{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where docket_id = \"FDA-1999-D-0081\" and posted_year = 2020 sorted by posted_date descending", "rows": [["FDA-1999-D-0081-0083", "FDA", "FDA-1999-D-0081", "Reference 30 Martineau et al 1997 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:44:44Z", null, 0, 0, "090000648430e1e5"], ["FDA-1999-D-0081-0060", "FDA", "FDA-1999-D-0081", "Reference 7 Vanin et al 1994 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:49:05Z", null, 0, 0, "090000648430e1be"], ["FDA-1999-D-0081-0053", "FDA", "FDA-1999-D-0081", "Reference List Testing of Retrovial Vector re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:50:25Z", null, 0, 0, "090000648430e0c9"], ["FDA-1999-D-0081-0054", "FDA", "FDA-1999-D-0081", "Reference 1 Donahue et al 1992 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:50:14Z", null, 0, 0, "090000648430e0ca"], ["FDA-1999-D-0081-0080", "FDA", "FDA-1999-D-0081", "Reference 27 Mohanal et al 2016 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:45:24Z", null, 0, 0, "090000648430e1e2"], ["FDA-1999-D-0081-0072", "FDA", "FDA-1999-D-0081", "Reference 19 Farley et al 2015 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:46:50Z", null, 0, 0, "090000648430e50e"], ["FDA-1999-D-0081-0052", "FDA", "FDA-1999-D-0081", "Testing of Retroviral Vector-Based Human Gene Therapy Products for\nReplication Competent Retrovirus During Product Manufacture and\nPatient Follow-up; Guidance for Industry", "Other", "Guidance", "2020-01-30T05:00:00Z", 2020, 1, "2020-01-30T05:00:00Z", null, "2024-11-12T23:16:47Z", null, 1, 0, "090000648430ded7"], ["FDA-1999-D-0081-0081", "FDA", "FDA-1999-D-0081", "Reference 28 Scholler et al 2012 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:45:11Z", null, 0, 0, "090000648430e1e3"], ["FDA-1999-D-0081-0074", "FDA", "FDA-1999-D-0081", "Reference 21 Rowe et al 1970 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:46:28Z", null, 0, 0, "090000648430e510"], ["FDA-1999-D-0081-0073", "FDA", "FDA-1999-D-0081", "Reference 20 Bassin et al 1971 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:46:40Z", null, 0, 0, "090000648430e50f"], ["FDA-1999-D-0081-0077", "FDA", "FDA-1999-D-0081", "Reference 24  Gene Therapy Clinical Trials \u2013 Observing Subjects for Delayed Adverse Events November 2006 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:45:57Z", null, 0, 0, "090000648430e52a"], ["FDA-1999-D-0081-0058", "FDA", "FDA-1999-D-0081", "Reference 5 Gunter et al 1993 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:49:23Z", null, 0, 0, "090000648430e1bc"], ["FDA-1999-D-0081-0065", "FDA", "FDA-1999-D-0081", "Reference 12 Wilson et al 1997 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:48:18Z", null, 0, 0, "090000648430e1c3"], ["FDA-1999-D-0081-0057", "FDA", "FDA-1999-D-0081", "Reference 4 Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:49:45Z", null, 0, 0, "090000648430e1bb"], ["FDA-1999-D-0081-0079", "FDA", "FDA-1999-D-0081", "Reference 26 McGarrityet al 2013 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:45:35Z", null, 0, 0, "090000648430e572"], ["FDA-1999-D-0081-0066", "FDA", "FDA-1999-D-0081", "Reference 13 Sakuma et al 2012 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:48:08Z", null, 0, 0, "090000648430e508"], ["FDA-1999-D-0081-0070", "FDA", "FDA-1999-D-0081", "Reference 17 Lander et al 1984 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:47:08Z", null, 0, 0, "090000648430e50c"], ["FDA-1999-D-0081-0056", "FDA", "FDA-1999-D-0081", "Reference 3 Kahn et al 2018 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:49:53Z", null, 0, 0, "090000648430e1ba"], ["FDA-1999-D-0081-0082", "FDA", "FDA-1999-D-0081", "Reference 29 Long et al 1998 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:44:59Z", null, 0, 0, "090000648430e1e4"], ["FDA-1999-D-0081-0061", "FDA", "FDA-1999-D-0081", "Reference 8 Cornetta et al 1991 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:48:56Z", null, 0, 0, "090000648430e1bf"], ["FDA-1999-D-0081-0075", "FDA", "FDA-1999-D-0081", "Reference 22 Sastry et al 2005 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:46:18Z", null, 0, 0, "090000648430e511"], ["FDA-1999-D-0081-0051", "FDA", "FDA-1999-D-0081", "Testing of Retroviral Vector-Based Human Gene Therapy Products for\nReplication Competent Retrovirus During Product Manufacture and\nPatient Follow-up; Guidance for Industry; Availability", "Notice", "Notice of Availability", "2020-01-30T05:00:00Z", 2020, 1, "2020-01-30T05:00:00Z", null, "2020-01-30T15:00:54Z", "2020-01700", 0, 0, "090000648430aa3d"], ["FDA-1999-D-0081-0068", "FDA", "FDA-1999-D-0081", "Reference 15 Fuller et al 2001 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:47:26Z", null, 0, 0, "090000648430e50a"], ["FDA-1999-D-0081-0062", "FDA", "FDA-1999-D-0081", "Reference 9 Kantoff et al 1986 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:48:48Z", null, 0, 0, "090000648430e1c0"], ["FDA-1999-D-0081-0076", "FDA", "FDA-1999-D-0081", "Reference 23 Sastry et al 2003 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:46:06Z", null, 0, 0, "090000648430e529"], ["FDA-1999-D-0081-0055", "FDA", "FDA-1999-D-0081", "Reference 2 Fields Chapter 47 Retroviridae re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:50:01Z", null, 0, 0, "090000648430e0cb"], ["FDA-1999-D-0081-0071", "FDA", "FDA-1999-D-0081", "Reference 18 Escarpe et al 2003 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:46:59Z", null, 0, 0, "090000648430e50d"], ["FDA-1999-D-0081-0064", "FDA", "FDA-1999-D-0081", "Reference 11 Riviere 2014 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:48:28Z", null, 0, 0, "090000648430e1c2"], ["FDA-1999-D-0081-0063", "FDA", "FDA-1999-D-0081", "Reference 10 Briefing Document - Testing for Replication Competent Retrovirus RCR-Lentivirus RCL in Retroviral and Lentiviral Vector Based Gene Therapy Products re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:48:39Z", null, 0, 0, "090000648430e1c1"], ["FDA-1999-D-0081-0069", "FDA", "FDA-1999-D-0081", "Reference 16 Wagner et al 2000 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:47:18Z", null, 0, 0, "090000648430e50b"], ["FDA-1999-D-0081-0078", "FDA", "FDA-1999-D-0081", "Reference 25 Abina et al 2015 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:45:46Z", null, 0, 0, "090000648430e52b"], ["FDA-1999-D-0081-0059", "FDA", "FDA-1999-D-0081", "Reference 6 Purcell et al 1996 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:49:15Z", null, 0, 0, "090000648430e1bd"], ["FDA-1999-D-0081-0067", "FDA", "FDA-1999-D-0081", "Reference 14 Vannuci et al 2013 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:47:36Z", null, 0, 0, "090000648430e509"], ["FDA-1999-D-0081-0084", "FDA", "FDA-1999-D-0081", "Reference  31 Miller et al 1985 re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry", "Supporting & Related Material", "Background Material", "2020-01-30T05:00:00Z", 2020, 1, null, null, "2020-03-09T15:44:33Z", null, 0, 0, "090000648430e1e6"]], "truncated": false, "filtered_table_rows_count": 34, "expanded_columns": [], "expandable_columns": [[{"column": "docket_id", "other_table": "dockets", "other_column": "id"}, "title"]], "columns": ["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"], "primary_keys": ["id"], "units": {}, "query": {"sql": "select 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 from documents where \"docket_id\" = :p0 and \"posted_year\" = :p1 order by posted_date desc limit 101", "params": {"p0": "FDA-1999-D-0081", "p1": "2020"}}, "facet_results": {"agency_id": {"name": "agency_id", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-1999-D-0081&posted_year=2020", "results": [{"value": "FDA", "label": "FDA", "count": 34, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1999-D-0081&posted_year=2020&agency_id=FDA", "selected": false}], "truncated": false}, "document_type": {"name": "document_type", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-1999-D-0081&posted_year=2020", "results": [{"value": "Supporting & Related Material", "label": "Supporting & Related Material", "count": 32, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1999-D-0081&posted_year=2020&document_type=Supporting+%26+Related+Material", "selected": false}, {"value": "Notice", "label": "Notice", "count": 1, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1999-D-0081&posted_year=2020&document_type=Notice", "selected": false}, {"value": "Other", "label": "Other", "count": 1, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1999-D-0081&posted_year=2020&document_type=Other", "selected": false}], "truncated": false}, "posted_year": {"name": "posted_year", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-1999-D-0081&posted_year=2020", "results": [{"value": 2020, "label": 2020, "count": 34, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1999-D-0081", "selected": true}], "truncated": false}}, "suggested_facets": [{"name": "subtype", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1999-D-0081&posted_year=2020&_facet=subtype"}, {"name": "open_for_comment", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1999-D-0081&posted_year=2020&_facet=open_for_comment"}, {"name": "posted_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1999-D-0081&posted_year=2020&_facet_date=posted_date"}, {"name": "comment_start_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1999-D-0081&posted_year=2020&_facet_date=comment_start_date"}, {"name": "last_modified", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-1999-D-0081&posted_year=2020&_facet_date=last_modified"}], "next": null, "next_url": null, "private": false, "allow_execute_sql": true, "query_ms": 2105.2926210686564, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}