Kremers Urban Pharmaceuticals Inc.; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets; Opportunity for a Hearing

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2016-N-3120] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for methylphenidate hydrochloride (HCl) extended-release (ER) tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal. DATES: Kremers Urban Pharmaceuticals Inc., may submit a request for a hearing by November 17, 2016. Submit all data, information, and analyses upon which the request for a hearing relies by December 19, 2016. Submit written or electronic comments by December 19, 2016. ADDRESSES: The request for a hearing may be submitted by Kremers Urban Pharmaceuticals Inc., by either of the following methods: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments to submit your request for a hearing. Your request for a hearing submitted electronically to http://www.regulations.gov , including any attachments to the request for hearing, will be posted to the docket unchanged. Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper request for a hearing): Division of Dockets Management (HFA-305), Food and Drug…