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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

19 rows where docket_id = "FDA-2022-D-0278" and posted_year = 2023 sorted by posted_date descending

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document_type 4

  • Supporting & Related Material 15
  • Other 2
  • Notice 1
  • Proposed Rule 1

posted_year 1

  • 2023 · 19 ✖

agency_id 1

  • FDA 19
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2022-D-0278-0061 FDA None FDA-2022-D-0278 Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Reopening of the Comment Period Notice Extension of Comment Period 2023-04-06T04:00:00Z 2023 4 2023-04-06T04:00:00Z   2025-02-07T20:57:23Z 2023-07187 0 0 09000064858f23a0
FDA-2022-D-0278-0036 FDA None FDA-2022-D-0278 Request for Extension from NYS Department of Agriculture and Markets Other Request for Extension 2023-03-24T04:00:00Z 2023 3 2023-03-24T04:00:00Z   2023-03-24T18:07:09Z   0 0 0900006485825e39
FDA-2022-D-0278-0011 FDA None FDA-2022-D-0278 Reference 8 - FDA, 2018. Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:21:32Z   0 0 09000064856066bb
FDA-2022-D-0278-0006 FDA None FDA-2022-D-0278 Reference 3 - Kolasinac, S.M., Lekic, S. S., Golijan, J. et al. 2018. Bioaccumulation Process and Health Risk Assessment of Toxic Elements in Tomato Fruit Grown under Zn Nutrition Treatment. Environmental Monitoring and Assessment, 190; 508. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:20:54Z   0 0 09000064856066a5
FDA-2022-D-0278-0002 FDA None FDA-2022-D-0278 Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry; Draft Guidance Other Guidance 2023-01-25T05:00:00Z 2023 1 2023-01-25T05:00:00Z 2023-05-09T03:59:59Z 2025-01-07T20:37:16Z   0 0 09000064856096a9
FDA-2022-D-0278-0001 FDA None FDA-2022-D-0278 Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Proposed Rule Advance Notice of Proposed Rulemaking (ANPRM) 2023-01-25T05:00:00Z 2023 1     2023-04-10T15:08:38Z 2023-01384 0 0 0900006485608b76
FDA-2022-D-0278-0015 FDA None FDA-2022-D-0278 Reference 12 - FDA Survey FY 2013-14. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:22:04Z   0 0 09000064856066b8
FDA-2022-D-0278-0012 FDA None FDA-2022-D-0278 Reference 9 - WHO/FAO Joint Expert Committee on Food Additives, 2011. Evaluation of Certain Contaminants in Food, 73rd Report of the World Health Organization/Food and Agriculture Organization of the United Nations Joint Expert Committee on Food Additives. WHO Technical Report Series 960. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availab Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:21:40Z   0 0 09000064856066bc
FDA-2022-D-0278-0017 FDA None FDA-2022-D-0278 Reference 14 - Pourrut, B., M. Shahid, C. Dumat, P. Winterton, E. Pinelli, 2011. Lead uptake, toxicity, and detoxification in plants. Reviews of Environmental Contamination and Toxicology, 213:113-136. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:22:19Z   0 0 09000064856066c1
FDA-2022-D-0278-0010 FDA None FDA-2022-D-0278 Reference 7 - Codex Alimentarius, 2021. Revision of the Code of Practice for the Prevention and Reduction of Lead Contamination in Foods. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:21:25Z   0 0 09000064856066ba
FDA-2022-D-0278-0003 FDA None FDA-2022-D-0278 List of references RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:20:29Z   0 0 0900006485606687
FDA-2022-D-0278-0009 FDA None FDA-2022-D-0278 Reference 6 - Entwistle, J. A., Amaibi, P. M., Dean, J. R., et al., 2019. An Apple a Day? Assessing Gardeners' Lead Exposure in Urban Agriculture Sites to Improve the Derivation of Soil Assessment Criteria. Environmental International, 122; 130-141. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:21:17Z   0 0 09000064856066ad
FDA-2022-D-0278-0008 FDA None FDA-2022-D-0278 Reference 5 - Huang, F., Zhou H., Gu, J., et al. 2020. Differences in Absorption of Cadmium and Lead Among Fourteen Sweet Potato Cultivars and Health Risk Assessment. Ecotoxicology and Environmental Safety, 203; 111012. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:21:09Z   0 0 09000064856066b0
FDA-2022-D-0278-0005 FDA None FDA-2022-D-0278 Reference 2 - Flannery, B.M., K. B. Middleton., 2022. Updated Interim Reference Levels for Dietary Lead to Support FDA’s Closer to Zero Action Plan. Reg. Toxicol. Pharmacol., 133. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:20:46Z   0 0 090000648560668d
FDA-2022-D-0278-0016 FDA None FDA-2022-D-0278 Reference 13 - FDA Survey FY 2021. Analytical Results for Lead in Food Intended for Babies and Young Children, FY2021. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:22:11Z   0 0 09000064856066c0
FDA-2022-D-0278-0004 FDA None FDA-2022-D-0278 Reference 1 - HHS, National Toxicology Program, 2012. NTP Monograph on Health Effects of Low-Level Lead. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:20:37Z   0 0 090000648560668a
FDA-2022-D-0278-0013 FDA None FDA-2022-D-0278 Reference 10 - FDA, 2021. Closer to Zero: Action Plan for Baby Foods. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:21:48Z   0 0 09000064856066b7
FDA-2022-D-0278-0007 FDA None FDA-2022-D-0278 Reference 4 - Office of Solid Waste and Emergency Response, U.S. Environmental Protection Agency, 2014. Technical Review Workgroup Recommendations Regarding Gardening and Reducing Exposure to Lead-Contaminated Soils. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:21:01Z   0 0 0900006485606697
FDA-2022-D-0278-0014 FDA None FDA-2022-D-0278 Reference 11 - FDA, 2022. Analytical Results for Lead in Food Intended for Babies and Young Children Sampled under the FDA’s Toxic Elements in Food and Foodware and Radionuclides in Food – Import and Domestic Compliance Program, FY 2008 to FY 2021. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability Supporting & Related Material Background Material 2023-01-25T05:00:00Z 2023 1     2023-01-25T20:21:56Z   0 0 09000064856066bf

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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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