Notice of NIST's Consortium for the Advancement of Genome Editing, 1335-1336 [2018-00315]

Download as PDF Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices for the revised certifications provided at the end of the Final Rule.9 Commerce intends to reject factual submissions in any proceeding segments if the submitting party does not comply with applicable revised certification requirements. srobinson on DSK9F5VC42PROD with NOTICES Extension of Time Limits Regulation Parties may request an extension of time limits before a time limit established under Part 351 expires, or as otherwise specified by the Secretary. See 19 CFR 351.302. In general, an extension request will be considered untimely if it is filed after the time limit established under Part 351 expires. For submissions which are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. on the due date. Examples include, but are not limited to: (1) Case and rebuttal briefs, filed pursuant to 19 CFR 351.309; (2) factual information to value factors under 19 CFR 351.408(c), or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2), filed pursuant to 19 CFR 351.301(c)(3) and rebuttal, clarification and correction filed pursuant to 19 CFR 351.301(c)(3)(iv); (3) comments concerning the selection of a surrogate country and surrogate values and rebuttal; (4) comments concerning U.S. Customs and Border Protection data; and (5) quantity and value questionnaires. Under certain circumstances, Commerce may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, Commerce will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. This modification also requires that an extension request must be made in a separate, stand-alone submission, and clarifies the circumstances under which Commerce will grant untimelyfiled requests for the extension of time limits. These modifications are effective for all segments initiated on or after October 21, 2013. Please review the final rule, available at https:// www.gpo.gov/fdsys/pkg/FR-2013-09-20/ html/2013-22853.htm, prior to submitting factual information in these segments. 9 See Certification of Factual Information To Import Administration During Antidumping and Countervailing Duty Proceedings, 78 FR 42678 (July 17, 2013) (Final Rule); see also the frequently asked questions regarding the Final Rule, available at https://enforcement.trade.gov/tlei/notices/factual_ info_final_rule_FAQ_07172013.pdf. VerDate Sep<11>2014 00:05 Jan 11, 2018 Jkt 244001 These initiations and this notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.221(c)(1)(i). Dated: January 8, 2018. James Maeder, Senior Director performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations. [FR Doc. 2018–00356 Filed 1–10–18; 8:45 am] BILLING CODE 3510–DS–P DEPARTMENT OF COMMERCE National Institute of Standards and Technology Notice of NIST’s Consortium for the Advancement of Genome Editing National Institute of Standards and Technology. ACTION: Notice of Research Consortium. AGENCY: 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 inkind 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 SUMMARY: PO 00000 Frm 00009 Fmt 4703 Sfmt 4703 1335 NIST’s Material Measurement Laboratory, 100 Bureau Drive, Mail Stop 8312, Gaithersburg, Maryland 20899, or via electronic mail to samantha@ nist.gov, 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 jeffrey.divietro@nist.gov, 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 E:\FR\FM\11JAN1.SGM 11JAN1 srobinson on DSK9F5VC42PROD with NOTICES 1336 Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices that can be used to mimic both of ontarget 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. VerDate Sep<11>2014 00:05 Jan 11, 2018 Jkt 244001 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 inkind 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. Kevin Kimball, NIST Chief of Staff. [FR Doc. 2018–00315 Filed 1–10–18; 8:45 am] BILLING CODE 3510–13–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648–XF917 Fisheries of the South Atlantic; South Atlantic Fishery Management Council; Public Meetings National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice of meeting of the South Atlantic Fishery Management Council’s Citizen Science Advisory Panel Projects/Topics Management; Finance & Infrastructure; Volunteers; Communication/Outreach/Education; and Data Management Action Teams. AGENCY: The South Atlantic Fishery Management Council (Council) will hold an all-hands meeting of its Citizen Science Advisory Panel Projects/Topics Management; Finance & Infrastructure; Volunteers; Communication/Outreach/ Education; and Data Management Action Teams via webinar. DATES: The Projects/Topics Management; Finance & Infrastructure; Volunteers; Communication/Outreach/ Education; and Data Management Action Team meeting will be held on Wednesday, January 31, 2018 at 9 a.m. The meeting is scheduled to last approximately three hours. Additional Action Team webinar dates and times will publish in a subsequent issue in the Federal Register. ADDRESSES: PO 00000 Frm 00010 Fmt 4703 Sfmt 9990 FOR FURTHER INFORMATION CONTACT: Amber Von Harten, Citizen Science Program Manager, SAFMC; phone (843) 302–8433 or toll free (866) SAFMC–10; fax: (843) 769–4520; email: amber.vonharten@safmc.net. The Council created a Citizen Science Advisory Panel Pool in June 2017. The Council appointed members of the Citizen Science Advisory Panel Pool to five Action Teams in the areas of Volunteers, Data Management, Projects/ Topics Management, Finance, and Communication/Outreach/Education to develop program policies and operations for the Council’s Citizen Science Program. Each Action Team has been meeting since August 2017 to work on developing recommendations on program policies and operations to be reviewed by the Council’s Citizen Science Committee. The January 31, 2018 meeting will bring all members of all five Action Teams together to review and discuss draft recommendations from each Action Team. Public comment will be accepted at the beginning of the meeting. Items to be addressed during these meetings: SUPPLEMENTARY INFORMATION: Authority: 15 U.S.C. 3710a. SUMMARY: Meeting address: The meeting will be held via webinar and is open to members of the public. Webinar registration is required and registration links will be posted to the Citizen Science program page of the Council’s website at www.safmc.net. Council address: South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N Charleston, SC 29405. 1. Overview and discussion of Action Team draft recommendations 2. Other Business Special Accommodations These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the council office (see ADDRESSES) 3 days prior to the meeting. Note: The times and sequence specified in this agenda are subject to change. Authority: 16 U.S.C. 1801 et seq. Dated: January 8, 2018. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 2018–00372 Filed 1–10–18; 8:45 am] BILLING CODE 3510–22–P E:\FR\FM\11JAN1.SGM 11JAN1

Agencies

[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)]
[Notices]
[Pages 1335-1336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

-----------------------------------------------------------------------

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


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