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Federal forms, ICRs, and supporting documents

Information Collection

Study Instruments: Consent; Pre- and Main Test; Questionnaire; Recruitment e-mail

IC 236001 under ICR 202211-0910-004 · OMB 0910-0872.

Documents and Forms
Document Name
Document Type
Other-Study Collection Instruments
Other-Study Collection Instruments
Other-Screener
Other-Screener
Other-Questionnaire
Other-Questionnaire
Information Collection (IC) Details

View Information Collection (IC)

Study Instruments: Consent; Pre- and Main Test; Questionnaire; Recruitment e-mail CDER/OPDP
 
No Modified
 
Voluntary
 
21 CFR 601, subpart E 21 CFR 314, subpart H  (To search for a specific CFR, visit the Code of Federal Regulations.)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Study Collection Instruments Accelerated Approval Disclosures Study II Appendices A B C D.pdf Yes Yes Fillable Fileable
Other-Screener Appendix B - Screener Main Study final 2022.docx Yes Yes Fillable Fileable
Other-Questionnaire Appendix C -- Questionnaire Main Study final 2022.docx Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

25,410 0
   
Individuals or Households
 
   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 25,410 0 0 0 0 25,410
Annual IC Time Burden (Hours) 2,335 0 0 0 0 2,335
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.