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

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34 rows where docket_id = "FDA-2015-N-0101" and posted_year = 2016 sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 25
  • Other 9

posted_year 1

  • 2016 · 34 ✖

agency_id 1

  • FDA 34
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-N-0101-1319 FDA None FDA-2015-N-0101 Advice Letter from FDA CDER to American Chemistry Council Other Letter(s) 2016-12-30T05:00:00Z 2016 12 2016-12-30T05:00:00Z   2016-12-30T18:11:04Z   0 0 0900006482442595
FDA-2015-N-0101-1318 FDA None FDA-2015-N-0101 Request for a Type C Meeting from American Chemistry Council Other Request 2016-10-25T04:00:00Z 2016 10 2016-10-25T04:00:00Z   2016-10-25T20:07:00Z   0 0 09000064823379ab
FDA-2015-N-0101-1315 FDA None FDA-2015-N-0101 Response Letter from FDA CDER to American Cleaning Institute Supporting & Related Material Background Material 2016-09-29T04:00:00Z 2016 9     2016-09-29T15:41:50Z   0 0 0900006482280335
FDA-2015-N-0101-1313 FDA None FDA-2015-N-0101 Attachment 3: GOJO Appendix B ICPIC Poster Presentation re: Comment from Beth Glasgow Supporting & Related Material Background Material 2016-09-19T04:00:00Z 2016 9     2016-09-19T12:26:47Z   0 0 09000064822263cc
FDA-2015-N-0101-1311 FDA None FDA-2015-N-0101 Attachment 1 : GOJO Cover Letter Approach and Plan to Address Key Elements for maximal Use PK Trial (MUsT) Design re: Comment from Beth Glasgow Supporting & Related Material Background Material 2016-09-19T04:00:00Z 2016 9     2016-09-19T12:24:10Z   0 0 090000648221d398
FDA-2015-N-0101-1312 FDA None FDA-2015-N-0101 Attachment 2: GOJO Appendix A Dr. Boyce Maximal Use Report re: Comment from Beth Glasgow Supporting & Related Material Background Material 2016-09-19T04:00:00Z 2016 9     2016-09-19T12:23:59Z   0 0 09000064822263cb
FDA-2015-N-0101-1314 FDA None FDA-2015-N-0101 Supplement (Work Plan) from American Cleaning Institute Supporting & Related Material Background Material 2016-09-19T04:00:00Z 2016 9     2016-09-19T12:47:54Z   0 0 09000064822263d0
FDA-2015-N-0101-1309 FDA None FDA-2015-N-0101 Metting Request - Written Response from FDA CDER to American Chemistry Council Other Letter(s) 2016-08-22T04:00:00Z 2016 8 2016-08-22T04:00:00Z   2016-12-15T14:42:28Z   0 0 090000648218d4a2
FDA-2015-N-0101-1305 FDA None FDA-2015-N-0101 Request for a Type C Meeting from American Chemistry Council Isopropanol Panel Other Request 2016-08-12T04:00:00Z 2016 8 2016-08-12T04:00:00Z   2016-08-12T16:38:08Z   0 0 0900006482035f88
FDA-2015-N-0101-1306 FDA None FDA-2015-N-0101 Response from American Cleaning Institute to FDA CDER Other Response(s) 2016-08-12T04:00:00Z 2016 8 2016-08-12T04:00:00Z   2016-08-12T16:54:05Z   0 0 0900006482060fe5
FDA-2015-N-0101-1308 FDA None FDA-2015-N-0101 Handwashing Habits Child Care Workers GLM 16123 National Online Study with Child Care Providers Conducted on Behalf of the American Cleaning Institute (April 2016) from Lewis and Harrison (Lonza Inc.) Supporting & Related Material Background Material 2016-08-12T04:00:00Z 2016 8     2016-08-12T19:21:02Z   0 0 0900006482172254
FDA-2015-N-0101-1307 FDA None FDA-2015-N-0101 Advice Letter from FDA CDER to American Cleaning Institute Other Letter(s) 2016-08-12T04:00:00Z 2016 8 2016-08-12T04:00:00Z   2016-08-12T18:36:40Z   0 0 0900006482171e29
FDA-2015-N-0101-1303 FDA None FDA-2015-N-0101 Letter from FDA CDER to American Cleaning Institute Responding to Additional Questions from February 19, 2015 Meeting Other Letter(s) 2016-07-21T04:00:00Z 2016 7 2016-07-21T04:00:00Z   2016-07-21T13:40:13Z   0 0 09000064820ddd9d
FDA-2015-N-0101-1302 FDA None FDA-2015-N-0101 Advice letter to American Cleaning Institute - 3-8-2016 Supporting & Related Material Background Material 2016-07-19T04:00:00Z 2016 7     2016-07-19T21:07:34Z   0 0 09000064820cf316
FDA-2015-N-0101-1298 FDA None FDA-2015-N-0101 Study No .3: Developmental Toxicity Evaluation of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) Administered by Gavage to CD Rats re: Studies from ADBAC Issues Steering Committee (Lewis and Harrison) Supporting & Related Material Studies and Reports 2016-05-26T04:00:00Z 2016 5     2018-02-07T16:54:59Z   0 0 0900006481ff0a53
FDA-2015-N-0101-1301 FDA None FDA-2015-N-0101 Study No. 9: Chronic Dietary Toxicity/Oncogenicity Study with Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) in Mice re: Studies from ADBAC Issues Steering Committee (Lewis and Harrison) Supporting & Related Material Studies and Reports 2016-05-26T04:00:00Z 2016 5     2018-02-07T16:54:32Z   0 0 0900006481ff0a5c
FDA-2015-N-0101-1299 FDA None FDA-2015-N-0101 Study No. 5: Evaluation of ADBAC in One-Year Chronic Dietary Toxicity Study in Dogs re: Studies from ADBAC Issues Steering Committee (Lewis and Harrison) Supporting & Related Material Studies and Reports 2016-05-26T04:00:00Z 2016 5     2018-02-07T16:55:12Z   0 0 0900006481ff0a55
FDA-2015-N-0101-1297 FDA None FDA-2015-N-0101 Study No.1: Developmental Toxicity Evaluation of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) Administered by Gavage to New Zealand White Rabbits re: Studies from ADBAC Issues Steering Committee (Lewis and Harrison) Supporting & Related Material Studies and Reports 2016-05-26T04:00:00Z 2016 5     2018-02-07T16:54:43Z   0 0 0900006481ff07bb
FDA-2015-N-0101-1300 FDA None FDA-2015-N-0101 Study No. 8: Chronic Dietary Toxicity/Oncogenicity Study with Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) in Rats re: Studies from ADBAC Issues Steering Committee (Lewis and Harrison) Supporting & Related Material Studies and Reports 2016-05-26T04:00:00Z 2016 5     2018-02-07T16:54:21Z   0 0 0900006481ff0a5b
FDA-2015-N-0101-1296 FDA None FDA-2015-N-0101 Studies from ADBAC Issues Steering Committee (Lewis and Harrison) Other Studies 2016-05-25T04:00:00Z 2016 5     2018-02-07T16:50:16Z   0 0 0900006481ff072d
FDA-2015-N-0101-1294 FDA None FDA-2015-N-0101 Attachment 13 Schade and Roukis Use of a Surgical Preparation and Sterile Dressing Change During Office Visit Treatment of Chronic Foot and Ankle Wounds Decreases the Incidence of Infection and Treatment Costs re: Comment from Care-Tech Laboratories, Inc Supporting & Related Material Background Material 2016-03-28T04:00:00Z 2016 3     2016-03-28T13:23:26Z   0 0 0900006481ca5f3d
FDA-2015-N-0101-1293 FDA None FDA-2015-N-0101 Meeting Minutes between FDA and the American Chemistry Council Other Minutes 2016-02-26T05:00:00Z 2016 2 2016-02-26T05:00:00Z   2016-02-26T15:30:27Z   0 0 0900006481e8a9ce
FDA-2015-N-0101-1285 FDA None FDA-2015-N-0101 Attachment 5 Time Kill Study Report Conducted by NIPA Lab Inc re: Comment from Care-Tech Laboratories, Inc Supporting & Related Material Background Material 2016-01-11T05:00:00Z 2016 1     2016-01-11T19:58:35Z   0 0 0900006481ca3056
FDA-2015-N-0101-1287 FDA None FDA-2015-N-0101 Attachment 7 Cited Article from University of Minnesota re: Comment from Care-Tech Laboratories, Inc Supporting & Related Material Background Material 2016-01-11T05:00:00Z 2016 1     2016-01-11T20:11:40Z   0 0 0900006481ca3058
FDA-2015-N-0101-1291 FDA None FDA-2015-N-0101 Attachment 11 Abstract from University of Minnesota re: Comment from Care-Tech Laboratories, Inc Supporting & Related Material Background Material 2016-01-11T05:00:00Z 2016 1     2016-01-11T20:16:15Z   0 0 0900006481ca305c
FDA-2015-N-0101-1281 FDA None FDA-2015-N-0101 Table of Contents re: Comment from Care-Tech Laboratories, Inc Supporting & Related Material Background Material 2016-01-11T05:00:00Z 2016 1     2016-01-11T19:51:41Z   0 0 0900006481ca2f98
FDA-2015-N-0101-1282 FDA None FDA-2015-N-0101 Attachment 1 Hill Top Biolabs, Inc - Cup scrub method Suppression of Skin Microflora re: Comment from Care-Tech Laboratories, Inc Supporting & Related Material Background Material 2016-01-11T05:00:00Z 2016 1     2016-01-11T19:52:42Z   0 0 0900006481ca3052
FDA-2015-N-0101-1286 FDA None FDA-2015-N-0101 Attachment 6 Antimicrobial Testing of Surgical Scrub Formulation Report Conducted by Ferro Corp re: Comment from Care-Tech Laboratories, Inc Supporting & Related Material Background Material 2016-01-11T05:00:00Z 2016 1     2016-01-11T19:59:51Z   0 0 0900006481ca3057
FDA-2015-N-0101-1289 FDA None FDA-2015-N-0101 Attachment 9 Cited Article from University of Minnesota re: Comment from Care-Tech Laboratories, Inc Supporting & Related Material Background Material 2016-01-11T05:00:00Z 2016 1     2016-01-11T20:14:00Z   0 0 0900006481ca305a
FDA-2015-N-0101-1292 FDA None FDA-2015-N-0101 Attachment 12 Catherine L. Statz Fighting Wound Infection re: Comment from Care-Tech Laboratories, Inc Supporting & Related Material Background Material 2016-01-11T05:00:00Z 2016 1     2016-01-11T20:17:24Z   0 0 0900006481ca305e
FDA-2015-N-0101-1288 FDA None FDA-2015-N-0101 Attachment 8 Techni-Care vs Mycobacterium Bovis TMC re: Comment from Care-Tech Laboratories, Inc Supporting & Related Material Background Material 2016-01-11T05:00:00Z 2016 1     2016-01-11T20:12:34Z   0 0 0900006481ca3059
FDA-2015-N-0101-1283 FDA None FDA-2015-N-0101 Attachment 3 Eyetex Screen - Occular Irritation re: Comment from Care-Tech Laboratories, Inc Supporting & Related Material Background Material 2016-01-11T05:00:00Z 2016 1     2016-01-11T19:55:20Z   0 0 0900006481ca3054
FDA-2015-N-0101-1290 FDA None FDA-2015-N-0101 Attachment 10 Cited Article from University of Florida College of Veterinary Medicine re: Comment from Care-Tech Laboratories, Inc Supporting & Related Material Background Material 2016-01-11T05:00:00Z 2016 1     2016-01-11T20:15:23Z   0 0 0900006481ca305b
FDA-2015-N-0101-1284 FDA None FDA-2015-N-0101 Attachment 4 Acute Oral Toxicity in Rats re: Comment from Care-Tech Laboratories, Inc Supporting & Related Material Background Material 2016-01-11T05:00:00Z 2016 1     2016-01-11T19:57:10Z   0 0 0900006481ca3055

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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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