Other waivers, reductions, refunds, exemptions under secs. 735 & 736

Prescription Drug User Fee Program

Documents and Forms

Document Name Document Type
21 USC 379h.pdf Other-Statutory Authority
21 USC 379h.pdf Other-Statutory Authority
Draft INSTRUCTIONS FOR FILLING OUT FORM FDA 4068 Feb 2022.docx Instruction
Draft INSTRUCTIONS FOR FILLING OUT FORM FDA 4068 Feb 2022.docx Instruction
FDA 4068 Waiver, Refund, and Exemption Request DRAFT Form FDA 4068.pdf Form
FDA 4068 Waiver, Refund, and Exemption Request DRAFT Form FDA 4068.pdf Form

Information Collection (IC) Details

IC Title:	Other waivers, reductions, refunds, exemptions under secs. 735 & 736	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Statutory Authority			21 USC 379h.pdf	Yes	Yes	Fillable Fileable
Form	FDA 4068	Waiver, Refund, and Exemption Request	DRAFT Form FDA 4068.pdf	Yes	Yes	Fillable Fileable
Instruction			Draft INSTRUCTIONS FOR FILLING OUT FORM FDA 4068 Feb 2022.docx	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 112	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	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	189	189
Annual IC Time Burden (Hours)	3,213	3,213
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.