Information Collection

Biological Products: Reporting of Biological Product Deviations in Manufacturing

IC 6151 under ICR 200401-0910-001 · OMB 0910-0458.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0458 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type

No indexed documents/forms are available for this IC yet. A refresh has been queued.

IC Title:

Biological Products: Reporting of Biological Product Deviations in Manufacturing

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Migrated

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	3486				Yes	Yes

Line of Business:

Subfunction:

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 6,343

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 40 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	33,922	-26,829	60,751
Annual IC Time Burden (Hours)	67,844	-193,804	261,648
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

Something went wrong when downloading this file. If you have any questions, please send an email to [email protected].