Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 77617-77619 [2022-27428]

Download as PDF Federal Register / Vol. 87, No. 242 / Monday, December 19, 2022 / Notices tkelley on DSK125TN23PROD with NOTICE NFPA requirements and to ensure sterile supply and medical equipment manufacturer instructions for use (IFUs) are considered before hospitals reduce relative humidity levels. ++ Section 488.5(a)(3), to correct formatting and technical errors in the crosswalk as requested by CMS. In addition to the standards review, CMS reviewed CIHQ’s comparable survey processes, which was conducted as described in section III. of this notice, and also reviewed corporate policies, which yielded the following areas where, as of the date of this notice, CIHQ has completed revising its survey processes to demonstrate that it uses survey processes that are comparable to state survey agency processes by: ++ Revising Facility & Life Safety worksheets for surveyors to explain that the worksheet does not include all 2012 LSC & Health Care Facilities Code requirements in accordance with survey comparability at § 488.5(a)(4)(ii). ++ Providing additional training to surveyors related to the number of medical records that should be reviewed during the survey of larger hospitals in accordance with survey comparability at § 488.5(a)(4)(ii). ++ Improving the level of detail in survey documentation in accordance with survey comparability at § 488.5(a)(4)(ii). ++ Providing CMS with the job description required for CIHQ’s LSC Consultants in accordance with the description of education and experience requirements surveyors must meet at § 488.5(a)(7). ++ Revising complaint procedures to ensure the survey investigation process is clearly documented in accordance with the organizations complaint procedures at § 488.5(a)(12). B. Term of Approval Based on our review and observations described in section III. and section V. of this notice, we approve CIHQ as a national accreditation organization for hospitals that request participation in the Medicare program. The decision announced in this notice is effective January 1, 2023 through January 1, 2028 (5 years). Due to the timing of the start of the fiscal year and associated travel restrictions, CMS was unable to conduct a hospital survey observation of CIHQ surveyors in accordance with 42 CFR 488.8(h), which is one component of the comparability evaluation. Therefore, we are providing CIHQ with a reduced term of approval. In accordance with 42 CFR 488.5(e)(2)(i), CMS may not give a term of the approval that exceeds 6 years. Based on our discussions with CIHQ and the information provided in its VerDate Sep<11>2014 19:38 Dec 16, 2022 Jkt 259001 application, we are confident that CIHQ will continue to ensure that its deemed hospitals will continue to meet or exceed Medicare standards. Additionally, CIHQ has applied for critical access hospital deeming authority and as part of that application we will complete a survey observation. Critical access hospitals have similar CoPs and survey process to hospitals and therefore we are confident in a 5year approval term for this application. VI. Collection of Information and Regulatory Impact Statement This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The Administrator of the Centers for Medicare & Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Dated: December 14, 2022. Lynette Wilson, Federal Register Liaison, Centers for Medicare & Medicaid Services. [FR Doc. 2022–27465 Filed 12–16–22; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–2810] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Food and Drug Administration, Department of Health and Human Services (HHS). ACTION: Notice; establishment of a public docket; request for comments. AGENCY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. On January 26, 2023, the committee will meet in open session to discuss the future vaccination SUMMARY: PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 77617 regimens addressing COVID–19. 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 January 26, 2023, from 8:30 a.m. to 5:30 p.m. Eastern Time. ADDRESSES: Please note that due to the impact of this 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, including information regarding special accommodations due to a disability, may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. The online web conference meeting will be available at the following link on the day of the meeting: https://youtu.be/ ZjULNuSYfd0. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2022–N–2810. Please note that late, untimely filed comments will not be considered. The docket will close on January 25, 2023. Either electronic or written comments on this public meeting must be submitted by January 25, 2023. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 25, 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 January 18, 2023, will be provided to the committee. Comments received after January 18, 2023, and by January 25, 2023, will be taken into consideration by FDA. In the event that the meeting is canceled, 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 E:\FR\FM\19DEN1.SGM 19DEN1 77618 Federal Register / Vol. 87, No. 242 / Monday, December 19, 2022 / Notices tkelley on DSK125TN23PROD with NOTICE 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–2810 for ‘‘Vaccines and Related Biological Products Advisory Committee (VRBPAC); 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:// VerDate Sep<11>2014 19:38 Dec 16, 2022 Jkt 259001 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-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: Sussan Paydar or Prabhakara Atreya, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993–0002, 240–506–4946, 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 the 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 coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On January 26, 2023, the committee will meet in open session to discuss the future vaccination regimens addressing COVID–19. This discussion will include consideration of the composition and schedule of the primary series and booster vaccinations. FDA intends to make background material available to the public no later than 2 business days before the meeting. PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the time of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is 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 Dockets (see ADDRESSES) on or before January 18, 2023, will be provided to the committee. Comments received after January 18, 2023, and by January 25, 2023, will be taken into consideration by FDA. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, along with their names, email addresses, and direct contact phone numbers of proposed participants, on or before 12 p.m. Eastern Time on January 18, 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 6 p.m. Eastern Time January 20, 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 Sussan Paydar or Prabhakara Atreya (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 E:\FR\FM\19DEN1.SGM 19DEN1 Federal Register / Vol. 87, No. 242 / Monday, December 19, 2022 / Notices 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: December 13, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–27428 Filed 12–16–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1998–D–0038] Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern; Revised Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #152 entitled ‘‘Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.’’ This draft guidance informs stakeholders about FDA’s current method for evaluating potential microbiological effects of antimicrobial new animal drugs on bacteria of human health concern as part of the new animal drug application process. DATES: Submit either electronic or written comments on the draft guidance by March 20, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: tkelley on DSK125TN23PROD with NOTICE 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, VerDate Sep<11>2014 19:38 Dec 16, 2022 Jkt 259001 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– 1998–D–0038 for ‘‘Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.’’ Received comments 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.’’ The Agency 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 to be made publicly available, you can provide this PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 77619 information on the cover sheet and not in the body of your comments and you must identify this 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Ruby Singh, Center for Veterinary Medicine (HFV–150), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0794, ruby.singh@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry #152 entitled ‘‘Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern.’’ Antimicrobial drugs have been used since the mid-20th century to control and cure infectious diseases in humans. Since their discovery, these drugs have prevented millions of human deaths worldwide, they have helped to promote animal health, and they have helped to provide an abundant and affordable supply of meat, milk, and eggs. Soon after antimicrobial drugs became widely available, scientists noted that their use could contribute to the emergence and selection of antimicrobial resistance in bacteria, thereby reducing the effectiveness of the E:\FR\FM\19DEN1.SGM 19DEN1

Agencies

[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Notices]
[Pages 77617-77619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27428]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2810]


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

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (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 
Biological Products Advisory Committee (VRBPAC). The general function 
of the committee is to provide advice and recommendations to FDA on 
regulatory issues. On January 26, 2023, the committee will meet in open 
session to discuss the future vaccination regimens addressing COVID-19. 
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 January 26, 2023, from 
8:30 a.m. to 5:30 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this 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, 
including information regarding special accommodations due to a 
disability, may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. The online web conference 
meeting will be available at the following link on the day of the 
meeting: https://youtu.be/ZjULNuSYfd0.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2022-N-2810. Please note that late, untimely 
filed comments will not be considered. The docket will close on January 
25, 2023. Either electronic or written comments on this public meeting 
must be submitted by January 25, 2023. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of January 25, 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 January 18, 2023, will be provided 
to the committee. Comments received after January 18, 2023, and by 
January 25, 2023, will be taken into consideration by FDA. In the event 
that the meeting is canceled, 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

[[Page 77618]]

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-2810 for ``Vaccines and Related Biological Products Advisory 
Committee (VRBPAC); 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: Sussan Paydar or Prabhakara Atreya, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 
20993-0002, 240-506-4946, [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 the 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 
coming to the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. On January 
26, 2023, the committee will meet in open session to discuss the future 
vaccination regimens addressing COVID-19. This discussion will include 
consideration of the composition and schedule of the primary series and 
booster vaccinations.
    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 at the time of the 
advisory committee meeting, and the background material will be posted 
on FDA's website after the meeting. Background material is 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 Dockets (see 
ADDRESSES) on or before January 18, 2023, will be provided to the 
committee. Comments received after January 18, 2023, and by January 25, 
2023, will be taken into consideration by FDA. Oral presentations from 
the public will be scheduled between approximately 1:30 p.m. and 2:30 
p.m. Eastern Time. Those individuals interested in making formal oral 
presentations should notify the contact person and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, along with their names, email addresses, and direct contact 
phone numbers of proposed participants, on or before 12 p.m. Eastern 
Time on January 18, 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 6 p.m. 
Eastern Time January 20, 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 Sussan Paydar or Prabhakara Atreya (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

[[Page 77619]]

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: December 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27428 Filed 12-16-22; 8:45 am]
BILLING CODE 4164-01-P

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