From: Lake, Robert S [Robert.Lake@STJUDE.ORG] Sent: Friday, December 29, 2006 11:22 AM To: Dockets, FDA Subject: Comments on Docket 2006N-0464 Please note that I am responding to Docket 2006N-0464, Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management. I wish to make reference to the FDA’s Electronic Submissions Meeting at the Agency on December 18, 2006. Additional reference is made to Docket 2006N-0464, which provides for commensurate comment until February 16, 2007. I greatly appreciate the opportunity to offer my remarks and trust that FDA will consider my suggestions as having merit for consideration. From at least the early 1990s, the Agency has strongly urged sponsors and applicants to supply electronic renditions of their submissions, either in part or in total. In nearly all cases, these electronic versions were intended to satisfy the FDA’s needs and to facilitate the review. In some instances, the electronic submission reflected the capability of the sponsor/applicant, while other submissions had the purpose of addressing the numerous Agency requests for submission utility, function, and service. It should be observed that during the past years, what was promulgated by the FDA as an organization was not always the same as what was being suggested by the Agency’s personnel who would review the electronic submission. In many cases, the reviewers would ask for simplicity with respect to the submissions, while the Agency as a whole would want multiple, complicated features. The FDA should recognize that industry symposia dealing with electronic submissions are generally attended by over 50% information technology persons, outnumbering those from regulatory affairs. It should not be surprising to note that organizations wanting to undertake electronic submission need the services of outside, third-parties (outsourcing) to handle the inherent technical issues. In order to affect an electronic submission, major investment is required in commensurate equipment and facilities. The ability to conduct activities pursuant to electronic submissions as described by the Agency is not equal between large and small organizations/institutions. Furthermore, it is my belief that the reasons for groups hesitating to make electronic submission are the following: a.. High cost of personnel and equipment needed to revise processes and assemble the submission b.. Delay in ultimate submission of the electronic document as compared to paper. c.. Change in technologies associated with electronic submissions d.. Revisions in the regulatory guidelines/requirements for electronic submissions. [It is my opinion that the FDA has in general asked for too much too soon given the available technology and resources at the time.] e.. Questionable advantage in submitting electronic versus paper. Previous dialogue between industry and FDA regarding electronic submissions has included the proposals of mandates and/or incentives as a vehicle to prosper the use of such submissions. I do not believe that these methods have the effect of being equitable across all organizations and institutions given their varying abilities and capacities. Another possible means, not previously mentioned for facilitating the use of electronic submissions, is to increase the relative ease of compliance. That is, consider the following: a.. In a situation where the environment and its associated technology are in state of flux, it is best to move in small, manageable steps. b.. Start out with electronic submissions in a very simple format that is easy for most, if not all, organizations and institutions to implement and use. c.. Early electronic submissions should be submitted along with paper versions. d.. As has been done in some European countries, FDA should develop and have available upon request an electronic template for use in constructing an electronic submission. If some sections are not applicable, a reason for its inapplicability should be provided. The FDA may want to start with having NDA applicants provide their summary section in electronic format, then increase the extent of the electronic submission. e.. If the Agency is interested in establishing an electronic database of pertinent information, then establish a "coding form" or similar device that organizations can use to transmit information in a fashion that will be easy to use by everyone, rather than using a large NDA or other document to meet the purpose. f.. As the capability of both industry and FDA becomes better, requirements for the submission (i.e., the template) can be gradually increased to better suit the Agency’s needs and to respond to changes in technology. Again, the simpler the electronic submission requirements are, the easier it will be to comply and the more often such submissions will be employed. In addition, as the capabilities of both industry and FDA become better with respect to electronic submissions, those subjects that have appeared unclear and confounding will become more lucid. I trust that you have found these comments useful. Robert S. Lake, D.Mgt., M.A., RAC Director of Regulatory Affairs St. Jude Children's Research Hospital 332 North Lauderdale Street Memphis, TN 38105-2794 (901) 495-5243 (telephone) (901) 495-2355 (telefax) robert.lake@stjude.org