From: BULLELKMAN@aol.com
Sent: Tuesday, February 17, 2004 1:11 AM
To: JBUTLER1@OC.FDA.GOV; FDADockets@oc.fda.gov; brownchas@erols.com; sandyduffy@comcast.net
Cc: Fourpawsca@aol.com
Subject: Docket Number - 2003N-0169 - Comments and Questions

Dear Ms. Butler,

 

On Sunday, February 15, 2004, I checked the docket for my name recorded to Docket Number - 2003N-0169 but I did not find the docket listed or my name listed.  I checked all 23 days of docket comments from January 12, 2004 to February 12, 2004 and did not find Docket Number – 2003N-0169 listed and I did not see my name listed.  I checked the docket from January 12, 2004 to February 12, 2004 at least three times, and never found Docket Number – 2003N-0169 recorded.    



I could not find my January 11, 2004 e-mail to Docket Number – 2003N-0169 recorded to the docket after 23 days.  I know that in the past there have been some e-mail problems, so I am resending this e-mail so that it can be posted to Docket Number – 2003N-0169.  

 

I have several important questions regarding docket management that I hope that you can answer for me.   All of my questions are listed in my January 11, 2004 e-mail that I am resending to you in this e-mail for Docket Number - 2003N-0169.  I look forward to hearing from you.   Thank you.    

 

Thank you for your help.

Thank you, 
Mary Ann Newell
File Manager for Consumers for Dental Choice

 

 

      Subject:
     Docket Number - 2003N-0169 - Questions
     
      Date:
     1/11/2004 7:56:54 PM Pacific Standard Time
     
      From:
     BULLELKMAN
     
            Reply To:
            
           
            To:
           JBUTLER1@OC.FDA.GOV, FDADockets@oc.fda.gov, brownchas@erols.com, sandyduffy@comcast.net
           
            CC:
           Fourpawsca
           

     

Dear Ms. Butler,

I just received my new copy of the CD rom of the submissions for Docket Number – 2003N-0169.  I am very upset with what I saw on my new copy of the CD rom.

The FDA records will show that Sandy Duffy and I purchased the CD rom of all the submissions to Docket Number – 2003N-0169 that were submitted during the "comment period" which ended July 1, 2003.  Around June 25, 2003, you and I spoke and you suggested and wanted to burn off the submissions to the CD rom after all the submissions were recorded which I really appreciated.  You were very considerate that Sandy Duffy and I get ALL the submissions to include ALL e-mails, ALL hard copies mailed to the FDA and ALL attachments that were submitted during the comment time that ended July 1, 2003. 

When I received my first CD rom in the mail, the letter that came with my CD rom was dated July 24, 2003.  When I checked my CD rom, the docket was burned to the CD rom on July 23, 2003.  Thank you for capturing all submissions for Docket Number – 2003N-0169 up until July 23, 2003 which was 22 days after the end of the "comment period".

The following week after I received the CD rom, I started reviewing the files and read the American Dental Association's letter that they sent to Docket Number – 2003N-0169.  Their letter was recorded on the CD rom as 03n-0169-c000001-vol1.pdf.  The ADA's letter referred to an attached bibliography.  I checked the entire CD rom for Docket Number – 2003N-0169 and never found the attached bibliography.  I checked my letter that I received with my CD rom and called Ms. Charlotte Williams to explain that the ADA's bibliography was not on CD rom of the Docket Number - Docket Number – 2003N-0169.  Ms. Williams checked the docket and COULD NOT FIND the ADA attached bibliography either.  She informed me that you were on vacation and I informed her that I would call you when you returned from your vacation.  

On August 12, 2003 I spoke to you about the ADA attached bibliography not being on the CD rom that I purchased.  You informed me that you did have it now and you would e-mail it to me.  You told me that the "Center" asked the ADA to send it in because it was not sent in with the ADA's letter.  I asked if you could e-mail it to me and Sandy Duffy.  You had trouble e-mailing the bibliography to me so you faxed it to me.  You faxed and I received all 14 pages to the ADA's bibliography on Tuesday, August 12, 2003 at 11:28am and I appreciated that you did that for me.  Thank you.  Sandy did receive your e-mail with the attached bibliography.  Thank you.

Another important thing is the Docket Management webpage, even now, January 7, 2004 still shows that the American Dental Association's submission was recorded on the Docket Management webpage on May 30, 2003 and it is recorded as C1 – American Dental Assn – Vol #1. 

Here are the questions/issues/concerns that have me very upset.  I hope that you can answer my questions. Thank you.

Q1:  Isn't Docket Management the official record keeper for the FDA for recording docket comments?

Q2:  Why did the late (at least 30 days late) ADA's bibliography get listed under the ADA's letter that was recorded on May 30, 2003 on the new CD rom dated 12/31/03? 

Q3:  Doesn't recording the ADA's bibliography as 03n-0169-c000001-02 bibibliography and 03n-0169-c000001-02 bibliography – vol. 1 give the "wrong recording" or "wrong accounting" information to people that would get a copy of the CD rom?  

Q4:  Doesn't having the ADA's bibliography recorded under the ADA's letter give the appearance/impression to the public that the ADA's bibliography was sent to the FDA on time by recording it under the ADA's letter?

Q5:  Shouldn't the ADA's bibliography have been recorded when it was sent to the Docket Management?

Q6:  Shouldn't the Docket Management record keeping be an actual account when e-mails, comments and files are sent to the Docket Management or received by the Docket Management staff?  

Q7:  Was the ADA's bibliography treated differently?

Q8:  If the ADA's bibliography was treated differently, why?

Q9:  Is it normal process for the FDA to ask people or organization like the ADA to send files and comments after the docket's comment time has ended?

Q10:  If I, Mary Ann Newell or Sandy Duffy had forgotten to attach a file, would have the FDA contacted us?

Q11:  Why was the American Dental Association's new comment sent on November 19, 2003 and recorded to the Docket Management Webpage on November 28, 2003 recorded in Vol 4 instead of Vol 6?

Q12:  Shouldn't late or later comments be recorded in chronological order?  

Q13:  Why wasn't the American Dental Association's new comment sent on November 19, 2003 and recorded to the Docket Management Webpage on November 28, 2003 recorded in Vol 6?   

Q14: After watching the two dockets on mercury dental fillings the last two years, the Docket Management seems to record the comments (e-mails and correspondences) when they recieve them, why are the ADA's comments treated differently? 

Thank you,
Mary Ann Newell
File Manager for Consumers for Dental Choice