80 FR 76292 - 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 235 (December 8, 2015)

Page Range		76292-76293
FR Document		2015-30892

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 235 (Tuesday, December 8, 2015)

[Federal Register Volume 80, Number 235 (Tuesday, December 8, 2015)]
[Notices]
[Pages 76292-76293]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30892]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10583]


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

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate or any other aspect of this 
collection of information, including 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 January 7, 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: 
OIRA_submission@omb.eop.gov.
    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 Paperwork@cms.hhs.gov.
    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

[[Page 76293]]

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: New collection (Request 
for a new OMB control number); Title of Information Collection: Data 
Collection for Medicare Beneficiaries Receiving Beta Amyloid Positron 
Emission Tomography (PET) for Dementia and Neurodegenerative Disease 
Use: In the Decision Memorandum #CAG-00431N issued on September 27, 
2013, CMS determined there is sufficient evidence that the use of beta 
amyloid PET is promising in 2 scenarios: (1) To exclude Alzheimer's 
Disease (AD) in narrowly defined and clinically difficult differential 
diagnoses; and (2) to enrich clinical trials seeking better treatments 
or prevention strategies for AD. CMS will cover one beta amyloid PET 
scan per patient through Coverage with Evidence Development under 
section 1862(a)(1)(E) of the Social Security Act, in clinical studies 
that meet specific criteria established by CMS. Clinical studies must 
be approved by CMS, involve subjects from appropriate populations, and 
be comparative and longitudinal. Radiopharmaceuticals used in the scan 
must be FDA approved. Approved studies must address defined research 
questions established by CMS. Clinical studies in this National 
Coverage Determination (NCD) must adhere to the designated timeframe 
and meet standards establish by CMS in the NCD. Consistent with section 
1142 of the Social Security Act, the Agency for Healthcare and Quality 
(AHRQ) supports clinical research studies that CMS determines meet 
specifically identified requirements and research questions.
    To qualify for payment, providers must prescribe beta amyloid PET 
for beneficiaries with a set of clinical criteria specific to each 
cancer. Data elements will be transmitted to CMS for evaluation of the 
short and long-term benefits of beta amyloid PET to beneficiaries and 
for use in future clinical decision making. Form Number: CMS-10583 (OMB 
control number: 0938-NEW); Frequency: Annually; Affected Public: 
Private sector (Business or other for-profit); Number of Respondents: 
300; Total Annual Responses: 3,700; Total Annual Hours: 6,475. (For 
policy questions regarding this collection contact Stuart Caplan at 
410-786-8564).

    Dated: December 3, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2015-30892 Filed 12-7-15; 8:45 am]
 BILLING CODE 4120-01-P

76292 Federal Register / Vol. 80, No. 235 / Tuesday, December 8, 2015 / Notices

previous year to determine whether the battery were similarly affected. long been used by government,
results consistent. In addition to Persistent differences will be examined academic, and private researchers to
comparing the unweighted and to determine whether there is any other evaluate both general health and
weighted frequencies, the input and interviewer effect such as results specific issues, such as smoking,
output specifications are reviewed, and comparing newly hired and experienced diabetes, health care coverage, and
the flowcharts are compared to the skip interviewers and newly added primary access to health care. It is a leading
instructions and universes for each sampling units compared to continuing source of data for the Congressionally-
question. If a difference is found, steps primary sampling units. In addition, mandated ‘‘Health US’’ and related
are taken to determine whether the national estimates on the key set of publications, as well as the single most
change is legitimate or whether there is indicators that are released in a important source of statistics to track
a factor other than the programming of quarterly report as part of the Early progress toward the National Health
the questionnaire such as the location or Release program will be monitored by Promotion and Disease Prevention
context of the question in the NHIS analysts. Objectives, ‘‘Healthy People 2020.’’
questionnaire. If a difference persists, In accordance with the 1995 initiative Burden hours have seen a net increase
the paradata are reviewed to determine to increase the integration of surveys of 1,367 hours compared to 2015 due to
whether there are changes in the mean within the DHHS, respondents to the the removal of the screener
or median time spent on that question, NHIS serve as the sampling frame for questionnaire and the addition of the
whether interviewers had a high rate of the Medical Expenditure Panel Survey questionnaire redesign activities. There
backing up to return to that question, conducted by the Agency for Healthcare is no cost to the respondents other than
and whether other questions in that Research and Quality. The NHIS has their time.

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

Adult Family Member ...................................... Family Questionnaire ..................................... 45,000 1 23/60
Sample Adult ................................................... Sample Adult Questionnaire .......................... 36,000 1 15/60
Adult Family Member ...................................... Sample Child Questionnaire .......................... 14,000 1 10/60
Adult Family Member ...................................... Supplements .................................................. 45,000 1 20/60
Adult Family Member ...................................... Special Projects ............................................. 15,000 1 20/60
Adult Family Member ...................................... Reinterview Questions ................................... 5,000 1 5/60

Total ......................................................... ......................................................................... ........................ ........................ 49,000

Leroy A. Richardson, extension or reinstatement of an existing Attention: CMS Desk Officer, Fax
Chief, Information Collection Review Office, collection of information, and to allow Number: (202) 395–5806 OR, Email:
Office of Scientific Integrity, Office of the a second opportunity for public OIRA_submission@omb.eop.gov.
Associate Director for Science, Office of the comment on the notice. Interested To obtain copies of a supporting
Director, Centers for Disease Control and persons are invited to send comments statement and any related forms for the
Prevention.
regarding the burden estimate or any proposed collection(s) summarized in
[FR Doc. 2015–30854 Filed 12–7–15; 8:45 am]
other aspect of this collection of this notice, you may make your request
BILLING CODE 4163–18–P information, including any of the using one of following:
following subjects: (1) The necessity and 1. Access CMS’ Web site address at
utility of the proposed information http://www.cms.hhs.gov/
DEPARTMENT OF HEALTH AND
collection for the proper performance of PaperworkReductionActof1995.
HUMAN SERVICES
the agency’s functions; (2) the accuracy 2. Email your request, including your
Centers for Medicare & Medicaid of the estimated burden; (3) ways to address, phone number, OMB number,
Services enhance the quality, utility, and clarity and CMS document identifier, to
of the information to be collected; and Paperwork@cms.hhs.gov.
[Document Identifiers: CMS–10583] (4) the use of automated collection 3. Call the Reports Clearance Office at
techniques or other forms of information (410) 786–1326.
Agency Information Collection
technology to minimize the information FOR FURTHER INFORMATION CONTACT:
Activities: Submission for OMB
collection burden. Reports Clearance Office at (410) 786–
Review; Comment Request
DATES:Comments on the collection(s) of 1326.
ACTION: Notice. information must be received by the SUPPLEMENTARY INFORMATION: Under the
SUMMARY: The Centers for Medicare & OMB desk officer by January 7, 2016: Paperwork Reduction Act of 1995 (PRA)
Medicaid Services (CMS) is announcing ADDRESSES: When commenting on the (44 U.S.C. 3501–3520), federal agencies
an opportunity for the public to proposed information collections, must obtain approval from the Office of
Lhorne on DSK9F6TC42PROD with NOTICES

comment on CMS’ intention to collect please reference the document identifier Management and Budget (OMB) for each
information from the public. Under the or OMB control number. To be assured collection of information they conduct
Paperwork Reduction Act of 1995 consideration, comments and or sponsor. The term ‘‘collection of
(PRA), federal agencies are required to recommendations must be received by information’’ is defined in 44 U.S.C.
publish notice in the Federal Register the OMB desk officer via one of the 3502(3) and 5 CFR 1320.3(c) and
concerning each proposed collection of following transmissions: OMB, Office of includes agency requests or
information, including each proposed Information and Regulatory Affairs, requirements that members of the public

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Document Created: 2015-12-14 13:27:01
Document Modified: 2015-12-14 13:27:01

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 January 7, 2016:
Contact		Reports Clearance Office at (410) 786- 1326.
FR Citation		80 FR 76292

80 FR 76292 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 80, Issue 235 (December 8, 2015)

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