Rules and Regulations. Notice; establishment of a public docket; request for comments

Agency: Food and Drug Administration, HHS
Action: Notice; establishment of a public docket; request for comments
Citation: FR Doc. 2021-20740 · Docket No. FDA-2021-N-0897

Summary

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

Dates

The meeting will be held on December 2, 2021, from 9 a.m. to 5 p.m. Eastern Time.

Supplementary Information

Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will hear updates on new drug applications (NDAs) approved under 21 CFR 314.500 (subpart H, accelerated approval regulations) that have not verified clinical benefit. This update will provide information on: (1) The status and results of confirmatory clinical studies for a given indication and (2) any ongoing and planned trials. Confirmatory studies are post-marketing studies to verify and describe the clinical benefit of a drug after it receives accelerated approval. Based on the updates provided, the committee will have a general discussion focused on next steps for each product including whether the indications should remain on the market while additional trial(s) are conducted. Specifically, the committee will receive updates on the following products: (1) NDA 205353, FARYDAK (panobinostat) capsules, submitted by Secura Bio, Inc., indicated in combination with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent and (2) NDA 202497, MARQIBO (vincristine sulfate LIPOSOME injection) for intravenous infusion, submitted by Acrotech Biopharma LLC, indicated for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA's website at the time of the advisory committee meeting. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES ) on or before November 18, 2021, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 11:15 a.m. to 11:45 a.m. and 3:45 p.m. to 4:15 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 8, 2021. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 9, 2021. For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact She-Chia Chen and Rhea Bhatt (see FOR FURTHER INFORMATION CONTACT ) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 17, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-20740 Filed 9-23-21; 8:45 am]