Notifications Required Under Sections 310.306 (unapproved drugs); 314.81(b)(3)(iii) (products approved under an NDA or ANDA); and 600.82 (products approved under a BLA)

Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products; Final Rule

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0759 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:	Notifications Required Under Sections 310.306 (unapproved drugs); 314.81(b)(3)(iii) (products approved under an NDA or ANDA); and 600.82 (products approved under a BLA)	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 310.306 21 CFR 314.81(b)(3)(iii) 21 CFR 600.82

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: 75	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	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	225	225
Annual IC Time Burden (Hours)	450	450
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.