Meeting of the National Vaccine Advisory Committee, 45664-45665 [2024-11274]

Download as PDF 45664 Federal Register / Vol. 89, No. 101 / Thursday, May 23, 2024 / Notices the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Mai Huynh, Center for Veterinary Medicine (HFV–142), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240–402–0669, Mai.Huynh@fda.hhs.gov SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with NOTICES1 I. Background FDA is announcing the availability of a draft GFI #115 (VICH GL22) entitled ‘‘Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1).’’ This draft revised guidance has been developed for veterinary use by the VICH. In order to establish the safety of veterinary drug residues in human food, a number of toxicological evaluations are recommended including the assessment of any effects on reproduction. The objective of this guidance is to ensure international harmonization of reproduction testing that is appropriate for the evaluation of effects on reproduction from long-term, low-dose exposures; these effects may be encountered from the presence of veterinary drug residues in food. FDA has participated in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The goal of the VICH is to develop harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and receives input from both regulatory and industry representatives. The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency; AnimalhealthEurope; FDA—Center for Veterinary Medicine and U.S. Department of Agriculture—Center for Veterinary Biologics; the U.S. Animal Health Institute; the Japanese Ministry VerDate Sep<11>2014 18:47 May 22, 2024 Jkt 262001 of Agriculture, Forestry and Fisheries; and the Japanese Veterinary Products Association. There are 10 observers to the VICH Steering Committee: one representative from government and one representative from industry of Australia, New Zealand, Canada, South Africa, and the United Kingdom. The World Organisation for Animal Health is an associate member of the VICH. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals. This level 1 draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1).’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in 21 CFR part 514 have been approved under OMB control numbers 0910–0032. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm, https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// www.regulations.gov. Dated: May 20, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–11313 Filed 5–22–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, Office of the AGENCY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Secretary, Department of Health and Human Services. ACTION: Notice. As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) hereby gives notice that the National Vaccine Advisory Committee (NVAC) will hold an inperson meeting. The meeting will be open to the public and public comment will be heard during the meeting. DATES: The meeting will be held June 13–14, 2024. The confirmed meeting times and agenda will be posted on the NVAC website at https://www.hhs.gov/ nvpo/nvac/meetings/ as soon as they become available. ADDRESSES: Instructions regarding attending this meeting will be posted online at: https://www.hhs.gov/nvpo/ nvac/meetings/ at least one week prior to the meeting. Preregistration is required for those who wish to attend the meeting in person or participate in public comment. Please register at https://www.hhs.gov/nvpo/ nvac/meetings/. FOR FURTHER INFORMATION CONTACT: Ann Aikin, Acting Designated Federal Officer, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services, Tower Building, Room, 1101 Wootton Parkway, Rockville, MD 20852. Email: nvac@hhs.gov. Phone: 202–795–7697. SUPPLEMENTARY INFORMATION: Pursuant to section 2101 of the Public Health Service Act (42 U.S.C. 300aa–1), the Secretary of HHS was mandated to establish the National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The NVAC was established to provide advice and make recommendations to the Director of the National Vaccine Program on matters related to the Program’s responsibilities. The Assistant Secretary for Health serves as Director of the National Vaccine Program. During this meeting, NVAC will hear presentations to support the recent charge on innovation from Admiral Rachel L. Levine, MD, the Assistant Secretary for Health and Director of the National Vaccine Program. NVAC will also hear presentations on recent surges in measles cases, tuberculosis and breast cancer vaccines in development, and mpox vaccination activities. Speakers will also discuss progress and priorities for the upcoming Vaccines National Strategic Plan. Global immunization and data modernization efforts will also SUMMARY: E:\FR\FM\23MYN1.SGM 23MYN1 Federal Register / Vol. 89, No. 101 / Thursday, May 23, 2024 / Notices be reviewed during the meeting. Please note that agenda items are subject to change, as priorities dictate. Information on the final meeting agenda will be posted prior to the meeting on the NVAC website: https://www.hhs.gov/ nvpo/nvac/. Members of the public will have the opportunity to provide comment at the NVAC meeting during the public comment period designated on the agenda. Public comments made during the meeting will be limited to three minutes per person to ensure time is allotted for all those wishing to speak. Members of the public may also submit written comments. Written comments should not exceed three pages in length. Individuals planning to submit comments should email their written comments or their request to provide a comment during the meeting to nvac@ hhs.gov at least five business days prior to the meeting. Dated: May 7, 2024. Ann Aikin, Acting Designated Federal Official, Office of the Assistant Secretary for Health. [FR Doc. 2024–11274 Filed 5–22–24; 8:45 am] BILLING CODE 4150–44–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Presidential Advisory Council on HIV/AIDS Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice of a meeting. AGENCY: As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/ AIDS (PACHA or the Council) will convene the 81st full council meeting on Wednesday, June 5–Thursday, June 6, 2024. The meeting will include panels on the state of HIV science; agencies’ perspectives on ending the HIV epidemic; State-level system approaches from health departments; and anti-LGBTQI+ laws and their impact nationally & globally. It will be open to the public and there will be a public comment session during the meeting; pre-registration is required to provide public comment. To pre-register to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business Tuesday, May 28, 2024. If you decide you would like to provide public comment but do not lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:47 May 22, 2024 Jkt 262001 pre-register, you may submit your written statement by emailing PACHA@ hhs.gov by close of business Thursday, June 13, 2024. The meeting agenda will be posted on the PACHA page on HIV.gov at https://www.hiv.gov/federalresponse/pacha/about-pacha prior to the meeting. The meeting will convene on Wednesday, June 5, 2024 from approximately 9 a.m. to 5 p.m. (ET) and Thursday, June 6, 2024 from approximately 9 a.m. to 4 p.m. (ET). DATES: DoubleTree Crystal City Hotel, 300 Army Navy Dr., Arlington, Virginia 22202. To attend the meeting virtually, please visit www.hhs.gov/live. ADDRESSES: Ms. Chloe Loving, MPH, Committee Manager for PACHA, at PACHA@ hhs.gov or 202–795–7697. Additional information can be obtained by accessing the Council’s page on the HIV.gov site at www.hiv.gov/pacha. FOR FURTHER INFORMATION CONTACT: PACHA was established by Executive Order 12963, dated June 14, 1995, as amended by Executive Order 13009, dated June 14, 1996 and is currently operating under the authority given in Executive Order 14109, dated September 29, 2023. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective HIV diagnosis, treatment, prevention, and quality care services. The functions of the Council are solely advisory in nature. The Council consists of not more than 35 members. Council members are selected from prominent community leaders with particular expertise in, or knowledge of, matters concerning HIV and AIDS, public health, global health, population health, philanthropy, marketing or business, as well as other national leaders held in high esteem from other sectors of society. PACHA selections also include persons with lived HIV experience and persons disproportionately affected by HIV. Council members are appointed by the Secretary. SUPPLEMENTARY INFORMATION: Dated: May 15, 2024. Caroline Talev, Executive Director, Presidential Advisory Council on HIV/AIDS, Senior Management Analyst, Office of Infectious Disease and HIV/ AIDS Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services. [FR Doc. 2024–11369 Filed 5–22–24; 8:45 am] BILLING CODE 4150–43–P PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 45665 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Advisory Committee on Seniors and Disasters Meeting Notice; Cancellation National Advisory Committee on Seniors and Disasters (NACSD), Administration for Strategic Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS). ACTION: Notice; cancellation of meeting. AGENCY: The Administration for Strategic Preparedness and Response (ASPR) published a notice in the Federal Register concerning a public meeting of the National Advisory Committee on Seniors and Disasters (NACSD). The public meeting, scheduled for Monday, May 20, 2024, at 2:30 p.m. ET, has been cancelled and will be rescheduled for a later date. The notice is in the Federal Register on Thursday, May 2, 2024, in FR Document Number 2024–09584 on pages 35843– 35844 (2 pages). FOR FURTHER INFORMATION CONTACT: Dr. Maxine Kellman; NACSD Designated Federal Official, at NACSD@HHS.GOV or (202) 260–0047. The Administrator and Assistant Secretary for Preparedness and Response of ASPR, Dawn O’Connell, having reviewed and approved this document, authorizes Mary Radebach, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. SUMMARY: Dated: May 17, 2024. Mary Radebach, Federal Register Liaison, Administration for Strategic Preparedness and Response. [FR Doc. 2024–11297 Filed 5–22–24; 8:45 am] BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcing the Call for Nominations for the 2024 President’s Council on Sports, Fitness & Nutrition Awards Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, U.S. Department of Health and Human Services. ACTION: Notice. AGENCY: The President’s Council on Sports, Fitness & Nutrition (Council or PCSFN) is calling for nominations from the public for its three awards—the Lifetime Impact Award, the Community SUMMARY: E:\FR\FM\23MYN1.SGM 23MYN1

Agencies

[Federal Register Volume 89, Number 101 (Thursday, May 23, 2024)]
[Notices]
[Pages 45664-45665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11274]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the National Vaccine Advisory Committee

AGENCY: Office of Infectious Disease and HIV/AIDS Policy, Office of the 
Assistant Secretary for Health, Office of the Secretary, Department of 
Health and Human Services.

ACTION: Notice.

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

SUMMARY: As stipulated by the Federal Advisory Committee Act, the 
Department of Health and Human Services (HHS) hereby gives notice that 
the National Vaccine Advisory Committee (NVAC) will hold an in-person 
meeting. The meeting will be open to the public and public comment will 
be heard during the meeting.

DATES: The meeting will be held June 13-14, 2024. The confirmed meeting 
times and agenda will be posted on the NVAC website at https://www.hhs.gov/nvpo/nvac/meetings/ as soon as they become 
available.

ADDRESSES: Instructions regarding attending this meeting will be posted 
online at: https://www.hhs.gov/nvpo/nvac/meetings/ at least 
one week prior to the meeting. Pre-registration is required for those 
who wish to attend the meeting in person or participate in public 
comment. Please register at https://www.hhs.gov/nvpo/nvac/meetings/.

FOR FURTHER INFORMATION CONTACT: Ann Aikin, Acting Designated Federal 
Officer, Office of Infectious Disease and HIV/AIDS Policy, U.S. 
Department of Health and Human Services, Tower Building, Room, 1101 
Wootton Parkway, Rockville, MD 20852. Email: [email protected]. Phone: 202-
795-7697.

SUPPLEMENTARY INFORMATION: Pursuant to section 2101 of the Public 
Health Service Act (42 U.S.C. 300aa-1), the Secretary of HHS was 
mandated to establish the National Vaccine Program to achieve optimal 
prevention of human infectious diseases through immunization and to 
achieve optimal prevention against adverse reactions to vaccines. The 
NVAC was established to provide advice and make recommendations to the 
Director of the National Vaccine Program on matters related to the 
Program's responsibilities. The Assistant Secretary for Health serves 
as Director of the National Vaccine Program.
    During this meeting, NVAC will hear presentations to support the 
recent charge on innovation from Admiral Rachel L. Levine, MD, the 
Assistant Secretary for Health and Director of the National Vaccine 
Program. NVAC will also hear presentations on recent surges in measles 
cases, tuberculosis and breast cancer vaccines in development, and mpox 
vaccination activities. Speakers will also discuss progress and 
priorities for the upcoming Vaccines National Strategic Plan. Global 
immunization and data modernization efforts will also

[[Page 45665]]

be reviewed during the meeting. Please note that agenda items are 
subject to change, as priorities dictate. Information on the final 
meeting agenda will be posted prior to the meeting on the NVAC website: 
https://www.hhs.gov/nvpo/nvac/.
    Members of the public will have the opportunity to provide comment 
at the NVAC meeting during the public comment period designated on the 
agenda. Public comments made during the meeting will be limited to 
three minutes per person to ensure time is allotted for all those 
wishing to speak. Members of the public may also submit written 
comments. Written comments should not exceed three pages in length. 
Individuals planning to submit comments should email their written 
comments or their request to provide a comment during the meeting to 
[email protected] at least five business days prior to the meeting.

    Dated: May 7, 2024.
Ann Aikin,
Acting Designated Federal Official, Office of the Assistant Secretary 
for Health.
[FR Doc. 2024-11274 Filed 5-22-24; 8:45 am]
BILLING CODE 4150-44-P
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