Information Collection

Study Instruments: Consent; Pre- and Main Test; Questionnaire; Recruitment e-mail

IC 236001 under ICR 202211-0910-004 · OMB 0910-0872.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Accelerated Approval Disclosures Study II Appendices A B C D.pdf	Other-Study Collection Instruments
Accelerated Approval Disclosures Study II Appendices A B C D.pdf	Other-Study Collection Instruments
Appendix B - Screener Main Study final 2022.docx	Other-Screener
Appendix B - Screener Main Study final 2022.docx	Other-Screener
Appendix C -- Questionnaire Main Study final 2022.docx	Other-Questionnaire
Appendix C -- Questionnaire Main Study final 2022.docx	Other-Questionnaire

IC Title:

Agency IC Tracking Number:

CDER/OPDP

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 601, subpart E 21 CFR 314, subpart H (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

table that charts list of instruments
Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Study Collection Instruments	Accelerated Approval Disclosures Study II Appendices A B C D.pdf	Yes	Yes	Fillable Fileable
Other-Screener	Appendix B - Screener Main Study final 2022.docx	Yes	Yes	Fillable Fileable
Other-Questionnaire	Appendix C -- Questionnaire Main Study final 2022.docx	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 25,410

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	25,410	25,410
Annual IC Time Burden (Hours)	2,335	2,335
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
No associated records found

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