83 FR 178 pgs. 46496-46497 - 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 Food for Animals
Type: NOTICEVolume: 83Number: 178Pages: 46496 - 46497
Pages: 46496, 46497Docket number: [Docket No. FDA-2018-N-1857]
FR document: [FR Doc. 2018-19909 Filed 9-12-18; 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-2018-N-1857]
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 Food for Animals
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:
Fax written comments on the collection of information by October 15, 2018.
ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0789. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 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 Food for Animals-21 CFR Part 507
OMB Control Number 0910-0789-Extension
The information collection supports FDA regulations. As amended by the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), the Federal Food, Drug, and Cosmetic Act (FD&C Act) enables the Agency to better protect the public health by helping to ensure the safety and security of the food supply. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Specifically, section 418 (21 U.S.C. 350g) of the FD&C Act sets forth requirements for hazard analysis and risk-based preventive controls for facilities that produce food for animals. To implement these provisions, regulations were codified under 21 CFR part 507- Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive Controls For Food For Animals. The regulations establish requirements for a written food safety plan; hazard analysis preventive controls; monitoring; corrective actions and corrections; verification; supply-chain program; recall plan; and associated records and became effective November 16, 2015. Currently, we continue to evaluate burden associated with the information collection requirements however, for purposes of extending the information collection we retain the currently approved figures as shown in the following tables.
In the Federal Register of May 24, 2018 (83 FR 24124), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received three comments, however none pertained to the information collection or underlying regulations.
We estimate our burden of the information collection as follows:
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| 21 CFR section; activity | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| 507.7 exemption: submit attestation of preventive controls or compliance with State and local laws (non-federal) | 1,120 | 0.5 | 560 | 0.5 (30 minutes) | 280 |
| 507.67, 507.69, and 507.71; submission of an appeal, including submission of a request for an informal hearing | 1 | 1 | 1 | 4 | 4 |
| 507.85(b); requests for reinstatement of exemption | 1 | 1 | 1 | 2 | 2 |
| Total | 286 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
| 21 CFR section; activity | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| Subpart A-General Provisions | |||||
| 507.7(e); records attesting that the facility is a "qualified" facility | 1,120 | 0.5 | 560 | 0.1 (6 minutes) | 56 |
| 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, monitoring, corrective actions, verification, 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 | |||||
| 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 |
| Totals | 11,635,372 | 1,163,258 | |||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
| 21 CFR section; activity | Number of respondents | Number of disclosures per respondent | Total annual disclosures | Average burden per disclosure | Total hours |
|---|---|---|---|---|---|
| 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 | 1,526 | 4 | 6,104 | 1 | 6,104 |
| 507.7(e)(2); change address on labeling (sales documents) for qualified facilities | 1,329 | 1 | 1,329 | 1 | 1,329 |
| 507.25(a)(2); animal food, including raw materials, other ingredients, and rework, is accurately identified | 330 | 312 | 102,960 | 0.01 (36 seconds) | 1,030 |
| 507.28(b); holding and distribution of human food byproducts for use as animal food | 40,798 | 2 | 81,596 | 0.25 (15 minutes) | 20,399 |
| Total | 29,687 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
As previously stated, we retain the currently approved burden estimate for the information collection. These figures are based on our regulatory impact analysis in support of the final rule on Preventive Controls for Food for Animals, which published in the Federal Register of September 17, 2015 (80 FR 56170). Using Agency data, we estimated the number of animal food facilities that we believe are subject to the regulations. We base our estimate of the time necessary for the individual reporting, recordkeeping, and third-party disclosure activities on our experience with similar information collections.
Dated: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19909 Filed 9-12-18; 8:45 am]
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