FDA’s Secret Emergency ICR Clearance

May 17, 2010

FDA has asked OMB to review a far reaching ICR ( Information Collection Rquest) dealing with menthol cigarettes.

FDA has asked OMB to appove its request on the same day it was sent to OMB, allowing for no input from the public.

In addition, FDA is demanding a response in July, a very short period of time for the development of such an important data base.

The speed and secrecy of the FDA request suggests that FDA has already made up its mind on the issue.

In lieu of the “emergency request” FDA should:

l. Publish its proposal in the Federal Register for comment.

2. Send the proposal to the tobacco advisory committee and seek their opinion.

3. In that the resultant data base will be used for years,  and if the data base is made available to the public,  the data base should be interactive, similar to the CRE IPD and allow for correction, deletion and addition by the public.

4. FDA should delineate a specfic portion of its Data [Information] Quality website specifying the procedures to be followed by the public  in filing DQA petitions.

The proposed FDA ICR is appended hereto.

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