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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2023-N-3329]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice; establishment of a public docket; request for comments.

# SUMMARY:

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the 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 virtually on November 16, 2023, from 9 a.m. to 1:30 p.m. eastern time.

# ADDRESSES:

All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform. 

                        Answers to commonly asked questions about FDA advisory committee meetings, may be accessed at:                         *https://www.fda.gov/​AdvisoryCommittees/​AboutAdvisoryCommittees/​ucm408555.htm.*

                        FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2023-N-3329. The docket will close on November 15, 2023. Please note that late, untimely filed comments will not be considered. The                         *https://www.regulations.gov*                         electronic filing system will accept comments until 11:59 p.m. eastern time at the end of November 15, 2023. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.                    

Comments received on or before November 1, 2023, will be provided to the Committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.

You may submit comments as follows:

### Electronic Submissions

Submit electronic comments in the following way: 
      -  Federal eRulemaking Portal: https://www.regulations.gov.                      Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to                      https://www.regulations.gov                      will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on                      https://www.regulations.gov. 
      - If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

### Written/Paper Submissions

Submit written/paper submissions as follows:
      -  Mail/Hand Delivery/Courier (for written/paper submissions):                      Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.                
      - For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

*Instructions:*                     All submissions received must include the Docket No. FDA-2023-N-3329 for “Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner (see                     **ADDRESSES**                    ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at                     *https://www.regulations.gov*                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.                
      - Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov.                      Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with  21 CFR 10.20  and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see  80 FR 56469 , September 18, 2015, or access the information at:                      https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf. 

*Docket:*                     For access to the docket to read background documents or the electronic and written/paper comments received, go to                     *https://www.regulations.gov*                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.                

# FOR FURTHER INFORMATION CONTACT:

                        Moon Hee V. Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-2894, email:                         *ODAC@fda.hhs.gov,*                         or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the                         **Federal Register**                         about last-minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check FDA's website at                         *https://www.fda.gov/​AdvisoryCommittees/​default.htm*                         and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before the meeting.                    

# SUPPLEMENTARY INFORMATION:

*Agenda:*                     The meeting presentations will be heard, viewed, captioned, and recorded through an online                           ( print page 68628)                        teleconferencing and/or video conferencing platform.                

The Committee will receive updates on the accelerated approval program in oncology and two new drug applications (NDAs) approved under 21 CFR 314.500 (subpart H, accelerated approval regulations) that have not met their agreed-upon milestones for completion of confirmatory trial(s). Confirmatory trials are postmarketing studies to verify and describe the clinical benefit of a drug after it receives accelerated approval. These updates will provide information on the status of all accelerated approvals granted in oncology, including products with delayed confirmatory trials, and the status of confirmatory trials for the specific NDAs to be discussed, including any ongoing and planned trials.

The two products to be discussed are: (1) FOLOTYN (pralatrexate), NDA 022468 submitted by Acrotech Biopharma Inc, indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), and (2) BELEODAQ (belinostat), NDA 206256 submitted by Acrotech Biopharma Inc, indicated for the treatment of patients with relapsed or refractory PTCL. Based on the updates provided, the Committee will have a general discussion about delayed confirmatory trials as well as a focused discussion on next steps for the two products, FOLOTYN (pralatrexate) and BELEODAQ (belinostat), approved for PTCL. The overall goal will be the continued optimization of the accelerated approval process with a focus on decreasing the amount of time to verify (or fail to verify) clinical benefit, while continuing to provide early availability of promising oncology products.

                    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 and/or video conference meeting 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 and video 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 to the Docket (see                     **ADDRESSES**                    ) on or before November 1, 2023, will be provided to the Committee. Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:30 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 October 24, 2023. 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 October 25, 2023.                

                    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 Moon Hee V. Choi (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. 1001*et seq.*). This meeting notice also serves as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 14.22(b), (f), and (g) relating to the location of advisory committee meetings are hereby waived to allow for this meeting to take place using an online meeting platform. This waiver is in the interest of allowing greater transparency and opportunities for public participation, in addition to convenience for advisory committee members, speakers, and guest speakers. No participant will be prejudiced by this waiver, and the ends of justice will be served by allowing for this modification to FDA's advisory committee meeting procedures.                

Dated: September 29, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2023-21984 Filed 10-3-23; 8:45 am]

BILLING CODE 4164-01-P