Original Applications

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⚠️ Notice: This information collection may be referencing outdated material.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 Original Applications 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:	Original Applications	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

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 ClinicalTrials.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	Yes	No	Printable Only

Line of Business: Health

Subfunction: Immunization Management

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 854	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: 0 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	854	854
Annual IC Time Burden (Hours)	641	641
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.