Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of 249 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs and is announcing an opportunity for the ANDA holders to request a hearing on this proposal. The basis for the proposal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs.
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-2019-N-5254] 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 249 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs and is announcing an opportunity for the ANDA holders to request a hearing on this proposal. The basis for the proposal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs. DATES: The ANDA holders may submit a request for a hearing by February 10, 2020. Submit all data, information, and analyses upon which the request for a hearing relies by March 9, 2020. Submit electronic or written comments by March 9, 2020. ADDRESSES: The request for a hearing may be submitted by the ANDA holders by either of the following methods: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments to submit your request for a hearing. Comments submitted electronically to https://www.regulations.gov , including any attachments to the request for a hearing, will be posted to the docket unchanged. Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305),…
Citation: 85 FR 1160
