89 FR 244 pgs. 103836-103838 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Laboratory Accreditation for Analyses of Foods
Type: NOTICEVolume: 89Number: 244Pages: 103836 - 103838
Pages: 103836, 103837, 103838Docket number: [Docket No. FDA-2024-N-3379]
FR document: [FR Doc. 2024-30230 Filed 12-18-24; 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-3379]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Laboratory Accreditation for Analyses of Foods
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA 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 January 21, 2025.
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
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.
Laboratory Accreditation for Analysis of Foods
OMB Control Number 0910-0898-Extension
This information collection helps to support implementation of FDA's statutory and regulatory authority governing our laboratory accreditation for analysis of foods program under section 422 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350k) and 21 CFR part 1, subpart R. FDA has statutory authority to establish a program for the testing of food by accredited laboratories; to establish a publicly available registry of recognized accreditation bodies and laboratories recognized by an accreditation body; and to require reports of any changes that would affect the recognition of such accreditation body or the accreditation of such laboratory.
The regulations require respondents to maintain and electronically submit certain test results, reports, notifications, and other records to FDA. We are clarifying that the information collection includes the use of an electronic information collection system (the FURLS Laboratory Accreditation for Analyses of Foods Program portal) (FDA Industry Systems). User guides for the Accreditation Bodies and Accredited Laboratories can be found at the following links: https://www.fda.gov/media/156097/download?attachment and https://www.fda.gov/media/161685/download?attachment. The laboratory accreditation program helps fulfill FDA's mandate to ensure the safety of the U.S. food supply and protect U.S. consumers by administering appropriate oversight of certain food testing that is of importance to public health. It also helps ensure that the testing is done in accordance with appropriate model standards, which will help produce consistently reliable and valid test results. You may access additional information about the laboratory accreditation program at: https://www.fda.gov/food/food-safety-modernization-act-fsma/fda-recognized-accreditation-bodies-laboratory-accreditation-analyses-foods-laaf-program. The public registry is available at https://datadashboard.fda.gov/ora/fd/laaf.htm.
Respondents to the information collection are accreditation bodies seeking recognition from FDA, recognized accreditation bodies, laboratories seeking accreditation from recognized accreditation bodies, and accredited laboratories. Participation in this program is voluntary for laboratories and accreditation bodies; however, only recognized accreditation bodies would be able to accredit laboratories to conduct food testing as specified in the regulations.
In the Federal Register of August 15, 2024 (89 FR 66417), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
FDA estimates the burden of this collection of information 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 |
|---|---|---|---|---|---|
| §§?1.1113 and 1.1114; Accreditation bodies (ABs) application for recognition (one-time submission) | 8 | 44 | 352 | 2.2068 (2 hours and 12 minutes) | 776.8 |
| §§?1.1113 and 1.1114; ABs-application for renewal of recognition | |||||
| §?1.1123; ABs-reports, notifications, and documentation requirements | |||||
| §?1.1116(a) and (b); ABs-notices of intent to relinquish, records custodian | 1 | 3 | 3 | 3 | 9 |
| §§?1.1138 and 1.1139; laboratories-submission of application for LAAF-accreditation (one-time submission) | 160 | 63.5 | 10,160 | 1.8051 (1 hour and 49 minutes) | 18,340 |
| §§?1.1149(a) and 1.1152(c)(1), (2); laboratories-submission of sampling plan, sample collection report, and sampler qualifications | |||||
| §§?1.1152(d) and 1.1153(a); laboratories-qualification to submit abridged analytical reports (one-time submission) | |||||
| §?1.1153; laboratories-abridged analytical reports submissions | |||||
| §?1.1149(c); laboratories-advance notice of sampling submissions | |||||
| §?1.1152(f); laboratories-immediate notification | |||||
| §?1.1140(a); laboratories-notices of intent to relinquish, records custodian | 2 | 3 | 6 | 1 | 6 |
| §?1.1152(c)(4) and (5); laboratories-validation and verification studies submissions | 50 | 5 | 250 | 1.5 (1 hour and 30 minutes) | 375 |
| §§?1.1142; 1.1171; 1.1173; and 1.1174; requests in response to FDA action | 1 | 1 | 1 | 1 | 1 |
| Total | 10,772 | 19,508 | |||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. |
|||||
| 2 ?Totals may not sum due to rounding. | |||||
| 21 CFR section; activity | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| §?1.1113; recordkeeping associated with ISO/IEC 17011:2017 | 8 | 2 | 8 | 22 | 176 |
| §?1.1124; ABs-additional recordkeeping requirements a recognized accreditation body must maintain, for 5 years after the date of creation of the records, records created while it is recognized demonstrating its compliance with this subpart | |||||
| §?1.1138; laboratories-becoming accredited to ISO/IEC 17025:2017 (one-time); Laboratories adding ISO 17025 to become LAAF-accredited | 9 | 1 | 9 | 91.06 (91 hours and 4 minutes) | 820 |
| §?1.1138; laboratories-maintaining ISO/IEC 17025: 2017 accreditation | 160 | 2 | 320 | 450.765 (450 hours and 46 minutes) | 144,245 |
| §?1.1154; laboratories-additional recordkeeping requirements; a LAAF-accredited laboratory must maintain, for 5 years after the date of creation, records created and received while it is LAAF-accredited that relate to compliance with this subpart | |||||
| Total | 345 | 145,241 | |||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
| 2 ?Totals may not sum due to rounding. | |||||
The burden we attribute to reporting and recordkeeping activities is assumed to be distributed among the individual elements of the respective information collection activities. Although we have not received a notice of intent to relinquish records since the last approval of this information collection, we include one response for the purpose of estimating burden.
We calculate the number of food testing laboratories seeking accreditation based on the number of applicants. As a result, the number of respondents to the information collection decreased (from 170 respondents in the currently approved collection to 160 respondents). Consequently, we have adjusted our burden estimate, which results in a decrease of 227 responses and 9,303 burden hours from the currently approved information collection.
Dated: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-30230 Filed 12-18-24; 8:45 am]
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