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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
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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;