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

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43 rows where docket_id = "FDA-2015-F-0537" sorted by posted_date descending

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posted_year 4

  • 2015 20
  • 2017 17
  • 2016 3
  • 2019 3

document_type 3

  • Supporting & Related Material 26
  • Other 14
  • Proposed Rule 3

agency_id 1

  • FDA 43
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-F-0537-0055 FDA None FDA-2015-F-0537 Memorandum from Roseann M. Costantino, Ph.D .to Hui C. Chang, Ph.D. Other Memorandum 2019-04-25T04:00:00Z 2019 4 2019-04-25T04:00:00Z   2019-04-25T11:38:30Z   0 0 0900006483bf31c5
FDA-2015-F-0537-0054 FDA None FDA-2015-F-0537 Letter from FDA CFSAN to Environmental Defense Fund Other Letter(s) 2019-04-25T04:00:00Z 2019 4 2019-04-25T04:00:00Z   2019-04-25T11:30:32Z   0 0 0900006483bf0e19
FDA-2015-F-0537-0053 FDA None FDA-2015-F-0537 Natural Resources Defense Council et al.: Response to the Objections and Denial of the Requests for a Public Hearing Proposed Rule Denial 2019-04-24T04:00:00Z 2019 4 2019-04-24T04:00:00Z   2019-04-24T15:54:26Z 2019-08262 0 0 0900006483be9aef
FDA-2015-F-0537-0030 FDA None FDA-2015-F-0537 Reference 3 - SAB Advice on Approaches to Derive a Maximum Contaminant Level Goal for Perchlorate re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:20:42Z   0 0 0900006482592f7d
FDA-2015-F-0537-0036 FDA None FDA-2015-F-0537 Reference 9 - Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:22:10Z   0 0 090000648259363a
FDA-2015-F-0537-0031 FDA None FDA-2015-F-0537 Reference 4 - Health Effects Assessment for Environmental Perchlorate Contamination: The Dose Response for Inhibition of Thyroidal Radioiodine Uptake in Humans re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:20:58Z   0 0 0900006482592f7e
FDA-2015-F-0537-0034 FDA None FDA-2015-F-0537 Reference 7 - WHITE PAPERLIFE STAGE CONSIDERATIONS AND INTERPRETATION OF RECENT EPIDEMIOLOGICAL EVIDENCE TO DEVELOP A MAXIMUM CONTAMINANT LEVEL GOAL FOR PERCHLORATE re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:21:38Z   0 0 0900006482593635
FDA-2015-F-0537-0035 FDA None FDA-2015-F-0537 Reference 8 - hypothesis re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:21:54Z   0 0 0900006482593636
FDA-2015-F-0537-0033 FDA None FDA-2015-F-0537 Reference 6 - Perchlorate (ClO4-) and Perchlorate Salts re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:21:23Z   0 0 0900006482592f80
FDA-2015-F-0537-0043 FDA None FDA-2015-F-0537 Reference 16 - Food Chemical News Week in Review re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:19:17Z   0 0 0900006482593655
FDA-2015-F-0537-0038 FDA None FDA-2015-F-0537 Reference 11 - Memorandum FAP 4B4808 (formerly PNC 1447) – Submission dated 7-31-14 (received 8-4-14), 10-15-14 (received 10-17-14) and 12-5-14 (received 12-8-14) Chemistry evaluation re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:22:44Z   0 0 090000648259363c
FDA-2015-F-0537-0040 FDA None FDA-2015-F-0537 Reference 13 - Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:15:13Z   0 0 090000648259363e
FDA-2015-F-0537-0032 FDA None FDA-2015-F-0537 Reference 5 - Hypothyroidism (Underactive Thyroid) re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T11:59:37Z   0 0 0900006482592f7f
FDA-2015-F-0537-0029 FDA None FDA-2015-F-0537 Reference 2 - Health Implications of Perchlorate Ingestion re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:20:24Z   0 0 0900006482592f7c
FDA-2015-F-0537-0042 FDA None FDA-2015-F-0537 Reference 15 - Memorandum - FAP 4B4808: Toxicology Analysis re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:18:03Z   0 0 0900006482593654
FDA-2015-F-0537-0037 FDA None FDA-2015-F-0537 Reference 10 - MEMORANDUM OF CONFERENCE THRESHOLD OF REGULATION COMMITTEE re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:22:26Z   0 0 090000648259363b
FDA-2015-F-0537-0028 FDA None FDA-2015-F-0537 Reference 1 - Threshold of Regulation Exemptions re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:20:06Z   0 0 0900006482592f7b
FDA-2015-F-0537-0041 FDA None FDA-2015-F-0537 Reference 14 - Evaluation of Perturbations in Serum Thyroid Hormones During Human Pregnancy Due to Dietary Iodide and Perchlorate Exposure Using a Biologically Based Dose-Response Model re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:16:43Z   0 0 0900006482593653
FDA-2015-F-0537-0039 FDA None FDA-2015-F-0537 Reference 12 - Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula 1 and/or Human Milk: Guidance for Industry re Natural Resources Defense Council et al.; Filing of Food Additive Petition Supporting & Related Material Background Material 2017-05-05T04:00:00Z 2017 5     2017-05-05T12:23:00Z   0 0 090000648259363d
FDA-2015-F-0537-0027 FDA None FDA-2015-F-0537 Natural Resources Defense Council et al.; Denial of Food Additive Petition Proposed Rule Denial 2017-05-04T04:00:00Z 2017 5 2017-05-04T04:00:00Z 2017-06-06T03:59:59Z 2017-06-06T13:02:09Z 2017-08987 0 0 09000064825909f4
FDA-2015-F-0537-0026 FDA None FDA-2015-F-0537 Letter from American Pacific to FDA CFSAN Other Letter(s) 2016-05-26T04:00:00Z 2016 5 2016-05-26T04:00:00Z   2016-05-26T18:55:17Z   0 0 0900006481ff5a98
FDA-2015-F-0537-0025 FDA None FDA-2015-F-0537 Memorandum of January 15, 2016 Teleconference between FDA CFSAN and Natural Resource Defense Council, et al. Other   2016-01-26T00:00:00Z 2016 1     2017-06-05T13:56:02Z   0 1 0900006481e2fa36
FDA-2015-F-0537-0024 FDA None FDA-2015-F-0537 Memorandum of August 7, 2015 Teleconference between FDA CFSAN and Natural Resource Defense Council, et al. Other   2016-01-26T00:00:00Z 2016 1     2017-06-05T13:55:54Z   0 1 0900006481e2fa35
FDA-2015-F-0537-0023 FDA None FDA-2015-F-0537 BASF Corp Appendix-D Spiking Validation at Low Perchlorate (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T15:28:46Z   0 0 0900006481ddf21b
FDA-2015-F-0537-0020 FDA None FDA-2015-F-0537 BASF Corp Appendix A Analysis Method (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T15:21:02Z   0 0 0900006481ddeef1
FDA-2015-F-0537-0019 FDA None FDA-2015-F-0537 BASF Corp Migration Report (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T15:18:34Z   0 0 0900006481ddeef0
FDA-2015-F-0537-0022 FDA None FDA-2015-F-0537 BASF Corp Appendix C Chromatograms (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T15:25:13Z   0 0 0900006481ddf21a
FDA-2015-F-0537-0021 FDA None FDA-2015-F-0537 BASF Corp Appendix B Detailed Sample Analysis Data (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T15:23:22Z   0 0 0900006481ddf219
FDA-2015-F-0537-0018 FDA None FDA-2015-F-0537 Supplemental Comments from BASF Corporation (Keller and Heckman LLP) Other Supplemental Comment 2015-11-16T05:00:00Z 2015 11 2015-11-16T05:00:00Z   2015-11-16T21:00:30Z   0 0 0900006481d4ae00
FDA-2015-F-0537-0017 FDA None FDA-2015-F-0537 Letter from American Pacific Corporation (AMPAC) to FDA CDER Other Letter(s) 2015-10-06T04:00:00Z 2015 10 2015-10-06T04:00:00Z   2015-10-06T15:43:46Z   0 0 0900006481cb1a80
FDA-2015-F-0537-0011 FDA None FDA-2015-F-0537 Attachment 1 Perchlorate Food Additive Petition from Natural Resources Defense Council et al re: Comment from Tom Neltner Supporting & Related Material Background Material 2015-09-02T04:00:00Z 2015 9     2015-09-02T14:03:27Z   0 0 0900006481c4f95d
FDA-2015-F-0537-0012 FDA None FDA-2015-F-0537 Attachment 2 Citzen Petition Denial Response from FDA CFSAN to Natural Resources Defense Council re: Comment from Tom Neltner Supporting & Related Material Background Material 2015-09-02T04:00:00Z 2015 9     2015-09-02T14:05:01Z   0 0 0900006481c4f95e
FDA-2015-F-0537-0015 FDA None FDA-2015-F-0537 Attachment 5 Letter from FDA CFSAN to Natural Resources Defense Council 90 Day Extension of Scientific Review re: Comment from Tom Neltner Supporting & Related Material Background Material 2015-09-02T04:00:00Z 2015 9     2015-09-02T14:06:54Z   0 0 0900006481c4f961
FDA-2015-F-0537-0014 FDA None FDA-2015-F-0537 Attachment 4 Letter from FDA CFSAN to Natural Resources Defense Council re: Comment from Tom Neltner Supporting & Related Material Background Material 2015-09-02T04:00:00Z 2015 9     2015-09-02T14:06:15Z   0 0 0900006481c4f960
FDA-2015-F-0537-0013 FDA None FDA-2015-F-0537 Attachment 3 Supplement from Natural Resources Defense Council re: Comment from Tom Neltner Supporting & Related Material Background Material 2015-09-02T04:00:00Z 2015 9     2015-09-02T14:05:35Z   0 0 0900006481c4f95f
FDA-2015-F-0537-0010 FDA None FDA-2015-F-0537 Memorandum of Meeting Between FDA CFSAN, BASF Corporation and Society of the Plastics Industries Other Memorandum 2015-07-13T04:00:00Z 2015 7 2015-07-13T04:00:00Z   2015-07-13T19:37:30Z   0 0 0900006481b8197b
FDA-2015-F-0537-0004 FDA None FDA-2015-F-0537 Food Additive Petition from Natural Resources Defense Council, et al Other Petition(s) 2015-05-06T04:00:00Z 2015 5 2015-05-06T04:00:00Z   2015-05-06T14:47:46Z   0 0 0900006481ad0437
FDA-2015-F-0537-0005 FDA None FDA-2015-F-0537 Letter from FDA CFSAN to Natural Resources Defense Council Other Letter(s) 2015-05-06T04:00:00Z 2015 5 2015-05-06T04:00:00Z   2015-05-06T14:47:54Z   0 0 0900006481ad0597
FDA-2015-F-0537-0007 FDA None FDA-2015-F-0537 Letter from FDA CFSAN to Natural Resources Defense Council Other Letter(s) 2015-05-06T04:00:00Z 2015 5 2015-05-06T04:00:00Z   2015-05-06T14:48:10Z   0 0 0900006481ad0599
FDA-2015-F-0537-0002 FDA None FDA-2015-F-0537 Food Additive Petition from Natural Resources Defense Council Other Petition(s) 2015-05-06T04:00:00Z 2015 5 2015-05-06T04:00:00Z   2015-05-06T14:47:29Z   0 0 0900006481ad0435
FDA-2015-F-0537-0006 FDA None FDA-2015-F-0537 Supplement from Natural Resources Defense Council Other Supplement (SUP) 2015-05-06T04:00:00Z 2015 5 2015-05-06T04:00:00Z   2015-05-06T14:48:02Z   0 0 0900006481ad0598
FDA-2015-F-0537-0003 FDA None FDA-2015-F-0537 Letter from FDA CFSAN to Natural Resources Defense Council Other Letter(s) 2015-05-06T04:00:00Z 2015 5 2015-05-06T04:00:00Z   2015-05-06T14:47:38Z   0 0 0900006481ad0436
FDA-2015-F-0537-0001 FDA None FDA-2015-F-0537 Natural Resources Defense Council et al.; Filing of Food Additive Petition Proposed Rule Notice of Proposed Rulemaking (NPRM) 2015-03-16T04:00:00Z 2015 3 2015-03-16T04:00:00Z 2015-05-16T03:59:59Z 2015-09-03T01:30:16Z 2015-05937 0 0 0900006481a461c4

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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;
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