Docket Management
Docket: 01N-0458 - Agency Collection Activities; Fast Track Drug Development Programs-Desig., Develop. and App. Review
Comment Number: EC -2

Accepted - Volume 1

Comment Record
Commentor Mr. Roy Stratton-MRS-RD Date/Time 2001-11-22 19:07:17
Organization Stratton Research
Category Other

Comments for FDA General
1. Is the proposed collection of information necessary for the proper performance of FDA's functions? Will the information have practical utility? I don't think so.
2. What is the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used? I would like to see some paper on this before it is approved
3. What are ways to enhance the quality, utility, and clarity of the information to be collected? I would like to some answers to what you are asking me.
5. General Comments to rush things to a conclusion before they are tested and approved and then used on soldiers or the general public is wrong and for our Congress to even think about letting it happen is playing games with the existing laws.

EC -2