Generic Drug Substitution in Special Populations

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⚠️ Notice: This information collection may be referencing outdated material.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_7_7_2017.pdf Other-Survey Instrument
Appendix B - Consents_7_7_2017.pdf Other-Consent Form
Appendix C - Focus group guide_6_26_2017.pdf Other-Study; Focus Group Guide
Auburn IRB revision approval.pdf Other-Protocol Review Form
FDAl_IAA_17_037D_6_01_2017.pdf Other-Chair Letter
0677 - Generic Drug Substitution in Special Populations 2017.doc GEN IC Allotment IC Document

Information Collection (IC) Details

IC Title:	Generic Drug Substitution in Special Populations	Agency IC Tracking Number:	CDER

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Survey Instrument	Appendix A - Recruitment mailer_7_7_2017.pdf	No		Paper Only
Other-Consent Form	Appendix B - Consents_7_7_2017.pdf	Yes	Yes	Fillable Fileable Signable
Other-Study; Focus Group Guide	Appendix C - Focus group guide_6_26_2017.pdf	No		Paper Only
Other-Protocol Review Form	Auburn IRB revision approval.pdf	No		Paper Only
Other-Chair Letter	FDAl_IAA_17_037D_6_01_2017.pdf	No		Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 28	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	28	28
Annual IC Time Burden (Hours)	28	28
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
GEN IC Allotment	0677 - Generic Drug Substitution in Special Populations 2017.doc	07/28/2017

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