600.80(h)(2)

Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements - Final Rule

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Document Name Document Type
Form 3500A 600.80(h)(2) Form
3500A MedWatch FORM FDA 3500A.pdf Form

Information Collection (IC) Details

IC Title:	600.80(h)(2)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 600.80(h)(2)

Information Collection 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: 5	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	5	5
Annual IC Time Burden (Hours)	5	5
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.