Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2018-N-1857]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
 DATES: Submit written comments (including recommendations) on the collection of information by October 4, 2021.
 ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to 
                        *https://www.reginfo.gov/​public/​do/​PRAMain.*
                         Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0751. Also include the FDA docket number found in brackets in the heading of this document.
 FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
                        *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 Animals—21 CFR Part 507 OMB Control Number 0910-0751—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. 111-353). 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-other-submissions/​qualified-facility-attestation.* Section 418(l)(2)(B)(ii) of the FD&C Act (21 U.S.C. 350g(l)(2)(B)(ii)) 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/​regulatory-information/​search-fda-guidance-documents/​guidance-industry-determination-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 0910-0854, with this information collection. In the 
                    **Federal Register**
                     of March 16, 2021 (86 FR 14436), we published a 60-day 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 1—Estimated Annual Reporting Burden 1
21 CFR section; reporting
Number of
                             respondents
Number of
                             responses per 
                             respondent
Total annual
                             responses
Average burden
                             per response
Total hours117.201(c); qualified facility as reported on Form FDA 3942a
37,134
2
                             0.5
18,567
0.5 (30 minutes)
9,284507.7(c); qualified facility as reported on Form FDA 3942b
1,120
0.5
560
0.5 (30 minutes)
280Total




9,5641
                         There are no capital costs or operating and maintenance costs associated with this collection of information.2
                         Reporting occurs biennially.
 Table 2—Estimated Annual Recordkeeping Burden: Human Foods 1
21 CFR section; activity
Number of
                             recordkeepers
Number of
                             records per 
                             recordkeeper
Total annual
                             records
Average burden per
                             recordkeeping
Total hours117.126(c) and 117.170(d); food safety plan and reanalysis
46,685
1
46,685
110
5,135,350117.136; assurance records
16,285
1
16,285
0.25 (15 minutes)
4,071117.145(c); monitoring records
8,143
730
5,944,390
0.05 (3 minutes)
297,220( print page 49545)117.150(d); corrective actions and corrections records
16,285
2
32,570
1
32,570117.155(b); verification records
8,143
244
1,986,892
0.05 (3 minutes)
99,345117.160; validation records
3,677
6
22,062
0.25 (15 minutes)
5,515117.475(c)(7)-(9); supplier records
16,285
10
162,850
4
651,400117.180(d); training records for preventive controls qualified individual
46,685
1
46,685
0.25 (15 minutes)
11,671Total




6,237,1421
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 Table 3—Estimated Annual Recordkeeping Burden: Animal Food 1
21 CFR section; activity
Number of
                             recordkeepers
Number of
                             records per 
                             recordkeeper
Total annual
                             records
Average burden per
                             recordkeeping
Total hours 2**Subpart A—General Provisions**507.4(d); documentation of animal food safety and hygiene training
7,469
0.75
5,579
0.05 (3 minutes)
279**Subpart C—Hazard Analysis and Risk-Based Preventive Controls**507.31 through 507.55; food safety plan—including hazard analysis, preventive controls, and procedures for monitoring, corrective actions, verification, recall plan, validation, reanalysis, modifications, and implementation records
7,469
519
3,876,411
0.1 (6 minutes)
387,641**Subpart E—Supply Chain Program**507.105 through 507.175; written supply-chain program—including records documenting program
7,469
519
3,876,411
0.1 (6 minutes)
387,641**Subpart F—Requirements Applying to Records That Must Be Established and Maintained**507.200 through 507.215; general requirements, additional requirements applying to food safety plan, requirements for record retention, use of existing records, and special requirements applicable to written assurance
7,469
519
3,876,411
0.1 (6 minutes)
387,641Total


11,635,372

1,163,2581
                         There are no capital costs or operating and maintenance costs associated with this collection of information.2
                         Total hours have been rounded.
 
 
 Table 4—Estimated Annual Third-Party Disclosure Burden: Human Foods 1
21 CFR section; activity
Number of
                             respondents
Number of
                             disclosures per 
                             respondent
Total annual
                             disclosures
Average burden
                             per disclosure
Total hours117.201(e); disclosure of food manufacturing facility address
37,134
1
37,134
0.25 (15 minutes)
9,2841
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 Table 5—Estimated Annual Third-Party Disclosure Burden: Animal Food 1
21 CFR section; activity
Number of
                             respondents
Number of
                             disclosures per 
                             respondent
Total annual
                             disclosures
Average burden
                             per disclosure
Total hours507.27(b); labeling for the animal food product contains the specific information and instructions needed so the food can be safely used for the intended animal species
330
10
3,300
0.25 (15 minutes)
825507.7(e)(1); change labels on products with labels
1,120
4
4,480
1
4,480507.7(e)(2); change address on labeling (sales documents) for qualified facilities
974
1
974
1
974507.25(a)(2); animal food, including raw materials, other ingredients, and rework, is accurately identified
373
312
116,376
0.01 (36 seconds)
1,163.76507.28(b); holding and distribution of human food byproducts for use as animal food
40,798
2
81,596
0.25 (15 minutes)
20,399Total




27,841.761
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 Based on a review of the information collection since our last request for OMB approval, we have made slight adjustments to reflect a decrease in third-party disclosure burden associated with animal food. In this submission we provide a cumulative estimate for related disclosure activities that we had previously accounted for separately. Dated: August 31, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy.


[FR Doc. 2021-19116 Filed 9-2-21; 8:45 am] BILLING CODE 4164-01-P