{"abstract":"The Food and Drug Administration (FDA) is establishing a public docket to make available to the public a report of the pediatric studies of Lorazepam that were conducted in accordance with the Public Health Service Act (PHS Act) and submitted to the Director of the National Institutes of Health (NIH) and the Commissioner of Food and Drugs.","action":"Notice; establishment of docket.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/03/29/2016-07012.html","cfr_references":[],"citation":"81 FR 17461","comment_url":null,"comments_close_on":"2016-04-28","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by April 28, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-3037"],"dockets":[{"supporting_documents":[{"title":"0074_R_IND79010_A0030_Status2_Corrected-CSR_Section14-clean","document_id":"FDA-2015-N-3037-0078"},{"title":"0073_R_IND79010_A0030_Status2_Corrected-CSR_Narrative-clean","document_id":"FDA-2015-N-3037-0077"},{"title":"0072_R_IND79010_A0030_Status2_Corrected-CSR_Narrative_track-changes","document_id":"FDA-2015-N-3037-0076"},{"title":"0071_R_IND79010_A0030_Status2_Corrected-CSR_Summary-of-Changes","document_id":"FDA-2015-N-3037-0075"},{"title":"0070_R_IND79010_A0030_FDA-Information-Request-and-Email-Response","document_id":"FDA-2015-N-3037-0074"},{"title":"0069_R_IND79010_A0030_Form-FDA-1571","document_id":"FDA-2015-N-3037-0073"},{"title":"0068_R_IND79010_A0030_Letter","document_id":"FDA-2015-N-3037-0072"},{"title":"0067_R_IND79010_A0028_RRI3_Status1-and-Status2_SAP-Non-Inferiority-Design","document_id":"FDA-2015-N-3037-0071"},{"title":"0066_R_IND79010_A0028_IA_Status2_CSR_Corrected-Tables-NA","document_id":"FDA-2015-N-3037-0070"},{"title":"0065_R_IND79010_A0028_RRI2_Status2-Concomitant-AEDs","document_id":"FDA-2015-N-3037-0069"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2016-03-29","updated_at":"2023-02-28T16:19:26.070-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-N-3037-0079","allow_late_comments":null,"id":"FDA-2015-N-3037-0079","comment_end_date":"2016-04-29","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":77,"id":"FDA-2015-N-3037","title":"Pediatric Studies of Lorazepam Conducted in Accordance With the Public Health Service Act; 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