Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol

Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol

OMB: 0910-0524

IC ID: 6242

Information Collection (IC) Details

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Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol
 
No Modified
 
Voluntary
 
21 CFR 50.58.120 21 CFR 500.514.117

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction 3536 Protocol for Non- Clinical Laboratory and Effectiveness Studies Form FDA 3536.pdf Yes Yes Fillable Printable

Health Consumer Health and Safety

 

190 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 103 0 0 3 0 100
Annual IC Time Burden (Hours) 21 0 0 1 0 20
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
Guidance for Industry: How to Submit a Protocol in Electronic Format by E-Mail Guidance - 0910-0524.pdf
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