusion in Psychiatric Residential Treatment Facilities (PRTFs) 
for Individuals Under Age 21 and Supporting Regulations; Use: 
Psychiatric residential treatment facilities are required to report 
deaths, serious injuries and attempted suicides to the State Medicaid 
Agency and the Protection and Advocacy Organization. They are also 
required to provide residents the restraint and seclusion policy in 
writing, and to document in the residents' records all activities 
involving the use of restraint and seclusion. Form Number: CMS-R-306 
(OMB Control Number 0938-0833); Frequency: Occasionally; Affected 
Public: Private sector (Business or other for-profits); Number of 
Respondents: 390; Total Annual Responses: 1,466,795; Total Annual 
Hours: 431,062. (For policy questions regarding this collection contact 
Cindy Ruff at 410-786-5916).

    Dated: April 28, 2015.
William N. Parham III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2015-10207 Filed 4-30-15; 8:45 am]
 BILLING CODE 4120-01-P



                                                                                    Federal Register / Vol. 80, No. 84 / Friday, May 1, 2015 / Notices                                            24935

                                                  and collected at the Contract-level or                  DEPARTMENT OF HEALTH AND                              and CMS document identifier, to
                                                  Plan-level: (1) Enrollment and                          HUMAN SERVICES                                        Paperwork@cms.hhs.gov.
                                                  disenrollment, (2) retail, home infusion,                                                                        3. Call the Reports Clearance Office at
                                                  and long-term care pharmacy access, (3)                 Centers for Medicare & Medicaid                       (410) 786–1326.
                                                  medication therapy management                           Services                                              FOR FURTHER INFORMATION CONTACT:
                                                  programs, (4) grievances, (5) coverage                                                                        Reports Clearance Office at (410) 786–
                                                                                                          [Document Identifiers: CMS–10500 and
                                                  determinations and redeterminations,                                                                          1326.
                                                                                                          CMS–R–306]
                                                  (6) long term care utilization, (7)                                                                           SUPPLEMENTARY INFORMATION: Under the
                                                  employer/union sponsored sponsors,                      Agency Information Collection                         Paperwork Reduction Act of 1995 (PRA)
                                                  and (8) plan oversight of agents. Form                  Activities: Submission for OMB                        (44 U.S.C. 3501–3520), federal agencies
                                                  Number: CMS–10185 (OMB control                          Review; Comment Request                               must obtain approval from the Office of
                                                  number 0938–0992); Frequency: Yearly                                                                          Management and Budget (OMB) for each
                                                  and semi-annually; Affected Public:                     ACTION:   Notice.                                     collection of information they conduct
                                                  Private sector (Business or other for-                                                                        or sponsor. The term ‘‘collection of
                                                                                                          SUMMARY:    The Centers for Medicare &
                                                  profits); Number of Respondents: 694;                                                                         information’’ is defined in 44 U.S.C.
                                                                                                          Medicaid Services (CMS) is announcing
                                                  Total Annual Responses: 6,875; Total                                                                          3502(3) and 5 CFR 1320.3(c) and
                                                                                                          an opportunity for the public to
                                                  Annual Hours: 10,865. (For policy                                                                             includes agency requests or
                                                                                                          comment on CMS’ intention to collect
                                                  questions regarding this collection                                                                           requirements that members of the public
                                                                                                          information from the public. Under the
                                                  contact Chanelle Jones at 410–786–                                                                            submit reports, keep records, or provide
                                                                                                          Paperwork Reduction Act of 1995
                                                                                                                                                                information to a third party. Section
                                                  8008).                                                  (PRA), federal agencies are required to
                                                                                                                                                                3506(c)(2)(A) of the PRA (44 U.S.C.
                                                    3. Type of Information Collection                     publish notice in the Federal Register
                                                                                                                                                                3506(c)(2)(A)) requires federal agencies
                                                  Request: Revision of a currently                        concerning each proposed collection of
                                                                                                                                                                to publish a 30-day notice in the
                                                  approved collection; Title of                           information, including each proposed
                                                                                                                                                                Federal Register concerning each
                                                  Information Collection: Skilled Nursing                 extension or reinstatement of an existing
                                                                                                                                                                proposed collection of information,
                                                  Facility and Skilled Nursing Facility                   collection of information, and to allow
                                                                                                                                                                including each proposed extension or
                                                                                                          a second opportunity for public
                                                  Health Care Complex Cost Report Form;                                                                         reinstatement of an existing collection
                                                                                                          comment on the notice. Interested
                                                  Use: Providers of services participating                                                                      of information, before submitting the
                                                                                                          persons are invited to send comments
                                                  in the Medicare program are required                                                                          collection to OMB for approval. To
                                                                                                          regarding the burden estimate or any
                                                  under sections 1815(a), 1833(e) and                                                                           comply with this requirement, CMS is
                                                                                                          other aspect of this collection of
                                                  1861(v)(1)(A) of the Social Security Act                                                                      publishing this notice that summarizes
                                                                                                          information, including any of the
                                                  (42 U.S.C. 1395g) to submit annual                                                                            the following proposed collection(s) of
                                                                                                          following subjects: (1) The necessity and
                                                  information to achieve settlement of                                                                          information for public comment:
                                                                                                          utility of the proposed information                      1. Type of Information Collection
                                                  costs for health care services rendered to              collection for the proper performance of
                                                  Medicare beneficiaries. In addition,                                                                          Request: Revision of a currently
                                                                                                          the agency’s functions; (2) the accuracy              approved collection; Title of
                                                  regulations at 42 CFR 413.20 and 413.24                 of the estimated burden; (3) ways to                  Information Collection: Consumer
                                                  require adequate cost data and cost                     enhance the quality, utility, and clarity             Assessment of Healthcare Providers and
                                                  reports from providers on an annual                     of the information to be collected; and               Systems Outpatient and Ambulatory
                                                  basis. The Form CMS–2540–10 cost                        (4) the use of automated collection                   Surgery (OAS CAHPS) Survey; Use: The
                                                  report is needed to determine a                         techniques or other forms of information              information collected in the national
                                                  provider’s reasonable cost incurred in                  technology to minimize the information                implementation of Outpatient/
                                                  furnishing medical services to Medicare                 collection burden.                                    Ambulatory Surgery Patient Experience
                                                  beneficiaries and reimbursement due to                  DATES: Comments on the collection(s) of               of Care Survey (A/ASPECS) will be used
                                                  or from a provider. The revisions made                  information must be received by the                   to: (1) Provide a source of information
                                                  to the SNF cost report are in accordance                OMB desk officer by June 1, 2015.                     from which selected measures can be
                                                  with the statutory requirement for                      ADDRESSES: When commenting on the                     publicly reported to beneficiaries to
                                                  hospice payment reform in § 3132 of the                 proposed information collections,                     help them make informed decisions for
                                                  Patient Protection and Affordable Care                  please reference the document identifier              outpatient surgery facility selection; (2)
                                                  Act (ACA). Form Number: CMS–2540–                       or OMB control number. To be assured                  aid facilities with their internal quality
                                                  10 (OMB control number 0938–0463);                      consideration, comments and                           improvement efforts and external
                                                  Frequency: Annually; Affected Public:                   recommendations must be received by                   benchmarking with other facilities; and
                                                  Private sector (Business or other for-                  the OMB desk officer via one of the                   (3) provide us with information for
                                                  profits and Not-for-profit institutions);               following transmissions:                              monitoring and public reporting
                                                  Number of Respondents: 14,398; Total                       OMB, Office of Information and                     purposes. The package has been revised
                                                  Annual Responses: 14,398; Total                         Regulatory Affairs, Attention: CMS Desk               subsequent to the publication of the 60-
                                                  Annual Hours: 2,908,396. (For policy                    Officer, Fax Number: (202) 395–5806 or                day Federal Register notice (January 16,
                                                  questions regarding this collection                     Email: OIRA_submission@omb.eop.gov.                   2015; 80 FR 2430). Previously, the
                                                  contact Amelia Citerone at 410–786–                        To obtain copies of a supporting                   package was entitled, ‘‘Outpatient/
                                                  8008).                                                  statement and any related forms for the               Ambulatory Surgery Patient Experience
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                                                                                                          proposed collection(s) summarized in                  of Care Survey (O/ASPECS).’’ Form
                                                     Dated: April 28, 2015.
                                                                                                          this notice, you may make your request                Number: CMS–10500 (OMB Control
                                                  William N. Parham III,                                  using one of following:                               Number: 0938–1240); Frequency: Once;
                                                  Director, Paperwork Reduction Staff, Office                1. Access CMS’ Web site address at                 Affected Public: Individuals and
                                                  of Strategic Operations and Regulatory                  http://www.cms.hhs.gov/                               households; Number of Respondents:
                                                  Affairs.                                                PaperworkReductionActof1995.                          2,813,610; Total Annual Responses:
                                                  [FR Doc. 2015–10208 Filed 4–30–15; 8:45 am]                2. Email your request, including your              2,813,610; Total Annual Hours: 365,769.
                                                  BILLING CODE 4120–01–P                                  address, phone number, OMB number,                    (For policy questions regarding this


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                                                  24936                             Federal Register / Vol. 80, No. 84 / Friday, May 1, 2015 / Notices

                                                  collection contact Memuna Ifedirah at                      ORI found by a preponderance of the                optimal fluoride concentration of 0.7
                                                  410–786–6849).                                          evidence that the Respondent                          milligrams/liter (mg/L). In this
                                                    2. Type of Information Collection                     intentionally and knowingly engaged in                guidance, the optimal concentration of
                                                  Request: Extension of a currently                       research misconduct by falsifying and/                fluoride in drinking water is the
                                                  approved collection; Title of                           or fabricating data that was provided to              concentration that provides the best
                                                  Information Collection: Use of Restraint                his mentor to include in grant                        balance of protection from dental caries
                                                  and Seclusion in Psychiatric Residential                application R01 GM095559–01A1                         while limiting the risk of dental
                                                  Treatment Facilities (PRTFs) for                        submitted to NIGMS, NIH, to obtain                    fluorosis. The earlier PHS
                                                  Individuals Under Age 21 and                            U.S. Public Health Service (PHS) funds.               recommendation for fluoride
                                                  Supporting Regulations; Use:                            Specifically, ORI found that the                      concentrations was based on outdoor air
                                                  Psychiatric residential treatment                       Respondent falsified data included in                 temperature of geographic areas and
                                                  facilities are required to report deaths,               Figures 4, 9, 11, 15, and 25 in R01                   ranged from 0.7–1.2 mg/L. This updated
                                                  serious injuries and attempted suicides                 GM095559–01A1 for enantiomeric                        guidance is intended to apply to
                                                  to the State Medicaid Agency and the                    excess (‘‘ee’’) to falsely show a high                community water systems that currently
                                                  Protection and Advocacy Organization.                   degree of selectivity for one enantiomer              fluoridate or that will initiate
                                                  They are also required to provide                       over another by a cut-and-paste method                fluoridation, and is based on
                                                  residents the restraint and seclusion                   and manipulation of the instrument to                 considerations that include:
                                                  policy in writing, and to document in                   give the desired result. Respondent also                 • Scientific evidence related to the
                                                  the residents’ records all activities                   falsified the underlying nuclear                      effectiveness of water fluoridation in
                                                  involving the use of restraint and                      magnetic resonance spectroscopy (NMR)                 caries prevention and control across all
                                                  seclusion. Form Number: CMS–R–306                       data for Compound 22 reported in                      age groups,
                                                  (OMB Control Number 0938–0833);                         Figure 15 in R01 GM095559–01A1 by a                      • Fluoride in drinking water as one of
                                                  Frequency: Occasionally; Affected                       cut-and-paste method to manipulate the                several available fluoride sources,
                                                  Public: Private sector (Business or other               NMR spectra and give the desired result.                 • Trends in the prevalence and
                                                  for-profits); Number of Respondents:                       Dr. Reddy has been debarred by the                 severity of dental fluorosis, and
                                                  390; Total Annual Responses:                            Federal agency with joint jurisdiction                   • Current evidence on fluid intake of
                                                  1,466,795; Total Annual Hours: 431,062.                 for a period of five (5) years, ending on             children across various outdoor air
                                                  (For policy questions regarding this                    August 26, 2018. ORI has implemented                  temperatures.
                                                  collection contact Cindy Ruff at 410–                   the following administrative action to                FOR FURTHER INFORMATION CONTACT:
                                                  786–5916).                                              coincide with the government-wide                     Barbara F. Gooch, DMD, MPH, Centers
                                                     Dated: April 28, 2015.                               debarment:                                            for Disease Control and Prevention,
                                                                                                             (1) Respondent is prohibited from                  National Center for Chronic Disease
                                                  William N. Parham III,
                                                                                                          serving in any advisory capacity to PHS               Prevention and Health Promotion,
                                                  Director, Paperwork Reduction Staff, Office
                                                                                                          including, but not limited to, service on             Division of Oral Health, 4770 Buford
                                                  of Strategic Operations and Regulatory
                                                  Affairs.                                                any PHS advisory committee, board,                    Highway NE., MS F–80, Atlanta, GA
                                                                                                          and/or peer review committee, or as a                 30341–3717; tel. 770–488–6054; fax
                                                  [FR Doc. 2015–10207 Filed 4–30–15; 8:45 am]
                                                                                                          consultant.                                           770–488–6080; email <BGooch@
                                                  BILLING CODE 4120–01–P
                                                                                                          FOR FURTHER INFORMATION CONTACT:                      cdc.gov>.
                                                                                                          Acting Director, Office of Research                   SUPPLEMENTARY INFORMATION: Because
                                                  DEPARTMENT OF HEALTH AND                                Integrity, 1101 Wootton Parkway, Suite                fluoridation of public drinking water
                                                  HUMAN SERVICES                                          750, Rockville, MD 20852, (240) 453–                  systems had been demonstrated as
                                                                                                          8800.                                                 effective in reducing dental caries, the
                                                  Findings of Research Misconduct                                                                               U.S. Public Health Service (PHS)
                                                                                                          Donald Wright,
                                                  AGENCY: Office of the Secretary, HHS.                                                                         provided recommendations regarding
                                                                                                          Acting Director, Office of Research Integrity.
                                                  ACTION: Notice.                                                                                               optimal fluoride concentrations in
                                                                                                          [FR Doc. 2015–10203 Filed 4–30–15; 8:45 am]
                                                                                                                                                                drinking water for community water
                                                                                                          BILLING CODE 4150–31–P
                                                  SUMMARY:   Notice is hereby given that                                                                        systems in 1962 (U.S. DHEW, 1962).
                                                  the Office of Research Integrity (ORI)                                                                        The U.S. Department of Health and
                                                  has taken final action in the following                                                                       Human Services (HHS) is releasing this
                                                                                                          DEPARTMENT OF HEALTH AND
                                                  case:                                                                                                         updated PHS recommendation because
                                                    Venkata J. Reddy, University of                       HUMAN SERVICES
                                                                                                                                                                of new data that address changes in the
                                                  Minnesota: Based upon the evidence                      Public Health Service                                 prevalence of dental fluorosis, the
                                                  and findings of an investigation report                 Recommendation for Fluoride                           relationship between water intake and
                                                  by the University of Minnesota (UMN),                   Concentration in Drinking Water for                   outdoor temperature in children, and
                                                  an investigation conducted by another                   Prevention of Dental Caries                           the contribution of fluoride in drinking
                                                  Federal agency, and additional                                                                                water to total fluoride exposure in the
                                                  information obtained by the Office of                   AGENCY:  Office of the Secretary, HHS.                United States. Although PHS
                                                  Research Integrity (ORI) during its                     SUMMARY:  Through this final                          recommends community water
                                                  oversight review of the UMN                             recommendation, the U.S. Public Health                fluoridation as an effective public health
                                                  investigation, ORI found that Mr.                       Service (PHS) updates and replaces its                intervention, the decision to fluoridate
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  Venkata J. Reddy, former Graduate                       1962 Drinking Water Standards related                 water systems is made by state and local
                                                  Student, Department of Chemistry,                       to community water fluoridation—the                   governments.
                                                  UMN, engaged in research misconduct                     controlled addition of a fluoride                        As of December 31, 2012, the Centers
                                                  in research that was included in grant                  compound to a community water                         for Disease Control and Prevention
                                                  application R01 GM095559–01A1,                          supply to achieve a concentration                     (CDC) estimated that approximately 200
                                                  submitted to the National Institute of                  optimal for dental caries prevention. For             million people in the United States were
                                                  General Medical Sciences (NIGMS),                       these community water systems that                    served by 12,341 community water
                                                  National Institutes of Health (NIH).                    add fluoride, PHS now recommends an                   systems that added fluoride to water or


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Document Created: 2018-02-21 10:21:03
Document Modified: 2018-02-21 10:21:03
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 June 1, 2015.
ContactReports Clearance Office at (410) 786- 1326.
FR Citation80 FR 24935 

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