Information Collection

601.26(f) - Additional Studies and Labeling

IC 209321 under ICR 201311-0910-007 · 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⚠️ Notice: This information collection may be referencing outdated material.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 2567 601.26(f) - Additional Studies and Labeling Form and Instruction
2567 Transmittal of Labels and Circulars FORM 2567 11-5-13.pdf Form and Instruction
356h Application to Market a New Drug Biologic or an Antibiot FORM FDA 356h 11-5-13.zip Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	601.26(f) - Additional Studies and Labeling	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 601.26(f)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	2567	Transmittal of Labels and Circulars	FORM 2567 11-5-13.pdf		Yes	Yes	Fillable Printable
Form and Instruction	356h	Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use	FORM FDA 356h 11-5-13.zip		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1	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.