Information Collection

Section 601, recordkeeping, Forms FDA 356h & 2567

IC 193381 under ICR 201006-0910-001 · OMB 0910-0338.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0338 can be found here:

Documents and Forms

Document Name Document Type
Form FDA 356h Section 601, recordkeeping, Forms FDA 356h & 2567 Form and Instruction
FDA 356h Application to Market a New Drug, Biologic, or an Antibi 0338 FDA-356h 2007.doc Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Section 601, recordkeeping, Forms FDA 356h & 2567	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 601.2(a) 21 CFR 610.60 21 CFR 610.61 21 CFR 601.62

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 356h	Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use	0338 FDA-356h 2007.doc		Yes	No	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 23	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 20 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	1	1
Annual IC Time Burden (Hours)	1	1
Annual IC Cost Burden (Dollars)	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.