83 FR 1335 - Notice of NIST's Consortium for the Advancement of Genome Editing

DEPARTMENT OF COMMERCE
National Institute of Standards and Technology

Federal Register Volume 83, Issue 8 (January 11, 2018)

The National Institute of Standards and Technology (NIST), an agency of the United States Department of Commerce is establishing the Genome Editing Consortium with the goal of bringing together stakeholders across the genome editing community to identify and address measurement and standards needs to support this technical area. The Consortium intends to evaluate genome editing assay pipelines, develop benchmark materials, generate benchmark data, develop suggested minimal information reporting for public studies, and generate a common lexicon for genome editing studies, with the intent these resources can be used to increase confidence in evaluating genome editing and lower the risk to utilizing these technologies in research and commercial products. Participation fees will be at least $20,000 annually or in- kind contributions of equivalent value. Participants will be required to sign a Cooperative Research and Development Agreement (CRADA).

[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)]
[Notices]
[Pages 1335-1336]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-00315]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology


Notice of NIST's Consortium for the Advancement of Genome Editing

AGENCY: National Institute of Standards and Technology.

ACTION: Notice of Research Consortium.

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SUMMARY: The National Institute of Standards and Technology (NIST), an 
agency of the United States Department of Commerce is establishing the 
Genome Editing Consortium with the goal of bringing together 
stakeholders across the genome editing community to identify and 
address measurement and standards needs to support this technical area. 
The Consortium intends to evaluate genome editing assay pipelines, 
develop benchmark materials, generate benchmark data, develop suggested 
minimal information reporting for public studies, and generate a common 
lexicon for genome editing studies, with the intent these resources can 
be used to increase confidence in evaluating genome editing and lower 
the risk to utilizing these technologies in research and commercial 
products. Participation fees will be at least $20,000 annually or in-
kind contributions of equivalent value. Participants will be required 
to sign a Cooperative Research and Development Agreement (CRADA).

DATES: NIST will accept letters of interest containing required 
information for participation in this Consortium until January 1, 2020. 
Acceptance of participants into the Consortium after the Commencement 
Date will depend on eligibility as determined by NIST based upon the 
information provided in the letter of interest and upon the 
availability resources.

ADDRESSES: Information in response to this notice, including completed 
letters of interest or requests for additional information about the 
Consortium can be directed via mail to the Consortium Manager, Dr. 
Samantha Maragh, Biosystems and Biomaterials Division of NIST's 
Material Measurement Laboratory, 100 Bureau Drive, Mail Stop 8312, 
Gaithersburg, Maryland 20899, or via electronic mail to 
[email protected], or by telephone at (301) 975-4947.

FOR FURTHER INFORMATION CONTACT: For further information about 
participation opportunities to join the Genome Editing Consortium, 
please contact Jeffrey DiVietro, CRADA Officer, National Institute of 
Standards and Technology's Technology Partnerships Office, by mail to 
100 Bureau Drive, Mail Stop 2200, Gaithersburg, Maryland 20899, by 
electronic mail to [email protected], or by telephone at (301) 
975-8779.

SUPPLEMENTARY INFORMATION: Targeted Genome Editing is a technology 
space where there is a great need for reliable measurement methods for 
assuring the results of editing. Modalities for targeted genome editing 
include but are not limited to Zinc Finger Proteins (ZFPs), Homing 
Endonucleases, Transcription Activator-Like Nucleases (TALENs) and 
Clustered, Regularly Interspaced Palindromic Repeats (CRISPR). These 
technologies are being actively pursued by industry, academic, 
government and non-profit sectors to advance medicine and bioscience in 
areas such as: Regenerative medicine, synthetic biology, novel 
antimicrobials and antivirals, protein therapeutic biomanufacturing, 
agriculture and global food production. Utilizing these technologies 
for production and medicine will first require robust quantitative 
assays and measurements to enable high confidence characterization of 
DNA alterations resulting from genome editing.
    NIST has reached out to companies to assess their measurement 
needs, and has co-led workshops that have brought together experts 
across the genome editing field including stakeholders in industry, 
academia and government. These discussions have identified common pre-
competitive measurement needs that if resolved can push forward the 
field as it relates to understanding the reliability of data from 
assays being used to measuring aspects of genome edited cells.
    This Consortium's purpose is to develop measurement solutions and 
standards to advance confidence in measurements supporting the genome 
editing technology space.
    The Consortium will have three working groups with the following 
responsibilities:
    (1) Specificity Measurements:
    a. Design, generate, and evaluate a set of purified DNA samples and 
mixtures

[[Page 1336]]

that can be used to mimic both of on-target and off-target genome 
editing induced variants at known frequencies in a background of human 
genomic DNA which can be used to benchmark validation of sequencing 
pipelines intended to identify genome editing induced variants.
    b. Design and conduct controlled evaluations of assays intended to 
identify where genome editing enzymes have been active in a genome, 
with an experimental design that allows for enough power to assess the 
sources of variability, repeatability, and reproducibility within an 
assay.
    (2) Data and Meta Data:
    a. Identify community norms for data formats and tools for 
benchmarking data analysis including in silico data sets and an 
experimental data set.
    b. Determine the type of meta data that would be needed to be 
shared, housed, and interrogated from genome editing experiments.
    (3) Lexicon: Identify terms and related definitions to form a 
common genome editing community lexicon.
    No proprietary information will be shared as part of the 
Consortium.
    Process: Interested parties with relevant genome editing associated 
capabilities (see below), products, and/or technical expertise to 
support this Consortium should contact NIST using the information 
provided in the ADDRESSES section of this notice. NIST will then 
provide each interested party with a letter of interest template, which 
the party must complete, and submit to NIST. NIST will contact 
interested parties if there are questions regarding the responsiveness 
of the letters. NIST will select participants who have submitted 
complete letters of interest based on the capabilities listed below. 
Eligibility will be determined solely by NIST based on information 
provided by interested organizations and upon the availability of 
necessary resources to NIST.
    To participate, the eligible applicant will be required to sign a 
CRADA with NIST.
    Requirements: Each letter of interest should provide the following 
information:
    (1) A description of the experience in genome editing or genome 
engineering, bioinformatics, next-generation sequencing, detection or 
quantitation of DNA variants or related expertise to contribute to the 
Consortium.
    (2) Subgroups or topic areas of interest for participation. There 
is no limit on the number of areas of participation.
    (3) List of interested party's anticipated participants.
    Letters of interest may not include business proprietary 
information. NIST will not treat any information provided in response 
to this Notice as proprietary information. NIST will notify each 
organization of its eligibility. In order to participate in this 
Consortium, each eligible organization must sign a CRADA for this 
Consortium. All participants to this Consortium will be bound by the 
same terms and conditions. Participants will be required to contribute 
financial or equivalent in-kind resources, as determined by NIST, of at 
least $20,000. NIST does not guarantee participation in the Consortium 
or in any other collaboration to any organization submitting a Letter 
of Interest.

    Authority: 15 U.S.C. 3710a.

Kevin Kimball,
NIST Chief of Staff.
[FR Doc. 2018-00315 Filed 1-10-18; 8:45 am]
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