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Regulatory Focus™ > News Articles > In Reversal, FDA to no Longer Publish Agreements in Federal Register

In Reversal, FDA to no Longer Publish Agreements in Federal Register

Posted 21 August 2012 | By Alexander Gaffney, RAC 

In a reversal, the US Food and Drug Administration (FDA) has released a final rule regarding the posting of all memoranda of understanding the agency signs with other agencies and organizations, saying it will no longer post them in the Federal Register.

The agency would previously make such agreements available in the Federal Register and on its website, but the duplicative posting was a drain on the agency's time and resources, FDA wrote. The agreements establish a legally binding framework for interaction between FDA and other entities, and usually involve protections for proprietary information.

FDA currently maintains three separate webpages for its agreements: one for domestic agreements, one for academic agreements and another page for all other agreements including those involving foreign entities. Under its final rule, all agreements would be posted on the three pages.

An identical proposal was withdrawn in June by FDA after the agency received a "significant adverse comment" by medical device manufacturer Cook Group Inc. In its 5 June 2012 letter to FDA, Cook explained the MOUs are much easier to read and find when they are posted in the Federal Register because it is a single place to find all information, and it is contained in a standardized format.

"On the other hand," explained Cook, "FDA's website has no single place where it lists all newly added information. It also has no clear standard of what is noteworthy enough to be included in any of its various 'what's new' pages." Similarly, changes in FDA's website, such as an overhaul launched in January 2012, can leave many existing links broken or missing.

Two Tracks for a Final Rule

Subsequent to Cook's comments, FDA said it was "withdrawing the direct final rule" because of the comments, and did so on 27 August.

FDA noted in its 21 August announcement that it was instead passing a nearly identical final rulepublished concurrently with the now-withdrawn final rule on 23 March. The second final rule, explained FDA, "Provided a procedural framework from which to proceed with standard notice-and-comment rulemaking in the event we were required to withdraw the direct final rule because of significant adverse comments."

In responding to Cook's comment, FDA said it believed its arguments for the cost and resource benefits of the rule, "Outweigh any arguable interest in reproducing these documents in their entirety in the Federal Register." FDA noted any significant documents would still be archived and available to the public upon request.

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