Information Collection

Formative Research Study to Understand the Impact of Generic Substitutes for Various Patient and Caregiver Populations

IC 252505 under ICR 202206-0910-015 · OMB 0910-0695.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0695 can be found here:

2024-03-07 - Extension without change of a currently approved collection

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Appendix M Sample Recruitment Media Advertisement Language_virtual revisions.docx	Other-Sample Recruitment Media Adver
Appendix M Sample Recruitment Media Advertisement Language_virtual revisions.docx	Other-Sample Recruitment Media Adver
Appendix N Adolescent Screener EpiPens_virtual revisions.docx	Other-Youth Screener
Appendix N Adolescent Screener EpiPens_virtual revisions.docx	Other-Youth Screener
Appendix O Adult AutoInjector Screener_virtual revisions.docx	Other-Adult Screener
Appendix O Adult AutoInjector Screener_virtual revisions.docx	Other-Adult Screener
Appendix P Programmed pre-screener_virtual revisions.docx	Other-Programmed pre-screener
Appendix P Programmed pre-screener_virtual revisions.docx	Other-Programmed pre-screener
Appendix Q Adult Consent Form_virtual revisions.docx	Other-Adult Consent Form
Appendix Q Adult Consent Form_virtual revisions.docx	Other-Adult Consent Form
Appendix R Youth Assent Form_virtual revisions.docx	Other-Youth Assent Form
Appendix R Youth Assent Form_virtual revisions.docx	Other-Youth Assent Form
Appendix S Parental Permission Form_virtual revisions.docx	Other-Parental Permission Form
Appendix S Parental Permission Form_virtual revisions.docx	Other-Parental Permission Form
Appendix T Moderator Guide_virtual revisions.docx	Other-Moderator Guide
Appendix T Moderator Guide_virtual revisions.docx	Other-Moderator Guide
Appendix U Recruitment Confirmation and Reminder Emails_virtual revisions.docx	Other-Recruitment Confirmation and R
Appendix U Recruitment Confirmation and Reminder Emails_virtual revisions.docx	Other-Recruitment Confirmation and R
Appendix V Advance Letter_virtual groups.docx	Other-Advance Letter
Appendix V Advance Letter_virtual groups.docx	Other-Advance Letter
Appendix W Mailed Instructions_virtual groups.docx	Other-Mailed Instructions
Appendix W Mailed Instructions_virtual groups.docx	Other-Mailed Instructions
Appendix X Focus Group Workbook__virtual revisions.docx	Other-Workbook
Appendix X Focus Group Workbook__virtual revisions.docx	Other-Workbook
OMB Memo - Formative Research Study on Impact of Generic Substitutions.docx OMB Memo - Formative Research Study on Impact of Generic Substitutions	IC Document
OMB Memo - Formative Research Study on Impact of Generic Substitutions.docx OMB Memo - Formative Research Study on Impact of Generic Substitutions	IC Document
FDA Generic List of Appendices for OMB 2.18.22.docx List of Appendices (original submission and resubmission to complete study)	IC Document
FDA Generic List of Appendices for OMB 2.18.22.docx List of Appendices (original submission and resubmission to complete study)	IC Document

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

Formative Research Study to Understand the Impact of Generic Substitutes for Various Patient and Caregiver Populations

Agency IC Tracking Number:

CDER

IC Status: Unchanged

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-Sample Recruitment Media Advertisement Language	Appendix M Sample Recruitment Media Advertisement Language_virtual revisions.docx	Yes	Yes	Fillable Fileable
Other-Youth Screener	Appendix N Adolescent Screener EpiPens_virtual revisions.docx	Yes	Yes	Fillable Fileable
Other-Adult Screener	Appendix O Adult AutoInjector Screener_virtual revisions.docx	Yes	Yes	Fillable Fileable
Other-Programmed pre-screener	Appendix P Programmed pre-screener_virtual revisions.docx	Yes	Yes	Fillable Fileable
Other-Adult Consent Form	Appendix Q Adult Consent Form_virtual revisions.docx	Yes	Yes	Fillable Fileable
Other-Youth Assent Form	Appendix R Youth Assent Form_virtual revisions.docx	Yes	Yes	Fillable Fileable
Other-Parental Permission Form	Appendix S Parental Permission Form_virtual revisions.docx	Yes	Yes	Fillable Fileable
Other-Moderator Guide	Appendix T Moderator Guide_virtual revisions.docx	Yes	Yes	Fillable Fileable
Other-Recruitment Confirmation and Reminder E-mails	Appendix U Recruitment Confirmation and Reminder Emails_virtual revisions.docx	Yes	Yes	Fillable Fileable
Other-Advance Letter	Appendix V Advance Letter_virtual groups.docx	Yes	Yes	Fillable Fileable
Other-Mailed Instructions	Appendix W Mailed Instructions_virtual groups.docx	Yes	Yes	Fillable Fileable
Other-Workbook	Appendix X Focus Group Workbook__virtual revisions.docx	Yes	Yes	Fillable Fileable

Federal Enterprise Architecture Business Reference Module

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: 100 %

table that charts list of burden
	Requested	Previously Approved
Annual Number of Responses for this IC	32	32
Annual IC Time Burden (Hours)	48	48
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
OMB Memo - Formative Research Study on Impact of Generic Substitutions	OMB Memo - Formative Research Study on Impact of Generic Substitutions.docx	03/31/2022
List of Appendices (original submission and resubmission to complete study)	FDA Generic List of Appendices for OMB 2.18.22.docx	03/31/2022

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