Information Collection

Right to try reporting requirements

IC 278276 under ICR 202509-0910-004 · OMB 0910-0014.

Documents and Forms

Document Name Document Type
Form FDA 5023 Right to try reporting requirements Form and Instruction
Form FDA 5023 Right to Try Annual Summary Right to try reporting requirements Form and Instruction
FDA 5023 Right to Try Annual Summary Form FDA 5023 Right to Try Annual Summary.pdf www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try-annual-reporting-summary Form and Instruction
FDA 5023 Right to Try Annual Summary Form FDA 5023 Right to Try Annual Summary.pdf www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try-annual-reporting-summary Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Right to try reporting requirements	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 300.200

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 5023	Right to Try Annual Summary	Form FDA 5023 Right to Try Annual Summary.pdf	https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try-annual-reporting-summary	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 10	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	10	10
Annual IC Time Burden (Hours)	3	3
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.

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