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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices
FOR FURTHER INFORMATION CONTACT:

Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017965733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed collection of information to OMB for review and clearance.
Current Good Manufacturing Practice and Hazard Analysis, and Risk-Based Preventive Controls for Human Food 21 CFR Part 117; Current Good Manufacturing Practice and Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals21 CFR
Part 507
OMB Control Number 09100751
Revision This information collection supports FDA regulations setting forth criteria and definitions applicable to human food and to animal food, as established under the FDA Food Safety and Modernization Act FSMA Pub. L.
111353. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system. The purpose of the regulations is to prevent the introduction of adulterated and/or misbranded products into the marketplace and ensure the safety of
both human foods and animal food in accordance with sections 402 and 403 of the Federal Food, Drug, and Cosmetic Act FD&C Act 21 U.S.C. 342 and 343.
Generally, domestic and foreign food facilities that are required to register in accordance with section 415 of the FD&C Act 21 U.S.C. 350d must comply with these requirements, unless an exemption applies. It is important to note, however, that applicability of the current good manufacturing practice requirements for animal food is dependent upon whether a facility is required to register, while the applicability of the current good manufacturing practice requirements for human food is not dependent upon whether a facility is required to register.
Regulations governing human food are set forth in part 117 21 CFR part 117, while regulations governing animal food are found in part 507 21 CFR part 507.
Respondents to the information collection are those who manufacture, prepare, pack, or hold food intended for humans or animals.
The regulations include recordkeeping necessary to demonstrate compliance with the requirements;
however, respondents that meet the definition of a qualified facility, under 21 CFR 117.3 and 507.3, are subject to reporting. To be subject to the modified requirements set forth in part 117, subpart D and part 507, subpart A
for human food and animal food, respectively, respondents must attest to their status. To assist respondents in this regard, we have developed Forms FDA 3942a Quality Facility Attestation:
Human Food and 3942b Quality Facility Attestation: Animal Food,
available for downloading from our website at: https www.fda.gov/food/
registration-food-facilities-and-othersubmissions/qualified-facilityattestation.
Section 418l2Bii of the FD&C
Act 21 U.S.C. 350gl2Bii directs us to issue guidance on documentation required to determine status as a qualified facility. Accordingly, we issued a guidance for industry entitled Determination of Status as a Qualified Facility Under part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and part 507:
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, also available for downloading from our website at:
https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industrydetermination-status-qualified-facility.
The guidance discusses the content, format, frequency, and timing of submissions. For efficiency of Agency operations, we are now accounting for burden we attribute to reporting associated with Forms FDA 3942a and 3942b, currently approved under OMB
control number 09100854, with this information collection.
In the Federal Register of March 16, 2021 86 FR 14436, we published a 60day notice requesting public comment on the proposed collection of information. No comments were received.
We estimate the burden of this collection of information as follows:

TABLE 1ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; reporting
Number of respondents
Number of responses per respondent
Total annual responses
Average burden per response
Total hours
117.201c; qualified facility as reported on Form FDA
3942a.
507.7c; qualified facility as reported on Form FDA 3942b.

37,134

2 0.5

18,567

0.5 30 minutes

9,284

1,120

0.5

560

0.5 30 minutes

280

Total

9,564

1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
occurs biennially.

2 Reporting
lotter on DSK11XQN23PROD with NOTICES1

TABLE 2ESTIMATED ANNUAL RECORDKEEPING BURDEN: HUMAN FOODS 1
21 CFR section; activity
Number of recordkeepers
117.126c and 117.170d;
food safety plan and reanalysis.
117.136; assurance records
117.145c; monitoring records
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16:55 Sep 02, 2021

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Number of records per recordkeeper
Total annual records
Average burden per recordkeeping
Total hours
46,685

1

46,685

110

5,135,350

16,285
8,143

1
730

16,285
5,944,390

0.25 15 minutes
0.05 3 minutes

4,071
297,220

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