Office of Regulatory Affairs

GENERAL

The Associate Commissioner for Regulatory Affairs has established a system of Field Committees to assist in managing the Office of Regulatory Affairs organization and its implementation of agency programs. There are two categories of field committees; those addressing specific program areas, i.e. human drugs, devices and radiological health, human foods and cosmetics, biologics, tobacco, and veterinary medicine/animal feed; and those addressing functional aspects of the ORA organization, i.e. human resources. This Directive will address the Program Committee only.

THE PROGRAM COMMITTEE

Role of the Program Committee

ORA is currently evaluating the use of a Center nominated co-chair to foster improved communication and coordination. Continuing with expansion of this program will be at the discretion of the ACRA. The primary role of the Program Committee is to serve as the program managers for ORA and Centers in a specific program area. This role is comprehensive in nature and entails the following functions:

• Serves as the principal contact for ORA (field and headquarters) and Center(s) on matters relating to the specific program area, including work planning and budget issues.
• Acts as liaison between ORA and the Center(s) on general program matters. As such, seeks input from ORA components on center proposals, programs, and initiatives in order to formulate an "institutional" ORA position. Similarly, seeks input from the Center(s) on ORA initiatives. Reviews and clears, with appropriate ORA input, compliance programs, circulars and changes thereto issued by the center to the field, consistent with ORA policy.
• Coordinates and participates with the Center in developing program implementation goals, strategies, procedures, strategic enforcement initiatives, problem solving, and evaluation measures necessary to assure effective execution of the agency's responsibilities.
• Advises ORM/DPEM in the monitoring of program activities by ORA assuring that assigned resources are effectively utilized in accomplishment of planned activities.
• Regularly communicates to respective ORA and Center components and counterparts the status of program activities. Keeps the ACRA and Center Director(s) advised of program policies and directions as they evolve and identifies potential quality issues for evaluation and attention.

Program Committee Responsibilities

In addition to the functions identified above, each Program Committee should:

• At a minimum, meet annually in a central location and have periodic (e.g. monthly) conference calls throughout the year
• Develop a plan of activities to include specific objectives, initiatives or other projects. This should be done on an annual basis and provided to the ACRA.
• Promptly, following the annual meeting, communicate those decisions, action items or major program changes to ORA managers via the ORA weekly conference call.
• Establish an eRoom to serve as a communication mechanism to promptly distribute meeting decisions, action items, meeting minutes and other communications throughout the year

Program Committee Membership; Selection and Tenure

Members of the Program Committee should represent field offices and ORAHQ offices having a significant industry pertinent to the focus of the committee or policy and operational responsibility, respectively; or individually have significant experience in implementing programs relating to the pertinent industry. To the extent possible, committee membership should also represent each region. Committee composition should consist of members as follows:

1 RFDD to serve as Committee Advisor, selected by the ACRA in consultation with the appropriate center for an indefinite term at the discretion of the ACRA.

1 District Director selected by the ACRA in consultation with the Committee Advisor, to serve as Committee Chair to serve a term of 3 years. Subsequent one year extensions may be authorized at the discretion of the ACRA. The Committee Chair position is filled by the Committee Vice Chair at the completion of his/her term as such.

1 District Director or equivalent to serve as Committee Vice Chair, selected by the Committee Chair in consultation with the Committee Advisor, to serve a term of 3 years and mirrors any extensions of the Committee Chair. At the end of this term, the Vice Chair assumes the position of Chair.

1 Executive Secretary, selected by the Committee Chair to serve an indefinite term at the discretion of the Chair.

1-2 District Directors or equivalent to serve as a Committee Member, selected by the Committee Chair to serve an indefinite term at the discretion of the Chair.

2-4 field (including OCI) managers below the level of district director to serve as Committee Member(s), selected by the Committee Chair for an indefinite term at the discretion of the Chair.

1 Public Affairs Specialist or Small Business Representative to serve as a Committee Member, selected by the Committee Chair for an indefinite term at the discretion of the Chair if that need is identified for a specific committee.

1-2 technical expert(s) (CSO, CO, Analyst) to serve as Committee Member, nominated by ORO and selected by the Committee Chair to serve an indefinite term at the discretion of the Chair.

ORA headquarters representatives to serve as Committee Members, nominated by the relevant Office Director and selected by the Committee Chair, to serve an indefinite term at the discretion of the Chair. ORAHQ Committee Members will typically represent the following functions, if needed for a specific committee: science, imports, inspections, criminal investigations, federal-state, compliance, risk management, and resources/work planning.

Note: While the committee is officially structured with ORA membership, Center personnel will be encouraged to participate in the annual meeting, general committee activities, and specific projects. ORA is currently evaluating the use of a Center nominated co-chair to foster improved communication and coordination. Continuing with expansion of this program will be a the discretion of the ACRA. It is further noted that the tenure specifications for committee membership constitute guidelines that may be adjusted if circumstances warrant, and with concurrence of the ACRA.

Program Committee Member Responsibilities and Accountability

Committee Advisor provides consultation and senior level advice to the committee. Serves as liaison with the Field Management Team (RFDDs) and Senior Management Team (RFDD's, Office Directors, ACRA and Deputy ACRAs). Provides support to the Committee Chair's execution of duties. Such role should be reflected and evaluated in the individual's SES performance plan.

Committee Chair provides overall management and direction of the committee. The chair's performance plan will acknowledge that up to 30% of the individual's time will be devoted to this activity. The Chair's performance should be reflected and evaluated in the individual's performance plan.

Committee Vice Chair serves in the absence of the Committee Chair and otherwise assists the Committee Chair in the management and direction of the committee. The performance plan of the Vice Chair will recognize at least 20% of the individual's time being devoted to the performance of this function. The Vice Chair's performance should be reflected and evaluated in the individual's performance plan.

Executive Secretary is responsible for maintaining committee files; creating minutes, tracking action items, and preparing other records to support committee activities; routing/distributing materials to members and others; planning, scheduling and coordinating committee meetings; and other administrative activities at the direction of the Committee Chair. The performance plan for the Executive Secretary will reflect that up to 30% of the individual's time will be devoted to this activity. The Executive Secretary's performance should be reflected and evaluated in the individual's performance plan.

The remaining Committee Members are responsible for participating in, and constructively contributing to, committee activities and accomplishments throughout the year. Members' performance plans will reflect that up to 15% of the individual's time will be devoted to this activity. Committee Members' performance should be reflected and evaluated in the individuals' performance plans.

Program Committee Chair Communication

The chairs of the Program Committees should strive to communicate with one another on a regular basis. A major objective of such communications is to assure uniformity in policies and procedures among the various agency program areas.

The committee chairs should strive to standardize the manner in which committee meeting notes are prepared and distributed. It is incumbent upon the committee chair to assure that content of such notes is properly characterized as to its suitability for implementation by the field organization. In other words, official policies should be clearly identified as suitable for implementation as opposed to issues that have not yet been adopted as official policy.

Program Committee Funding

The Committee Chair, in consultation with the Committee Advisor, will prepare and submit a budget proposal to the Office of Resource Management at the beginning of each year (or when specified by that office). Such budget shall provide for travel funds permitting at least one meeting of the committee annually as well as any travel required by the Committee Chair or other members as a result of such membership. Requests for additional funds to support more than the annual meeting or special committee projects/initiatives may be included, but must be carefully justified. The Office of Resource Management will consider said request and provide the committee with an annual budget that is managed by the Committee Chair.

Refer to The Office of Regional Operations Field Committee Intranet site for the current listing of all field committee members.