[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR1008.15]



[Page 1212]

 

                         TITLE 42--PUBLIC HEALTH

 

      GENERAL--HEALTH CARE, DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

PART 1008_ADVISORY OPINIONS BY THE OIG--Table of Contents

 

Subpart B_Preliminary Obligations and Responsibilities of the Requesting 

                                  Party

 

Sec.  1008.15  Facts subject to advisory opinions.



    (a) The OIG will consider requests from a requesting party for 

advisory opinions regarding the application of specific facts to the 

subject matters set forth in Sec.  1008.5(a) of this part. The facts 

must relate to an existing arrangement, or one which the requestor in 

good faith plans to undertake. The plans may be contingent upon 

receiving a favorable advisory opinion. The advisory opinion request 

should contain a complete description of the arrangement that the 

requestor is undertaking, or plans to undertake.

    (b) Requests presenting a general question of interpretation, posing 

a hypothetical situation, or regarding the activities of third parties 

do not qualify as advisory opinion requests.

    (c) Advisory opinion request will not be accepted, and/or opinions 

will not be issued when--

    (1) The request is not related to a named individual or entity;

    (2) The same, or substantially the same, course of action is under 

investigation, or is or has been the subject of a proceeding involving 

the Department of Health and Human Services or another governmental 

agency; or

    (3) An informed opinion cannot be made, or could be made only after 

extensive investigation, clinical study, testing, or collateral inquiry.



[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38324, July 16, 1998]



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