Small business waiver requests

Prescription Drug User Fee Program

Documents and Forms

Document Name Document Type
GFI User-Fee-Waivers--Reductions--and-Refunds-for-Drug-and-Biological-Products.pdf Other-Agency Guidance
GFI User-Fee-Waivers--Reductions--and-Refunds-for-Drug-and-Biological-Products.pdf Other-Agency Guidance
21 USC 379h.pdf Other-Statutory Authority
21 USC 379h.pdf Other-Statutory Authority
FDA 3971 Small Business Waiver and Refund Request Form FDA 3971 Small Business Waiver and Refund Request.pdf Form and Instruction
FDA 3971 Small Business Waiver and Refund Request Form FDA 3971 Small Business Waiver and Refund Request.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Small business waiver requests	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

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-Agency Guidance			GFI User-Fee-Waivers--Reductions--and-Refunds-for-Drug-and-Biological-Products.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3971	Small Business Waiver and Refund Request	Form FDA 3971 Small Business Waiver and Refund Request.pdf	Yes	Yes	Fillable Fileable
Other-Statutory Authority			21 USC 379h.pdf	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 37	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	Previously Approved
Annual Number of Responses for this IC	37	-146	183
Annual IC Time Burden (Hours)	74	-2,556	2,630
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.