Information Collection

Requests for Special Protocol Assessment

IC 6167 under ICR 202004-0910-004 · OMB 0910-0470.

Documents and Forms

Document Name Document Type
0470 Guidance Special Protocol Assessment GFI.pdf Other-Agency Guidance Document

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Requests for Special Protocol Assessment	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 312.30; 314.126; 601.12

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance Document			0470 Guidance Special Protocol Assessment GFI.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: 113	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	116	-104	220
Annual IC Time Burden (Hours)	1,740	-1,560	3,300
Annual IC Cost Burden (Dollars)	0	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.