0 

[Type a quote from the document or the summary of an interesting point. You can position the text box 

anywhere in the document. Use the Drawing Tools tab to change the formatting of the pull quote text 

box.]

FDA Strategic Plan for 

Risk Communication 

and Health Literacy 

2017-2019 

September, 2017 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table of Contents
 

Executive Summary.................................................................................... 1
 

Introduction............................................................................................... 2
 

Using the SPRCHL Document.................................................................. 2
 

Acting on SPRCHL............................................................................. 2
 

Monitoring Progress in SPRCHL............................................................ 3
 

SPRCHL Structure and FDA Structure........................................................ 3
 

A Close Look at SPRCHL's Strategic Framework.............................................. 4
 

Major Contributing Outcomes.................................................................... 4
 

I. Increased use of clear communication best practices and plain language in 

developing messages........................................................................... 4
 

II. Increased development of messages and communications specifically
 

for target audiences.............................................................................. 6
 

III. Improved efficiency of internal operations for writing and developing
 

Communications.................................................................................. 8
 

IV. Improved dissemination of FDA's communications and information................ 8
 

Implementation Plan.................................................................................... 10
 

Performance Indicators................................................................................ 10
 

Performance Monitoring Planning.................................................................. 10
 

Appendix 1: SPRCHL and Previous Strategic Plan........................................... 11
 

Appendix 2: FDA’s Strategic Framework for Risk Communication 

and Health Literacy................................................................... 14
 

Appendix 3: Implementation Plan.................................................................. 15
 

Appendix 4: Performance Indicators – Monitoring – Phase I................................ 24
 
 

 

 

 

•	 

•	 

•	 

 

 

 

 

Strategic Plan for Risk Communication 

and Health Literacy, 2017 - 2019 

Executive Summary 

The Department of Health and Human Services and the Food and Drug 

Administration (FDA) aim to empower people to make informed choices 

for their health. FDA’s mission includes helping people protect their 

health through informed decisions about using FDA-regulated products. 

FDA aims to help patients, consumers, and health care professionals 

make informed decisions about FDA-regulated products using the best 

science and communication practices. 

The purpose of this Strategic Plan for Risk Communication and Health 

Literacy (SPRCHL) is to clarify how FDA can more effectively 

communicate the benefits and risks of FDA-regulated products to our 

target audiences. To do so, FDA must accomplish the following four 

outcomes: 

I. Increased use of clear communication best practices and plain 

language in developing messages 

II. Increased development of messages and communications 

specifically for target audiences 

III. Improved efficiency of internal operations for writing and 

developing communications 

IV. Improved dissemination of communications and information 

The primary audience for this plan is FDA staff members, though the 

public can read it on FDA’s website. SPRCHL is a guide by FDA staff 

members, for FDA staff members. This plan lays out potential action 

steps and methods to track FDA’s progress. SPRCHL includes: 

Strategic Framework: a hierarchical diagram of outcomes that FDA 

must achieve to meet our goal of better communication 

Implementation Plan: a map of potential activities to specific 

outcomes in the Strategic Framework, offering a foundation to help 

Centers and Offices plan specific action steps for the next 1-3 years 

Performance Indicators Phase I: specific indicators for outcomes in 

the Strategic Framework that FDA plans to monitor in the near term 

We have also created a Performance Monitoring Plan, which is an 

internal working draft document on collecting and analyzing data for 

additional performance indicators. 

How to Use This Document 

• This document explains the 

connection between the SPRCHL 

Strategic Framework, 

Implementation Plan, and 

Performance Indicators Phase I. 

• Refer to the Strategic 

Framework as you read the 

short description in the narrative 

below of each outcome (each 

box) 

• Refer to the 

Implementation Plan and the 

Performance Indicators, Phase I, 

for next steps on activities and 

performance measures 

• Note that the highest level 

outcome can be achieved by 

accomplishing the four Major 

Contributing Outcomes (I, II, III, 

and IV), and onward through 

Lower Level Outcomes. 

The numbers are for reference 

and do not imply relative 

importance. They are used 

consistently throughout the plan 

and appendices. 

Strategic Framework Hierarchy 

>Overarching Outcome 

 >Major Contributing Outcomes I-IV 

 >Contributing Outcomes (A, B...) 

 >Lower Level Outcomes (a, b...) 

 >Activities (1, 2...) 

1 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Introduction 

The Department of Health and Human Services, and the Food and Drug Administration (FDA), aim to 

empower people to make informed choices for their health. FDA’s mission includes helping people 

protect their health through informed decisions about using FDA-regulated products. This plan intends to 

help FDA staff in working toward FDA’s mission by promoting risk communication and health literacy. 

FDA aims to help patients, consumers, and health care professionals make informed decisions about the 

benefits and risks of FDA-regulated products, using the best science and communication practices. 

Health literacy describes the match between the information we provide and people’s capacity to find, 

understand, and use that information for their health. 

The purpose of this Strategic Plan for Risk Communication and Health Literacy (SPRCHL) is to clarify 

how FDA can accomplish our mission by more effectively communicating the benefits and risks of FDAregulated products to our target audiences. For information on how SPRCHL relates to FDA’s previous 

Strategic Plan for Risk Communication, see Appendix 1. 

The primary audience for this plan is FDA staff members, though the public can read it on FDA’s website. 

SPRCHL is a guide by FDA staff members, for FDA staff members. This plan lays out potential action 

steps and methods to track FDA’s progress along four complementary paths to promote staff 

understanding and use of best practices for clear communication, to strengthen social and behavioral 

science for better communication, increase process efficiency, and make information more easily 

available to the public. 

Using the SPRCHL Document 

SPRCHL was developed by staff members across FDA and is a broad and careful analysis of how we 

can achieve FDA’s aim of empowering people to make informed choices about using FDA-regulated 

products. SPRCHL, and especially the Strategic Framework, presents an overall view of how our 

activities and outcomes relate to the aim. SPRCHL is not, however, an algorithm or a procedural 

sequence to follow. 

The Strategic Framework shows how we can work toward Lower Level Outcomes that support Major 

Contributing Outcomes that ultimately promote FDA’s aim of empowering people to make informed 

choices about using FDA-regulated products. Each outcome is represented by a box in the Strategic 

Framework, with arrows showing the connections between outcomes. The outcomes are numbered 

hierarchically like an outline (Roman numeral, capital letter, small letter). That system makes it easy to 

see how a particular outcome is situated in the Strategic Framework. 

SPRCHL lists broad activities and specific steps that FDA’s Centers and Offices can take as they work 

toward achieving outcomes. Please note that the Centers and Offices likely will accomplish activities in 

different ways. In the Strategic Framework, there are numbered circles indicating the activities associated 

with each of the Lower Level Outcomes. The numbers correspond to the activities listed in the 

Implementation Plan and in the narrative below. The particular activities that are needed to achieve the 

outcomes will change over time, and we may need to modify the outcomes. As a reader, you may find it 

helpful to review the Strategic Framework and the Implementation Plan at the same time. This 

narrative, starting on page 4, walks through SPRCHL’s Strategic Framework in detail. It starts with FDA’s 

communication aim and works toward the Lower Level Outcomes. 

Acting on SPRCHL 

In addition to the recommended activities for each Lower Level Outcome in the Strategic Framework, the 

Risk Communication and Health Literacy Working Group members provided examples of specific steps 

2 
 

 

 

 

 

 

 

 

 

 

that different Centers and Offices can take to engage in these activities and to achieve the associated 

outcomes. The Implementation Plan shows the Lower Level Outcomes, the associated recommended 

activities, and examples of specific steps for near term work. We list only selected examples of specific 

steps so that each Center and Office may take different steps, according to their specific circumstances. 

We will update specific steps over time. 

Monitoring Progress in SPRCHL 

The Risk Communication and Health Literacy Working Group monitors the progress of SPRCHL. The 

Performance Indicators Phase I table lists items we track. We selected this subset of potential 

indicators based on their feasibility and usefulness in monitoring our progress toward particular outcomes. 

We developed performance indicators for all the outcomes in the Strategic Framework, and plan to 

include additional indicators in future updates. Some indicators would provide helpful information but also 

would require substantial resources (personnel and financial) to monitor. We may expand monitoring to 

include the more resource intensive indicators at a later date. 

SPRCHL Structure and FDA Structure 

FDA’s communications are extensive and varied across the Agency. SPRCHL shows a framework for 

how FDA’s communications-related work supports the accomplishment of our aim of empowering people 

to make informed choices about using FDA-regulated products. We recognize at the same time that the 

outcome, better informed decisions, is affected by additional influences beyond FDA’s control. 

FDA is unified, but it is composed of distinct Centers and Offices with different regulatory roles. Some 

Centers and Offices focus on pre-market review or post-marketing surveillance, or coordinate work on 

products grouped by intended users (such as pediatric products) rather than by product type. Likewise, 

some communications are issued directly by the Center or Office most involved in the topic, while others 

are developed and issued by the Office of the Commissioner. FDA strives to maintain flexibility to 

account for the communication processes and vehicles that make most sense in the situation, either from 

the Center or for the Agency overall. 

3 
 

 

 

 

 

 

 

 

 

 

 

 

A Close Look at SPRCHL’s Strategic Framework
 

Overarching Outcome:

Increased accessibility to actionable and accurate FDA
 

communication and benefit/risk information
 

The Overarching Outcome is the highest level outcome over which FDA risk communication, health 

literacy, and plain language staff members have significant influence. In the Strategic Framework, each 

outcome is supported by the one below it. The top outcome is our aim of empowering people to make 

informed choices about using FDA-regulated products, which is supported by the outcome below it 

(improved knowledge of the risks, benefits, and important information related to FDA-regulated products 

by consumers, patients, providers, and professionals), and that outcome is supported by the Overarching 

Outcome listed above. 

When FDA accomplishes this Overarching Outcome, the public will have access to actionable and 

accurate information about FDA-regulated products. Such information will help people become more 

knowledgeable about FDA-regulated products. This improved knowledge will help people make informed 

decisions about FDA-regulated products, FDA’s aim for risk communication and health literacy. The 

acceptable balance of benefits and risks of FDA-regulated products can vary for several reasons. 

Individuals can have different risk preferences; hence a risk that is acceptable for one person may be 

unacceptable for another. Products that provide important and rare benefits in dire situations (such as a 

treatment for advanced-stage cancer) may also have high risks. Other products may be less risky, but 

even so, are less acceptable because effective and safer alternatives exist. Moreover, patients need 

information to help them discuss therapeutic products and foods with their healthcare provider. 

Healthcare professionals also need to be informed about products and foods to properly advise patients. 

These are some of the ways that FDA’s communication staff works to improve public health by facilitating 

access to actionable and accurate information about FDA-regulated products. Regardless of what people 

do with the knowledge in the end, the decision making process itself can be better with accurate and 

actionable information. 

Major Contributing Outcomes 

The Strategic Framework shows that four Major Contributing Outcomes drive the Overarching Outcome: 

I. Increased use of clear communication best practices and plain language in developing messages 

II. Increased development of messages and communications specifically for target audiences 

III. Improved efficiency of internal operations for writing and developing communications 

IV. Improved dissemination of FDA's communications and information 

Please continue to refer to the Strategic Framework as you read to see how each of these Major 

Contributing Outcomes depends on the accomplishment of lower level outcomes and activities. 

I.	 Increased use of clear communication best practices and plain language in 

developing messages 

The purpose of this Major Contributing Outcome is to increase FDA’s use of best practices and tools that 

promote clear communication and plain language. This will contribute to increased access to actionable 

and accurate information in FDA communications. 

Three contributing outcomes, A – C, support Major Contributing Outcome I: 

4 
 

 

 

 

 

 

 

A.	 Increased accountability across FDA for plain language requirements and FDA best 

practices 

FDA does not uniformly track the accomplishments of staff members and programs as they 

implement best practices and plain language requirements for communications. FDA could more 

systematically plan and track these best practices and requirements. FDA can improve 

accountability if staff members clearly understand who should perform what actions and then 

track their accomplishment. 

To support Contributing Outcome I.A. we plan to: 

1 Develop a cross-agency approach to track health literacy actions in accord with the HHS 

Biennial Action Plan1 

2 Incorporate plain language elements into PMAP and SES plans 2 3 

3 Promote Plain Language Awards 

B. Increased availability and access to FDA clear communication best practices 

FDA must inform its communications staff about available resources (such as templates, 

checklists, and other tools) and how to use them in developing clear communications. In some 

cases, FDA must modify existing resources to meet its needs. 

To support Contributing Outcome I.B. we plan to:
 

4 Continue to expand Plain Language Resource Center
 

assets (e.g., tools) on the FDA intranet
 

5 Adapt best practices and tools for FDA use
 

C.	 Improved knowledge across FDA of the value of 

communicating clearly, and how to write effectively in 

plain language 

FDA must also ensure that all staff members understand 

how clear communication and plain language advances the 

Agency’s mission and how they can demonstrate these 

skills in their work.
 

To support Contributing Outcome I.C. we plan to: 

6 Train all staff who routinely review and clear public
 

information to practice plain language principles
 

7 Implement an FDA-adapted tool based on the Clear
 

Communication Index4 across all FDA Centers and 

Offices
 

8 Develop and execute internal campaigns to create

awareness of plain language and best practices
 


 

Hint to Readers: 

•

•

•

The numbered circles 

presented in this section 

match the numbered 

activities in the Strategic 

Framework and the 

Implementation Plan. 

Some of the activities are 

long-term and complex. 

Check the “Specific Steps” 

column of the 

Implementation Plan for 

some specific examples of 

action steps. 

The Centers and Offices 

may take different 

specific action steps. 

These activities are 

examples, and may be 

added to or modified. 

1 The Department of Health and Human Services (HHS) Biennial Action Plan for Health Literacy was developed by a
 

cross-departmental working group. The goal is to promote awareness of actions across HHS promoting health
 

literacy. The group asks HHS agencies to report on their health literacy activities.

2 Performance Management Appraisal Plan (PMAP)
 3 Senior Executive Service (SES)
 4 The Clear Communication Index is a tool for reviewing draft communications, developed by the CDC.
 

5 
 

 

 

 

II.	 Increased development of messages and communications specifically for target

audiences 

FDA communicators, subject matter experts, and other staff members need to know who their target 

audience is, what information the audience needs, and how to convey usable information. Therefore FDA 

communicators must study their audiences and apply communications science to their messages. This 

Major Contributing Outcome will increase FDA’s ability to develop communications that are effective for 

its target audiences. 

Three contributing outcomes A – C support Major Contributing Outcome II: 

A.	 Improved understanding of the knowledge, attitudes, behaviors, uses, needs, and wants of 

target audiences 

Information that is accessible and actionable for consumers, patients, or caregivers often differs 

from information prepared for professionals. Different groups require different levels of detail and 

modes of communication. If FDA is to create communications that are clear for target audiences, 

its staff must first understand these audience members and their needs. 

Four Lower-Level Contributing outcomes a – d promote the accomplishment of Contributing 

Outcome II.A. 

a.	 Expanded two-way communication pathways between FDA and external stakeholders 

FDA needs reliable and active communication with external stakeholders. This allows FDA to 

obtain information about what audiences need and to provide our stakeholders with 

information they need. Our stakeholders, in turn, will then be able to communicate our 

messages more effectively to other third parties. 

To support Lower-Level Contributing Outcome II.A.a. we plan to: 

9 Expand communication pathways to encourage the public to report adverse events 

10 Expand use of social media tools to learn about stakeholder concerns 

11 Conduct stakeholder meetings, public hearings, and forums to build relationships and 

discover opportunities to reach target populations 

b.	 Increased access to, and leveraging of, external research related to risk
 

communication
 

FDA needs to learn from applicable research conducted by other organizations, such as 

academia, professional associations, and industry. This will help the FDA staff to rely on the 

best communications science available. 

To support Lower-Level Contributing Outcome II.A.b. we plan to: 

12 Continue and expand use of Special Government Employees for expert advice 

13 Issue new grants, contracts, and cooperative agreements for research 

c.	 Increased FDA-led or championed evaluative and formative research 

FDA is uniquely positioned to conduct or fund research on risk communication and health 

literacy. This research will focus on 1) how best to communicate information to target 

audiences and 2) how communications can improve the effectiveness of FDA programs. 

6 
 

 

 

 

 

To support Lower-Level Contributing Outcome II.A.c. we plan to: 

14 Conduct research studies that evaluate and inform health literacy actions and programs 

15 Hold focus groups to inform the development of FDA communications 

16 Use social media analytics to evaluate public understanding, knowledge, attitudes, and 

beliefs 

d.	 Improved intra-agency knowledge and research exchange 

FDA should use data and expertise on communications of one type of FDA regulated product 

to inform communication for other types of regulated products. 

To support Lower-Level Contributing Outcome II.A.d. we plan to: 

17 Provide timely updates to FDA and HHS senior staff on key FDA actions 

18 Organize internal FDA forums to share research in progress and research results 

B.	 Increased skills and abilities of FDA staff to develop accurate and actionable 

communications 

FDA staff members communicate about new scientific knowledge to target audiences. Since this 

information changes continually, FDA staff members’ knowledge base must likewise grow. Staff 

development is a critical building block in improving FDA’s communications. 

To support Contributing Outcome II.B. we plan to: 

19 Promote FDA staff professional development in communications science and other sciences 

C.	 Improved application of research evidence and feedback knowledge into operations 

As FDA staff members conduct communications research and test messages, they must share 

the results with the developers of the communications. The developers of the communications 

must then incorporate the information about responses of target audiences. 

Three Lower-Level Contributing Outcomes a – c support Contributing Outcome II.C.: 

a.	 Increased coordination with the scientific community in communication development 

FDA communicators coordinate with FDA scientific staff to ensure accuracy of 

communications. Communicators should apply the best available knowledge on how to 

communicate effectively without compromising scientific accuracy. 

To support Lower-Level Contributing Outcome II.C.a. we plan to: 

20 Examine the workflow in FDA organizations, such as development and clearance 

processes, to ensure that all involved staff members can collaborate effectively to 

incorporate communications science in FDA information 

b.	 Increased use of message testing 

Research shows that target audience members may not receive and understand a message 

as communicators predict, even for the most carefully crafted communications. Thus, testing 

messages is an important step to improve communication effectiveness. The best way to 

understand how a message is perceived is to seek feedback from individuals who are as 

close to the target audience as possible. 

To support Lower-Level Contributing Outcome II.C.b. we plan to: 

21 Maintain an internal message testing network to test FDA's communications 

22 Develop external message testing capabilities to test FDA’s communications 

7 
 

 

 

 

 

 

 

 

c.	 Improved internal processes for moving research and knowledge into communications 

development 

FDA communication planners must make it easier to incorporate communications research 

and knowledge into staff routines. Behavior change takes time and energy, so FDA should 

make it easy and routine. 

To support Lower-Level Contributing Outcome II.C.c. we plan to: 

23 Evaluate research projects for best practices. These will then be incorporated into 

internal standard operating procedures or appropriate public guidance documents 

III.	 Improved efficiency of internal operations for writing and developing

communications 

FDA communications professionals and scientists must make the best use of their time. One way to do 

that is to streamline internal operations to speed up the production of high quality communications. 

Two Lower Level Outcomes support Major Contributing Outcome III: 

A.	 Improved internal review and oversight processes for communication 

Internal review and oversight of communications are crucial for quality and consistency with FDA 

policy. The valuable time of reviewers can be used best, however, if they know how the 

communication has been developed. For example, if they know what subject matter and 

communications science expertise has been applied, then they may have more confidence in the 

communication and approve it quickly. Consistency in expectations of review and oversight 

processes can contribute to more efficient development of communications. 

To support Contributing Outcome III.A. we plan to: 

24 Identify areas to improve efficiency in FDA’s communication process through review and 

assessment 

B.	 Improved consistency in the branding, formatting, and presentation of FDA
 

communications
 

The more communications appear in a consistent format, the easier it is for audiences to find the 

information they need. Therefore, FDA staff members must consistently adhere to FDA brand 

guidelines, while retaining the flexibility to express what is unique about different programs and 

the products they communicate about. 

To support Contributing Outcome III.B. we plan to:
 

25 Share and adopt new content publishing guidelines for FDA.gov
 

26 Ensure implementation of a consistent FDA visual identity
 

IV.	 Improved dissemination of FDA's communications and information 

FDA needs to communicate directly with target audiences to increase accessibility to actionable 

and accurate information. FDA must make this information readily available to their audiences. 

This information may be distributed from FDA directly or through other communicators. 

Four Lower Level Outcomes A – D support Major Contributing Outcome IV: 

8 
 

 

A.	 Improved leveraging of communication pathways with outreach partners 

The Agency’s outreach partners may be able to disseminate and amplify FDA’s messages in 

ways that are most effective for a particular audience. 

To support Contributing Outcome IV.A. we plan to: 

27 Educate research sponsors and principal investigators on improving informed consent 

documents for prospective participants 

28 Support FDA’s public affairs specialists in reaching stakeholders in FDA's field offices 

29 Target and use external organizations to disseminate FDA messages 

B.	 Improved response and coordination during crisis and recall situations 

Communication in crisis and recall situations is even more sensitive than routine 

communications, as the stakes are higher. FDA can earn greater public trust if staff members 

prepare for crises and recalls so that they can promptly share information with the public in an 

emergency. FDA must also be prepared to share that information efficiently with federal 

agencies and state and local officials, so that all sources communicate a consistent message. 

To support Contributing Outcome IV.B. we plan to: 

30 Develop communication strategies and research-tested messages to help ensure effective 

communications in the event of urgent public health situations 

31 Create or adapt tools to guide communications for specific audiences in crisis and recall 

situations 

C.	 Improved alignment of Industry benefit and risk messages with FDA research and 

guidance 

Manufacturers of FDA-regulated products communicate about the benefits and risks of their 

products and, where applicable, comply with regulations about product labeling and promotion. 

Consistent alignment of their messages with FDA research and communications guidance will 

make manufacturers’ communications more understandable to the target audience. 

To support Contributing Outcome IV.C. we plan to: 

32 Complete Guidances for Industry on communications, and involve input from stakeholder 

and stakeholder advocacy groups 

33 Translate regulatory documents into plain language, or provide supplementary plain 

language explanations for official regulatory documents 

D.	 Improved accessibility of consumer-facing content 

FDA communicators aim to make information for consumers as accessible as possible. FDA 

should use understandable formats and accessible channels for its communications. In addition, 

FDA should also provide information in languages other than English as often as possible. 

To support Contributing Outcome IV.D. we plan to: 

34 Develop materials to help consumers understand the benefits and risks of FDA-regulated 

products 

35 Develop and expand communications for consumers to reflect plain language and health 

literacy principles 

36 Administer the Language Access Plan 

37 Incorporate current, effective Web styles to develop and format Web resources 

9 
 

 

 

 

Implementation Plan 

The Implementation Plan reviews the recommended potential activities for each of the Lower Level 

Outcomes in the Strategic Framework. Each activity in this document and the Strategic Framework is 

consistently numbered. The Implementation Plan suggests some specific steps for the near term in the 

Centers and Agency-wide. Although the working group agreed that these action steps are valuable to the 

Agency, it recognizes that these steps may need to be revised or amended over time. Therefore we 

expect to update the Implementation Plan in future years. 

Performance Indicators 

Performance indicators are measures related to outcomes in the Strategic Framework. By observing 

these measures and noting changes over time, we can track progress toward the related outcomes. 

Potential performance indicators vary widely in how easily we can track them, and in how directly they 

reflect the related outcome. Information that is more easily collected, such as the number of trainings 

staff attends, may not directly reflect improved FDA communications. In contrast, information that is more 

difficult to collect, such as a national survey of public understanding of FDA messages, would more 

directly reflect improved FDA communications. This survey, however, would be so costly that FDA could 

not undertake the project immediately. 

Performance Monitoring Planning 

The Performance Indicators Phase I table shows indicators that FDA can track in the near term. We 

will update our monitoring plans to include more indicators in later phases of monitoring. 

10 
•

•

•

•

•

Appendix 1: SPRCHL and Previous Strategic Plan 

Background and Method 

Risk communication and health literacy are ongoing concerns for FDA. FDA’s previous plan for risk 

communication needed revising and updating. To meet FDA’s need for an updated plan, a cross-agency 

working group developed a new plan using the Strategic Program Planning method. The plan is titled 

Strategic Plan for Risk Communication and Health Literacy, 2017-2019, abbreviated SPRCHL 

[pronounced “sparkle”]. SPRCHL presents the basic connections between risk communication, health 

literacy, and plain language to address FDA’s aim of empowering people to make informed choices about 

using FDA-regulated products. It also offers practical action steps that we can implement in 1-3 years. 

The purpose of SPRCHL is to clarify how FDA can communicate the benefits and risks of regulated 

products to target audiences more effectively to promote better informed decision making. SPRCHL lays 

out an approach to achieve FDA’s aim of empowering people to make informed choices about using 

FDA-regulated products. 

Who developed SPRCHL? And who is it for? 

FDA’s working groups on risk communication, health literacy, and plain language merged at the 

beginning of plan development. The resulting Risk Communication and Health Literacy Working Group 

developed the plan and will monitor FDA’s progress. The primary audience for this plan is FDA staff 

members. SPRCHL is a guide by FDA staff members, for FDA staff members, showing how our work 

connects to improve risk communication and support for health literacy at FDA. 

How does SPRCHL relate to earlier strategic planning for risk 

communication? 

The cross-agency working group first reviewed FDA’s previous Strategic Plan for Risk Communication 

(SPRC). Before SPRC, the FDA’s Risk Communication Advisory Committee’s (RCAC) had 

recommended that FDA should develop a strategic plan for risk communication. Acting on the RCAC’s 

recommendation, FDA’s Risk Communication Staff collaborated with a cross-agency group and 

developed a draft of SPRC, which the RCAC reviewed and endorsed in April 2009. SPRC presented 

three goals with corresponding strategies including: 

Strengthen the science that supports effective risk communication 

Expand FDA’s capacity to generate, disseminate, and oversee effective risk communication 

Optimize FDA’s policies on communicating risks and benefits 

After publishing SPRC in 2009, FDA monitored its progress and published an update listing 32 

accomplishments. Many of the underlying ideas from SPRC are still important in SPRCHL. 

Continuities between SPRC and SPRCHL 

a. SPRC noted (p. 3) that: 

FDA takes the approach that risk communication: 

is integral to carrying out FDA’s mission effectively; 

is a two-way process; 

11 
12 

•	 

•	 

must be adapted to the various needs of the parties involved; and 

must be evaluated to ensure optimal effectiveness. 

The current SPRCHL continues to recognize that clear communication is integral to FDA’s mission, is 

two-way and must be audience-appropriate, and that evaluation is critical. 

b.	 SPRC mentioned health literacy is important to reach audiences with limited health literacy and to 

build awareness of health literacy among FDA Staff members. SPRCHL does so as well, but 

highlights health literacy more directly, in accord with the Department of Health and Human Services 

approach in its Biennial Action Plan for Health Literacy: 

Health literacy results from the match between the health information and 

services created for the public and people’s capacity to find, understand 

and use them. 

c.	 SPRC explained that FDA communication is produced by FDA but also communicated through our 

partners. SPRC pointed out that FDA works to provide information directly to consumers, patients, 

and health care professionals, and to provide guidance to regulated industry on communication that is 

clear and not misleading: 

FDA Risk Communication is interactively sharing risk and benefit information to enable
 

people to make informed judgments about use of FDA-regulated products and providing
 

guidance to industry about how to most effectively communicate the risks and benefit
 

of regulated products. (SPRC p.8)
 

SPRCHL likewise includes both direct and indirect communications. Both plans were developed through 

a cross agency group of communicators and related staff members, and both benefitted from advice from 

FDA’s RCAC. 

d.	 SPRC recognized communication and understanding does not automatically cause a particular 

behavior: 

[E]ven if people are getting direct FDA recommendations, it is ultimately an individual’s 

personal choice to, for example, purchase a prescription drug and take or give it to their pet, 

pick the right food choice for their health, use a medical device appropriately for a particular 

patient, or avoid unnecessary exposure to radiation. It is critical that individuals receive information 

that is adequate to ensure that they make informed choices. (SPRC p. 9) 

FDA communication remains multifaceted in its aims. In some cases, FDA aims to ensure that decision 

makers, whether consumers, patients, or health care professionals, have complete and up to date 

information. We recognize that the right decision can differ from one individual or circumstance to 

another. In other cases, we have advice that is specific, for example, to locate any product of a recalled 

lot and discard it. In those cases, we aim to persuade as well as inform. It is critical that FDA 

communications make the aim of the communication clear. That means identifying who is the audience 

and what is the key message. 

Advances from SPRC to SPRCHL 

a.	 Actionability: The previous plan SPRC explained the concept of risk communication, argued for the 

importance of risk communication, and gave examples of how FDA’s mission depends on risk 

communication for success. The current plan SPRCHL simply assumes all that, plus health literacy, 

to be foundational to FDA’s communication aim. The previous plan SPRC ended with specific actions 
13 

FDA could take. The current plan SPRCHL starts with what we want to accomplish and what actions 

we can take to achieve our aim. 

b.	 Method of Development: SPRC was developed in a strategic planning process that had been used 

before, but did not follow the latest best practices in strategic planning. The current plan SPRCHL 

was developed through disciplined application of the Strategic Program Planning method, starting 

with desired outcomes and working back through what we must accomplish to bring about those 

outcomes, what activities we can do, and how we can track progress. 
Appendix 2 

FDA’s Strategic Framework for Risk Communicatio

People are empowered to make 

informed choices about using FDAregulated products 

Improved knowledge of the risks, benefits, and 

important info related to FDA-regulated 

products by consumers, patients, providers, and 

professionals 

II 

Increased development of 

messages and communications 

specifically for target audiences 

I 

Increased use of clear 

communication best practices 

and plain language in developing messages 

I.B 

Increased availability and 

access to FDA clear 

communication best 

practices 

I.A 

Increased accountability 

across FDA for plain 

language requirements 

and FDA best practices 

II.A 

Improved understanding of 

the knowledge, attitudes, 

behaviors, uses, needs and 

wants of target audiences 

II.A.d 

Improved intra-agency 

knowledge and 

research exchange 

II.B 

Increased skills and abilities 

of FDA staff to develop 

accurate and actionable 

communications 

Overarching Outcome 

Increased accessibility to actionable and 

accurate 

FDA communication and benefit/risk 

information 

II.C.a 

Increased coordination with 

the science community in 

communication 

development 

II.C.b 

Increased use of 

message testing 

I.C 

Improved knowledge 

across FDA of the value of 

communicating clearly, and 

how to write effectively in 

plain language 

II.C 

Improved application of 

research evidence and 

feedback knowledge 

into operations 

II.A.b 

Increased access to, and 

leveraging of, external 

research related to risk 

communication 

II.A.c 

Increased FDA-led or 

championed 

evaluative and 

formative research 

II.A.a 

Expanded two-way 

communication pathways 

between FDA and 

external stakeholders 

II.C.c 

Improved internal processes for 

moving research and knowledge 

into communications 

development 

Imp

and 

1 2 3 4 5 6 7 8 

9 10 11 12 13 14 15 16 17 18 20 21 22 23 

19 
15

Appendix 3: Implementation Plan

The Implementation Plan below reviews the recommended potential activities for each of the Lower Level 

Outcomes in the Strategic Framework. Each activity in this document and the Strategic Framework is 

consistently numbered. The Implementation Plan suggests some specific steps for the near term in the 

Centers and Agency-wide. Although the working group agreed that these action steps would of value to 

the Agency, it recognizes that these steps may need to be revised or amended over time. Therefore we 

expect to update the Implementation Plan in future years.

Implementation Plan

Lowest Level 

Outcomes

NumberRecommended 

Activities

Examples of 

Specific Steps

I.A 

Increased 

accountability 

across FDA for 

Plain Language 

requirements and 

FDA best 

practices

1 

Develop a crossagency approach 

to track health 

literacy actions in 

accord with HHS 

Biennial Action 

Plan 

• Complete annual Plain Writing Act reports

• Develop a process for retrieving annual 

documents for preparation of Plain Language 

Annual Reports.

• Ensure that HHS health literacy measures are 

included in FDA’s; collection throughout the 

year

2 

Incorporate plain 

language elements 

into PMAP and SES 

plans

• Research a method to insert Plain Language elements into 

SES plans

• Develop model Plain Language elements that can be added to 

elements of FDA staff’s PMAP 

3 Promote Plain 

Language Awards

• Encourage nominations for Center-Level awards, publicize 

winners

• Propose new Agency-level honor award for plain language

• Research costs and benefits of pursuing funding and 

nominations for Clear Mark awards 

I.B 

Increased 

availability and 

access to FDA 

clear 

communication 

best practices 

4 

Continue to 

expand Plain 

Language Resource 

Center assets (e.g., 

tools) on the FDA 

intranet.

• Add information and resources writers-editors need to 

improve published information

• Add social media policy and practices

• Add procedures for how to make documents and messages 

accessible to people with disabilities

• Develop a one page Fact Sheet (with justifications) of why 

using Plain Language is important

• Complete YouTube policy document and disseminate within 

FDA

• Update resources from other agencies and add any missing 

links to these resources
16

Lowest Level 

Outcomes

NumberRecommended 

Activities

Examples of 

Specific Steps

5 

Adapt best 

practices and tools 

for FDA use

• Compile a list of communication platforms across the Agency 

and develop communication materials appropriate for each

• Evaluate and establish standardized templates for frequently 

used communication types (e.g. information advisories)

• Conduct an inventory of Center and Office specific editorial 

style guides

• Produce FDA-oriented plain language editorial guide plus a 

dictionary of words commonly used in FDA writing, including 

regulatory and medical terms

• Develop a drug-specific plain language glossary or dictionary 

that can be used for communications materials

• Adapt Clear Communication Index to address FDA needs 

identified through the pilot study

• Create easy to use FDA best-practices guidelines using 

information on various FDA web sites; include CDC guidelines; 

spin off a laminated sheet for new hires and as a refresher for 

current staff members

I.C Improved 

knowledge across 

FDA of the value 

of communicating 

clearly, and how 

to write 

effectively in 

plain language

6 

Train all staff who 

routinely review 

and clear public 

information to 

practice plain 

language principles

• Encourage use of plain language training (already developed 

and provided through FDA University and consider new ways 

to promote the training Agency-wide

7 

Implement an FDAadapted tool based 

on the Clear 

Communication 

Index across all 

FDA Centers and 

offices

• Conduct training on using the FDA-adapted tool based on 

Clear Communication Index

• Showcase a comparison of Foresee survey results for 

communications developed using FDA tool (based on Clear 

Communication Index) against non-scored communications 

8 

Develop and 

execute internal 

campaigns to 

create awareness 

of plain language 

and best practices 

• Establish campaign research to explore most effective ways 

to promote the use of plain language across FDA

• Develop posters and videos on use of plain language for 

distribution in the White Oak campus lobby

• Create information sheet containing real-life examples of the 

impact of not using plain language

• Conduct brown bag presentations on effective writing 

techniques and formatting, include writing for web

communications

• Publish monthly articles demonstrating how to write 

complex, critical information in plain language
17

Lowest Level 

Outcomes

NumberRecommended 

Activities

Examples of 

Specific Steps

II.A.a 

Expanded twoway 

communication 

pathways 

between FDA and 

external 

stakeholders

9 

Expand 

communication 

pathways to 

encourage the 

public to report 

adverse events

• Create online tutorials, specifically for different target 

audiences, to help navigate reporting adverse events related 

to tobacco

• Develop Pinterest and 50-state call, as well as additional 

webinars working with the Office of Health and Constituent 

Affairs and the Office of Regulatory Affairs’ District Directors

to improve reporting of adverse events

• Use Consumer Updates, Web page, webinars, Twitter, 

Facebook, and presentations to public affairs specialists at 

district offices, Google AdWords, CFSAN Educators 

Newsletter, WebMD interview, and distribution of handouts 

at conferences to improve reporting of adverse events 

related to cosmetics

• Create a list of FDA communication platforms centrally 

available

10 

Expand use of 

social media tools 

to learn about 

stakeholder 

concerns

• Continue to use and promote the Apprio/Brandwatch social 

media dashboards to identify influential social media posts 

from stakeholders to which FDA can respond, and trends of 

interest or concern about emerging issues (safety, new 

technology, etc.)

11 

Conduct 

stakeholder 

meetings, public 

hearings, and 

forums to build 

relationships and 

discover 

opportunities to 

reach target 

populations

• Conduct stakeholder meetings and activities through the 

Public Affairs and Stakeholder Engagement (PACE) group

• Conduct meetings with Patient Liaison Program/ Office of 

Health and Constituent Affairs to gather input of the patient 

perspective (CDER Patient Focused Drug Development 

Initiative)

• Hold public hearings to provide and gather public info (e.g., 

Generic Drugs User Fee Act regulatory science), external 

stakeholder meetings during user fee agreement negotiations

• Use the Office of Health and Constituent Affairs' Health 

Professional Liaison Program to get perspectives from health 

professional stakeholders

12 

Continue and 

expand use of 

Special 

Government 

Employees (SGEs)

for expert advice

• Hold Risk Communication Advisory Committee meetings

• Expand use of SGEs for special projects related to enhancing 

communication effectiveness

• Appoint permanent or temporary members (when 

appropriate) with communications expertise to other 

advisory committees 
18

Lowest Level 

Outcomes

NumberRecommended 

Activities

Examples of 

Specific Steps

II.A.b 

Increased access 

to, and leveraging 

of, external 

research related 

to risk 

communication

13 

Issue new grants, 

contracts, and 

cooperative 

agreements for 

research

• Issue new grants and contracts for research on post-market 

evaluation of drug safety, equivalence of complex products 

and locally-acting products, therapeutic equivalence 

evaluation and standards, and any computational and 

analytical tools related to communications

• Issue Generic Drug User Fee Act regulatory science grants and 

contracts on post-market safety of generic drugs, including 

attention to collaborative communication development 

requirements

• Administer cooperative agreements, e.g., with University of 

Chicago and Auburn University to study knowledge gaps 

about generic drugs among influencers of generic drug use

• Issue grants and contracts supporting regulatory science 

goals related to communication (e.g., tobacco regulation)

II.A.c 

Increased FDA-led 

or championed 

evaluative and 

formative 

research

14 

Conduct research 

studies that 

evaluate and 

inform health 

literacy actions and 

programs

• Conduct a series of studies on consumer understanding of 

quantitative information in prescription drug promotion (e.g. 

Experimental Study of Format Variations in the Brief Summary 

of DTC Print Advertisements, Communication of Effectiveness 

Information in DTC Print Ads+B20, and Presentation of 

Quantitative Benefit Information in DTC Television and Print 

Advertisements for Prescription Drugs) 

• Conduct Studies to Enhance FDA Communications Addressing 

Opioids and Other Potentially Addictive Pain Medications: a 

Comprehensive Risk Communication Research Program

• Collect and publish data on Understanding Consumer 

Perceptions of Modified Risk Tobacco Product Claims

• Develop a paper to examine existing counseling practices, 

techniques and tools, as well as identifying opportunities to 

provide more effective standardized counseling by healthcare 

providers to their patients to improve effectiveness of 

communicating serious risks vs benefits for patients 

considering or taking those drugs with a Risk Evaluation and 

Mitigation Strategy

15 

Hold focus groups 

to inform the 

development of 

FDA 

communications

• Hold focus groups to inform development of targeted 

educational messages about FDA's restaurant menu labeling 

requirements

• Establish focus groups to inform the development of

messages about biosimilars to increase prescriber and 

pharmacist knowledge in order to increase mainstream 

acceptance of the products

16 

Use social media 

analytics to 

evaluate public 

understanding, 

knowledge, 

attitudes, and 

beliefs

• Continue to use and promote FDA's social media contract 

with Apprio/Brandwatch to monitor consumers' online 

conversations about FDA-regulated products to assess public 

understanding, knowledge, attitudes, and beliefs around 

relevant issues
19

Lowest Level 

Outcomes

NumberRecommended 

Activities

Examples of 

Specific Steps

II.A.d 

Improved intraagency 

knowledge and 

research 

exchange

17 

Provide timely 

updates to FDA 

and HHS senior 

staff on key FDA 

actions

• Produce briefings in preferred formats when needed by FDA 

and HHS Senior Staff

18 

Organize internal 

FDA forums to 

share research in 

progress and 

research results

• Hold Office of Generic Drugs Science forum

• Hold an annual Health Literacy Poster Session where 

everyone at FDA can present ongoing research related to 

health literacy

• Provide a forum for working group members educate one 

another on their respective center's research agendas

II.B 

Increased skills 

and abilities of 

FDA staff to 

develop accurate 

and actionable 

communications

19 

Promote FDA staff 

professional 

development in 

communications 

science and other 

sciences 

• Identifying areas for increasing knowledge of frequent 

subject matter for communications

• Locating educational opportunities such as conferences 

and symposia

II.C.a 

Increased 

coordination with 

science 

community in 

communication 

development

20 

Examine workflow 

in FDA 

organizations, such 

as development 

and clearance 

processes, to 

ensure that all 

involved staff 

members can 

collaborate 

effectively to 

incorporate 

communications 

science in FDA 

information

• Identifying opportunities for enhancing coordination with 

subject matter experts specifically about characterizing the 

target audience 

• Developing communications to provide the scientific 

information specifically needed and usable by that target 

audience.

II.C.b 

Increased use of 

message testing

21 

Maintain an 

internal message 

testing network to 

test FDA's 

communications

• Advertise message testing services across Agency

• Conduct message testing

• Solicit more message testing volunteers from within Agency

22 

Develop external 

message testing 

capabilities to test 

FDA’s 

communications

• Develop proposal for funding to contract with external 

internet panel access to perform message testing
20

Lowest Level 

Outcomes

NumberRecommended 

Activities

Examples of 

Specific Steps

II.C.c 

Improved internal 

processes for 

moving research 

and knowledge 

into 

communications 

development

23 

Evaluate research 

projects for best 

practices. These 

will then be 

incorporated into 

internal standard 

operating 

procedures or 

appropriate public 

guidance 

documents

• Gather and catalog all research projects relevant to risk 

communication/health literacy

• Scan external literature to update FDA's communication best 

practices to newer standards on an ongoing basis

• Develop before/after materials to show internal colleagues 

the value of incorporating research results into 

communications

III.A 

Improved internal

review and 

oversight

processes for

communication 

24 

Identify areas to 

improve efficiency 

in FDA's 

communication 

process through 

review and 

assessment 

• Members of Risk Communication and Health Literacy 

Working Group who are involved in clearance processes

discuss how to observe their own organization's workflow, 

identifying areas for potential streamlining, and bringing

suggestions to attention of supervisors for consideration. 

III.B 

Improved 

consistency in the 

branding, 

formatting, and 

presentation of 

FDA 

communications

25 

Share and adopt 

new content 

publishing 

guidelines for 

FDA.gov

• Complete migration to Drupal web content management 

system

26 

Ensure 

implementation of

a consistent FDA 

visual identity

• Develop and disseminate in FDA a graphic standards manual 

and design templates and examples for key products 

• Provide education as needed throughout FDA, explaining the 

role of consistency in branding, formatting, and other aspects 

of communication to promote target audience understanding

IV.A 

Improved 

leveraging of 

communication 

pathways with 

outreach partners

27 

Educate research 

sponsors and 

principal 

investigators on 

improving 

informed consent 

documents for 

prospective 

participants

• Disseminate resources and recommendations to sponsors 

and principal investigators that improve understandability of 

informed consent documents, recruitment tools, 

questionnaires and surveys

28 

Support FDA’s 

Public Affairs 

Specialists in 

reaching 

stakeholders in 

FDA's field offices 

• Make presentations to local groups, answer questions, and 

interact with state, local, tribal, and non-governmental 

organization partners

29 

Target and use 

external 

organizations to 

disseminate FDA 

messages

• Maintain relationships, e.g., through current memoranda of 

understanding, with professional societies and other groups

• Expand relationships with external groups, for example, by 

holding public meetings with patients, patient organizations 

and healthcare professional to discuss health literacy on our 

FDA website and how to improve message delivery
21

Lowest Level 

Outcomes

NumberRecommended 

Activities

Examples of 

Specific Steps

IV.B

Improved 

response and 

coordination 

during crisis and 

recall situations

30 

Develop

communication 

strategies and 

research-tested 

messages to help 

ensure effective 

communications in 

the event of urgent 

public health 

situations 

• Catalog the most likely and serious difficulties that may 

complicate emergency administration of medical 

countermeasures (MCMs) 

• Maintain and expand the MCM issues page in providing a 

centralized list of issue-specific resources for a variety of 

topics, linking to the various center pages, news releases, 

guidance, and external links 

• Institute an FDA wide MCM communicators round-table

31 

Create or adapt

tools to guide 

communications 

for specific 

audiences in crisis 

and recall 

situations 

• Create a message library to use during crisis situations (e.g., 

pandemic influenza), with audience tested and pre-cleared 

messages to help FDA communicate more rapidly to the 

public with effective crisis messages

• Project likely target audiences (e.g., message mapping)

IV.C 

Improved 

alignment of 

industry benefit 

and risk messages 

with FDA 

research and 

guidance

32 

Complete 

Guidances for 

Industry on 

communications, 

and involve input 

from stakeholder 

and stakeholder 

advocacy groups

• Complete and implement patient medication information 

project with guidance, education, etc.

• Continue developing Guidelines for Industry in an order

prioritized by needs of stakeholders

33 

Translate

regulatory 

documents into 

plain language, or 

provide

supplementary 

plain language 

explanations for 

official regulatory 

documents

• Create a list of highest priority documents
22

Lowest Level 

Outcomes

NumberRecommended 

Activities

Examples of 

Specific Steps

IV.D 

Improved 

accessibility of 

consumer-facing 

content

34 

Develop materials 

to help consumers 

understand the 

benefits and risks 

of FDA regulated 

products

• Continue releasing and promoting health safety and other 

relevant information to the public through FDA Consumer 

Updates

• Develop materials on cosmetic ingredients, such as the 

different uses of formaldehyde 

• Develop additional tools to broaden outreach efforts for 

alerting consumers to safety issues (e.g. cosmetics)

• Develop webinar series accessible to low-literacy audiences 

(e.g. similar to “Get to Know ClinicalTrials.gov")

• Identify high priority documents to be rewritten in more plain

language, e.g., at an eighth grade level.

• Produce CBER-oriented blogs and research article summaries 

for posting on CBER's Innovation and Regulatory Science web 

site

• Produce CBER-oriented posters on the center's research for 

display in Building 1 for viewing by FDA staff and visitors; 

poster images also put on Innovation web site

35 

Develop and 

expand 

communications 

for consumers to 

reflect plain 

language and 

health literacy 

principles

• Examples include: Consumer Updates, webpages for a 

patient audience, and FDA 101’s to new patient 

representative recruits, standardize external email 

communications as much as possible to make more succinct, 

compelling, and plain language as appropriate for intended 

audiences

• Expand the translation of FDA conducted science in readily 

accessible formats (e.g. Posters based on published research)

• Summarize GDUFA research results for the public 

• Publish materials that tell the story of Agency's scientific 

activity in plain language

• Update and promote the Consumer Update about health 

literacy

36 

Administer the 

Language Access 

Plan

• Standardize the language translation processes

• Develop use of internal volunteer network to check 

translations

• Continue updating the Language Access Plan Steering 

Committee SharePoint site, to serve as a central location for 

Language Access Program

• Plan inter-agency multi-lingual workshop, based on successful 

pilot in which Office of Minority Health (OMH) partnered with 

FDA Office of External Affairs (OEA), USAGov, and 

Department of Justice

• Plan multi-lingual outreach activities, based on successful 

pilot in which, OMH, OEA and the Office of Regulatory Affairs’ 

Office of Health Fraud launched a multilingual campaign 

during Consumer Health Protection Week on dangers of 

some imported dietary supplement products. 
23

Lowest Level 

Outcomes

NumberRecommended 

Activities

Examples of 

Specific Steps

37 

Incorporate 

current, effective 

Web styles to 

develop and 

format Web 

resources

• Evaluate high level sections of the FDA website (e.g. the 

"Report a Problem") to identify areas for improvement

• Consolidate information and reduce the number of links on 

the FDA website

• Evaluate and ensure that all consumer-facing content is 

accessible by smart phone 

• Review and revise older documents to adapt to current 

effective Web style and placement of search terms

• Share new content publishing guidelines developed for 

migration to Drupal web content management system
Appendix 4: Performance Indicators – Monitoring – Phase I 

Outcome Performance Indicator – Phase I Tracking

I 

Increased use of clear communication 

best practices and plain language in 

developing messages

Percent increase/decrease of questions into call center after revising a selected piece of 

communication

I.B 

Increased availability and access to FDA 

clear communication best practices 

Percent increase in best practices published in centralized FDA location online

Number of methods and/or venues used to distribute plain language/best practices

II 

Increased development of messages 

and communications specifically for 

target audiences

Number of external expert consults 

Number of external research studies conducted for specific communication needs at FDA

II.A.a 

Expanded two-way communication 

pathways between FDA and external 

stakeholders

Number of memos of understanding or other types of agreements with external stakeholder 

groups

Number of patient preference meetings and information collections

Number of participants in social media platforms (Number of twitter chats, etc.) 

II.A.b. Increased access to, and leveraging of, 

external research related to risk 

communication

Number of FDA attendees at conferences where communication research is presented

Number of conferences attended by FDA staff where communications research is presented

II.A.c 

Increased FDA-led or championed 

evaluative and formative research

Number of ongoing external studies related to risk communication and health literacy, 

including contract, co-operative agreement, or if applicable grant. (disaggregate by FDA-led 

and FDA-funded)

Number of publications of FDA-led or championed research (including both peer-reviewed 

and FDA web-published reports)

Number of presentations of FDA-conducted or sponsored research at scientific/professional 

meetings or conferences

II.A.d 

Improved intra-agency knowledge and 

research exchange

Number of FDA research presentations at an FDA venue

II.B 

Increased skills and abilities of FDA staff 

to develop accurate and actionable 

communications

Number of training events offered on latest communication-related research and 

development techniques, and number of participants

Number of training events offered on communications best practices

Number of staff participating in training events on communications best practices

IV 

Improved dissemination of FDA's 

communications and information

Average length of time from clearance to dissemination (planned vs actual)

Number of different dissemination channels used for same message

IV.A 

Improved leveraging of communication 

pathways with outreach partners

Number of retweets/likes/sharing of FDA social media messages

Number of referring links to FDA messages

IV.B 

Improved response and coordination 

during crisis and recall situations

Number of exercises conducted with partner communication offices

Number of communication plans developed for different potential crisis situations

IV.D 

Improved accessibility of consumerfacing content

Percent of messages translated into other languages by FDA and released

Percent of 508 compliance, based on a DHHS scan of FDA’s website

24