[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

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 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.



[[Page 73]]



    (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.