OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies and issuance of guidance to help comply with regulatory requirements (312.145)

IC 189332 under ICR 202509-0910-004 · OMB 0910-0014.

Documents and Forms

Documents and forms in this information collection
Document NameDocument Type
ICH Guidance - Good Clinical Practice March 2018.pdf Other-Agency Guidance
ICH Guidance - Good Clinical Practice March 2018.pdf Other-Agency Guidance

Information Collection (IC) Details

View Information Collection (IC)

layout table

Information Collection Instruments:
table that charts list of instruments
Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance Yes Yes Fillable Fileable

Federal Enterprise Architecture Business Reference Module


table that charts list of burden
  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 24,359 0 0 0 0 24,359
Annual IC Time Burden (Hours) 630,299 0 0 0 0 630,299
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Documents for IC
table that charts IC Documents
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.
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