2024-18277. Agency Information Collection Activities; Proposed Collection; Comment Request; Laboratory Accreditation for Analyses of Foods

Table 1—Estimated Annual Reporting Burden ^{1  2}

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.

Table 2—Estimated Annual Recordkeeping Burden ^{1  2}

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
( print page 66420)
§ 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.