Information Collection

Submitting Controlled Correspondence under GDUFA I

IC 217370 under ICR 201808-0910-011 · OMB 0910-0797.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0797 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type

No indexed documents/forms are available for this IC yet. A refresh has been queued.

IC Title:

Submitting Controlled Correspondence under GDUFA I

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 314.102

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

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 390

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,482	462	1,020
Annual IC Time Burden (Hours)	7,480	2,380	5,100
Annual IC Cost Burden (Dollars)	0	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.