Information Collection

CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports

IC 189329 under ICR 202209-0910-001 · 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⚠️ Notice: This information collection may be referencing outdated material.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
GFI Pharmacogenomic Data Submissions.pdf	Other-Agency Guidance Document
GFI Pharmacogenomic Data Submissions.pdf	Other-Agency Guidance Document

IC Title:

CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.20-312.38

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-Agency Guidance Document			GFI Pharmacogenomic Data Submissions.pdf		Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 31,025

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	100,261	100,261
Annual IC Time Burden (Hours)	20,215,682	20,215,682
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.