80_FR_48476 80 FR 48321 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

80 FR 48321 - 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 155 (August 12, 2015)

Page Range48321-48322
FR Document2015-19837

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 155 (Wednesday, August 12, 2015)
[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48321-48322]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19837]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-2540-10]


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 September 11, 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

[[Page 48322]]

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: Skilled Nursing 
Facility and Skilled Nursing Facility Health Care Complex Cost Report 
Form; Use: Providers of services participating in the Medicare program 
are required under sections 1815(a), 1833(e) and 1861(v)(1)(A) of the 
Social Security Act (42 U.S.C. 1395g) to submit annual information to 
achieve settlement of costs for health care services rendered to 
Medicare beneficiaries. In addition, regulations at 42 CFR 413.20 and 
413.24 require adequate cost data and cost reports from providers on an 
annual basis. The Form CMS-2540-10 cost report is needed to determine a 
provider's reasonable cost incurred in furnishing medical services to 
Medicare beneficiaries and reimbursement due to or from a provider. The 
revisions made to the SNF cost report are in accordance with the 
statutory requirement for hospice payment reform in Sec.  3132 of the 
Patient Protection and Affordable Care Act (ACA). Form Number: CMS-
2540-10 (OMB control number 0938-0463); Frequency: Annually; Affected 
Public: Private sector (Business or other for-profits and Not-for-
profit institutions); Number of Respondents: 14,398; Total Annual 
Responses: 14,398; Total Annual Hours: 2,908,396. (For policy questions 
regarding this collection contact Amelia Citerone at 410-786-8008).

    Dated: August 7, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2015-19837 Filed 8-11-15; 8:45 am]
 BILLING CODE 4120-01-P



                                                                             Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices                                          48321

                                                  largely extends the transparency                        the HH face-to-face encounter for                     utility of the proposed information
                                                  reporting provisions set forth in section               Medicare purposes. Once completed by                  collection for the proper performance of
                                                  1311(e)(3) to non-grandfathered group                   the physician, the resulting progress                 the agency’s functions; (2) the accuracy
                                                  health plans (including large group and                 note or clinic note would be part of the              of the estimated burden; (3) ways to
                                                  self-insured health plans) and health                   medical record. The primary users of                  enhance the quality, utility, and clarity
                                                  insurance issuers offering group and                    these new clinical templates will be                  of the information to be collected; and
                                                  individual health insurance coverage                    physicians and/or allowed non-                        (4) the use of automated collection
                                                  (non-QHP issuers), the Departments                      physician practitioners (NPPs). The                   techniques or other forms of information
                                                  intend to propose other transparency                    templates will help users to capture the              technology to minimize the information
                                                  reporting requirements at a later time,                 necessary information needed to                       collection burden.
                                                  through a separate rulemaking                           complete the face-to-face encounter                   DATES: Comments on the collection(s) of
                                                  conducted by the Departments, for non-                  documentation. This will help                         information must be received by the
                                                  QHP issuers and non-grandfathered                       physicians and/or allowed NPPs comply                 OMB desk officer by September 11,
                                                  group health plans. Those proposed                      with Medicare policy requirements,                    2015.
                                                  reporting requirements may differ from                  thereby reducing the possibility of a
                                                  those prescribed in the HHS proposal                    home health claim not being paid                      ADDRESSES:   When commenting on the
                                                  under section 1311(e)(3), and will take                 because of failure to meet Medicare                   proposed information collections,
                                                  into account differences in markets,                    requirements. Form Number: CMS–                       please reference the document identifier
                                                  reporting requirements already in                       10564 (OMB control number: 0938–                      or OMB control number. To be assured
                                                  existence for non-QHPs (including                       New); Frequency: Occasionally;                        consideration, comments and
                                                  group health plans), and other relevant                 Affected Public: Private Sector (Business             recommendations must be received by
                                                  factors. The Departments also intend to                 or other For-profit and Not-for-profit                the OMB desk officer via one of the
                                                  streamline reporting under multiple                     institutions); Number of Respondents:                 following transmissions: OMB, Office of
                                                  reporting provisions and reduce                         2,926,420; Total Annual Responses:                    Information and Regulatory Affairs,
                                                  unnecessary duplication. The                            2,926,420; Total Annual Hours:                        Attention: CMS Desk Officer, Fax
                                                  Departments intend to implement any                     1,220,317. (For policy questions                      Number: (202) 395–5806 or Email:
                                                  transparency reporting requirements                     regarding this collection contact Kristal             OIRA_submission@omb.eop.gov.
                                                  applicable to non-QHP issuers and non-                  Vines at 410–786–0119).                                 To obtain copies of a supporting
                                                  grandfathered group health plans only                      Dated: August 7, 2015.
                                                                                                                                                                statement and any related forms for the
                                                  after notice and comment, and after                                                                           proposed collection(s) summarized in
                                                                                                          William N. Parham, III,
                                                  giving those issuers and plans sufficient                                                                     this notice, you may make your request
                                                                                                          Director, Paperwork Reduction Staff, Office
                                                  time, following the publication of final                                                                      using one of following:
                                                                                                          of Strategic Operations and Regulatory
                                                  rules, to come into compliance with                     Affairs.                                                1. Access CMS’ Web site address at
                                                  those requirements. Form Number:                                                                              http://www.cms.hhs.gov/Paperwork
                                                                                                          [FR Doc. 2015–19818 Filed 8–11–15; 8:45 am]
                                                  CMS–10572 (OMB control number:                                                                                ReductionActof1995.
                                                                                                          BILLING CODE 4120–01–P
                                                  0938–New); Frequency: Annually;                                                                                 2. Email your request, including your
                                                  Affected Public: Private Sector (Business                                                                     address, phone number, OMB number,
                                                  or other For-profit and Not-for-profit                  DEPARTMENT OF HEALTH AND                              and CMS document identifier, to
                                                  institutions); Number of Respondents:                   HUMAN SERVICES                                        Paperwork@cms.hhs.gov.
                                                  475; Total Annual Responses: 475; Total                                                                         3. Call the Reports Clearance Office at
                                                  Annual Hours: 16,150. (For policy                       Centers for Medicare & Medicaid                       (410) 786–1326.
                                                  questions regarding this collection                     Services                                              FOR FURTHER INFORMATION CONTACT:
                                                  contact Valisha Price at 301–492–4343).                 [Document Identifier: CMS–2540–10]                    Reports Clearance Office at (410) 786–
                                                     3. Type of Information Collection                                                                          1326.
                                                  Request: New collection (Request for a                  Agency Information Collection                         SUPPLEMENTARY INFORMATION:     Under the
                                                  new OMB control number); Title of                       Activities: Submission for OMB                        Paperwork Reduction Act of 1995 (PRA)
                                                  Information Collection: Home Health                     Review; Comment Request                               (44 U.S.C. 3501–3520), federal agencies
                                                  Face-to-Face Encounter Clinical                         ACTION:   Notice.                                     must obtain approval from the Office of
                                                  Templates; Use: The Centers for                                                                               Management and Budget (OMB) for each
                                                  Medicare & Medicare Services (CMS) is                   SUMMARY:   The Centers for Medicare &                 collection of information they conduct
                                                  requesting the Office of Management                     Medicaid Services (CMS) is announcing                 or sponsor. The term ‘‘collection of
                                                  and Budget (OMB) approval of the                        an opportunity for the public to                      information’’ is defined in 44 U.S.C.
                                                  collection of data required to support                  comment on CMS’ intention to collect                  3502(3) and 5 CFR 1320.3(c) and
                                                  the eligibility of Medicare home health                 information from the public. Under the                includes agency requests or
                                                  services. Home health services are                      Paperwork Reduction Act of 1995                       requirements that members of the public
                                                  covered under the Hospital Insurance                    (PRA), federal agencies are required to               submit reports, keep records, or provide
                                                  (Part A) and Supplemental Medical                       publish notice in the Federal Register                information to a third party. Section
                                                  Insurance (Part B) benefits of the                      concerning each proposed collection of                3506(c)(2)(A) of the PRA (44 U.S.C.
                                                  Medicare program. It consists of part-                  information, including each proposed                  3506(c)(2)(A)) requires federal agencies
                                                  time, medically necessary skilled care                  extension or reinstatement of an existing             to publish a 30-day notice in the
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                                                  (nursing, physical therapy, occupational                collection of information, and to allow               Federal Register concerning each
                                                  therapy, and speech-language therapy)                   a second opportunity for public                       proposed collection of information,
                                                  that is ordered by a physician. The CMS                 comment on the notice. Interested                     including each proposed extension or
                                                  has developed a list of clinical elements               persons are invited to send comments                  reinstatement of an existing collection
                                                  within a suggested electronic clinical                  regarding the burden estimate or any                  of information, before submitting the
                                                  template that would allow electronic                    other aspect of this collection of                    collection to OMB for approval. To
                                                  health record vendors to create prompts                 information, including any of the                     comply with this requirement, CMS is
                                                  to assist physicians when documenting                   following subjects: (1) The necessity and             publishing this notice that summarizes


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                                                  48322                      Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices

                                                  the following proposed collection(s) of                 comment on our proposed collection of                 information, including the validity of
                                                  information for public comment:                         certain information by the Agency.                    the methodology and assumptions used;
                                                    1. Type of Information Collection                     Under the Paperwork Reduction Act of                  (3) ways to enhance the quality, utility,
                                                  Request: Revision of a currently                        1995 (the PRA), Federal Agencies are                  and clarity of the information to be
                                                  approved collection; Title of                           required to publish notice in the                     collected; and (4) ways to minimize the
                                                  Information Collection: Skilled Nursing                 Federal Register concerning each                      burden of the collection of information
                                                  Facility and Skilled Nursing Facility                   proposed collection of information,                   on respondents, including through the
                                                  Health Care Complex Cost Report Form;                   including each proposed extension of an               use of automated collection techniques,
                                                  Use: Providers of services participating                existing collection of information, and               when appropriate, and other forms of
                                                  in the Medicare program are required                    to allow 60 days for public comment.                  information technology.
                                                  under sections 1815(a), 1833(e) and                     This notice solicits comments on the
                                                  1861(v)(1)(A) of the Social Security Act                                                                      Labeling of Certain Beers Subject to the
                                                                                                          information collection provisions of the
                                                  (42 U.S.C. 1395g) to submit annual                                                                            Labeling Jurisdiction of the Food and
                                                                                                          recommended labeling of certain beers
                                                  information to achieve settlement of                                                                          Drug Administration—(OMB Control
                                                                                                          subject to our labeling jurisdiction.
                                                  costs for health care services rendered to                                                                    Number 0910–0728)—Extension
                                                                                                          DATES: Submit either electronic or
                                                  Medicare beneficiaries. In addition,                    written comments on the collection of                    The definition of ‘‘food’’ under
                                                  regulations at 42 CFR 413.20 and 413.24                 information by October 13, 2015.                      section 201(f) of the Federal Food, Drug,
                                                  require adequate cost data and cost                     ADDRESSES: Submit electronic
                                                                                                                                                                and Cosmetic Act (the FD&C Act) See 21
                                                  reports from providers on an annual                     comments on the collection of                         U.S.C. 321(f), includes ‘‘articles used for
                                                  basis. The Form CMS–2540–10 cost                        information to http://                                food or drink’’ and thus includes
                                                  report is needed to determine a                         www.regulations.gov. Submit written                   alcoholic beverages. As such, alcoholic
                                                  provider’s reasonable cost incurred in                  comments on the collection of                         beverages are subject to the FD&C Act’s
                                                  furnishing medical services to Medicare                 information to the Division of Dockets                adulteration and misbranding
                                                  beneficiaries and reimbursement due to                  Management (HFA–305), Food and Drug                   provisions, and implementing
                                                  or from a provider. The revisions made                  Administration, 5630 Fishers Lane, Rm.                regulations, related to food. For
                                                  to the SNF cost report are in accordance                1061, Rockville, MD 20852. All                        example, manufacturers of alcoholic
                                                  with the statutory requirement for                      comments should be identified with the                beverages are responsible for adhering
                                                  hospice payment reform in § 3132 of the                 docket number found in brackets in the                to the registration of food facilities
                                                  Patient Protection and Affordable Care                  heading of this document.                             requirements in 21 CFR part 1 and to
                                                  Act (ACA). Form Number: CMS–2540–                                                                             the good manufacturing practice
                                                                                                          FOR FURTHER INFORMATION CONTACT: FDA
                                                  10 (OMB control number 0938–0463);                                                                            regulations in 21 CFR part 110. There
                                                                                                          PRA Staff, Office of Operations, Food                 are also certain requirements for
                                                  Frequency: Annually; Affected Public:                   and Drug Administration, 8455
                                                  Private sector (Business or other for-                                                                        nutrition labeling on menus, menu
                                                                                                          Colesville Rd., COLE–14526, Silver                    boards, and other written materials for
                                                  profits and Not-for-profit institutions);               Spring, MD 20993–0002, PRAStaff@
                                                  Number of Respondents: 14,398; Total                                                                          alcohol beverages served in restaurants
                                                                                                          fda.hhs.gov.                                          or similar retail food establishments in
                                                  Annual Responses: 14,398; Total
                                                  Annual Hours: 2,908,396. (For policy                    SUPPLEMENTARY INFORMATION: Under the                  21 CFR part 101 (79 FR 71156,
                                                  questions regarding this collection                     PRA (44 U.S.C. 3501–3520), Federal                    December 1, 2014). However, as
                                                  contact Amelia Citerone at 410–786–                     Agencies must obtain approval from the                reflected in a 1987 Memorandum of
                                                  8008).                                                  Office of Management and Budget                       Understanding between FDA and the
                                                                                                          (OMB) for each collection of                          Alcohol and Tobacco Tax and Trade
                                                     Dated: August 7, 2015.                               information they conduct or sponsor.                  Bureau (TTB), TTB is responsible for the
                                                  William N. Parham, III,                                 ‘‘Collection of information’’ is defined              promulgation and enforcement of
                                                  Director, Paperwork Reduction Staff, Office             in 44 U.S.C. 3502(3) and 5 CFR                        regulations with respect to the labeling
                                                  of Strategic Operations and Regulatory                  1320.3(c) and includes Agency requests                of distilled spirits, certain wines, and
                                                  Affairs.                                                or requirements that members of the                   malt beverages pursuant to the Federal
                                                  [FR Doc. 2015–19837 Filed 8–11–15; 8:45 am]             public submit reports, keep records, or               Alcohol Administration Act (FAA Act).
                                                  BILLING CODE 4120–01–P                                  provide information to a third party.                 In TTB Ruling 2008–3, dated July 7,
                                                                                                          Section 3506(c)(2)(A) of the PRA (44                  2008, TTB clarified that certain beers,
                                                                                                          U.S.C. 3506(c)(2)(A)) requires Federal                which are not made from both malted
                                                  DEPARTMENT OF HEALTH AND                                Agencies to provide a 60-day notice in                barley and hops but are instead made
                                                  HUMAN SERVICES                                          the Federal Register concerning each                  from substitutes for malted barley (such
                                                  Food and Drug Administration                            proposed collection of information,                   as sorghum, rice, or wheat) or are made
                                                                                                          including each proposed extension of an               without hops, do not meet the definition
                                                  [Docket No. FDA–2009–D–0268]                            existing collection of information,                   of a ‘‘malt beverage’’ under the FAA
                                                                                                          before submitting the collection to OMB               Act. Accordingly, TTB stated in its
                                                  Agency Information Collection                           for approval. To comply with this                     ruling that such products (other than
                                                  Activities; Proposed Collection;                        requirement, we are publishing notice of              sake, which is classified as a wine under
                                                  Comment Request; Labeling of Certain                    the proposed collection of information                the FAA Act), are not subject to the
                                                  Beers Subject to the Labeling                           set forth in this document.                           labeling, advertising, or other provisions
                                                  Jurisdiction of the Food and Drug                          With respect to the following                      of the TTB regulations promulgated
                                                  Administration
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                                                                                                          collection of information, we invite                  under the FAA Act.
                                                  AGENCY:    Food and Drug Administration,                comments on these topics: (1) Whether                    In cases where an alcoholic beverage
                                                  HHS.                                                    the proposed collection of information                is not covered by the labeling provisions
                                                  ACTION:   Notice.                                       is necessary for the proper performance               of the FAA Act, the product is subject
                                                                                                          of our functions, including whether the               to ingredient and other labeling
                                                  SUMMARY: The Food and Drug                              information will have practical utility;              requirements under the FD&C Act and
                                                  Administration (FDA or we) is                           (2) the accuracy of our estimate of the               the implementing regulations that we
                                                  announcing an opportunity for public                    burden of the proposed collection of                  administer. In addition, as provided for


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Document Created: 2016-09-27 22:27:32
Document Modified: 2016-09-27 22:27:32
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 September 11, 2015.
ContactReports Clearance Office at (410) 786- 1326.
FR Citation80 FR 48321 

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