Initial listing (including NDC) information

Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

⚠️ Notice: This information collection may be referencing outdated material.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

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

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

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 207 21 CFR 207.33 21 CFR 207.41, 207.45, 207.49 21 CFR 207.53, 207.54, 207.55

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,713	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	Previously Approved
Annual Number of Responses for this IC	12,470	12,470
Annual IC Time Burden (Hours)	18,705	18,705
Annual IC Cost Burden (Dollars)	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.