Information Collection

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

IC 246630 under ICR 202104-0910-002 · OMB 0910-0899.

Documents and Forms

Documents and forms in this information collection
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

IC Title:

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of 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 %

table that charts list of burden
	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.