documents

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

21 rows where docket_id = "FDA-1997-N-0011" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1997-N-0011-0049 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Supporting Statement re OMB Information Collection Supporting Statement: Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing OMB #0910-0469 Supporting & Related Material Statement (Supporting and Related Material) 2010-09-10T04:00:00Z 2010 9     2017-08-08T15:36:37Z   0 0 09000064805c9af8
FDA-1997-N-0011-0048 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Notice of Approval re Agency Information Collection Activities; Announcement of OMB Approval; Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing Notice Notice of Approval 2010-09-10T04:00:00Z 2010 9 2010-09-10T04:00:00Z   2016-01-14T18:21:47Z   0 0 09000064805c9af9
FDA-1997-N-0011-0047 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Notice of Final Rule re Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing Rule Final Rule 2010-09-10T04:00:00Z 2010 9 2010-09-10T04:00:00Z   2016-01-14T18:25:10Z   0 0 09000064805c9af7
FDA-1997-N-0011-0051 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Notice of Confirmation of Effective Date re Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing Notice Notice of Confirmation of Effective Date 2010-09-10T04:00:00Z 2010 9 2010-09-10T04:00:00Z   2016-01-14T18:17:12Z   0 0 09000064805c9afb
FDA-1997-N-0011-0044 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Notice of Approval re Agency Information Collection Activities; Announcement of OMB Approval; Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products Notice Notice of Approval 2010-09-09T04:00:00Z 2010 9 2010-09-09T04:00:00Z   2016-01-14T18:40:12Z   0 0 09000064805c9af4
FDA-1997-N-0011-0045 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Reply Statement re Supporting Statement for Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products OMB No. 0910-0372 Other Reply 2010-09-09T04:00:00Z 2010 9 2010-09-09T04:00:00Z   2016-01-15T17:10:06Z   0 0 09000064805c9af3
FDA-1997-N-0011-0033 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Reference 2 - "Letter from the Northwest Tissue Center to FDA dated December 4, 1995" - [Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products; Proposed Rule; Reopening of Comment Period] re: FDA-1997-N-0011-0030 Supporting & Related Material Background Material 2010-09-09T04:00:00Z 2010 9     2016-01-14T18:43:09Z   0 0 0900006480b39507
FDA-1997-N-0011-0030 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Notice of Proposed Rule; Reopening of Comment Period re Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products Notice General Notice 2010-09-09T04:00:00Z 2010 9 2010-09-09T04:00:00Z 1999-02-09T04:59:59Z 2016-01-15T15:11:39Z   0 0 09000064805c9aec
FDA-1997-N-0011-0032 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Reference 1 - "Letter from the American Red Cross to FDA dated November 14, 1995" - [Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products; Proposed Rule; Reopening of Comment Period] re: FDA-1997-N-0011-0030 Supporting & Related Material Background Material 2010-09-09T04:00:00Z 2010 9     2016-01-14T18:27:36Z   0 0 0900006480b3947f
FDA-1997-N-0011-0034 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Reference 3 - "Transcript of Meeting - Proposed Approach to Regulation of Cellular and Tissue-Based Products, March 17, 1997" - [Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products; Proposed Rule; Reopening of Comment Period] re: FDA-1997-N-0011-0030 Supporting & Related Material Background Material 2010-09-09T04:00:00Z 2010 9     2016-01-14T18:45:54Z   0 0 0900006480b39508
FDA-1997-N-0011-0031 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Background Information re Index of Supporting Documents - [Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products; Proposed Rule; Reopening of Comment Period] re: FDA-1997-N-0011-0030 Supporting & Related Material Background Material 2010-09-09T04:00:00Z 2010 9     2016-01-14T16:58:29Z   0 0 0900006480b3947d
FDA-1997-N-0011-0027 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Summary of Pilot Study of Tissue Establishment Registration and Listing Other Summary (SUM) 2010-09-09T04:00:00Z 2010 9 2010-09-09T04:00:00Z   2016-12-08T22:08:53Z   0 0 09000064805c9ae9
FDA-1997-N-0011-0037 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Reference 7 - "Transcript of Transmissible Spongiform Encephalopathies Advisory Committee Meeting - October 7, 1997" - [Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products; Proposed Rule; Reopening of Comment Period] re: FDA-1997-N-0011-0030 Supporting & Related Material BKG-Background Material 2010-09-09T04:00:00Z 2010 9     2016-01-15T20:40:32Z   0 0 0900006480b395f8
FDA-1997-N-0011-0036 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Reference 6 - "Transcript of Transmissible Spongiform Encephalopathies Advisory Committee Meeting - October 6, 1997" - [Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products; Proposed Rule; Reopening of Comment Period] re: FDA-1997-N-0011-0030 Supporting & Related Material BKG-Background Material 2010-09-09T04:00:00Z 2010 9     2016-01-15T20:45:38Z   0 0 0900006480b395f7
FDA-1997-N-0011-0035 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Reference 4 - "Meeting Between FDA and AATB regarding Demineralized Bone Matrix Regulation, July 11, 1997" - [Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products; Proposed Rule; Reopening of Comment Period] re: FDA-1997-N-0011-0030 Supporting & Related Material Background Material 2010-09-09T04:00:00Z 2010 9     2016-01-14T18:52:11Z   0 0 0900006480b3950a
FDA-1997-N-0011-0026 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 FDA/CBER Response Letter dated April 30, 1998 Other Letter(s) 2010-09-09T04:00:00Z 2010 9 2010-09-09T04:00:00Z   2016-12-08T22:10:22Z   0 0 09000064805c9ae8
FDA-1997-N-0011-0008 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Request for Extension re Comment from Heller Ehrman White & McAuliffe Other Request for Extension 2010-09-07T04:00:00Z 2010 9 2010-09-02T04:00:00Z 1998-08-13T03:59:59Z 2016-12-09T15:43:48Z   0 0 09000064805c9ad6
FDA-1997-N-0011-0004 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Reference re Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products Supporting & Related Material Reference (internal unless indicated) 2010-09-02T04:00:00Z 2010 9     2016-12-09T15:47:50Z   0 0 09000064805c9ad1
FDA-1997-N-0011-0003 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Notice of Proposed Rulemaking re FDA Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products Proposed Rule Notice of Proposed Rulemaking (NPRM) 2010-09-02T04:00:00Z 2010 9 2010-09-02T04:00:00Z 1998-08-13T03:59:59Z 2016-12-09T15:46:51Z   0 0 09000064805c9ad2
FDA-1997-N-0011-0002 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Notice of Correction re Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Correction Notice Correction 2004-02-09T05:00:00Z 2004 2 2004-01-30T05:00:00Z   2016-01-14T18:13:27Z   0 0 09000064805c9afc
FDA-1997-N-0011-0001 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0011 Notice of Final Rule re Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing Rule Final Rule 2004-01-29T05:00:00Z 2004 1 2004-01-23T05:00:00Z 2004-04-27T03:59:59Z 2016-01-14T18:15:41Z   0 0 09000064805c9acf

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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;