Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 5008-5010 [2023-01553]

Download as PDF 5008 Federal Register / Vol. 88, No. 17 / Thursday, January 26, 2023 / Notices Quality Branch 3; and established Data Quality Branch 4. In the Division of Talent Services IV (DTS IV) realigned the ORA Branch 1 functions to DTS III and retitled as the Recruitment and Staffing Branch 10; realigned the ORA Branch 2 functions to DTS III and retitled as the Recruitment and Staffing Branch 11; and abolished DTS IV. In the Division of Talent Sourcing and Staffing (DTSS) realigned the Corporate Recruitment and Title 38 Branch functions and resources to the OTS Immediate Office Executive Resources Staff and retitled as the Scientific Programs and Executive Resources Staff; realigned the Scientific Staffing and Outreach Branch functions and resources to the OTS Immediate Office Scientific Talent Recruitment Staff and retitled as the Science, Technology, Engineering, and Mathematics Outreach Staff; realigned the Customer Care and Data Quality Branch functions and resources to DTS III and retitled as the Data Quality Branch 1; and abolished DTSS. Under Part D, FDA, OO, OTS has been restructured as follows: DCNJ. ORGANIZATION. The Office of Talent Solutions is headed by the FDA Chief Talent Officer and includes the following organizational units: lotter on DSK11XQN23PROD with NOTICES1 Business Operations Staff Policy, Programs, and Accountability Staff Scientific Programs and Executive Resources Staff Science, Technology, Engineering, and Mathematics Outreach Staff Division of Talent Solutions I Recruitment and Staffing Branch 1 Recruitment and Staffing Branch 2 Recruitment and Staffing Branch 3 Recruitment and Staffing Branch 4 Special Hiring and Pay Branch Division of Talent Solutions II Recruitment and Staffing Branch 5 Recruitment and Staffing Branch 6 Recruitment and Staffing Branch 7 Recruitment and Staffing Branch 8 Recruitment and Staffing Branch 9 Classification Branch 1 Classification Branch 2 Division of Talent Solutions III Recruitment and Staffing Branch 10 Recruitment and Staffing Branch 11 Delegated Examining Branch Data Quality Branch 1 Data Quality Branch 2 Data Quality Branch 3 Data Quality Branch 4 Under Part D, FDA, OO has been restructured as follows: DCNK. ORGANIZATION. The Office of FDA Commissioned Corps (OFCC) is headed by the Director of FDA Commissioned Corps. VerDate Sep<11>2014 17:17 Jan 25, 2023 Jkt 259001 II. Delegations of Authority Pending further delegation, directives, or orders by the Commissioner of Food and Drugs, all delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegations, provided they are consistent with this reorganization. III. Electronic Access This reorganization is reflected in FDA’s Staff Manual Guide (SMG). Persons interested in seeing the complete SMG can find it on FDA’s website at: https://www.fda.gov/ AboutFDA/ReportsManualsForms/ StaffManualGuides/default.htm (Authority: 44 U.S.C. 3101.) Xavier Becerra, Secretary of Health and Human Services. [FR Doc. 2023–01567 Filed 1–25–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Statement of Organization, Functions, and Delegations of Authority AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA), Office of Operations (OO), Office of Enterprise Management Services (OEMS) has modified its structure. This new organizational structure was approved by the Deputy Secretary of Health and Human Services on September 26, 2022, and effective on September 26, 2022. FOR FURTHER INFORMATION CONTACT: Tiffany Branch, Associate Director for Management, Office of Enterprise Management Services, Office of Operations, Food and Drug Administration, 3 White Flint North, 11601 Landsdown Street, North Rockville, MD 20852, 240–402–3156. SUPPLEMENTARY INFORMATION: SUMMARY: I. Introduction Part D, Chapter D–B, (Food and Drug Administration), the Statement of Organization, Functions and Delegations of Authority for the Department of Health and Human Services (35 FR 3685, February 25, 1970, 60 FR 56606, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 50112, August 30, 2007, 74 FR 41713, August PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 18, 2009, 76 FR 45270, July 28, 2011, and 84 FR 22854, May 20, 2019) is amended to reflect reorganization of OEMS. This reorganization realigned the FDA History Office function from the Office of the Commissioner (OC), Office of External Affairs (OEA) to OO, OEMS and revised the OEA and OEMS functional statements to this function realignment. The Food and Drug Administration, Office of Operations, Office of Enterprise Management Services has been restructured as follows: DCNA. ORGANIZATION. OEMS is headed by the Director of Enterprise Management Services and includes the following organizational units: Division of Compliance and Conflict Prevention Division of Human Capital Division of Information Governance FDA History Office Division of Resources Management Division of Vendor Management II. Delegations of Authority Pending further delegation, directives, or orders by the Commissioner of Food and Drugs, all delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegations, provided they are consistent with this reorganization. III. Electronic Access This reorganization is reflected in FDA’s Staff Manual Guide (SMG). Persons interested in seeing the complete SMG can find it on FDA’s website at: https://www.fda.gov/ AboutFDA/ReportsManualsForms/ StaffManualGuides/default.htm. (Authority: 44 U.S.C. 3101). Xavier Becerra, Secretary of Health and Human Services. [FR Doc. 2023–01566 Filed 1–25–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–2174] Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. ACTION: E:\FR\FM\26JAN1.SGM 26JAN1 Federal Register / Vol. 88, No. 17 / Thursday, January 26, 2023 / Notices 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. SUMMARY: The meeting will be held virtually on March 9, 2023, from 12 p.m. to 5 p.m. Eastern Time. ADDRESSES: Please note that due to the impact of the COVID–19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing 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–2022–N–2174. Please note that late, untimely filed comments will not be considered. The docket will close on March 8, 2023. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 8, 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 February 24, 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: DATES: lotter on DSK11XQN23PROD with NOTICES1 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 VerDate Sep<11>2014 17:17 Jan 25, 2023 Jkt 259001 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– 2022–N–2174for ‘‘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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 5009 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: Yvette Waples, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 240– 402–5343, 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 platform. The committee will discuss supplemental biologics license application (BLA) 761121/S–008, for POLIVY (polatuzumab vedotin-piiq) for injection, submitted by Genentech, Inc. The proposed indication (use) for this product is in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL). This product was approved under 21 CFR 601.41 (subpart E, accelerated approval regulations) for use in combination with bendamustine and a rituximab product for the E:\FR\FM\26JAN1.SGM 26JAN1 lotter on DSK11XQN23PROD with NOTICES1 5010 Federal Register / Vol. 88, No. 17 / Thursday, January 26, 2023 / Notices treatment of adult patients with relapsed or refractory DLBCL, not otherwise specified, after at least two prior therapies. Confirmatory studies are post-marketing studies to verify and describe the clinical benefit of a product after it receives accelerated approval. The new proposed indication is based on the confirmatory study, POLARIX (Study GO39942), conducted to fulfill post-marketing requirement 3630–1 detailed in the June 10, 2019, approval letter, available at https:// www.accessdata.fda.gov/drugsatfda_ docs/appletter/2019/ 761121Orig1s000ltr.pdf. Based on the results of the POLARIX study, the committee will discuss the benefit-risk profile of POLIVY in patients with previously untreated DLBCL. 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 February 24, 2023, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 3:15 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 February 14, 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 VerDate Sep<11>2014 17:17 Jan 25, 2023 Jkt 259001 notify interested persons regarding their request to speak by February 15, 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 Yvette Waples (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/AboutAdvisory Committees/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: January 23, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–01553 Filed 1–25–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; RFA DK22–003 Promoting Organ and Tissue Donation Among Health Disparity Populations (R01— Clinical Trial Optional). Date: March 9, 2023. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute of Diabetes and Digestive PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 and Kidney Diseases, Democracy II, 6707 Democracy Blvd. Bethesda, MD 20892 (Virtual Meeting). Contact Person: Ann A. Jerkins, Ph.D., Scientific Review Officer, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD 20892, 301–594–2242, jerkinsa@niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: January 20, 2023. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–01541 Filed 1–25–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Analytics and Statistics for Population Research Panel B Study Section. Date: February 22–23, 2023. Time: 10:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Maria De Jesus Diaz Perez, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1000G, Bethesda, MD 20892, (301) 496–4227, diazperezm2@csr.nih.gov. Name of Committee: Cell Biology Integrated Review Group; Cell Structure and Function 1 Study Section. Date: February 23–24, 2023. Time: 9:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\26JAN1.SGM 26JAN1

Agencies

[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Notices]
[Pages 5008-5010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01553]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2174]


Oncologic Drugs Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

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

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

[[Page 5009]]

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 virtually on March 9, 2023, from 12 
p.m. to 5 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic, 
all meeting participants will be joining this advisory committee 
meeting via an online teleconferencing 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-2022-N-2174. Please note that late, untimely 
filed comments will not be considered. The docket will close on March 
8, 2023. The https://www.regulations.gov electronic filing system will 
accept comments until 11:59 p.m. Eastern Time at the end of March 8, 
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 February 24, 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-2022-N-2174for ``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: Yvette Waples, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-5343, 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 platform. The committee 
will discuss supplemental biologics license application (BLA) 761121/S-
008, for POLIVY (polatuzumab vedotin-piiq) for injection, submitted by 
Genentech, Inc. The proposed indication (use) for this product is in 
combination with a rituximab product, cyclophosphamide, doxorubicin, 
and prednisone for the treatment of adult patients with previously 
untreated diffuse large B-cell lymphoma (DLBCL). This product was 
approved under 21 CFR 601.41 (subpart E, accelerated approval 
regulations) for use in combination with bendamustine and a rituximab 
product for the

[[Page 5010]]

treatment of adult patients with relapsed or refractory DLBCL, not 
otherwise specified, after at least two prior therapies. Confirmatory 
studies are post-marketing studies to verify and describe the clinical 
benefit of a product after it receives accelerated approval. The new 
proposed indication is based on the confirmatory study, POLARIX (Study 
GO39942), conducted to fulfill post-marketing requirement 3630-1 
detailed in the June 10, 2019, approval letter, available at https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761121Orig1s000ltr.pdf. Based on the results of the POLARIX study, the 
committee will discuss the benefit-risk profile of POLIVY in patients 
with previously untreated DLBCL.
    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 February 24, 2023, will be provided to the 
committee. Oral presentations from the public will be scheduled between 
approximately 3:15 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 February 14, 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 February 15, 2023.
    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 Yvette Waples (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: January 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01553 Filed 1-25-23; 8:45 am]
BILLING CODE 4164-01-P

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