Information Collection

Quality Facility Attestation; Forms FDA 3942a and 3942b

IC 248149 under ICR 202107-0910-001 · OMB 0910-0751.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0751 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
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

IC Title:

Quality Facility Attestation; Forms FDA 3942a and 3942b

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

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.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			QualifiedFacilityGuidance2018.pdf	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-qualified-facility	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	Change Due to Adjustment in Agency Estimate
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.