Information Collection List

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