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Government Website Troubles Spread to Regulations.gov, Impacting Ability to Make, Track Comments

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By Alexander Gaffney, RF News Editor

Troubles with the Obama Administration's signature healthcare website, Healthcare.gov, may be occupying the front pages of newspapers around the country, but this week has seen the meltdown of another website, one of integral importance to the US regulatory process.

The website in question is Regulations.gov, the government's repository of official documents where it posts regulations, guidance documents, citizen petitions, public comments and government responses to all of the above. It is, in other words, the hub of the government's regulatory activity.

But from 10 p.m. on 4 November 2013 through 4:30 p.m. on 6 November, the website was entirely unavailable, giving anyone attempting to go to the website an error message.

Unlike other websites, the outage of Regulations.gov has significant implications for federal regulators. Correlated with most official documents is a date by which the government will legally consider comments for the purposes of making changes. Under normal circumstances, if a submission is made after that date, it will not be considered.

However, if Regulations.gov is brought down (as it sometimes is for maintenance purposes), regulators have several options at their disposal. They can accept the comments anyway (as FDA did last month for an AdvaMed petition), they can extend the comment period (which FDA often does for complex documents or ones that receive many comments), or they can do nothing.

But when the federal docket came back online on 6 November, it didn't come back with all its information. The most recent FDA-related document posted on Regulations.gov, for example, was posted on 2 August 2013.

While links to comments posted later seem to still work, there is no way of finding more recent documents on the site—a significant challenge for members of industry or the public wishing to comment on recent regulatory documents or the citizen petitions posted by other companies.

The website had no information on when those documents would again be listed.

You can see FDA's Regulations.gov docket here.




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