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

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30 rows where docket_id = "FDA-2011-N-0146" and posted_year = 2015 sorted by posted_date descending

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  • 2015 · 30 ✖

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2011-N-0146-0205 FDA None FDA-2011-N-0146 Reference 10: International Organization for Standardization/International Electrotechnical Commission, “ISO/IEC 17020:2012 Conformity Assessment--Requirements for the Operation of Various Types of Bodies Performing Inspection,” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:04:04Z   0 0 0900006481d5be77
FDA-2011-N-0146-0206 FDA None FDA-2011-N-0146 Reference 11: Global Food Safety Initiative, “Enhancing Food Safety Through Third-Party Certification,” March 2011 re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:06:34Z   0 0 0900006481d5bf1a
FDA-2011-N-0146-0198 FDA None FDA-2011-N-0146 Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Rule Final Rule 2015-11-27T05:00:00Z 2015 11 2015-11-27T05:00:00Z   2015-11-27T14:49:51Z 2015-28160 0 0 0900006481d76139
FDA-2011-N-0146-0204 FDA None FDA-2011-N-0146 Reference 8: International Organization for Standardization, ISO 19011:2011 Guidelines for Auditing Management Systems,” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T17:59:05Z   0 0 0900006481d5be76
FDA-2011-N-0146-0208 FDA None FDA-2011-N-0146 Reference 13: International Accreditation Forum, “IAF Endorsed Normative Documents, Issue 4 (IAF PR 4:2007),” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:09:44Z   0 0 0900006481d5bf1c
FDA-2011-N-0146-0209 FDA None FDA-2011-N-0146 Reference 14: Codex Alimentarius Commission, “Principles for Food Import and Export Inspection and Certification (CAC/GL 20-1995)” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:11:21Z   0 0 0900006481d5bf1d
FDA-2011-N-0146-0199 FDA None FDA-2011-N-0146 Reference List re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T16:26:13Z   0 0 0900006481d5be74
FDA-2011-N-0146-0218 FDA None FDA-2011-N-0146 Reference 25: FDA, “Tribal Summary Impact Statement: Final Rule on Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue,” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:23:56Z   0 0 0900006481d5bf35
FDA-2011-N-0146-0212 FDA None FDA-2011-N-0146 Reference 17: American National Standards Institute, “About ANSI,” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:15:57Z   0 0 0900006481d5bf20
FDA-2011-N-0146-0216 FDA None FDA-2011-N-0146 Reference 23: Safe Quality Food Institute, “SQF Code, Edition 7.2: A HACCP-Based Supplier Assurance Code for the Food Industry,” July 2014 re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:21:07Z   0 0 0900006481d5bf33
FDA-2011-N-0146-0203 FDA None FDA-2011-N-0146 Reference 7: International Organization for Standardization/International Electrotechnical Commission, “ISO/IEC 17065:2012 Conformity Assessment--Requirements for Bodies Certifying Products, Processes and Services,” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T17:56:24Z   0 0 0900006481d5be75
FDA-2011-N-0146-0210 FDA None FDA-2011-N-0146 Reference 15: Armour, S., Lippert, J., and Smith, M., “Food Sickens Millions as Company-Paid Checks Find It Safe,” Bloomberg Business, October 11, 2012 re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:12:50Z   0 0 0900006481d5bf1e
FDA-2011-N-0146-0211 FDA None FDA-2011-N-0146 Reference 16: Zheng, Y., Muth, M.M., Kosa, K., “Economic Analysis of Third-Party Food Safety Certification of Imported Food,” RTI International, June 2012 re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:14:34Z   0 0 0900006481d5bf1f
FDA-2011-N-0146-0207 FDA None FDA-2011-N-0146 Reference 12: International Organization for Standardization/International Electrotechnical Commission, “ISO/IEC 17040:2005 Conformity Assessment--General Requirements for Peer Assessment of Conformity Assessment Bodies and Accreditation Bodies,” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:08:20Z   0 0 0900006481d5bf1b
FDA-2011-N-0146-0213 FDA None FDA-2011-N-0146 Reference 18: United Kingdom Accreditation Service, “About UKAS,” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:17:02Z   0 0 0900006481d5bf21
FDA-2011-N-0146-0214 FDA None FDA-2011-N-0146 Reference 19: Danish Accreditation Fund, “DANAK Home” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:18:08Z   0 0 0900006481d5bf22
FDA-2011-N-0146-0217 FDA None FDA-2011-N-0146 Reference 24: International Organization for Standardization, “ISO/TS 22003:2013 Food Safety Management Systems--Requirements for Bodies Providing Audit and Certification of Food Safety Management Systems,” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:22:32Z   0 0 0900006481d5bf34
FDA-2011-N-0146-0215 FDA None FDA-2011-N-0146 Reference 21: International Organization for Standardization/International Electrotechnical Commission, “ISO 22000:2005 Food Safety Management Systems--Requirements for Any Organization in the Food Chain,” re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:19:38Z   0 0 0900006481d5bf30
FDA-2011-N-0146-0202 FDA None FDA-2011-N-0146 Reference 3: FDA Office of Foods and Veterinary Medicine Memorandum to the Division of Dockets Management on FDA Records of Outreach Sessions,” November 21, 2013 re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:04:43Z   0 0 0900006481d766b0
FDA-2011-N-0146-0201 FDA None FDA-2011-N-0146 Reference 2: Transcript: FSMA Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies, Public Meeting, Day Two, September 20, 2013 re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:04:35Z   0 0 0900006481d766ab
FDA-2011-N-0146-0200 FDA None FDA-2011-N-0146 Reference 1: Transcript: FSMA Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors, Certification Bodies, Public Meeting, Day One, September 19, 2013 re Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-11-27T05:00:00Z 2015 11     2015-11-27T18:04:26Z   0 0 0900006481d769b1
FDA-2011-N-0146-0190 FDA None FDA-2011-N-0146 User Fee Program To Provide for Accreditation of Third-Party Auditors/ Certification Bodies To Conduct Food Safety Audits and To Issue Certifications; Correction Proposed Rule Notice of Proposed Rulemaking (NPRM) 2015-09-17T04:00:00Z 2015 9 2015-09-17T04:00:00Z   2015-09-17T14:18:51Z 2015-23333 0 0 0900006481c7bc0f
FDA-2011-N-0146-0184 FDA None FDA-2011-N-0146 Reference 2 MDUF Small Business Guidance re User Fee Program To Provide for Accreditation of Third-Party Auditors/Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-07-27T04:00:00Z 2015 7     2015-07-27T17:09:04Z   0 0 0900006481ba7aa6
FDA-2011-N-0146-0185 FDA None FDA-2011-N-0146 Reference 3 User Fee Waivers Guidance re User Fee Program To Provide for Accreditation of Third-Party Auditors/Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-07-27T04:00:00Z 2015 7     2015-07-27T17:09:14Z   0 0 0900006481ba7aa7
FDA-2011-N-0146-0182 FDA None FDA-2011-N-0146 List of References re User Fee Program To Provide for Accreditation of Third-Party Auditors/Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-07-27T04:00:00Z 2015 7     2015-07-27T17:08:55Z   0 0 0900006481ba7aa4
FDA-2011-N-0146-0186 FDA None FDA-2011-N-0146 Reference 4 Memorandum: Proposed Rule: User Fees for FDA’s Third Party Accreditation Program for Food and Feed,” March 3, 2015 re User Fee Program To Provide for Accreditation of Third-Party Auditors/Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-07-27T04:00:00Z 2015 7     2015-07-27T17:09:22Z   0 0 0900006481ba7aa8
FDA-2011-N-0146-0183 FDA None FDA-2011-N-0146 Reference 1 FDA, “Preliminary Regulatory Impact Analysis re User Fee Program To Provide for Accreditation of Third-Party Auditors/Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Supporting & Related Material Background Material 2015-07-27T04:00:00Z 2015 7     2015-07-27T17:08:46Z   0 0 0900006481ba7aa5
FDA-2011-N-0146-0179 FDA None FDA-2011-N-0146 Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2015-07-24T04:00:00Z 2015 7 2015-07-24T04:00:00Z 2015-10-08T03:59:59Z 2015-10-09T01:30:41Z 2015-18142 0 0 0900006481b9da54
FDA-2011-N-0146-0180 FDA None FDA-2011-N-0146 Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Draft Guidance for Industry and Food and Drug Administration Staff Other Guidance 2015-07-24T04:00:00Z 2015 7 2015-07-24T04:00:00Z   2024-11-11T21:09:05Z   1 0 0900006481b9dfd9
FDA-2011-N-0146-0181 FDA None FDA-2011-N-0146 User Fee Program To Provide for Accreditation of Third-Party Auditors/Certification Bodies To Conduct Food Safety Audits and To Issue Certifications Proposed Rule Amendment 2015-07-24T04:00:00Z 2015 7 2015-07-24T04:00:00Z 2015-10-08T03:59:59Z 2015-10-21T01:31:23Z 2015-18141 0 0 0900006481b9db5b

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    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
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
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;