Production of New Label Statement on Immediate Container Label or Outside Package (Web site and Toll-Free Number)

Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products - Proposed Rule

Documents and Forms

Document Name Document Type

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

Information Collection (IC) Details

IC Title:	Production of New Label Statement on Immediate Container Label or Outside Package (Web site and Toll-Free Number)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 606.121(c)(8)(ii) 21 CFR 610.60(a)(8) 21 CFR 610.61(t) 21 CFR 201.100(b)(8)

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: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 3,550	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	175,015	175,015
Annual IC Time Burden (Hours)	4,200,360	4,200,360
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.