(a) This subpart provides a respondent an opportunity to contest ORI findings of research misconduct and/or proposed HHS administrative actions included in a charge letter.

(b) A respondent may contest ORI's research misconduct findings and proposed HHS administrative actions by filing a notice of appeal with an Administrative Law Judge (ALJ) at the DAB.

(c) Based on the administrative record, the ALJ shall rule on whether ORI's research misconduct findings and any proposed HHS administrative actions are reasonable and not based on a material error of law or fact. The ALJ's ruling constitutes a recommended decision to the Assistant Secretary for Health (ASH) in accordance with § 93.511(b).

(d) A respondent must exhaust all available administrative remedies under this subpart before seeking judicial review of ORI's findings and/or HHS administrative actions. The contested findings and/or administrative actions shall be inoperative while the respondent is pursuing administrative remedies under this subpart.

(a) Time to file. A respondent may contest ORI's findings of research misconduct and/or proposed HHS administrative actions by filing a notice of appeal within 30 days of receipt of the charge letter provided under § 93.405.

(b) Form of a notice of appeal. The respondent's notice of appeal must be:

(1) In writing;

(2) Signed by the respondent or by the respondent's attorney; and

(3) Submitted to the DAB Chair through the DAB electronic filing system, with a copy sent to ORI by certified mail, electronic mail, or other equivalent (i.e., with a verified method of delivery).

(c) Contents of a notice of appeal. The notice of appeal must:

(1) Admit or deny each ORI finding of research misconduct and each factual assertion made in support of each finding;

(2) Accept or challenge each proposed HHS administrative action;

(3) Provide detailed, substantive reasons for each denial or challenge with references to the administrative record;

(4) Identify any legal issues or defenses that the respondent intends to raise during the proceeding, with references to the administrative record; and

(5) Identify any mitigating factors in the administrative record.

(a) Within 30 days of receiving a notice of appeal, the DAB Chair, in consultation with the Chief ALJ, must designate an ALJ to determine whether the notice of appeal is timely filed and within the ALJ's jurisdiction under this subpart. If the appeal is determined to be timely and within the ALJ's jurisdiction, the ALJ shall decide the reasonableness of the ORI research misconduct findings and proposed HHS administrative actions in accordance with this subpart. The ALJ shall dismiss an appeal if it is untimely or not within the ALJ's jurisdiction under this subpart.

(b) No ALJ may serve in any proceeding under this subpart if they have any actual or apparent conflict of interest, bias, or prejudice that might reasonably impair their objectivity in the proceeding.

(c) Any party to the proceeding may request the ALJ to withdraw from the proceeding because of an actual or apparent conflict of interest, bias, or prejudice under paragraph (b) of this section. The motion to disqualify must be timely and state with particularity the grounds for disqualification. The ALJ may rule upon the motion or certify it to the Chief ALJ for decision. If the ALJ rules upon the motion, either party may appeal the decision to the Chief ALJ.

(d) An ALJ must withdraw from any proceeding for any reason found by the ALJ or Chief ALJ to be disqualifying.

(a) For appeals that are not dismissed under § 93.502(a), ORI will file the administrative record for the appeal.

(b) The ALJ's review will be based on the administrative record.

(c) The parties have no right to supplement the administrative record.

(a) The ALJ shall review the administrative record to determine whether the ORI research misconduct findings and proposed HHS administrative actions reflected in the charge letter are reasonable and not based on a material error of law or fact.

(b) The ALJ may permit the parties to file briefs making legal and factual arguments based on the administrative record.

(a) The parties to the appeal are the respondent and ORI. The investigating institution is not a party to the case unless it is a respondent.

(b) Except as otherwise limited by this subpart, the parties may:

(1) Be accompanied, represented, and advised by an attorney;

(2) Participate in any case-related conference held by the ALJ; and

(3) File motions or briefs in writing before the ALJ.

(c) The parties have no right to discovery before the ALJ.

(a) The ALJ assigned to the case must conduct a fair and impartial proceeding, avoid unnecessary delay, maintain order, and assure that a complete and accurate record of the proceeding is properly made. The ALJ is bound by, and may not refuse to follow or find invalid, all Federal statutes and regulations, Secretarial delegations of authority, and applicable HHS policies, as provided in paragraph (c)(5) of this section.

(b) Subject to review as provided elsewhere in this subpart, the ALJ may:

(1) Hold conferences with the parties to identify or simplify the issues, or to consider other matters that may aid in the prompt disposition of the proceeding;

(2) Rule on motions and other procedural matters;

(3) Except for the respondent's notice of appeal, modify the time for the filing of any document required or authorized under the rules in this subpart;

(4) Upon motion of a party, decide cases, in whole or in part, by summary judgment where there is no disputed issue of material fact;

(5) Regulate the course of the appeal and the conduct of representatives and parties; and

(6) Take action against any party for failing to follow an order or procedure or for disruptive conduct.

(c) The ALJ does not have the authority to:

(1) Enter an order in the nature of a directed verdict;

(2) Compel settlement negotiations;

(3) Enjoin any act of the Secretary;

(4) Review suspension or proposed debarment;

(5) Find invalid or refuse to follow Federal statutes or regulations, Secretarial delegations of authority, or HHS policies;

(6) Authorize the parties to engage in discovery; and

(7) Modify the time for filing the respondent's notice of appeal.

(d) The Federal Rules of Evidence and the Federal Rules of Civil Procedure do not govern the proceedings under this subpart.

(a) No party, attorney, or other party representative may communicate ex parte with the ALJ on any matter at issue in a case, unless both parties have notice and an opportunity to participate in the communication.

(b) If an ex parte communication occurs, the ALJ will disclose it to the other party and offer the other party an opportunity to comment.

(c) The provisions of this section do not apply to communications between an employee or contractor of the DAB and the ALJ.

(a) Filing. (1) Unless the ALJ provides otherwise, all submissions required or authorized to be filed in the proceeding must be filed with the ALJ.

(2) Submissions are considered filed when they are filed with the DAB according to the DAB's filing guidance.

(b) Format. (1) The ALJ may designate the format for copies of nondocumentary materials such as videotapes, computer disks, or physical evidence. This provision does not apply to the charge letter or other written notice provided under § 93.405.

(2) Every submission filed in the proceeding must include the title of the case, the docket number, and a designation of the nature of the submission.

(3) Every submission filed in the proceeding must be signed by and contain the address and telephone number of the party on whose behalf the document or paper was filed, or the attorney of record for the party.

(c) Service. Service of a submission on other parties is accomplished by filing the submission with the ALJ through the DAB electronic filing system.

(a) Parties must file all motions and requests for an order or ruling with the ALJ, serve them on the other party, state the nature of the relief requested, provide the legal authority relied upon, and state the facts alleged in support of the motion or request.

(b) All motions must be in writing.

(c) Within 10 days after being served with a motion, or other time as set by the ALJ, a party may file a response to the motion. The moving party may not file a reply to the response unless allowed by the ALJ.

(d) The ALJ may not grant a motion before the time for filing a response has expired, except with the parties' consent. However, the ALJ may overrule or deny any motion without awaiting a response.

(e) The ALJ must make a reasonable effort to dispose of all motions promptly.

(a) The ALJ must schedule an initial conference with the parties within 30 days of the DAB Chair's assignment of the case.

(b) The ALJ may use the initial conference to discuss:

(1) Identification and simplification of the issues, specification of genuine disputes of fact and their materiality to the ORI findings of research misconduct, and any proposed HHS administrative actions;

(2) Identification of material legal issues and any need for briefing;

(3) Scheduling dates for the filing of briefs based on the administrative record; and

(4) Other matters that may encourage the fair, just, and prompt disposition of the proceedings.

(c) The ALJ may schedule additional conferences as appropriate, upon reasonable notice to or request of the parties.

(d) All conferences will be recorded with copies provided to the parties upon request.

(e) Whenever possible, the ALJ shall memorialize in writing any oral rulings within 10 days after a conference is held.

(a) Based on the administrative record, the ALJ shall issue a ruling in writing within 60 days after the last submission by the parties in the case, setting forth whether ORI's research misconduct findings and proposed HHS administrative actions reflected in the charge letter are reasonable and not based on a material error of law or fact. If the ALJ is unable to meet the 60-day deadline, the ALJ must set a new deadline and promptly notify the parties. The ALJ shall serve a copy of the ruling upon the parties and the ASH.

(b) The ruling of the ALJ constitutes a recommended decision to the ASH. The ASH may review the ALJ's recommended decision and adopt, modify, or reject it (in whole or in part) as needed to ensure that the decision is reasonable and not based on a material error of law or fact. Within 30 days after service of the ALJ's recommended decision, the ASH shall notify the parties of the ASH's intent to review or not to review the ALJ's recommended decision. If the ASH does not provide notice of intent within the 30-day period or notifies the parties that the ASH does not intend to review the ALJ's recommended decision, the ALJ's recommended decision shall become final. An ALJ's recommended decision that becomes final in that manner or the ASH's decision after review constitutes the final HHS action on both ORI's findings of research misconduct and any HHS administrative actions.