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Committee Detail

Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.


HHS - 1013 - Novel and Exceptional Technology and Research Advisory Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameNovel and Exceptional Technology and Research Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2020Committee Number1013
Original Establishment Date11/17/1962Committee StatusChartered
Actual Termination Date Committee URLhttps://osp.od.nih.gov/biotechnology/main-nextr...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*25
Current Charter Date6/30/2019Designated Fed Officer Position Title*Director, Biosafety, Biosecurity, and Emerging Biotechnology, Policy Division, Office of Science Policy, Office of the Director, NIH
Date Of Renewal Charter6/30/2021Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*JESSICA
Exempt From Renewal*NoDesignated Federal Officer Middle Name
Specific Termination AuthorityDesignated Federal Officer Last Name*TUCKER
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPh.D.
Specific Establishment Authority*42 USC 282(b)(16)Designated Federal Officer Phone*(301) 496-9838
Effective Date Of Authority*11/4/1988Designated Federal Officer Fax*301-496-9839
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*jessica.tucker@nih.gov
Committee Type*Continuing
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot 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 closer to its original vision of focusing on the scientific, safety, and ethical issues associated with emerging biotechnologies. The NExTRAC will continue 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 comprised of experts from a wide range of scientific and medical disciplines and also includes ethicists and patient and public representatives. In FY20, the Committee met one time on December 5-6, 2019 to discuss pathways for responsible innovation in emerging biotechnologies, characteristics of emerging biotechnologies, and proactive approaches to addressing scientific and societal implications of emerging biotechnologies.
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 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 will meet 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 FY20, the Committee met once on December 5-6, 2019. The Working Group to Establish a NExTRAC Framework met on 2/14/20, 3/6/20, 3/20/20, 4/17/20, 5/1/20, 5/15/20, 6/5/20, 6/19/20, 7/17/20, 8/7/20, 8/21/20, and 9/18/20. The Gene Drives in Biomedical Research Working Group met on 2/14/20, 3/24/20, 4/14/20, 4/28/20, 5/26/20, 6/23/20, 7/28/20, 8/25/20 and 9/15/20. The Committee met only once during FY20, due to a focus on the work of two working groups formed to 1) establish a NExTRAC framework and 2) consider issues related to gene drives in biomedical research.
Why advice can't be obtained elsewhere?*This Committee is composed of recognized experts in the field of biotechnology research as well as non-scientists who are nationally known experts in fields such as law, ethics, and standards of professional conduct and practice. The composition of the NExTRAC provides a unique balance of expertise and opinions that cannot be obtained from federal staff or on an ad hoc basis because of the diversity in scientific and non-scientific viewpoints needed, the importance of non federal perspectives, and the need for continuity as the Committee considers issues over time.
Why close or partially close meetings?N/A
Recommendation RemarksReports: This committee did not produce any public reports.

Meetings: The Committee met once during FY20, due to a focus on the work of two working groups formed to 1) establish a NExTRAC framework and 2) consider issues related to gene drives in biomedical research.

Members: The terms for Richard Whitley, Mildred Cho, Dean Lee and Douglas McCarty changed due to reappointments. The terms for Zach Adelman, Lorraine Albritton, Kathleen Boris-Lawrie, Benhur Lee, and Matthew Porteus changed due to administrative extensions. As such, their terms of service end date is different than what was reported on the FY19 ACR. The terms for Richard Whitley, Mildred Cho, Dean Lee, Douglass McCarty, Zach Adelman, Benhur Lee, and Lorraine Albritton are longer than the charter allows due to their reappointment to the NExTRAC given their specific scientific expertise and the need to assure continuity as the Recombinant DNA Advisory Committee (RAC) transitioned into the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC).

The DFO and Committee Decision Maker positions are held by the same individual because of the assignment of responsibilities within the Institute.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction Reallocate ResourcesNo
Outcome Major Policy ChangesYesAction Issued New RegulationsNo
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionNoAction CommentAs the RAC, the Committee has made recommendations to NIH on matters related to (1) the conduct and oversight of research involving recombinant or synthetic nucleic acid molecules, including the content and implementation of the NIH Guidelines, as amended, and (2) other NIH activities pertinent to recombinant or synthetic nucleic acid molecule technology. The NExTRAC will provide advice on broader scientific, safety, and ethical issues associated with emerging biotechnologies.
Outcome Implement Laws/Reg RequirementsNoGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentNANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentNIH 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 CommentNA
Number Of Recommendations*848Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentIn FY20, no recommendations were made. The inaugural meeting of the committee as the NExTRAC was held in December 2019 at which the committee received two charges currently being deliberated. The NExTRAC will provide advice on broad scientific, safety, and ethical issues associated with emerging biotechnologies.Access Agency WebsiteYes
% of Recs Fully Implemented*0.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentDue 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 WebsiteYes
% of Recs Partially Implemented*0.00%Access PublicationsNo
% of Recs Partially Implemented CommentNAAccess OtherNo
Agency Feedback*YesAccess CommentN/A
Agency Feedback Comment*The agency provides meeting minutes, written reports, and oral presentations.Narrative Description*The mission of the NExTRAC is to advise the NIH Director on the scientific, safety, and ethical dimensions of emerging biotechnologies. The committee will serve as a public forum to advise NIH on scientific, safety, and ethical issues associated with emerging biotechnologies. The NExTRAC conducts all of its meetings in public and webcasts the proceedings in order to inform researchers and the public.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$3,600.00Est Payments to Non-Fed Members Next FY*$3,600.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$160,742.00Estimated Payments to Federal Staff*$131,445.00
Payments to Consultants*$3,600.00Est. Payments to Consultants Next FY*$3,600.00
Travel Reimb. For Non-Federal Members*$11,754.00Est Travel Reimb Non-Fed Members nextFY*$11,817.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$9,142.00Est Travel Reimb to Consultants Next FY*$9,191.00
Other Costs$113,257.00Est. Other Costs Next FY*$114,693.00
Total Costs$302,095.00Est. Total Next FY*$274,346.00
Federal Staff Support (FTE)*0.90Est. Fed Staff Support Next FY*0.70
Cost RemarksActual operating costs are lower than projected in FY19 due to only one meeting being held during FY20. The increase in Federal Staff Costs and support in FY20 is due to several staffing changes during the fiscal year.Est Cost Remarks
Hide Section - Interest Areas

Interest Areas

Category
Area
Medicine
Health and Health Research
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-036623Novel and Exceptional Technology and Research Advisory Committee2019
 COM-034836Recombinant DNA Advisory Committee2018
 COM-001945Recombinant DNA Advisory Committee2017
 COM-002250Recombinant DNA Advisory Committee2016
 COM-004089Recombinant DNA Advisory Committee2015
 COM-004676Recombinant DNA Advisory Committee2014
 COM-006152Recombinant DNA Advisory Committee2013
 COM-006566Recombinant DNA Advisory Committee2012
 COM-008195Recombinant DNA Advisory Committee2011
 COM-008667Recombinant DNA Advisory Committee2010
 COM-010337Recombinant DNA Advisory Committee2009
 COM-010637Recombinant DNA Advisory Committee2008
 COM-012256Recombinant DNA Advisory Committee2007
 COM-012852Recombinant DNA Advisory Committee2006
 COM-014009Recombinant DNA Advisory Committee2005
 COM-014434Recombinant DNA Advisory Committee2004
 COM-015908Recombinant DNA Advisory Committee2003
 COM-016523Recombinant DNA Advisory Committee2002
 COM-017925Recombinant DNA Advisory Committee2001
 COM-018710Recombinant DNA Advisory Committee2000
 COM-019674Recombinant DNA Advisory Committee1999
 COM-020307Recombinant DNA Advisory Committee1998
 COM-021691Recombinant DNA Advisory Committee1997