dockets: FDA-2019-P-6100

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id agency_id title docket_type last_modified object_id rin dkabstract category subtype keywords program short_title effective_date organization attrs_raw attr_source
FDA-2019-P-6100 FDA Requests that the Commissioner of Food and Drugs take actions with respect to human ADM allografts used for post-mastectomy breast reconstruction surgery: Human ADM allografts that meet requirements under Section 361 PHSA not be considered non-homologous or ineligible 361 HCT/Ps and Revise the Final Guidance Regulatory Considerations for Human Cells, Tissues and Cellular and Tissue-Based Products Nonrulemaking 2022-08-25T15:59:39Z 0b0000648425e24a   CLOSED     ["Citizen Petition", "American Association of Tissue Banks", "CBER", "human ADM allografts", "Section 361", "non-homologous", "361 HCT/Ps", "post-mastectomy breastreconstruction", "Regulatory Considerations for Human Cells", "Tissues, and Cellular and Tissue-Based Products", "Minimal Manipulationand Homologous Use", "2017"] CBER Requests that the FDA take the two actions 1) Confirm that human ADM allografts that otherwise meet the requirement for regulation solely under Section 361 PHSA shall not be considered     {"displayProperties": [{"name": "abstract", "label": "General Information", "tooltip": "Describes an agency's specific regulatory action; equivalents: Abstract, Description, Docket Subject, Related To, Summary."}, {"name": "generic", "label": "Docket Item Code", "tooltip": "An agency specific code that identifies the type of document that established the docket (regulatory action)."}, {"name": "program", "label": "Center", "tooltip": "The agency specific program associated with the docket (regulatory action); equivalents: Docket Item Code, Location."}, {"name": "field2", "label": "Docket Status", "tooltip": "Used to Identity that a Docket's Status is Open or Closed"}, {"name": "shortTitle", "label": "Short Title", "tooltip": "A combination of letters and or numbers assigned to an agency's regulatory action for purposes of brevity."}], "keywords": ["Citizen Petition", "American Association of Tissue Banks", "CBER", "human ADM allografts", "Section 361", "non-homologous", "361 HCT/Ps", "post-mastectomy breastreconstruction", "Regulatory Considerations for Human Cells", "Tissues, and Cellular and Tissue-Based Products", "Minimal Manipulationand Homologous Use", "2017"], "modifyDate": "2022-08-25T15:59:39Z", "dkAbstract": "CLOSED", "agencyId": "FDA", "program": "CBER", "shortTitle": "Requests that the FDA take the two actions 1) Confirm that human ADM allografts that otherwise meet the requirement for regulation solely under Section 361 PHSA shall not be considered", "subType2": null, "title": "Requests that the Commissioner of Food and Drugs take actions with respect to human ADM allografts used for post-mastectomy breast reconstruction surgery: Human ADM allografts that meet requirements under Section 361 PHSA not be considered non-homologous or ineligible 361 HCT/Ps and Revise the Final Guidance Regulatory Considerations for Human Cells, Tissues and Cellular and Tissue-Based Products", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "Open", "effectiveDate": null, "objectId": "0b0000648425e24a"} single_get

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