[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 <a href="/cdn-cgi/l/email-protection#085b606d7a6d7c7c6d266e7d66666b67646d6569664860607b266f677e"><span class="__cf_email__" data-cfemail="b2e1dad7c0d7c6c6d79cd4c7dcdcd1ddded7dfd3dcf2dadac19cd5ddc4">[email protected]</span></a>, 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
----------------------------------------------------------------------------------------------------------------
                                                                  Number of     Average  burden
             Type of respondent                  Number of      responses per    (in hours) per    Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
Health Center...............................            1873                1                1            1,873
----------------------------------------------------------------------------------------------------------------


Seleda Perryman,
Office of the Secretary, Paperwork Reduction Act Clearance Officer.
[FR Doc. 2011-6087 Filed 3-15-11; 8:45 am]
BILLING CODE 4152-01-P


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