Notification for Carcinogenicity Protocols

Special Protocol Assessment (SPA)

Documents and Forms

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

Information Collection (IC) Details

IC Title:	Notification for Carcinogenicity Protocols	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: 106	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	189	136	53
Annual IC Time Burden (Hours)	1,510	1,086	424
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.