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)

Page Range		1335-1336
FR Document		2018-00315

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 Issue 8 (Thursday, January 11, 2018)

[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]
BILLING CODE 3510-13-P

Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices 1335

for the revised certifications provided at These initiations and this notice are NIST’s Material Measurement
the end of the Final Rule.9 Commerce in accordance with section 751(a) of the Laboratory, 100 Bureau Drive, Mail Stop
intends to reject factual submissions in Act (19 U.S.C. 1675(a)) and 19 CFR 8312, Gaithersburg, Maryland 20899, or
any proceeding segments if the 351.221(c)(1)(i). via electronic mail to samantha@
submitting party does not comply with Dated: January 8, 2018. nist.gov, or by telephone at (301) 975–
applicable revised certification James Maeder, 4947.
requirements. Senior Director performing the duties of FOR FURTHER INFORMATION CONTACT: For
Extension of Time Limits Regulation Deputy Assistant Secretary for Antidumping further information about participation
and Countervailing Duty Operations. opportunities to join the Genome
Parties may request an extension of [FR Doc. 2018–00356 Filed 1–10–18; 8:45 am] Editing Consortium, please contact
time limits before a time limit BILLING CODE 3510–DS–P Jeffrey DiVietro, CRADA Officer,
established under Part 351 expires, or as National Institute of Standards and
otherwise specified by the Secretary. Technology’s Technology Partnerships
See 19 CFR 351.302. In general, an DEPARTMENT OF COMMERCE Office, by mail to 100 Bureau Drive,
extension request will be considered Mail Stop 2200, Gaithersburg, Maryland
untimely if it is filed after the time limit National Institute of Standards and 20899, by electronic mail to
established under Part 351 expires. For Technology jeffrey.divietro@nist.gov, or by
submissions which are due from telephone at (301) 975–8779.
Notice of NIST’s Consortium for the
multiple parties simultaneously, an Advancement of Genome Editing SUPPLEMENTARY INFORMATION: Targeted
extension request will be considered Genome Editing is a technology space
untimely if it is filed after 10:00 a.m. on AGENCY: National Institute of Standards where there is a great need for reliable
the due date. Examples include, but are and Technology. measurement methods for assuring the
not limited to: (1) Case and rebuttal ACTION: Notice of Research Consortium. results of editing. Modalities for targeted
briefs, filed pursuant to 19 CFR 351.309; genome editing include but are not
(2) factual information to value factors SUMMARY: The National Institute of limited to Zinc Finger Proteins (ZFPs),
under 19 CFR 351.408(c), or to measure Standards and Technology (NIST), an Homing Endonucleases, Transcription
the adequacy of remuneration under 19 agency of the United States Department Activator-Like Nucleases (TALENs) and
CFR 351.511(a)(2), filed pursuant to 19 of Commerce is establishing the Genome Clustered, Regularly Interspaced
CFR 351.301(c)(3) and rebuttal, Editing Consortium with the goal of Palindromic Repeats (CRISPR). These
clarification and correction filed bringing together stakeholders across technologies are being actively pursued
pursuant to 19 CFR 351.301(c)(3)(iv); (3) the genome editing community to by industry, academic, government and
comments concerning the selection of a identify and address measurement and non-profit sectors to advance medicine
surrogate country and surrogate values standards needs to support this and bioscience in areas such as:
and rebuttal; (4) comments concerning technical area. The Consortium intends Regenerative medicine, synthetic
U.S. Customs and Border Protection to evaluate genome editing assay biology, novel antimicrobials and
data; and (5) quantity and value pipelines, develop benchmark materials, antivirals, protein therapeutic
questionnaires. Under certain generate benchmark data, develop biomanufacturing, agriculture and
circumstances, Commerce may elect to suggested minimal information global food production. Utilizing these
specify a different time limit by which reporting for public studies, and technologies for production and
extension requests will be considered generate a common lexicon for genome medicine will first require robust
untimely for submissions which are due editing studies, with the intent these quantitative assays and measurements
from multiple parties simultaneously. In resources can be used to increase to enable high confidence
such a case, Commerce will inform confidence in evaluating genome editing characterization of DNA alterations
parties in the letter or memorandum and lower the risk to utilizing these resulting from genome editing.
setting forth the deadline (including a technologies in research and NIST has reached out to companies to
specified time) by which extension commercial products. Participation fees assess their measurement needs, and
requests must be filed to be considered will be at least $20,000 annually or in- has co-led workshops that have brought
timely. This modification also requires kind contributions of equivalent value. together experts across the genome
that an extension request must be made Participants will be required to sign a editing field including stakeholders in
in a separate, stand-alone submission, Cooperative Research and Development industry, academia and government.
and clarifies the circumstances under Agreement (CRADA). These discussions have identified
which Commerce will grant untimely- DATES: NIST will accept letters of common pre-competitive measurement
filed requests for the extension of time interest containing required information needs that if resolved can push forward
limits. These modifications are effective for participation in this Consortium the field as it relates to understanding
for all segments initiated on or after until January 1, 2020. Acceptance of the reliability of data from assays being
October 21, 2013. Please review the participants into the Consortium after used to measuring aspects of genome
final rule, available at http:// the Commencement Date will depend edited cells.
www.gpo.gov/fdsys/pkg/FR-2013-09-20/ on eligibility as determined by NIST This Consortium’s purpose is to
html/2013-22853.htm, prior to based upon the information provided in develop measurement solutions and
submitting factual information in these the letter of interest and upon the standards to advance confidence in
segments. availability resources. measurements supporting the genome
srobinson on DSK9F5VC42PROD with NOTICES

ADDRESSES: Information in response to editing technology space.
9 See Certification of Factual Information To this notice, including completed letters The Consortium will have three
Import Administration During Antidumping and of interest or requests for additional working groups with the following
Countervailing Duty Proceedings, 78 FR 42678 (July information about the Consortium can responsibilities:
17, 2013) (Final Rule); see also the frequently asked
questions regarding the Final Rule, available at
be directed via mail to the Consortium (1) Specificity Measurements:
http://enforcement.trade.gov/tlei/notices/factual_ Manager, Dr. Samantha Maragh, a. Design, generate, and evaluate a set
info_final_rule_FAQ_07172013.pdf. Biosystems and Biomaterials Division of of purified DNA samples and mixtures

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1336 Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices

that can be used to mimic both of on- Letters of interest may not include Meeting address: The meeting will be
target and off-target genome editing business proprietary information. NIST held via webinar and is open to
induced variants at known frequencies will not treat any information provided members of the public. Webinar
in a background of human genomic in response to this Notice as proprietary registration is required and registration
DNA which can be used to benchmark information. NIST will notify each links will be posted to the Citizen
validation of sequencing pipelines organization of its eligibility. In order to Science program page of the Council’s
intended to identify genome editing participate in this Consortium, each website at www.safmc.net.
induced variants. eligible organization must sign a
b. Design and conduct controlled CRADA for this Consortium. All Council address: South Atlantic
evaluations of assays intended to participants to this Consortium will be Fishery Management Council, 4055
identify where genome editing enzymes bound by the same terms and Faber Place Drive, Suite 201, N
have been active in a genome, with an conditions. Participants will be required Charleston, SC 29405.
experimental design that allows for to contribute financial or equivalent in- FOR FURTHER INFORMATION CONTACT:
enough power to assess the sources of kind resources, as determined by NIST, Amber Von Harten, Citizen Science
variability, repeatability, and of at least $20,000. NIST does not Program Manager, SAFMC; phone (843)
reproducibility within an assay. guarantee participation in the
302–8433 or toll free (866) SAFMC–10;
(2) Data and Meta Data: Consortium or in any other
a. Identify community norms for data fax: (843) 769–4520; email:
collaboration to any organization
formats and tools for benchmarking data amber.vonharten@safmc.net.
submitting a Letter of Interest.
analysis including in silico data sets and Authority: 15 U.S.C. 3710a. SUPPLEMENTARY INFORMATION: The
an experimental data set. Council created a Citizen Science
b. Determine the type of meta data Kevin Kimball, Advisory Panel Pool in June 2017. The
that would be needed to be shared, NIST Chief of Staff. Council appointed members of the
housed, and interrogated from genome [FR Doc. 2018–00315 Filed 1–10–18; 8:45 am] Citizen Science Advisory Panel Pool to
editing experiments. BILLING CODE 3510–13–P five Action Teams in the areas of
(3) Lexicon: Identify terms and related Volunteers, Data Management, Projects/
definitions to form a common genome
Topics Management, Finance, and
editing community lexicon. DEPARTMENT OF COMMERCE
No proprietary information will be Communication/Outreach/Education to
shared as part of the Consortium. National Oceanic and Atmospheric develop program policies and
Process: Interested parties with Administration operations for the Council’s Citizen
relevant genome editing associated Science Program.
RIN 0648–XF917
capabilities (see below), products, and/ Each Action Team has been meeting
or technical expertise to support this Fisheries of the South Atlantic; South since August 2017 to work on
Consortium should contact NIST using Atlantic Fishery Management Council; developing recommendations on
the information provided in the Public Meetings program policies and operations to be
ADDRESSES section of this notice. NIST reviewed by the Council’s Citizen
will then provide each interested party AGENCY: National Marine Fisheries
Science Committee. The January 31,
with a letter of interest template, which Service (NMFS), National Oceanic and
2018 meeting will bring all members of
the party must complete, and submit to Atmospheric Administration (NOAA),
all five Action Teams together to review
NIST. NIST will contact interested Commerce.
and discuss draft recommendations
parties if there are questions regarding ACTION: Notice of meeting of the South
from each Action Team. Public
the responsiveness of the letters. NIST Atlantic Fishery Management Council’s
comment will be accepted at the
will select participants who have Citizen Science Advisory Panel
beginning of the meeting.
submitted complete letters of interest Projects/Topics Management; Finance &
based on the capabilities listed below. Infrastructure; Volunteers; Items to be addressed during these
Eligibility will be determined solely by Communication/Outreach/Education; meetings:
NIST based on information provided by and Data Management Action Teams. 1. Overview and discussion of Action
interested organizations and upon the Team draft recommendations
SUMMARY: The South Atlantic Fishery
availability of necessary resources to
Management Council (Council) will 2. Other Business
NIST.
hold an all-hands meeting of its Citizen
To participate, the eligible applicant Special Accommodations
Science Advisory Panel Projects/Topics
will be required to sign a CRADA with
Management; Finance & Infrastructure; These meetings are physically
NIST.
Requirements: Each letter of interest Volunteers; Communication/Outreach/
accessible to people with disabilities.
should provide the following Education; and Data Management
Requests for auxiliary aids should be
information: Action Teams via webinar.
directed to the council office (see
(1) A description of the experience in DATES: The Projects/Topics
ADDRESSES) 3 days prior to the meeting.
genome editing or genome engineering, Management; Finance & Infrastructure;
Volunteers; Communication/Outreach/ Note: The times and sequence specified in
bioinformatics, next-generation
Education; and Data Management this agenda are subject to change.
sequencing, detection or quantitation of
DNA variants or related expertise to Action Team meeting will be held on Authority: 16 U.S.C. 1801 et seq.
srobinson on DSK9F5VC42PROD with NOTICES

contribute to the Consortium. Wednesday, January 31, 2018 at 9 a.m.
Dated: January 8, 2018.
(2) Subgroups or topic areas of The meeting is scheduled to last
approximately three hours. Additional Tracey L. Thompson,
interest for participation. There is no
limit on the number of areas of Action Team webinar dates and times Acting Deputy Director, Office of Sustainable
participation. will publish in a subsequent issue in the Fisheries, National Marine Fisheries Service.
(3) List of interested party’s Federal Register. [FR Doc. 2018–00372 Filed 1–10–18; 8:45 am]
anticipated participants. ADDRESSES: BILLING CODE 3510–22–P

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Document Created: 2018-01-11 04:54:16
Document Modified: 2018-01-11 04:54:16

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of Research Consortium.
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.
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.
FR Citation		83 FR 1335

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

DEPARTMENT OF COMMERCENational Institute of Standards and Technology

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

DEPARTMENT OF COMMERCE
National Institute of Standards and Technology