CDER - Requests for Formal Dispute Resolution

Guidance for Industry on Formal Dispute Resolutions; Appeals Above the Division Level

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0430 can be found here:

Documents and Forms

Document Name Document Type
FINAL GUIDANCE 0430 10-16-2015.pdf Other-Guidance

Information Collection (IC) Details

IC Title:	CDER - Requests for Formal Dispute Resolution	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 314 21 CFR 312

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			FINAL GUIDANCE 0430 10-16-2015.pdf		Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 8	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	31	13	18
Annual IC Time Burden (Hours)	248	104	144
Annual IC Cost Burden (Dollars)	0	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.