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Guidance for Industry: How to Submit a Study Protocol Without Data in Electronic Format to the Center for Veterinary Medicine

IC 6242 under ICR 201004-0910-010 · OMB 0910-0524.

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Guidance for Industry: How to Submit a Study Protocol Without Data in Electronic Format to the Center for Veterinary Medicine
 
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

 

40 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 43 0 0 -60 0 103
Annual IC Time Burden (Hours) 14 0 0 -7 0 21
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 02/16/2007
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.