# Presentation: 378433

## Welcome to Plain Language

**Hello!  **
**Welcome to the fundamentals **
**section of plain language training!**
**This slide will not be projected**

## You’ll learn to:

**Correct them without slowing your productivity**
**Learn more writing tips as you go along**

**You’ll learn to:**

## What is plain language?

**Five top requirements of plain language:**
**1.  Active Voice**
**2.  Concise Word Use**
**3.  Reader-focus**
**4.  Professional, jargon-free tone**
**5.  Cohesive structure**

## Active voice

**Keep the actor and action beside each other in the sentence**
**Make sure you have an actor**
**Be on the look out for hidden verbs**
**Stay clear of empty actors**

## Keep the actor and action beside each other in the sentence

- Before:** *****A Notice of Availability of the revised FDA CPG 7132c.02 was published by the FDA in the Federal Register of September 27, 1984.***

## After:  We published a Notice of Availability of the revised FDA CPG in the Federal Register of September 27, 1984.

- After:  ***We published a Notice of Availability of the revised FDA CPG in the Federal Register of September 27, 1984.***

## Make sure you have an actor

- Before: ***Federal agencies are advised of all warning letters about drugs.***

## After: We advise federal agencies of all warning letters about drugs.

**After: *****We advise federal agencies of all warning letters about drugs.***

## Be on the look out for hidden verbs

- Before: ***Such misrepresentation at the time of entry appears to be an attempt to circumvent FDA's statutory requirement***
*** ***

## After:  Companies sometimes misrepresent their products in their attempt to circumvent FDA's statutory requirement.

**After:  *****Companies sometimes***** *****misrepresent their products in their attempt to circumvent FDA's statutory requirement.***

## Stay clear of empty actors

- Before:** *****If there is a failure to correct these deviations, it will be necessary for regulatory action to occur.***

## After: If you fail to correct these deviations immediately, we may take regulatory action.

- After: ***If you fail to correct these deviations immediately, we may take regulatory action.***

## 	Examples - Change From Active to Passive Voice

**1. Our review of the label for Product X, imported by your firm, reveals that it causes the product to be in violation of the Federal Food, Drug and Cosmetic Act.**
**2. The Product is further misbranded with the statement and incomplete declarations in a foreign language.**
**3.  Failure to promptly correct this situation and prevent future violative shipments may result in regulatory action without further notice such as seizure or automatic detention of future shipments.**
**  **
**4.  The referenced FDA sample, consisting of a shipment of approximately 1234 products that had been detained by our office on or about May 1 was distributed into commerce without a proper release by us.**
**5.  You are advised that performing mammography without a certificate issued by the Food and Drug Administration is unlawful under the MQSA. **

## ANSWERS

**1. We reviewed the label of Product Y which your firm imported and found it violates the FD&C Act.**
**2. You further misbranded the product by providing a statement and incomplete declarations in a foreign language.**
**3. If you fail to correct this situation promptly, we may take regulatory action without further notice such as seizing or automatically detaining future shipments.  **
**4. You** **distributed** **the referenced FDA sample containing a shipment of approximately 1234 products that we detained on or about May 1 without a proper FDA release.**
**5. We are advising you that if you perform a mammography without a Food and Drug Administration issued certificate you are breaking the law under the MQSA. **

## 1.  Our review of the label for Product X, imported by your firm, reveals that it causes the product to be in violation of the Federal Food, Drug and Cosmetic Act.

**Answer**
**1. We reviewed the label of Product Y which your firm imported and found it violates the FD&C Act.**

## 2.  The product is further misbranded with the statement and incomplete declarations in a foreign language.

**Answer**
**2. You further misbranded the product by providing a statement and incomplete declarations in a foreign language.**

## 3.  Failure to promptly correct this situation and prevent future violative shipments may result in regulatory action without further notice such as seizure or automatic detention of future shipments.

**Answer**
**3. If you fail to correct this situation promptly, we may take regulatory action without further notice such as seizing or automatically detaining future shipments.  **
**  **

## 4.  The referenced FDA sample, consisting of a shipment of approximately 1234 products that had been detained by our office on or about May 1 was distributed into commerce without a proper release by us.

**Answer**
**4. You** **distributed** **the referenced FDA sample containing a shipment of approximately 1234 products that we detained on or about May 1 without a proper FDA release.**

## 5.  You are advised that performing mammography without a certificate issued by the Food and Drug Administration is unlawful under the MQSA.

**Answer**
**5. We are advising you that if you perform a mammography without a Food and Drug Administration issued certificate you are breaking the law under the MQSA. **

## Reader-focus

**Show what the reader will get, do, or needs –  not what FDA will get, do, or needs**
**Use the second person “you” whenever possible**
**Position information so the reader can see it**

## Focus on the readers’ concerns  not the FDA’s

- Before:**  *****The kind of information you need to submit in order to obtain this clearance is described in the enclosed materials.***

## After:  To obtain this clearance, you must submit the kind of information that we have described in the enclosed materials.

- After: ** *****To obtain this clearance, you must submit the kind of information that we have described in the enclosed materials.***

## Use the second person “you” whenever possible

- Before:** *****This is a violation of Title 21, Code of Federal Regulations, Section 1.90, which requires the importer to hold an entry intact pending receipt of a May Proceed or Release Notice from FDA.***

## After: You have violated Title 21, Code of Federal Regulations, Section 1.90, which requires that you hold an entry intact until you receive a May Proceed or Release Notice from the FDA.

## Position information so the reader can see it

**Keep paragraphs short**
** ****Five lines for an opening   **
**    ****paragraph; between 10 and 15 **
**    ****for all others**

## Position information so the reader can see it

**Place most important information first**
** ****Focus on what you want the **
**    ****reader to do after reading your**
**    ****message**

## Position information so the reader can see it

**Use interesting headings**
-  **They must provide information, **
**    ****sound interesting, help the **
**    ****structure flow smoothly from **
**    ****point to point**

## Professional, Jargon-free Tone

**Avoid hyperformal language**
**Stay 100% jargon-free**
**Define industry language for lay people**

## Industry Terminology vs. Jargon

- Industry:
***Particular to industry***
***Grammatically correct and uses common grammar***
***Cannot be replaced by other words***

## Industry Terminology vs. Jargon

- Jargon:
*** ******Particular to industry***
*** ******Grammatically incorrect and does  not use common grammar***
*** ******Other words can replace them***

## Create Jargon-free, Reader-focused Messages 

**1. These drug products are adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.**
**2.  Field compliance testing of fully certified diagnostic x-ray systems assembled by FBY Company has shown that 45% percent of the x-ray systems tested failed to comply with the Performance Standard for Diagnostic X-ray Systems and Their Major Components (Performance Standard).**
**3. In the event that we determine that you have resumed performing mammography without adequate corrective action, your facility may be subject to additional regulatory action.**
**4. You have failed to maintain an adequate record of complaint investigations including any control number used, the nature of the complaint, and the reply to the complaint [21 CFR 820.198(c)].  **
**5. Failure to promptly correct these violations can result in seizure and/or injunction and/or the imposition of civil penalties as provided for in Section 539 of the Act.  Persons violating Section 538 of the Act are subject to civil penalties of up to $1,000 per violation; up to a maximum of $300,000.**

## Answers

**1. Your drugs are not consistent with the requirements in Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.**
**2.** **Our** **tests of the certified diagnostic x-ray systems that FBY Company assembles has shown that 45% percent of the x-ray systems failed to comply with the FDA’s Performance Standard for Diagnostic X-ray Systems and Their Major Components (Performance Standard). **
**3. If we determine that you have started performing mammography without correcting this ****problem, we may take additional regulatory action.**
**4. You failed to maintain adequate records of your investigations into complaints, including the control number you used, the nature of the complaint, and your response to the complaint [21 CFR 820.198(c)].**
**5. If you fail to promptly correct these violations, we could do any or all of the following:**
**seize your product**
**file and injunction**
**impose civil penalties as Section 539 of the Act states, or, if you violate Section 538, to$1,000 per violation with a maximum of $300,000.**

## Before:  1. These drug products are adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

**After:  1. Your drugs are not consistent with the requirements in Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.**

## Before:  2.  Field compliance testing of fully certified diagnostic x-ray systems assembled by FBY Company has shown that 45% percent of the x-ray systems tested failed to comply with the Performance Standard for Diagnostic X-ray Systems and Their Major Components (Performance Standard).

**After:  2.** **Our** **tests of the certified diagnostic x-ray systems that FBY Company assembles has shown that 45% percent of the x-ray systems failed to comply with the FDA’s Performance Standard for Diagnostic X-ray Systems and Their Major Components (Performance Standard). **

## Before:  3. In the event that we determine that you have resumed performing mammography without adequate corrective action, your facility may be subject to additional regulatory action.

**After:  3. If we determine that you have started performing mammography without correcting this problem, we may take additional regulatory action.**

## Before:  4. You have failed to maintain an adequate record of complaint investigations including any control number used, the nature of the complaint, and the reply to the complaint [21 CFR 820.198(c)].  

**After:  4. You failed to maintain adequate records of your investigations into complaints, including the control number you used, the nature of the complaint, and your response to the complaint [21 CFR 820.198(c)].**

## Before:  5. Failure to promptly correct these violations can result in seizure and/or injunction and/or the imposition of civil penalties as provided for in Section 539 of the Act.  Persons violating Section 538 of the Act are subject to civil penalties of up to $1,000 per violation; up to a maximum of $300,000.

**After:  5. If you fail to promptly correct these violations, we could do any or all of the following:**
**seize your product**
**file and injunction**
**impose civil penalties as Section 539 of the Act states, or, if you violate Section 538, to$1,000 per violation with a maximum of $300,000.**

## Concise word-use

**Beware of unsightly little word build up**
**Say one thing once **

## Beware of unsightly little-word-build-up

**Before: *****You must immediately adopt the practice of preparing adequate mammography reports for all mammograms produced at your facility. You must also provide reports to either referring health care providers or examinees, if no referring health care provider is present.***

## After:  Immediately begin preparing adequate mammography reports for all mammograms at your facility.  Provide the reports to either referring health care providers or examinees, if the provider is not present.

## Say one thing once 

- Before: ***The label and/or labeling distributed with this product states or suggests that this  product is useful in treating or preventing disease(s).  ***
***   ******Such labeling includes statements which represent and suggest that this article is intended to be used in the cure, mitigation, treatment or prevention of a disease which is neither self-limiting nor amenable to self-diagnosis and treatment by the laity.***

*** ***

## Cohesive Structure

**Make sure the introduction contains the *****what***** of message**
**Provide information in logical order**
**Mention enclosures and future plans and secondary information last**

## Identify the Biggest Problems in This Letter

**During an inspection of WVB firm located at 2000 Main Street on May 18,our investigation determined that your firm manufactures and distributes blood bank software.  Your system, which includes Post Haste software,  is a device as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).**
**The inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Good Manufacturing Practice (GMP) for Medical Devices Regulations, as specified in Title 21, **_**Code of Federal Regulations**_** (21 CFR), part 820.   During the inspection of your firm, our investigator(s) observed the following deviations:**
**1. Failure to maintain adequate device master records for Post Haste software.**
**2.  Failure to establish, implement, and control written manufacturing specifications.**
**3. Failure to maintain an adequate record of complaint investigations including any control number used, the nature of the complaint, and the reply to the complain.**
**The above identified deviations are not intended to be an all inclusive list of deficiencies at your facility.**
** **
**You should take prompt measures to correct these deviations.  Failure to promptly correct these deviations may result in regulatory action without further notice.  Such action includes license suspension and/or revocation.  Federal agencies are advised of the issuance of all Warning Letters about drugs and devices so that they may take this information into account when considering the award of contracts.**
**Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent their recurrence.  If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.**

## Which Problems Did You Detect?

**1. Passive Voice**
***...******the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation...***

## 2. Wordiness

***You should take prompt measures to correct these deviations. Failure to promptly correct these deviations...***

## 3. FDA-focus not reader-focus

***During an inspection of WVB firm...The inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Act... During the inspection of your firm, our investigator(s) observed the following deviations:***

## 4. Jargon

**4. Jargon**
***...******.these devices are adulterated within the meaning of Section 501(h) of the Act...***

## 5. Problem structure

**5. Problem structure**
**The most important point is buried:**
**...****.*****Please notify this office in writing, within 15 working days of receipt of this letter***

## Sample Rewrite

**On May 18, while inspecting WVB firm at 2000 Main Street, our investigator found that the Post Haste software your firm manufactures and distributes violates FDA requirements.  Unless you write us within 15 days about specific steps that you have taken to correct and prevent these violations, we may take regulatory action against you without further notice.  These include suspending or revoking your license.**
**Among possibly other violations, you failed to:**
**1. Maintain adequate device master records for Post Haste software;**
**2. Establish, implement, and control written manufacturing specifications;**
**3. Maintain an adequate record of your investigations into complaints including the control numbers you used, the nature of the complaints, and your reply to them.**
**In specific, Post Haste software is a device as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).  Our inspection revealed that the software, according to the meaning of Section 501(h) of the Act, is not in conformance with the Good Manufacturing Practice (GMP) for Medical Devices Regulations, as specified in Title 21, **_**Code of Federal Regulations**_** (21 CF R), part 820.**
**If you need more than 15 days to respond, state how much more time you need and why you need it. Finally, please note that we forward warning letters to other agencies so they can consider them when awarding contracts. **

## Review:Five Points of Plain Language

**	****1. Active Voice**
**	****2. Concise Word Use**
**	****3. Reader-focus**
**	****4. Professional, jargon-free tone**
**	****5. Cohesive structure**

## www.fda.gov/ora/ora_home_page.htmlwww.plainlanguage.gov

## “The National Grain and Feed 

**Association also commends FDA’s **
**CVM for issuing the agency’s first **
**regulations under the “plain English” **
**mandate of the Clinton administration.  **
**We believe the format, clarity and **
**preciseness with which the regulations **
**are written will enhance their understanding **
**and facilitate compliance and effective **
**enforcement.” **