Notice of NIST's Mouse Cell Line Authentication Consortium, 70665-70666 [2016-24768]

Download as PDF Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Notices Dated: October 11, 2016. Brian Walch, Director, Communications and Public Engagement. [FR Doc. 2016–24956 Filed 10–11–16; 4:15 pm] BILLING CODE 6335–01–P DEPARTMENT OF COMMERCE National Institute of Standards and Technology Notice of NIST’s Mouse Cell Line Authentication Consortium National Institute of Standards and Technology, Department of Commerce. 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 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 jamie.almeida@nist.gov. 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 Lhorne on DSK30JT082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:07 Oct 12, 2016 Jkt 241001 to 100 Bureau Drive, Mail Stop 2200, Gaithersburg, Maryland 20899, by electronic mail to honeyeh.zube@ nist.gov, 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-15103.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 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 70665 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 E:\FR\FM\13OCN1.SGM 13OCN1 70666 Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Notices 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 DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Notice To Extend the Public Comment Period for the Draft Environmental Impact Statement and Draft Management Plan for the Proposed Designation of the He1eia National Estuarine Research Reserve in Hawai1i Office for Coastal Management, National Ocean Service, National Oceanic and Atmospheric Administration, Department of Commerce. ACTION: Notification of extension of public comment period for the Draft Environmental Impact Statement and Draft Management Plan for the proposed designation of the He1eia National Estuarine Research Reserve in Hawai1i. AGENCY: The National Oceanic and Atmospheric Administration (NOAA), Office for Coastal Management (OCM) is issuing this notice to advise the public of a 13-day extension to the public comment period on the Draft Environmental Impact Statement and Draft Management Plan (DEIS/DMP) prepared for the proposed designation Lhorne on DSK30JT082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:07 Oct 12, 2016 Jkt 241001 of the He1eia National Estuarine Research Reserve in Hawai1i. The initial Notice of Availability was published in the Federal Register on September 2, 2016 (81 FR 60676), and established a public comment period from September 2, 2016 through October 17, 2016. NOAA OCM is hereby extending the deadline for submitting public comments on this matter to October 30, 2016. NOAA will consider all relevant comments received by October 30, 2016. The October 6, 2016, date of the associated public hearing described in the September 2, 2016, Notice of Availability remains unchanged. DATES: NOAA is accepting public comments through 5:00 p.m. (HST), October 30, 2016. NOAA is soliciting the views of interested persons and organizations on the adequacy of the DEIS/DMP. All relevant comments received at the hearing and during the extended public comment period ending 5:00 p.m. (HST), October 30, 2016, will be considered in the preparation of the Final Environmental Impact Statement (FEIS) and Final Management Plan (FMP). ADDRESSES: Comments may be submitted by any one of the following methods: • Electronic Submissions: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/ #!docketDetail;D=NOAA-NOS-20160114, click the ‘‘Comment Now!’’ icon, complete the required fields and enter or attach your comments. • Mail: Joelle Gore, Stewardship Division, Office for Coastal Management, National Ocean Service, NOAA, 1305 East West Highway, N/ ORM2, Room 10622 Silver Spring, MD 20910. Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NOAA. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. FOR FURTHER INFORMATION CONTACT: Jean Tanimoto, Coastal Management Specialist, Policy, Planning, and Communications Division, Office for Coastal Management at (808) 725–5253 or via email at jean.tanimoto@noaa.gov. Electronic copies of the Draft Environmental Impact Statement and PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 Draft Management Plan may be found on the OCM Web site at http:// coast.noaa.gov/czm/compliance/ or may be obtained upon request from coastal.info@noaa.gov. Dated: October 5, 2016. Keelin Kuipers, Division Chief, Policy, Planning and Communication, Office for Coastal Management, National Ocean Service, National Oceanic and Atmospheric Administration. (Federal Domestic Assistance Catalog 11.420, Coastal Zone Management Estuarine Research Reserves) [FR Doc. 2016–24679 Filed 10–12–16; 8:45 am] BILLING CODE 3510–08–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648–XE212 Endangered and Threatened Species; Recovery Plans National Marine Fisheries Service, National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice of availability. AGENCY: NOAA’s National Marine Fisheries Service (NMFS) announces the adoption of the Final Endangered Species Act (ESA) Coastal Multispecies Recovery Plan for the California Coastal (CC) Chinook salmon (Oncorhynchus tshawytscha) Evolutionarily Significant Unit (ESU), Northern California (NC) steelhead (O. mykiss) Distinct Population Segment (DPS), and Central California Coast (CCC) steelhead (O. mykiss) DPS. These species spawn and rear in streams and rivers along the central and northern California coast, and in tributaries to San Francisco Bay. ADDRESSES: Electronic copies of the Public Final Recovery Plan are available online at: http:// www.westcoast.fisheries.noaa.gov/ protected_species/salmon_steelhead/ recovery_planning_and_ implementation/north_central_ california_coast/north_central_ california_coast_salmon_recovery_ domain.html. A CD–ROM of these documents can be obtained by emailing a request to Andrea.Berry@noaa.gov or by writing to: Recovery Team, National Marine Fisheries Service, 777 Sonoma Avenue, Room 325, Santa Rosa, CA 95404. SUMMARY: FOR FURTHER INFORMATION CONTACT: Korie Schaeffer, (707) 575–6087, Korie.Schaeffer@noaa.gov, or Erin E:\FR\FM\13OCN1.SGM 13OCN1

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[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.

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

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 
jamie.almeida@nist.gov.

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 honeyeh.zube@nist.gov, 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