Docket Management
Docket: 00N-1567 - Registration of Producers of Drugs in Commercial Distribution
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Ms. Sharon Henson Date/Time 2000-11-29 15:55:49
Organization Private
Category Individual

Comments for FDA General
Questions
1. Is the proposed collection of information necessary for the proper performance of FDA's functions? Will the information have practical utility? Just because 5 doctors mis-diagnosed Lotronex to patients with colon problems, is that an excuse to discontinue the product????
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? Just because 5 doctors mis-diagnosed Lotronex to patients with colon problems, is that an excuse to discontinue the product????
3. What are ways to enhance the quality, utility, and clarity of the information to be collected? Just because 5 doctors mis-diagnosed Lotronex to patients with colon problems, is that an excuse to discontinue the product????
4. What are ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology? Just because 5 doctors mis-diagnosed Lotronex to patients with colon problems, is that an excuse to discontinue the product????
5. General Comments Just because 5 doctors mis-diagnosed Lotronex to patients with colon problems, is that an excuse to discontinue the product????




EC -1