Vaccines and Related Biological Products Advisory Committee; Amendment of Notice-Selection of the 2024 to 2025 Formula for COVID-19 Vaccines, 44996-44997 [2024-11216]

Download as PDF 44996 Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations, and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for a particular device panel. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests. IV. Application Procedure Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Nomination must include a current, complete résumé or curriculum vitae for each nominee including current business address and telephone number, email address if available, and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Committee Membership Nomination Portal (see ADDRESSES) within 30 days of publication of this document (see DATES). Nominations must also specify the advisory panel for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the particular device panels listed in table 1. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process.) FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore encourages nominations of appropriately qualified candidates from these groups. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.), relating to advisory committees. Dated: May 16, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–11178 Filed 5–21–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2021–N–0403, FDA– 2023–N–4181, and FDA–2021–N–0584] ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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. The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. SUPPLEMENTARY INFORMATION: Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB Control No. Title of collection Food Additives; Food Contact Substances Notification System ............................................................................. Cattle Materials Prohibited From Use in Animal Food or Feed .............................................................................. Standardized Reporting Forms for Federally Funded Public Health Projects and Agreements ............................ Dated: May 16, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–11180 Filed 5–21–24; 8:45 am] Food and Drug Administration [Docket No. FDA–2024–N–0970] BILLING CODE 4164–01–P khammond on DSKJM1Z7X2PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Vaccines and Related Biological Products Advisory Committee; Amendment of Notice—Selection of the 2024 to 2025 Formula for COVID– 19 Vaccines AGENCY: Food and Drug Administration, HHS. ACTION: VerDate Sep<11>2014 17:06 May 21, 2024 Jkt 262001 PO 00000 Fmt 4703 4/30/2027 4/30/2027 4/30/2027 The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological Products Advisory Committee. This meeting was announced in the Federal Register of March 4, 2024. The amendment is being made to reflect a change in the meeting date in the SUMMARY and DATES portions of the document from May 16, 2024, to June 5, 2024. There are no other changes. SUMMARY: FOR FURTHER INFORMATION CONTACT: Kathleen Hayes or Prabhakara Atreya, Center for Biologics Evaluation and Notice. Frm 00041 0910–0495 0910–0627 0910–0909 Date approval expires Sfmt 4703 E:\FR\FM\22MYN1.SGM 22MYN1 Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993–0002, 301–796–6985, CBERVRBPAC@fda.hhs.gov; or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting. For press inquiries, please contact the Office of Media Affairs at 301–796–4540 or fdaoma@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of March 4, 2024 (89 FR 15590), FDA announced that a meeting of the Vaccines and Related Biological Products Advisory Committee would be held on May 16, 2024. On page 15590, in the second column, the SUMMARY and DATES portions of the document are changed to read as follows: SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. On June 5, 2024, the Committee will meet in open session to discuss and make recommendations on the selection of the 2024 to 2025 formula for COVID–19 vaccines. The meeting will be open to the public. DATES: The meeting will be held virtually on June 5, 2024, from 8:30 a.m. to 4:30 p.m. EST. This notice is issued under the Federal Advisory Committee Act 5 U.S.C. 1001 et seq. and 21 CFR part 14, relating to the advisory committees. Dated: May 17, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–11216 Filed 5–21–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration khammond on DSKJM1Z7X2PROD with NOTICES [Docket No. FDA–2024–N–0001] Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing the following public workshop entitled SUMMARY: VerDate Sep<11>2014 17:06 May 21, 2024 Jkt 262001 ‘‘Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products.’’ The purpose of the public workshop is to discuss transplacental transfer of drug and biological products with immunosuppressive properties and the potential clinical impact on the developing fetus and newborn infant, understand the gaps in knowledge, and consider innovative approaches to improve collection of relevant data. DATES: The public workshop will be held on July 11, 2024, from 9 a.m. to 5 p.m. Eastern Time and on July 12, 2024, from 9 a.m. to 1 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at FDA’s White Oak Campus and online. Entrance for the registered public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/about-fda/visitorinformation. FOR FURTHER INFORMATION CONTACT: Meshaun Payne and Michelle Pollack, Office of New Drugs Public Meeting Support Team, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6466, Silver Spring, MD 20993–0002, 301–796–6668, ONDPublicMTGSupport@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Drug and biological products are widely used in various therapeutic areas during pregnancy to treat various conditions. Some products can be actively or passively transported across the placenta from a pregnant individual to their fetus. When this occurs for products with immunosuppressive properties, it is biologically plausible that these products can exert immunosuppressive effects on the developing fetus and newborn infant. Historically, pregnant individuals have generally been excluded from clinical trials, resulting in a paucity of data available on transplacental transfer and its potential consequences to the developing fetus and newborn infant. This lack of data poses challenges in providing adequate information in product labeling to help prescribers and patients make informed decisions about use of these products during pregnancy. II. Topics for Discussion at the Public Workshop Pregnant individuals may have chronic and/or acute conditions that need to be treated, and published data PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 44997 show that most pregnant individuals take at least one medication (excluding vitamins) during pregnancy. Therefore, understanding the safety of medications when used during pregnancy is important. The main objective of the ‘‘Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products’’ workshop is to discuss the available data on the placental transfer of drug and biological products with immunosuppressive effects and the potential clinical impact on infants exposed in utero, identify gaps in knowledge, and explore innovative and practical approaches for collection of relevant data. In addition, the workshop will allow for an open dialogue among regulators, academia, industry, and patient organizations regarding the potential safety concerns of medicines that may need to be used during pregnancy and approaches to data collection. III. Participating in the Public Workshop Registration: To register for the public workshop, please visit the following website: https://lu.ma/5vdmbibm. Please register by July 10, 2024, at 11:59 p.m. Eastern time. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by July 10, 2024, at 11:59 p.m. Eastern time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If you need special accommodations due to a disability, please contact Brittany Witcher, OND Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov no later than July 1, 2024. Streaming Webcast of the Public Workshop: This public workshop will also be streamed virtually via Zoom. Virtual attendees may register at the following website to receive the Zoom link: https://lu.ma/5vdmbibm. Although FDA verified the website addresses in this document, please note that websites are subject to change over time. Transcripts and Recordings: Please be advised that as soon as transcripts and recordings of the public workshop are available, they will be accessible on the FDA event web page https:// www.fda.gov/drugs/news-events- E:\FR\FM\22MYN1.SGM 22MYN1

Agencies

[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 44996-44997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11216]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0970]


Vaccines and Related Biological Products Advisory Committee; 
Amendment of Notice--Selection of the 2024 to 2025 Formula for COVID-19 
Vaccines

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Vaccines and Related 
Biological Products Advisory Committee. This meeting was announced in 
the Federal Register of March 4, 2024. The amendment is being made to 
reflect a change in the meeting date in the SUMMARY and DATES portions 
of the document from May 16, 2024, to June 5, 2024. There are no other 
changes.

FOR FURTHER INFORMATION CONTACT: Kathleen Hayes or Prabhakara Atreya, 
Center for Biologics Evaluation and

[[Page 44997]]

Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Silver Spring, MD 20993-0002, 301-796-6985, [email protected]; 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area). Please call the Information Line for 
up-to-date information on this meeting. For press inquiries, please 
contact the Office of Media Affairs at 301-796-4540 or 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of March 4, 2024 (89 
FR 15590), FDA announced that a meeting of the Vaccines and Related 
Biological Products Advisory Committee would be held on May 16, 2024. 
On page 15590, in the second column, the SUMMARY and DATES portions of 
the document are changed to read as follows:

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Vaccines and Related 
Biological Products Advisory Committee (the Committee). The general 
function of the Committee is to provide advice and recommendations to 
FDA on regulatory issues. On June 5, 2024, the Committee will meet in 
open session to discuss and make recommendations on the selection of 
the 2024 to 2025 formula for COVID-19 vaccines. The meeting will be 
open to the public.

DATES: The meeting will be held virtually on June 5, 2024, from 8:30 
a.m. to 4:30 p.m. EST. This notice is issued under the Federal Advisory 
Committee Act 5 U.S.C. 1001 et seq. and 21 CFR part 14, relating to the 
advisory committees.

    Dated: May 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11216 Filed 5-21-24; 8:45 am]
BILLING CODE 4164-01-P
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