Information Collection

503A; Reporting

IC 241791 under ICR 202210-0910-015 · OMB 0910-0800.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0800 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0800 503A final std MOU FDA Cleared.pdf	Other-Memorandum of Understanding
0800 503A final std MOU FDA Cleared.pdf	Other-Memorandum of Understanding
0800 503A GFI 2016.pdf	Other-Agency Guidance Document
0800 503A GFI 2016.pdf	Other-Agency Guidance Document

IC Title:

503A; Reporting

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Voluntary

CFR Citation:

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-Memorandum of Understanding			0800 503A final std MOU FDA Cleared.pdf		Yes	Yes	Fillable Fileable
Other-Agency Guidance Document			0800 503A GFI 2016.pdf		No		Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 45

Number of Respondents for Small Entity: 0

Affected Public: State, Local, and Tribal Governments

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	8,879	8,879
Annual IC Time Burden (Hours)	7,698	7,698
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.