89 FR 206 pgs. 84895-84898 - 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 Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food
Type: NOTICEVolume: 89Number: 206Pages: 84895 - 84898
Pages: 84895, 84896, 84897, 84898Docket number: [Docket No. FDA-2024-N-2177]
FR document: [FR Doc. 2024-24771 Filed 10-23-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2177]
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 Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) 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 November 25, 2024.
ADDRESSES:
[top] 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
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 Animal Food-21 CFR part 507
OMB Control Number 0910-0751-Extension
This information collection supports implementation of section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350g). Section 418(a) requires the owner, operator, or agent in charge of a facility to evaluate hazards that could affect food manufactured, processed, packed, or held by the facility; identify and implement preventive controls; monitor the performance of those controls; and maintain records demonstrating compliance. Section 418(b) through (i) of the FD&C Act contains more specific requirements applicable to facilities, including corrective actions (section 418(e)), verification (section 418(f)), a written plan and documentation (section 418(h)), and reanalysis of hazards (section 418(i)). Finally, section 301(uu) of the FD&C Act (21 U.S.C. 331(uu)) prohibits "[t]he operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 [of the FD&C Act]." FDA has issued regulations in part 117 (21 CFR part 117) governing human food, while regulations governing food for animals are found in part 507 (21 CFR part 507). 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 foods in accordance with sections 402 and 403 of the 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 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. 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 §§?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 D 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.
Information collected will assist FDA in determining facility compliance with current good manufacturing practice requirements and in ensuring that food safety systems include hazard analysis and risk-based preventive controls. Records will be examined during food facility inspections and in the event of an outbreak or other food safety incident involving the food manufactured at the facility.
Section 418(l)(2)(B)(ii) of the FD&C Act 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.
In the Federal Register of June 5, 2024 (89 FR 48172) we published a 60-day notice requesting public comment on the proposed collection of information. Although no comments were received, on our own initiative we have modified estimates since publication of our 60-day notice. Specifically, we have modified estimates for certain recordkeeping elements associated with animal foods in tables 2 and 3.
We estimate the burden of this collection of information as follows:
| 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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| 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. | |||||
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| 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 |
| 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. | |||||
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.
Dated: October 21, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24771 Filed 10-23-24; 8:45 am]
BILLING CODE 4164-01-P