Dangerous Documents: Avoiding Land Mines in Your FDA Records and Emails

Government employees need to be able to communicate freely.  For this reason, the public generally is denied access to intra-agency communication under the deliberate process exemption of the Freedom of Information Act. This may give the staff a false sense of security when writing such “protected” documents. Unfortunately, some government employees might not take the necessary time to be precise and professional when they write emails and other documents.  These employees may be shocked when, during congressional investigations, their private documents are leaked to the media. Historically, there are many examples of leaked documents containing hastily written statements that, when taken out of context, embarrassed both the agencies and the individuals who wrote them.

  • Recognize that government agencies are under scrutiny
  • Comprehend how the public gets access to intra-agency or inter-agency documents
  • Experience what happens in a congressional oversight hearing
  • Acknowledge the problems with attaching sticky notes to files
  • Understand the types of information that should and should not be included in meeting minutes
  • Distinguish between fact and opinion
  • Recognize the problems that could occur from writing personal emails at work
  • Identify how to respond to an inappropriate email
  • Learn the consequences of posting information about a government employee’s personal activities on social media

FOR THE OFFICE OF COMPLIANCE AND ENFORCEMENT ONLY

June 18, 2015  9:00am - 12:00pm

Administrative Records Training

This seminar will provide training on the development of administrative records to support the Center’s decisions and actions.  Failure to maintain adequate administrative records can result in serious consequences for the Center, such as invalidation of a regulation or a dismissal of an enforcement action.

Federal Docket Management System

FDA's Dockets Management serves as the official repository for the administrative proceedings and rule-making documents for the Food and Drug Administration (FDA), an operating division of the U.S. Department of Health and Human Services (HHS). Dockets Management is administered by the Federal Dockets Management System (FDMS) located at Regulations.gov (see FR announcing this transition). The system allows consumers to access FDA's administrative proceedings and rule-making documents more readily, including Federal Registers, Petitions, supporting documents and comments. Regulations.gov also serves as a vehicle for making your voice heard at FDA by providing the ability to submit comments electronically

Paperwork Reduction Act Training

The Paperwork Reduction Act asks government agencies to minimize paperwork requirements on the public and improve the quality and use of information collected by Federal agencies.  The Paperwork Reduction Act is mandatory for all federal agencies and it states that any collection of information involving more than nine non-federal respondents, unless exempted, must be approved by the Office of Management and Budget

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