[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR1008.15]

[Page 1198]
 
                         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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