[Federal Register Volume 80, Number 235 (Tuesday, December 8, 2015)]
[Notices]
[Pages 76292-76293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 
[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

[[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