[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: 42CFR1008.36]

[Page 1200-1201]
 
                         TITLE 42--PUBLIC HEALTH
 
      GENERAL--HEALTH CARE, DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
PART 1008_ADVISORY OPINIONS BY THE OIG--Table of Contents
 
    Subpart D_Submission of a Formal Request for an Advisory Opinion
 
Sec. 1008.36  Submission of a request.


    (a) A request for a formal advisory opinion must be submitted in 
writing. An original and 2 copies of the request should be addressed to 
the headquarter offices of the OIG.
    (b) Each request for an advisory opinion must include--
    (1) To the extent known to the requestor, the identities, including 
the names and addresses, of the requestor and of all other actual and 
potential parties to the arrangement, that are the subject of the 
request for an advisory opinion;
    (2) The name, title, address, and daytime telephone number of a 
contact person who will be available to discuss the request for an 
advisory opinion with the OIG on behalf of the requestor;
    (3) A declaration of the subject category or categories as described 
in Sec. 1008.5 of this part for which the advisory opinion is 
requested. To the extent an individual or entity requests an advisory 
opinion in accordance with Sec. Sec. 1008.5(a)(3) or (a)(5) of this 
part, the requesting individual or entity should identify the specific 
subsections of sections 1128, 1128A or 1128B of the Act or the specific 
provision of Sec. 1001.952 of this chapter about which an advisory 
opinion is sought:
    (4) A complete and specific description of all relevant information 
bearing on the arrangement for which an advisory opinion is requested 
and on the circumstances of the conduct, \1\ including--
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    \1\ The requestor is under an affirmative obligation to make full 
and true disclosure with respect to the facts regarding the advisory 
opinion being requested.
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    (i) Background information,
    (ii) For existing arrangements, complete copies of all operative 
documents,

[[Page 1201]]

    (iii) For proposed arrangements, complete copies of all operative 
documents, if possible, and otherwise descriptions of proposed terms, 
drafts, or models of documents sufficient to permit the OIG to render an 
informed opinion,
    (iv) Detailed statements of all collateral or oral understandings, 
if any, and
    (v) If applicable, a designation of trade secrets or confidential 
commercial or financial information in the manner described in 45 CFR 
5.65;
    (5) Signed certifications by the requestor(s), as described in Sec. 
1008.37 of this part;
    (6) A check or money order payable to the Treasury of the United 
States in the amount of $250, as discussed in Sec. 1008.31(b) of this 
part;
    (7) A declaration regarding whether an advisory opinion in 
accordance with part 411 of this title has been or will be requested 
from CMS about the arrangement that is the subject of the advisory 
opinion request; and
    (8) Each requesting party's Taxpayer Identification Number.

(Approved by the Office of Management and Budget under control number 
0990-0213)

[62 FR 7357, Feb. 19, 1997, as amended at 63 FR 38325, July 16, 1998]