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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

31 rows where docket_id = "FDA-2018-N-2727" sorted by posted_date descending

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document_type 5

  • Supporting & Related Material 25
  • Proposed Rule 3
  • Notice 1
  • Other 1
  • Rule 1

posted_year 4

  • 2024 24
  • 2018 5
  • 2019 1
  • 2023 1

agency_id 1

  • FDA 31
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2018-N-2727-0075 FDA None FDA-2018-N-2727 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations Notice Announcement 2024-01-18T05:00:00Z 2024 1 2024-01-18T05:00:00Z   2024-01-18T13:44:49Z 2024-00886 0 0 09000064863a76e8
FDA-2018-N-2727-0066 FDA None FDA-2018-N-2727 15 SACHRP (2017) Recommendations on the Expedited Review List Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:54:47Z   0 0 090000648634e019
FDA-2018-N-2727-0065 FDA None FDA-2018-N-2727 14 FDA (1998) Protection of Human Subjects Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:54:32Z   0 0 090000648634e018
FDA-2018-N-2727-0067 FDA None FDA-2018-N-2727 16 OHRP (2021) Revised Common Rule Q&As Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:54:52Z   0 0 090000648634e639
FDA-2018-N-2727-0062 FDA None FDA-2018-N-2727 11WMA (2022) Declaration of Helsinki--Ethical Principles for Medical Research Involving Human Subjects Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:54:05Z   0 0 090000648634e015
FDA-2018-N-2727-0064 FDA None FDA-2018-N-2727 13 FDA (2010) Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device Studies--Frequently Asked Questions Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:54:24Z   0 0 090000648634e017
FDA-2018-N-2727-0070 FDA None FDA-2018-N-2727 TAB A - IRB Waiver RIA as Submitted to OMB Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:56:09Z   0 0 090000648638fd1f
FDA-2018-N-2727-0069 FDA None FDA-2018-N-2727 TAB A - IRB Waiver Final Rule as Submitted to OMB Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:55:56Z   0 0 090000648638f8a8
FDA-2018-N-2727-0071 FDA None FDA-2018-N-2727 TAB B - IRB Waiver Final Rule Track Changes Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:56:32Z   0 0 090000648638fd20
FDA-2018-N-2727-0068 FDA None FDA-2018-N-2727 Memorandum to FDA DMS on IRB Waiver FR (FDA-2018-N-2727) Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:55:33Z   0 0 090000648638f8a5
FDA-2018-N-2727-0059 FDA None FDA-2018-N-2727 8 FDA and OHRP (2018) Institutional Review Board (IRB) Written Procedures Guidance for Institutions and IRBs Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:53:47Z   0 0 090000648634e012
FDA-2018-N-2727-0063 FDA None FDA-2018-N-2727 12 FDA (2006) Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:54:17Z   0 0 090000648634e016
FDA-2018-N-2727-0060 FDA None FDA-2018-N-2727 9 FDA (2006) Information Sheet Guidance for IRBs Clinical Investigators and Sponsors Significant Risk and Nonsignificant Risk Medical Device Studies Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:53:54Z   0 0 090000648634e013
FDA-2018-N-2727-0052 FDA None FDA-2018-N-2727 1 US Dept of State (2011) Fourth Periodic Report of the United States of America to the United Nations Committee on Human Rights Concerning the ICCPR Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:52:48Z   0 0 090000648634e5ef
FDA-2018-N-2727-0058 FDA None FDA-2018-N-2727 7 Kraft et al. (2017)Research on Medical Practices Why Patients Consider Participating and the Investigational Misconception Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:53:34Z   0 0 090000648634e011
FDA-2018-N-2727-0073 FDA None FDA-2018-N-2727 TAB C - IRB Waiver Final Rule as Cleared by OMB Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:57:08Z   0 0 090000648638fd24
FDA-2018-N-2727-0053 FDA None FDA-2018-N-2727 2 SACHRP (2008) Recommendations Related to Waiver of Informed Consent and Interpretation of Minimal Risk Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:52:56Z   0 0 090000648634e5f0
FDA-2018-N-2727-0055 FDA None FDA-2018-N-2727 4 Baker and Merz (2018) What Gives Them the Right Legal Privilege and Waivers of Consent for Research Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:53:05Z   0 0 090000648634e5f2
FDA-2018-N-2727-0061 FDA None FDA-2018-N-2727 10 CIOMS (2016) International Ethical Guidelines for Health-related Research Involving Humans Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:53:58Z   0 0 090000648634e014
FDA-2018-N-2727-0057 FDA None FDA-2018-N-2727 6 Kripalani et al. (2021) Disparities in Research Participation by Level of Health Literacy Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:53:25Z   0 0 090000648634e010
FDA-2018-N-2727-0056 FDA None FDA-2018-N-2727 5 van Zon et al. (2016) Active Recruitment and Limited Participant-load Related to High Participation in Large Population-based Biobank Studies Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:53:13Z   0 0 090000648634e5f3
FDA-2018-N-2727-0072 FDA None FDA-2018-N-2727 TAB B - IRB Waiver RIA Track Changes Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:56:50Z   0 0 090000648638fd21
FDA-2018-N-2727-0074 FDA None FDA-2018-N-2727 TAB C - IRB Waiver RIA as Cleared by OMB Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:57:31Z   0 0 090000648638fd25
FDA-2018-N-2727-0054 FDA None FDA-2018-N-2727 3 EoP (1997) Strengthened Protections for Human Subject of Classified Research Supporting & Related Material Background Material 2024-01-10T05:00:00Z 2024 1     2024-01-10T16:53:01Z   0 0 090000648634e5f1
FDA-2018-N-2727-0051 FDA None FDA-2018-N-2727 Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations Rule Direct Final Rule 2023-12-21T05:00:00Z 2023 12 2023-12-21T05:00:00Z   2023-12-21T15:50:35Z 2023-27935 0 0 090000648634dce5
FDA-2018-N-2727-0042 FDA None FDA-2018-N-2727 Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Reopening of Comment Period Proposed Rule Extension of Comment Period 2019-02-25T05:00:00Z 2019 2 2019-02-25T05:00:00Z 2019-03-08T04:59:59Z 2019-03-09T02:02:09Z 2019-03195 0 0 0900006483aa313c
FDA-2018-N-2727-0011 FDA None FDA-2018-N-2727 Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Extension of Comment Period Proposed Rule Extension of Comment Period 2018-12-20T05:00:00Z 2018 12 2018-12-20T05:00:00Z 2019-02-14T04:59:59Z 2019-02-15T02:02:47Z 2018-27519 0 0 09000064839b9103
FDA-2018-N-2727-0006 FDA None FDA-2018-N-2727 Request for Extension from Advanced Medical Technology Association (AdvaMed) Other Request for Extension 2018-11-28T05:00:00Z 2018 11 2018-11-28T05:00:00Z   2018-11-28T21:09:16Z   0 0 09000064838e21ce
FDA-2018-N-2727-0001 FDA None FDA-2018-N-2727 Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations Proposed Rule Notice of Proposed Rulemaking (NPRM) 2018-11-15T05:00:00Z 2018 11 2018-11-15T05:00:00Z 2019-01-15T04:59:59Z 2019-01-15T02:01:45Z 2018-24822 0 0 09000064838d9668
FDA-2018-N-2727-0002 FDA None FDA-2018-N-2727 Reference - 2 - 2017-9-20 Memo to file.FDA data analysis re: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations Supporting & Related Material Background Material 2018-11-15T05:00:00Z 2018 11     2018-11-15T21:03:12Z   0 0 09000064838db0ae
FDA-2018-N-2727-0003 FDA None FDA-2018-N-2727 Reference 3- 2018-8-20 Memo re: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations Supporting & Related Material Background Material 2018-11-15T05:00:00Z 2018 11     2018-11-15T21:00:17Z   0 0 09000064838db657

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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;
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