Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Use of Minimal Residual Disease as an Endpoint in Multiple Myeloma Clinical Trials, 20984-20986 [2024-06314]

Download as PDF 20984 Federal Register / Vol. 89, No. 59 / Tuesday, March 26, 2024 / Notices voluntarily permit FDA to withdraw approval of the indication for the treatment of adult patients with deleterious germline BRCA mutationassociated advanced ovarian cancer who have been treated with three or more chemotherapies, pursuant to § 314.150(d) and waive its opportunity for a hearing for NDA 208558. On August 19, 2022, AZ submitted a letter requesting withdrawal of approval of this indication for LYNPARZA (olaparib) Tablets (NDA 208558) pursuant to § 314.150(d) and waiving its opportunity for a hearing. B. Withdrawal of Approval of Indication for Lynparza Tablets Therefore, under § 314.150(d), approval of the indication for the treatment of adult patients with deleterious germline BRCA mutationassociated advanced ovarian cancer who have been treated with three or more chemotherapies for LYNPARZA (olaparib) Tablets is withdrawn as of March 26, 2024. Withdrawal of approval of this indication does not affect any other approved indication for LYNPARZA (200laparib) Tablets. ddrumheller on DSK120RN23PROD with NOTICES1 III. ZEJULA (Niraparib) Capsules A. Application Background On October 23, 2019, FDA approved NDA 208447 for ZEJULA (niraparib) Capsules, EQ 100 mg base, for the treatment of adult patients with advanced ovarian cancer (see table for full indication). On August 4, 2022, FDA met with GSK to discuss the status of the ZEJULA (niraparib) Capsules indication for the treatment of adult patients with advanced ovarian cancer. FDA requested that GSK voluntarily permit FDA to withdraw approval of this indication because the results from randomized trials of rucaparib and olaparib in similar treatment settings showed OS may be reduced in patients receiving PARP inhibitors. FDA stated that these results from two independent trials were concerning and suggested a class-wide effect for PARP inhibitors. In correspondence dated August 24, 2022, GSK acknowledged that because of the uncontrolled nature of the trial entitled ‘‘A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens’’ 4 on which 4 The study, under its abbreviated title ‘‘A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens (QUADRA),’’ is available VerDate Sep<11>2014 18:10 Mar 25, 2024 Jkt 262001 approval of this indication was based, it would be difficult to demonstrate that niraparib does not impact survival in this treatment setting. Therefore, GSK agreed to voluntarily withdraw the advanced ovarian cancer indication. On September 7, 2022, GSK submitted a letter requesting withdrawal of approval of this indication for ZEJULA (niraparib) Capsules pursuant to § 314.150(d) and waiving its opportunity for a hearing. B. Withdrawal of Approval of Indication for Zejula Capsules Therefore, under § 314.150(d), approval of the indication for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with HRD positive status defined by either a deleterious or suspected deleterious BRCA mutation or genomic instability and who have progressed more than 6 months after response to the last platinum-based chemotherapy for ZEJULA (niraparib) Capsules is withdrawn as of March 26, 2024. Withdrawal of approval of this indication does not affect any other approved indication for ZEJULA (niraparib) Capsules. Dated: March 19, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–06299 Filed 3–25–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–1179] Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Use of Minimal Residual Disease as an Endpoint in Multiple Myeloma Clinical Trials AGENCY: Food and Drug Administration, 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 April 12, 2024, from 9 a.m. to 4 p.m. Eastern Time. ADDRESSES: FDA and invited participants may attend the meeting at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. The public will have the option to participate via an online teleconferencing and/or video conferencing platform, and the advisory committee meeting will be heard, viewed, captioned, and recorded through 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/Advisory Committees/AboutAdvisoryCommittees/ ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2024–N–1179. The docket will close on April 11, 2024. 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 April 11, 2024. 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 April 3, 2024, 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: HHS. Electronic Submissions Notice; establishment of a public docket; request for comments. 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 ACTION: 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 SUMMARY: on the NIH National Library of Medicine’s ClinicalTrials.gov web page at https://clinicaltrials. gov/ct2/show/NCT02354586. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\26MRN1.SGM 26MRN1 Federal Register / Vol. 89, No. 59 / Tuesday, March 26, 2024 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 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– 2024–N–1179 for ‘‘Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Use of Minimal Residual Disease as an Endpoint in Multiple Myeloma Clinical Trials.’’ 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 VerDate Sep<11>2014 18:10 Mar 25, 2024 Jkt 262001 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-201509-18/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: Takyiah Stevenson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 240– 402–2507, 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 teleconferencing and/or video conferencing platform. The Committee will discuss the use of minimal residual disease (MRD) as an endpoint in multiple myeloma clinical trials, including considerations regarding timing of assessment, patient populations, and trial design for future studies that intend to use MRD to support accelerated approval of a new product or a new indication. FDA intends to make background material available to the public no later PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 20985 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 for online participants 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 April 3, 2024, will be provided to the Committee. Oral presentations from the public will be scheduled between approximately 1:15 p.m. to 2:15 p.m. Eastern Time and will take place entirely through an online meeting platform. 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 April 1, 2024. 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 April 2, 2024. 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 Takyiah Stevenson (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/Advisory Committees/AboutAdvisoryCommittees/ E:\FR\FM\26MRN1.SGM 26MRN1 20986 Federal Register / Vol. 89, No. 59 / Tuesday, March 26, 2024 / Notices 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 both in-person and 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. The conditions for issuance of a waiver under 21 CFR 10.19 are met. Dated: March 20, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–06314 Filed 3–25–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2023–N–3168; FDA– 2023–N–2780; FDA–2023–N–0940; and FDA–2023–N–3490] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 SUMMARY: Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. SUPPLEMENTARY INFORMATION: TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection Extralabel Drug Use in Animals .............................................................................................................................. Premarket Notification for a New Dietary Ingredient ............................................................................................... Food and Drug Administration Rapid Response Surveys ...................................................................................... Application for Participation in Food and Drug Administration Fellowship Programs ............................................ Dated: March 20, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–06265 Filed 3–25–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–1077] AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of New Drug Application for LYNPARZA (Olaparib) Capsules AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) for LYNPARZA (olaparib) Capsules, 50 milligrams (mg) held by AstraZeneca Pharmaceuticals LP (AZ), 1800 Concord Pike, Wilmington, DE 19803. AZ has voluntarily requested that FDA withdraw approval of this application ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:10 Mar 25, 2024 Jkt 262001 and has waived its opportunity for a hearing. DATES: Approval is withdrawn as of March 26, 2024. FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993–0002, 301– 796–3137, Kimberly.Lehrfeld@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: On December 19, 2014, FDA approved NDA 206162 for LYNPARZA (olaparib) Capsules, 50 mg, as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. On July 14, 2022, FDA met with AZ to discuss the final overall survival (OS) results from the clinical trial entitled ‘‘A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physician’s Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 0910–0325 0910–0330 0910–0500 0910–0780 Date approval expires 2/28/2027 2/28/2027 2/28/2027 2/28/2027 Cancer in Patients Carrying Germline BRCA1/2 Mutations’’ (SOLO3).’’ 1 The results indicated that patients who were taking olaparib potentially had a shorter OS than patients not on olaparib, particularly in the subgroup analysis of patients who had received three or more lines of chemotherapy. On July 26, 2022, the Agency asked AZ, in writing, to voluntarily permit FDA to withdraw approval of NDA 206162, pursuant to § 314.150(d) (21 CFR 314.150(d)) and waive its opportunity for a hearing for NDA 206162. On January 19, 2023, AZ submitted a letter requesting withdrawal of approval of the application for LYNPARZA (olaparib) Capsules (NDA 206162) pursuant to § 314.150(d) and waiving its opportunity for a hearing. Approval of NDA 206162 for LYNPARZA (olaparib) Capsules, and all amendments and supplements thereto, is also withdrawn under § 314.150(d) as 1 The study, under its abbreviated title ‘‘Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments (SOLO3),’’ is available on the NIH National Library of Medicine’s ClinicalTrials.gov web page at https:// clinicaltrials.gov/ct2/show/NCT02282020. E:\FR\FM\26MRN1.SGM 26MRN1

Agencies

[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Notices]
[Pages 20984-20986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06314]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1179]


Oncologic Drugs Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments--Use of Minimal 
Residual Disease as an Endpoint in Multiple Myeloma Clinical Trials

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 on April 12, 2024, from 9 a.m. to 4 
p.m. Eastern Time.

ADDRESSES: FDA and invited participants may attend the meeting at FDA 
White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, 
the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. The public 
will have the option to participate via an online teleconferencing and/
or video conferencing platform, and the advisory committee meeting will 
be heard, viewed, captioned, and recorded through 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-2024-N-1179. The docket will close on April 
11, 2024. 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 April 11, 
2024. 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 April 3, 2024, 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

[[Page 20985]]

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-2024-N-1179 for ``Oncologic Drugs Advisory Committee; Notice of 
Meeting; Establishment of a Public Docket; Request for Comments--Use of 
Minimal Residual Disease as an Endpoint in Multiple Myeloma Clinical 
Trials.'' 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: Takyiah Stevenson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-2507, email: [email protected], 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 teleconferencing and/or video 
conferencing platform. The Committee will discuss the use of minimal 
residual disease (MRD) as an endpoint in multiple myeloma clinical 
trials, including considerations regarding timing of assessment, 
patient populations, and trial design for future studies that intend to 
use MRD to support accelerated approval of a new product or a new 
indication.
    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 for online 
participants 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 April 3, 2024, will be provided to the Committee. Oral 
presentations from the public will be scheduled between approximately 
1:15 p.m. to 2:15 p.m. Eastern Time and will take place entirely 
through an online meeting platform. 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 April 1, 2024. 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 April 2, 2024.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] 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 Takyiah Stevenson (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/

[[Page 20986]]

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 both 
in-person and 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. The conditions for issuance of a 
waiver under 21 CFR 10.19 are met.

    Dated: March 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06314 Filed 3-25-24; 8:45 am]
BILLING CODE 4164-01-P
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