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Communicating Information About Agency Procedures - Considerations


Background

Summary of Public Comments

Transparency Report Arrow Considerations

View All Draft Proposals for This Topic   


The Task Force agrees that it is a critical part of FDA’s mission to disseminate information about its policies in a form that can be accessed by all interested members of industry.  FDA personnel should conduct and participate in as many industry training opportunities as resources allow.

The Task Force also agrees that information about FDA policies should be disseminated promptly to facilitate compliance, and increased access to presentations provided by FDA employees to industry may improve understanding of and compliance with FDA requirements.  Industry should receive timely responses to regulatory questions.

In determining how to improve dissemination of information to industry, the Task Force considered the information that is currently available to regulated industry about the agency’s procedures.  There are currently several mechanisms available to inform industry about FDA processes, including FDA employee participation in meetings sponsored by the agency or members of industry, industry-specific information available on the FDA Web site, the email notification system for new information posted on certain pages on the FDA Web site, and FDA-TRACK, the agency’s performance management system.  In FY 2009, agency employees participated in at least 100 meetings sponsored by the agency or members of industry.  There are also additional cost-effective means the agency can undertake to provide information to industry.

The Task Force considered whether existing information could be made more accessible to regulated industry and updated on a more frequent basis, weighing the resources required to provide increased access to information online.  A consideration was the resources involved in making materials 508 compliant for posting online.

In addition, the Task Force considered whether transcripts from public meetings could be disseminated sooner.  FDA employees must review meeting transcripts for accuracy prior to posting online.  The Task Force discovered that requesting an expedited transcript from a transcription service costs significantly more money; for example, for one company the agency has worked with in the past, it would cost 50% more for the agency to receive a transcript in 5 days, as compared to the typical processing time of 10 days (for simple requests).

The Task Force considered the diverse set of responsibilities faced by some employees and the need to balance those responsibilities in order to ensure an efficient regulatory process.  For example, FDA medical reviewers are often responsible for reviewing premarket applications, working on guidance documents in their area of expertise, and participating in training workshops to educate the public about FDA’s standards and expectations.  These same employees may also be the subject matter experts capable of providing an answer to a specific question.

 

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