Information Collection

Quality Facility Attestation; Forms FDA 3942a and 3942b

IC 248149 under ICR 202410-0910-013 · OMB 0910-0751.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3942b Qualified Facility Attestation for Animal Food Facility Quality Facility Attestation; Forms FDA 3942a and 3942b	Form and Instruction
Form 3942a Qualified Facility Attestation for Human Food Facility Quality Facility Attestation; Forms FDA 3942a and 3942b	Form and Instruction
QualifiedFacilityGuidance2018.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-qualified-facili	Other-Agency Guidance
QualifiedFacilityGuidance2018.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-qualified-facili	Other-Agency Guidance
FDA 3942b Qualified Facility Attestation for Animal Food Facility Form FDA 3942b Animal Foods.pdf www.fda.gov/food/qualified-facility-attestation/instructions-submitting-qualified-facility-attestation	Form and Instruction
3942a Qualified Facility Attestation for Human Food Facility Form FDA 3942a Human Foods exp 11-24.pdf www.fda.gov/food/qualified-facility-attestation/instructions-submitting-qualified-facility-attestation	Form and Instruction

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 117.201; 507.7

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance		https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-qualified-facility	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3942b	https://www.fda.gov/food/qualified-facility-attestation/instructions-submitting-qualified-facility-attestation	Yes	Yes	Fillable Fileable
Form and Instruction	3942a	https://www.fda.gov/food/qualified-facility-attestation/instructions-submitting-qualified-facility-attestation	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 38,254

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	Previously Approved
Annual Number of Responses for this IC	19,127	19,127
Annual IC Time Burden (Hours)	9,564	9,564
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.

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