Group 3: Facilities Outside U.S. Engaged in Drug Product Manufacturing (in addition to other possible activites)

Survey of Drug Product Manufacturing, Processing, and Packing Facilities

Documents and Forms

Document Name Document Type
Survey Pre-Notification_Survey Link.docx Other-Survey Pre-Notification Link
Survey Pre-Notification_Survey Link.docx Other-Survey Pre-Notification Link
Survey.docx Other-Survey Instrument
Survey.docx Other-Survey Instrument
Survey Reminder.docx Survey Reminder IC Document
Survey Reminder.docx Survey Reminder IC Document
Cover letter.docx Cover Letter IC Document
Cover letter.docx Cover Letter IC Document
Postcard.pdf Postcard IC Document
Postcard.pdf Postcard IC Document
Glossary.docx Glossary IC Document
Glossary.docx Glossary IC Document

Information Collection (IC) Details

IC Title:	Group 3: Facilities Outside U.S. Engaged in Drug Product Manufacturing (in addition to other possible activites)	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Survey Pre-Notification Link			Survey Pre-Notification_Survey Link.docx		Yes	No	Printable Only
Other-Survey Instrument			Survey.docx		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 407	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	407	407
Annual IC Time Burden (Hours)	895	895
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.