OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

Content of Labeling Submissions in NDAs, ANDAs, Supplemental NDAs and ANDAs, and Annual Reports

IC 6248 under ICR 201309-0910-009 · OMB 0910-0530.

Documents and Forms
Document Name
Document Type
No indexed documents/forms are available for this IC yet. A refresh has been queued.
Information Collection (IC) Details

View Information Collection (IC)

Content of Labeling Submissions in NDAs, ANDAs, Supplemental NDAs and ANDAs, and Annual Reports
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 314.50 21 CFR 314.94(d)(1)(ii) 21 CFR 314.81(b)(2)(iii)(b)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety

 

500 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 5,750 0 0 750 0 5,000
Annual IC Time Burden (Hours) 7,188 0 0 938 0 6,250
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.