OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

Focus Groups to assess the post-marketing safety of authorized generic drug products

IC 221655 under ICR 201604-0910-008 · OMB 0910-0677.

Documents and Forms
Document Name
Document Type
Other-Study recruitment mailer
Other-Study Screening Guide
Other-Focus group guide
IC Document
IC Document
Information Collection (IC) Details

View Information Collection (IC)

Focus Groups to assess the post-marketing safety of authorized generic drug products CDER
 
New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Study recruitment mailer Appendix A - Recruitment mailer_3_14_2016.pdf No   Paper Only
Other-Study Screening Guide Appendix B - Screening_guides_3_30_2016.pdf No   Paper Only
Other-Focus group guide Appendix C - Focus group guide_4-8-2016.pdf No   Paper Only

Health Consumer Health and Safety

 

32 0
   
Individuals or Households
 
   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 32 0 32 0 0 0
Annual IC Time Burden (Hours) 64 0 64 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB Request for Generic Allotment Memo Focus Groups About Drug Products.pdf 05/23/2016
FDA-OMB Q&A June 2016 OMB-FDA Q&A June 2016.docx 08/10/2016
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.