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

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

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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	353	128	225
Annual IC Time Burden (Hours)	705	255	450
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.