Information Collection

511.1(b)(4) NCIE for clinical investigations

IC 5728 under ICR 201507-0910-004 · OMB 0910-0117.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0117 can be found here:

Documents and Forms

Document Name Document Type
NCIE Procedures.pdf Instruction
NCIE_eSubmitter_Template.pdf Other-e-Submission screenshot

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	511.1(b)(4) NCIE for clinical investigations	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 511.1(b)(4)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction			NCIE Procedures.pdf		Yes	Yes	Fillable Fileable
Other-e-Submission screenshot			NCIE_eSubmitter_Template.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: 263	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	1,395	157	1,238
Annual IC Time Burden (Hours)	1,395	157	1,238
Annual IC Cost Burden (Dollars)	607,376	607,376	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.