Notification for Carcinogenicity Protocols

Special Protocol Assessment (SPA)

OMB: 0910-0470

IC ID: 181848

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

View Information Collection (IC)

Notification for Carcinogenicity Protocols
No Modified
Required to Obtain or Retain Benefits
21 CFR 312.30; 314.126; 601.12

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance Document 0470 Guidance Special Protocol Assessment GFI.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety


106 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 189 0 0 136 0 53
Annual IC Time Burden (Hours) 1,510 0 0 1,086 0 424
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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