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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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10-8 - AD HOC COMMITTEE

10-8 - AD HOC COMMITTEE
      10-8-1 - Purpose
      10-8-2 - Composition
      10-8-3 - Procedures
      10-8-4 - Responsibilities

  10-8 - AD HOC COMMITTEE

  10-8-1 - Purpose

This section outlines the function, composition, and activities of agency ad hoc committees that are convened for enforcement purposes, and lists the responsibilities of the field and headquarters units in recommending and carrying out their goals.

Function

There are four principle types of ad hoc committees: “strategy,” “referral,” “appeal,” and “seizure/injunction.”

  1. Strategy ad hoc committees are formed to resolve issues for which agency precedent is lacking on matters that involve complex and difficult enforcement issues, or where there is a dispute between two or more offices over strategy.
  2. Referral ad hoc committees are formed to consider the referral of a matter to the Department of Justice for further criminal investigations or proceedings.  See Chapter 6, “Judicial Actions.”

Note: The Office of Criminal Investigations (OCI) is responsible for reviewing all matters within FDA’s jurisdiction for which a criminal investigation may be recommended.  If the district or center office believes that there is a need for a criminal investigation, they must contact OCI immediately.  If OCI concludes that they will not be participating in the matter at the time, the district office or center may then proceed as outlined below under “Procedures.”

  1. Appeal ad hoc committees are formed to resolve issues pertaining to a legal, administrative, or regulatory course of action when enforcement policy is inconsistent, unclear or not fully developed.
  2. Seizure/injunction ad hoc committees may be convened at any time during the preliminary assessment, case initiation, or concurrent review process (see Chapter 6) when a Regional Food and Drug Director (RFDD); the Director, Office of Regional Operations (ORO); the Director, Office of Enforcement (OE); the Center Director, or the Deputy Chief Counsel for Litigation, or a designee, cannot agree on the strategy or viability of a seizure or injunction case.

Ad hoc committees may be formed at any point in the case development or review process; however, early identification of the need for an ad hoc committee enables a more prompt review of the action.

  10-8-2 - Composition

The ad hoc committee will be chaired by the Director, OE, and will consist of the RFDD, the appropriate Center Director of Compliance, the Deputy Chief Counsel for Litigation and, if appropriate, the Director, OCI.  The Director, ORO, should be included when the matter involves the Division of Foreign Field Inspections (DFFI).  When a committee member is unable to participate in a scheduled ad hoc meeting, he or she must designate an appropriate official to serve in his or her absence.

The committee members or their designated representatives should be prepared to make agency decisions on the issues based upon the evidence presented prior to and during the ad hoc committee meeting.  The committee members are also responsible for identifying and arranging for the participation of any additional personnel and for other resources that they feel are necessary.  Personnel should be limited to those individuals who have knowledge of the events at issue or who can significantly help in the decision making process.

  10-8-3 - Procedures

Requests for forming a strategy, referral, appeal, or seizure/injunction ad hoc committee may originate from an RFDD; the Director, ORO; the Director, OE; a Director of Compliance; or the Deputy Chief Counsel for Litigation.

If the parties cannot reach an agreement working on their own or with the help of Division of Compliance Management and Operations (DCMO), DCMO will schedule an ad hoc committee meeting.

  1. The person who requests an ad hoc committee must submit a memorandum via CMS to OE, DCMO.  The memorandum should specify the type of ad hoc committee being requested.
    1. The person who requests a strategy ad hoc committee should include in the memorandum the recommended outcome of the meeting.
    2. The person who requests a referral ad hoc committee should include in the memorandum a description of the evidence expected to be gained through further criminal investigations or proceedings and the reasons it is necessary to refer the matter to the Department of Justice instead of continuing with an FDA investigation.
    3. The person who requests an appeal ad hoc committee does not need to summarize the facts and evidence in the memorandum if the committee participants are already familiar with the case; however, if the committee participants are unfamiliar with the case, the person who requests an appeal ad hoc should include sufficient background and supporting information in the memorandum.
    4. The person who requests a seizure/injunction ad hoc committee should describe any disputed data, information, or views in the memorandum.  When an ad hoc committee is requested, the clock for reviewing seizure/injunction cases will be tolled.  Therefore, the time it takes to review the ad hoc request will not be applied against the timelines for reviewing seizure/injunction cases, described in section 6-1-5 (4).  The ad hoc committee will immediately establish a time schedule for its review of the case.

At the ad hoc committee meeting, the person who requested the meeting will briefly summarize the reason for the request, recommend an outcome of the meeting, describe any foreseeable problems, and provide whatever information may be useful in reaching a decision.

All decisions made by the ad hoc committee, including necessary follow-up and strategy, will be recorded, disseminated, and noted in the appropriate section of CMS by the DCMO Compliance Officer assigned to the case.

The ad hoc committee may reconvene in cases of significant changes or revisions to the original ad hoc supporting material, the discovery of new information or evidence, or when other issues arise that could impact the original decision of the committee.  These changes must first be reviewed under the regular review process.  If it is necessary to reconvene the ad hoc committee, the original ad hoc attendees should make every effort to attend any follow-up ad hoc meeting.

In most instances, the committee will reach a decision through consensus of the members. When consensus is not possible, the Director, OE will refer the matter to the Associate Commissioner for Regulatory Affairs (ACRA) with a recommendation for making a final decision.

All committee decisions are subject to review by the ACRA and OCC, and the final decision will not be subject to appeal.

  10-8-4 - Responsibilities

OE receives the request for convening an ad hoc committee review.  OE assesses the request to determine if there is a clear indication of a dispute or other issue in need of resolution, determines whether sufficient information was submitted, attempts to obtain a resolution with the parties, and if a resolution cannot be reached, establishes the time and place for the meeting.  OE will also disseminate the request and any supporting material to the principal members of the ad hoc committee.

The Director, OE, chairs the ad hoc committee and issues the final decision based upon the ad hoc committee’s discussion.  If the ad hoc committee cannot reach a decision, the Director, OE, refers the matter to the ACRA for a final decision.

The Director, ORO, may recommend convening an ad hoc committee based on issues that arise from ORO headquarters based program activities.

The RFDDs make a final decision on all recommendations for an ad hoc committee from the field. The Regional Director serves as a principal on the ad hoc committee.

The District Director may recommend the convening of an ad hoc committee and forward the recommendation to OE/DCMO through the RFDD.

The Director of Compliance of the appropriate Center approves or disapproves all recommendations for an ad hoc committee from the center and will serve as a principal on the ad hoc committee.

The Deputy Chief Counsel for Litigation will serve as a principal on the ad hoc committee to provide legal counsel, and to advise on a particular recommendation.

The ACRA may review all committee decisions.

Committee members who are unable to participate in a scheduled ad hoc meeting are responsible for designating an appropriate official to serve in their absence.  The committee members are also responsible for identifying and arranging for the participation of any appropriate resource persons they feel are necessary, and for providing necessary background information to those persons.