Information Collection

Initial listing (including NDC) information

IC 183173 under ICR 202408-0910-003 · OMB 0910-0045.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0045 can be found here:

Documents and Forms

Document Name Document Type
Reg and Listing 2009 Guidance.pdf Other-Agency Guidance

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Initial listing (including NDC) information	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 207, 207.33 21 CFR 207.41, 207.45, 207.49 21 CFR 207.53, 207.54, 207.55 (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			Reg and Listing 2009 Guidance.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: 3,040	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	22,130	9,660	12,470
Annual IC Time Burden (Hours)	33,197	14,492	18,705
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.