Information Collection

Pediatric Study Plan

IC 270421 under ICR 202408-0910-008 · OMB 0910-0718.

Documents and Forms

Document Name Document Type
0718 GFI Pediatric Study Plans July 2020.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/pediatric-study-plans-content-and-process-submitting-in Other-Agency Guidance

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Pediatric Study Plan	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			0718 GFI Pediatric Study Plans July 2020.pdf	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pediatric-study-plans-content-and-process-submitting-initial-pediatric-study-plans-and-amended	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 11	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	11	11
Annual IC Time Burden (Hours)	420	420
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.