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 the goals of the ad hoc committee.

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10-8-2 - Background

 In 1984, an Office of Planning and Evaluation (OPE) study of the routine and non-routine case procedure disclosed considerable support for the ad hoc committee system from agency managers and case reviewers. An updated 1986 OPE study demonstrated that the use of ad hoccommittees expedited the processing of injunctions by resolving issues, planning regulatory procedures, and committing responsible units to an action plan.

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10-8-3 - Function

There are three principle types of ad hoc committees, "strategy," "referral," and "appeal."

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 the scope of FDA 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."
   
   Either type of ad hoc committee may be formed at any point in the case development or review process. However, early identification of the need for an ad hoc committee expedites subsequent decision-making and enables a more prompt review of legal actions. Every effort should be made to use this procedure in the early stages of a complex or difficult investigation, before enforcement action is recommended or fully developed.
3. An appeal ad hoc committee may also be convened when an agency component appeals an adverse decision (See APPEAL PROCESS) or disputes a regulatory course of action, because enforcement policy is inconsistent, unclear or non-existent. Before such an ad hoc is requested, the parties in disagreement should first attempt to resolve the disputed issues between themselves.

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10-8-4 - Composition

The ad hoc committee will be chaired by the Director, Office of Enforcement (OE), and will consist of the Regional Food and Drug Director (RFDD), the appropriate Center Director of Compliance, the Deputy Chief Counsel for Litigation and, if appropriate, the Director, OCI. These individuals are the "principals." When the principals are unable to participate in a scheduled ad hoc meeting, they must designate a senior compliance official (or attorney for the Office of Chief Counsel (OCC)) to serve in their absence.

The principals 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 meeting. The principals are also responsible for identifying and arranging for the participation of any appropriate resource persons they feel are necessary. Resource persons should be limited to those individuals who have knowledge of the events at issue or who can significantly help in the decision making process.en themselves.

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10-8-5 - Procedures

Requests for forming an ad hoc committee may originate from an RFDD, a District Director (with RFDD concurrence), a Center Director of Compliance or its equivalent, the Director, Office of Regional Operations (ORO), the Director, OE, or the Deputy Chief Counsel for Litigation.

The requesting office must submit an original and three copies of the ad hoc request and supporting material to OE, Division of Compliance Management and Operations (DCMO), HFC-210. Except in case of an immediate emergency, the committee must be given at least ten working days to review the ad hoc request and the accompanying material.

The ad hoc request (consisting of an executive summary no greater than five pages in length) must provide the following information:

1. A brief factual background of the case or enforcement matter.
2. A description of the evidence that FDA has in hand, including pertinent exhibits (exhibits should be limited to the matter at issue).
3. For a strategy ad hoc, the requesting office's recommended outcome of the ad hoc meeting.
4. For a referral ad hoc, a description of the evidence expected to be gained through the grand jury and the reasons it is necessary to refer the matter to the grand jury instead of continuing with an FDA investigation.
5. For an appeal ad hoc, the appeal memorandum (RPM section 10-9-5) and a summary of DCMO attempts to gain resolution of the disagreement by the parties to the appeal.
6. A description of options previously considered, and the reasons those options were rejected.
7. Any other reasons for submitting the ad hoc request.

The meeting will be chaired by the Director, Office of Enforcement. The principal committee member requesting the ad hoc meeting will briefly summarize the reason for the request, the recommended outcome of the meeting, describe any foreseeable problems, and provide whatever additional information that may be useful in reaching a decision.

All decisions made by the ad hoc committee, including necessary follow-up and strategy, will be recorded and disseminated by the DCMO Compliance Officer assigned to the matter. The ad hoc committee may reconvene in cases of significant changes/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. If it is necessary to reconvene the ad hoccommittee, the ad hoc principals attending the original meeting 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.

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10-8-6 - Responsibilities

OE/DCMO receives the request for convening an ad hoc committee, reviews and assesses the submission to determine if there is a clear indication of a dispute or other issue in need of resolution, determines that the supporting information is complete, establishes the time and place for the meeting, and disseminates 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 rise 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 with appropriate background information to OE through the RFDD.

The Center Director of Compliance or equivalent 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, OCC, will serve as a principal on the ad hoc committee to provide legal counsel.

Principals who are unable to participate in a scheduled ad hoc meeting are responsible for designating a senior compliance official to serve in their absence. The principals 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.

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