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

Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0872 can be found here:

Documents and Forms

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

Information Collection (IC) Details

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

Document Type	Form No.	Form Name	Instrument File	URL	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

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 %

	Approved	Change Due to Adjustment in Agency Estimate
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

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.