Information Collection

Supplements and Annual Reports for Abbreviated New Drug Applications

IC 209222 under ICR 201311-0910-001 · OMB 0910-0758.

Documents and Forms

Document Name Document Type
CMC FINAL GUIDANCE 11-4-13.doc Other-Guidance

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Supplements and Annual Reports for Abbreviated New Drug Applications	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 314.97

Information Collection 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: 215	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	2,075	2,075
Annual IC Time Burden (Hours)	166,000	166,000
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.