FACACLASSIC

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HHS - 1013 - Novel and Exceptional Technology and Research Advisory Committee - Authorized by Law

GENERAL INFORMATION

Committee Name	Novel and Exceptional Technology and Research Advisory Committee	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	1013
Original Establishment Date	11/1/1974	Committee Status	Chartered
Actual Termination Date	6/30/2025	Committee URL	https://osp.od.nih.gov/policies/novel-and-excep...
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	25
Terminated This FY	Yes	Designated Fed Officer Position Title*	Deputy Director, Office of Science Policy
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	9/24/2025	Designated Federal Officer First Name*	Jessica
Date Of Renewal Charter	9/24/2027	Designated Federal Officer Middle Name
Projected Termination Date		Designated Federal Officer Last Name*	Tucker
Exempt From Renewal*	No	Designated Federal Officer Suffix	Ph.D.
Specific Termination Authority	Charter Expiration	Designated Federal Officer Phone*	(301) 496-9838
Establishment Authority*	Authorized by Law	Designated Federal Officer Fax*	(301) 496-9839
Specific Establishment Authority*	42 USC 282(b)(16)	Designated Federal Officer Email*	jessica.tucker@nih.gov
Effective Date Of Authority*	11/4/1988
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not Applicable
How does cmte accomplish its purpose?*	In April 2019, the NIH renamed the Recombinant DNA Advisory Committee the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) and restored it to its vision of focusing on the scientific, safety, and ethical issues associated with emerging biotechnologies. The NExTRAC continued in its role as a forum for public discussion on these matters to incorporate diverse perspectives and broad scientific and public participation. It provides advice to the NIH Director on issues associated with emerging biotechnologies. The NExTRAC is composed of experts from a wide range of scientific and medical disciplines and also includes ethicists and patient and public representatives. In FY25, the Committee met twice. The meetings on December 3, 2024, and September 29, 2025, include updates from the Working Group on Engaging the Public as Partners in Clinical Research.
How is membership balanced?*	Under its current charter, the Committee will consist of up to 25 voting members, including the Chair, appointed by the Director, NIH. A majority of the voting appointed members must be knowledgeable in relevant emerging scientific fields (e.g., gene therapy, gene editing, synthetic biology). As needed, the Committee may include persons knowledgeable in fields such as public health, laboratory safety, occupational health, protection of human participants in research, the environment, ethics, law, public attitudes or related fields.
How frequent & relevant are cmte mtgs?*	The NExTRAC met as needed, approximately two times per year, to provide advice to NIH and to serve as a public forum for scientific, safety, and ethical issues associated with emerging biotechnologies. The issues are of interest to a broad range of individuals and organizations, including researchers, the biotechnology industry, other Federal agencies, research participants, and other members of the public. In FY25, the Committee met twice on December 3, 2024, and September 29, 2025, to receive updates from the Working Group on Engaging the Public as Partners in Clinical Research. The Working Group on Engaging the Public as Partners in Clinical Research met on 10/2/24, 10/7/24, 10/17/24, 10/23/24, 11/4/24, 11/6/24, 12/4/24, 12/4/24, 12/9/24, 12/19/24, 1/8/25, 1/16/25, 6/9/25, 6/18/25, 7/7/25, 7/21/25, and 8/19/25.
Why advice can't be obtained elsewhere?*	This Committee is composed of recognized experts in the field of biotechnology research as well as nationally known experts in fields such as law, ethics, standards of professional conduct and practice, and public engagement. To reduce the costs associated with managing and supporting advisory committees, the NExTRAC will sunset as an advisory committee in early FY26. The type of transparent discourse that was fostered by the NExTRAC will continue to be prioritized by NIH in other venues.
Why close or partially close meetings?	N/A
Recommendation Remarks	Charter terminated due to expiration. Reports: In FY24, the Committee did not prepare any reports this fiscal year. Recommendations: In FY24, the NExTRAC did not provide any new recommendations. Membership: The NExTRAC is authorized to appoint up to 25 members. Currently, there are 15 active members and 10 vacancies. Membership (Retired): Dr. Leigh Garven Turner’s term ended 01/27/2024. Membership (Reappointments): The following members were reappointed to the committee in FY24: Drs. Bloss, Gronvall, Leshner, Ossorio, Oye, and Riley. Administrative Extensions: The following member's terms have been administratively extended until 01/27/2025: Drs. Bloss, Gronvall, Leshner, Ossorio, Oye, and Riley. The terms are longer than the charter allows due to their administrative extensions given their specific scientific expertise and the need to continue to assure continuity on the committee. Leadership: The DFO and Committee Decision Maker roles are held by the same individual due to internal assignment of responsibilities within the Institute.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	Yes
Outcome Trust In Government	Yes	Action Reallocate Resources	No
Outcome Major Policy Changes	Yes	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	Yes
Outcome Increased Customer Satisfaction	No	Action Comment	The Novel and Exceptional Technology and Research Advisory Committee will provide advice on scientific, safety, and ethical issues associated with emerging biotechnologies.
Outcome Implement Laws/Reg Requirements	No	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	NA	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 diagnostic tests and new ways to treat and prevent diseases.	Grants Review Comment	NA
Number Of Recommendations*	4	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	During the life of the Committee, NExTRAC has made a total of 874 recommendations. In FY 2025, the Committee delivered 4 recommendations arising from the Working Group on Engaging the Public as Partners in Clinical Research.	Access Agency Website	Yes
% 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 that affect the broader biomedical research enterprise (both federally and privately funded research), NIH 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	Due to the large breadth and complexity of the recommendations made by this committee that affect the broader biomedical research enterprise (both federally and privately funded research), NIH staff is unable to determine which recommendations have been fully or partially implemented solely in response to this committee's activities.	Access Other	No
Agency Feedback*	Yes	Access Comment	N/A
Agency Feedback Comment*	The agency provides meeting minutes, written reports, and oral presentations. Information is provided to the public at each meeting. The public can view information related to the Committee through the committee’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. The mission of the Novel and Exceptional Technology and Research Advisory Committee is to provide advice to the Director, National Institutes of Health (NIH), on matters related to the conduct and oversight of research involving emerging technologies in biomedical science (also referred to as emerging biotechnologies). The Novel and Exceptional Technology and Research Advisory Committee conducts all of its meetings in public and webcasts the proceedings in order to inform researchers and the public.

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 9:58 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Health Public Health Medicine Health and Health Research

Custom Links

Committee Level Reports