[Federal Register Volume 72, Number 218 (Tuesday, November 13, 2007)]
[Notices]
[Page 63899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22086]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-New]


Agency Information Collection Request; 30-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 collection 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 
received within 30 days of this notice directly to the OS OMB Desk 
Officer all comments must be faxed to OMB at 202-395-6974.
    Title: Safe Harbor for Federally Qualified Health Centers 
Arrangements under the Anti-kickback Statute--OMB No. 0990-New--Office 
of Inspector General (OIG).
    Proposed Project: The Office of the Inspector General (OIG), Office 
of the Secretary (OS), Department of Health and Human Services (HHS) is 
requesting a 3-year 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 goods, 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.  001.952(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 from 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.
    OIG previously solicited comments on this section of the PRA on 
July 1, 2005, upon publication of the 60-day notice of proposed 
rulemaking (70 FR 38081). OIG did not receive any comments specifically 
addressing the PRA in response to that notice; however, OIG is now 
providing an additional opportunity for comment on the PRA aspect of 
the rule only.

                                        Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
                                                           Number of        Average burden
       Type of  respondent             Number of         responses per         hours per      Total burden hours
                                      respondents         respondent           response
----------------------------------------------------------------------------------------------------------------
Health Centers (Administrative                1,873                   1                   1               1,873
 Professionals).................
----------------------------------------------------------------------------------------------------------------


    Dated: November 1, 2007.
Alice Bettencourt,
Office of the Secretary, Paperwork Reduction Act Reports Clearance 
Officer.
 [FR Doc. E7-22086 Filed 11-9-07; 8:45 am]
BILLING CODE 4152-01-P