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93 rows where docket_id = "FDA-2019-N-3325" sorted by posted_date descending

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id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2019-N-3325-0170 FDA None FDA-2019-N-3325 Laboratory Accreditation for Analyses of Foods; Program Implementation; Determination of Sufficient Laboratory Capacity for Import-Related Food Testing Covered by the Regulation Rule Advance Notice of Proposed Rulemaking (ANPRM) 2024-06-03T04:00:00Z 2024 6     2024-06-03T14:01:40Z 2024-12027 0 0 090000648659257d
FDA-2019-N-3325-0169 FDA None FDA-2019-N-3325 Laboratory Accreditation for Analyses of Foods; Correction Rule Correction 2022-02-02T05:00:00Z 2022 2 2022-02-02T05:00:00Z   2022-02-02T14:06:34Z 2022-02046 0 0 0900006484f4c786
FDA-2019-N-3325-0168 FDA None FDA-2019-N-3325 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice Notice of Approval 2022-01-28T05:00:00Z 2022 1 2022-01-28T05:00:00Z   2022-01-28T17:22:34Z 2022-01692 0 0 0900006484f3ec5c
FDA-2019-N-3325-0162 FDA None FDA-2019-N-3325 FRIA 23 Reference 23 Laboratory Costs of ISO-IEC 17025 Accreditation Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:16:04Z   0 0 0900006484ea3eec
FDA-2019-N-3325-0135 FDA None FDA-2019-N-3325 15 Reference 15 FDA Memo to lab rule NPRM docket_DWPESamplingAndAnalysis_finaldraft_cleared20Nov2018 Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:25:40Z   0 0 0900006484ea3957
FDA-2019-N-3325-0160 FDA None FDA-2019-N-3325 FRIA 21 Reference 21 CNN Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:13:32Z   0 0 0900006484ea3eea
FDA-2019-N-3325-0125 FDA None FDA-2019-N-3325 00 LAAF Final Rule Reference List Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:15:51Z   0 0 0900006484e9f71b
FDA-2019-N-3325-0128 FDA None FDA-2019-N-3325 06 Reference 6 APHL FS-2019Jan-Best-Practices-Human-Animal-Food-Data Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:18:31Z   0 0 0900006484e9f71e
FDA-2019-N-3325-0129 FDA None FDA-2019-N-3325 07 Reference 7 ASSESS _ definition in the Cambridge English Dictionary Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:19:34Z   0 0 0900006484e9f71f
FDA-2019-N-3325-0136 FDA None FDA-2019-N-3325 17 Reference 17 FDA Rev05 2021 Complete Investigations Operations Manual_0 Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:26:36Z   0 0 0900006484ea3958
FDA-2019-N-3325-0138 FDA None FDA-2019-N-3325 19 Reference 19 AAFCO GOODSamples Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:28:23Z   0 0 0900006484ea395a
FDA-2019-N-3325-0154 FDA None FDA-2019-N-3325 FRIA 14 - Reference 14 Food Labeling Rule 81FR34000_27May2016 Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:06:06Z   0 0 0900006484ea3ee1
FDA-2019-N-3325-0164 FDA None FDA-2019-N-3325 FRIA 25 - Reference 25 FDA CP7303.819 Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:19:12Z   0 0 0900006484ea3eee
FDA-2019-N-3325-0166 FDA None FDA-2019-N-3325 FRIA 27 Reference 27 US SBA Table of Size Standards Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:33:09Z   0 0 0900006484ea3ef1
FDA-2019-N-3325-0144 FDA None FDA-2019-N-3325 FRIA 02 - Reference 2 FSMA Reports and Studies FDA Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T15:52:49Z   0 0 0900006484ea3b66
FDA-2019-N-3325-0148 FDA None FDA-2019-N-3325 FRIA 06 - Reference 6 Requirements Pertaining to Sampling 69 FR 23460_29Apr2004 Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T15:58:53Z   0 0 0900006484ea3edb
FDA-2019-N-3325-0141 FDA None FDA-2019-N-3325 22 Reference 22 FDA Memo 0023_LAAF FinalRule_CatEx Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:44:18Z   0 0 0900006484ea395e
FDA-2019-N-3325-0126 FDA None FDA-2019-N-3325 01 Reference 1 Cong Hearing105shrg51562_Safety of Food Imports Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:16:02Z   0 0 0900006484e9f71c
FDA-2019-N-3325-0137 FDA None FDA-2019-N-3325 18 Reference 18 UGA Extension Biosecurity Basics for Poultry Growers 1306_6 Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:27:33Z   0 0 0900006484ea3959
FDA-2019-N-3325-0140 FDA None FDA-2019-N-3325 21 Reference 21 ORA Lab Manual Vol. II Section 5.4.5 Methods-Method Verification and Validation Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:42:48Z   0 0 0900006484ea395d
FDA-2019-N-3325-0150 FDA None FDA-2019-N-3325 FRIA 08 - Reference 8 FDA Memo to lab rule NPRM docket_DWPESamplingAndAnalysis_finaldraft_cleared20Nov2018 Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:01:13Z   0 0 0900006484ea3edd
FDA-2019-N-3325-0151 FDA None FDA-2019-N-3325 FRIA 09 - Reference 9 Prevention of SE in Shell Eggs 74FR33030_09Jul2009 Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:04:48Z   0 0 0900006484ea3ede
FDA-2019-N-3325-0155 FDA None FDA-2019-N-3325 FRIA 15 Reference 15 FDA Modeling the Effects of Food Handling Practices Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:07:04Z   0 0 0900006484ea3ee5
FDA-2019-N-3325-0143 FDA None FDA-2019-N-3325 FRIA 01 - Reference 1 FDA Memo to File ADO Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T15:51:53Z   0 0 0900006484ea3b65
FDA-2019-N-3325-0145 FDA None FDA-2019-N-3325 FRIA 03 - Reference 3 FDA Memo to file - Facility registration Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T15:53:35Z   0 0 0900006484ea3ed8
FDA-2019-N-3325-0147 FDA None FDA-2019-N-3325 FRIA 05 Reference 5 Molting of Laying Hens Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T15:57:50Z   0 0 0900006484ea3eda
FDA-2019-N-3325-0157 FDA None FDA-2019-N-3325 FRIA 17 Reference 17 Foodborne Illness Acquired in the United States Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:10:06Z   0 0 0900006484ea3ee7
FDA-2019-N-3325-0132 FDA None FDA-2019-N-3325 10 Reference 10 Codex CAC-GL-50-2004 Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:22:36Z   0 0 0900006484ea3954
FDA-2019-N-3325-0133 FDA None FDA-2019-N-3325 11 Reference 11 Draft-Guidance-for-Industry--Control-of-Listeria-monocytogenes-in-Ready-To-Eat-Foods-(PDF) Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:23:41Z   0 0 0900006484ea3955
FDA-2019-N-3325-0139 FDA None FDA-2019-N-3325 20 Reference 20 AAFCO GoodTP_final_web Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:30:11Z   0 0 0900006484ea395b
FDA-2019-N-3325-0149 FDA None FDA-2019-N-3325 FRIA 07- Reference 7 2009 PLAP Draft GFI - withdrawn Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:00:18Z   0 0 0900006484ea3edc
FDA-2019-N-3325-0146 FDA None FDA-2019-N-3325 FRIA 04 Reference 4 ERG Laboratory and Analytical Testing Profile Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T15:55:53Z   0 0 0900006484ea3ed9
FDA-2019-N-3325-0159 FDA None FDA-2019-N-3325 FRIA 20 Reference 20 US Egg Farm Price Received Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:12:19Z   0 0 0900006484ea3ee9
FDA-2019-N-3325-0167 FDA None FDA-2019-N-3325 FRIA 28 Reference 28 2012 Manufacturing (NAICS Sector 31) Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:34:28Z   0 0 0900006484ea3ef2
FDA-2019-N-3325-0153 FDA None FDA-2019-N-3325 FRIA 11 - Reference 11 Beverages-Bottled Water 74FR25651_29May2009 Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:04:26Z   0 0 0900006484ea3ee0
FDA-2019-N-3325-0161 FDA None FDA-2019-N-3325 FRIA 22 Reference 22 US Department of Labor- Employment and Wages Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:14:33Z   0 0 0900006484ea3eeb
FDA-2019-N-3325-0142 FDA None FDA-2019-N-3325 FRIA 00 FRIA Reference List Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T15:50:53Z   0 0 0900006484ea3b64
FDA-2019-N-3325-0134 FDA None FDA-2019-N-3325 12 Reference 12 FDA -Outbreak Investigation of Scombrotoxin .. Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:24:36Z   0 0 0900006484ea3956
FDA-2019-N-3325-0158 FDA None FDA-2019-N-3325 FRIA 18 Reference 18 Ciguatera and scombroid fish poisoning in the US Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:11:16Z   0 0 0900006484ea3ee8
FDA-2019-N-3325-0156 FDA None FDA-2019-N-3325 FRIA 16 Reference 16 Outbreaks of Disease Associated with Food Imported into US Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:08:36Z   0 0 0900006484ea3ee6
FDA-2019-N-3325-0163 FDA None FDA-2019-N-3325 FRIA 24 Reference 24 UPS retail rates Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:17:24Z   0 0 0900006484ea3eed
FDA-2019-N-3325-0165 FDA None FDA-2019-N-3325 FRIA 26 Reference 26 FDA Bacteriological Analytical Manual Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:27:29Z   0 0 0900006484ea3ef0
FDA-2019-N-3325-0127 FDA None FDA-2019-N-3325 05 Reference 5 PFP Laboratory Best Practices Manual Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:18:16Z   0 0 0900006484e9f71d
FDA-2019-N-3325-0130 FDA None FDA-2019-N-3325 08 Reference 8 revised_circular_a-119_as_of_01-22-2016 Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:20:45Z   0 0 0900006484ea3952
FDA-2019-N-3325-0131 FDA None FDA-2019-N-3325 09 Reference 9 NIST.SP.2000-02 Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T14:21:39Z   0 0 0900006484ea3953
FDA-2019-N-3325-0152 FDA None FDA-2019-N-3325 FRIA 10 - Reference 10 Produce Safety Rule 80FR74354_27Nov2015 Supporting & Related Material Background Material 2021-12-06T05:00:00Z 2021 12     2021-12-06T16:05:11Z   0 0 0900006484ea3edf
FDA-2019-N-3325-0124 FDA None FDA-2019-N-3325 Laboratory Accreditation for Analyses of Foods Rule Final Rule 2021-12-03T05:00:00Z 2021 12 2021-12-03T05:00:00Z   2021-12-03T16:37:13Z 2021-25716 0 0 0900006484e9c71c
FDA-2019-N-3325-0123 FDA None FDA-2019-N-3325 Memo for the Record Lab Accreditation Final Rule USDA APHIS NPIP consultation November 2021 Other Memorandum 2021-11-30T05:00:00Z 2021 11 2021-11-30T05:00:00Z   2021-11-30T20:01:07Z   0 0 0900006484e8d7eb
FDA-2019-N-3325-0100 FDA None FDA-2019-N-3325 Summary of 03052020 FDA AFFI CBA meeting Supporting & Related Material Background Material 2020-06-10T04:00:00Z 2020 6     2020-06-10T15:06:09Z   0 0 09000064846dc1f5
FDA-2019-N-3325-0099 FDA None FDA-2019-N-3325 Summary of 02252020 FDA conf call with ACIL Supporting & Related Material Background Material 2020-06-10T04:00:00Z 2020 6     2020-06-10T15:06:02Z   0 0 09000064846dbdf8
FDA-2019-N-3325-0098 FDA None FDA-2019-N-3325 Summary of 02212020 FDA ACIL meeting Supporting & Related Material Background Material 2020-06-10T04:00:00Z 2020 6     2020-06-10T15:05:55Z   0 0 09000064846dbdf7
FDA-2019-N-3325-0088 FDA None FDA-2019-N-3325 Laboratory Accreditation for Analyses of Foods; Extension of Comment Period Proposed Rule Notice of Extension 2020-04-06T04:00:00Z 2020 4 2020-04-06T04:00:00Z 2020-07-07T03:59:59Z 2020-04-06T13:33:03Z 2020-07171 0 0 090000648448a367
FDA-2019-N-3325-0079 FDA None FDA-2019-N-3325 Laboratory Accreditation for Analyses of Foods; Extension of Comment Period Proposed Rule Extension of Comment Period 2020-02-28T05:00:00Z 2020 2 2020-02-28T05:00:00Z 2020-07-07T03:59:59Z 2020-04-06T13:55:03Z 2020-03944 0 0 09000064843c5307
FDA-2019-N-3325-0007 FDA None FDA-2019-N-3325 Reference 5: “Action Plan for Import Safety.” Interagency Working Group on Import Safety. November 2007. http://www.itagc.org/docs/ITAGC-2010-11-10-FDA-4.pdf. Accessed June 17, 2019 Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:11:15Z   0 0 090000648411b183
FDA-2019-N-3325-0029 FDA None FDA-2019-N-3325 Reference 4: FDA Memo to Administrative Record, “Assessment of DWPE sampling and analysis data to determine what portion of sampling and analysis of food under DWPE is conducted by accredited entities.” From Tyler Scandalios and Toni Morales, November 20, 2018 Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:18:12Z   0 0 090000648411c83c
FDA-2019-N-3325-0022 FDA None FDA-2019-N-3325 Reference 20: Meeting Record, “FSMA Lab Accreditation/Food Laboratory Alliance Meeting Record August 21, 2015.” FDA. July 21, 2015. Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:13:58Z   0 0 090000648411b207
FDA-2019-N-3325-0028 FDA None FDA-2019-N-3325 Reference 3: Middlebrook, Ken, “Do accredited laboratories perform better in proficiency testing than non-accredited laboratories?”, Accreditation and Quality Assurance (22) 2017. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:17:34Z   0 0 090000648411c67a
FDA-2019-N-3325-0018 FDA None FDA-2019-N-3325 Reference 16: “Accreditation Requirements: ISO/IEC 17025 Testing Laboratories (Non-Forensics).” ANSI/ASQ National Accreditation Board. October 9, 2018. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:13:18Z   0 0 090000648411b1d2
FDA-2019-N-3325-0021 FDA None FDA-2019-N-3325 Reference 19: FDA Memorandum, “Guidelines for the Validation of Chemical Methods for the FDA FVM Program, 2nd Edition.” FDA Foods and Veterinary Medicine Science and Research Steering Committee. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:13:48Z   0 0 090000648411b203
FDA-2019-N-3325-0032 FDA None FDA-2019-N-3325 Reference 7: Produce Safety final rule, 80 FR 74353, November 27, 2015.Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:19:18Z   0 0 090000648411c6d8
FDA-2019-N-3325-0034 FDA None FDA-2019-N-3325 Reference 9: Thompson, Michael; Kenneth Mathieson; Linda Owen; Andrew P. Damant; Roger Wood, “The relationship between accreditation status and performance in a proficiency test,” Accreditation and Quality Assurance, 14, 2009 Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:19:39Z   0 0 090000648411c6da
FDA-2019-N-3325-0011 FDA None FDA-2019-N-3325 Reference 9: “Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals, An Aid to Interpretation of ISO/IEC 17025:2005.” AOAC International. April 2015. Copies are available from AOAC International, 2275 Research Blvd, ste. 300, Rockville, MD 20850-3250, USA Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T14:16:50Z   0 0 090000648411ad7b
FDA-2019-N-3325-0037 FDA None FDA-2019-N-3325 Reference 12: Minor, Travis, Angela Lasher, Karl Klontz, Bradley Brown, Clark Nardinelli, and David Zorn; “The Per Case and Total Annual Costs of Foodborne Illness in the United States,” Risk Analysis; June 35(6):1125-39, 2014. Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:20:10Z   0 0 090000648411c451
FDA-2019-N-3325-0017 FDA None FDA-2019-N-3325 Reference 15: “R103--General Requirements: Proficiency Testing for ISO/IEC Laboratories.” American Association for Laboratory Accreditation. September 19, 2013. https://portal.a2la.org/requirements/R103_2013.pdf. Accessed on June 17, 2019. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:13:08Z   0 0 090000648411b1d1
FDA-2019-N-3325-0002 FDA None FDA-2019-N-3325 Laboratory Accreditation NPRM - REFERENCE LIST Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T14:02:06Z   0 0 090000648411b298
FDA-2019-N-3325-0040 FDA None FDA-2019-N-3325 Reference 20: U.S. Small Business Administration, Table of Small Business Size Standards Matched to North American Industry Classification System Codes. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:21:50Z   0 0 090000648411c454
FDA-2019-N-3325-0026 FDA None FDA-2019-N-3325 Reference 1: Sampling proposed rule, 69 FR 23460, April 29, 2004 Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:17:07Z   0 0 090000648411c678
FDA-2019-N-3325-0031 FDA None FDA-2019-N-3325 Reference 6: Shell-egg Final rule, 74 FR 33029, July 9, 2009. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:18:48Z   0 0 090000648411c6d7
FDA-2019-N-3325-0006 FDA None FDA-2019-N-3325 Reference 4: “ISO/IEC 17025:2005 “General Requirements for the Competence of Testing and Calibration Laboratories” (withdrawn). Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:10:55Z   0 0 090000648411b181
FDA-2019-N-3325-0030 FDA None FDA-2019-N-3325 Reference 5: FDA Memo to Administrative Record, “Use of Labs by Shell-Egg Industry.” July 15, 2015 Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:18:23Z   0 0 090000648411c83d
FDA-2019-N-3325-0023 FDA None FDA-2019-N-3325 Reference 21: FDA. Accreditation of Laboratories to Conduct Food Testing: Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, Unfunded Mandates Reform Act Analysis, Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:15:08Z   0 0 090000648411b208
FDA-2019-N-3325-0027 FDA None FDA-2019-N-3325 Reference 2: FDA Draft Guidance for Industry, “Submission of Laboratory Packages by Accredited Laboratories” (withdrawn). FDA. January 16, 2009. Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:17:20Z   0 0 090000648411c679
FDA-2019-N-3325-0016 FDA None FDA-2019-N-3325 Reference 14: Meeting Minutes, “Sampling Accreditation Discussion with ABs.” FDA. November 13, 2017. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:12:57Z   0 0 090000648411b1d0
FDA-2019-N-3325-0025 FDA None FDA-2019-N-3325 PRIA 00 Reference List Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:16:52Z   0 0 090000648411c677
FDA-2019-N-3325-0008 FDA None FDA-2019-N-3325 Reference 6: GAO Report, “Federal Oversight of Food Safety: FDA’s Food Protection Plan Proposes Positive First Steps, but Capacity to Carry Them Out Is Critical (GAO-08-435T).” Government Accountability Office. January 29, 2008. https://www.gao.gov/assets/120/118821.pdf. Accessed on June 17, 2019. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:11:27Z   0 0 090000648411b184
FDA-2019-N-3325-0012 FDA None FDA-2019-N-3325 Reference 10: “IAF/ILAC Multi-Lateral Mutual Recognition Arrangements (Arrangements): Requirements and Procedures for Evaluation of a Single Accreditation Body.” International Accreditation Forum/International Laboratory Accreditation Cooperation. January 2018. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:12:11Z   0 0 090000648411b1cc
FDA-2019-N-3325-0038 FDA None FDA-2019-N-3325 Reference 16: Association of Public Health Laboratories, “Laboratory Costs of ISO/IEC 17025 Accreditation: A 2017 Survey Report.” February 2018 Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:21:20Z   0 0 090000648411c452
FDA-2019-N-3325-0010 FDA None FDA-2019-N-3325 Reference 8: FDA Draft Guidance for Industry, “Submission of Laboratory Packages by Accredited Laboratories” (withdrawn). FDA. January 16, 2009.Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:11:50Z   0 0 090000648411b186
FDA-2019-N-3325-0033 FDA None FDA-2019-N-3325 Reference 8: Bottled Water final rule, 74 FR 25651, May 29, 2009. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:19:29Z   0 0 090000648411c6d9
FDA-2019-N-3325-0005 FDA None FDA-2019-N-3325 Reference 3: “Private Laboratory Guidance,” ORA Laboratory Manual, Vol. III, Section 7, document number III-07. FDA. January 30, 2013. https://www.fda.gov/media/81810/download. Accessed on June 17, 2019. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T14:02:45Z   0 0 090000648411ad50
FDA-2019-N-3325-0009 FDA None FDA-2019-N-3325 Reference 7: GAO Report, “Food Safety: FDA’s Imported Seafood Safety Program Shows Some Progress, but Further Improvements are Needed (GAO-04-246).” Government Accountability Office. January 30, 2004. https://www.gao.gov/assets/250/241327.pdf. Accessed on June 17, 2019.Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:11:40Z   0 0 090000648411b185
FDA-2019-N-3325-0035 FDA None FDA-2019-N-3325 Reference 10: FDA, Serving Size final rule, 81 FR 34000, May 27, 2016 Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:19:48Z   0 0 090000648411c44f
FDA-2019-N-3325-0036 FDA None FDA-2019-N-3325 Reference 11: FDA, Modeling the Effects of Food Handling Practices on the Incidence of Foodborne Illness, Final Report” ERG Task No. 0193.16.004.001, March 18, 2009. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:19:58Z   0 0 090000648411c450
FDA-2019-N-3325-0039 FDA None FDA-2019-N-3325 Reference 18: FDA, Compliance Program Guidance Manual, Program 7303.819, Chapter 3. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:21:39Z   0 0 090000648411c453
FDA-2019-N-3325-0003 FDA None FDA-2019-N-3325 Reference 1: FDA Memorandum, “Assessment of DWPE Sampling and Analysis Data to Determine what Portion of Sampling and Analysis of Food under DWPE is Conducted by Accredited Entities.” Toni Morales and Tyler Scandalios, FDA. November 20, 2018. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:10:22Z   0 0 090000648411ad4c
FDA-2019-N-3325-0014 FDA None FDA-2019-N-3325 Reference 12: “ISO/IEC 17011:2017(E), “Conformity Assessment–Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies.” International Organization for Standardization/International Electrotechnical Commission. November 2017. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:12:32Z   0 0 090000648411b1ce
FDA-2019-N-3325-0020 FDA None FDA-2019-N-3325 Reference 18: “Methods, Method Verification and Validation,” ORA Laboratory Manual, Vol. II, Section 2, document number ORA-LAB.5.4.5. FDA. August 29, 2014. https://www.fda.gov/media/73920/download. Accessed on June 17, 2019. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:13:38Z   0 0 090000648411b202
FDA-2019-N-3325-0013 FDA None FDA-2019-N-3325 Reference 11: “OMB Circular A–119: Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities.” Office of Management and Budget. January 2016. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:12:23Z   0 0 090000648411b1cd
FDA-2019-N-3325-0024 FDA None FDA-2019-N-3325 Reference 22: FDA Memorandum. “Proposed Rule: Amendment of 21 CFR Parts 1, 11, 16, and 129 to Establish a Program for Laboratory Accreditation for Analyses of Foods as Required by FD&C Act.” Leah D. Proffitt, FDA, June 14, 2019. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:15:35Z   0 0 090000648411b209
FDA-2019-N-3325-0019 FDA None FDA-2019-N-3325 Reference 17: ISO/IEC 17043:2010, “Conformity Assessment--General Requirements for Proficiency Testing.” International Organization for Standardization/International Electrotechnical Commission. February 2010. Copies are available from the International Organization for Standardization Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T14:04:48Z   0 0 090000648411b1d5
FDA-2019-N-3325-0004 FDA None FDA-2019-N-3325 Reference 2: Congressional Hearing, “The Safety of Food Imports: Fraud & Deception in the Food Import Process; Hearings Before the Senate Committee on Governmental Affairs, Permanent Subcommittee on Investigations.” September 10, 1998. https://www.gpo.gov/fdsys/pkg/CHRG-105shrg51562/pdf/CHRG-105shrg51562.pdf. Accessed on June 17, 2019. Re: Laboratory Accreditation for Analyses of Foods Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T13:10:32Z   0 0 090000648411ad4e
FDA-2019-N-3325-0015 FDA None FDA-2019-N-3325 Reference 13: ISO/IEC 17025:2017(E), “General Requirements for the Competence of Testing and Calibration Laboratories.” International Organization for Standardization/International Electrotechnical Commission. November 2017. Copies are available from the International Organization for Standardization, Chemin de Blandonnet 8, 1214 Vernier, Geneva, Switzerland, or on the internet at Supporting & Related Material Background Material 2019-11-05T05:00:00Z 2019 11     2019-11-05T14:04:20Z   0 0 090000648411b1cf
FDA-2019-N-3325-0001 FDA None FDA-2019-N-3325 Laboratory Accreditation for Analyses of Foods Proposed Rule Advance Notice of Proposed Rulemaking (ANPRM) 2019-11-04T05:00:00Z 2019 11 2019-11-04T05:00:00Z 2020-07-07T03:59:59Z 2020-07-08T01:02:34Z 2019-23870 0 0 090000648411a07f

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