Supplements and Annual Reports for Abbreviated New Drug Applications

Final Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes to be Documented in Annual Reports

OMB: 0910-0758

IC ID: 209222

Documents and Forms
Document Name
Document Type
Other-Guidance
Information Collection (IC) Details

View Information Collection (IC)

Supplements and Annual Reports for Abbreviated New Drug Applications
 
No New
 
Voluntary
 
21 CFR 314.97

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance CMC FINAL GUIDANCE 11-4-13.doc Yes No Paper Only

Health Consumer Health and Safety

 

215 0
   
Private Sector Businesses or other for-profits
 
   0 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 2,075 0 2,075 0 0 0
Annual IC Time Burden (Hours) 166,000 0 166,000 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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