2024-24771. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and Current Good ...

Table 1—Estimated Annual Reporting Burden ¹

21 CFR section; reporting activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Human Foods: 117.201(c); qualified facility as reported on Form FDA 3942a	37,134	2  0.5	18,567	0.5 (30 minutes)	9,284
Animal Foods: 507.7(c); qualified facility as reported on Form FDA 3942b	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.
2  Reporting occurs biennially.

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Table 2—Estimated Annual Recordkeeping Burden ¹

21 CFR section; recordkeeping activity	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours 2
Human Foods: Subparts A—Required Records and B—General Provisions
117.126(c) and 117.170(d); food safety plan and reanalysis	46,685	1	46,685	110	5,135,350
117.136; assurance records	16,285	1	16,285	0.25 (15 minutes)	4,071
117.145(c); monitoring records	8,143	730	5,944,390	0.05 (3 minutes)	297,220
117.150(d); corrective actions and corrections records	16,285	2	32,570	1	32,570
117.155(b); verification records	8,143	244	1,986,892	0.05 (3 minutes)	99,345
117.160; validation records	3,677	6	22,062	0.25 (15 minutes)	5,515
117.475(c)(7) through (c)(9); supplier records	16,285	10	162,850	4	651,400
117.180(d); training records for preventive controls qualified individual	46,685	1	46,685	0.25 (15 minutes)	11,671
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)	387,641
Total					7,400,400
1  There are no capital costs or operating and maintenance costs associated with this collection of information.
2  Total hours have been rounded.

Table 3—Estimated Annual Third-Party Disclosure Burden ¹

21 CFR section; activity	Number of respondents	Number of disclosures per respondent	Total annual disclosures	Average burden per disclosure	Total hours
117.201(e); disclosure of food manufacturing facility address	37,134	1	37,134	0.25 (15 minutes)	9,284
507.27(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)	825
507.7(e)(1); change labels on products with labels	1,120	4	4,480	1	4,480
507.7(e)(2); change address on labeling (sales documents) for qualified facilities	974	1	974	1	974
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507.25(a)(2); animal food, including raw materials, other ingredients, and rework, is accurately identified	373	312	116,376	0.01 (36 seconds)	1,163.76
507.28(b); holding and distribution of human food by-products for use as animal food	40,798	2	81,596	0.25 (15 minutes)	20,399
Total					37,125.76
1  There are no capital costs or operating and maintenance costs associated with this collection of information.