Information Collection

Supplements and Other Changes to Approved New Animal Drug Applications - Final Rule

IC 178965 under ICR 200703-0910-002 · OMB 0910-0600.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Guidance FDAMA 116.doc Guidance for Industry: Chemistry Manufacturing and Control Changes for Approved NADA or ANADA	IC Document

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 500.514.8

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 40

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	1,228	1,228
Annual IC Time Burden (Hours)	63,561	63,561
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
Guidance for Industry: Chemistry Manufacturing and Control Changes for Approved NADA or ANADA	Guidance FDAMA 116.doc

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