Information Collection

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

IC 183054 under ICR 200809-0910-001 · OMB 0910-0616.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
FDAAA Title VIII-Public Law 110-85.pdf	Other-Public Law
0616 guidance.htm	Other-guidance document

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:

table that charts list of 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		No	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 33,334

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 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	33,334	33,334
Annual IC Time Burden (Hours)	8,334	8,334
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.