FACACLASSIC

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HHS - 76836 - Frederick National Laboratory Advisory Committee to the National Cancer Institute - Authorized by Law

GENERAL INFORMATION

Committee Name	Frederick National Laboratory Advisory Committee to the National Cancer Institute	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	76836
Original Establishment Date	3/30/2011	Committee Status	Terminated
Actual Termination Date	4/1/2025	Committee URL
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	16
Terminated This FY	Yes	Designated Fed Officer Position Title*	Supervisory Health Scientist Administrator and Program Officer
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	3/30/2023	Designated Federal Officer First Name*	Christopher
Date Of Renewal Charter	3/30/2025	Designated Federal Officer Middle Name	Dennis
Projected Termination Date		Designated Federal Officer Last Name*	Kane
Exempt From Renewal*	No	Designated Federal Officer Suffix	Ph.D.
Specific Termination Authority	2025 Secretary Directive	Designated Federal Officer Phone*	301-846-1728
Establishment Authority*	Authorized by Law	Designated Federal Officer Fax*
Specific Establishment Authority*	42 U.S.C. 285a-2(b)(7)	Designated Federal Officer Email*	christopher.kane@nih.gov
Effective Date Of Authority*	11/20/1985
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Terminate
Legislation to Terminate Required	Yes
Legislation Status	Not Applicable
How does cmte accomplish its purpose?*	The Committee was composed of distinguished scientists from outside the NCI. The Committee provided scientific advice on existing and new projects (extramural and intramural) to be performed at the Frederick National Laboratory for Cancer Research (FNLCR). The Committee advised the Director, NCI and Associate Director, FNLCR about the intrinsic merit of the projects, and provided insight on proposed directions for ongoing and future work to be done at the FNLCR. This Committee periodically reviewed the existing portfolio of projects (extramural and intramural) at the FNLCR, evaluated their productivity, helped determine which of these projects should be transitioned into more conventional mechanisms of support, i.e., (grants, contracts, cooperative agreements) and which should be considered for termination. The Committee represented viewpoints from the broader, extramural research community, and helped to ensure that the operations at FNLCR were open, transparent, and in the best interests of the entire cancer research community. The Committee submitted a written description of the research and its recommendations to the Director, NCI, Deputy Directors, NCI, and the Associate Director, FNLCR. During FY202, the Frederick National Laboratory Advisory Committee (FNLAC) received presentations on various topics related to the organization of the FNLCR and the types of research that are being conducted. Committee discussions involved the Discovery and Development of AIT-102 as a Targeted Therapy for Ewing Sarcoma and Rhabdoid Tumor, the National Cryo-EM Program (NCEP): Enabling Structural Biology in the Extramural Community and Enabling a Systems Biomedicine Approach to Cancer Treatment: a Foundation for the National Institutes of Health (FNIH) Partnership.
How is membership balanced?*	The Committee was composed of distinguished scientists from outside the NCI. The Committee provided scientific advice on existing and new projects (extramural and intramural) to be performed at the Frederick National Laboratory for Cancer Research (FNLCR). The Committee advised the Director, NCI and Associate Director, FNLCR about the intrinsic merit of the projects, and provided insight on proposed directions for ongoing and future work to be done at the FNLCR. This Committee periodically reviewed the existing portfolio of projects (extramural and intramural) at the FNLCR, evaluated their productivity, helped determine which of these projects should be transitioned into more conventional mechanisms of support, i.e., (grants, contracts, cooperative agreements) and which should be considered for termination. The Committee represented viewpoints from the broader, extramural research community, and helped to ensure that the operations at FNLCR were open, transparent, and in the best interests of the entire cancer research community. The Committee submitted a written description of the research and its recommendations to the Director, NCI, Deputy Directors, NCI, and the Associate Director, FNLCR. During FY202, the Frederick National Laboratory Advisory Committee (FNLAC) received presentations on various topics related to the organization of the FNLCR and the types of research that are being conducted. Committee discussions involved the Discovery and Development of AIT-102 as a Targeted Therapy for Ewing Sarcoma and Rhabdoid Tumor, the National Cryo-EM Program (NCEP): Enabling Structural Biology in the Extramural Community and Enabling a Systems Biomedicine Approach to Cancer Treatment: a Foundation for the National Institutes of Health (FNIH) Partnership.
How frequent & relevant are cmte mtgs?*	FNLAC meetings were planned for three occasions during the fiscal year. However, during FY2025 only a single virtual committee meeting was convened on October 23, 2025 while all subsequent meetings were cancelled. The FNLAC provided ongoing review of the relevance and effectiveness of the existing scientific programs (extramural and intramural) at the FNLAC. The FNLAC also established working groups to provide the highest quality oversight to the technical aspects of high-visibility/ high-impact FNLCR programs such as the NCI RAS Initiative and the National Cryo-EM Program and to provide findings, recommendations, and reports to the Frederick National Laboratory Advisory Committee (FNLAC) on an as needed basis. The FNLAC RAS Ad Hoc Working Group typically meet 3-4 times/year. This group met virtually on December 5, 2024 and subsequent meetings were canceled. The FNLAC Ad Hoc National Cryo-Electron Microscopy Program Oversight Working Group meetings are typically held twice/year. No Cryo-Electron Microscopy Working Group meetings were held during FY25. This Committee was composed of recognized biomedical research authorities from outside the NIH to secure unbiased and objective evaluation of research performed at FNLCR. Their recommendations were invaluable because the complex nature of the research required a unique balance and breadth of expertise not available at NIH or from other established sources.
Why advice can't be obtained elsewhere?*	This Committee was composed of recognized biomedical research authorities from outside the NIH in order to secure unbiased and objective evaluation of research performed at FNLCR. Their recommendations were invaluable because the complex nature of the research requires a unique balance and breadth of expertise not available at NIH or from other established sources.
Why close or partially close meetings?	N/A
Recommendation Remarks	Per Executive Order (E.O.) 14217, "COMMENCING THE REDUCTION OF THE FEDERAL BUREAUCRACY" this FACA Committee has been terminated. This committee no longer has a Website. Reports: The Frederick National Laboratory Advisory Committee to the National Cancer Institute did not produce a report this fiscal year. Members: The terms for Drs. Timothy Chan and Candace Johnson were changed due to reappointment. As such their terms of service end date differ with what was reported on the FY23 ACR. The terms for Drs. Lisa Coussens and Nilsa Ramirez-Milan were changed due to administration extensions. As such, their terms of service end date differ from what was reported on FY23 ACR. The terms for Drs. Coussens, Johnson, and Ramirez-Milan are longer than the charter allows due to their reappointment to the FNLAC given their specific scientific expertise and the need to assure continuity in the functions of the FNLAC and the deliberation of issues brought before the Board. The DFO and Committee Decision Maker positions are held by the same individual because of the assignment of responsibilities within the Institute.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	No
Outcome Trust In Government	No	Action Reallocate Resources	No
Outcome Major Policy Changes	No	Action Issued New Regulations	No
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	No
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	No
Outcome Increased Customer Satisfaction	No	Action Comment	The committee continued to review the state of research (extramural and intramural) at the Frederick National Laboratory for Cancer Research (FNLCR) and make recommendations for the best use of its capabilities and infrastructure. They reviewed major new projects proposed to be performed at FNLCR and periodically review the existing portfolio of projects at FNLCR. The Committee helped to assure that the operations at FNLCR are open, transparent, and in the best interests of the entire cancer research community. The Committee also considered proposed research and provided advice as to whether the FNLCR is the best mechanism for carrying out these projects which it deems to be of merit and to be consistent with the mission of the National Cancer Institute (NCI) and FNLCR. The October 23, 2024 discussion focused on FNLCR impact to translational research and collaborations with the extramural cancer research community. This included presentations regarding the NCl's Natural Products Branch, the National Cryo-EM Program (NCEP), and a potential partnership to enable a Systems Biomedicine Approach to Cancer Treatment. The first discussion explained that natural products continued to make a significant impact in cancer chemotherapy and highlighted examples of two natural products that are moving forward toward clinical approval for cancer. Natural products and their derivatives have a record of success in clinical trials. FNLCR holds the largest U.S. repository of crude and natural extracts, representing collections from around the world and from various sources (e.g., marine, plants, microbes). To date, more than 680,000 fractions have been produced from NCI crude extracts. A pre-fractionated library of 500,000 natural product samples has been publicly released, and more than 9 million wells have been shipped to screening centers. Discovery and development activities for EC8042, a mithramycin analog, for treatment of Ewing sarcoma was highlighted. The team’s data suggested that for this drug to be effective in reversing the oncogenic transcriptome, it must be administered continuously, and this work presented an opportunity to evaluate the continuous infusion based on the mechanistically defined schedule. The discussion concluded by emphasizing that this work reflects efforts by DTP, DCTD, NPB, extramural researchers, and industry partners. This is currently an approved next-development project moving into broader animal toxicity studies, with a goal of being advanced to the clinic. The importance of NCI and FNLCR was underscored in these efforts. The National Cryo-EM Facility (NCEF) was established in 2017 to support the extramural community, and the facility was intended to expand as technologies continue to develop. The program supports three user groups: (1) research groups with experience in cryo­ EM technology, (2) structural biologists from adjacent disciplines (e.g., X-ray, nuclear magnetic resonance), and (3) biologists focused on important biomedical problems who are interested in adding cryo-EM methods to their toolkit. The technology development team has pushed the boundaries of resolution using lower-energy electron microscopes and pairing them with next-generation or newer-generation detectors to assess whether inexpensive platforms can yield high-resolution structures. NCEF has collected data for 160 investigators from more than 60 institutions. The team completed 1,300 imaging sessions, with an average of 19 imaging sessions per month in 2024. This work resulted in 128 scientific papers throughout the past 7 years (with 21 papers in the past year), many of which are published in high-impact journals. More than 240 structures have been deposited in the Electron Microscopy Data Bank, and NCEF users are distributed across the United States. Recent NCEF user successes were highlighted including multiple nucleoside analogs, which can be applied to the development of cancer and antiviral therapeutics. The team identified differences in their binding and transport properties that will inform future drug design. The third discussion provided an introduction to the development of SysCan, a systems cancer biomedicine demonstration project. SysCan builds on the successes of previous FNLCR projects, with a focus on emerging needs across the cancer research community. The team invited leading cancer researchers from across the research continuum to discuss ideas for FNLCR projects. All the ideas were reviewed, organized by topic, and assigned to either FNLCR or NCI, as appropriate. SysCan, which synthesizes three of the themes for FNLCR (spatial systems biology, experimental therapeutics, and perturbation technology) into a single initiative. This initiative approaches cancer as a disease that affects the entire body. SysCan is an FNIH/NCI demonstration project to develop, deploy, and test a systems biomedicine–based treatment strategy for an important human cancer that simultaneously attacks cancer cells directly and purposefully manipulates multiple intercellular interactions to create strong antitumor (i.e., tumoricidal) microenvironments. The project was envisioned in two phases. First, the team plans to engage leaders from the intramural and extramural research communities, potential pharmaceutical and biotechnology partners, relevant academic societies, patients and advocates, and regulatory agencies to refine the overall approach. The proposed next phase of the project would focus on implementation. proposed that FNLCR could act as a hub for SysCan, coordinating such activities as engagement with regulatory agencies, academic research and technology development, public and private informatics initiatives, biotechnology partnerships for diagnostics and therapeutic delivery platforms, pharmaceutical partnerships for drug development, and coordination between FNIH and NCI. This concept is still in the early stages, and it was agreed to keep the FNLAC members updated on the team’s progress.
Outcome Implement Laws/Reg Requirements	No	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	Based on the recommendations of this committee, effective direction of the activities at the FNLCR had the potential to provide significant advances in cancer research and public health. The projects and programs at FNLCR, for which this Committee provided advice, could lead to new approaches and tools for cancer investigation, prevention, diagnosis and therapeutic interventions. The results and technologies may be applicable to other human health concerns.	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	NIH supported basic and clinical research accomplishments often take many years to unfold into new diagnostic tests and new ways to treat and prevent diseases. Robust prioritization of promising programs, therapies, and diagnostics lowered the opportunity cost of complex biomedical R&D.	Grants Review Comment	N/A
Number Of Recommendations*	64	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	The committee made two general recommendations during FY25.	Access Agency Website	No
% of Recs Fully Implemented*	0.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	Due to the large breadth and complexity of the recommendations made by this committee, NCI staff were unable to determine which recommendations have been fully implemented solely in response to this committee's activities.	Access GSA FACA Website	Yes
% of Recs Partially Implemented*	0.00%	Access Publications	Yes
% of Recs Partially Implemented Comment	Due to the large breadth and complexity of the recommendations made by this committee, NCI staff were unable to determine which recommendations have been partially implemented solely in response to this committee's activities.	Access Other	Yes
Agency Feedback*	Yes	Access Comment	Information on the FNLAC could have been found at the NCI Division of Extramural Activities: Advisory Boards and Groups website at http://deainfo.nci.nih.gov/advisory/fac/fac.htm. Each NCI committee’s charter, minutes, agenda, roster, future meeting dates, meeting PowerPoint presentations and reports was located there. Additionally, the public could have viewed the FNLAC meetings via the NIH Videocast at the following website: http://videocast.nih.gov/.
Agency Feedback Comment*	At each meeting, the NCI Director, the NCI Deputy Directors, and other NCI leaders provided a report to the Committee members and the public. The public could have viewed information related to the Committee through the Committee’s official website.	Narrative Description*	The goal of NIH research was to have acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability, from the rarest genetic disorder to the common cold. The NIH mission is to uncover new knowledge that will lead to better health for everyone. NIH works toward that mission by the Frederick National Laboratory Advisory Committee (FNLAC) to the National Cancer Institute. The Committee was to have reviewed major new projects proposed to be performed at Frederick National Laboratory for Cancer Research (FNLCR) and advise the Director, NCI and Associate Director, FNLCR about the intrinsic merit of the projects (extramural and intramural) and about whether they should have been done at the FNLCR. In addition, this Committee periodically reviewed the existing portfolio of projects (extramural and intramural) at FNLCR, evaluate their productivity, help determine which of these projects should have been transitioned to more conventional mechanisms of support, i.e., (grants, contracts, cooperative agreements) and which should have been considered for termination. The Committee was to have help to assure that the operations at FNLCR are open, transparent, and in the best interest of the entire cancer research community. The Committee would have submitted a written description of the research and its recommendations to the Director, NCI, Deputy Directors, NCI, and the Associate Director, FNLCR.

COSTS

1. Payments to Non-Federal Members*	$2,400.00	1. Est Paymnts to Non-Fed Membrs Nxt FY*	$0.00
2. Payments to Federal Members*	$0.00	2. Est. Payments to Fed Members Next FY*	$0.00
3. Payments to Federal Staff*	$14,140.00	3. Estimated Payments to Federal Staff*	$0.00
4. Payments to Consultants*	$600.00	4. Est. Payments to Consultants Next FY*	$0.00
5. Travel Reimb. For Non-Federal Membrs*	$0.00	5. Est Travel Reimb Non-Fed Membr nxtFY*	$0.00
6. Travel Reimb. For Federal Members*	$0.00	6. Est Travel Reimb For Fed Members*	$0.00
7. Travel Reimb. For Federal Staff*	$0.00	7. Est. Travel Reimb to Fed Staf Nxt FY*	$0.00
8. Travel Reimb. For Consultants*	$0.00	8. Est Travel Reimb to Consltnts Nxt FY*	$0.00
10. Other Costs	$13,810.00	10. Est. Other Costs Next FY*	$0.00
11. Total Costs	$30,950.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	9/11/2025 8:54 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Medicine Health and Health Research Research Basic Research Research and Development

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