[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR8.27]

[Page 72-73]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 8--CERTIFICATION OF OPIOID TREATMENT PROGRAMS--Table of Contents
 
Subpart C--Procedures for Review of Suspension or Proposed Revocation of 
    OTP Certification, and of Adverse Action Regarding Withdrawal of 
                    Approval of an Accreditation Body
 
Sec. 8.27  Opportunity for oral presentation.

    (a) Electing oral presentation. If an opportunity for an oral 
presentation is desired, the appellant shall request it at the time it 
submits its written request for review to the reviewing official. The 
reviewing official will grant the request if the official determines 
that the decisionmaking process will be substantially aided by oral 
presentations and arguments. The reviewing official may also provide for 
an oral presentation at the official's own initiative or at the request 
of the respondent.
    (b) Presiding official. The reviewing official or designee will be 
the presiding official responsible for conducting the oral presentation.
    (c) Preliminary conference. The presiding official may hold a 
prehearing conference (usually a telephone conference call) to consider 
any of the following: Simplifying and clarifying issues; stipulations 
and admissions; limitations on evidence and witnesses that will be 
presented at the hearing; time allotted for each witness and the hearing 
altogether; scheduling the hearing; and any other matter that will 
assist in the review process. Normally, this conference will be 
conducted informally and off the record; however, the presiding official 
may, at the presiding official's discretion, produce a written document 
summarizing the conference or transcribe the conference, either of which 
will be made a part of the record.
    (d) Time and place of oral presentation. The presiding official will 
attempt to schedule the oral presentation within 45 days of the date 
appellant's request for review is received or within 15 days

[[Page 73]]

of submission of the last reply brief, whichever is later. The oral 
presentation will be held at a time and place determined by the 
presiding official following consultation with the parties.
    (e) Conduct of the oral presentation.--(1) General. The presiding 
official is responsible for conducting the oral presentation. The 
presiding official may be assisted by one or more HHS officers or 
employees or consultants in conducting the oral presentation and 
reviewing the evidence. While the oral presentation will be kept as 
informal as possible, the presiding official may take all necessary 
steps to ensure an orderly proceeding.
    (2) Burden of proof/standard of proof. In all cases, the respondent 
bears the burden of proving by a preponderance of the evidence that its 
decision to suspend, propose revocation, or take adverse action is 
appropriate. The appellant, however, has a responsibility to respond to 
the respondent's allegations with evidence and argument to show that the 
respondent is incorrect.
    (3) Admission of evidence. The rules of evidence do not apply and 
the presiding official will generally admit all testimonial evidence 
unless it is clearly irrelevant, immaterial, or unduly repetitious. Each 
party may make an opening and closing statement, may present witnesses 
as agreed upon in the pre-hearing conference or otherwise, and may 
question the opposing party's witnesses. Since the parties have ample 
opportunity to prepare the review file, a party may introduce additional 
documentation during the oral presentation only with the permission of 
the presiding official. The presiding official may question witnesses 
directly and take such other steps necessary to ensure an effective and 
efficient consideration of the evidence, including setting time 
limitations on direct and cross-examinations.
    (4) Motions. The presiding official may rule on motions including, 
for example, motions to exclude or strike redundant or immaterial 
evidence, motions to dismiss the case for insufficient evidence, or 
motions for summary judgment. Except for those made during the hearing, 
all motions and opposition to motions, including argument, must be in 
writing and be no more than 10 double-spaced pages in length. The 
presiding official will set a reasonable time for the party opposing the 
motion to reply.
    (5) Transcripts. The presiding official shall have the oral 
presentation transcribed and the transcript shall be made a part of the 
record. Either party may request a copy of the transcript and the 
requesting party shall be responsible for paying for its copy of the 
transcript.
    (f) Obstruction of justice or making of false statements. 
Obstruction of justice or the making of false statements by a witness or 
any other person may be the basis for a criminal prosecution under 18 
U.S.C. 1001 or 1505.
    (g) Post-hearing procedures. At the presiding official's discretion, 
the presiding official may require or permit the parties to submit post-
hearing briefs or proposed findings and conclusions. Each party may 
submit comments on any major prejudicial errors in the transcript.