FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number:

DIR-000082

Revision #: 00

Revised:

31 August 2020

Title: 

FMD-30B: ORA/CVM Animal Food Program Committee Page 1 of 11

For the most current and official copy, check QMiS.

Sections in This Document

1. Purpose ................................................................................................................................. 1

2. Scope .................................................................................................................................... 1

3. Responsibility ........................................................................................................................ 2

4. Background ........................................................................................................................... 5

5. References ............................................................................................................................ 5

6. Procedure.............................................................................................................................. 6

6.1. Animal Food Program Committee Membership: Selection and Tenure........................ 6

6.2. Animal Food Program Committee Meetings and Frequency........................................ 9

6.3. Animal Food Program Committee Communication ...................................................... 9

6.4. Animal Food Program Committee Reporting, Program Metrics, and Activities............. 9

6.5. Animal Food Program Committee Funding.................................................................. 9

7. Glossary/Definitions............................................................................................................. 10

8. Records ............................................................................................................................... 11

9. Supporting Documents ........................................................................................................ 11

10. Document History ................................................................................................................ 11

11. Change History.................................................................................................................... 11

12. Attachments......................................................................................................................... 11

1. Purpose

This Directive provides for the formation and operation of the Office of 

Regulatory Affairs (ORA) – Office of Human and Animal Food Operations 

(OHAFO) and the Center for Veterinary Medicine (CVM) Animal Food Program

Committee to discuss and address Agency priorities and Center initiatives of 

protecting human and animal health as relates to foods for animals, food 

products derived from animals, and animal food additives. The Committee also 

identifies workplanning activities and targets, develops annual work plans

(WP) and establishes strategic priorities to include inspections, compliance 

determinations, analytical needs, and import operations, and utilizes strategic 

thinking to recommend solutions to issues and challenges.

2. Scope

The scope of this document defines the role of the ORA/CVM Animal Food 

Program Committee. This document covers the roles and responsibilities for 
FOOD AND DRUG ADMINISTRATION

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Document Number:

DIR-000082

Revision #: 00

Revised:

31 August 2020

Title: 

FMD-30B: ORA/CVM Animal Food Program Committee Page 2 of 11

For the most current and official copy, check QMiS.

the Committee members as well as the process to collaborate and execute the 

Agency’s priorities for each fiscal year (FY).

3. Responsibility

A. ORA Executive Management

1. Provides support and leadership for the ORA/CVM Animal Food 

Program Committee.

2. Selects ORA representatives to support the Committee and to 

participate and attend meetings.

B. CVM Executive Management

1. Provides support and leadership for the ORA/CVM Animal Food 

Program Committee. 

2. Selects CVM representatives to support the Committee and to 

participate and attend meetings.

C. ORA/CVM Animal Food Program Committee

1. Serves as the program managers for ORA and CVM.

2. Serves as the principal contact for ORA (field and headquarters 

(HQ)) and CVM on matters relating to food for animals, food derived 

from animals, animal food additives, including work planning and 

budget issues.

3. Acts as liaison between ORA and CVM on general program matters. 

4. Seeks input from ORA and CVM units on proposals, programs, 

assignments, and initiatives. 

5. Reviews and provides input for field assignments, compliance 

programs, directives and procedural changes consistent with 

Agency policy.

6. Coordinates and participates in developing program goals, 

strategies, procedures, enforcement initiatives, and evaluation 

measures necessary to assure effective execution of the Agency's 

responsibilities.

7. Advises appropriate offices in the monitoring of program activities, 

assuring that assigned resources are effectively utilized in the

accomplishment of planned activities.
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8. Regularly communicates to respective ORA and CVM units and 

counterparts the status of program activities.

9. Identifies potential issues for evaluation and attention.

10.Keeps the Associate Commissioner for Regulatory Affairs (ACRA)

and Center Director(s) advised of program policies and directions as 

appropriate.

D. ORA Committee Representatives

1. Serve as the principal contacts for ORA (field and HQ).

2. Seek input from ORA units on CVM proposals, programs, and 

initiatives.

3. Seek input from CVM on ORA initiatives.

4. Review and provide feedback on documents related to program 

impacts and priorities.

5. Review and provide input for compliance programs, directives, 

assignments, and procedural changes to be issued by CVM to the 

field, consistent with ORA policy.

6. Manage program assignments and resources.

7. Execute program priorities to include related animal food issues 

involving ORA field laboratories & imports operations. 

8. Identify inspectional assignments, sample collections, field exams, 

sample analyses as needed to meet Agency priorities.

9. Develop workplans jointly with CVM and communicates

appropriately with the FDA Governance Board (GB).

10.Review new authorities granted by legislation and assist in 

implementation of regulations related to foods for animals, food 

products derived from animals, and animal food additives.

11.Work with external partners such as states, local and tribal officials, 

and territorial and foreign counterparts in the management of state, 

federal and local relations.

12.Maintain communications with ORA managers and field staff.

13.Identify and coordinate training needs as appropriate for field staff. 

E. CVM Committee Representatives

1. Share information and provide insight on Commissioner and CVM

level activities and priorities.
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Document Number:

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2. Serve as the principal contacts for CVM interactions and 

communications with ORA.

3. Communicate program strategic priorities and address issues raised 

by the Committee and during the review of documents such as the 

WP, compliance programs and/or assignments.

4. Develop and share information on the WP, assignments, program 

summaries, and evaluations.

5. Communicate policy, compliance, and enforcement strategies for 

major programs.

6. Establish and share information on inspections, sampling data, and

priorities.

7. Address requests for resource adjustments throughout the FY.

8. Manage communications with the GB.

9. Share information regarding budget development and budget 

priorities.

10.Facilitate approval and finalization of FY WP with the GB.

F. Ad Hoc Committee and Invited Representatives

1. Responsible for participating in, and constructively contributing to 

committee activities and accomplishments throughout the year. 

2. Represent field, HQ and CVM offices with operational responsibility 

and/or relevant experience with or impacted by the animal food 

program areas. 

3. Review and provide feedback on documents related to program 

operations, evaluations, and strategic priorities when appropriate.

4. Communicate strategic objectives, action items or major program 

changes to ORA and CVM managers and staff as applicable.

5. Participate in developing program goals, procedures, enforcement 

initiatives, problem solving, and evaluation measures necessary to 

assure effective execution of the Agency's responsibilities.

G. Animal Food Program Committee Co-advisors 

1. Provides consultation and senior level advice to the Committee. 

2. Serves as liaison with the ORA Senior Management Team and CVM 

Leadership Team. 

3. Provides support to the Committee Chairs execution of duties.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number:

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Revision #: 00

Revised:

31 August 2020

Title: 

FMD-30B: ORA/CVM Animal Food Program Committee Page 5 of 11

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H. Animal Food Program Committee Co-chairs 

1. Provide overall management, operation and direction for the

Committee. 

I. Animal Food Program Committee Vice Chair 

1. Serves in the absence of the ORA Committee Co-chair and assists 

the Committee Co-chairs in the management, operation and 

direction of the Committee. 

J. Executive Secretary 

1. Responsible for maintaining committee files, creating and storing 

minutes, tracking action items, and preparing other records to 

support Committee activities.

2. Responsible for distributing and routing materials to members and 

others; planning, scheduling and coordinating Committee meetings.

3. Conducts other administrative activities at the direction of the 

Committee Advisor and Chairs. 

4. Background

The Associate Commissioner for Regulatory Affairs previously established a 

system of Field Committees (FMD 30) to assist in managing the ORA 

organization and its implementation of Agency programs. In May 2017, ORA 

was realigned into distinct product-based regulatory programs areas to 

strengthen the workforce, improve public health response, and enable staff to 

work more closely with FDA scientific and technical experts on novel and 

complex regulatory challenges. 

As part of the ORA realignment, the specialized OHAFO was established. 

OHAFO was designated to lead ORA’s collaboration with the CFSAN and the 

CVM in protecting the safety of the nation's domestically produced and 

imported human and animal foods, dietary supplements, food products derived 

from animals, cosmetics and animal food additives. In addition, OHAFO is 

responsible for providing advice and counsel to FDA leaders regarding human 

and animal food products, field operations, and emergency response activities.

5. References

FMD-30 – ORA Program Committees
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Document Number:

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Revision #: 00

Revised:

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Title: 

FMD-30B: ORA/CVM Animal Food Program Committee Page 6 of 11

For the most current and official copy, check QMiS.

6. Procedure

6.1. Animal Food Program Committee Membership: Selection and Tenure

Members of the ORA/CVM Animal Food Program Committee include

representatives from the ORA (field and HQ) and CVM offices with operational 

responsibilities and/or involved with or impacted by the animal food program 

and/or have relevant experiences or expertise in the animal foods program 

areas.

A. The ORA/CVM Animal Food Program Committee composition consists

of the following:

1. Program Director: One (1) 

a. To serve as Animal Food Program Committee Co-advisor

selected by ORA Assistant Commissioner for Human and Animal 

Foods Operations (ACO) in consultation with the ACRA and 

CVM Director for an indefinite term at the discretion of the ACO.

2. Center Senior Director: One (1) 

a. To serve as Animal Food Program Committee Co-advisor 

selected by the Center Director and the ORA Assistant 

Commissioner for Human and Animal Foods Operations (ACO) 

in consultation with the ACRA and CVM director for an indefinite 

term at the discretion of the Center Director. 

3. Program Division Director: One (1) 

a. To serve as Animal Food Program Committee Co-chair selected 

by the ACO in consultation with the Animal Food Program 

Committee Advisor for a 3-year term. Subsequent one (1) year 

extensions may be authorized at the discretion of the ACO. 

4. CFSAN Senior Director: One (1)

a. To serve as Animal Food Program Committee Co-chair selected 

by the CVM Director in consultation with the ACO and the Animal 

Food Program Committee Advisor for a 3-year term. Subsequent 

one (1) year extensions may be authorized at the discretion of 

the CVM Director

5. Program Division Director or equivalent: One (1)

a. To serve as Animal Food Program Committee Vice Chair

selected by the Animal Food Program Committee Advisor in 
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Document Number:

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Revision #: 00

Revised:

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Title: 

FMD-30B: ORA/CVM Animal Food Program Committee Page 7 of 11

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consultation with the ACO for a 3-year term and mirror any 

extensions of the ORA Committee Co-chair. At the end of this 

term, the Vice Chair assumes the position of the ORA Co-chair.

6. Executive Secretary: One (1) 

a. Selected by the Animal Food Program Committee Chairs to 

serve an indefinite term at the discretion of the Chairs.

7. Program Division Director or equivalent: One (1)

a. To serve as a Committee Member, selected by the Animal Food

Program Committee Advisor and Chairs to serve an indefinite 

term at the discretion of the Chairs.

8. Division of Import Operations (DIO) Senior Director or Import 

Manager: One (1)

a. To serve as a Committee Member, selected by the Committee 

Chairs in consultation with the DIO Director to serve an indefinite 

term at the discretion of the Chairs.

9. ORS Senior Director: One (1)

a. To serve as a Committee Member, selected by the Committee 

Chairs in consultation with ORS Director to serve an indefinite 

term at the discretion of the Chairs. 

10.State Liaison: One (1)

a. To serve as Committee Member, selected by the Committee 

Chairs and Advisors for an indefinite term at the discretion of the 

Chairs.

11.Field Managers (below the level of Program Division Director): Two 

to Four (2-4)

a. Include at least one (1) Director, Investigations Branch (DIB) and 

one (1) Director, Compliance Branch (DCB). 

b. May include any combination of Supervisory Consumer Safety 

Officer (SCSO) and other field managers.

i. To serve as Committee Member(s), selected by the Animal 

Food Program Committee Chairs and Advisor for an indefinite 

term at the discretion of the Chairs.

12.Technical Expert(s): One to Two (1-2) 

a. This may include a Consumer Safety Officer (CSO), Compliance 

Officer (CO), Analyst, National or Program Expert.
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Document Number:

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Revision #: 00

Revised:

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Title: 

FMD-30B: ORA/CVM Animal Food Program Committee Page 8 of 11

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b. To serve as Committee Member(s)selected by the Animal Food 

Program Committee Chairs and Advisor to serve an indefinite 

term at the discretion of the Chairs.

c. Other Technical Experts may be called upon as needed, on a 

case-by-case basis to temporarily assist with specific projects 

and initiatives. 

13.CVM Division Directors and Managers: One to Two (1-2) 

a. To serve as Committee Member(s), selected by the Animal Food 

Program Committee Advisor to serve an indefinite term at the 

discretion of the Chairs.

14.CVM Technical Experts: One to Two (1-2)

a. To serve as Committee Member(s), nominated by the Animal 

Food Program Committee Advisor and Chairs to serve an 

indefinite term at the discretion of the Chairs.

B. Ad Hoc Committee and Invited Representatives: (As Needed))

1. To include ORA or CVM representatives involved with or impacted 

by the animal food program from the following areas: 

a. State Cooperative Programs

b. Federal-State Relations or Partnerships

c. Science (laboratory) 

d. Imports

e. Foreign Offices/Program

f. Resources/Work Planning 

g. Criminal Investigations

h. Compliance & Enforcement

i. Risk Management 

j. Quality System Management

k. Operational Policy

2. To serve as Committee Members or on Ad-Hoc Committees, 

selected by the Animal Food Program Committee Advisor and 

Chairs to serve an indefinite term at the discretion of the Chairs. 
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Document Number:

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Revision #: 00

Revised:

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Title: 

FMD-30B: ORA/CVM Animal Food Program Committee Page 9 of 11

For the most current and official copy, check QMiS.

6.2. Animal Food Program Committee Meetings and Frequency

A. At a minimum, the ORA/CVM Animal Food Program Committee meets 

annually face-to-face in a central location preferably during the first half 

of each calendar year. 

B. The Committee meets jointly with the ORA/CFSAN Human Food 

Program Committee for a period during the face-to-face annual 

meeting. 

C. The Committee has monthly virtual calls.

D. During the year, the ORA/CVM Animal Food Program Committee has at 

least one virtual call jointly with the ORA/CFSAN Human Food Program 

Committee.

6.3. Animal Food Program Committee Communication

A. The Committee Chairs and executive secretary communicate with other 

program committee chairs on a regular basis. 

1. To assure uniformity in policies and procedures among the various 

Agency program areas.

B. The Committee Chairs standardize the way committee meeting notes 

are prepared and distributed. 

1. To assure content of minutes and notes are accurate and properly 

suitable for use, distribution, and/or action. 

2. To clearly identify issues that have not yet been adopted as official 

policy.

6.4. Animal Food Program Committee Reporting, Program Metrics, and Activities

A. During the animal food program committee meetings, the Committee 

may identify assignments that require monitoring during the FY.

1. The Committee determines the strategic evaluation mechanisms for 

animal food program committee assignments and activities. 

2. The Committee establishes a process for memorializing decisions 

and meeting notes. 

6.5. Animal Food Program Committee Funding

A. ORA and CVM funds Committee members attendance and participation 

in Committee activities and meetings where appropriate.

B. ORA and CVM support costs and resources associated with the 

membership outlined in this Field Management Directive (FMD). 
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Title: 

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C. For ORA funding, the ORA Committee Chairs, in consultation with the 

Committee Advisors, prepares and submits a budget proposal to the 

ORA Office of Management (OM) at the beginning of each fiscal year 

(or when specified by OM). 

1. To provide funding for attendance and participation to include a 

face-to-face meeting of the Committee annually if possible as well as 

any other travel or expenses required by the Chair and/or other 

committee members as appropriate. 

2. To support requests for Committee special projects and/or initiatives. 

3. Upon receipt, OM reviews the budget proposal and provides the 

Committee with a budget that is managed by the Animal Food 

Program Committee Chairs.

7. Glossary/Definitions

A. Acronyms

1. ACRA: Associate Commissioner for Regulatory Affairs

2. ACO: Assistant Commissioner for Office of Human and Animal 

Foods

3. CFSAN: Center for Food Safety and Nutrition

4. CO: Compliance Officer

5. CSO: Consumer Safety Officer 

6. CVM: Center for Veterinary Medicine

7. DCB: Director, Compliance Branch

8. DIB: Director, Investigations Branch

9. DIO: Division of Import Operations

10.FMD: Field Management Directive

11.FY: Fiscal Year

12.GB: FDA Governance Board

13.HQ: Headquarters

14.OHAFO: Office of Human and Animal Foods Operations

15.OM: Office of Management

16.ORA: Office of Regulatory Affairs
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Revised:

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Title: 

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17.ORS: Office of Regulatory Science

18.SCSO: Supervisory Consumer Safety Officer

19.WP: Work Plan

8. Records

None 

9. Supporting Documents

None

10. Document History

Revision

#

Status*

(D, I, R)

Date Author Name and Title Approving Official Name 

and Title

00 I SEE DATE IN 

HEADER 

ABOVE

CHARLES BECOAT

DEPUTY DIRECTOR, OHAFO

EAST PROGRAM

MICHAEL ROGERS 

ASSISTANT COMMISSIONER, 

OHAFO PROGRAM

* - D: Draft, I: Initial, R: Revision

11. Change History

Revision 

#

Change

00 NOT APPLICABLE

12. Attachments

None