Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Accelerated Approval Designation - CDER New 33 3300 0 Other-Agency Guidance
Breakthrough Therapy Designation Requests - CBER New 17 1190 0 Other-Agency Guidance
Breakthrough Therapy Designation Requests - CDER Modified 77 5390 0 Other-Agency Guidance
Fast Track Designation Requests - CBER New 77 4620 0 Other-Agency Guidance
Fast Track Designation Requests - CDER Modified 277 16620 0 Other-Agency Guidance
Premeeting Packages - CBER New 277 27700 0 Other-Agency Guidance
Premeeting packages - CDER Modified 165 16500 0 Other-Agency Guidance
Other-Agency Guidance
Priority Review Designation Requests (Expedited Programs for Serious Conditions) - CBER New 8 240 0 Other-Agency Guidance
Priority Review Designation Requests (Expedited Programs for Serious Conditions) - CDER Modified 124 3720 0 Other-Agency Guidance
RMAT Designation Requests - CBER Modified 36 2160 0 Other-Agency Guidance
Total burden requested under this ICR: 1091 81440 0  
To view an IC, click on IC Title