Information Collection

Generic Drug Substitution in Special Populations

IC 227471 under ICR 201703-0910-009 · 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⚠️ Notice: This information collection may be referencing outdated material.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_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

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.