Information Collection

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

IC 251676 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⚠️ Notice: This information collection may be referencing outdated material.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
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

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:

table that charts list of 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 %

table that charts list of burden
	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

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.