{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-2019-N-2175\" sorted by posted_date descending", "rows": [["FDA-2019-N-2175-0072", "FDA", "FDA-2019-N-2175", "FDA Tribal Consultation Summary", "Other", "Summary (SUM)", "2023-02-14T05:00:00Z", 2023, 2, "2023-02-14T05:00:00Z", null, "2023-02-14T16:51:34Z", null, 0, 0, "090000648569412c"], ["FDA-2019-N-2175-0042", "FDA", "FDA-2019-N-2175", "Protection of Human Subjects and Institutional Review Boards, and\nInstitutional Review Boards; Cooperative Research; Extension of Comment Period", "Proposed Rule", "Extension of Comment Period", "2022-11-14T05:00:00Z", 2022, 11, "2022-11-14T05:00:00Z", null, "2022-11-28T19:58:49Z", "2022-24689", 0, 0, "09000064854ab725"], ["FDA-2019-N-2175-0040", "FDA", "FDA-2019-N-2175", "Request for Extension from Stanford University", "Other", "Request for Extension", "2022-11-01T04:00:00Z", 2022, 11, "2022-11-01T04:00:00Z", null, "2022-11-01T18:45:42Z", null, 0, 0, "0900006485475431"], ["FDA-2019-N-2175-0036", "FDA", "FDA-2019-N-2175", "Request for Extension from University of California Office of the President", "Other", "Request for Extension", "2022-10-31T04:00:00Z", 2022, 10, "2022-10-31T04:00:00Z", null, "2022-10-31T17:08:19Z", null, 0, 0, "09000064854663a6"], ["FDA-2019-N-2175-0032", "FDA", "FDA-2019-N-2175", "Request for Extension from PhRMA & BIO (Joint Submission)", "Other", "Request for Extension", "2022-10-05T04:00:00Z", 2022, 10, "2022-10-05T04:00:00Z", null, "2022-10-05T15:35:16Z", null, 0, 0, "09000064853ba9ea"], ["FDA-2019-N-2175-0026", "FDA", "FDA-2019-N-2175", "TAB A 2017-1110 Cooperative Research NPRM as Submitted to OMB RE Memorandum to FDA DMS on Cooperative Research Proposed Rule", "Supporting & Related Material", "Background Material", "2022-10-04T04:00:00Z", 2022, 10, null, null, "2022-10-04T16:17:14Z", null, 0, 0, "09000064853a9f15"], ["FDA-2019-N-2175-0025", "FDA", "FDA-2019-N-2175", "Memorandum to FDA DMS on Cooperative Research Proposed Rule", "Other", "Memorandum", "2022-10-04T04:00:00Z", 2022, 10, "2022-10-04T04:00:00Z", null, "2022-10-04T16:16:15Z", null, 0, 0, "09000064853a677f"], ["FDA-2019-N-2175-0030", "FDA", "FDA-2019-N-2175", "TAB C 2017-1110 Cooperative Research NPRM as Cleared by OMB RE Memorandum to FDA DMS on Cooperative Research Proposed Rule", "Supporting & Related Material", "Background Material", "2022-10-04T04:00:00Z", 2022, 10, null, null, "2022-10-04T16:18:33Z", null, 0, 0, "09000064853aa7ea"], ["FDA-2019-N-2175-0031", "FDA", "FDA-2019-N-2175", "TAB C 2017-1110 Cooperative Research PRIA as Cleared by OMB RE Memorandum to FDA DMS on Cooperative Research Proposed Rule", "Supporting & Related Material", "Background Material", "2022-10-04T04:00:00Z", 2022, 10, null, null, "2022-10-04T16:18:42Z", null, 0, 0, "09000064853a9f18"], ["FDA-2019-N-2175-0027", "FDA", "FDA-2019-N-2175", "TAB A 2017-1110 Cooperative Research PRIA as Submitted to OMB RE Memorandum to FDA DMS on Cooperative Research Proposed Rule", "Supporting & Related Material", "Background Material", "2022-10-04T04:00:00Z", 2022, 10, null, null, "2022-10-04T16:17:24Z", null, 0, 0, "09000064853a9f16"], ["FDA-2019-N-2175-0029", "FDA", "FDA-2019-N-2175", "TAB B 2017-1110 Cooperative Research PRIA Track Changes RE Memorandum to FDA DMS on Cooperative Research Proposed Rule", "Supporting & Related Material", "Background Material", "2022-10-04T04:00:00Z", 2022, 10, null, null, "2022-10-04T16:18:22Z", null, 0, 0, "09000064853a9f17"], ["FDA-2019-N-2175-0028", "FDA", "FDA-2019-N-2175", "TAB B 2017-1110 Cooperative Research NPRM Track Changes RE Memorandum to FDA DMS on Cooperative Research Proposed Rule", "Supporting & Related Material", "Background Material", "2022-10-04T04:00:00Z", 2022, 10, null, null, "2022-10-04T16:18:13Z", null, 0, 0, "09000064853aa7e9"], ["FDA-2019-N-2175-0016", "FDA", "FDA-2019-N-2175", "PRIA Reference 9 - Bureau of Labor Statistics, \u201cOccupational Employment and Wages, May 2017, 25-1071 Health Specialties Teachers, Postsecondary,\u201d available at: https://www.bls.gov/oes/2017/may/oes251071.htm, accessed February 26, 2019. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:27:09Z", null, 0, 0, "090000648537a934"], ["FDA-2019-N-2175-0005", "FDA", "FDA-2019-N-2175", "Reference 3 - Check D.K., K.P. Weinfurt, C.B. Dombeck, et.al. (2013), \u201cUse of Central Institutional Review Boards for Multicenter Clinical Trials in the United States: A Review of the Literature,\u201d Clinical Trials 10: 560-567. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:20:08Z", null, 0, 0, "090000648537a088"], ["FDA-2019-N-2175-0019", "FDA", "FDA-2019-N-2175", "PRIA Reference 12 - Memorandum to File, FDA summary of data analysis; HHS, \u201cOffice for Human Research Protections (OHRP) Database for Registered IORGs & IRBs, Approved FWAs, and Documents Received in Last 60 Days,\u201d prepared by Christian Brown, FDA, March 28, 2019. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:29:13Z", null, 0, 0, "090000648537a937"], ["FDA-2019-N-2175-0010", "FDA", "FDA-2019-N-2175", "PRIA Reference 3 - Stoffel, Brandy, et. al., (2017) \u201cUse of a Single, Independent IRB: Case Study of an NIH funded Consortium,\u201d Contemporary Clinical Trials Communications 8 (2017) 114-121. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:24:16Z", null, 0, 0, "090000648537a92f"], ["FDA-2019-N-2175-0023", "FDA", "FDA-2019-N-2175", "PRIA Reference 16 - U.S. Small Business Administration, Size Standards, https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf, accessed on May 1, 2018. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:31:19Z", null, 0, 0, "090000648537a955"], ["FDA-2019-N-2175-0001", "FDA", "FDA-2019-N-2175", "Institutional Review Boards; Cooperative Research", "Proposed Rule", "Notice of Proposed Rulemaking (NPRM)", "2022-09-28T04:00:00Z", 2022, 9, "2022-11-28T05:00:00Z", "2022-12-29T04:59:59Z", "2022-12-30T02:01:24Z", "2022-21089", 0, 0, "0900006485378f80"], ["FDA-2019-N-2175-0003", "FDA", "FDA-2019-N-2175", "Reference 1 - Flynn K.E, C.L. Hahn, J.M. Kramer, et al. (2013), \u201cUsing Central IRBs for Multicenter Clinical Trials in the United States,\u201d PLOS ONE 8(1): e54999. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:18:31Z", null, 0, 0, "0900006485379fd7"], ["FDA-2019-N-2175-0008", "FDA", "FDA-2019-N-2175", "PRIA Reference 1 - Greene, Sarah M. and Geiger, Ann M., (2006) A Review Finds that Multicenter Studies Face Substantial Challenges but Strategies Exist to Achieve Institutional Review Board Approval, Journal of Clinical Epidemiology 59 (2006) 784-790. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:23:28Z", null, 0, 0, "090000648537a08f"], ["FDA-2019-N-2175-0002", "FDA", "FDA-2019-N-2175", "FDA-2019-N-2175 References List RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:18:01Z", null, 0, 0, "090000648537a4a9"], ["FDA-2019-N-2175-0015", "FDA", "FDA-2019-N-2175", "PRIA Reference 8 - Bureau of Labor Statistics. \u201cOccupational Employment and Wages, May 2017, 11-9033 Education Administrators, Postsecondary,\u201d available at: https://www.bls.gov/oes/current/oes119033.htm, accessed February 26, 2019. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:26:48Z", null, 0, 0, "090000648537a890"], ["FDA-2019-N-2175-0018", "FDA", "FDA-2019-N-2175", "PRIA Reference 11 - Department of Health and Human Services, Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices, 2017, available at https://aspe.hhs.gov/reports/valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework, accessed December 10, 2021.", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:28:52Z", null, 0, 0, "090000648537a891"], ["FDA-2019-N-2175-0006", "FDA", "FDA-2019-N-2175", "Reference 4 - Massett, H.A., S.L. Hampp, J.L. Goldberg, et al. (2018), Meeting the Challenge: The National Cancer Institute\u2019s Central Institutional Review Board for Multi-Site Research, Journal of Clinical Oncology 36 8: 819-824. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:22:10Z", null, 0, 0, "090000648537a4af"], ["FDA-2019-N-2175-0012", "FDA", "FDA-2019-N-2175", "PRIA Reference 5 - Abramovici, Adi, et. al. (2015) \u201cReview of Multicenter Studies by Multiple Institutional Review Boards: Characteristics and Outcomes for Perinatal Studies Implemented by a Multicenter Network,\u201d American Journal of Obstetrics & Gynecology January 2015. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:25:27Z", null, 0, 0, "090000648537a915"], ["FDA-2019-N-2175-0007", "FDA", "FDA-2019-N-2175", "Reference 5 - FDA, Preliminary Economic Analysis of Impacts, Docket No. FDA-2019-N-2175, available at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:22:37Z", null, 0, 0, "090000648537a5c6"], ["FDA-2019-N-2175-0009", "FDA", "FDA-2019-N-2175", "PRIA Reference 2 - Sobolski, Gregory, et al., (2007) \u201cInstitutional Review Board Review of Multicenter Studies,\u201d Annuals of Internal Medicine Vol 146(10), April 30, 2007 page 759. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:23:53Z", null, 0, 0, "090000648537a92e"], ["FDA-2019-N-2175-0021", "FDA", "FDA-2019-N-2175", "PRIA Reference 14 - Clinical Trials Transformation Initiative (CTTI). Use of Central IRBs for Multicenter Clinical Trials: Final Report. Available at: https://ctti-clinicaltrials.org/our-work/ethics-and-human-research-protection/single-irb, accessed June 7, 2022. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:30:38Z", null, 0, 0, "090000648537a893"], ["FDA-2019-N-2175-0017", "FDA", "FDA-2019-N-2175", "PRIA Reference 10 - Bureau of Labor Statistics, Occupational Employment and Wages, May 2017, 43-0000 Office and Administrative Support Occupations (Major Group), available at: https://www.bls.gov/oes/current/oes430000.htm, accessed on February 26, 2019.RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:28:09Z", null, 0, 0, "090000648537a935"], ["FDA-2019-N-2175-0022", "FDA", "FDA-2019-N-2175", "PRIA Reference 15 - North American Industry Classification System (NAICS), U.S. Census Bureau Data, \u201cGeneral Medical and Surgical Hospitals NAICs Code 622110\u201d available at https://www.census.gov/naics/? input=622110&year=2017&details=622110, accessed on June 2, 2022 RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:30:59Z", null, 0, 0, "090000648537a954"], ["FDA-2019-N-2175-0014", "FDA", "FDA-2019-N-2175", "PRIA Reference 7 - \u201cFederal Policy for the Protection of Human Subjects\u201d, 82 Fed. Reg. 7149 (January 19, 2017), available at https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf, accessed on March 5, 2018. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:26:26Z", null, 0, 0, "090000648537a931"], ["FDA-2019-N-2175-0004", "FDA", "FDA-2019-N-2175", "Reference 2 - Greene, S.M. and A.M. Geiger (2006), A Review Finds that Multicenter Studies Face Substantial Challenges but Strategies Exist to Achieve Institutional Review Board Approval, Journal of Clinical Epidemiology 59 (2006) 784-790. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:19:44Z", null, 0, 0, "0900006485379fd8"], ["FDA-2019-N-2175-0011", "FDA", "FDA-2019-N-2175", "PRIA Reference 4 - Mansbach, Jonathan, et. al. (2007) Variation in Institutional Review Board Responses to a Standard Observational Pediatric Research Protocol, Society for Academic Emergency Medicine (2007) 377- 380. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:25:00Z", null, 0, 0, "090000648537a5c8"], ["FDA-2019-N-2175-0013", "FDA", "FDA-2019-N-2175", "PRIA Reference 6 - Department of Health and Human Services, \u201cGuidelines for Regulatory Impact Analysis,\u201d 2016, available at: https://aspe.hhs.gov/reports/guidelines-regulatory-impact-analysis, accessed December 10, 2021. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:25:50Z", null, 0, 0, "090000648537a916"], ["FDA-2019-N-2175-0020", "FDA", "FDA-2019-N-2175", "PRIA Reference 13 - Sugarman, Jeremy, et al., (2005) \u201cThe Cost of Institutional Review Boards in Academics Medical Centers,\u201d New England Journal of Medicine 352;17 April 28, 2005 pages 1825 to 1827. RE Institutional Review Boards; Cooperative Research", "Supporting & Related Material", "Background Material", "2022-09-28T04:00:00Z", 2022, 9, null, null, "2022-09-28T19:30:10Z", null, 0, 0, "090000648537a953"]], "truncated": false, "filtered_table_rows_count": 35, "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 \"agency_id\" = :p0 and \"docket_id\" = :p1 order by posted_date desc limit 101", "params": {"p0": "FDA", "p1": "FDA-2019-N-2175"}}, "facet_results": {"agency_id": {"name": "agency_id", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175", "results": [{"value": "FDA", "label": "FDA", "count": 35, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2019-N-2175", "selected": true}], "truncated": false}, "document_type": {"name": "document_type", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175", "results": [{"value": "Supporting & Related Material", "label": "Supporting & Related Material", "count": 28, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175&document_type=Supporting+%26+Related+Material", "selected": false}, {"value": "Other", "label": "Other", "count": 5, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175&document_type=Other", "selected": false}, {"value": "Proposed Rule", "label": "Proposed Rule", "count": 2, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175&document_type=Proposed+Rule", "selected": false}], "truncated": false}, "posted_year": {"name": "posted_year", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175", "results": [{"value": 2022, "label": 2022, "count": 34, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175&posted_year=2022", "selected": false}, {"value": 2023, "label": 2023, "count": 1, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175&posted_year=2023", "selected": false}], "truncated": false}}, "suggested_facets": [{"name": "subtype", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175&_facet=subtype"}, {"name": "posted_date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175&_facet=posted_date"}, {"name": "posted_month", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175&_facet=posted_month"}, {"name": "posted_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175&_facet_date=posted_date"}, {"name": "comment_start_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175&_facet_date=comment_start_date"}, {"name": "comment_end_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175&_facet_date=comment_end_date"}, {"name": "last_modified", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?agency_id=FDA&docket_id=FDA-2019-N-2175&_facet_date=last_modified"}], "next": null, "next_url": null, "private": false, "allow_execute_sql": true, "query_ms": 59.99066308140755, "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"}