dockets: FDA-2020-P-2236

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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-2020-P-2236 FDA Requests that the FDA take the actions set forth with respect to the grant of case-by-case waivers of the prohibition on importation set forth in section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act. Nonrulemaking 2022-12-30T13:28:26Z 0b0000648497902f   CLOSED     ["CDER", "Covington & Burling LLP", "Pharmaceutical Research and Manufacturers", "of America", "requests that FDA", "Discontinue section 804(j) implementation", "efforts", "including withdraw HHS and FDA's", "Request for Proposals Regarding Waivers", "for Individual Drug Importation Plans", "and refrain from approving any", "Individual Waiver Importation Plans", "Refrain from granting waivers to", "authorize personal importation pursuant", "to section", "804(j)(2) unless and until FDA", "Certifies to Congress, after an appropriate", "notice-and-comment proceeding that", "the implementation of section 804", "of the FDCA", "poses no additional risk to", "the public\u2019s health and safety and", "results in a significant", "reduction in the cost of covered products", "to the American consumer", "Publishes a final guidance document", "in accordance with FDA\u2019s Good", "Guidance Practices that describes", "the circumstances under which the", "Secretary will grant", "case-by-case waivers prior to", "issuing any waiver pursuant to", "compliance with statutory requirements", "appropriate due process procedures for", "informal adjudications under", "Administrative Procedure Act", "Publishes notice of any approvals", "of any individual drug importation", "plans or grants of", "case-by-case waivers immediately", "upon issuance"] CDER       {"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"}], "keywords": ["CDER", "Covington & Burling LLP", "Pharmaceutical Research and Manufacturers", "of America", "requests that FDA", "Discontinue section 804(j) implementation", "efforts", "including withdraw HHS and FDA's", "Request for Proposals Regarding Waivers", "for Individual Drug Importation Plans", "and refrain from approving any", "Individual Waiver Importation Plans", "Refrain from granting waivers to", "authorize personal importation pursuant", "to section", "804(j)(2) unless and until FDA", "Certifies to Congress, after an appropriate", "notice-and-comment proceeding that", "the implementation of section 804", "of the FDCA", "poses no additional risk to", "the public\u2019s health and safety and", "results in a significant", "reduction in the cost of covered products", "to the American consumer", "Publishes a final guidance document", "in accordance with FDA\u2019s Good", "Guidance Practices that describes", "the circumstances under which the", "Secretary will grant", "case-by-case waivers prior to", "issuing any waiver pursuant to", "compliance with statutory requirements", "appropriate due process procedures for", "informal adjudications under", "Administrative Procedure Act", "Publishes notice of any approvals", "of any individual drug importation", "plans or grants of", "case-by-case waivers immediately", "upon issuance"], "modifyDate": "2022-12-30T13:28:26Z", "dkAbstract": "CLOSED", "agencyId": "FDA", "program": "CDER", "shortTitle": null, "subType2": null, "title": "Requests that the FDA take the actions set forth with respect to the grant of case-by-case waivers of the prohibition on importation set forth in section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act.", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "CLOSED", "effectiveDate": null, "objectId": "0b0000648497902f"} single_get

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