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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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), “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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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