Information Collection

New Marketing Applications/Resubmissions (NDA/BLA) for CDER and CBER

IC 199616 under ICR 201109-0910-006 · OMB 0910-0616.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3674 New Marketing Applications/Resubmissions (NDA/BLA) 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

IC Title:

New Marketing Applications/Resubmissions (NDA/BLA) for CDER and CBER

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

table that charts list of 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: 165

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 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	165	165
Annual IC Time Burden (Hours)	124	124
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.