OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

Citizen petitions and petitions related to ANDA, certain NDAs, and certain BLAs

IC 216306 under ICR 202309-0910-006 · OMB 0910-0191.

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

View Information Collection (IC)

Citizen petitions and petitions related to ANDA, certain NDAs, and certain BLAs
 
No Unchanged
 
Required to Obtain or Retain Benefits
 
21 CFR 10.30; 10.31

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance Document 505q FinalGuidance-9-17-19.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

200 0
   
Private Sector Businesses or other for-profits
 
   99 %

  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 200 0 0 0 0 200
Annual IC Time Burden (Hours) 4,800 0 0 0 0 4,800
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.