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Re: 1bill post# 22806

Tuesday, 12/17/2013 8:45:30 PM

Tuesday, December 17, 2013 8:45:30 PM

Post# of 448101
Not knowing the FDA processes....I am purely guessing based on my federal experience with documents, files/dockets, tracking, etc.....

When the case is received - it is assigned a docket number. It is that docket number that allows us to access what is there online.

It looks like the FDA receives the CP, scans it in, then keeps two copies. One is the full version with all personal info on the filer. That copy requires password access which FDA employees would have. The second version - is a .pdf labled 'redacted'. That blocks out any personal information that the privacy office would deem not accessable to the public.

So - once the original version is received and accepted....the FDA sends an acknowledgement to the petitioner. On the acknowledgement - you should also see personal info redacted. It is the acknowledgement which is closed to comment. NOT the petition. After the acknowledgement letter is written/signed, that document along with the password protected and redacted versions CP are uploaded into the system.

The electronic file is probably the number that we use to access - what I don't know is whether they lump them altogether or if they have subfolders within the docket folder for each CP and individual CP related response. Because it is a singular docket number....they may well combine them all and deal with it as a singular response at some point.

Right now - there are only 7 documents - the 7 redacted versions of the Cp that are open to comment. The info redacted is not substantive in that it relates only to the personal information of the petitioner (address, phone number, etc).

Focus on the CP redacted - and perhaps any comments to other submitted comments if we can make those as well.....
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