Information Collection

Requests for Information under 513(g) of the FFDCA

IC 259088 under ICR 202303-0910-002 · OMB 0910-0511.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0511 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
CDRH Requests for Info 513(g) December 2019.pdf	Other-Agency Guidance
CDRH Requests for Info 513(g) December 2019.pdf	Other-Agency Guidance
513(g) Flat (eSTAR).pdf	Other-Digital Screenshot
513(g) Flat (eSTAR).pdf	Other-Digital Screenshot

IC Title:

Requests for Information under 513(g) of the FFDCA

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

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-Agency Guidance			CDRH Requests for Info 513(g) December 2019.pdf		Yes	Yes	Fillable Fileable
Other-Digital Screenshot			513(g) Flat (eSTAR).pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 118

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
	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	118	118
Annual IC Time Burden (Hours)	1,416	1,416
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.