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. drugs, devices, foods, etc.; and those addressing functional aspects of the ORA organization, i.e. public affairs, human resources development, etc.

THE PROGRAM COMMITTEE

Role Of The Program Committee

The primary role of the Program Committee is to serve as the program manager for ORA 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 Centers on matters relating to the specific program area, including work planning and budget issues.

- Acts as liaison between ORA and the Center 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 FMD-17.

- Reviews, utilizing ORA component input, and clears compliance programs, circulars, amendments and changes issued by the center to the field.

- 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.

- Consults with ORA field and headquarters components in the development of partnership agreements consistent with the ORA-21 Partnership Agreement Document.

- Monitors program activities by ORA assuring that assigned resources are effectively utilized in accomplishment of planned activities. Identifies and communicates to field managers under/over accomplishments in program areas.

- Regularly communicates to ORA components and Center counterparts the status of program activities. Keeps the ACRA advised of program policies and directions as they evolve. Identifies potential quality issues for evaluation and attention.

Program Committee Responsibilities

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

- 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 meeting, communicate those decisions, action items or major program changes to ORA managers via the weekly conference call.

Additionally, the Program Committee may:

- Develop a mission statement. This should be compatible with those of the agency, center, and ORA and should be updated annually and provided to the ACRA.

Program Committee Membership; Selection and Tenure

Members of the Program Committee should represent field offices having a significant industry pertinent to the focus of the committee; or individually have significant experience in implementing programs relating to the pertinent industry. To the extent possible, committee membership should also represent the geographic distribution of the industry in the United States. Committee composition should consist of 8-10 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 or equivalent selected by the ACRA in consultation with the Committee Advisor, to serve as Committee Chair to serve a term of 2-3 years. Subsequent terms by the same individual may be served provided they are interrupted by at least one term of another individual. 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 no more than 2-3 years. At the end of this term, the Vice Chair assumes the position of Chair.

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

1-2 field (including OCI) manager(s) below the level of district director such as branch directors, steering committee members, or first line supervisors, 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 technical expert (CSO, CO, Analyst) to serve as Committee Member, selected by the Committee Chair to serve an indefinite term at the discretion of the Chair.

ORA headquarters resource representatives to serve as Committee Members, selected by the Committee Chair and the appropriate ORA headquarters Office Director to serve an indefinite term at the discretion of the Chair.

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

Note: While the committee is officially structured with ORA membership, it is expected that Center personnel will be encouraged to participate in general committee activities and specific projects. There is no prohibition, if the Chair so desires, of having Center personnel participate in Committee activities as a Committee Member. Moreover, as has been customary practice when conducting formal meetings with the Centers, chair responsibilities should be shared between the Committee Chair and the respective Center counterpart, i.e. Office Director, Center Director, etc.

It is 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 ORA management. Provides support to the Committee Chair's execution of duties. Such role will 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 20% of the individual's time will be devoted to this activity. It will provide for an evaluation of the effectiveness of the individual in performing the responsibilities of the Committee Chair. The Chair's rating official should consult with the Committee Advisor and counterpart Center management when assessing performance.

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 rating official should consult with the Committee Chair and Committee Advisor when assessing performance.

Committee Members are responsible for participating in, and constructively contributing to, committee activities and accomplishments. Members' performance plans will reflect that up to 15% of the individual's time will be devoted to this activity. It will provide for an evaluation of the effectiveness of the individual in performing committee member responsibilities. The member's rating official shall consult with the Committee Chair when assessing member performance.

Executive Secretary is responsible for maintaining committee files; creating minutes and 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 individual's performance plan will reflect from 20% to 30% of the individual's time will be devoted to this activity and will provide for an evaluation of the individual's performance of these responsibilities. The rating official shall consult with the Committee Chair when assessing the individual's performance.

ORA Resource Person has the same responsibilities as set forth above for Committee Members. In addition, this individual provides staff assistance to the committee in the coordination of committee activities among headquarters components and represents ORA headquarters components during Committee meetings and other functions. The individual's performance plan may reflect an appropriate percentage of time representing the demands of committee work and thus an evaluation of the individual's performance of these responsibilities. The rating official shall consult with the Committee Chair when assessing the individual's performance.

Program Committee Chair Communication

The chairs of the Program Committees should strive to communicate with one another on a regular basis. Conference calls and video conferences should be used for this purpose. Senior staff meetings and other such meetings should be seized as opportunities to meet and communicate. 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 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 mark.

THE FUNCTIONAL COMMITTEE

Role of The Functional Committee

The primary role of the Functional Committees is to assist in the management of ORA resources, interagency and intragency 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 addition to the functions identified above, each Functional Committee should:

- Develop a mission statement which should be updated annually and provided to the ACRA.

- Develop an annual activities plan to share with senior ORA management.

- Provide an annual report of accomplishments to ORA field and headquarters management.

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 7-9 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 Director(s) or equivalent to serve as Committee Member(s), selected by the Committee Chair for an indefinite term at the discretion of the Committee Chair.

1-2 field manager(s) below the district director level such as 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.

1-2 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 or more technical expert (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.

1 Public Affairs Specialist may serve as a Committee Member on the following functional committees; Federal/State Relations; Public Affairs; Human Resources; and International Trade, to serve as a Committee Member selected by the Committee Chair for an indefinite term at the discretion of the Committee Chair.

Functional Committee Member Responsibilities and Accountability

Committee members' responsibilities and accountability for Functional Committees is the same as that described above for members of Program Committees. The performance evaluations elements for members belonging to agency components other than ORA will require negotiation between the Committee Chair and the sponsoring component, as necessary.

Functional Committee Funding

The funding mechanism identified above for Program Committees shall be followed to address the funding needs of the Functional Committees.

FMD #30 ATTACHMENT

ORA FIELD COMMITTEE MEMBERSHIP

(January 2003)

PROGRAM COMMITTEES

CFSAN:

Chairperson:  Singleton, DD, FLA-DO
Advisor:         Dykstra, RFDD, Southeast
Member:        Wekell, Director, NRL (Vice Chair)
Member:        Ormond, Special Assistant, FLA-DO (Ex Secy)
Member:        Kravchuk, DIB, NWE-DO
Member:        Corcoran, DIB, SEA-DO
Member:        Grelle, DCB, CIN-DO
Member:        Hart, DIOB, NYK-DO
Member:        Givens, DD, DET-DO
Member:        Cato, DCB, SWID
Member:       Weineke, NE, ORO/DFI
HQ Resource Member:        Saben, Special Assistant, ORA
Member:        ORO, OE and ORM Representatives

CDER:

Chairperson:  Ellsworth, DD, NWJ-DO
Advisor:         Setterberg, RFDD, Central
Member:        Baumgarten, DD, CHI-DO (Vice Chair)
Member:        CER CSO, Rotational (Ex Secy)
Member:        Breen, DD, SEA-DO
Member:        Fricke, Director, FCC
Member:        Becoat, DLB, PHI-DO
Member:        Thorsky, DCB, KAN-DO
Member:        Eng, DIB, NYK-DO
HQ Resource Member:        Murphy, Scientific Coordinator, ORO/DFS
Member:        ORO, OE and ORM Representatives

CBER:

Chairperson:  Bowers, DD, BLT-DO
Advisor:         Kolaitis, RFDD, Northeast
Member:        Draper, DD, NOL-DO (Vice Chair)
Member:        Jacobson, SCSO, NYK-DO (Ex Secy)
Member:        Elder, DCB, NWE-DO
Member:        Woleske, DD, ATL-DO
Member:        Thornburg, DIB, DAL-DO
Member:        Keville, Director, PRL-SW
Member:        Collins, DD, DEN-DO
Member:        Guilfoyle, Microbiologist, NRL
Member:        Loreng, NE, ORO/DFI
Member:        Carden, NE, ORO/DFI
HQ Resource Member:        Lynch, Special Assistant, ORO
Member:        ORO, OE and ORM Representatives

CVM:

Chairperson:  Woyshner, DD, NYK-DO
Advisor:         Holman, RFDD, Pacific
Member:        Gardine, DD, PHI-DO (Vice Chair)
Member:        TBD (Ex Secy)
Member:        Linsley, DD, SAN-DO
Member:        Lancette, Director, SRL
Member:        Sedgwick, DD, KAN-DO
Member:        Lewis, DIB, NOL-DO/Nashville
Member:        Long, Director, PRL-NW
HQ Resource Member:      Dunnie, CSO, ORO/DFI
Member:        ORO, OE and ORM Representatives

CDRH:

Chairperson: Chappell, DD, DAL-DO
Advisor:        Pierce, RFDD, Southwest
Member:       Costello, DD, NWE-DO (Vice Chair)
Member:       Yetts, Special Assistant, DAL-DO (Ex Secy)
Member:       Finkelson, Director, WEAC
Member:       Cruse, DD, LOS-DO
Member:       Miller, DCB, PHI-DO
Member:       Heppe, DD, CIN-DO
Member:       Trout, RRHR, SER-RO
HQ Resource Member:       Governale, CSO, OE
Member:       ORO, OE, OCI and ORM Representatives

Functional Committees

Human Resources:

Chairperson:  Setterberg, RFDD, Central
Member:       Holden, Director, ORM/DPO
Member:       Breeden, DMPSB, CER (Ex Secy)
Member:       DD member (TBD)
Member:       Hart, DIOB, NYK-DO
Member:       Bonnin, ACNA Director, SRL
Member:       Rodriguez, DCB, DAL-DO
Member:       Wyman, RTO, PAR
Member:       German, Director, DHRD

International Programs:

Chairperson: Pierce, RFDD, Southwest
Member:       Holman, RFDD, Pacific (Vice Chair)
Member:       Pace, SWR (Ex Secy)
Member:       Dunkin, OCI
Member:       Gardine, DD, PHI-DO
Member:       Kaiser, CSI, DET-DO
Member:       Singleton, DD, FLA-DO
Member:       Cruse, DD, LOS-DO
Member:       Woyshner, DD, NYK-DO
Member:       Nielsen, Director, ORO/DIOP
Ex Officio:    Solomon, Deputy Director, ORO
Ex Officio:    England, ORA
Ex Officio:    Barber, International Program Manager, ORO      

Chief Counsel:

Chairperson: Taylor, Director, OE
Member:       Chappell, DD, DAL-DO
Member:       Bowers, DD, BLT-DO
Member:       Ellsworth, DD, NWJ-DO
Member:       Singleton, DD, FLA-DO
Member:       Woyshner, DD, NYK-DO
Member:       Thomas, DCB, NYK-DO
Member:       Thorsky, DCB, KAN-DO
Ex Officio:    Ralston, Director, ORO

Research & Technology Transfer:

Chairperson: Setterberg, RFDD, Central
Member:       Montalvo and Porter, ORO/DFS (Ex Secys)
Member:       O'Neill, Branch Director, PRL-NW
Member:       Schenk, Research Chemist, SRL
Member:       Sciacchitano, ORO/DFS
Member:       Sofos, Science Advisor, ORO/DFS
Member:       Specchio, Science Advisor, ORO/DFS
Member:       Wekell, Director, NRL
Member:       Wolnik, Branch Director, FCC
Member:       NCTR member (TBD)
Ex Officio:    Olson, Director, ORO/DFS

Federal/State Relations:

Chairperson: Dykstra, RFDD, Southeast
Member:       Farmer, SER (Ex Secy)
Member:       Bonanno, Deputy RFDD, CER
Member:       German, Director, ORM/DHRD
Member:       Eu, PAS, LOS-DO
Member:       Corby, State Rep., AFDO
Member:       Strayer, State Rep., CFP
Member:       Barnes, Director, ORO/DFSR
Member:       Schrade, DSPB, NER
Member:       Bowers, DD, BLT-DO
Member:       Thornburg, DIB, DAL-DO

Administrative Management Operations

Chairperson: Kolaitis, RFDD, Northeast
Member:       Breeden, ORM/DMO
Member:       Evans, Deputy RFDD, Southwest
Member:       Franklin, SAS, CHI-DO
Member:       Linsley, DD, SAN-DO
Member:       Muccioli, DMPSB, NWE-DO
Member:       Thies, SEA-DO
Member:       Farmer, SER
Member:       Swerock, ORM/DMO
Ex Officio:    Strachan, Deputy Director, ORM