Clinical Amendments to Marketing Applications - CDER and CBER

Certification to Accompany Drug, Biological Product, and Device Applications or Submissions

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0616 can be found here:

Documents and Forms

Document Name Document Type
FINAL GUIDANCE 0616 12-19-14.pdf Other-Guidance
FDA 3674 Certification of Compliance Form_3674.pdf Form

Information Collection (IC) Details

IC Title:	Clinical Amendments to Marketing Applications - CDER and CBER	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			FINAL GUIDANCE 0616 12-19-14.pdf		Yes	No	Paper Only
Form	FDA 3674	Certification of Compliance	Form_3674.pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,067	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits, Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 70 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,067	135	932
Annual IC Time Burden (Hours)	800	101	699
Annual IC Cost Burden (Dollars)	0	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.