Submission for OMB Review; 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI), 56965-56966 [2022-20083]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 87, No. 179 / Friday, September 16, 2022 / Notices third and final Report to Congress and the HHS Secretary. The 2022 report will address a wide range of topics related to tick-borne diseases, such as, surveillance, prevention, diagnosis, diagnostics, and treatment; identify advances made in research, as well as overlap and gaps in tick-borne disease research; and provide recommendations regarding any appropriate changes or improvements to such activities and research. DATES: The public can view the meeting online via webcast on October 25, 2022 from approximately 9:00 a.m. to 5:00 p.m. ET (times are tentative and subject to change) each day. The confirmed times and agenda items for the meeting will be posted on the TBDWG web page at https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/ 2022-10-25/ 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, Tower Building, 1101 Wootton Parkway, Rockville, MD 20852. Email: tickbornedisease@hhs.gov. Phone: 202– 795–7608. SUPPLEMENTARY INFORMATION: A link to view the webcast can be found on the meeting website at https://www.hhs.gov/ ash/advisory-committees/ tickbornedisease/meetings/2022-10-25/ index.html when it becomes available. 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/2022-10-25/ index.html and respond by midnight October 17, 2022 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 VerDate Sep<11>2014 16:43 Sep 15, 2022 Jkt 256001 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: September 8, 2022. James J. Berger, Designated Federal Officer, Tick-Borne Disease Working Group, Office of Infectious Disease and HIV/AIDS Policy. [FR Doc. 2022–20088 Filed 9–15–22; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Secretary; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Science Advisory Board for Biosecurity. The meeting will be held as a virtual meeting and is open to the public. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting should notify the Contact Person listed below in advance of the meeting. The meeting will be videocast and can be accessed from the NIH Videocasting and Podcasting website (https://videocast.nih.gov/). Name of Committee: National Science Advisory Board for Biosecurity. Date: September 21, 2022. Time: 1:00 p.m. to 5:00 p.m. Agenda: The National Science Advisory Board for Biosecurity (NSABB) meeting will include a progress update from the NSABB Working Group to Review and Evaluate Potential Pandemic Pathogen Care and Oversight (PC3O) Policy, and stakeholder engagement on topics related to the U.S. Government policies for the Oversight of Dual Use Research of Concern (DURC). Place: National Institutes of Health, 6705 Rockledge Drive, Suite 630, Bethesda, MD 20892, (Virtual Meeting Link will be available at https://osp.od.nih.gov/ biotechnology/national-science-advisoryboard-for-biosecurity-nsabb/#meetings). Contact Person: Cari Young, ScM, Acting Director, Division of Biosafety, Biosecurity, and Emerging Biotechnology Policy, Office of Science Policy, Office of the Director, National Institutes of Health, 6705 Rockledge Drive, Suite 630, Bethesda, MD 20892, (301) 594–3746, SciencePolicy@od.nih.gov. To sign up to make an oral public comment at the meeting, please send an email to the Contact Person listed above at least one business day prior to the meeting date. Once all time slots are filled, only written comments will be accepted. Any interested PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 56965 person may file written comments by forwarding the statement to the Contact Person listed on this notice at least one business day prior to the meeting date. The statement should include the name, address, telephone number and, when applicable, the business or professional affiliation of the interested person. Other than name and contact information, please do not include any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your comments. Please note that any written comments NIH receives may be posted unredacted to the Office of Science Policy website. Information is also available on the NIH Office of Science Policy website: https:// osp.od.nih.gov/biotechnology/nationalscience-advisory-board-for-biosecuritynsabb/#meetings, where an agenda, link to the webcast meeting, and any additional information for the meeting will be posted when available. Materials for this meeting will be posted prior to the meeting. Please check this website for updates. This notice is being published less than 15 days prior to the meeting due to scheduling difficulties. Dated: September 13, 2022. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2022–20098 Filed 9–15–22; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open SUMMARY: E:\FR\FM\16SEN1.SGM 16SEN1 56966 Federal Register / Vol. 87, No. 179 / Friday, September 16, 2022 / Notices for Public Comments’’ or by using the search function. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Gisele Sarosy, MD, Coordinating Center for Clinical Trials (CCCT), National Cancer Institute, 9609 Medical Center Drive, 6W134, Rockville, MD 20852 or call non-tollfree number 240–276–6172 or Email your request, including your address to: gisele.sarosy@nih.gov. FOR FURTHER INFORMATION CONTACT: This proposed information collection was previously published in the Federal Register on June 29, 2022, page 38765 (Vol. 87, No. 124) and allowed 60 days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 SUPPLEMENTARY INFORMATION: Need and Use of Information Collection: The Clinical Trials Reporting Program (CTRP) is an electronic resource that serves as a single, definitive source of information about all NCI-supported clinical research. This resource allows the NCI to consolidate reporting, aggregate data, and reduce redundant submissions. Clinical research administrators submit information as designees of clinical investigators who conduct NCIsupported clinical research. The designees can electronically access the CTRP website to complete the initial trial registration. After registration, four amendments and four study subject accrual updates occur per trial annually. days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed Collection: The Clinical Trials Reporting Program (CTRP) Database (NCI), 0925–0600, Expiration Date 10/31/2022—EXTENSION, National Cancer Institute (NCI), National Institutes of Health (NIH). OMB approval is requested for three years. There are no costs to respondents other than their time. The estimated annualized burden hours are 18,000. ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Average time per response (in hours) Total annual burden hours Type of respondents Initial Registration ............................. Amendment ....................................... Update ............................................... Accrual Updates ................................ Clinical Trials .................................... 3,000 1,500 1,500 3,000 1 4 4 4 1 1 1 15/60 3,000 6,000 6,000 3,000 Totals ......................................... ........................................................... 9,000 27,000 ........................ 18,000 Dated: September 13, 2022. Diane Kreinbrink, Project Clearance Liaison, National Cancer Institute, National Institutes of Health. individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. [FR Doc. 2022–20083 Filed 9–15–22; 8:45 am] Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIDA Animal Genomics Program. Date: October 25, 2022. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Drug Abuse, 301 North Stonestreet Avenue, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Ipolia R. Ramadan, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, National Institute on Drug Abuse, NIH, 301 North Stonestreet Avenue, MSC 6021, Bethesda, MD 20892, (301) 827–4471, ramadanir@mail.nih.gov. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Single Cell Opioid Responses in the Context of HIV (SCORCH) Program Expansion: CNS Data Generation for Chronic Opioid, Methamphetamine, Cocaine and/or Cannabinoid Exposures. Date: November 22, 2022. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meetings khammond on DSKJM1Z7X2PROD with NOTICES Number of respondents Form name Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings 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 VerDate Sep<11>2014 16:43 Sep 15, 2022 Jkt 256001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Drug Abuse, 301 North Stonestreet Avenue, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Soyoun Cho, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, National Institute on Drug Abuse, NIH, 301 North Stonestreet Avenue, MSC 6021, Bethesda, MD 20892, (301) 594–9460, Soyoun.cho@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.277, Drug Abuse Scientist Development Award for Clinicians, Scientist Development Awards, and Research Scientist Awards; 93.278, Drug Abuse National Research Service Awards for Research Training; 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: September 12, 2022. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2022–20060 Filed 9–15–22; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\16SEN1.SGM 16SEN1

Agencies

[Federal Register Volume 87, Number 179 (Friday, September 16, 2022)]
[Notices]
[Pages 56965-56966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20083]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; The Clinical 
Trials Reporting Program (CTRP) Database (NCI)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30 days of the date of 
this publication.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open

[[Page 56966]]

for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Gisele Sarosy, MD, Coordinating Center for 
Clinical Trials (CCCT), National Cancer Institute, 9609 Medical Center 
Drive, 6W134, Rockville, MD 20852 or call non-toll-free number 240-276-
6172 or Email your request, including your address to: 
[email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on June 29, 2022, page 
38765 (Vol. 87, No. 124) and allowed 60 days for public comment. One 
public comment was received. The purpose of this notice is to allow an 
additional 30 days for public comment. The National Cancer Institute 
(NCI), National Institutes of Health, may not conduct or sponsor, and 
the respondent is not required to respond to, an information collection 
that has been extended, revised, or implemented on or after October 1, 
1995, unless it displays a currently valid OMB control number.
    In compliance with section 3507(a)(1)(D) of the Paperwork Reduction 
Act of 1995, the National Institutes of Health (NIH) has submitted to 
the Office of Management and Budget (OMB) a request for review and 
approval of the information collection listed below.
    Proposed Collection: The Clinical Trials Reporting Program (CTRP) 
Database (NCI), 0925-0600, Expiration Date 10/31/2022--EXTENSION, 
National Cancer Institute (NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: The Clinical Trials 
Reporting Program (CTRP) is an electronic resource that serves as a 
single, definitive source of information about all NCI-supported 
clinical research. This resource allows the NCI to consolidate 
reporting, aggregate data, and reduce redundant submissions. Clinical 
research administrators submit information as designees of clinical 
investigators who conduct NCI-supported clinical research. The 
designees can electronically access the CTRP website to complete the 
initial trial registration. After registration, four amendments and 
four study subject accrual updates occur per trial annually.
    OMB approval is requested for three years. There are no costs to 
respondents other than their time. The estimated annualized burden 
hours are 18,000.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
           Form name                 Type of         Number of     responses per   per response    Total annual
                                   respondents      respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
Initial Registration..........  Clinical Trials.           3,000               1               1           3,000
Amendment.....................                             1,500               4               1           6,000
Update........................                             1,500               4               1           6,000
Accrual Updates...............                             3,000               4           15/60           3,000
                                                 ---------------------------------------------------------------
    Totals....................  ................           9,000          27,000  ..............          18,000
----------------------------------------------------------------------------------------------------------------


    Dated: September 13, 2022.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2022-20083 Filed 9-15-22; 8:45 am]
BILLING CODE 4140-01-P


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