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

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1,246 rows where docket_id = "FDA-2015-N-0101" and posted_year = 2015 sorted by posted_date descending

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  • 2015 · 1,246 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-N-0101-1252 FDA None FDA-2015-N-0101 Letter from FDA CDER to American Chemical Council Granting Meeting Request Other Letter(s) 2015-10-13T04:00:00Z 2015 10 2015-10-13T04:00:00Z   2015-10-13T13:50:38Z   0 0 0900006481cc3f44
FDA-2015-N-0101-1249 FDA None FDA-2015-N-0101 Supplement from GOJO Industries, Inc. Other Supplement (SUP) 2015-10-05T04:00:00Z 2015 10 2015-10-05T04:00:00Z   2015-10-05T19:30:12Z   0 0 0900006481b6a2d7
FDA-2015-N-0101-1248 FDA None FDA-2015-N-0101 Memorandum of Meeting Minutes Re: GOJO Industries Inc Other Minutes 2015-09-02T04:00:00Z 2015 9 2015-09-02T04:00:00Z   2015-09-02T19:27:00Z   0 0 0900006481c5196a
FDA-2015-N-0101-1247 FDA None FDA-2015-N-0101 Meeting Granted Letter to GOJO Industries, Inc. Other Letter(s) 2015-07-29T04:00:00Z 2015 7 2015-07-29T04:00:00Z   2015-07-29T14:23:11Z   0 0 0900006481bad9d2
FDA-2015-N-0101-1245 FDA None FDA-2015-N-0101 Tab B 1 of 2 Substantive Changes Between Draft Regulatory Impact Analysis and Cleared Regulatory Impact Analysis Submitted to OIRA re Memorandum of Health Care Antiseptics Supporting & Related Material Background Material 2015-06-17T04:00:00Z 2015 6     2015-06-17T16:26:49Z   0 0 0900006481b40f80
FDA-2015-N-0101-1241 FDA None FDA-2015-N-0101 Memorandum of Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Other Memorandum 2015-06-17T04:00:00Z 2015 6 2015-06-17T04:00:00Z   2015-07-29T14:11:40Z   0 0 0900006481b40f1b
FDA-2015-N-0101-1243 FDA None FDA-2015-N-0101 Tab A 2 of 2 Preliminary Regulatory Impact Analysis re Memorandum of Health Care Antiseptics Supporting & Related Material Background Material 2015-06-17T04:00:00Z 2015 6     2015-06-17T16:14:49Z   0 0 0900006481b40f7e
FDA-2015-N-0101-1244 FDA None FDA-2015-N-0101 Tab B 1 of 2 Substantive Changes Between Draft Regulatory Action and Cleared Regulatory Action Submitted to OIRA re Memorandum of Health Care Antiseptics Supporting & Related Material Background Material 2015-06-17T04:00:00Z 2015 6     2015-06-17T16:26:43Z   0 0 0900006481b40f7f
FDA-2015-N-0101-1242 FDA None FDA-2015-N-0101 Tab A 1 of 2 Draft Regulatory Action Submitted to OMB's Office of Information and Regulatory Affairs re Memorandum of Health Care Antiseptics Supporting & Related Material Background Material 2015-06-17T04:00:00Z 2015 6     2015-06-17T16:13:34Z   0 0 0900006481b40f1c
FDA-2015-N-0101-1237 FDA None FDA-2015-N-0101 Meeting Request from GOJO Industries, Inc. Other Request 2015-06-17T04:00:00Z 2015 6 2015-06-17T04:00:00Z   2015-06-17T15:38:56Z   0 0 0900006481ad2e52
FDA-2015-N-0101-1202 FDA None FDA-2015-N-0101 Economics Section - References List re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:10:25Z   0 0 0900006481b0a339
FDA-2015-N-0101-1206 FDA None FDA-2015-N-0101 Econ Reference 4 - Aiello, A. E. et al. re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:10:46Z   0 0 0900006481b0a33d
FDA-2015-N-0101-1215 FDA None FDA-2015-N-0101 Econ Reference 13 - Stoker, T. E., E. K. Gibson, and L. M. Zorrilla re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:11:32Z   0 0 0900006481b0a400
FDA-2015-N-0101-1203 FDA None FDA-2015-N-0101 Econ Reference 1 - Centers for Disease Control and Prevention re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:10:30Z   0 0 0900006481b0a33a
FDA-2015-N-0101-1211 FDA None FDA-2015-N-0101 Econ Reference 9 - Jacobs, M. N., G. T. Nolan, and S. R. Hood re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:11:11Z   0 0 0900006481b0a3fc
FDA-2015-N-0101-1229 FDA None FDA-2015-N-0101 Econ Reference 27 - Jia H., Lubetkin EI re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:26:56Z   0 0 0900006481b0a40e
FDA-2015-N-0101-1205 FDA None FDA-2015-N-0101 Econ Reference 3 - World Health Organization re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:10:39Z   0 0 0900006481b0a33c
FDA-2015-N-0101-1219 FDA None FDA-2015-N-0101 Econ Reference 17 - Bernal, A. J. and R. L. Jirtle re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:22:13Z   0 0 0900006481b0a404
FDA-2015-N-0101-1231 FDA None FDA-2015-N-0101 Econ Reference 29 - Chaix, Carine, Isabelle Durand-Zaleski, Corinne Alberti, and Christian Brun-Buisson re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:27:07Z   0 0 0900006481b0a410
FDA-2015-N-0101-1234 FDA None FDA-2015-N-0101 Econ Reference 32 - RTI (Muth, M.K., Melanie J. Ball, Michaela C. Coglaiti, and Shawn A. Karns) re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:27:24Z   0 0 0900006481b0a413
FDA-2015-N-0101-1235 FDA None FDA-2015-N-0101 Econ Reference 33 - Paulson, Marsha and Gayle Mulberry re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:27:28Z   0 0 0900006481b0a414
FDA-2015-N-0101-1222 FDA None FDA-2015-N-0101 Econ Reference 20 - Centers for Disease Control and Prevention re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:26:20Z   0 0 0900006481b0a407
FDA-2015-N-0101-1217 FDA None FDA-2015-N-0101 Econ Reference 15 - Diamanti-Kandarakis, E. et al. re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:11:43Z   0 0 0900006481b0a402
FDA-2015-N-0101-1223 FDA None FDA-2015-N-0101 Econ Reference 21 - Centers for Disease Control and Prevention re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:26:25Z   0 0 0900006481b0a408
FDA-2015-N-0101-1204 FDA None FDA-2015-N-0101 Econ Reference 2 - Mangram, A. J. et al. re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:10:35Z   0 0 0900006481b0a33b
FDA-2015-N-0101-1214 FDA None FDA-2015-N-0101 Econ Reference 12 - Paul, K. B. et al. re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:11:27Z   0 0 0900006481b0a3ff
FDA-2015-N-0101-1216 FDA None FDA-2015-N-0101 Econ Reference 14 - Zorrilla, L. M. et al. re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:11:37Z   0 0 0900006481b0a401
FDA-2015-N-0101-1213 FDA None FDA-2015-N-0101 Econ Reference 11 - Kumar, V. et al. re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:11:21Z   0 0 0900006481b0a3fe
FDA-2015-N-0101-1224 FDA None FDA-2015-N-0101 Econ Reference 22 - Beggs, Clive, Simon Shepherd, and Kevin Kerr re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:26:30Z   0 0 0900006481b0a409
FDA-2015-N-0101-1225 FDA None FDA-2015-N-0101 Econ Reference 23 - Centers for Disease Control and Prevention re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:26:34Z   0 0 0900006481b0a40a
FDA-2015-N-0101-1226 FDA None FDA-2015-N-0101 Econ Reference 24 - The California Department of Public Health re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:26:39Z   0 0 0900006481b0a40b
FDA-2015-N-0101-1227 FDA None FDA-2015-N-0101 Econ Reference 25 - Center for the Evaluation of Value and Risk in Health re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:26:45Z   0 0 0900006481b0a40c
FDA-2015-N-0101-1228 FDA None FDA-2015-N-0101 Econ Reference 26 - Jia H., Zack M.M., Moriarty D.G., Fryback D.G re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:26:51Z   0 0 0900006481b0a40d
FDA-2015-N-0101-1230 FDA None FDA-2015-N-0101 Econ Reference 28 - Singh, Nina, David Paterson, Feng Yea Chang, Timothy Gayowski, Cheryl Squier, Marilyn Wagener, and Ignazio Marino re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:27:02Z   0 0 0900006481b0a40f
FDA-2015-N-0101-1212 FDA None FDA-2015-N-0101 Econ Reference 10 - Jacobs, M. N., G. T. Nolan, and S. R. Hood re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:11:16Z   0 0 0900006481b0a3fd
FDA-2015-N-0101-1218 FDA None FDA-2015-N-0101 Econ Reference 16 - Anway, M. D. and M. K. Skinner re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:11:51Z   0 0 0900006481b0a403
FDA-2015-N-0101-1221 FDA None FDA-2015-N-0101 Econ Reference 19 - Lindgren, Debbie re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:26:14Z   0 0 0900006481b0a406
FDA-2015-N-0101-1209 FDA None FDA-2015-N-0101 E0007 Econ Reference 7 - Ahn, K. C. et al. Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:11:00Z   0 0 0900006481b0a3fa
FDA-2015-N-0101-1232 FDA None FDA-2015-N-0101 Econ Reference 30 - Plowman, R., N. Graves, M.A.S Griffin, J.A. Roberts, A.V. Swan, B. Cookson, and L. Taylor re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:27:12Z   0 0 0900006481b0a411
FDA-2015-N-0101-1236 FDA None FDA-2015-N-0101 Econ Reference 34 - Baker-Smith, Carissa, Daniel K Benjamin Jr, Henry G Grabowski, Elizabeth D Reid, Barry Mangum, John v Goldsmith, M Dianne, Murphy, Edwards re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:27:32Z   0 0 0900006481b0a415
FDA-2015-N-0101-1208 FDA None FDA-2015-N-0101 Econ Reference 6 - Crofton, K. M. et al. re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:10:56Z   0 0 0900006481b0a33f
FDA-2015-N-0101-1210 FDA None FDA-2015-N-0101 Econ Reference 8 - Gee, R. H. et al. re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:11:05Z   0 0 0900006481b0a3fb
FDA-2015-N-0101-1220 FDA None FDA-2015-N-0101 Econ Reference 18 - IMS Health re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:22:23Z   0 0 0900006481b0a405
FDA-2015-N-0101-1207 FDA None FDA-2015-N-0101 Econ Reference 5 - Chen, J. et al. re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:10:51Z   0 0 0900006481b0a33e
FDA-2015-N-0101-1233 FDA None FDA-2015-N-0101 Econ Reference 31 - Bureau of Labor Statistics re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-28T04:00:00Z 2015 5     2015-05-28T20:27:19Z   0 0 0900006481b0a412
FDA-2015-N-0101-1110 FDA None FDA-2015-N-0101 Reference 202 - Jeng et al, The Effect of Povidone-Iodine on Thyroid Function of Neonates with Different Birth Sizes re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:22:45Z   0 0 0900006481af616c
FDA-2015-N-0101-1113 FDA None FDA-2015-N-0101 Reference 205 - Nobukuni and Kawahara, Thyroid Function in Nurses The Influence of Povidone-Iodine Hand Washing and Gargling re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:23:03Z   0 0 0900006481af616f
FDA-2015-N-0101-1171 FDA None FDA-2015-N-0101 Reference 263 - Cookson, Clinical Significance of Emergence of Bacterial Antimicrobial Resistance in the Hospital Environment re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:30:40Z   0 0 0900006481af602d
FDA-2015-N-0101-1177 FDA None FDA-2015-N-0101 Reference 269 - Lan et al, TCS Exhibits a Tendency to Accumulate in the Epididymis and Shows Sperm Toxicity in Male Rats re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:31:14Z   0 0 0900006481af6035
FDA-2015-N-0101-1168 FDA None FDA-2015-N-0101 Reference 260 - C85 Docket 1975N-0183H re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:30:21Z   0 0 0900006481af602a
FDA-2015-N-0101-1195 FDA None FDA-2015-N-0101 Reference 287 - Singer et al, TCS Occurrence and Fate of a Widely Used Biocide in the Aquatic Environment re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:33:14Z   0 0 0900006481af6049
FDA-2015-N-0101-1199 FDA None FDA-2015-N-0101 Reference 291 - SCENIHR Research Strategy to Address the Knowledge Gaps on the Antimicrbial Resistance Effects of Biocides re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:33:35Z   0 0 0900006481af604d
FDA-2015-N-0101-1200 FDA None FDA-2015-N-0101 Reference 292 - NIAAA Fetal Alcohol Exposure re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:33:40Z   0 0 0900006481af604e
FDA-2015-N-0101-1132 FDA None FDA-2015-N-0101 Reference 224 - Tyl et al, Developmental Toxicity Evaluation of Isopropanol by Gavage in Rats and Rabbits re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:24:56Z   0 0 0900006481af619a
FDA-2015-N-0101-1134 FDA None FDA-2015-N-0101 Reference 226 - Allen et al, Calculation of Benchmark Doses for Reproductive and Developmental Toxicity Observed after Exposure to Isopropanol re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:25:10Z   0 0 0900006481af619c
FDA-2015-N-0101-1152 FDA None FDA-2015-N-0101 Reference 244 - Plezia, CP12 Ciba A Pilot Study for In Vivo Evaluation of the Percutaneous Absorption of TCS re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:27:03Z   0 0 0900006481af61ae
FDA-2015-N-0101-1161 FDA None FDA-2015-N-0101 Reference 253 - Wu et al, Determination of TCS metabolites by Using HPLC re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:27:48Z   0 0 0900006481af61b7
FDA-2015-N-0101-1165 FDA None FDA-2015-N-0101 Reference 257 - Trimmer, 90 Day Subchronic Dermal Toxicity Study C1 1994 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:30:02Z   0 0 0900006481af6027
FDA-2015-N-0101-1125 FDA None FDA-2015-N-0101 Reference 217 - Slaughter et al, Isopropanol Poisoning re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:24:11Z   0 0 0900006481af6193
FDA-2015-N-0101-1151 FDA None FDA-2015-N-0101 Reference 243 - Beiswanger & Tuohy, Analysis of Blood Plasma Samples for Free TCS from Subjects Using a TSC Dentrifice or Bar Soap and Deodorant re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:26:59Z   0 0 0900006481af61ad
FDA-2015-N-0101-1126 FDA None FDA-2015-N-0101 Reference 218 - WHO IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Re-Evaluation of Some Organic Chemicals Hydrazine and Hydrogen Peroxide 1999 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:24:18Z   0 0 0900006481af6194
FDA-2015-N-0101-1144 FDA None FDA-2015-N-0101 Reference 236 - Birch et al, Biotransformation Products of TCC in Rat Monkey and Man re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:26:13Z   0 0 0900006481af61a6
FDA-2015-N-0101-1154 FDA None FDA-2015-N-0101 Reference 246 - Allmyr et al, Human Exposure to TSC via Toothpaste Does not Change CYP3A4 Activity or Plasma Concentration of Tyroid Hormones re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:27:12Z   0 0 0900006481af61b0
FDA-2015-N-0101-1160 FDA None FDA-2015-N-0101 Reference 252 - Van Dijk Ciba TCS ADME in mice re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:27:43Z   0 0 0900006481af61b6
FDA-2015-N-0101-1164 FDA None FDA-2015-N-0101 Reference 256 - Burns et al, 14-Day Repeated Dose Dermal Study of TC in CD-1 Mice CHV 2763-100 Part 1 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:29:56Z   0 0 0900006481af61ba
FDA-2015-N-0101-1097 FDA None FDA-2015-N-0101 Reference 189 - Arrington et al, Effects of Excess Dietary Iodine Upon Rabbits Hamster Rats and Swine re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:20:55Z   0 0 0900006481af615f
FDA-2015-N-0101-1102 FDA None FDA-2015-N-0101 Reference 194 - Shoyinka et al, Effect of Iodine Supplementation on Thyroid and Testicular Morphology and Function in Euthyroid Rats re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:21:38Z   0 0 0900006481af6164
FDA-2015-N-0101-1105 FDA None FDA-2015-N-0101 Reference 197 - Calaciura et al, Childhood IQ Measurements in Infants with Tranient Congenital Hypothyroidism re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:22:07Z   0 0 0900006481af6167
FDA-2015-N-0101-1143 FDA None FDA-2015-N-0101 Reference 235 - Schebb t al, Investigation of Human Exposure to TCC after Showering and Preliminary Evaluation of its Biological Effects re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:26:08Z   0 0 0900006481af61a5
FDA-2015-N-0101-1169 FDA None FDA-2015-N-0101 Reference 261 - Morseth, Two-Generation Reproduction Study in Rats TCS RPT7 Vol I & II re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:30:26Z   0 0 0900006481af602b
FDA-2015-N-0101-1194 FDA None FDA-2015-N-0101 Reference 286 - Kinney et al, Bioaccumulation of Pharmaceuticals and Other Anthropogenic Waste Indicators in Earthworms From Agricultural Soil Amended with Biosolid or Swine Manure re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:33:08Z   0 0 0900006481af6046
FDA-2015-N-0101-1201 FDA None FDA-2015-N-0101 Reference 293 - Little et al, Effects of Alcohol on the Hypothalamic-Pituitary-Gonadal Axis in the Developing Male Rat re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:33:46Z   0 0 0900006481af604f
FDA-2015-N-0101-1129 FDA None FDA-2015-N-0101 Reference 221 - Faber et al, Review of Reproductive and Developmental Toxicity Studies with Isopropanol re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:24:33Z   0 0 0900006481af6197
FDA-2015-N-0101-1145 FDA None FDA-2015-N-0101 Reference 237 - Gruenke et al, A Selected Ion Monitoring GCMS Assay for TCC and its Metabolites in Biological Fluids re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:26:19Z   0 0 0900006481af61a7
FDA-2015-N-0101-1159 FDA None FDA-2015-N-0101 Reference 251 - Van Dijk, Ciba TCS ADME in hamsters re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:27:36Z   0 0 0900006481af61b5
FDA-2015-N-0101-1158 FDA None FDA-2015-N-0101 Reference 250 - Tulp et al, Metabolism of TCS re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:27:31Z   0 0 0900006481af61b4
FDA-2015-N-0101-1096 FDA None FDA-2015-N-0101 Reference 188 - Takegawa et al, Large Amount of Vit A has no Major Effects on Thyoidal Hormone Synthesis in two stage Rat Thyroid Carcinogenesis Model re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:20:50Z   0 0 0900006481af615e
FDA-2015-N-0101-1101 FDA None FDA-2015-N-0101 Reference 193 - Linder et al, Topical Iodine Containing Antiseptics and Subclinical Hypothyroidism in Preterm Infants re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:21:24Z   0 0 0900006481af6163
FDA-2015-N-0101-1112 FDA None FDA-2015-N-0101 Reference 204 - Lyen et al, Transient Thyroid Suppression Associated with Topically Applied Povidone-Iodine re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:22:56Z   0 0 0900006481af616e
FDA-2015-N-0101-1121 FDA None FDA-2015-N-0101 Reference 213 - Martinez et al, A Comparison of the Absorption and Metabolism of Isopropyl Alcohol by Oral Dermal and Inhalation Routes re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:23:51Z   0 0 0900006481af618f
FDA-2015-N-0101-1122 FDA None FDA-2015-N-0101 Reference 214 - Slauter et al, Disposition and Pharmacokinetics of Isopropaol in Rats and Mice re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:23:56Z   0 0 0900006481af6190
FDA-2015-N-0101-1167 FDA None FDA-2015-N-0101 Reference 259- Chasseaud et al, TCS hamster TK PR5 1999 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:30:16Z   0 0 0900006481af6029
FDA-2015-N-0101-1170 FDA None FDA-2015-N-0101 Reference 262 - James et al, TCS Is a Potent Inhibitor of Estradiol and Estrone Sulfonation in Sheep Placenta re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:30:32Z   0 0 0900006481af602c
FDA-2015-N-0101-1179 FDA None FDA-2015-N-0101 Reference 271 - Hernandez et al, The Binding of TCS to SmeT the Repressor of the Multidrug Efflux Pump SmeDEF Induces Antibiotic Resistance in Stenotrophomonas re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:31:33Z   0 0 0900006481af6037
FDA-2015-N-0101-1172 FDA None FDA-2015-N-0101 Reference 264 - MacIsaac et al, Health Care WOrker Exposures to the Antibacterial Agent TCS re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:30:46Z   0 0 0900006481af602e
FDA-2015-N-0101-1178 FDA None FDA-2015-N-0101 Reference 270 - Fernando et al, TCS Can Select for an ADEIJK Overexpressing Mutant of Acinetobacter that Displays Reduced Susceptibility to Antibiotics re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:31:27Z   0 0 0900006481af6036
FDA-2015-N-0101-1193 FDA None FDA-2015-N-0101 Reference 285 - Halden & Paull, Co-Occurrence of TCC and TCS in US Water Resources re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:33:02Z   0 0 0900006481af6045
FDA-2015-N-0101-1142 FDA None FDA-2015-N-0101 Reference 234 - Schebb et al, Whole Blood is the Sample Matrix of Choice for Monitoring Systemic TCC Levels re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:26:03Z   0 0 0900006481af61a4
FDA-2015-N-0101-1091 FDA None FDA-2015-N-0101 Reference 183 - Nobukuni et al, The Influence of Long Term Treatment with Povidone Iodine on Thyoid Function re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:20:16Z   0 0 0900006481af6159
FDA-2015-N-0101-1100 FDA None FDA-2015-N-0101 Reference 192 - Delange et al, Topical Iodine Breastfeeding and Neonatal Hypothyroidism re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:21:18Z   0 0 0900006481af6162
FDA-2015-N-0101-1114 FDA None FDA-2015-N-0101 Reference 206 - Perez-Lopez, Iodine and Thyroid Hormones During Pregnancy and Postpartum re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:23:08Z   0 0 0900006481af6170
FDA-2015-N-0101-1131 FDA None FDA-2015-N-0101 Reference 223 - Nelson et al, Teratogenicity of n-Propanol and Isopropanol Adminstered at High Inhalation Concentrations to Rats re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:24:51Z   0 0 0900006481af6199
FDA-2015-N-0101-1135 FDA None FDA-2015-N-0101 Reference 227 - Gorkal & Namasivayam, Effect of Isopropanol on Rat Brain Monoamine Levels re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:25:15Z   0 0 0900006481af619d
FDA-2015-N-0101-1089 FDA None FDA-2015-N-0101 Reference 181 - Brown et al, Routine Skin Cleansing with Povidone-iodine is not a Common Cause of Transient Neonatal Hypothyroidism in North America re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:20:03Z   0 0 0900006481af6157
FDA-2015-N-0101-1098 FDA None FDA-2015-N-0101 Reference 190 - Coakley et al, Transient Primary Hypothyrodidism in the Newborn Experience of the Victorian Neonatal Thyroid Screening Programme re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:21:06Z   0 0 0900006481af6160
FDA-2015-N-0101-1106 FDA None FDA-2015-N-0101 Reference 198 - Casteels et al, Transient Neonatal Hypothyroidism During Breastfeeding after Post-Natal Maternal Topical Iodine Treatment re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:22:15Z   0 0 0900006481af6168
FDA-2015-N-0101-1120 FDA None FDA-2015-N-0101 Reference 212 - Boatman et al, Dermal Absorption and Pharmacokinetics of Isopropanol in the Male and Female F344 Rat re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:23:47Z   0 0 0900006481af618e
FDA-2015-N-0101-1123 FDA None FDA-2015-N-0101 Reference 215 - Kapp et al, Isopropanol Summary of TSCA Test Rule Studies and Relevance to Hazard Identification re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:24:02Z   0 0 0900006481af6191
FDA-2015-N-0101-1186 FDA None FDA-2015-N-0101 Reference 278 - Nielsen et al, Stapylococcus but Not Listeria Adapt to TCS and Adaptation Correlates with Increased fabI Expression re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:32:08Z   0 0 0900006481af603e
FDA-2015-N-0101-1191 FDA None FDA-2015-N-0101 Reference 283 - Lanini et al, Molecular Epidemiology of Pseudomonas aeruginosa Hospital Outbreak Driven by a Contaminated Disinfectant Soap Dispenser re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2015-05-27T04:00:00Z 2015 5     2015-05-27T19:32:38Z   0 0 0900006481af6043

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