Docket Management
Docket: 02D-0402 - Guidance: "Regulatory Procedures Manual, Chapter 9, Subchapter, 'Import for Export'"
Comment Number: EC -4

Accepted - Volume 1

Comment Record
Commentor Dr. Najib Sehat Date/Time 2003-03-20 09:23:12
Organization Merck KGaA
Category Company

Comments for FDA General
1. General Comments Dear Sir or Madam, in general we aggree with the drafted implementation guidelines of the bioterrorism act of the US and all activities that might increase the general safety - especially in the supply chain of food and drugs. However, as we were requested for comments and ideas due to an effective implementation of all necessary activities, we would like to ask the FDA to generate a system for a confidential handling of information. We do have concerns to disclose all the manufacturers and traders of our substances directly to the customers as this transperancy of the complete market might lead to an abuse of information as well. We would encourrage a system that allows the direct submission of information to the FDA as it is for example already realized by the Drug Master Files-procedure. Best regards Najib Sehat _____________________________ Dr. Najib Sehat Merck KGaA Life Science Products Regulatory Affairs Frankfurter Strasse 250 D-64293 Darmstadt +49 (0)6151/72-6060 +49 (0)6151/72-916060 E-Mail:

EC -4