CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies and issuance of guidance to help comply with regulatory requirements (312.145)

Investigational New Drug Regulations

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Document Name Document Type
ICH Guidance - Good Clinical Practice March 2018.pdf Other-Agency Guidance
ICH Guidance - Good Clinical Practice March 2018.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies and issuance of guidance to help comply with regulatory requirements (312.145)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.110-312.145

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			ICH Guidance - Good Clinical Practice March 2018.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,187	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	24,359	9,242	15,117
Annual IC Time Burden (Hours)	630,299	138,744	491,555
Annual IC Cost Burden (Dollars)	0	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.