Certification to Accompany Drug, Biological Product, and Device Applications or Submissions

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0616 can be found here:

Documents and Forms

Document Name Document Type
FDAAA Title VIII-Public Law 110-85.pdf Other-Public Law
0616 guidance.htm Other-guidance document

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Certification to Accompany Drug, Biological Product, and Device Applications or Submissions	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Public Law			FDAAA Title VIII-Public Law 110-85.pdf		No	No	Paper Only
Other-guidance document			0616 guidance.htm		Yes	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 21,448	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits, Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Previously Approved
Annual Number of Responses for this IC	21,448	21,448
Annual IC Time Burden (Hours)	16,086	16,086
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.