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

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25 rows where docket_id = "FDA-2019-P-6100" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-P-6100-0036 FDA None FDA-2019-P-6100 Response Letter from CBER to American Association of Tissue Banks Other Agency Response 2022-08-25T04:00:00Z 2022 8 2022-08-25T04:00:00Z   2022-08-25T19:58:37Z   0 0 09000064852760b2
FDA-2019-P-6100-0034 FDA None FDA-2019-P-6100 Response Letter from CBER to American Association of Tissue Banks Other Letter(s) 2020-06-09T04:00:00Z 2020 6 2020-06-09T04:00:00Z   2020-06-09T16:19:01Z   0 0 09000064846dbb88
FDA-2019-P-6100-0033 FDA None FDA-2019-P-6100 Letter from American Association of Tissue Banks to CBER Other Letter(s) 2020-06-09T04:00:00Z 2020 6 2020-06-09T04:00:00Z   2020-06-09T16:17:21Z   0 0 09000064846dbb87
FDA-2019-P-6100-0031 FDA None FDA-2019-P-6100 Interim Response Letter from FDA CBER to American Association of Tissue Banks (AATB) Other Letter(s) 2020-05-06T04:00:00Z 2020 5 2020-05-06T04:00:00Z   2020-05-06T16:09:26Z   0 0 0900006484568fde
FDA-2019-P-6100-0004 FDA None FDA-2019-P-6100 Attachment C- The Classic Reprint: The Use and Uses of Large Split Skin Grafts of Intermediate Thickness re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:18:17Z   0 0 090000648425e4dd
FDA-2019-P-6100-0005 FDA None FDA-2019-P-6100 Attachment D- 50 Years of Burn Care at Shriners Hospitals for Children, Galveston re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:18:30Z   0 0 090000648425e4de
FDA-2019-P-6100-0002 FDA None FDA-2019-P-6100 Attachment A- The Classic Reprint re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:15:06Z   0 0 090000648425e4db
FDA-2019-P-6100-0009 FDA None FDA-2019-P-6100 Attachment H- Pelvic, Abdominal, and Chest Wall Reconstruction with Allo Derm in Patients at Increased Risk for Mesh-Related Complications re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:19:20Z   0 0 090000648425e54c
FDA-2019-P-6100-0008 FDA None FDA-2019-P-6100 Attachment G- Sterile Decellularized Dermis - Instructions for Use re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:19:07Z   0 0 090000648425e54b
FDA-2019-P-6100-0001 FDA None FDA-2019-P-6100 Citizen Petition from American Association of Tissue Banks Other Citizen Petition 2019-12-31T05:00:00Z 2019 12 2019-12-31T05:00:00Z   2022-08-25T19:59:25Z   0 0 090000648425e332
FDA-2019-P-6100-0015 FDA None FDA-2019-P-6100 Attachment R- The use of a cellular dermal matrix in breast reconstruction evolution of techniques over 2 decades re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:22:44Z   0 0 090000648425e552
FDA-2019-P-6100-0003 FDA None FDA-2019-P-6100 Attachment B- Early Care of Burns re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:15:26Z   0 0 090000648425e4dc
FDA-2019-P-6100-0011 FDA None FDA-2019-P-6100 Attachments J Through N re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:21:10Z   0 0 090000648425e54e
FDA-2019-P-6100-0007 FDA None FDA-2019-P-6100 Attachment F- Decellularization Strategies for Regenerative Medicine: From Processing Techniques to Applications re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:18:55Z   0 0 090000648425e4e0
FDA-2019-P-6100-0010 FDA None FDA-2019-P-6100 Attachment I- Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:20:08Z   0 0 090000648425e54d
FDA-2019-P-6100-0012 FDA None FDA-2019-P-6100 Attachment O- Achilles Tendon Augmented Repair Using Human Acellular Dermal Matrix: A Case Series re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:22:03Z   0 0 090000648425e54f
FDA-2019-P-6100-0018 FDA None FDA-2019-P-6100 Attachment U Part 1- The use of acellular dermal matrix in breast reconstruction: evolution of techniques over 2 decades re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:23:24Z   0 0 090000648425e4f4
FDA-2019-P-6100-0016 FDA None FDA-2019-P-6100 Attachment S- Market Recap: Q418/FY18 Market Recap: US Surgical Matrices re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:23:00Z   0 0 090000648425e553
FDA-2019-P-6100-0020 FDA None FDA-2019-P-6100 Attachment V Shuren Letter re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:23:57Z   0 0 090000648425e4f6
FDA-2019-P-6100-0019 FDA None FDA-2019-P-6100 Attachment U Part 2- Prepectoral Breast Reconstruction with Fenestrated Acellular Dermal Matrix: A Novel Design re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:23:45Z   0 0 090000648425e4f5
FDA-2019-P-6100-0021 FDA None FDA-2019-P-6100 Acknowledgment Letter from FDA DMS to American Association of Tissue Banks Other Acknowledgement Letter/Receipt 2019-12-31T05:00:00Z 2019 12 2019-12-31T05:00:00Z   2020-01-02T14:23:18Z   0 0 090000648425dfef
FDA-2019-P-6100-0017 FDA None FDA-2019-P-6100 Attachment T AATB Letter re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:23:12Z   0 0 090000648425e554
FDA-2019-P-6100-0006 FDA None FDA-2019-P-6100 Attachment E- The US Navy Tissue Bank: 50 years on the cutting edge RE: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:18:42Z   0 0 090000648425e4df
FDA-2019-P-6100-0013 FDA None FDA-2019-P-6100 Attachment P- A Randomized controlled trial comparing a human acellular dermal matrix versus conventional care for the treatment of venous leg ulcers re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:22:17Z   0 0 090000648425e550
FDA-2019-P-6100-0014 FDA None FDA-2019-P-6100 Attachment Q- Clinical Evaluation of Acellular Allograft Dermis for the Treatment of Human Gingival Recession re: Citizen Petition from American Association of Tissue Banks Supporting & Related Material Background Material 2019-12-31T05:00:00Z 2019 12     2020-01-06T20:22:29Z   0 0 090000648425e551

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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;