Docket Management
Docket: 02N-0319 - Blood Establishment Registration/Product Listing, Form FDA 2830
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Dr. Celso Bianco Date/Time 2002-09-25 21:13:09
Organization America's Blood Centers
Category Association

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? ABC concurs that the use of an annual registration form, form FDA 2830, is helpful to FDA in performing its function, in that it allows the agency to be aware of activities that are being conducted at FDA-registered facilities
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? We believe that the estimate of one hour for response time for initial registration has been underestimated. Applicants are not familiar with the registration form when initially registering, and it may take up to two hours per registered site to complete each form accurately. We believe that the estimate for re-registration is accurate at 0.5 hours, since the applicant has seen the form before and changes are usually minor in nature. We believe that the time to complete the product listing update has been underestimated at 0.25 hours. 0.5 hours is a more reasonable estimate, since the current listing must first be reviewed, and then changes must be confirmed with appropriate responsible people before the form can be completed.
3. What are ways to enhance the quality, utility, and clarity of the information to be collected? We have no comments on this question.
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? We request that the annual registration process be automated so that each facility could electronically submit the form, if desired. We also request that FDA continue to send a copy of the form and instructions for completion in October as a tool and reminder for registrants to re-register.




EC -1