Regulatory Focus™ > News Articles > Simpler, More User-Friendly Forms Coming to FDA

Simpler, More User-Friendly Forms Coming to FDA

Posted 09 August 2012 | By

Cass Sunstein is going out not with a whimper, but with a bang.

Sunstein, the director of the White House's Office of Information and Regulatory Affairs, last week announced his planned resignation from the agency where he has worked for the last three years, choosing instead to go back to Harvard University where he previously taught.

But while Sunstein's departure is planned for late August 2012, OIRA is continuing to move ahead as planned, releasing a directive aimed at requiring federal agencies to test forms to make sure they are capable of being understood by those most likely to use them.

In his 9 August announcement, Sunstein said people are often required to fill out, "lots of forms."

"Too often, however, those forms are too confusing and complicated, especially for individuals and small businesses," observed Sunstein.

Mandatory Testing for Forms

No longer, Sunstein said in a letter to the heads of federal agencies.

"To the extent feasible and appropriate, especially for complex or lengthy forms, agencies shall engage in advance testing of information collections, including Federal forms, in order (1) to ensure that they are not unnecessarily complex, burdensome, or confusing, (2) to obtain the best available information about the likely burdens on members of the public (including small businesses), and (3) to identify ways to reduce burdens and to increase simplification and ease of comprehension," wrote Sunstein.

Going forward, agencies, including the US Food and Drug Administration (FDA), will be required to test forms using focus groups, web-based experiments, in-person observations or other testing capable of discerning whether a member of the public is likely to find the form a significant burden or easily comprehensible.

"Agencies shall, to the extent feasible and appropriate, compile actual evidence about the burden imposed by those requests, and refine or simplify the requests on the basis of such evidence," remarked Sunstein.

The testing of these forms would either occur before the issuance of an information collection or during the comment period for the same collection.


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