Establishment of the Applied Therapeutics for Cancer Integrated Review Group, 66859-66860 [2023-21233]

Download as PDF Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices Institutional Training Mechanism Study Section. Date: December 1, 2023. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge I, 6705 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Michael P. Reilly, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6705 Rockledge Drive, Room 208–Z, Bethesda, MD 20892, 301–827–7975, reillymp@nhlbi.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: September 22, 2023. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–21145 Filed 9–27–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting ddrumheller on DSK120RN23PROD with NOTICES1 Pursuant to section 1009 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: Heart, Lung, and Blood Initial Review Group; Heart, Lung, and Blood Program Project Study Section. Date: December 1, 2023. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: DoubleTree by Hilton McLean Tysons, 1960 Chain Bridge Rd., McLean, VA 22102. Contact Person: Melissa H. Nagelin, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6705 Rockledge Drive, Room 208–R, Bethesda, MD 20892, (301) 827–7951, nagelinmh2@nhlbi.nih.gov. VerDate Sep<11>2014 18:09 Sep 27, 2023 Jkt 259001 (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: September 22, 2023. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–21146 Filed 9–27–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental and Craniofacial Research; Notice of Closed Meetings Pursuant to section 1009 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 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 Dental and Craniofacial Research Special Emphasis Panel; Review of NIDCR R03 and DSR Member-Conflict Applications. Date: November 2, 2023. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Dental and Craniofacial Research, 6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Yun Mei, MD, Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, 6701 Democracy Boulevard, Bethesda, MD 20892, (301) 827–4639, yun.mei@nih.gov. Name of Committee: National Institute of Dental and Craniofacial Research Special Emphasis Panel; Review of RFA–DE–24–001 and RFA–DE–24–002. Date: November 15, 2023. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Dental and Craniofacial Research, 6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Christopher T. Campbell, Ph.D., MD, Scientific Review Officer, PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 66859 Scientific Review Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, 6701 Democracy Boulevard, Bethesda, MD 20892, (301) 594– 5593, christopher.campbell@nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) Dated: September 22, 2023. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–21151 Filed 9–27–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Establishment of the Applied Therapeutics for Cancer Integrated Review Group Pursuant to the Federal Advisory Committee Act, as amended (5 U.S.C. 1001–1014), the Director, National Institutes of Health (NIH) announces the establishment of the Applied Therapeutics for Cancer Integrated Review Group (IRG) as authorized by 42 U.S.C. 282(b)(16), section 402(b)(16) of the Public Health Service Act, as amended. The Director, NIH, has determined that the Applied Therapeutics for Cancer IRG is in the public interest in connection with the performance of duties imposed on NIH by law, and that these duties can best be performed through the advice and counsel of the committee. The committee provides advice and recommendations on funding applications and proposals, including but not limited to, the scientific and technical merit of applications for grants-in-aid for research, research training, or research-related grants and cooperative agreements, or contract proposals relating to scientific areas relevant to translational and clinical investigations that encompass cancer therapeutic development and cancer treatment. Inquiries may be directed to Claire Harris, Director, Office of Federal Advisory Committee Policy, Office of the Director, National Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, Maryland 20892 (Mail code 4875), Telephone (301) 496– 2123, or Claire.Harris@nih.gov. E:\FR\FM\28SEN1.SGM 28SEN1 66860 Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices Dated: September 21, 2023. Lawrence A. Tabak, Acting NIH Director, National Institutes of Health. [FR Doc. 2023–21233 Filed 9–27–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Request for Information (RFI): Inviting Comments and Suggestions on Opportunities and Challenges for the Collection, Use, and Sharing of RealWorld Data (RWD) Including Electronic Health Records, for National Institutes of Health (NIH) Supported Biomedical and Behavioral Research AGENCY: National Institutes of Health, HHS. ACTION: Request for information. The purpose of this National Institutes of Health (NIH) Request for Information (RFI) is to solicit public comments on the use of Real-World Data (RWD), including Electronic Health Records, for Biomedical and Behavioral Research. DATES: The NIH RFI is open for public comment. To assure consideration, your response must be received by December 14, 2023, 11:59 p.m. (ET). ADDRESSES: All comments must be submitted electronically on the submission website at https:// datascience.nih.gov/rfi-rwd. Responses must be received by 11:59:59 p.m. (ET) on December 14, 2023. Responses to this RFI are voluntary and may be submitted anonymously. You may voluntarily include your name and contact information with your response. If you choose to provide NIH with this information, NIH will not share your name and contact information outside of NIH unless required by law. Other than your 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 response. The Government will use the information submitted in response to this RFI at its discretion. Other than your name and contact information, the Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:09 Sep 27, 2023 Jkt 259001 cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information. We look forward to your input and hope that you will share this RFI opportunity with your colleagues. FOR FURTHER INFORMATION CONTACT: Questions about this request for information should be directed to Dr. Susan Gregurick, 301–435–1923, RWDrfi@od.nih.gov, National Institutes of Health, Office of Data Science Strategy, 9000 Rockville Pike, Bethesda, Maryland 20892. SUPPLEMENTARY INFORMATION: The National Institutes of Health (NIH) is requesting public comment on the use of Real World Data (RWD) for NIH supported biomedical and behavioral research, including opportunities for leveraging the benefits of RWD and strategies for responsible use. NIH also seeks to better understand community perspectives on the potential value and constraints—including scientific, administrative, legal, business, and bioethical—for the greater use of RWD in NIH-sponsored biomedical and behavioral research. This request for information (RFI) is in accordance with 42 U.S.C. 281 as amended. Background Researchers are increasingly using data collected in real-world settings to augment traditional research studies, as well as develop more effective treatments and interventions for patients. These ‘‘real-world data (RWD)’’, defined by the U.S. Food and Drug Administration, are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status. While these data hold tremendous promise for biomedical and behavioral research, they can be collected from a variety of sources through multiple mechanisms, creating challenges for researchers and questions for those whose data are being shared. Importantly, NIH is committed to ensuring participant privacy and PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 autonomy are protected in all NIHsupported research. As NIH establishes health-related research data platforms that include access to RWD, NIH continues to prioritize maximizing data access while upholding participant preferences regarding the collection and use of their data. Most recently, through the Advisory Committee to the NIH Director, (https://www.acd.od.nih.gov/ index.html), NIH staff met with stakeholders to better understand their perspectives on benefits and risks of combining and using human datasets, particularly from disparate sources (e.g., research and non-research settings) and how their data should be used in biomedical and behavioral research. NIH will continue working to incorporate these perspectives in its research studies to build trust and honor participant preferences. Input requested on this RFI will be used to inform NIH’s continuing development of guidance on the use of RWD for research and assist in the planning for appropriate mechanisms and programs for research with RWD. Information Requested NIH is requesting public comment on the use of RWD for NIH-supported biomedical and behavioral research, including opportunities for leveraging the benefits of RWD and strategies for its responsible use. NIH also seeks to better understand community perspectives on the potential value and constraints— including scientific, administrative, legal, business, and bioethical—for the increased use of RWD in biomedical and behavioral research. Response to this RFI is voluntary and may be submitted anonymously. Respondents are free to address any or all topics listed below, as well as other relevant topics, for NIH’s consideration. 1. Scientific value and quality considerations for collection, use, and sharing of RWD in biomedical and behavioral research. NIH seeks broad input on how RWD is acquired and used in NIH-funded research, the demonstrated and anticipated value of RWD in research, and opportunities and challenges related to data standards and quality, representativeness, and potential biases for using RWD in research. Additionally, NIH is seeking information on: (a) Biomedical and behavioral research questions that could be investigated using RWD, including novel unanticipated insights that have been enabled by using RWD in research. (b) Barriers to using RWD in research, such as bias, underrepresentation of populations in data, and technical E:\FR\FM\28SEN1.SGM 28SEN1

Agencies

[Federal Register Volume 88, Number 187 (Thursday, September 28, 2023)]
[Notices]
[Pages 66859-66860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21233]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Establishment of the Applied Therapeutics for Cancer Integrated 
Review Group

    Pursuant to the Federal Advisory Committee Act, as amended (5 
U.S.C. 1001-1014), the Director, National Institutes of Health (NIH) 
announces the establishment of the Applied Therapeutics for Cancer 
Integrated Review Group (IRG) as authorized by 42 U.S.C. 282(b)(16), 
section 402(b)(16) of the Public Health Service Act, as amended.
    The Director, NIH, has determined that the Applied Therapeutics for 
Cancer IRG is in the public interest in connection with the performance 
of duties imposed on NIH by law, and that these duties can best be 
performed through the advice and counsel of the committee.
    The committee provides advice and recommendations on funding 
applications and proposals, including but not limited to, the 
scientific and technical merit of applications for grants-in-aid for 
research, research training, or research-related grants and cooperative 
agreements, or contract proposals relating to scientific areas relevant 
to translational and clinical investigations that encompass cancer 
therapeutic development and cancer treatment.
    Inquiries may be directed to Claire Harris, Director, Office of 
Federal Advisory Committee Policy, Office of the Director, National 
Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, 
Maryland 20892 (Mail code 4875), Telephone (301) 496-2123, or 
[email protected].


[[Page 66860]]


    Dated: September 21, 2023.
Lawrence A. Tabak,
Acting NIH Director, National Institutes of Health.
[FR Doc. 2023-21233 Filed 9-27-23; 8:45 am]
BILLING CODE 4140-01-P

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