{"abstract":"The Food and Drug Administration (FDA or the Agency) is announcing a formal evidentiary public hearing on the proposal to withdraw approval of the abbreviated new drug application (ANDA) 091695, submitted by Kremers Urban Pharmaceuticals, Inc. (Kremers) for methylphenidate hydrochloride extended-release tablets. On October 18, 2016, the Director of FDA's Center for Drug Evaluation and Research (CDER) published a notice of opportunity for hearing on a proposal to withdraw approval of ANDA 091695. Kremers submitted a timely request for hearing on that proposal. This notice of hearing provides factual and legal information concerning CDER's proposal to withdraw approval of ANDA 091695 and identifies the factual issues that will be the subject of the evidentiary hearing.","action":"Notice.","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/2026/08/13/2026-16536.html","cfr_references":[],"citation":"91 FR 52307","comment_url":"http://www.regulations.gov/commenton/FDA-2016-N-3120-0570","comments_close_on":null,"correction_of":null,"corrections":[],"dates":"A prehearing conference will be held on September 28, 2026, beginning at 10:00 a.m. Eastern Daylight Time. Any person wishing to participate in this hearing shall submit a written notice of participation by September 14, 2026. Disclosure of data and information as required by 21 CFR 12.85(b) must be made by October 13, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-3120"],"dockets":[{"supporting_documents":[{"title":"Reference 121 Wigal, et al (1998). Reliability and validity of the SKAMP rating scale in a laboratory school setting. Psychopharm Bull, 34(1), 47-56. re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0489"},{"title":"Reference 116 Vitiello et al (2001). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0484"},{"title":"Reference 115 United States Pharmacopeia (USP), Convention (2017). Methylphenidate Hydrochloride Monograph re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0483"},{"title":"Reference 107 Stein et al (2003). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0475"},{"title":"Reference 101 Shram et al (2012). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0469"},{"title":"Reference 81 Modi et al (2000). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0449"},{"title":"Reference 78 Micheal & Balamurali (2015). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0446"},{"title":"Reference 77 Massachusetts General Hospital, PK/PD Pediatric ADHD Classroom Study. NCT02536105 re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0445"},{"title":"Reference 63 IMS Health National Sales Perspectives re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0431"},{"title":"Reference 55 Copyright Article (see abstract) re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0423"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-08-13","updated_at":"2026-09-19T04:56:41.391-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-3120-0570","allow_late_comments":false,"id":"FDA-2016-N-3120-0570","comment_end_date":"2026-10-14","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":527,"id":"FDA-2016-N-3120","title":"Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets"}],"document_number":"2026-16536","effective_on":null,"end_page":52310,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/08/13/2026-16536.xml","html_url":"https://www.federalregister.gov/documents/2026/08/13/2026-16536/kremers-urban-pharmaceuticals-inc-grant-of-hearing-request-regarding-a-proposal-to-withdraw-approval","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-16536?publication_date=2026-08-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-08-13/2026-16536/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":299,"last_updated":"2026-09-20 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-13/pdf/2026-16536.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16536.pdf?1786538718","publication_date":"2026-08-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/08/13/2026-16536.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 121 Wigal, et al (1998). Reliability and validity of the SKAMP rating scale in a laboratory school setting. Psychopharm Bull, 34(1), 47-56. re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0489"},{"title":"Reference 116 Vitiello et al (2001). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0484"},{"title":"Reference 115 United States Pharmacopeia (USP), Convention (2017). Methylphenidate Hydrochloride Monograph re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0483"},{"title":"Reference 107 Stein et al (2003). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0475"},{"title":"Reference 101 Shram et al (2012). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0469"},{"title":"Reference 81 Modi et al (2000). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0449"},{"title":"Reference 78 Micheal & Balamurali (2015). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0446"},{"title":"Reference 77 Massachusetts General Hospital, PK/PD Pediatric ADHD Classroom Study. NCT02536105 re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0445"},{"title":"Reference 63 IMS Health National Sales Perspectives re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0431"},{"title":"Reference 55 Copyright Article (see abstract) re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0423"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-3120","supporting_documents_count":527,"docket_id":"FDA-2016-N-3120","document_id":"FDA-2016-N-3120-0570","regulation_id_number":null,"title":"Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets","checked_regulationsdotgov_at":"2026-09-20T10:55:03Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2016-N-3120-0570","significant":null,"signing_date":null,"start_page":52307,"subtype":null,"title":"Kremers Urban Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets","toc_doc":"Kremers Urban Pharmaceuticals, Inc., Extended-Release Methylphenidate Tablets; Grant of Hearing Request","toc_subject":"Withdrawal of Approval of Drug Application","topics":[],"type":"Notice","volume":91}