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HHS - 31924 - Council of Councils - Statutory (Congress Created)

GENERAL INFORMATION

Committee Name	Council of Councils	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	31924
Original Establishment Date	4/11/2007	Committee Status	Chartered
Actual Termination Date		Committee URL	http://dpcpsi.nih.gov/council/
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	27
Terminated This FY	No	Designated Fed Officer Position Title*	Director, Office of Research Infrastructure Programs
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	4/11/2025	Designated Federal Officer First Name*	Franziska
Date Of Renewal Charter	4/11/2027	Designated Federal Officer Middle Name	B.
Projected Termination Date		Designated Federal Officer Last Name*	Grieder
Exempt From Renewal*	No	Designated Federal Officer Suffix	D.V.M., Ph.D.
Specific Termination Authority		Designated Federal Officer Phone*	(301) 435-0744
Establishment Authority*	Statutory (Congress Created)	Designated Federal Officer Fax*
Specific Establishment Authority*	42 USC 402 (l)	Designated Federal Officer Email*	griederf@mail.nih.gov
Effective Date Of Authority*	1/16/2007
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Other Committee

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not Applicable
How does cmte accomplish its purpose?*	The NIH Reform Act of 2006 (P.L. 109-482), passed by Congress in December 2006, and signed into law by the President in January 2007, established the Council of Councils. The Council of Councils (Council) advises the Director, NIH, and Director, Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) on matters related to the policies and activities of DPCPSI. The Council makes recommendations in support of research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from the support of additional research that requires collaboration between two or more Institutes/Centers. A major function of the Council is to make recommendations on research that would be funded through the NIH Common Fund (CF), the Office of Research Infrastructure Programs (ORIP), the All of Us Research Program, and the Environmental influences on Child Health Outcomes (ECHO) Program. Concepts for the DPCPSI Program Offices and the Office of Intramural Research are cleared, as necessary. The Council also carries out second-level review for the NIH Director’s Pioneer Award, New Innovator Award, Transformative Research Award, and Early Independence Award programs and for grant programs administered by ORIP, All of Us, and ECHO, as appropriate. In FY 2025, the Council reviewed 1,866 applications requesting $2,281,360,331. In FY 2025, the Council met on April 21, 2025, May 29, 2025, and September 11-12, 2025. The April, May, and September meetings were virtual. At the April, May, and September meetings, the Council conducted business in closed session when reviewing NIH grant applications. The Executive Secretary and program staff presented relevant information and answered questions. Votes were conducted. At the April meeting, NIH Director, Dr. Jay Bhattacharya, presented NIH updates, including information on NIH leadership changes, as well as his background and vision for NIH, and Acting DPCPSI Director and Acting Chair of the Council of Councils, Dr. Nicole Kleinstreuer, introduced herself to the Council and provided updates on the activities of DPCPSI. Four concept clearances were presented by NIH staff: Dr. Ritesh Tandon, representing the Office of Research Infrastructure Programs (ORIP), presented on the Small Grant Program for ORIP Special Emphasis Research Career Award (SERCA) K01 Recipients (R03 Clinical Trials Not Allowed); Drs. Patricia Labosky and Becky Miller, representing the Office of Strategic Coordination (OSC), presented on the High-Risk, High-Reward (HRHR) Research Program; Dr. Richard Hodes, Director of the National Institute on Aging, presented on the Cellular Senescence Network (SenNet) Program; and Dr. Michael Chiang, Director of the National Eye Institute and Dr. Bruce Tromberg, Director of the National Institute of Biomedical Imaging and Bioengineering, presented on Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program. Additional presentations were as follows: Dr. Carolyn Hutter, OSC Director, presented on a proposed Transformative Research Working Group of the Council of Councils; Dr. Marina Volkov, Director of the Office of Evaluation, Performance, and Reporting, presented on a proposed Council of Councils Working Group on Science of Science; and the meeting ended with a discussion from departing Council members. At the May meeting, Dr. Nicole Kleinstreuer presented NIH and DPCPSI updates, Dr. Susan Gregurick, NIH Associate Director for Data Science, and Dr. Rafael Irizarry, Council member, presented the final recommendation report of the NIH Generalist Repository Ecosystem (GREI) Council of Councils Working Group; Dr. Gregurick and Council members, Drs. Karen Johnston and Jean King, presented the recommendation report of the NIH AIM-AHEAD Working Group; Dr. Andrew Bremer, representing the Office of Nutrition Research (ONR) and Office of Dietary Supplements (ODS), presented on the ONR and ODS Strategic Plans; and Dr. Adam Kuszak, representing ODS, presented on Strengthening the Rigor and Reproducibility of Dietary Supplement Research. At the September meeting, Dr. Nicole Kleinstreuer presented updates to the Council Operating Procedures and a vote was taken, Dr. Matthew Memoli, NIH Principal Deputy Director, gave the NIH Update, Dr. Franziska Grieder, Director of the Office of Research Infrastructure Programs (ORIP), gave an update on the ORIP Strategic Plan, Dr. Taylor Gilliland, Senior Scientific Advisor to the DPCPSI Director, presented on the Autism Data Science Initiative, Dr. Kleinstreuer presented on the Real-World Data Network, Dr. Michelle Hamlet, representing the Office of Strategic Coordination (OSC), provided an update on the Common Fund Venture Program, Drs. Danilo Tagle and Kevin Howcroft, representing OSC, presented the closeout of the Extracellular RNA (exRNA) Communication Program, and Council Members participated in a discussion on changes in NIH policy and procedures. NIH staff presented the following four concepts: All of Us Research Program concept on Accelerating Discovery through Partnered Research with All of Us to Analyze Participant Biospecimens and vote; OSC concept on the RNomics Program and vote; OSC concept on the Ultra-Processed Foods Program and vote; and Office of Data Science Strategy concept renewal on Early Stage and Established Biomedical Data Repositories and Knowledgebases and vote.
How is membership balanced?*	Per committee Charter, the Council will consist of 27 non-federal members and 2 federal members. The members will be appointed with the concurrence of the Secretary from among the list, updated and maintained by the Director, NIH, of individuals who have been nominated to serve on the Council. The list of nominees will contain: For each national research institute and national center, three individuals nominated by the head of such institute or center from among the members of the advisory council of the institute or center, of which (1) two will be scientists and (2) one will be from the general public or a leader in the field of public policy, law, health policy, economics or management. For each office within the Division of Program Coordination, Planning, and Strategic Initiatives, one individual nominated by the head of such office. In selecting the appointed members of the Council, the Director, NIH, will ensure (1) the representation of a broad range of disciplines and perspectives; and (2) the ongoing inclusion of at least one representative from each national research institute whose budget is substantial relative to a majority of the other institutes. The Chair will be the Director, DPCPSI, who is not eligible to vote. The Principal Deputy Director, NIH will serve as a non-voting ex officio member.
How frequent & relevant are cmte mtgs?*	The Council meets approximately three times a year and provides advice and recommendations to the Director, NIH or other appropriate delegated officials on matters related to the policies and activities of DPCPSI, including making recommendations with respect to the conduct and support of research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting additional research that involves collaborations between two or more national research institutes or national centers, or would otherwise benefit from strategic coordination and planning. In FY 2025, the Council met three times: April 21, 2025, May 29, 2025, and September 11-12, 2025. The April, May, and September meetings were virtual. In addition, the Council working groups, AIM-AHEAD Working Group (AIM), Disability Health Research Working Group (DHR), Environmental influences on Child Health Outcomes External Scientific Board (ECHO), Generalist Repository Ecosystem Initiative (GREI) Working Group, and the Working Group on the Science of Science (SoS) met on the following dates: October 15, 2024 (AIM): virtual; October 21, 2024 (GREI): virtual; November 5, 2024 (GREI): virtual; November 14, 2024 (AIM): virtual; December 12, 2024 (AIM and GREI): virtual; January 7, 2025 (ECHO): virtual; January 8, 2025 (GREI): virtual; January 14, 2025 (GREI): virtual; February 13, 2025 (AIM): virtual; February 20, 2025 (AIM): virtual; March 13, 2025 (AIM): virtual; March 20, 2025 (GREI): virtual; April 10, 2025 (AIM): virtual; May 6, 2025 (ECHO): hybrid; August 8, 2025 (DHR): virtual; and September 4, 2025 (SoS): virtual.
Why advice can't be obtained elsewhere?*	Public Law 42 USC 402(l) requires the Director, NIH, to establish the Council for the purpose of advising on matters related to the policies and activities of the DPCPSI.
Why close or partially close meetings?	The January, May, and September meetings of the committee were partially closed to the public for the review of grant applications. Sections 552b(c)(4) and 552b(c)(6) of the Government in the Sunshine Act permit the closing of meetings where discussion could reveal confidential trade secrets or commercial property such as patentable material and personal information, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Recommendation Remarks	During the reporting period, there were 1,866 grant review recommendations made by the Committee. The Council of Councils reviewed and deliberated on concepts covering a wide variety of topics including the following: 1. ORIP Concept Clearance (Reissue): Limited Competition: Small Grant Program for ORIP Special Emphasis Research Career Award (SERCA) K01 Recipients (R03 Clinical Trials Not Allowed); 2. OSC Concept Clearance (Reissue): High-Risk, High-Reward (HRHR) Research Program; 3. Proposed Transformative Research Working Group of the Council of Councils and vote; 4. Proposed Council of Councils Working Group on Science of Science and vote; 5. OSC Concept Clearance (Stage 2): Cellular Senescence Network (SenNet) Program; 6. OSC Concept Clearance (New): Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program; 7. Generalist Repository Ecosystem Initiative (GREI) Council of Councils Working Group Recommendations Report and vote; 8. AIM-AHEAD Program Council of Councils Working Group Recommendations Report and vote; 9. All of Us Concept Clearance (New): Accelerating Discovery through Partnered Research with All of Us to Analyze Participant Biospecimens; 10. OSC Concept Clearance (New): The RNomics Program; 11. OSC Concept Clearance (New): Ultra-Processed Foods Program; 12. ODSS Concept Clearance (Renewal): Early Stage and Established Biomedical Data Repositories and Knowledgebases; and 13. Council Operating Procedures.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	No
Outcome Trust In Government	No	Action Reallocate Resources	Yes
Outcome Major Policy Changes	No	Action Issued New Regulations	No
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	No
Outcome Effective Grant Making	Yes	Action Approved Grants Or Other Payments	Yes
Outcome Improved Service Delivery	No	Action Other	No
Outcome Increased Customer Satisfaction	No	Action Comment	An action of approved or recommended for grants receiving review by this Council does not infer that the grant will be or has been funded. Research grant applications submitted to NIH must go through a two-step review process that includes the initial peer review for scientific and technical merit and a second step of review and approval by the National Advisory Council that includes program relevance. In addition, prior to an award or funding being made, NIH staff must conduct an administrative review for a number of other considerations. These include alignment with NIH's funding principles, review of the project budget, assessment of the applicant's management systems, determination of applicant eligibility, and compliance with public policy requirements. After all these steps have been completed, NIH officials make funding decisions on individual grant applications.
Outcome Implement Laws/Reg Requirements	No	Grants Review*	Yes
Outcome Other	No	Number Of Grants Reviewed	1,866
Outcome Comment	N/A	Number Of Grants Recommended	1,866
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$1,598,998,699.00
Cost Savings Comment	NIH supported basic and clinical research accomplishments often take many years to be translated into new diagnostics, prevention approaches, and treatments for diseases and disorders.	Grants Review Comment	The Council carries out second-level review for Common Fund programs such as the NIH Director's Pioneer Award, New Innovator Award, Transformative Research Award, and Early Independence Awards, the All of Us Research Program, Environmental Influences on Child Health Outcomes, and for Office of Research Infrastructure Program grant applications.
Number Of Recommendations*	25,212	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	During the reporting period, there were 1,688 grant review recommendations made by the Committee. The Council of Councils reviewed and deliberated on concepts covering a wide variety of topics including the following: 1. Reissue ORIP Concept Clearance: Shared Instrumentation Program; 2. OSC Concept Clearance: Venture Space initiative(s); 3. OSC Concept Clearance: Complement Animal Research in Experimentation (Complement-ARIE); 4. OSC Concept Clearance: Gabriella Miller Kids First 2.0; 5. Reissue Concept Clearance: NIH Lasker Clinical Research Scholars Program; 6. OSC Concept Clearance: Somatic Cell Genome Editing (SCGE) Clinical Trials; 7. Office of Data Science Strategy (ODSS) Concept Clearance: Preparing the Next Generation of Biomedical Research Teams for Ethical AI: Workforce and Curricula Development; 8. ORIP Concept Clearance (Reissue): National Primate Research Centers Program; 9. OBSSR Concept Clearance (New): Resource and Capacity Building to Advance the Science of Aggression Across Species and Disciplines; 10. ECHO Concept Clearance (New): Expanding Access to ECHO Cohort Data and Biospecimens through X01; 11. ECHO Concept Clearance (Reissue): Dissertation and Postdoctoral Fellowship Grants for the Analysis of Publicly Accessible ECHO Data; 12. OBSSR Concept Clearance (Renewal): Short Courses on Innovative Methodologies and Approaches in the Behavioral and Social Sciences (R25 - Independent Clinical Trial Not Allowed); 13. Common Fund Update and Concept Clearance: Upcoming Venture Initiatives; 14. OSC Concept Clearance (New): Harnessing Data Science for Health Discovery and Innovation in Africa (DS-I Africa) Stage 2; 15. Proposed Council of Councils Working Group to Evaluate the NIH Generalist Repository Ecosystem Initiative and Vote; 16. Proposed Council of Councils Working Group on AIM-AHEAD and vote, 17. All of Us Reflection and Advancement Working Group Report, and 18. Council Operating Procedures.	Access Agency Website	Yes
% of Recs Fully Implemented*	0.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	Information on the research funded by NIH is available through the RePORT (Research Portfolio Online Reporting Tool) website. RePORT provides access to reports, data, and analyses of NIH research activities that advance the mission of the NIH, including information on NIH expenditures, strategic plans, reports on NIH funding, and reports on the organization and people involved in NIH research and research training. The RePORT website is located at http://report.nih.gov. Due to the complexity of the recommendations made by this committee on policy and program areas, staff is unable to determine which recommendations have been fully or partially implemented solely in response to this committee's activities.	Access GSA FACA Website	Yes
% of Recs Partially Implemented*	0.00%	Access Publications	No
% of Recs Partially Implemented Comment	Information on the research funded by NIH is available through the RePORT (Research Portfolio Online Reporting Tool) website. RePORT provides access to reports, data, and analyses of NIH research activities that advance the mission of the NIH, including information on NIH expenditures, strategic plans, reports on NIH funding, and reports on the organization and people involved in NIH research and research training. The RePORT website is located at http://report.nih.gov. Due to the complexity of the recommendations made by this committee on policy and program areas, staff is unable to determine which recommendations have been fully or partially implemented solely in response to this committee's activities.	Access Other	Yes
Agency Feedback*	Yes	Access Comment	NIH-COCS website: http://dpcpsi.nih.gov/council/ Committee information listed here includes the committee charter, minutes, agenda and future meeting dates.
Agency Feedback Comment*	Information is provided to the public at the open session of each Council meeting through reports and the Director’s update. The public can view information related to the Council through the council’s official website.	Narrative Description*	NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. NIH works toward that mission, in part, through advice provided by the NIH Council of Councils (Council). The Council advises the Director, NIH, and Director, Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) on matters related to the policies and activities of DPCPSI. The Council makes recommendations in support of research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from the support of additional research that requires collaboration between two or more Institutes/Centers. A major function of the Council is to make recommendations on concept proposals that would be funded through the NIH Common Fund (CF), the Office of Research Infrastructure Programs (ORIP), the All of Us Research Program, the Environmental Influences on Child Health Outcomes (ECHO) Program, or the NIH Lasker Clinical Research Scholars Program. The Council assesses the policies and activities of the above-mentioned programs, particularly whether the research can provide transformative outcomes of broad application to a range of disease research areas. The Council also carries out second-level review for the NIH Director’s Pioneer Award, New Innovator Award, Transformative Research Award, and Early Independence Award programs, and for grant programs administered by ORIP, All of Us, and ECHO. In FY 2024, the Council met four times: January 25-26, 2024, April 5, 2024, May 30, 2024, and September 12-13, 2024. During the four 2024 meetings, updates or reports were provided by staff of the Office of Behavioral and Social Sciences Research, Office of Data Science Strategy, Office of Dietary Supplements, Office of Disease Prevention, ORIP, Office of Research on Women’s Health, and Office of Strategic Coordination, and the NIH Director and Principal Deputy Director presented the NIH update. Council business matters, including review of and vote on the 2024 meeting minutes are posted on the DPCPSI website: https://dpcpsi.nih.gov/council

COSTS

1. Payments to Non-Federal Members*		1. Est Paymnts to Non-Fed Membrs Nxt FY*
2. Payments to Federal Members*		2. Est. Payments to Fed Members Next FY*
3. Payments to Federal Staff*		3. Estimated Payments to Federal Staff*
4. Payments to Consultants*		4. Est. Payments to Consultants Next FY*
5. Travel Reimb. For Non-Federal Membrs*		5. Est Travel Reimb Non-Fed Membr nxtFY*
6. Travel Reimb. For Federal Members*		6. Est Travel Reimb For Fed Members*
7. Travel Reimb. For Federal Staff*		7. Est. Travel Reimb to Fed Staf Nxt FY*
8. Travel Reimb. For Consultants*		8. Est Travel Reimb to Consltnts Nxt FY*
10. Other Costs		10. Est. Other Costs Next FY*
11. Total Costs	$0.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	3/14/2025 9:17 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Government Federal Government Medicine Health and Health Research

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