Information Collection

Supplements and Annual Reports for New Drug Applications

IC 209221 under ICR 201311-0910-001 · OMB 0910-0758.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
CMC FINAL GUIDANCE 11-4-13.doc	Other-Guidance

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 314.70 and 314.71

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-Guidance			CMC FINAL GUIDANCE 11-4-13.doc		Yes	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 281

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	801	801
Annual IC Time Burden (Hours)	120,150	120,150
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.