Information Collection

Small business waiver requests

IC 242948 under ICR 202202-0910-010 · OMB 0910-0297.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0297 can be found here:

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.