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

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34 rows where docket_id = "FDA-2016-D-1814" and posted_year = 2016 sorted by posted_date descending

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document_type 3

posted_year 1

  • 2016 · 34 ✖

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-D-1814-0029 FDA None FDA-2016-D-1814 Reference 26 - Guidlelines for Carcinogen Risk Assessment re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-12T05:00:00Z 2016 12     2016-12-12T13:17:42Z   0 0 09000064823f82c6
FDA-2016-D-1814-0027 FDA None FDA-2016-D-1814 Reference 24 - A Review of the Reference Dose and Reference Concentration Processes re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-12T05:00:00Z 2016 12     2016-12-12T13:08:57Z   0 0 09000064823f82c4
FDA-2016-D-1814-0030 FDA None FDA-2016-D-1814 Reference 27 - Supplemental Guidance for Assessing Susceptibility from Early-life Exposure to Carcinogens re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-12T05:00:00Z 2016 12     2016-12-12T13:21:20Z   0 0 09000064823f9b7a
FDA-2016-D-1814-0025 FDA None FDA-2016-D-1814 Reference 22 - Differential Sensitivity of Children and Adults to Chemical Toxicity re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-12T05:00:00Z 2016 12     2016-12-12T12:58:09Z   0 0 09000064823f82c2
FDA-2016-D-1814-0026 FDA None FDA-2016-D-1814 Reference 23 - Children as sensitive subgroup & their role in reg. toxicology re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-12T05:00:00Z 2016 12     2016-12-12T13:00:45Z   0 0 09000064823f82c3
FDA-2016-D-1814-0034 FDA None FDA-2016-D-1814 Reference 31 - Species comparison of postnatal bone growth and development re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-12T05:00:00Z 2016 12     2016-12-12T13:36:01Z   0 0 09000064823f9b7e
FDA-2016-D-1814-0028 FDA None FDA-2016-D-1814 Reference 25 - Determination of the Appropriate FQPA Safety Factor(s) in Tolerance Assessment re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-12T05:00:00Z 2016 12     2016-12-12T13:14:47Z   0 0 09000064823f82c5
FDA-2016-D-1814-0031 FDA None FDA-2016-D-1814 Reference 28 - Exposure Factors Handbook 2011 Edition re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-12T05:00:00Z 2016 12     2016-12-12T13:27:51Z   0 0 09000064823f9b7b
FDA-2016-D-1814-0033 FDA None FDA-2016-D-1814 Reference 30 - Species comparison of anatomical and functional renal development re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-12T05:00:00Z 2016 12     2016-12-12T13:33:05Z   0 0 09000064823f9b7d
FDA-2016-D-1814-0032 FDA None FDA-2016-D-1814 Reference 29 - Postnatal growth and morphological development of the brain - a species comparison re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-12T05:00:00Z 2016 12     2016-12-12T13:30:53Z   0 0 09000064823f9b7c
FDA-2016-D-1814-0014 FDA None FDA-2016-D-1814 Reference 11 - Incorporating pharmacokinetic differences between children and adults in assessing children’s risks to environmental toxicants re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T19:11:05Z   0 0 09000064823f6e11
FDA-2016-D-1814-0015 FDA None FDA-2016-D-1814 Reference 13 - Developmental neurotoxicity of industrial chemicals re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T19:24:52Z   0 0 09000064823f6e13
FDA-2016-D-1814-0008 FDA None FDA-2016-D-1814 Reference 5 - Estimation of Toxic Hazard – A Decision Tree Approach re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T17:32:04Z   0 0 09000064823f6198
FDA-2016-D-1814-0023 FDA None FDA-2016-D-1814 Reference 20 - Direct Dosing of Preweaning Rodents in Toxicity Testing and Research - Deliberations of an ILSI RSI Expert Working Group re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T19:46:18Z   0 0 09000064823f6f32
FDA-2016-D-1814-0012 FDA None FDA-2016-D-1814 Reference 9 - Assessment of health risks resulting from early-life exposures - Are current chemical toxicity testing protocols and risk assessment methods adequate re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T17:47:01Z   0 0 09000064823f619c
FDA-2016-D-1814-0021 FDA None FDA-2016-D-1814 Reference 18 - Early life environment and developmental immunotoxicity in inflammatory dysfunction and disease re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T19:41:40Z   0 0 09000064823f6f30
FDA-2016-D-1814-0002 FDA None FDA-2016-D-1814 Draft Guidance - Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and-or Human Milk Other Guidance 2016-12-09T05:00:00Z 2016 12 2016-12-09T05:00:00Z   2024-11-12T06:17:07Z   1 0 09000064823f5852
FDA-2016-D-1814-0001 FDA None FDA-2016-D-1814 Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Notice Notice of Availability 2016-12-09T05:00:00Z 2016 12 2016-12-09T05:00:00Z 2017-02-08T04:59:59Z 2017-02-08T02:04:29Z 2016-29587 0 0 09000064823f44a8
FDA-2016-D-1814-0019 FDA None FDA-2016-D-1814 Reference 16 - Children's vulnerability to toxic chemicals - a challenge and opportunity to strengthen health and environmental policy re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T19:36:02Z   0 0 09000064823f6f2e
FDA-2016-D-1814-0018 FDA None FDA-2016-D-1814 Reference 12 -Evaluation of child-adult pharmacokinetic differ. from a database derived from the therapeutic drug literature re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T19:31:42Z   0 0 09000064823f6e12
FDA-2016-D-1814-0010 FDA None FDA-2016-D-1814 Reference 7 - Current status of developmental immunotoxicity - early-life patterns and testing re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T17:37:20Z   0 0 09000064823f619a
FDA-2016-D-1814-0003 FDA None FDA-2016-D-1814 List of References re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T17:02:00Z   0 0 09000064823f6542
FDA-2016-D-1814-0020 FDA None FDA-2016-D-1814 Reference 17 -Different dietary patterns in relation to age and the consequences for intake of food chemicals re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T19:39:08Z   0 0 09000064823f6f2f
FDA-2016-D-1814-0016 FDA None FDA-2016-D-1814 Reference 14 - Detection Of Toxicity To Reproduction For Medicinal Products & Toxicity To Male Fertility S5(R2) re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T19:28:04Z   0 0 09000064823f6e14
FDA-2016-D-1814-0009 FDA None FDA-2016-D-1814 Reference 6 - Toxicity Evaluation of Bisphenol A Administered by Gavage to Sprague Dawley Rats From Gestation Day 6 Through Postnatal Day 90 re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T17:34:30Z   0 0 09000064823f6199
FDA-2016-D-1814-0011 FDA None FDA-2016-D-1814 Reference 8 - SCIENTIFIC REPORT submitted to EFSA re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T17:40:30Z   0 0 09000064823f619b
FDA-2016-D-1814-0004 FDA None FDA-2016-D-1814 Reference 1 - Pharmacokinetics in the newborn re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T17:15:59Z   0 0 09000064823f6543
FDA-2016-D-1814-0005 FDA None FDA-2016-D-1814 Reference 2 - Differences in sensitivity of children and adults to chemical toxicity - the NAS panel report re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T17:16:23Z   0 0 09000064823f6544
FDA-2016-D-1814-0006 FDA None FDA-2016-D-1814 Reference 3 - Juvenile Animal Toxicity Study Designs to Support Pediatric Drug Development re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T17:21:34Z   0 0 09000064823f6545
FDA-2016-D-1814-0022 FDA None FDA-2016-D-1814 Reference 19 - A lifestage-specific approach to hazard and dose-response characterization for children's health risk assessment re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T19:44:00Z   0 0 09000064823f6f31
FDA-2016-D-1814-0024 FDA None FDA-2016-D-1814 Reference 21 - Infant Toxicology - State of the science and considerations in eval. of safety re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T19:53:08Z   0 0 09000064823f6cf7
FDA-2016-D-1814-0007 FDA None FDA-2016-D-1814 Reference 4 - Comparison of Life-Stage-Dependent Internal Dosimetry for Bisphenol A, Ethinyl Estradiol, a Reference Estrogen, and Endogenous Estradiol to Test an Estrogenic Mode of Action in Sprague Dawley Rats re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T17:26:39Z   0 0 09000064823f6197
FDA-2016-D-1814-0017 FDA None FDA-2016-D-1814 Reference 15 - National Vital Statistics Reports; Deaths - Preliminary Data for 2009 re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T19:31:16Z   0 0 09000064823f6e15
FDA-2016-D-1814-0013 FDA None FDA-2016-D-1814 Reference 10 - Pediatric pharmacokinetic data - implications for environmental risk assessment for children re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2016-12-09T05:00:00Z 2016 12     2016-12-09T17:51:15Z   0 0 09000064823f619d

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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;