[Federal Register Volume 81, Number 198 (Thursday, October 13, 2016)]
[Notices]
[Pages 70665-70666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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 
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]
 BILLING CODE 3510-13-P