Information Collection

Efficacy Supplements/Resubmissions (BLA Only)

IC 214355 under ICR 201412-0910-013 · 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⚠️ Notice: This information collection may be referencing outdated material.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
FINAL GUIDANCE 0616 12-19-14.pdf	Other-Guidance
3674 Certification of Compliance FORM FDA 3674 12-19-14.pdf	Form

IC Title:

Efficacy Supplements/Resubmissions (BLA Only)

Agency IC Tracking Number:

CBER

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
Other-Guidance			FINAL GUIDANCE 0616 12-19-14.pdf		Yes	No	Paper Only
Form	3674	Certification of Compliance	FORM FDA 3674 12-19-14.pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 25

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: 70 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	25	25
Annual IC Time Burden (Hours)	19	19
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.