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Quality Facility Attestation; Forms FDA 3942a and 3942b
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food and Food for Animals
OMB: 0910-0751
IC ID: 248149
OMB.report
HHS/FDA
OMB 0910-0751
ICR 202410-0910-013
IC 248149
( )
Documents and Forms
Document Name
Document Type
QualifiedFacilityGuidance2018.pdf
www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-qualified-facili
Other-Agency Guidance
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Quality Facility Attestation; Forms FDA 3942a and 3942b
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Unchanged
Obligation to Respond:
Required to Obtain or Retain Benefits
CFR Citation:
21 CFR 117.201; 507.7
Information Collection 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
Federal Enterprise Architecture Business Reference Module
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 %
Requested
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
19,127
0
0
0
0
19,127
Annual IC Time Burden (Hours)
9,564
0
0
0
0
9,564
Annual IC Cost Burden (Dollars)
0
0
0
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.