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withdrawn,object_id FDA-2019-N-3325-0170,FDA,FDA-2019-N-3325,Laboratory Accreditation for Analyses of Foods; Program Implementation; Determination of Sufficient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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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