Information Collection

312.42(e) Biologics; Request to remove clinical hold

IC 189349 under ICR 201503-0910-002 · OMB 0910-0014.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0014 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:

312.42(e) Biologics; Request to remove clinical hold

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Removed

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.42(e)

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

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 74

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	-111	111
Annual IC Time Burden (Hours)	-31,524	31,524
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.