Information Collection

CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers

IC 5669 under ICR 201709-0910-004 · 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⚠️ Notice: This information collection may be referencing outdated material.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
Form 1571 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Form
1571 Investigational New Drug Application FORM FDA 1571 3-4-2015.pdf	Form
1572 Statement of Investigator FORM FDA 1572 3-4-2015.pdf	Form and Instruction

IC Title:

CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.1-312.10

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	1571	Investigational New Drug Application	FORM FDA 1571 3-4-2015.pdf		Yes	Yes	Fillable Fileable Signable
Form and Instruction	1572	Statement of Investigator	FORM FDA 1572 3-4-2015.pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 239

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
	Approved	Previously Approved
Annual Number of Responses for this IC	287	287
Annual IC Time Burden (Hours)	7,608	7,608
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.