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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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ORA Functional Committee

Subject:
ORA Functional Committee
Area:
Operations Management
Date Revised:
March, 26 2010

 

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 functional committee only.

 

Role of the Functional Committee

 

The primary role of the Functional Committees is to assist in the management of ORA resources, inter-agency and intra-agency coordination, and other activities of the organization, as more specifically reflected in the individual committee’s mission statements.  This role includes the following functions:

 

  • Serves as the focal point in ORA in the specified area
  • Identifies and facilitates resolution of problems
  • Develops, coordinates, and assists in the execution of initiatives designed to improve operations or otherwise support ORA activities.
  • Communicates to ORA components, the status and results of committee activities.

 

Functional Committee Responsibilities

 

In additions to the functions identified above, each Functional Committee should:

 

  • Develop a mission statement and provide it to the ACRA for review; the mission statement should be reviewed annually and updated when needed.
  • Develop an annual activities plan and provide it to the ORA Senior Management Team for review.
  • Prepare an annual report of accomplishments and provide it to the ORA Senior Management team for review; after review, issue the annual report to field and headquarters management.
  • Review the membership of the committee annually and make adjustments as needed to promote the continued success of the committee. 

 

Functional Committee Membership; Selection and Tenure

 

The members of the Functional Committee should include individuals having knowledge and interest in the specific areas.  Committee composition should consist of about 7-14 members as follows:

 

1 RFDD to serve as Committee Chair, selected by the ACRA for an indefinite term at the discretion of the ACRA

 

1-2 District or Division Director(s) to serve as Committee Member(s), selected by the Committee Chair for an indefinite term at the discretion of the Committee Chair.

 

1 Laboratory Manager, at or below the Laboratory Director level, to serve as Committee Member(s), selected by the Committee Chair for an indefinite term at the discretion of the Committee Chair.

 

1-3 field manager(s) below the district director level (e.g. branch directors, steering committee members, leadership team members, first line supervisors, or team leaders) to serve as Committee Member(s), selected by the Committee Chair for an indefinite term at the discretion of the Committee Chair.

 

1-3 individuals from the ORA headquarters counterpart functional component or such component having interests in the committee’s area to serve as Committee Member(s), selected by the Committee Chair and the appropriate ORA headquarters office director for an indefinite term at the discretion of the Committee Chair.

 

1 Executive Secretary (optional, at the discretion of the Committee Chair) to serve as a Committee Member, selected by the Committee Chair for an indefinite term at the discretion of the Committee Chair.

 

1-3 technical experts (the need of which to be determined by the Committee Chair) to serve as a Committee Member, selected from any FDA component by the Committee Chair and the manager of the sponsoring component, for an indefinite term at the discretion of the Committee Chair.

 

Functional Committee Member Responsibilities and Accountability

 

 

Committee Chair provides senior level advice, overall management and direction to the Committee, and serves as liaison with the ORA Senior Management Team. Such role should be reflected (as much as 25% of the individual’s time may be devoted to this activity) and evaluated in the individual's SES performance plan.

 

Committee Vice Chair is designated by the Committee Chair and is typically one of the District or Division Director members. The 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 25% 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.

 

Functional Committee Funding

 

The Committee Chair 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 proposal 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. Any budget request above that baseline requires careful justification. 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 functional committees and their members.