Information Collection

Reporting: NAD for Investigational Use

IC 5728 under ICR 201806-0910-009 · 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⚠️ Notice: This information collection may be referencing outdated material.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

Documents and forms in this information collection
Document Name	Document Type
NCIE Procedures.pdf	Instruction
NCIE_eSubmitter_Template.pdf	Other-e-Submission screenshot

IC Title:

Reporting: NAD for Investigational Use

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 511; 511.1 (To search for a specific CFR, visit the Code of Federal Regulations.)

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
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: 104

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	Previously Approved
Annual Number of Responses for this IC	1,663	268	1,395
Annual IC Time Burden (Hours)	2,000	605	1,395
Annual IC Cost Burden (Dollars)	0	-607,376	607,376

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.