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

Focus Groups About Drug Products As Used by The Food and Drug Administration

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0677 can be found here:

Documents and Forms

Document Name Document Type
Appendix A - Recruitment mailer_3_14_2016.pdf Other-Study recruitment mailer
Appendix B - Screening_guides_3_30_2016.pdf Other-Study Screening Guide
Appendix C - Focus group guide_4-8-2016.pdf Other-Focus group guide
Focus Groups About Drug Products.pdf OMB Request for Generic Allotment Memo IC Document
OMB-FDA Q&A June 2016.docx FDA-OMB Q&A June 2016 IC Document

Information Collection (IC) Details

IC Title:	Focus Groups to assess the post-marketing safety of authorized generic drug products	Agency IC Tracking Number:	CDER

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available 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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 32	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	32	32
Annual IC Time Burden (Hours)	64	64
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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.