Efficacy Supplements/Resubmissions - CDER and CBER

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

Documents and Forms

Document Name Document Type
Guidance.pdf Other-Guidance
Guidance.pdf Other-Guidance
FDA 3674 Certification of Compliance Form_3674.pdf Form
FDA 3674 Certification of Compliance Form_3674.pdf Form

Information Collection (IC) Details

IC Title:	Efficacy Supplements/Resubmissions - CDER and CBER	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Removed

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
Form	FDA 3674	Certification of Compliance	Form_3674.pdf		Yes	Yes	Fillable Fileable Signable
Other-Guidance			Guidance.pdf		Yes	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 253	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 70 %

	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	-253	253
Annual IC Time Burden (Hours)	-190	190
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.