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:
In the attached letter from CRE to Dr. Hersey, CRE is asking for his views and those of his co-authors on the CRE review of the said study. CRE’s operation of an Interactive Public Docket (IPD) requires studies and their attendant reviews to be conducted in public and on the record.
CRE encourages input from the scientific community. CRE will make the appropriate modifications to its analysis, if appropriate, subsequent to receipt of the views of the authors and the public. In that the said study is one highlighted by FDA to the Advisory Committee, we welcome the input from the FDA.
CRE is requesting public comment on its review of the Hersey study. CRE has made a number of conclusions including:
