Request Waivers or Reductions in User Fees - Sections 735 and 736 of the FD&C Act

Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0693 can be found here:

Documents and Forms

Document Name Document Type
GUIDANCE 0693 7-17-14.pdf Other-Guidance

Information Collection (IC) Details

IC Title:	Request Waivers or Reductions in User Fees - Sections 735 and 736 of the FD&C Act	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 379g and 379h FD&C Act (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			GUIDANCE 0693 7-17-14.pdf		Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 100	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	120	30	90
Annual IC Time Burden (Hours)	1,920	480	1,440
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.