[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11571-11572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04861]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10152]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

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 (the PRA), federal agencies are require; 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 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates 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 must be received by May 3, 2016.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number _________, Room C4-26-05, 7500 Security Boulevard, 
Baltimore, Maryland 21244-1850.
    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: 

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-10152 Data Collection for Medicare Beneficiaries Receiving NaF-18 
Positron Emission Tomography (PET) To Identify Bone Metastasis in 
Cancer

    Under the 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 requires federal agencies 
to publish a 60-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.
    1. Type of Information Collection Request: Extension of a 
previously approved collection; Title: Data Collection for Medicare 
Beneficiaries Receiving NaF-18 Positron Emission Tomography (PET) to 
Identify Bone Metastasis in Cancer; Use: In Decision Memorandum #CAG-
00065R, issued on February 26, 2010, the Centers for Medicare and 
Medicaid Services (CMS) determined that the evidence is sufficient to 
conclude that for Medicare beneficiaries receiving NaF-18 PET scan to 
identify bone metastasis in cancer is reasonable and necessary only 
when the provider is participating in and patients are enrolled in a 
clinical study designed to information at the time of the scan to 
assist in initial antitumor treatment planning or to guide subsequent 
treatment strategy by the identification, location and quantification 
of bone metastases in beneficiaries in whom bone metastases are 
strongly suspected based on clinical symptoms or the results of other 
diagnostic studies. Qualifying clinical studies must ensure that 
specific hypotheses are addressed; appropriate data elements are 
collected; hospitals and providers are qualified to provide the PET 
scan and interpret the results; participating hospitals and

[[Page 11572]]

providers accurately report data on all Medicare enrolled patients; and 
all patient confidentiality, privacy, and other Federal laws must be 
followed. Consistent with section 1142 of the Social Security Act (the 
Act), the Agency for Healthcare Research and Quality (AHRQ) supports 
clinical research studies that CMS determines meets specified standards 
and address the specified research questions. To qualify for payment, 
providers must prescribe certain NaF-18 PET scans for beneficiaries 
with a set of clinical criteria specific to each solid tumor. The 
statuary authority for this policy is section 1862(a)(1)(E) of the Act. 
The need to prospectively collect information at the time of the scan 
is to assist the provider in decision making for patient management. 
Form Number: CMS-10152 (OCN: 0938-0968); Frequency: Annual; Affected 
Public: Private Sector (Business or other for-profits); Number of 
Respondents: 25,000; Total Annual Responses: 25,000; Total Annual 
Hours: 2,084 hours. (For policy questions regarding this collection 
contact Stuart Caplan at 410-786-8564.)

    Dated: March 1, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-04861 Filed 3-3-16; 8:45 am]
 BILLING CODE 4120-01-P