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Format & content for new OTC drug products (included FDA recommendations on statutory requirements)

IC 5943 under ICR 202412-0910-011 · OMB 0910-0340.

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

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Format & content for new OTC drug products (included FDA recommendations on statutory requirements)
 
No Unchanged
 
Mandatory
 
21 CFR 201 21 CFR 201.66

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Statutory Authority FFDCA Sec 502 - 21 USC 352.pdf Yes Yes Fillable Fileable
Other-Agency Guidance Labeling of nonRx drugs under NDCPA GFI Sept 2009.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

875 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 29,116 0 0 0 0 29,116
Annual IC Time Burden (Hours) 133,525 0 0 0 0 133,525
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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