81_FR_70863 81 FR 70665 - Notice of NIST's Mouse Cell Line Authentication Consortium

81 FR 70665 - Notice of NIST's Mouse Cell Line Authentication Consortium

DEPARTMENT OF COMMERCE
National Institute of Standards and Technology

Federal Register Volume 81, Issue 198 (October 13, 2016)

Page Range70665-70666
FR Document2016-24768

The National Institute of Standards and Technology (NIST), an agency of the United States Department of Commerce, is establishing the Mouse Cell Line Authentication Consortium and invites organizations to participate in this Consortium. The Consortium will collaborate to obtain concordant short tandem repeat (STR) profiles for mouse cell lines, draft consensus standards for mouse cell line authentication, and create a public database of STR profiles for mouse cell lines. The Consortium has been developed in collaboration with American Type Culture Collection (ATCC). Participation in this Consortium is open to all eligible organizations, as described below.

Federal Register, Volume 81 Issue 198 (Thursday, October 13, 2016)
[Federal Register Volume 81, Number 198 (Thursday, October 13, 2016)]
[Notices]
[Pages 70665-70666]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24768]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology


Notice of NIST's Mouse Cell Line Authentication Consortium

AGENCY: National Institute of Standards and Technology, Department of 
Commerce.

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 
Mouse Cell Line Authentication Consortium and invites organizations to 
participate in this Consortium. The Consortium will collaborate to 
obtain concordant short tandem repeat (STR) profiles for mouse cell 
lines, draft consensus standards for mouse cell line authentication, 
and create a public database of STR profiles for mouse cell lines. The 
Consortium has been developed in collaboration with American Type 
Culture Collection (ATCC). Participation in this Consortium is open to 
all eligible organizations, as described below.

DATES: NIST will accept responses for participation in this Consortium 
on an ongoing basis. The Consortium's activities will commence on or 
about December 15, 2016 (``Commencement Date''). Acceptance of 
participants into the Consortium after the Commencement Date will 
depend on eligibility and the availability of testing reagents and 
other resources.

ADDRESSES: Information in response to this Notice and requests for 
additional information about the Consortium can be directed via mail to 
the Consortium Manager, Jamie Almeida, Biosystems and Biomaterials 
Division of NIST's Material Measurement Laboratory, 100 Bureau Drive, 
Gaithersburg, Maryland 20899-8312, or via electronic mail to 
[email protected].

FOR FURTHER INFORMATION CONTACT: For further information about 
participation opportunities or about the terms and conditions of NIST's 
Cooperative Research and Development Agreement (CRADA), please contact 
Honeyeh Zube, CRADA and License 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-
2209.

SUPPLEMENTARY INFORMATION: The estimated cost due to the use of 
misidentified and contaminated cell lines used in research exceeds 
millions of dollars. The authentication of cell lines is recommended by 
many journals and research funding entities prior to publication and 
funding, respectively. On June 9, 2015, the National Institute of 
Health issued a notice titled, ``Enhancing Reproducibility through 
Rigor and Transparency'' (NOT-OD-15-103) to address the revision of 
grant application instructions and grant review criteria to highlight 
the need to authenticate key biological materials, including cell 
lines. The NIH notice is available here: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-103.html. Currently, there is a consensus 
standard in place for human cell line authentication using short tandem 
repeat (STR) profiling which describes in detail the specific 
procedures to obtain reliable genotyping results. Databases of human 
STR profiles and commercial kits for human STR genotyping are also 
available. For non-human cell line authentication, however, there are 
no standards, STR genotyping kits, or databases available to 
researchers.
    NIST researchers have developed a panel of STR markers specific to 
the mouse genus that can be used to discriminate among mouse cell 
lines. These STR markers are used in a multiplex polymerase chain 
reaction (PCR) assay and the PCR products are separated based on size 
using capillary electrophoresis (CE). This technology is the subject of 
a pending patent application owned by the United Stated Department of 
Commerce (US Patent Application Number 13/935,285).
    The purpose of this Consortium is to draft guidance documents or 
consensus documentary standards that will delineate the definitive 
methods for mouse cell line authentication based on the data collected 
in a concordance study conducted as a part of the Consortium. These 
efforts will enable quality services to be provided for mouse cell line 
authentication. The Consortium is managed by NIST in collaboration with 
ATCC. NIST and ATCC will provide protocol test reagent kit and DNA 
samples from mouse cell lines to the Consortium members under specific 
terms and conditions. NIST will provide the Consortium members with a 
standard operating procedure (SOP) and genotyping kit which each 
Consortium member will be required to use to generate data for the 
mouse cell line DNA samples. The Consortium members will determine the 
parameters for data analysis and define the rules for interpretation of 
identity guided by the data collected. NIST will collect concordant STR 
profile data for each mouse cell line which will be used to build a 
public database for mouse cell lines. NIST will anonymize the data from 
individual labs. NIST will share summaries of the data for all the 
mouse cell lines tested. NIST intends to publish the results of the 
research in the form of reports and publications in scientific journals 
with the members of the Consortium as co-authors, as appropriate.
    Participation Process: Researchers at university core labs, at 
companies offering cell line authentication methods, at cell line 
repositories, and at other organizations that would benefit from mouse 
cell line authentication services, are invited to respond to this 
Notice to participate in this Consortium. Eligibility will be 
determined solely by NIST based on the information provided by 
interested organizations in response to this Notice on a first-come, 
first-serve basis to the extent that interested organizations are 
eligible and that testing reagents and other resources are available to 
accommodate additional participants. In order to be eligible to 
participate, the Consortium member will be required to have expert 
experience in STR genotyping, human cell line authentication, and CE 
operation. Additionally, the Consortium member will need to demonstrate 
that it has access to a thermal cycler and CE instrumentation, as 
required to complete the tasks in the SOP. Consortium members will be 
responsible for their own consumables for PCR and CE fragment analysis, 
except for the mouse STR kit and mouse cell line DNA, which will be 
provided by NIST and ATCC. NIST will evaluate the written responses to 
this Notice to determine eligibility to participate in this Consortium. 
Organizations responding to this Notice should provide the following 
information to NIST's Consortium Manager:
    (1) A description of the experience in cell line authentication, 
STR analysis, polymerase chain reaction (PCR), and STR genotyping 
software analysis. Please also indicate whether the organization offers 
cell line authentication services. Please also describe the methods and 
kits typically used by organization, and the number of years of 
experience of the researchers at the organization who have been doing

[[Page 70666]]

this type of work and who would be participating in this Consortium.
    (2) Type of Instruments: The Consortium will provide STR profile 
concordance data for mouse cell lines. Please indicate the make and 
model of the thermal cycler and CE instrument that will be used to 
collect STR profile data. Also provide the type of polymer and array 
used for the CE instrument.
    (3) Type of Software: Please indicate the type of software that 
will be used to analyze and generate electropherograms from the CE 
fragment data.
    A responding organization may not include any business proprietary 
information in its response to this request for information. NIST will 
not treat any information provided in response to this Notice as 
proprietary information. NIST will notify each organization of its 
eligibility. All Consortium members will be required to sign the 
Cooperative Research and Development Agreement (CRADA) with NIST in 
order to participate in this Consortium. All Consortium members will be 
bound to the same terms and conditions.

    Dated: October 7, 2016.
Kevin Kimball,
Chief of Staff.
[FR Doc. 2016-24768 Filed 10-12-16; 8:45 am]
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                                                                         Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Notices                                           70665

                                               Dated: October 11, 2016.                              to 100 Bureau Drive, Mail Stop 2200,                  genotyping kit which each Consortium
                                             Brian Walch,                                            Gaithersburg, Maryland 20899, by                      member will be required to use to
                                             Director, Communications and Public                     electronic mail to honeyeh.zube@                      generate data for the mouse cell line
                                             Engagement.                                             nist.gov, or by telephone at (301) 975–               DNA samples. The Consortium
                                             [FR Doc. 2016–24956 Filed 10–11–16; 4:15 pm]            2209.                                                 members will determine the parameters
                                             BILLING CODE 6335–01–P                                  SUPPLEMENTARY INFORMATION: The                        for data analysis and define the rules for
                                                                                                     estimated cost due to the use of                      interpretation of identity guided by the
                                                                                                     misidentified and contaminated cell                   data collected. NIST will collect
                                             DEPARTMENT OF COMMERCE                                  lines used in research exceeds millions               concordant STR profile data for each
                                                                                                     of dollars. The authentication of cell                mouse cell line which will be used to
                                             National Institute of Standards and                     lines is recommended by many journals                 build a public database for mouse cell
                                             Technology                                              and research funding entities prior to                lines. NIST will anonymize the data
                                                                                                     publication and funding, respectively.                from individual labs. NIST will share
                                             Notice of NIST’s Mouse Cell Line                        On June 9, 2015, the National Institute               summaries of the data for all the mouse
                                             Authentication Consortium                                                                                     cell lines tested. NIST intends to
                                                                                                     of Health issued a notice titled,
                                             AGENCY: National Institute of Standards                 ‘‘Enhancing Reproducibility through                   publish the results of the research in the
                                             and Technology, Department of                           Rigor and Transparency’’ (NOT–OD–15–                  form of reports and publications in
                                             Commerce.                                               103) to address the revision of grant                 scientific journals with the members of
                                                                                                     application instructions and grant                    the Consortium as co-authors, as
                                             ACTION: Notice of research consortium.
                                                                                                     review criteria to highlight the need to              appropriate.
                                             SUMMARY:    The National Institute of                                                                            Participation Process: Researchers at
                                                                                                     authenticate key biological materials,
                                             Standards and Technology (NIST), an                                                                           university core labs, at companies
                                                                                                     including cell lines. The NIH notice is
                                             agency of the United States Department                                                                        offering cell line authentication
                                                                                                     available here: http://grants.nih.gov/
                                             of Commerce, is establishing the Mouse                                                                        methods, at cell line repositories, and at
                                                                                                     grants/guide/notice-files/NOT-OD-15-
                                             Cell Line Authentication Consortium                                                                           other organizations that would benefit
                                                                                                     103.html. Currently, there is a
                                             and invites organizations to participate                                                                      from mouse cell line authentication
                                                                                                     consensus standard in place for human
                                             in this Consortium. The Consortium                                                                            services, are invited to respond to this
                                                                                                     cell line authentication using short
                                             will collaborate to obtain concordant                                                                         Notice to participate in this Consortium.
                                                                                                     tandem repeat (STR) profiling which                   Eligibility will be determined solely by
                                             short tandem repeat (STR) profiles for                  describes in detail the specific
                                             mouse cell lines, draft consensus                                                                             NIST based on the information provided
                                                                                                     procedures to obtain reliable genotyping              by interested organizations in response
                                             standards for mouse cell line                           results. Databases of human STR
                                             authentication, and create a public                                                                           to this Notice on a first-come, first-serve
                                                                                                     profiles and commercial kits for human                basis to the extent that interested
                                             database of STR profiles for mouse cell                 STR genotyping are also available. For
                                             lines. The Consortium has been                                                                                organizations are eligible and that
                                                                                                     non-human cell line authentication,                   testing reagents and other resources are
                                             developed in collaboration with                         however, there are no standards, STR
                                             American Type Culture Collection                                                                              available to accommodate additional
                                                                                                     genotyping kits, or databases available               participants. In order to be eligible to
                                             (ATCC). Participation in this                           to researchers.
                                             Consortium is open to all eligible                                                                            participate, the Consortium member
                                                                                                        NIST researchers have developed a                  will be required to have expert
                                             organizations, as described below.                      panel of STR markers specific to the
                                             DATES: NIST will accept responses for
                                                                                                                                                           experience in STR genotyping, human
                                                                                                     mouse genus that can be used to                       cell line authentication, and CE
                                             participation in this Consortium on an                  discriminate among mouse cell lines.
                                             ongoing basis. The Consortium’s                                                                               operation. Additionally, the Consortium
                                                                                                     These STR markers are used in a                       member will need to demonstrate that it
                                             activities will commence on or about                    multiplex polymerase chain reaction                   has access to a thermal cycler and CE
                                             December 15, 2016 (‘‘Commencement                       (PCR) assay and the PCR products are                  instrumentation, as required to
                                             Date’’). Acceptance of participants into                separated based on size using capillary               complete the tasks in the SOP.
                                             the Consortium after the                                electrophoresis (CE). This technology is              Consortium members will be
                                             Commencement Date will depend on                        the subject of a pending patent                       responsible for their own consumables
                                             eligibility and the availability of testing             application owned by the United Stated                for PCR and CE fragment analysis,
                                             reagents and other resources.                           Department of Commerce (US Patent                     except for the mouse STR kit and mouse
                                             ADDRESSES: Information in response to                   Application Number 13/935,285).                       cell line DNA, which will be provided
                                             this Notice and requests for additional                    The purpose of this Consortium is to               by NIST and ATCC. NIST will evaluate
                                             information about the Consortium can                    draft guidance documents or consensus                 the written responses to this Notice to
                                             be directed via mail to the Consortium                  documentary standards that will                       determine eligibility to participate in
                                             Manager, Jamie Almeida, Biosystems                      delineate the definitive methods for                  this Consortium. Organizations
                                             and Biomaterials Division of NIST’s                     mouse cell line authentication based on               responding to this Notice should
                                             Material Measurement Laboratory, 100                    the data collected in a concordance                   provide the following information to
                                             Bureau Drive, Gaithersburg, Maryland                    study conducted as a part of the                      NIST’s Consortium Manager:
                                             20899–8312, or via electronic mail to                   Consortium. These efforts will enable                    (1) A description of the experience in
                                             jamie.almeida@nist.gov.                                 quality services to be provided for                   cell line authentication, STR analysis,
                                             FOR FURTHER INFORMATION CONTACT: For                    mouse cell line authentication. The                   polymerase chain reaction (PCR), and
                                             further information about participation                 Consortium is managed by NIST in                      STR genotyping software analysis.
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                                             opportunities or about the terms and                    collaboration with ATCC. NIST and                     Please also indicate whether the
                                             conditions of NIST’s Cooperative                        ATCC will provide protocol test reagent               organization offers cell line
                                             Research and Development Agreement                      kit and DNA samples from mouse cell                   authentication services. Please also
                                             (CRADA), please contact Honeyeh Zube,                   lines to the Consortium members under                 describe the methods and kits typically
                                             CRADA and License Officer, National                     specific terms and conditions. NIST will              used by organization, and the number of
                                             Institute of Standards and Technology’s                 provide the Consortium members with a                 years of experience of the researchers at
                                             Technology Partnerships Office, by mail                 standard operating procedure (SOP) and                the organization who have been doing


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                                             70666                       Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Notices

                                             this type of work and who would be                      of the He1eia National Estuarine                      Draft Management Plan may be found
                                             participating in this Consortium.                       Research Reserve in Hawai1i. The initial              on the OCM Web site at http://
                                                (2) Type of Instruments: The                         Notice of Availability was published in               coast.noaa.gov/czm/compliance/ or may
                                             Consortium will provide STR profile                     the Federal Register on September 2,                  be obtained upon request from
                                             concordance data for mouse cell lines.                  2016 (81 FR 60676), and established a                 coastal.info@noaa.gov.
                                             Please indicate the make and model of                   public comment period from September                    Dated: October 5, 2016.
                                             the thermal cycler and CE instrument                    2, 2016 through October 17, 2016.                     Keelin Kuipers,
                                             that will be used to collect STR profile                NOAA OCM is hereby extending the
                                                                                                                                                           Division Chief, Policy, Planning and
                                             data. Also provide the type of polymer                  deadline for submitting public                        Communication, Office for Coastal
                                             and array used for the CE instrument.                   comments on this matter to October 30,                Management, National Ocean Service,
                                                (3) Type of Software: Please indicate                2016. NOAA will consider all relevant                 National Oceanic and Atmospheric
                                             the type of software that will be used to               comments received by October 30, 2016.                Administration.
                                             analyze and generate electropherograms                  The October 6, 2016, date of the                      (Federal Domestic Assistance Catalog 11.420,
                                             from the CE fragment data.                              associated public hearing described in                Coastal Zone Management Estuarine
                                                A responding organization may not                    the September 2, 2016, Notice of                      Research Reserves)
                                             include any business proprietary                        Availability remains unchanged.                       [FR Doc. 2016–24679 Filed 10–12–16; 8:45 am]
                                             information in its response to this                     DATES: NOAA is accepting public                       BILLING CODE 3510–08–P
                                             request for information. NIST will not                  comments through 5:00 p.m. (HST),
                                             treat any information provided in                       October 30, 2016. NOAA is soliciting
                                             response to this Notice as proprietary                  the views of interested persons and                   DEPARTMENT OF COMMERCE
                                             information. NIST will notify each                      organizations on the adequacy of the
                                             organization of its eligibility. All                    DEIS/DMP. All relevant comments                       National Oceanic and Atmospheric
                                             Consortium members will be required to                  received at the hearing and during the                Administration
                                             sign the Cooperative Research and                       extended public comment period
                                             Development Agreement (CRADA) with                                                                            RIN 0648–XE212
                                                                                                     ending 5:00 p.m. (HST), October 30,
                                             NIST in order to participate in this                    2016, will be considered in the                       Endangered and Threatened Species;
                                             Consortium. All Consortium members                      preparation of the Final Environmental                Recovery Plans
                                             will be bound to the same terms and                     Impact Statement (FEIS) and Final
                                             conditions.                                             Management Plan (FMP).                                AGENCY:  National Marine Fisheries
                                               Dated: October 7, 2016.                                                                                     Service, National Oceanic and
                                                                                                     ADDRESSES: Comments may be
                                             Kevin Kimball,
                                                                                                                                                           Atmospheric Administration (NOAA),
                                                                                                     submitted by any one of the following
                                                                                                                                                           Commerce.
                                             Chief of Staff.                                         methods:
                                                                                                        • Electronic Submissions: Submit all               ACTION: Notice of availability.
                                             [FR Doc. 2016–24768 Filed 10–12–16; 8:45 am]
                                             BILLING CODE 3510–13–P                                  electronic public comments via the                    SUMMARY:    NOAA’s National Marine
                                                                                                     Federal e-Rulemaking Portal. Go to                    Fisheries Service (NMFS) announces the
                                                                                                     www.regulations.gov/                                  adoption of the Final Endangered
                                             DEPARTMENT OF COMMERCE                                  #!docketDetail;D=NOAA-NOS-2016-                       Species Act (ESA) Coastal Multispecies
                                                                                                     0114, click the ‘‘Comment Now!’’ icon,                Recovery Plan for the California Coastal
                                             National Oceanic and Atmospheric                        complete the required fields and enter                (CC) Chinook salmon (Oncorhynchus
                                             Administration                                          or attach your comments.                              tshawytscha) Evolutionarily Significant
                                                                                                        • Mail: Joelle Gore, Stewardship
                                             Notice To Extend the Public Comment                                                                           Unit (ESU), Northern California (NC)
                                                                                                     Division, Office for Coastal
                                             Period for the Draft Environmental                                                                            steelhead (O. mykiss) Distinct
                                                                                                     Management, National Ocean Service,
                                             Impact Statement and Draft                                                                                    Population Segment (DPS), and Central
                                                                                                     NOAA, 1305 East West Highway, N/
                                             Management Plan for the Proposed                                                                              California Coast (CCC) steelhead (O.
                                                                                                     ORM2, Room 10622 Silver Spring, MD
                                             Designation of the He1eia National                                                                            mykiss) DPS. These species spawn and
                                                                                                     20910.
                                             Estuarine Research Reserve in Hawai1i                                                                         rear in streams and rivers along the
                                                                                                        Instructions: Comments sent by any
                                                                                                                                                           central and northern California coast,
                                             AGENCY:  Office for Coastal Management,                 other method, to any other address or
                                                                                                                                                           and in tributaries to San Francisco Bay.
                                             National Ocean Service, National                        individual, or received after the end of
                                                                                                     the comment period, may not be                        ADDRESSES: Electronic copies of the
                                             Oceanic and Atmospheric                                                                                       Public Final Recovery Plan are available
                                             Administration, Department of                           considered by NOAA. All comments
                                                                                                     received are a part of the public record              online at: http://
                                             Commerce.                                                                                                     www.westcoast.fisheries.noaa.gov/
                                             ACTION: Notification of extension of
                                                                                                     and will generally be posted for public
                                                                                                     viewing on www.regulations.gov                        protected_species/salmon_steelhead/
                                             public comment period for the Draft                                                                           recovery_planning_and_
                                             Environmental Impact Statement and                      without change. All personal identifying
                                                                                                     information (e.g., name, address, etc.),              implementation/north_central_
                                             Draft Management Plan for the proposed                                                                        california_coast/north_central_
                                             designation of the He1eia National                      confidential business information, or
                                                                                                     otherwise sensitive information                       california_coast_salmon_recovery_
                                             Estuarine Research Reserve in Hawai1i.                                                                        domain.html. A CD–ROM of these
                                                                                                     submitted voluntarily by the sender will
                                             SUMMARY:   The National Oceanic and                     be publicly accessible.                               documents can be obtained by emailing
                                             Atmospheric Administration (NOAA),                      FOR FURTHER INFORMATION CONTACT: Jean
                                                                                                                                                           a request to Andrea.Berry@noaa.gov or
                                                                                                                                                           by writing to: Recovery Team, National
Lhorne on DSK30JT082PROD with NOTICES




                                             Office for Coastal Management (OCM) is                  Tanimoto, Coastal Management
                                             issuing this notice to advise the public                Specialist, Policy, Planning, and                     Marine Fisheries Service, 777 Sonoma
                                             of a 13-day extension to the public                     Communications Division, Office for                   Avenue, Room 325, Santa Rosa, CA
                                             comment period on the Draft                             Coastal Management at (808) 725–5253                  95404.
                                             Environmental Impact Statement and                      or via email at jean.tanimoto@noaa.gov.               FOR FURTHER INFORMATION CONTACT:
                                             Draft Management Plan (DEIS/DMP)                           Electronic copies of the Draft                     Korie Schaeffer, (707) 575–6087,
                                             prepared for the proposed designation                   Environmental Impact Statement and                    Korie.Schaeffer@noaa.gov, or Erin


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Document Created: 2016-10-13 00:53:59
Document Modified: 2016-10-13 00:53:59
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of research consortium.
DatesNIST will accept responses for participation in this Consortium on an ongoing basis. The Consortium's activities will commence on or about December 15, 2016 (``Commencement Date''). Acceptance of participants into the Consortium after the Commencement Date will depend on eligibility and the availability of testing reagents and other resources.
ContactFor further information about participation opportunities or about the terms and conditions of NIST's Cooperative Research and Development Agreement (CRADA), please contact Honeyeh Zube, CRADA and License 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- 2209.
FR Citation81 FR 70665 

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