FY2021

OTED Annual Report

U.S. Food and Drug Administration

Office of Regulatory Affairs

Office of Training Education and Development (OTED)
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U.S. Food and Drug Administration/ORA/OTED

11919 Rockville Pike

Rockville, MD 20852

Phone: 301-796-4550

Phone: 301-827-8708

Email: oted@fda.hhs.gov

Intranet Website: Office of Training, Education and Development - Home (sharepoint.com)

Internet Website: Office of Training Education and Development (OTED) | FDA
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Table Of Contents 

Introduction by OTED Director ............................................................................3

OTED Mission, Vision & Responsibilities.............................................................4

Goals and Objectives ..........................................................................................4

OTED FY2021 Strategic Priorities .......................................................................5

OTED Training & Certification FY2021 Routine Workplan...................................6

Accomplishments by Division:

• Division of Instructional Systems and Technology (DIST) ........................8

• Division of Multi-Program Leadership and Management 

Training (DMPLMT)................................................................................. 10

• Division of Programmatic Training (DPT) ............................................... 12

• Division of Test, Measurement and Certification (DTMC)....................... 14

FY21 Data and Charts ...................................................................................... 16
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Introduction by OTED Director, 

Patricia Alcock

Welcome to our FY2021 OTED Annual Report!

The Office of Training Education and Development (OTED) provides training, education, 

and development opportunities to our ORA colleagues and to our Human and Animal 

Food state, local, tribal, and territorial regulatory partners. We provide mandatory and 

voluntary personnel certification programs to ORA inspectional employees. OTED’s 

mission is to help people realize their full potential through timely, cost-effective learning 

products that support the FDA mission. FY2021 required OTED, our instructors,

students, and contractors to continue to show flexibility, resilience and innovation during 

the ongoing COVID-19 pandemic. 

OTED, like many other organizations, had attrition due to promotions and/or retirements 

of OTED staff members. Many of our staff responded to Department of Health and 

Human Services (HHS) and Public Health Service (PHS) deployments including the 

Unaccompanied Minors Program and COVID19 vaccination clinics. Through all of the 

challenges we encountered in FY2021, we remained true to our mission and continued 

to deliver critical training and developed new approaches to expand our reach. This 

included completing more work with less staff when compared to FY2020! I am 

extremely proud of the work accomplished through our critical and collaborative 

relationships between OTED staff, contractors, cooperative grantees, and FDA Center 

and ORA experts, who provide their expertise, knowledge, and time to support our 

public health workforce. 

I hope you find our FY2021 OTED Annual Report helpful in seeing all we accomplished 

in FY2021 by OTED and our collaborative relationships with dedicated public health 

professionals! 

Patricia L. Alcock

Patricia L. Alcock
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OTED Mission

OTED’s mission is to provide high quality learning opportunities through timely, costeffective teaching products that support the Food and Drug Administration’s (FDA) 

mission and strategic goals and meets current training and development needs of ORA 

personnel, state and local regulatory officials, and other stakeholders.

OTED Vision

Developing and delivering collaborative FDA training products by leveraging our staff 

strengths to assist public health regulatory officials in excelling in their job performances 

and improving public health safety for all.

OTED Responsibilities 

ORA’s Office of Training Education and Development (OTED) is responsible for the 

training and development of a 5,000 member staff located in ORA's field and 

headquarters offices throughout the United States and the Commonwealth of Puerto 

Rico and the US Virgin Islands. In addition, OTED is responsible for providing training to 

state, local, tribal and territorial regulatory partners involved in the regulation of human 

and animal food products regulated by FDA.

Goals and Objectives

OTED’s primary function is to deliver training, education, development and certification 

products to ORA and our State, local, tribal and territorial partners. This requirement is 

critical to our success and includes making sure our course content is accurate; OTED 

staff have the tools, procedures and resources to do our jobs; we demonstrate how our 

work products support and enhance FDA’s public health mission; and utilize the various 

data sources supporting our mission. The recent and ongoing pandemic has required 

OTED to deliver our courses via virtual Instructor Led Training (vILT) and continue to 

modernize our approaches with virtual delivery platforms. 

OTED’s routine work products and priority initiatives are well aligned with the ORA 

Strategic Priorities. 
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As a reminder, the ORA Strategic Priorities are:

• Manage a world class workforce and promote a culture of excellence;

• Improve ORA’s core business processes;

• Leverage and expand ORA’s Public Health Partnerships;

• Improve ORA’s Administrative Processes, Facilities and IT Infrastructure.

OTED FY21 Strategic Priorities

FY2021 was the fourth year the OTED Director established priorities in addition to our 

routine training and certification delivery schedule. The establishment of Office-wide 

priorities allows for clear and transparent identification of highest priority work 

assignments and projects. In addition, the priorities allow OTED staff to relate their 

work efforts to HHS, FDA and/or ORA strategic plans. The establishment of OTED 

priorities in any given FY allow OTED leadership and staff to assess workload capacity 

management. 

The following is a high-level summary of several of OTED’s FY2021 Strategic Priorities

completed in FY2021 across OTED. Our priorities were focused on continuous 

improvement for our stakeholders as well as internally at OTED. Each of the OTED

priorities align under the ORA priorities and has been noted as such with a bolded 

parentheses following each statement. 

1. Develop and issue an FY2021 OTED Annual Report that summarizes our 

accomplishments in training, education, development and certification. Report 

will also summarize our critical accomplished projects and initiatives. (#1 

Manage a world class workforce and promote a culture of excellence)

2. Implement OTED’s FY2021 Annual Quality Audit Plan and management reviews 

including any corrective action measures. (#2 Improve ORA's core business 

processes)

3. Identify and implement the FY2021 Federal Employee Viewpoint Survey 

improvements. This includes hosting an OTED wide Focus Group in FY2021 

following the FY2020 OTED EVS Survey results and developing 1-2 areas for 

improvement in FY2021. (#1 Manage a world class workforce and promote a 

culture of excellence & #2 Improve ORA's core business processes)
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4. Align Independent Course Delivery, Instructor Qualification, and Train the Trainer 

programs with OTED procedures, forms, and practices for implementation in 

FY2021/FY2022. This new Train the Trainer program will allow OTED to have 

State personnel deliver specific and required ORA training programs, on their 

own behalf, allowing OTED and ORA to leverage training resources and meet 

the needs of our state partners. (# 3 Leverage and Expand ORA's Public 

Health Partnerships)

5. Implement OTED’s Records Management Plan by having FY2019 and FY2020 

training records copied and moved to the appropriate location. This will allow 

OTED to have a central repository for all training records, including course 

materials, for Freedom of Information Act (FOIA) requests, GAO/OIG requests, 

National Archives and Records Administration (NARA) requirements, and for 

future OTED Training Officers/Training Specialists. (#4 Improve ORA's 

Administrative Processes, Facilitates and IT Infrastructure)

6. Procure a new Learning Management System for integration and implementation 

in FY2022. (#4 Improve ORA's Administrative Processes, Facilitates and IT 

Infrastructure, #3 Leverage and Expand Public Health Partnerships)

OTED Training & Certification FY2021 Routine Workplan

OTED’s routine work includes the design, development and delivery of training and 

certification in support of our stakeholder’s needs. For FY2021, due to the ongoing 

COVID-19 pandemic, our work products were delivered virtually. Using a variety of 

virtual delivery platforms (Adobe Connect, Zoom.gov, WebEx) required our staff, 

students, and instructors to learn new delivery platforms. This prompted OTED to 

provide additional training on these tools to all involved including our students, 

instructors and contractors, where necessary. In FY2021, we continued to convert 

instructor led training materials to virtual instructor led materials for delivery in FY2021 

and beyond. This work was completed by OTED staff as well as contractors and 

cooperative agreement partners and reviewed by subject matter experts. 

Our work products and deliverables, whether it is training courses, job aids, certification 

exams or development programs, are accomplished by collaboration within OTED’s 

Divisions and with our ORA and FDA Center Subject Matter Experts. 
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A high-level summary of our routine work is provided:

1. Delivered 354 individual learning events (e.g., courses, webinars, facilitated 

group conversations, panel discussions, leadership program culminations, etc.) 

in 50+ regulatory commodity areas (i.e., Human and Animal Foods, Medical 

Devices, Emergency Response, Biologics, Bioresearch Monitoring Operations 

(BIMO), Pharma and Cooperative programs [retail, milk and shellfish] areas). 

Thanks to our exceptional partnerships and contracts, approximately 16% of 

these courses were delivered through partnerships with the following three (3) 

cooperative agreement grantees and three (3) academic institutions:

A.Association of Food and Drug Officials (AFDO)

B.National Environmental Health Association (NEHA)

C.International Food Protection Training Institute (IFPTI)

D.Purdue University

E.Ohio State University

F. North Caroline State University

2. Converted 55 courses from Instructor Led Training (ILT) to Virtual Instructor-Led 

Training (vILT) for delivery in FY2021 and beyond. This includes:

A. 41 course conversions in the Division of Programmatic Training (DPT)

B. 14 course conversions in the Division of Multi-Program, Leadership, and 

Management Training (DMPLMT)

3. Collaborated and streamlined across OTED to revise and update 18 documents 

in total for the Course Announcement Policy, Templates, and Samples. The 

streamlined templates removed the redundant information and provided succinct 

information students need to know to attend the training course.

4. Nine Public Health Service (PHS) Officers on staff in OTED served on 

deployments supporting the HHS Unaccompanied Minors Mission and/or 

provided COVID-19 vaccine administrations, nursing and pharmacy support. 

Additionally, several OTED civilian staff members assisted with the HHS 

Unaccompanied Minors Mission. 
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In addition to the above-mentioned accomplishments, we are providing additional 

accomplishments for FY2021 under each OTED Division heading in this Annual Report. 

Specific FY2021 Accomplishments by OTED Division

Division of Instructional Systems and Technology (DIST)

What is DIST responsible for in OTED? 

DIST is responsible to contributing to the design 

and development of training and supporting and 

enriching learning technologies with multimedia. 

This Division is also responsible for Section 508 

of the Rehabilitation Act, where our staff verifies 

that our training, education, development and 

certification deliverables are accessible to people 

with disabilities. 

FY2021 DIST Accomplishments

1. Conducted a comprehensive analysis of the ORA Basic Investigator Training 

Curriculum, including classroom, pre-requisites, e-learning modules, and 

supporting materials. Developed recommendation for consideration in 

redesigning the training program to determine path forward for new curriculum 

design.

2. Collaborated with FDA, ORA and OTED internal and external stakeholder to 

create multiple video production projects. Highlights include:

A. ORA Consumer Safety Officer New Hire Fundamentals Program

B. Orientation to International Inspections training

C. Food GMPs and Evidence Development training

D. Managing a Newly Hired Consumer Safety Officer training

E. ORA All Hands Meeting Videos including: 

i. ACRA Senior Executive Team’s Thank You Message

ii. ORA All Hands Introduction Video

iii. ORA Honor Award Ceremony
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iv. Combined Federal Campaign Finish Strong Message

F. ORA ACRA Messages for regulatory associations, including: 

i. Parental Drug Association

ii. Conference for Food Protection

G. CDER requested videos to assist in the NBC4 and Telemundo 44 

Health and Fitness Expo by providing three (3) informational videos on 

Sickle Cell Anemia. 

3. Designed, developed and delivered Adobe Connect training to OTED staff and 

ORA Program Training Officers (PTOs) to assist in learning Adobe Connect 

platform for training courses and meetings. 

4. Maintenance and update of OTED’s intranet and internet web pages. Updates 

included coordination with OTED personnel to improve, update and redesign 

OTED’s internet page, following FDA’s decision to migrate all intranet pages to 

SharePoint. Webmaster and OTED staff also reviewed, redesigned, remarket, 

rebranded OTED’s internet pages as a result of continuous improvement and 

information sharing with external stakeholders. 

5. Provided training to DIST staff to increase skill sets with variety of online training 

tools including but not limited to: Adobe Connect, Lectora and Captivate. 

6. Instructional System Specialists were responsible for the development and 

monitoring of contract agreements and verification that work products were 

developed by contractors met OTED’s needs. Contract work managed at DIST 

included: 

A. Web module development for ORA Pharmaceutical and Biologics training

B. Adobe Connect Audio package which was required as part of Adobe 

Connect training utilized by OTED

C. Foreign Language Contract for ORA Operational staff to use to assist on 

foreign inspections.

7. Collaboration with OTED Divisions and Quality Team, including: 

A. In-Service Training of OTED staff on Needs Analysis Reports 

B. In-Service Training of OTED staff on Curriculum Design Documents

C. Development and finalization of using SMART Objectives for OTED learning 

objectives
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Division of Multi-Program Leadership and Management Training 

(DMPLMT)

What is DMPLMT responsible for in 

OTED? 

DMPLMT is responsible for designing, developing, 

and implementing training and educational 

programs, professional development, and career 

growth opportunities for ORA investigators, 

analysts, compliance officers, support staff, 

managers, supervisors, and the Food Emergency 

Response Network (FERN). These programs 

include a variety of classroom, virtual, and online trainings and skill-building tools and 

resources in the areas of compliance, imports, laboratory, ORA information technology 

systems, administration, leadership, management, and basic investigator programs.

FY2021 DMPLMT Accomplishments

1. Delivered 79 individual learning events (courses, webinars, facilitated group 

conversations, panel discussions, leadership program culmination sessions) in 

FY2021

2. Launched three cohorts of our FY2021 ORA’s Leadership Development 

programs concluded, in support of developing future and existing leaders in 

ORA. This includes the completion of three developmental programs including: 

A. Potential Supervisors Program Cohort 4: 36 ORA participants

B. Leadership Excellence Advancement Program (LEAP) Cohort 2: 19 ORA 

participants

C. Resilient Leadership Program Cohort 10: 30 ORA participants

3. Collaborated with ORA’s Office of Management to revise and update the ORA 

New Supervisor Checklist and job aid for inclusion in the ORA Supervisory 

Toolkit for Onboarding, Acculturation, and Offboarding ORA Employees

4. To accommodate ORA’s onboarding and training of recently hired Consumer 

Safety Officers in ORA Programs, OTED increased class size for Basic New Hire 
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Program from 30 to 60 people per virtual class offering. 

5. Updated the existing ORA Basic Analyst Training Control Document, working in 

collaboration with ORS and OTED peers to address improvements and changing 

needs. 

6. Reviewed and updated 15 online Microbiological Control Module courses in 

ComplianceWire for newly hire analysts, in collaboration with ORS. Update was 

necessary based on changes in science, technology and ORS needs. 

7. Converted a total of 17 OTED Instructor Led Training courses to virtual Instructor 

Lead courses for delivery in FY2021. Specific courses included: 

A. Using Online Reporting Analysis Decision Support (ORADDS) – Domestic 

(CS154)

B. Using ORADDS – Laboratory (CS156)

C. Advanced ORADDS (CS159)

D. Import Operations (IM101)

E. Advanced Import Operations (IM201)

F. Regulatory Science (LB236)

G. Introduction to Fundamentals of Regulatory Chemistry (LB237B)

H. Overview of BSL-2 and BSL-3 Principles (LB313B)

I. Personnel Practices for New Supervisors (MG106)

J. Soft Skills for Supervisors (MG130)

K. Soft Skills for Professionals (MG132)

L. Resilient Leadership (MG301)

M. Personnel Practices for ORA Supervisors and Managers (MG308)

N. Leadership Excellence Advancement Program (LEAP)(MG314) 

O. Computer Aided Inspections (MP143)

P. Introduction to FDA Fundamentals (OD108)

Q. Leading with Impact (OD201)

8. Collaboration in progress with OPM to rescope the ORA Management and 

Leadership Development Program (MLDP) and update management 

competencies for training programs. 
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Division of Programmatic Training (DPT)

What is DPT responsible for in OTED? 

The Division of Programmatic Training’s primary 

responsibility is designing, developing, and 

delivering training and educational programs for 

the ORA staff and other regulatory partners in 

the program areas of Human and Animal Food, 

Pharmaceutical Quality, Biologics, Bioresearch 

Monitoring, Medical Device and Radiological 

Health, and Tobacco.

DPT collaborates with regulatory associations and OTED funded cooperative grantees

to design the Human and Animal Food Integrated Food Safety System (IFSS) National 

Curriculum Standard (NCS). 

DPT actively participates with internal and external workgroups, delivers conference 

presentations, represents OTED on program Steering Committees, collaborates with 

boards and committees and guides the development of commodity specific program 

standards.

FY2021 DPT Accomplishments

1. Delivered 275 individual learning events (e.g., courses, webinars, facilitated 

group conversations, etc.) in regulatory commodity areas (i.e., Human and 

Animal Foods, Medical Devices, Emergency Response, Biologics, BIMO, 

Pharma and Cooperative programs [retail, milk and shellfish] areas). Thanks to 

our exceptional partnerships and contracts, approximately 16% of these courses 

were delivered through partnerships with the following three (3) cooperative 

agreement grantees and three (3) academic institutions:

A. Association of Food and Drug Officials (AFDO)

B. National Environmental Health Association (NEHA)

C. International Food Protection Training Institute (IFPTI)

D. Purdue University

E. Ohio State University

F. North Caroline State University
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2. Finalized and delivered new Medical Product Training Courses in Pharmaceutical 

Quality and Bioresearch Monitoring. Specifically, 

A. Non-Sterile cGMP Pharmaceutical Surveillance Inspection Site Visit 

(DG221)

B. Non-Sterile Active Pharmaceutical Ingredient Inspection Course (DG222)

C. Post marketing Adverse Drug Experience (PADE) Reporting Inspections / 

Risk Evaluation and Mitigation Strategies (REMS) Reporting Inspections 

(BR227)

3. Participated in FDA Agency Workgroups to include New Era for Smarter Food 

Safety Core Elements 2 and 3

4. Participated in various cross-operational FDA teams, work groups and 

committees in support of training. Examples include: 

A. Retail Food Executive Leadership Assessment Team (ELAT) for retail 

program, 

B. National Retail Food Team workgroups, 

C. Milk and Dairy Programs Steering Committees 

D. Shellfish Steering Committees and Workgroups

5. Participated in regulatory association work group meetings and conferences 

including:

A. Conference for Food Protection (CFP) parliamentarian team

B. Partnership for Food Protection (PFP) Training and Certification Work 

Group

6. Continued to manage and collaborate with OTED’s Cooperative Agreements for 

projects with the Association of Food and Drug Officials (AFDO), Association of 

Public Health Laboratories (APHL); the International Food Protection Training 

Institute (IFPTI), the National Environmental Health Association (NEHA) and the 

University of Tennessee- Kentucky (UTK).

A. Major project highlights are course redevelopment/virtual conversion to 

virtual training support during COVID 19 crisis.

B. Assistance with the development and operation of the Integrated Food 

Safety System (IFSS) National Curriculum Standard Development 

7. Collaborated with OSCP and regulatory partners to streamline the State, Local, 

Tribal, Territorial registration process to increase local agencies availability. The 
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new approach of prioritizing attendees from agencies allowed for an increase in 

new local agencies having access to FDA training. 

Division of Testing, Measurement and Certification (DTMC)

What is DTMC responsible for in OTED? 

The Division of Testing, Measurement, and 

Certification (DTMC) is responsible for maintaining 

the ongoing quality of ORA personnel certification 

programs, including Level 1 Investigator and Level 1 

Analyst programs, Level 2 Cooperative certification 

programs, and the voluntary Commodity-specific 

certification programs. DTMC develops, administers, 

and maintains certification examinations for investigators in the areas of Seafood, LowAcid Canned Foods/Acidified Foods, Import, Blood Bank/Plasma Center, Clinical BIMO, 

Drug and Medical Devices. 

DTMC is responsible for leading organizational measurement initiatives, survey-based 

information gathering, and data-driven change management. DTMC works with DPT, 

DMPLMT, and DIST to leverage course assessment information as a key component of 

OTED’s training evaluation mission. 

FY2021 DTMC Accomplishments

1. Implemented the FY21 Certification and Job Task Analysis Schedule. Specific 

accomplishments include: 

A. Conducted and completed 11 Job Task Analyses (JTAs) (full and updates) 

in the following areas aligned by ORA Office: OHAFO (6), OMPTO (3), 

ORS (1), Compliance (1).

B. Completed assessment development or review work for 8 courses (of 15 

requested). This included the establishment of test blueprint, test 

questions that are defensible, and a clear interpretation of what the test 

means to the student regarding his/her learning at the training course. 
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2. In support of ORA’s Retail Food Specialist Program, OTED, working 

collaboratively with Office of State Cooperative Programs (OSCP) to develop 

updated training and certification standards for the ORA Retail Food Specialist 

position. This initiative will assist ORA and OSCP in developing specific training

framework to effectively train, certify and qualify Retail Food Specialists. The 

following work was accomplished in support of the training and certification 

program for ORA Retail Food Specialists: 

A. Completed Retail Specialist Job Task Analysis (JTA) report outlining the 

knowledge, skills, abilities, and behaviors required for the ORA position

B. Completed Gap Analysis report of the JTA versus the current Retail Food 

Specialist training curriculum and provided recommendations.

C. Developed and received approval by OSCP leadership for a two-year 

project plan for the training and certification program development.

D. Established joint OTED/OSCP development team to develop and 

implement recommendations for training and certification program for ORA 

Retail Specialists.

3. Conducting comprehensive evaluations of OTED training course evaluations, 

including for: 

A. National New Hire Course FY2012-2021, for:

i. Food and Drug Law Course (MP101)

ii. Evidence and Development (MP102)

iii. Personal Safety & Interviewing (MP118)

B. FDA Alumni Advisor Program (FDAAAP) summary evaluation and program 

close out report

C. FY2020 Course Evaluation Roll-up review for both Instructor Led and 

Virtual Instructor Led training courses. 

4. Collaborated with OTED peers in cross-operational assignments impacting OTED 

including: 

A. ORA Basic Analyst Training Control Document updates

B. Course Announcement Policy, Templates and sample documents

5. Designed and facilitated FY2021 OTED Listening Session following the OTED 

FY2020 Federal Employee Viewpoint Survey results. Provided OTED leadership 

with recommendations to consider for implementation based on analysis and 

feedback. 
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FY2021 OTED Data and Charts

Training Summary Report

The below charts highlight the training and certification events held in FY 2021. They 

provide a summary of training courses by commodity, by employee type, and by 

delivery method. 

The first two charts highlight the number of course offerings held in each program area 

and the number of student completions for that program. The first chart covers all 

program areas with the exception of Human and Animal Foods and Emergency 

Response, which are covered in the second chart.

Training Summary by Commodity

4 2 5 1 5 6 2 7 2

20 22

6

53

27

63

19

76

144

32

159

35

228

935

124

# of Classes Held # of Completions
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Training Summary – FDA Human and Animal Foods Program 

Training

9

103

242

2385

Emergency Response Food

# of Classes Held # of Completions
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The following charts depict student completions by employee type and delivery method

for Emergency Response, Human and Animal Foods, and Veterinary Medicine 

programs

This chart covers courses delivered as Virtual Instructor Led Training, traditional 

Classroom delivery, and blended methods (which combines independent work and precourse work with classroom time, whether traditional or virtual). 

FY21 Completions – Blended, Classroom and vILT Courses*

*VM: Veterinary Medicine did not deliver any FY21 Completions

137

1 5 0 1 3

95

420

8

79

45

12 14

853

FDA Industry Local/County Military Other Other Federal State

ER: Emergency Response & Investigations FD: Food
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The chart below depicts course completions with the three program areas from ondemand course delivery, which includes Web-Based Training modules, Video, and 

Webinars.

FY21 Completions – Online Content, Videos, Webinars

11 0 8 0 0 1 14

1567

9

1203

93 62 96

2260

280

0 0 0 0 4

303

FDA Industry Local/County Military Other Other Federal State

ER: Emergency Response & Investigations FD: Food VM: Veterinary Medicine
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This chart shows our support for our external SLTT partners. Focused primarily on HAF 

courses, our SLTT partners completed the following total number of courses.

SLTT Course Completions

621

1327

Local/County State
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Certification Events Summary Report

The final chart compares the number of certification events held in FY2020 versus 

FY2021.

Certification Chart

36

1

23

39

4

1 1 1 1 0 0 0

43

11

2 2

0

2

2020 2021