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[Federal Register Volume 78, Number 240 (Friday, December 13, 2013)]
[Notices]
[Pages 75925-75926]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29725]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers CMS-116 and CMS-10225]

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 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 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 February 11, 2014.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number (OCN). 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 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: 

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).

[[Page 75926]]

    CMS-116 Clinical Laboratory Improvement Amendments (CLIA) 
Application Form and Supporting Regulations.
    CMS-10225 Disclosures Required of Certain Hospitals and Critical 
Access Hospitals Regarding Physician Ownership.
    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.

Information Collections

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Clinical 
Laboratory Improvement Amendments (CLIA) Application Form and 
Supporting Regulations; Use: The application must be completed by 
entities performing laboratory's testing specimens for diagnostic or 
treatment purposes. This information is vital to the certification 
process. Form Number: CMS-116 (OCN: 0938-0581); Frequency: 
Biennially and Occasionally; Affected Public: Private sector--Business 
or other for-profits and Not-for-profit institutions; Number of 
Respondents: 242,000; Total Annual Responses: 34,200; Total Annual 
Hours: 25,650. (For policy questions regarding this collection contact 
Sheila Ward at 410-786-3115.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Disclosures 
Required of Certain Hospitals and Critical Access Hospitals Regarding 
Physician Ownership; Use: There is no Medicare prohibition against 
physician investment in a hospital or critical access hospitals (CAH). 
Likewise, there is no Medicare requirement that a hospital or CAH have 
a physician on-site at all times, although there is a requirement that 
they be able to provide basic elements of emergency care to their 
patients. Medicare quality and safety standards are designed to provide 
a national framework that is sufficiently flexible to apply 
simultaneously to hospitals of varying sizes, offering varying ranges 
of services in differing settings across the nation. At the same time, 
however, patients might consider an ownership interest by their 
referring physician, the presence of a physician on-site or both to be 
important factors in their decisions about where to seek hospital care. 
A well-educated consumer is essential to improving the quality and 
efficiency of the healthcare system. Accordingly, patients should be 
made aware of the physician ownership of a hospital, whether or not a 
physician is present in the hospital at all times, and the hospital's 
plans to address patients' emergency medical conditions when a 
physician is not present. The intent of the disclosures is to increase 
the transparency of the hospital's ownership and operations to patients 
as they make decisions about receiving care at the hospital. Form 
Number: CMS-10225 (OCN: 0938-1034); Frequency: Occasionally; Affected 
Public: Private sector--Business or other for-profits and Not-for-
profit institutions; Number of Respondents: 265; Total Annual 
Responses: 57,387,927; Total Annual Hours: 1,265,116. (For policy 
questions regarding this collection contact Teresa Walden at 410-786-
3755).

    Dated: December 9, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2013-29725 Filed 12-12-13; 8:45 am]
BILLING CODE 4120-01-P
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