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

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46 rows where docket_id = "FDA-1978-N-0023" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1978-N-0023-0166 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Report from Nonprescription Drug Manufacturers Association Other Report 2012-12-24T05:00:00Z 2012 12 2012-12-24T05:00:00Z   2019-09-25T19:25:17Z   0 0 090000648055f19c
FDA-1978-N-0023-0167 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Acknowledgment Letter from FDA DDM to Michael T. Benson Other Acknowledgement Letter/Receipt 2012-12-24T05:00:00Z 2012 12     2019-09-13T15:31:17Z   0 0 0900006480a3d7cf
FDA-1978-N-0023-0168 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Supplement from Paul A. Lehman, M.Sc. and Thomas J. Franz, M.D. Other Supplement (SUP) 2012-12-24T05:00:00Z 2012 12 2012-12-24T05:00:00Z   2019-09-16T13:33:03Z   0 0 090000648055fd10
FDA-1978-N-0023-0161 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Reference 1 Minutes of Open Public Meeting Carcinogenicity Assessment Committe December 4 1996 re FDA-1978-N-0023-0160 Supporting & Related Material Citizen Petition 2009-10-06T04:00:00Z 2009 10     2012-12-24T19:59:54Z   0 0 0900006480a33acc
FDA-1978-N-0023-0164 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Reference 7 International Agency for Research on Cancer (IARC) - Summaries and Evaluation, HYDROQUINOLONE, (Group 3) re FDA-1978-N-0023-0160 Supporting & Related Material Citizen Petition 2009-10-06T04:00:00Z 2009 10     2012-12-24T20:00:21Z   0 0 0900006480a33ad2
FDA-1978-N-0023-0160 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Citizen Petition from Michael T. Benson Other Citizen Petition 2009-10-06T04:00:00Z 2009 10 2009-10-06T04:00:00Z   2024-11-07T22:04:39Z   1 0 0900006480a3d615
FDA-1978-N-0023-0163 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Reference 6 The Covalent Bond re FDA-1978-N-0023-0160 Supporting & Related Material Citizen Petition 2009-10-06T04:00:00Z 2009 10     2012-12-24T20:00:11Z   0 0 0900006480a33ad1
FDA-1978-N-0023-0165 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Reference 8 Nordlund, The Safety of Hydroquinone re FDA-1978-N-0023-0160 Supporting & Related Material Citizen Petition 2009-10-06T04:00:00Z 2009 10     2012-12-24T20:00:31Z   0 0 0900006480a33ad3
FDA-1978-N-0023-0162 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Reference 5 -Glucuronide (Wikipedia) re FDA-1978-N-0023-0160 Supporting & Related Material Citizen Petition 2009-10-06T04:00:00Z 2009 10     2012-12-24T20:00:02Z   0 0 0900006480a33ad0
FDA-1978-N-0023-0081 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Answer from FDA/CDER to Joan A. Kuriansky ,Older Women's League Other Answer 2008-10-06T04:00:00Z 2008 10 2008-10-06T04:00:00Z 1979-02-02T04:59:59Z 2019-11-01T20:17:14Z   0 0 090000648055f147
FDA-1978-N-0023-0047 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter from FDA/CDER to Dr. John Kennedy, Jr. Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-25T19:34:22Z   0 0 090000648055f1b8
FDA-1978-N-0023-0043 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Correction Letter from Hunter, Maclean, Exley & Dunn, P.C. On Behalf Of Carson Products Company to FDA DDM Other Correction(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-30T13:12:32Z   0 0 090000648055f024
FDA-1978-N-0023-0060 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Tab Reference 1: Kari, F. W., "NTP Technical Report of the Toxicology and Carcinogenesis Studies of Hydroquinone in F344/N Rats and B6C3F1 Mice (Gavage Studies)," NTP TR366, NTP Publication No. 89-2821, 1989. (Page 101-200) re: Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets Supporting & Related Material Background Material 2008-10-03T04:00:00Z 2008 10     2019-10-02T17:48:55Z   0 0 090000648055f20c
FDA-1978-N-0023-0046 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter from FDA/CDER to University of Pennsylvania Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-25T19:28:44Z   0 0 090000648055f1b4
FDA-1978-N-0023-0039 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Enclosure 2: Salient Observations from the Published Literature on Exogenous Ochronosis Reportedly Associated with Skin Discoloration Fade Products re: Letter from the Nonprescription Drug Manufacturers Association to FDA/CDER Supporting & Related Material Background Material 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-27T17:26:10Z   0 0 090000648055f0b2
FDA-1978-N-0023-0031 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Request For Extension From Rogers Hoge & Hills On Behalf Of Browne Drug Co., Inc. Other Request for Extension 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z 1979-02-02T04:59:59Z 2019-09-24T13:20:48Z   0 0 090000648055eff9
FDA-1978-N-0023-0057 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Tab Reference 1: Kari, F. W., "NTP Technical Report of the Toxicology and Carcinogenesis Studies of Hydroquinone in F344/N Rats and B6C3F1 Mice (Gavage Studies)," NTP TR366, NTP Publication No. 89-2821, 1989. (Page 1-100) re: Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets Supporting & Related Material Background Material 2008-10-03T04:00:00Z 2008 10     2019-10-02T17:49:27Z   0 0 090000648055f1ec
FDA-1978-N-0023-0040 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Enclosure 1: Chronic Health Effects Testing for Hydroquinone re: Letter from the Nonprescription Drug Manufacturers Association to FDA/CDER Supporting & Related Material Background Material 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-27T17:25:50Z   0 0 090000648055f0c4
FDA-1978-N-0023-0050 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter from FDA/CDER to National Medical Association Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-25T19:57:30Z   0 0 090000648055f1c3
FDA-1978-N-0023-0030 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Report from the National Toxicology Program, Toxicology and Carcinogenesis Studies of Hydroquinone (CAS No. 123-31-9) in F344/N Rats and B6C3F Mice (Gavage Studies) Other Report 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-10-29T14:53:24Z   0 0 090000648055f02b
FDA-1978-N-0023-0035 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 A Report By The City of New York Department of Consumer Affairs; A Study In Hype And Risk: The Marketing Of Skin Bleaches Other Report 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-30T13:03:09Z   0 0 090000648055f070
FDA-1978-N-0023-0054 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Ref. 1: Memorandum of Meeting between FDA CDER, NDMA and Carcinogenicity Assessment Committee Other Memorandum 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-10-10T18:59:54Z   0 0 090000648055f1d3
FDA-1978-N-0023-0053 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Memorandum of Meeting between Nonprescription Drug Manufacturers Association et. al. and FDA Other Memorandum 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-26T12:01:08Z   0 0 090000648055f1d0
FDA-1978-N-0023-0058 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Tab Reference 6: Bio/dynamics Inc., "A Developmental Toxicity Study in Rabbits With Hydroquinone," Project No. 87-3Z20, 1989, in OTC Vol. 16ATFM2. re: Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets Management (HFA-350) August 17 2006 Supporting & Related Material Background Material 2008-10-03T04:00:00Z 2008 10     2019-10-02T17:48:18Z   0 0 090000648055f206
FDA-1978-N-0023-0052 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter from FDA/CDER to Lilly A. Jackson Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-26T11:48:24Z   0 0 090000648055f1cc
FDA-1978-N-0023-0037 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter From FDA/CDER to Nonprescription Drug Manufacturers Association Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-26T16:44:48Z   0 0 090000648055f099
FDA-1978-N-0023-0041 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter from the Nonprescription Drug Manufacturers Association to FDA/CDER Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-27T17:24:43Z   0 0 090000648055f0ed
FDA-1978-N-0023-0051 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter from FDA/CDER to King-Drew Medical Center Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-26T11:45:27Z   0 0 090000648055f1c8
FDA-1978-N-0023-0048 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter from FDA/CDER to Dr. Harold Minus Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-25T19:39:09Z   0 0 090000648055f1bb
FDA-1978-N-0023-0044 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter From Nonprescription Drug Manufacturers Association to FDA/CDER Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-27T18:08:12Z   0 0 090000648055f149
FDA-1978-N-0023-0055 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter from FDA/CDER to Nonprescription Drug Manufacturers Association Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-26T12:34:55Z   0 0 090000648055f1d6
FDA-1978-N-0023-0045 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Report from Nonprescription Drug Manufacturers Association Other Report 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-25T19:10:40Z   0 0 090000648055f14b
FDA-1978-N-0023-0056 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Tab Reference 1: Kari, F. W., "NTP Technical Report of the Toxicology and Carcinogenesis Studies of Hydroquinone in F344/N Rats and B6C3F1 Mice (Gavage Studies)," NTP TR366, NTP Publication No. 89-2821, 1989. (Page 201-253) re: Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets Supporting & Related Material Background Material 2008-10-03T04:00:00Z 2008 10     2019-10-02T17:49:41Z   0 0 090000648055f1e3
FDA-1978-N-0023-0029 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Reference List From The Proprietary Association Other Background Material 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-30T13:27:15Z   0 0 090000648055f020
FDA-1978-N-0023-0033 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter From Nonprescription Drug Manufacturers Association to FDA/CDER Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-30T13:06:41Z   0 0 090000648055f06b
FDA-1978-N-0023-0034 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter From Nonprescription Drug Manufacturers Association to FDA/Office of the Commissioner Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-30T13:04:47Z   0 0 090000648055f06d
FDA-1978-N-0023-0038 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter From Nonprescription Drug Manufacturers Association to FDA CDER Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-30T12:42:04Z   0 0 090000648055f0b0
FDA-1978-N-0023-0042 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Memorandum Of Meeting Between FDA/CDER And Nonprescription Drug Manufacturers Association Hydroquinone Task Force Representatives Other Memorandum 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-30T12:35:15Z   0 0 090000648055f127
FDA-1978-N-0023-0049 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter from FDA/CDER to Dr. Rebat Halder Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-25T19:54:27Z   0 0 090000648055f1bf
FDA-1978-N-0023-0032 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter From New York City Department of Consumer Affairs to FDA Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-30T13:09:08Z   0 0 090000648055f065
FDA-1978-N-0023-0036 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter From FDA/CDER to New York City Department of Consumer Affairs Other Letter(s) 2008-10-03T04:00:00Z 2008 10 2008-10-03T04:00:00Z   2019-09-27T18:46:56Z   0 0 090000648055f076
FDA-1978-N-0023-0059 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets Management (HFA-350) August 17 2006 Supporting & Related Material Background Material 2008-10-03T04:00:00Z 2008 10     2019-09-11T19:06:13Z   0 0 090000648055f208
FDA-1978-N-0023-0020 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Memorandum of Telephone Conversation between FDA/CDER and Venable, LLP Other Memorandum 2006-12-21T05:00:00Z 2006 12     2019-09-16T13:06:41Z   0 0 090000648055fba3
FDA-1978-N-0023-0008 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Internal Memo from Jeffery Shuren, FDA/Office of the Commissioner, to FDA/DDM (HFA-305) dated December 19, 2006 Other Memorandum 2006-12-20T05:00:00Z 2006 12     2019-10-11T16:36:58Z   0 0 090000648055f84b
FDA-1978-N-0023-0006 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Letter from FDA to Colleague Other Letter(s) 2006-09-08T04:00:00Z 2006 9     2019-09-27T13:06:58Z   0 0 090000648055f272
FDA-1978-N-0023-0005 FDA Skin Bleaching Drug Products- OPEN FDA-1978-N-0023 Skin Bleaching Drug Products For Over-the-Counter Human Use; Proposed Rule Proposed Rule Notice of Proposed Rulemaking (NPRM) 2006-08-29T04:00:00Z 2006 8 2006-08-28T04:00:00Z 2006-12-28T04:59:59Z 2019-09-26T13:15:35Z E6-14263 0 0 090000648055f1de

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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);