Information Collection

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

IC 189329 under ICR 202608-0910-010 · OMB 0910-0014.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
GFI Pharmacogenomic Data Submissions.pdf	Other-Agency Guidance Document
0470 GFI Special Protocol Assessment April 2018.pdf	Other-Agency Guidance
Expedited_IND_Pilot_Application_DRAFT.pdf	Other-DRAFT Form for Pilot Participa

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.20-312.38

Information Collection Instruments:

table that charts list of instruments
Document Type	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance Document	Yes	Yes	Paper Only
Other-Agency Guidance	Yes	Yes	Fillable Fileable
Other-DRAFT Form for Pilot Participation	Yes	Yes	Fillable Fileable

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
	Requested	Previously Approved
Annual Number of Responses for this IC	101,751	101,751
Annual IC Time Burden (Hours)	20,220,727	20,220,727
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.

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