89 FR 158 pgs. 66417-66420 - Agency Information Collection Activities; Proposed Collection; Comment Request; Laboratory Accreditation for Analyses of Foods
Type: NOTICEVolume: 89Number: 158Pages: 66417 - 66420
Pages: 66417, 66418, 66419, 66420Docket number: [Docket No. FDA-2024-N-3379]
FR document: [FR Doc. 2024-18277 Filed 8-14-24; 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; Proposed Collection; Comment Request; Laboratory Accreditation for Analyses of Foods
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA's Laboratory Accreditation for Analyses of Foods (LAAF).
DATES:
Either electronic or written comments on the collection of information must be submitted by October 15, 2024.
ADDRESSES:
[top] You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing
Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").
Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."
Instructions: All submissions received must include the Docket No. FDA-2024-N-3379 for "Laboratory Accreditation for Analyses of Food." Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions-To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
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:
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. "Collection of information" is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Laboratory Accreditation for Analysis of Foods-21 CFR Part 1, Subpart R
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 (FD&C 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.
[top] The regulations require respondents to maintain and electronically submit certain test results, reports, notifications, and other records to FDA. The submissions can be made through 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
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.
FDA estimates the burden of this collection of information as follows:
| 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. | |||||
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| 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.
New information technology applications have more accurately calculated the number of food testing laboratories seeking accreditation and 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: August 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18277 Filed 8-14-24; 8:45 am]
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