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⚠️ Notice: This information collection may be referencing outdated material.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: Unchanged

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	Previously Approved
Annual Number of Responses for this IC	120	120
Annual IC Time Burden (Hours)	1,920	1,920
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.