Information Collection

Pediatric uses outside approved indication

IC 242006 under ICR 202005-0910-007 · OMB 0910-0748.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Providing-Information-about-Pediatric-Uses-of-Medical-Devices---Guidance-for-Industry-and-FDA-Staff.pdf	Other-Agency Guidance Document
eCopy Guidance.pdf	Other-Agency Guidance Document

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 814

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance Document			Providing-Information-about-Pediatric-Uses-of-Medical-Devices---Guidance-for-Industry-and-FDA-Staff.pdf		Yes	Yes	Fillable Fileable
Other-Agency Guidance Document			eCopy Guidance.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: 800

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	800	800
Annual IC Time Burden (Hours)	400	400
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.