National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments, 11724-11725 [2022-04389]

Download as PDF 11724 Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices OMB control number 0910–0338; the collections of information in §§ 201.56 and 201.57 for the content and format requirements for labeling of human prescription drug and biological products have been approved under OMB control number 0910–0572. In addition, the following collections of information in FDA’s guidances have been approved by OMB (https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents): • Collections in FDA’s draft guidance for industry entitled ‘‘Formal Meetings Between the FDA and Sponsors and Applicants for PDUFA Products’’ have been approved under OMB control number 0910–0429. • Collections in FDA’s guidance for industry entitled ‘‘Special Protocol Assessment’’ have been approved under OMB control number 0910–0470. • Collections in FDA’s guidance for industry entitled ‘‘Establishment and Operation of Clinical Trial Data Monitoring Committees’’ have been approved under OMB control number 0910–0581. • Collections in FDA’s guidance for industry entitled ‘‘Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring’’ have been approved under OMB control number 0910–0733. • Collections in FDA’s guidance for industry entitled ‘‘Expedited Programs for Serious Conditions—Drugs and Biologics’’ have been approved under OMB control number 0910–0765. • Collections in FDA’s guidance for industry entitled ‘‘E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)’’ have been approved under OMB control number 0910–0843. III. Electronic Access lotter on DSK11XQN23PROD with NOTICES1 Persons with access to the internet may obtain the guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: February 24, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–04398 Filed 3–1–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Vaccines Federal Implementation Plan National Institutes of Health Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, Office of Infectious Disease and HIV/AIDS Policy. AGENCY: ACTION: Notice. 17:34 Mar 01, 2022 The Department of Health and Human Services’ Office of Infectious Disease and HIV/AIDS Policy in the Office of the Assistant Secretary for Health announces that the draft Vaccines Federal Implementation Plan 2021–2025 is available for public comment. The Vaccines Federal Implementation Plan is a companion document to the Vaccines National Strategic Plan 2021–2025 (VNSP), which was published in January 2021. The Vaccines Federal Implementation Plan is a compilation of federal agency immunization activities that collectively advance the goals of the VNSP. Its target audience is other federal agencies and external partners who work in the area of vaccination. The public will be interested in how the implementation plan documents federal agency efforts. It does not outline mandates or other COVID–19 response measures. SUMMARY: The public comment period for the Vaccines Federal Implementation Plan starts on February 28, 2022 at 9 a.m. ET and ends on March 29, 2022 at 5 p.m. ET. All comments must be received by 5 p.m. ET on March 29, 2022 to be considered. DATES: All comments must be submitted electronically to nvp.rfi@ hhs.gov. ADDRESSES: FOR FURTHER INFORMATION CONTACT: David Kim, MD, MA, Director, Division of Vaccines, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, Room L616, Switzer Building, 330 C St. SW, Washington, DC 20024. Phone: 202–795–7697; Email: nvp.rfi@ hhs.gov. Dated: February 17, 2022. David Kim, Designated Federal Officer, Vaccines Federal Implementation Plan, Office of the Assistant Secretary for Health. [FR Doc. 2022–04327 Filed 3–1–22; 8:45 am] Jkt 256001 PO 00000 Frm 00039 Fmt 4703 AGENCY: National Institutes of Health, HHS. ACTION: Notice. This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is a virtual meeting and is open to the public. Written comments will be accepted and registration is required to present oral comments. SUMMARY: BILLING CODE 4150–44–P VerDate Sep<11>2014 National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments Sfmt 4703 DATES: Meeting: Scheduled for April 19, 2022, 12:30 p.m.–2:00 p.m. Eastern Standard Time (EST). Ending times are approximate; meeting may end earlier or run later. Written Public Comment Submissions: Deadline is April 12, 2022. Registration for Oral Comments: Deadline is April 12, 2022. ADDRESSES: Meeting Web Page: The preliminary agenda, registration, and other meeting materials will be available at https:// ntp.niehs.nih.gov/go/165 by March 14, 2022. Virtual Meeting: The URL for viewing the virtual meeting will be provided on the meeting web page the day before the meeting. FOR FURTHER INFORMATION CONTACT: Dr. Mary Wolfe, Designated Federal Official for the BSC, Office of Policy, Review, and Outreach, Division of NTP, NIEHS, P.O. Box 12233, K2–03, Research Triangle Park, NC 27709. Phone: 984– 287–3209, Fax: 301–451–5759, Email: wolfe@niehs.nih.gov. Hand Deliver/ Courier address: 530 Davis Drive, Room K2130, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: The BSC will provide input to the NTP on programmatic activities and issues. The preliminary agenda topics include presentations on a contract concept: Bioinformatics Support for the NIEHS. The preliminary agenda, roster of BSC members, background materials, public comments, and any additional information, when available, will be posted on the BSC meeting web page (https://ntp.niehs.nih.gov/go/165) or E:\FR\FM\02MRN1.SGM 02MRN1 lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices may be requested in hardcopy from the Designated Federal Official for the BSC. Following the meeting, summary minutes will be prepared and made available on the BSC meeting web page. Meeting Attendance Registration: The meeting is open to the public with time scheduled for oral public comments. Registration is not required to view the virtual meeting; the URL for the virtual meeting is provided on the BSC meeting web page (https://ntp.niehs.nih.gov/go/ 165) the day before the meeting. TTY users should contact the Federal TTY Relay Service at 800–877–8339. Requests should be made at least five business days in advance of the event. Written Public Comments: NTP invites written public comments. Guidelines for public comments are available at https://ntp.niehs.nih.gov/ ntp/about_ntp/guidelines_public_ comments_508.pdf. The deadline for submission of written comments is April 12, 2022. Written public comments should be submitted through the meeting web page. Persons submitting written comments should include name, affiliation, mailing address, phone, email, and sponsoring organization (if any). Written comments received in response to this notice will be posted on the NTP web page, and the submitter will be identified by name, affiliation, and sponsoring organization (if any). Oral Public Comment Registration: The agenda allows for one formal public comment period on the agenda topics (up to 5 commenters total, up to 5 minutes per speaker per topic). Persons wishing to make an oral comment are required to register online at https:// ntp.niehs.nih.gov/go/165 by April 12, 2022. Oral comments will be received only during the formal comment period indicated on the preliminary agenda. Oral comments will only be by teleconference line. The access number for the teleconference line will be provided to registrants by email prior to the meeting. Registration is on a firstcome, first-served basis. Each organization is allowed one time slot per topic. After the maximum number of speakers is exceeded, individuals registered to provide oral comment will be placed on a wait list and notified should an opening become available. Commenters will be notified approximately one week before the meeting about the actual time allotted per speaker. If possible, oral public commenters should send a copy of their slides and/ or statement or talking points to NTPMeetings@icf.com by April 12, 2022. Meeting Materials: The preliminary meeting agenda will be available on the VerDate Sep<11>2014 17:34 Mar 01, 2022 Jkt 256001 meeting web page (https://ntp.niehs. nih.gov/go/165) by March 14, 2022, and will be updated one week before the meeting. Individuals are encouraged to access the meeting web page to stay abreast of the most current information regarding the meeting. Background Information on the BSC: The BSC is a technical advisory body comprised of scientists from the public and private sectors that provides primary scientific oversight to the NTP. Specifically, the BSC advises the NTP on matters of scientific program content, both present and future, and conducts periodic review of the program for the purpose of determining and advising on the scientific merit of its activities and their overall scientific quality. Its members are selected from recognized authorities knowledgeable in fields such as toxicology, pharmacology, pathology, epidemiology, risk assessment, carcinogenesis, mutagenesis, cellular biology, computational toxicology, neurotoxicology, genetic toxicology, reproductive toxicology or teratology, and biostatistics. Members serve overlapping terms of up to four years. The BSC usually meets periodically. The authority for the BSC is provided by 42 U.S.C. 217a, section 222 of the Public Health Service Act (PHS), as amended. The BSC is governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. app.), which sets forth standards for the formation and use of advisory committees. Dated: February 24, 2022. Brian R. Berridge, Associate Director, National Toxicology Program. [FR Doc. 2022–04389 Filed 3–1–22; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 11725 individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Resource-Related Research Projects (R24 Clinical Trial Not Allowed). Date: March 30, 2022. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G42, Rockville, MD 20892 (Virtual Meeting). Contact Person: Sandip Bhattacharyya, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G42, Rockville, MD 20852, (240) 292–0189, sandip.bhattacharyya@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: February 24, 2022. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2022–04363 Filed 3–1–22; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Resource-Related Research Projects (R24 Clinical Trial Not Allowed). Date: March 25, 2022. Time: 1:00 p.m. to 3:00 p.m. E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11724-11725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04389]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program Board of Scientific Counselors; 
Announcement of Meeting; Request for Comments

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: This notice announces the next meeting of the National 
Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, 
a federally chartered, external advisory group composed of scientists 
from the public and private sectors, will review and provide advice on 
programmatic activities. This meeting is a virtual meeting and is open 
to the public. Written comments will be accepted and registration is 
required to present oral comments.

DATES: 
    Meeting: Scheduled for April 19, 2022, 12:30 p.m.-2:00 p.m. Eastern 
Standard Time (EST). Ending times are approximate; meeting may end 
earlier or run later.
    Written Public Comment Submissions: Deadline is April 12, 2022.
    Registration for Oral Comments: Deadline is April 12, 2022.

ADDRESSES: 
    Meeting Web Page: The preliminary agenda, registration, and other 
meeting materials will be available at https://ntp.niehs.nih.gov/go/165 
by March 14, 2022.
    Virtual Meeting: The URL for viewing the virtual meeting will be 
provided on the meeting web page the day before the meeting.

FOR FURTHER INFORMATION CONTACT: Dr. Mary Wolfe, Designated Federal 
Official for the BSC, Office of Policy, Review, and Outreach, Division 
of NTP, NIEHS, P.O. Box 12233, K2-03, Research Triangle Park, NC 27709. 
Phone: 984-287-3209, Fax: 301-451-5759, Email: [email protected]. 
Hand Deliver/Courier address: 530 Davis Drive, Room K2130, Morrisville, 
NC 27560.

SUPPLEMENTARY INFORMATION: The BSC will provide input to the NTP on 
programmatic activities and issues. The preliminary agenda topics 
include presentations on a contract concept: Bioinformatics Support for 
the NIEHS. The preliminary agenda, roster of BSC members, background 
materials, public comments, and any additional information, when 
available, will be posted on the BSC meeting web page (https://ntp.niehs.nih.gov/go/165) or

[[Page 11725]]

may be requested in hardcopy from the Designated Federal Official for 
the BSC. Following the meeting, summary minutes will be prepared and 
made available on the BSC meeting web page.
    Meeting Attendance Registration: The meeting is open to the public 
with time scheduled for oral public comments. Registration is not 
required to view the virtual meeting; the URL for the virtual meeting 
is provided on the BSC meeting web page (https://ntp.niehs.nih.gov/go/165) the day before the meeting. TTY users should contact the Federal 
TTY Relay Service at 800-877-8339. Requests should be made at least 
five business days in advance of the event.
    Written Public Comments: NTP invites written public comments. 
Guidelines for public comments are available at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
    The deadline for submission of written comments is April 12, 2022. 
Written public comments should be submitted through the meeting web 
page. Persons submitting written comments should include name, 
affiliation, mailing address, phone, email, and sponsoring organization 
(if any). Written comments received in response to this notice will be 
posted on the NTP web page, and the submitter will be identified by 
name, affiliation, and sponsoring organization (if any).
    Oral Public Comment Registration: The agenda allows for one formal 
public comment period on the agenda topics (up to 5 commenters total, 
up to 5 minutes per speaker per topic). Persons wishing to make an oral 
comment are required to register online at https://ntp.niehs.nih.gov/go/165 by April 12, 2022. Oral comments will be received only during 
the formal comment period indicated on the preliminary agenda. Oral 
comments will only be by teleconference line. The access number for the 
teleconference line will be provided to registrants by email prior to 
the meeting. Registration is on a first-come, first-served basis. Each 
organization is allowed one time slot per topic. After the maximum 
number of speakers is exceeded, individuals registered to provide oral 
comment will be placed on a wait list and notified should an opening 
become available. Commenters will be notified approximately one week 
before the meeting about the actual time allotted per speaker.
    If possible, oral public commenters should send a copy of their 
slides and/or statement or talking points to [email protected] by 
April 12, 2022.
    Meeting Materials: The preliminary meeting agenda will be available 
on the meeting web page (https://ntp.niehs.nih.gov/go/165) by March 14, 
2022, and will be updated one week before the meeting. Individuals are 
encouraged to access the meeting web page to stay abreast of the most 
current information regarding the meeting.
    Background Information on the BSC: The BSC is a technical advisory 
body comprised of scientists from the public and private sectors that 
provides primary scientific oversight to the NTP. Specifically, the BSC 
advises the NTP on matters of scientific program content, both present 
and future, and conducts periodic review of the program for the purpose 
of determining and advising on the scientific merit of its activities 
and their overall scientific quality. Its members are selected from 
recognized authorities knowledgeable in fields such as toxicology, 
pharmacology, pathology, epidemiology, risk assessment, carcinogenesis, 
mutagenesis, cellular biology, computational toxicology, 
neurotoxicology, genetic toxicology, reproductive toxicology or 
teratology, and biostatistics. Members serve overlapping terms of up to 
four years. The BSC usually meets periodically. The authority for the 
BSC is provided by 42 U.S.C. 217a, section 222 of the Public Health 
Service Act (PHS), as amended.
    The BSC is governed by the provisions of the Federal Advisory 
Committee Act, as amended (5 U.S.C. app.), which sets forth standards 
for the formation and use of advisory committees.

    Dated: February 24, 2022.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2022-04389 Filed 3-1-22; 8:45 am]
BILLING CODE 4140-01-P
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