Applications, amendments, resubmissions using form FDA 3674

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

Documents and Forms

Document Name Document Type
0616 guidance.pdf Other-Guidance
0616 guidance.pdf Other-Guidance
FDA 3674 Certificate of Compliance Under 42 U.S.C. 282(j)(5)(B), FDA 3674.pdf Form and Instruction
FDA 3674 Certificate of Compliance Under 42 U.S.C. 282(j)(5)(B), FDA 3674.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Applications, amendments, resubmissions using form FDA 3674	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
Form and Instruction	FDA 3674	Certificate of Compliance Under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank	FDA 3674.pdf		Yes	Yes	Fillable Fileable Signable
Other-Guidance			0616 guidance.pdf		Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 17,409	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: 80 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	17,409	15,359	2,050
Annual IC Time Burden (Hours)	5,976	5,464	512
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.