Meeting of the Tick-Borne Disease Working Group, 35313 [2020-12432]

Download as PDF Federal Register / Vol. 85, No. 111 / Tuesday, June 9, 2020 / Notices emergency, FDA intends to revise and replace this guidance with any appropriate changes based on comments received on this guidance and the Agency’s experience with implementation. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID– 19 Public Health Emergency.’’ 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 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3521). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014; the collections of information relating to the protection of human subjects and IRBs have been approved under OMB control number 0910–0130; and the collections of information in FDA’s guidance for industry on ‘‘Individual Patient Expanded Access Applications: Form FDA 3926’’ have been approved under OMB control number 0910–0814. III. Electronic Access jbell on DSKJLSW7X2PROD with NOTICES 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/ emergency-preparedness-and-response/ mcm-issues/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders, or https:// www.regulations.gov. Dated: June 3, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–12429 Filed 6–8–20; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 23:08 Jun 08, 2020 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Tick-Borne Disease Working Group Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a virtual meeting. The meeting will be open to the public. For this meeting, the TBDWG will review the draft 2020 report to the HHS Secretary and Congress and review and approve graphics and images for the report. The 2020 report will address ongoing tickborne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, and interventions for individuals with tick-borne diseases; advances made pursuant to such research; federal activities related to tick-borne diseases; and gaps in tickborne disease research. DATES: The meeting will be held online via webcast on July 8, 2020, from 9:00 a.m. to 5:30 p.m. ET (times are tentative and subject to change). The confirmed times and agenda items for the meeting will be posted on the TBDWG webpage at https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/ 2020-7-8/ when this information becomes available. FOR FURTHER INFORMATION CONTACT: James Berger, Designated Federal Officer for the TBDWG; Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services, Mary E. Switzer Building, 330 C Street SW, Suite L600, Washington, DC 20024. Email: tickbornedisease@ hhs.gov; Phone: 202–795–7608. SUPPLEMENTARY INFORMATION: Please register for the virtual meeting at https://kauffmaninc.adobeconnect.com/ tbdwg_july2020/event/event_info.html. After registering, you will receive an email confirmation with a personalized link to access the webcast on July 8. The public will have an opportunity to present their views to the TBDWG orally during the meeting’s public comment session or by submitting a written public comment. Comments should be pertinent to the meeting discussion. Persons who wish to provide verbal or written public SUMMARY: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 35313 comment should review instructions at https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/ 2020-7-8/ and respond by midnight June 24, 2020, ET. Verbal comments will be limited to three minutes each to accommodate as many speakers as possible during the 30 minute session. Written public comments will be accessible to the public on the TBDWG web page prior to the meeting. Background and Authority: The TickBorne Disease Working Group was established on August 10, 2017, in accordance with Section 2062 of the 21st Century Cures Act, and the Federal Advisory Committee Act, 5 U.S.C. App., as amended, to provide expertise and review federal efforts related to all tickborne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities. The TBDWG is required to submit a report to the HHS Secretary and Congress on their findings and any recommendations for the federal response to tick-borne disease every two years. Dated: May 20, 2020. James J. Berger, Designated Federal Officer, Tick-Borne Disease Working Group, Office of Infectious Disease and HIV/AIDS Policy. [FR Doc. 2020–12432 Filed 6–8–20; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier OS–4040–0018] Agency Information Collection Request. 30-Day Public Comment Request Office of the Secretary, HHS Notice. AGENCY: ACTION: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before July 9, 2020. ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via facsimile to (202) 395–5806. FOR FURTHER INFORMATION CONTACT: Ed Calimag, ed.calimag@hhs.gov or (202) 690–7569. When submitting comments or requesting information, please include the document identifier 4040– 0018–30D and project title for reference. SUMMARY: E:\FR\FM\09JNN1.SGM 09JNN1

Agencies

[Federal Register Volume 85, Number 111 (Tuesday, June 9, 2020)]
[Notices]
[Page 35313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12432]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Tick-Borne Disease Working Group

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

ACTION: Notice.

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

SUMMARY: As required by the Federal Advisory Committee Act, the 
Department of Health and Human Services (HHS) is hereby giving notice 
that the Tick-Borne Disease Working Group (TBDWG) will hold a virtual 
meeting. The meeting will be open to the public. For this meeting, the 
TBDWG will review the draft 2020 report to the HHS Secretary and 
Congress and review and approve graphics and images for the report. The 
2020 report will address ongoing tick-borne disease research, including 
research related to causes, prevention, treatment, surveillance, 
diagnosis, diagnostics, and interventions for individuals with tick-
borne diseases; advances made pursuant to such research; federal 
activities related to tick-borne diseases; and gaps in tick-borne 
disease research.

DATES: The meeting will be held online via webcast on July 8, 2020, 
from 9:00 a.m. to 5:30 p.m. ET (times are tentative and subject to 
change). The confirmed times and agenda items for the meeting will be 
posted on the TBDWG webpage at https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/2020-7-8/ when this 
information becomes available.

FOR FURTHER INFORMATION CONTACT: James Berger, Designated Federal 
Officer for the TBDWG; Office of Infectious Disease and HIV/AIDS 
Policy, Office of the Assistant Secretary for Health, Department of 
Health and Human Services, Mary E. Switzer Building, 330 C Street SW, 
Suite L600, Washington, DC 20024. Email: [email protected]; 
Phone: 202-795-7608.

SUPPLEMENTARY INFORMATION: Please register for the virtual meeting at 
https://kauffmaninc.adobeconnect.com/tbdwg_july2020/event/event_info.html. After registering, you will receive an email 
confirmation with a personalized link to access the webcast on July 8.
    The public will have an opportunity to present their views to the 
TBDWG orally during the meeting's public comment session or by 
submitting a written public comment. Comments should be pertinent to 
the meeting discussion. Persons who wish to provide verbal or written 
public comment should review instructions at https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/2020-7-8/ and 
respond by midnight June 24, 2020, ET. Verbal comments will be limited 
to three minutes each to accommodate as many speakers as possible 
during the 30 minute session. Written public comments will be 
accessible to the public on the TBDWG web page prior to the meeting.
    Background and Authority: The Tick-Borne Disease Working Group was 
established on August 10, 2017, in accordance with Section 2062 of the 
21st Century Cures Act, and the Federal Advisory Committee Act, 5 
U.S.C. App., as amended, to provide expertise and review federal 
efforts related to all tick-borne diseases, to help ensure interagency 
coordination and minimize overlap, and to examine research priorities. 
The TBDWG is required to submit a report to the HHS Secretary and 
Congress on their findings and any recommendations for the federal 
response to tick-borne disease every two years.

    Dated: May 20, 2020.
James J. Berger,
Designated Federal Officer, Tick-Borne Disease Working Group, Office of 
Infectious Disease and HIV/AIDS Policy.
[FR Doc. 2020-12432 Filed 6-8-20; 8:45 am]
 BILLING CODE 4150-28-P
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