Information Collection

600.81(b)(2)

IC 211827 under ICR 201406-0910-005 · OMB 0910-0770.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0770 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 3500A 600.81(b)(2)	Form
3500A MedWatch FORM FDA 3500A.pdf	Form
FINAL RULE PUB ESRR 6-10-2014.pdf Final Rule	IC Document
COMMENT 1 ESRR.html Comment	IC Document

IC Title:

600.81(b)(2)

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 600.81(b)(2)

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	3500A	MedWatch	FORM FDA 3500A.pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Health Care Services

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: 100 %

table that charts list of burden
	Requested	Program Change Due to Agency Discretion
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

table that charts IC Documents
Title	Document	Date Uploaded
Final Rule	FINAL RULE PUB ESRR 6-10-2014.pdf	06/10/2014
Comment	COMMENT 1 ESRR.html	06/10/2014

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.