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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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40 rows where docket_id = "FDA-2019-N-3325" and posted_year = 2019 sorted by posted_date descending

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  • 2019 · 40 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-3325-0007 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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    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
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CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;