[Federal Register Volume 76, Number 51 (Wednesday, March 16, 2011)]
[Notices]
[Pages 14398-14399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-6087]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0322; 60-Day Notice]
Agency Information Collection Request; 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Office of the Secretary (OS),
Department of Health and Human Services, is publishing the following
summary of a proposed information collection request for public
comment. Interested persons are invited to send comments regarding this
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. To obtain copies of the supporting statement and any
related forms for the proposed paperwork collections referenced above,
e-mail your request, including your address, phone number, OMB number,
and OS document identifier, to [email protected], or call
the Reports Clearance Office on (202) 690-6162. Written comments and
recommendations for the proposed information collections must be
directed to the OS Paperwork Clearance Officer at the above e-mail
address within 60-days.
Proposed Project: Safe Harbor for Federally Qualified Health
Centers Arrangements-Extension OMB No. 0990-0322--Office of Inspector
General.
Abstract: The Office of the Inspector General (OIG), Office of the
Secretary (OS), Department of Health and Human Services (HHS) is
requesting a 3-year extension of clearance for the data collection
under the anti-kickback statute, as described below. In order for an
arrangement between a health center and a donor individual or entity to
enjoy safe harbor protection, the arrangement (1) Must be set out in
writing (Sec. 1001.952(w)(1)(i)(A)); (2) the written agreement must be
signed by the parties (Sec. 1001.952(w)(1)(i)(B)); (3) the written
agreement must cover, and specify the amount of, all good, items,
services, donations, or loans provided by the individual or entity to
the health center (Sec. 1001.952(w)(1)(i)(C)); (4) the health center
must document its basis for its reasonable expectation that the
arrangement will benefit a medically underserved population (Sec.
1001.952(w)(3)); and (5) the health center, at reasonable intervals,
must reevaluate the arrangement to ensure that it is expected to
continue to benefit a medically underserved population, and must
document the re-evaluation contemporaneously (Sec. 1001.952(w)(4)).
OIG may request to see documentation kept pursuant to the safe
harbor in order to determine compliance with the terms of the safe
harbor and the fraud and abuse laws. Compliance with the safe harbor is
voluntary, and no party is ever required to comply with the safe
harbor.
The safe harbor does not entail a routine and continuous
affirmative collection of data form the regulated community. However,
health centers that choose to avail themselves of the safe harbor must
have initial documentation and a re-evaluation of the arrangement at
least annually. The respondents are businesses and/or other private
sector for-profit and not-for-profit institutions.
[[Page 14399]]
Estimated Annualized Burden Table
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Number of Average burden
Type of respondent Number of responses per (in hours) per Total burden
respondents respondent response hours
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Health Center............................... 1873 1 1 1,873
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Seleda Perryman,
Office of the Secretary, Paperwork Reduction Act Clearance Officer.
[FR Doc. 2011-6087 Filed 3-15-11; 8:45 am]
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