Information Collection

Promotional Materials for Accelerated Approval Under Section 314.550

IC 209911 under ICR 201703-0910-010 · OMB 0910-0765.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0765 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
GUIDANCE 9-24-13.pdf	Other-Guidance

IC Title:

Promotional Materials for Accelerated Approval Under Section 314.550

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Removed

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 314.550

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-Guidance			GUIDANCE 9-24-13.pdf		Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 20

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
	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	-140	140
Annual IC Time Burden (Hours)	-16,800	16,800
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.