81 FR 51914 - 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 151 (August 5, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 151 (August 5, 2016)
| Page Range | 51914-51915 | |
| FR Document | 2016-18664 |
[Federal Register Volume 81, Number 151 (Friday, August 5, 2016)] [Notices] [Pages 51914-51915] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18664] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10243] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (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 6, 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: Reinstatement with change of a previously approved collection; Title of Information Collection: Testing Experience and Functional Tools: Functional Assessment Standardized Items (FASI) Based on the CARE Tool; Use: In 2012, CMS funded a project entitled, Technical Assistance to States for Testing Experience and Functional Tools (TEFT) Grants. One component of this demonstration is to amend and test the reliability of a setting- agnostic, interoperable set of data elements, called ``items,'' that can support standardized assessment of individuals across the continuum of care. Items that were created for use in post-acute care settings using the Continuity Assessment Record and Evaluation (CARE) tool have been adopted, modified, or supplemented for use in community-based long-term services and supports (CB-LTSS) programs. This project will test the reliability and validity of the function-related assessment items, now referred to as Functional Assessment Standardized Items (FASI), when applied in community settings, and in various populations: Elders (65 years and older); younger adults (18-64) with physical disabilities; and adults of any age with intellectual or developmental disabilities, with severe mental illness, or with traumatic brain injury. Individual-level data will be collected two times using the TEFT FASI Item Set. The first data collection effort will collect data that can be analyzed to evaluate the reliability and validity of the FASI items when used with the five waiver populations. Assessors will conduct functional assessments in client homes using the TEFT FASI Item Set. Changes may be recommended to individual TEFT FASI items, to be made prior to releasing the TEFT FASI items for use by the states. The FASI Field Test Report will be released to the public. The second data collection will be conducted by the states to demonstrate their use of the FASI data elements. The assessment data could be used by the states for multiple purposes. They may use the standardized items to determine individual eligibility for state programs, or to help determine levels of care within which people can receive services, or other purposes. In the second round of data collection, states will demonstrate their proposed uses, manage their FASI data collection and conduct their own analysis, to the extent they propose to do such tasks. The states have been funded under the demonstration grant to conduct the round 2 data collection and analysis. These states will submit reports to CMS describing their experience in the Round 2 data collection, including the items they collected, how they planned to use the data, and the types of challenges and successes they encountered in doing so. The reports may be used by CMS in their evaluation of the TEFT grants. Subsequent to the publication of our 60-day Federal Register notice (May 2, 2016; 81 FR 26235), we have made several minor modifications to the form. The changes are intended to further protect participant identification and improve the response efficiency by removing several checkboxes that we were using for item screening purposes. The instructions were revised accordingly. The revisions have no impact on our 60-day burden estimates. Form Number: CMS-10243 (OMB control number: 0938-1037); Frequency: On occasion; Affected Public: Individuals and Households; Number of Respondents: 5,650; Total Annual Responses: 5,650; Total Annual Hours: 2,825. (For policy questions regarding this collection contact Allison Weaver at 410-786-4924.) [[Page 51915]] Dated: August 2, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-18664 Filed 8-4-16; 8:45 am] BILLING CODE 4120-01-P
![51914 Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices
[FR Doc. 2016–18546 Filed 8–4–16; 8:45 am] 1. Access CMS’ Web site address at populations: Elders (65 years and older);
BILLING CODE 4120–01–C http://www.cms.hhs.gov/ younger adults (18–64) with physical
PaperworkReductionActof1995. disabilities; and adults of any age with
2. Email your request, including your intellectual or developmental
DEPARTMENT OF HEALTH AND address, phone number, OMB number, disabilities, with severe mental illness,
HUMAN SERVICES and CMS document identifier, to or with traumatic brain injury.
Paperwork@cms.hhs.gov. Individual-level data will be collected
Centers for Medicare & Medicaid 3. Call the Reports Clearance Office at two times using the TEFT FASI Item
Services (410) 786–1326. Set. The first data collection effort will
FOR FURTHER INFORMATION CONTACT: collect data that can be analyzed to
[Document Identifier: CMS–10243] evaluate the reliability and validity of
Reports Clearance Office at (410) 786–
1326. the FASI items when used with the five
Agency Information Collection
waiver populations. Assessors will
Activities: Submission for OMB SUPPLEMENTARY INFORMATION: Under the
conduct functional assessments in client
Review; Comment Request Paperwork Reduction Act of 1995 (PRA)
homes using the TEFT FASI Item Set.
(44 U.S.C. 3501–3520), federal agencies
AGENCY: Centers for Medicare & Changes may be recommended to
must obtain approval from the Office of
Medicaid Services, HHS. individual TEFT FASI items, to be made
Management and Budget (OMB) for each
ACTION: Notice. prior to releasing the TEFT FASI items
collection of information they conduct
for use by the states. The FASI Field
or sponsor. The term ‘‘collection of
SUMMARY: The Centers for Medicare & Test Report will be released to the
information’’ is defined in 44 U.S.C. public.
Medicaid Services (CMS) is announcing
3502(3) and 5 CFR 1320.3(c) and The second data collection will be
an opportunity for the public to
includes agency requests or conducted by the states to demonstrate
comment on CMS’ intention to collect
requirements that members of the public their use of the FASI data elements. The
information from the public. Under the
submit reports, keep records, or provide assessment data could be used by the
Paperwork Reduction Act of 1995
information to a third party. Section states for multiple purposes. They may
(PRA), federal agencies are required to
3506(c)(2)(A) of the PRA (44 U.S.C. use the standardized items to determine
publish notice in the Federal Register
3506(c)(2)(A)) requires federal agencies individual eligibility for state programs,
concerning each proposed collection of
to publish a 30-day notice in the or to help determine levels of care
information, including each proposed
Federal Register concerning each within which people can receive
extension or reinstatement of an existing
proposed collection of information, services, or other purposes. In the
collection of information, and to allow
including each proposed extension or second round of data collection, states
a second opportunity for public
reinstatement of an existing collection will demonstrate their proposed uses,
comment on the notice. Interested
of information, before submitting the manage their FASI data collection and
persons are invited to send comments
collection to OMB for approval. To conduct their own analysis, to the
regarding the burden estimate or any
comply with this requirement, CMS is extent they propose to do such tasks.
other aspect of this collection of
publishing this notice that summarizes The states have been funded under the
information, including any of the
the following proposed collection(s) of demonstration grant to conduct the
following subjects: (1) The necessity and
information for public comment: round 2 data collection and analysis.
utility of the proposed information 1. Type of Information Collection
collection for the proper performance of These states will submit reports to CMS
Request: Reinstatement with change of a describing their experience in the
the agency’s functions; (2) the accuracy previously approved collection; Title of
of the estimated burden; (3) ways to Round 2 data collection, including the
Information Collection: Testing items they collected, how they planned
enhance the quality, utility, and clarity Experience and Functional Tools:
of the information to be collected; and to use the data, and the types of
Functional Assessment Standardized challenges and successes they
(4) the use of automated collection Items (FASI) Based on the CARE Tool;
techniques or other forms of information encountered in doing so. The reports
Use: In 2012, CMS funded a project may be used by CMS in their evaluation
technology to minimize the information entitled, Technical Assistance to States
collection burden. of the TEFT grants.
for Testing Experience and Functional Subsequent to the publication of our
DATES: Comments on the collection(s) of Tools (TEFT) Grants. One component of 60-day Federal Register notice (May 2,
information must be received by the this demonstration is to amend and test 2016; 81 FR 26235), we have made
OMB desk officer by September 6, 2016. the reliability of a setting-agnostic, several minor modifications to the form.
ADDRESSES: When commenting on the interoperable set of data elements, The changes are intended to further
proposed information collections, called ‘‘items,’’ that can support protect participant identification and
please reference the document identifier standardized assessment of individuals improve the response efficiency by
or OMB control number. To be assured across the continuum of care. Items that removing several checkboxes that we
consideration, comments and were created for use in post-acute care were using for item screening purposes.
recommendations must be received by settings using the Continuity The instructions were revised
the OMB desk officer via one of the Assessment Record and Evaluation accordingly. The revisions have no
following transmissions: OMB, Office of (CARE) tool have been adopted, impact on our 60-day burden estimates.
Information and Regulatory Affairs, modified, or supplemented for use in Form Number: CMS–10243 (OMB
Attention: CMS Desk Officer, Fax community-based long-term services control number: 0938–1037); Frequency:
mstockstill on DSK3G9T082PROD with NOTICES
Number: (202) 395–5806 or Email: and supports (CB–LTSS) programs. This On occasion; Affected Public:
OIRA_submission@omb.eop.gov. project will test the reliability and Individuals and Households; Number of
To obtain copies of a supporting validity of the function-related Respondents: 5,650; Total Annual
statement and any related forms for the assessment items, now referred to as Responses: 5,650; Total Annual Hours:
proposed collection(s) summarized in Functional Assessment Standardized 2,825. (For policy questions regarding
this notice, you may make your request Items (FASI), when applied in this collection contact Allison Weaver at
using one of following: community settings, and in various 410–786–4924.)
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![Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 51915
Dated: August 2, 2016. SUPPLEMENTARY INFORMATION: public testimony on the evidence
William N. Parham, III, available to address the impact of
I. Background
Director, Paperwork Reduction Staff, Office medical items and services on health
of Strategic Operations and Regulatory The Secretary signed the initial outcomes of Medicare beneficiaries. The
Affairs. charter for the Medicare Coverage MEDCAC may also advise the Centers
[FR Doc. 2016–18664 Filed 8–4–16; 8:45 am] Advisory Committee (MCAC) on for Medicare & Medicaid Services (CMS)
BILLING CODE 4120–01–P
November 24, 1998. A notice in the as part of Medicare’s ‘‘coverage with
Federal Register (63 FR 68780) evidence development’’ initiative.
announcing establishment of the MCAC
DEPARTMENT OF HEALTH AND was published on December 14, 1998. II. Provisions of the Notice
HUMAN SERVICES The MCAC name was updated to more As of January 2017, there will be 31
accurately reflect the purpose of the membership terms expiring. Of the 31
Centers for Medicare & Medicaid committee and on January 26, 2007, the memberships expiring, 3 are industry
Services Secretary published a notice in the representatives, 1 is a patient advocate,
Federal Register (72 FR 3853), and the remaining 27 membership
[CMS–3335–N]
announcing that the Committee’s name openings are for the at-large standing
Medicare Program; Request for changed to the Medicare Evidence MEDCAC membership.
Nominations for Members for the Development & Coverage Advisory All nominations must be
Medicare Evidence Development & Committee (MEDCAC). The current accompanied by curricula vitae.
Coverage Advisory Committee Secretary’s Charter for the MEDCAC is Nomination packages should be sent to
available on the CMS Web site at: http:// Maria Ellis at the address listed in the
AGENCY: Centers for Medicare & www.cms.hhs.gov/FACA/Downloads/ ADDRESSES section of this notice.
Medicaid Services, HHS. medcaccharter.pdf, or you may obtain a Nominees are selected based upon their
ACTION: Notice. copy of the charter by submitting a individual qualifications. Nominees for
request to the contact listed in the FOR membership must have expertise and
SUMMARY: This notice announces the FURTHER INFORMATION section of this experience in one or more of the
request for nominations for membership notice. following fields:
on the Medicare Evidence Development The MEDCAC is governed by • Clinical medicine including
& Coverage Advisory Committee provisions of the Federal Advisory subspecialties
(MEDCAC). Among other duties, the Committee Act, Pub. L. 92–463, as • Administrative medicine
MEDCAC provides advice and guidance amended (5 U.S.C. App. 2), which sets • Public health
to the Secretary of the Department of forth standards for the formulation and • Biological and physical sciences
Health and Human Services (the use of advisory committees, and is • Epidemiology and biostatistics
Secretary) and the Administrator of the authorized by section 222 of the Public • Clinical trial design
Centers for Medicare & Medicaid Health Service Act as amended (42 • Health care data management and
Services (CMS) concerning the U.S.C. 217A). analysis
adequacy of scientific evidence We are requesting nominations for • Patient advocacy
available to CMS in making coverage candidates to serve on the MEDCAC. • Health care economics
determinations under the Medicare Nominees are selected based upon their • Medical ethics
program. individual qualifications and not solely • Other relevant professions
The MEDCAC reviews and evaluates as representatives of professional We are looking particularly for
medical literature and technology associations or societies. We wish to experts in a number of fields. These
assessments, and hears public testimony ensure adequate representation of the include cancer screening, genetic
on the evidence available to address the interests of both women and men, testing, clinical epidemiology,
impact of medical items and services on members of all ethnic groups, and psychopharmacology, screening and
health outcomes of Medicare physically challenged individuals. diagnostic testing analysis, and vascular
beneficiaries. Therefore, we encourage nominations of surgery. We also need experts in
qualified candidates who can represent biostatistics in clinical settings,
DATES: Nominations must be received
these interests. dementia treatment, minority health,
by Tuesday, September 6, 2016.
The MEDCAC consists of a pool of observational research design, stroke
ADDRESSES: You may mail nominations 100 appointed members including: 94 epidemiology, and women’s health.
for membership to the following at-large standing members (6 of whom The nomination letter must include a
address: Centers for Medicare & are patient advocates), and 6 statement that the nominee is willing to
Medicaid Services, Center for Clinical representatives of industry interests. serve as a member of the MEDCAC and
Standards and Quality, Attention: Maria Members generally are recognized appears to have no conflict of interest
Ellis, 7500 Security Boulevard, Mail authorities in clinical medicine that would preclude membership. We
Stop: S3–02–01, Baltimore, MD 21244 including subspecialties, administrative are requesting that all curricula vitae
or send via email to medicine, public health, biological and include the following:
MEDCACnomination@cms.hhs.gov. physical sciences, epidemiology and • Date of birth
FOR FURTHER INFORMATION CONTACT: biostatistics, clinical trial design, health • Place of birth
Maria Ellis, Executive Secretary for the care data management and analysis, • Social security number
MEDCAC, Centers for Medicare & patient advocacy, health care • Title and current position
mstockstill on DSK3G9T082PROD with NOTICES
Medicaid Services, Center for Clinical economics, medical ethics or other • Professional affiliation
Standards and Quality, Coverage and relevant professions. • Home and business address
Analysis Group, S3–02–01, 7500 The MEDCAC works from an agenda • Telephone and fax numbers
Security Boulevard, Baltimore, MD provided by the Designated Federal • Email address
21244 or contact Ms. Ellis by phone Official. The MEDCAC reviews and • List of areas of expertise
(410–786–0309) or via email at evaluates medical literature and In the nomination letter, we are
Maria.Ellis@cms.hhs.gov. technology assessments, and hears requesting that nominees specify
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Document Created: 2016-08-05 06:43:46
Document Modified: 2016-08-05 06:43:46
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on the collection(s) of information must be received by the OMB desk officer by September 6, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 51914 |
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