Clinical Protocol Amendments (IND) for CDER and CBER

Certification to Accompany Drug, Biological Product, and Device Applications or Submissions

OMB: 0910-0616

IC ID: 183055

Information Collection (IC) Details

View Information Collection (IC)

Clinical Protocol Amendments (IND) for CDER and CBER
 
No Modified
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3674 Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. 282(j)) FDA 3674.pdf Yes Yes Fillable Fileable Signable
Other-Guidance document OIRA0616_guidance_document_Final.doc http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm Yes No Printable Only

Health Immunization Management

 

13,240 0
   
Private Sector Businesses or other for-profits, Not-for-profit institutions
 
   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 13,240 0 -8,208 0 0 21,448
Annual IC Time Burden (Hours) 3,310 0 -12,776 0 0 16,086
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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