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.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.