Replies to post #46116 on Amarin Corp Plc (AMRN)

[sts66]

The FDA, by hiding our comments were in violation of the paperwork reduction act which carries fines against the violators.

Sorry, nope - no punishment - maybe budget ramifications, but I highly doubt that actually happens - and the violations are from collecting unapproved info, not from hiding comments to CPs:

http://www.hhs.gov/ocio/policy/collection/infocollectfaq.html#23

Q. What happens if an OPDIV has already conducted a collection for which PRA approval was not obtained? What happens if an OPDIV does not obtain PRA approval for a future collection?

A. The Paperwork Reduction Act is a law and failure to comply with the requirements of the Act is breaking the law. The Chief Information Officer (CIO) is the senior policy official for the Department of Health and Human Services (HHS) responsible for compliance with the law. When OMB becomes aware of a violation of the Paperwork Reduction Act it is brought to the CIO's attention. If the violation is not resolved in a timely manner, the issue is raised in OMB's management chain and can result in official Departmental reprimands and may have budget implications.

If an unapproved collection has already occurred and it is ongoing in nature, the OPDIV should bring the violation to the attention of the Departmental Reports Clearance Officer and work to resolve the violation as soon as possible. If an unapproved collection is conducted and it is a one-time collection, there is no further action that an OPDIV can take to rectify the violation in the short term.

Annually, each OPDIV must submit a summary of information collection activity for the previous fiscal year and a forecast for the coming fiscal year. This report is included in the annual Information Collection Budget (ICB). This summary must also include a description of each violation and the action taken, if any, to resolve the issue.

While the consequences of violating the Paperwork Reduction Act do not involve fines or jail sentences, there are legal ramifications to conducting or sponsoring a collection of information without OMB approvals. When a collection occurs without approval, HHS leaves itself open to lawsuits from individuals in the public.