E7-22086. 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 [e-mail], or call the Reports Clearance Office on [phone]. 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 (§ 1001.952(w)(1)(i)(A)); (2) the written agreement must be signed by the parties (§ 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 (§ 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 (§ 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 (§ 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

Type of respondent	Number of respondents	Number of responses per respondent	Average burden hours per response	Total burden hours
Health Centers (Administrative Professionals)	1,873	1	1	1,873

Dated: November 1, 2007.

Alice Bettencourt,

Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer.