Requests for Tier-Two Dispute Resolution

Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0563 can be found here:

Documents and Forms

Document Name Document Type
GUIDANCE 0563 12-24-14.pdf Other-Guidance

Information Collection (IC) Details

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

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			GUIDANCE 0563 12-24-14.pdf		Yes	No	Printable Only

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	1	1
Annual IC Time Burden (Hours)	8	8
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.