Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
PART 314: Subparts E through I Unchanged 45045 444697 0 Form FDA 3938
Subpart B - Applications Modified 66924 1234195 0 Form and Instruction FDA 3331a
Form FDA 2252
Instruction
Form FDA 2253
Instruction
Other-Performance Goals
Other-Legislative Authority
Form and Instruction FDA 3542
Form and Instruction FDA 3542a
Other-Statutory Authority
Form FDA 356h
Instruction
Subpart C - Abbreviated Applications Unchanged 27334 2439794 0 Other-Agency Guidance
Subpart D - FDA Action on Applications Unchanged 6666 83778 0 Other-Agency Guidance
Other-Agency Guidance
Total burden requested under this ICR: 145969 4202464 0  
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