Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments: Strain Selection for Influenza Vaccines, 76849-76851 [2024-21431]

Download as PDF Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices www.healthaffairs.org/doi/full/10.1377/ hlthaff.25.2.313. Silver Spring, MD 20993–0002, 301– 796–3471, Martha.Nguyen@fda.hhs.gov. Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of nine abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. Dated: September 16, 2024. Lauren K. Roth, Associate Commissioner for Policy. SUMMARY: [FR Doc. 2024–21433 Filed 9–18–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Approval is withdrawn as of October 21, 2024. DATES: [Docket No. FDA–2024–N–4289] Allergan, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications AGENCY: ACTION: FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, HHS. 76849 The applicants listed in table 1 have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. SUPPLEMENTARY INFORMATION: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, TABLE 1—ANDAS FOR WHICH APPROVAL IS WITHDRAWN Application No. Drug Applicant ANDA 062452 .... Gentamicin Sulfate solution/drop, Equivalent to (EQ) 0.3% base. Cefuroxime Sodium injectable, EQ 7.5 grams (g) base/vial ... Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92612. ACS Dobfar S.p.A., U.S. Agent Interchem Corp., 120 Route 17 North, Paramus, NJ 07652. Woodward Pharma Services, LLC, 47220 Cartier Dr., Suite A, Wixom, MI 48393. ANDA 064124 .... ANDA 077151 .... ANDA 079032 .... ANDA 079075 .... ANDA 206155 .... Olanzapine tablet, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg. ANDA 206204 .... Piperacillin Sodium and Tazobactam Sodium injectable, EQ 12 gm base/vial, EQ 1.5 gm base/vial. Acyclovir Sodium injectable, EQ 50 mg base/mL ................... ANDA 207919 .... ANDA 209708 .... lotter on DSK11XQN23PROD with NOTICES1 Milrinone Lactate injectable, EQ 40 milligrams (mg) base/200 milliliters (mL) (EQ 0.2 mg base/mL) EQ 20 mg base/100 mL (EQ 0.2 mg base/mL). Ondansetron Hydrochloride preservative free injectable, EQ 2 mg base/mL. Fentanyl Citrate tablet, EQ 0.1 mg base, EQ 0.2 mg base, EQ 0.4 mg base, EQ 0.6 mg base, and EQ 0.8 mg base. Mivacurium Chloride solution, EQ 10 mg base/5 mL (EQ 2 mg base/mL) and EQ 20 mg base/10 mL (EQ 2 mg base/ mL). Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of October 21, 2024. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from table 1. Introduction or delivery for introduction into interstate commerce of products listed in table 1 without an approved new drug application or ANDA violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are listed in table 1 that are in inventory on October 21, 2024 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or VerDate Sep<11>2014 16:59 Sep 18, 2024 Jkt 262001 American Regent, Inc., 5 Ramsey Rd., Shirley, NY 11967. Watson Laboratories, Inc., (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Bldg. A, Parsippany, NJ 07054. Indoco Remedies Ltd., U.S. Agent RegCon Solutions, LLC, 9920 Pacific Heights Blvd., Suite 250, San Diego, CA 92121. Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. Dr. Reddy’s Laboratories, Inc., 107 College Rd. East, Princeton, NJ 08540. Woodward Pharma Services, LLC. otherwise become violative, whichever occurs first. Dated: September 16, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–21432 Filed 9–18–24; 8:45 am] BILLING CODE 4164–01–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–4189] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments: Strain Selection for Influenza Vaccines AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related SUMMARY: Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1 76850 Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices Biological Products Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The Committee will meet in open session to discuss three separate topics. At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held virtually on October 10, 2024, from 8 a.m. to 5:30 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. The online web conference meeting will be available at the following link on the day of the meeting: https:// youtube.com/live/RXdJ2BfutAE. 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–4189. The docket will close on October 9, 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 of October 9, 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 October 2, 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: 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 VerDate Sep<11>2014 16:59 Sep 18, 2024 Jkt 262001 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– 2024–N–4189 for ‘‘Vaccines and Related Biological Products 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 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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: Kathleen Hayes or Sussan Paydar, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993–0002, 202–657–8533, CBERVRBPAC@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. On October 10, 2024, the Committee will meet in open session to discuss the following three separate topics. Under Topic I, the Committee will discuss and make recommendations on the strain selection for the influenza virus vaccines for the 2025 southern hemisphere influenza season. Under Topic II, the Committee will discuss pandemic preparedness for highly pathogenic avian influenza virus E:\FR\FM\19SEN1.SGM 19SEN1 lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices including considerations for vaccine composition for (H5) vaccines. Under Topic III, the Committee will hear an overview of the research programs in the Laboratory of Pediatric & Respiratory Viral Diseases and the Laboratory of DNA Viruses in the Division of Viral Products, Office of Vaccines Research and Review, CBER. After the open session, the meeting will be closed to the public for committee deliberations. 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: On October 10, 2024, from 8 a.m. to 11:15 a.m. Eastern Time for Topic I, from 11:45 a.m. to 2:30 p.m. Eastern Time for Topic II, and from 2:40 p.m. to 4:20 p.m. Eastern Time for Topic III, the meeting is open to the public. 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 October 2, 2024, will be provided to the Committee. Comments received on or after October 2, 2024, and by October 9, 2024, will be taken into consideration by FDA. Oral presentations from the public will be scheduled between approximately 9:55 a.m. to 10:15 a.m. Eastern Time for Topic I, 1:10 p.m. to 1:30 p.m. Eastern Time for Topic II, and 4 p.m. to 4:20 p.m. Eastern Time for Topic III. 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, along with their names, email addresses, and direct contact phone numbers of proposed participants, and an indication of the approximate time requested to make their presentation on or before 12 p.m. Eastern Time on September 24, 2024. Time allotted for each presentation may be limited. If the number of registrants VerDate Sep<11>2014 16:59 Sep 18, 2024 Jkt 262001 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 September 27, 2024. Closed Committee Deliberations: On October 10, 2024, the meeting will be closed from 4:30 p.m. to 5:30 p.m. to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The recommendations of the advisory committee regarding the progress of the individual investigators’ research programs, along with other information, will be discussed during this session. We believe that public discussion of these discussions and committee recommendations on individual scientists would constitute an unwarranted invasion of personal privacy. 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 Kathleen Hayes or Sussan Paydar (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/ 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. The conditions for issuance of a waiver under 21 CFR 10.19 are met. Dated: September 16, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–21431 Filed 9–18–24; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 76851 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–0022] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form 3601a AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by October 21, 2024. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0511. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form FDA 3601a OMB Control Number 0910–0511— Revision This information collection supports the FDA medical device and device user fee programs. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee and Modernization Act of 2002 E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76849-76851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21431]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-4189]


Vaccines and Related Biological Products Advisory Committee; 
Notice of Meeting; Establishment of a Public Docket; Request for 
Comments: Strain Selection for Influenza Vaccines

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 Vaccines and Related

[[Page 76850]]

Biological Products Advisory Committee (the Committee). The general 
function of the Committee is to provide advice and recommendations to 
FDA on regulatory issues. The Committee will meet in open session to 
discuss three separate topics. At least one portion of the meeting will 
be closed to the public. FDA is establishing a docket for public 
comment on this document.

DATES: The meeting will be held virtually on October 10, 2024, from 8 
a.m. to 5:30 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.
    The online web conference meeting will be available at the 
following link on the day of the meeting: https://youtube.com/live/RXdJ2BfutAE.
    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-4189. The docket will close on October 
9, 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 of 
October 9, 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 October 2, 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 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-4189 for ``Vaccines and Related Biological Products 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: Kathleen Hayes or Sussan Paydar, 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 
20993-0002, 202-657-8533, [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. On October 10, 2024, the Committee will meet in 
open session to discuss the following three separate topics. Under 
Topic I, the Committee will discuss and make recommendations on the 
strain selection for the influenza virus vaccines for the 2025 southern 
hemisphere influenza season. Under Topic II, the Committee will discuss 
pandemic preparedness for highly pathogenic avian influenza virus

[[Page 76851]]

including considerations for vaccine composition for (H5) vaccines. 
Under Topic III, the Committee will hear an overview of the research 
programs in the Laboratory of Pediatric & Respiratory Viral Diseases 
and the Laboratory of DNA Viruses in the Division of Viral Products, 
Office of Vaccines Research and Review, CBER. After the open session, 
the meeting will be closed to the public for committee deliberations.
    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: On October 10, 2024, from 8 a.m. to 11:15 a.m. Eastern 
Time for Topic I, from 11:45 a.m. to 2:30 p.m. Eastern Time for Topic 
II, and from 2:40 p.m. to 4:20 p.m. Eastern Time for Topic III, the 
meeting is open to the public. 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 October 2, 2024, will be provided to the 
Committee. Comments received on or after October 2, 2024, and by 
October 9, 2024, will be taken into consideration by FDA. Oral 
presentations from the public will be scheduled between approximately 
9:55 a.m. to 10:15 a.m. Eastern Time for Topic I, 1:10 p.m. to 1:30 
p.m. Eastern Time for Topic II, and 4 p.m. to 4:20 p.m. Eastern Time 
for Topic III. 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, along with their names, email addresses, and direct contact 
phone numbers of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 12 
p.m. Eastern Time on September 24, 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 September 27, 2024.
    Closed Committee Deliberations: On October 10, 2024, the meeting 
will be closed from 4:30 p.m. to 5:30 p.m. to permit discussion where 
disclosure would constitute a clearly unwarranted invasion of personal 
privacy (5 U.S.C. 552b(c)(6)). The recommendations of the advisory 
committee regarding the progress of the individual investigators' 
research programs, along with other information, will be discussed 
during this session. We believe that public discussion of these 
discussions and committee recommendations on individual scientists 
would constitute an unwarranted invasion of personal privacy.
    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 Kathleen Hayes or Sussan Paydar (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. The conditions for issuance of a 
waiver under 21 CFR 10.19 are met.

    Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21431 Filed 9-18-24; 8:45 am]
BILLING CODE 4164-01-P
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