2006N-0464
  

  
 Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC8
  



  

  
Submitter : 
  

  
Mr. Jason Rock
  

  
Date & Time: 
  

  
12/08/2006 09:12:45
  



  

  
Organization : 
  

  
GlobalSubmit
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 [Docket No. 2006N0464]

Jason Rock

Chief Information Officer

GlobalSubmit, Inc

332 Haddon Ave

Haddon Twp, NJ 08108

Phone: 856.854.4455 x 105

Fax: 856.854.4457

Jason.Rock@GlobalSubmit.com



I am also the project leader for the Regulated Product Submission (RPS) standard developed on Health Level 7



I request 30 minutes.



I plan on talking about the importance of standards where both industry and agencies can collaborate. When both industry and agency are both involved in the creation of the standard, both parties can evaluate their infrastructure and help alter the standard to be more cost effective early in the process, instead of waiting until it is too late. Although RPS has only been approved as a draft Standard, I plan to talk about the broad participation that we received and the positive effects the participation has on the standard.



 



I also plan to talk about the need for the FDA to provide joint guidance and procedures, for all centers, on the submission of electronic information.


More specifically, I plan to address the lack of the labor pool that can help us make the transition from print to electronic. If the FDA consolidates their guidances and procedures, experts can be shared; thus, effectively increasing the available work force.