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

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35 rows where docket_id = "FDA-2019-N-2175" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-N-2175-0072 FDA None FDA-2019-N-2175 FDA Tribal Consultation Summary Other Summary (SUM) 2023-02-14T05:00:00Z 2023 2 2023-02-14T05:00:00Z   2023-02-14T16:51:34Z   0 0 090000648569412c
FDA-2019-N-2175-0042 FDA None FDA-2019-N-2175 Protection of Human Subjects and Institutional Review Boards, and Institutional 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   2022-11-28T19:58:49Z 2022-24689 0 0 09000064854ab725
FDA-2019-N-2175-0040 FDA None 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   2022-11-01T18:45:42Z   0 0 0900006485475431
FDA-2019-N-2175-0036 FDA None 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   2022-10-31T17:08:19Z   0 0 09000064854663a6
FDA-2019-N-2175-0032 FDA None 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   2022-10-05T15:35:16Z   0 0 09000064853ba9ea
FDA-2019-N-2175-0026 FDA None 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     2022-10-04T16:17:14Z   0 0 09000064853a9f15
FDA-2019-N-2175-0025 FDA None 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   2022-10-04T16:16:15Z   0 0 09000064853a677f
FDA-2019-N-2175-0030 FDA None 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     2022-10-04T16:18:33Z   0 0 09000064853aa7ea
FDA-2019-N-2175-0031 FDA None 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     2022-10-04T16:18:42Z   0 0 09000064853a9f18
FDA-2019-N-2175-0027 FDA None 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     2022-10-04T16:17:24Z   0 0 09000064853a9f16
FDA-2019-N-2175-0029 FDA None 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     2022-10-04T16:18:22Z   0 0 09000064853a9f17
FDA-2019-N-2175-0028 FDA None 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     2022-10-04T16:18:13Z   0 0 09000064853aa7e9
FDA-2019-N-2175-0016 FDA None FDA-2019-N-2175 PRIA Reference 9 - Bureau of Labor Statistics, “Occupational Employment and Wages, May 2017, 25-1071 Health Specialties Teachers, Postsecondary,” 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     2022-09-28T19:27:09Z   0 0 090000648537a934
FDA-2019-N-2175-0005 FDA None FDA-2019-N-2175 Reference 3 - Check D.K., K.P. Weinfurt, C.B. Dombeck, et.al. (2013), “Use of Central Institutional Review Boards for Multicenter Clinical Trials in the United States: A Review of the Literature,” Clinical Trials 10: 560-567. RE Institutional Review Boards; Cooperative Research Supporting & Related Material Background Material 2022-09-28T04:00:00Z 2022 9     2022-09-28T19:20:08Z   0 0 090000648537a088
FDA-2019-N-2175-0019 FDA None FDA-2019-N-2175 PRIA Reference 12 - Memorandum to File, FDA summary of data analysis; HHS, “Office for Human Research Protections (OHRP) Database for Registered IORGs & IRBs, Approved FWAs, and Documents Received in Last 60 Days,” 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     2022-09-28T19:29:13Z   0 0 090000648537a937
FDA-2019-N-2175-0010 FDA None FDA-2019-N-2175 PRIA Reference 3 - Stoffel, Brandy, et. al., (2017) “Use of a Single, Independent IRB: Case Study of an NIH funded Consortium,” 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     2022-09-28T19:24:16Z   0 0 090000648537a92f
FDA-2019-N-2175-0023 FDA None 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     2022-09-28T19:31:19Z   0 0 090000648537a955
FDA-2019-N-2175-0001 FDA None 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 None FDA-2019-N-2175 Reference 1 - Flynn K.E, C.L. Hahn, J.M. Kramer, et al. (2013), “Using Central IRBs for Multicenter Clinical Trials in the United States,” PLOS ONE 8(1): e54999. RE Institutional Review Boards; Cooperative Research Supporting & Related Material Background Material 2022-09-28T04:00:00Z 2022 9     2022-09-28T19:18:31Z   0 0 0900006485379fd7
FDA-2019-N-2175-0008 FDA None 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     2022-09-28T19:23:28Z   0 0 090000648537a08f
FDA-2019-N-2175-0002 FDA None 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     2022-09-28T19:18:01Z   0 0 090000648537a4a9
FDA-2019-N-2175-0015 FDA None FDA-2019-N-2175 PRIA Reference 8 - Bureau of Labor Statistics. “Occupational Employment and Wages, May 2017, 11-9033 Education Administrators, Postsecondary,” 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     2022-09-28T19:26:48Z   0 0 090000648537a890
FDA-2019-N-2175-0018 FDA None 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     2022-09-28T19:28:52Z   0 0 090000648537a891
FDA-2019-N-2175-0006 FDA None 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’s 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     2022-09-28T19:22:10Z   0 0 090000648537a4af
FDA-2019-N-2175-0012 FDA None FDA-2019-N-2175 PRIA Reference 5 - Abramovici, Adi, et. al. (2015) “Review of Multicenter Studies by Multiple Institutional Review Boards: Characteristics and Outcomes for Perinatal Studies Implemented by a Multicenter Network,” 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     2022-09-28T19:25:27Z   0 0 090000648537a915
FDA-2019-N-2175-0007 FDA None 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     2022-09-28T19:22:37Z   0 0 090000648537a5c6
FDA-2019-N-2175-0009 FDA None FDA-2019-N-2175 PRIA Reference 2 - Sobolski, Gregory, et al., (2007) “Institutional Review Board Review of Multicenter Studies,” 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     2022-09-28T19:23:53Z   0 0 090000648537a92e
FDA-2019-N-2175-0021 FDA None 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     2022-09-28T19:30:38Z   0 0 090000648537a893
FDA-2019-N-2175-0017 FDA None 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     2022-09-28T19:28:09Z   0 0 090000648537a935
FDA-2019-N-2175-0022 FDA None FDA-2019-N-2175 PRIA Reference 15 - North American Industry Classification System (NAICS), U.S. Census Bureau Data, “General Medical and Surgical Hospitals NAICs Code 622110” 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     2022-09-28T19:30:59Z   0 0 090000648537a954
FDA-2019-N-2175-0014 FDA None FDA-2019-N-2175 PRIA Reference 7 - “Federal Policy for the Protection of Human Subjects”, 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     2022-09-28T19:26:26Z   0 0 090000648537a931
FDA-2019-N-2175-0004 FDA None 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     2022-09-28T19:19:44Z   0 0 0900006485379fd8
FDA-2019-N-2175-0011 FDA None 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     2022-09-28T19:25:00Z   0 0 090000648537a5c8
FDA-2019-N-2175-0013 FDA None FDA-2019-N-2175 PRIA Reference 6 - Department of Health and Human Services, “Guidelines for Regulatory Impact Analysis,” 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     2022-09-28T19:25:50Z   0 0 090000648537a916
FDA-2019-N-2175-0020 FDA None FDA-2019-N-2175 PRIA Reference 13 - Sugarman, Jeremy, et al., (2005) “The Cost of Institutional Review Boards in Academics Medical Centers,” 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     2022-09-28T19:30:10Z   0 0 090000648537a953

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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;