New Applications (IND) for 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⚠️ Notice: This information collection may be referencing outdated material.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
Form FDA 3674 New Applications (IND) for CDER and CBER Form and Instruction
OIRA0616_guidance_document_Final.doc www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm Other-guidance document
FDA 3674 Certification of Compliance, under 42 U.S.C. 282(j)(5)(B FDA 3674.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	New Applications (IND) for 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
Form and Instruction	FDA 3674	Certification of Compliance, under 42 U.S.C. 282(j)(5)(B), with Requirements of Clinical Trials.gov Data Bank (42 U.S.C. 282(j))	FDA 3674.pdf		Yes	Yes	Fillable Fileable Signable
Other-guidance document			OIRA0616_guidance_document_Final.doc	http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm	No		Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,033	Number of Respondents for Small Entity: 200

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

Percentage of Respondents Reporting Electronically: 25 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	2,033	-31,301	33,334
Annual IC Time Burden (Hours)	508	-7,826	8,334
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.