[Federal Register Volume 77, Number 23 (Friday, February 3, 2012)]
[Notices]
[Pages 5489-5491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-2459]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

[Docket No. 120104006-2006-01]


Identification of Human Cell Lines Project

AGENCY: National Institute of Standards and Technology, Commerce.

ACTION: Notice.

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SUMMARY: The National Institute of Standards and Technology (NIST) 
Biochemical Science Division announces its intent to identify by short 
tandem repeat (STR) profiling up to 1500 human cell line samples as 
part of the Identification of Human Cell Lines Project. All data and 
corresponding information will be posted in a publically held database 
at the National Center For Biotechnology Information (NCBI).

DATES: On the first of each month beginning after February 3, 2012 NIST 
will post the number of cell lines accepted on the NIST Applied 
Genetics Group Web site at http://www.nist.gov/mml/biochemical/genetics/index.cfm. Once the total number of accepted submissions has 
reached 1400 cell lines, the next month will be the final month NIST 
will accept submissions, with the total time for acceptance not to 
exceed one year beyond February 3, 2012.

ADDRESSES: Hard copies of submissions must be submitted to the 
attention of Margaret Kline at the National Institute of Standards and 
Technology; 100 Bureau Drive, Stop 8314; Gaithersburg, MD 20899-8314. 
Electronic submissions must be submitted to [email protected].

FOR FURTHER INFORMATION CONTACT: Margaret Kline via email at 
[email protected] or telephone (301) 975-3134.

SUPPLEMENTARY INFORMATION:
    Program Description: The National Institute of Standards and 
Technology (NIST) Biochemical Science Division announces its intent to 
unambiguously identify by short tandem repeat (STR) profiling up to 
1500 human cell line samples as part of the Identification of Human 
Cell Lines Project. All data and corresponding information will be 
posted in a publically held database.
    The use of misidentified cell lines in cancer and other biomedical 
research continues to occur, resulting in the possibility that a 
significant proportion of the literature describing studies employing 
cell lines may be misleading or even false. The end result of this 
unfortunate situation is that millions of dollars may be spent on 
research using misidentified cell lines every year worldwide. This, in 
turn, may delay discoveries and the effective translation of research 
findings from the laboratory to the clinic or the market. Scientists 
may believe or claim that they are working with cells derived from one 
individual or animal species, only to eventually learn that the cells 
were derived from a different individual or species. With the advent of 
standardized, simple, and rapid methods for human cell line 
authentication the identity of a cell line need no longer be in doubt. 
NIST is undertaking this project to provide that cell line 
authentication.
    Human cell lines submitted for identification as part of this 
project will undergo STR profiling, a DNA profiling method that 
examines/screens for STRs (DNA elements 2-6 bps long repeated in 
tandem) in the human chromosomes, that has been shown to be not only 
rapid and inexpensive, but also able to generate reproducible data in a 
format suitable for use in a standard reference database. STR analysis 
involves simultaneous amplification of eight STR markers (e.g., D5S818, 
D13S317, D7S820, D16S539. vWA, THO1, TPOX, CSF1PO) and the amelogenin 
gene for gender determination. For each STR marker used, the power of 
discrimination improves by about an order of magnitude. Thus, with 8 
STRs, random match probabilities on the order of 1 in 100 million are 
expected between cell line DNA samples originating from unrelated 
individuals. Each unique human cell line has a distinct DNA profile and 
when the STR DNA fragment sizes are converted to numeric values, the 
DNA profiles are readily compared among different laboratories. It 
should be noted,

[[Page 5490]]

however, that STR profiling cannot detect interspecies cross-
contamination. For this reason, cell lines grown on non-human feeder 
cells will not be accepted for this project.
    The attributes of STR-profiling which have driven the selection of 
this technology over other possible candidates for this project 
include: (i) The ability to discriminate human cell lines to the 
individual level upon evaluating a relatively limited number of allelic 
markers; (ii) reproducibility of the endpoint across different 
laboratories and therefore the feasibility of assembling and 
maintaining a searchable and public (freely accessible) database for 
authenticating established cell lines; (iii) the commercial 
availability of STR-profiling kits, allowing individual laboratories to 
bring this technology in-house; (iv) relatively low cost; (v) rapidity; 
and (vi) reduced need for specialized technical expertise and/or 
reagents, compared with many of the other authentication technologies. 
Presently, cell line STR profiling appears to represent the greatest 
value to the scientific community for authenticating human cell lines 
unambiguously, quickly, and for the least expense.
    There is a tremendous need for scientific researchers using cell 
lines to know with confidence that the cells they are using are of the 
desired origin. This interactive database will be used by the research 
and development community to validate cell lines of interest. The 
database will offer DNA profiles of commonly used standard cell lines, 
primary, differentiating, and commonly used immortalized and 
transformed cell lines, as donated by interested parties.
    Furthermore, the database will allow disparate laboratories to 
compare their lines, thereby facilitating the validation of 
experimental data. Thus, the database will address the need for 
investigators to know much more about the samples used in their 
research, and will fulfill an overarching need of researchers to 
characterize their substrates with an accepted standard.
    The current databases for cell lines generated using various 
numbers of STR loci will be useful as long as the new extended set of 
STR loci include the current loci. Thus, the current database will not 
be absolute and can be updated when existing cell lines are retyped as 
a routine measure using the extended set of STR loci.
    Information on cell lines in the database will include multiple 
attributes of the cell lines (name and possible synonyms of cell line, 
organism, tissue of origin, morphology, pathologic or disease-state, 
hybrid or mixed culture, feeder cells, date of origin, etc), the STR 
markers and procedures used in identification, the submitter and 
appropriate links, other descriptive material, and the STR profile 
(electropherogram) of the cell line.
    Scientists at NIST will evaluate data from STR profiling as 
described in Designation: ASN-0002 Authentication of Human Cell Lines: 
Standardization of STR Profiling by NIST will make no conclusions 
regarding uniqueness of cell line, whether the cell line matches 
another cell line, whether the cell line is misidentified, cross-
contaminated, or genetically unstable.
    Identification by STR profiling of human cell lines will be 
provided by the Biochemical Science Division (BSD)/Material Measurement 
Laboratory (MML)/NIST. This program is contingent upon the availability 
of BSD/MML/NIST program funds, BSD/MML/NIST program objectives, and the 
discretion of BSD/MML/NIST advisors. The timeline for completing the 
STR profiling will be contingent on resources available.
    NIST anticipates entering into a Materials Transfer Agreement with 
each submitter. To obtain a copy of the NIST Materials Transfer 
Agreement to be used for this project, please contact Margaret Kline, 
whose contact information is given in the ADDRESSES section above.
    Applicants who submit complete information about their cell lines 
and who enter into a Material Transfer Agreement with NIST will be 
eligible to participate in the Identification of Human Cell Lines 
Project on a first-come, first served basis. Once the Material Transfer 
Agreement is executed, institutions will have 30 business days to 
submit the agreed-upon cell lines. Note that submitters must be willing 
to have submitter information made public in the aforementioned 
database.
    Submission Process: Submitters should contact Margaret Kline with a 
list of proposed cell lines for identification. Each submitter may 
submit up to 15 cell lines. Note that no cell lines grown on non-human 
feeder cells will be accepted due to the possibility of contamination. 
NIST will perform STR profiling of up to 1500 cell lines submitted with 
complete information on a first-come, first-serve basis. As part of the 
submission, the following information, using standard nomenclature, 
should be included for each cell line or DNA extract, as applicable. 
Please do not include any personally identifiable information regarding 
the source of the cell lines.

Submitter

Name:
Title:
Department:
Institution:
Institution Address:
Phone number:
Fax number:
Email:

Originator

Name:
Title:
Department:
Institution:
Institution Address:
Phone number:
Fax number:
Email:

Generic Information:

Cell Line Name =

Organism =

Tissue of Origin =

Morphology =

Pathologic or Disease-State =

Hybrid or Mixed Culture =

Specialized Information

Feeder Cells (species):
Passage Number:
Population Doubling Level (PDL):
Complete Growth Media:
Date of Origin/Date Established:
Reference:
    If DNA extracts are submitted, the following information is 
required:

Source of DNA:

Cell line or derivatives
Fresh biopsy/tissue
Frozen biopsy/tissue
OCT-treated tissue
FFPE-treated tissue

DNA Isolation Method:

Organic (phenol/chloroform)
Salting-out
Other (Cellmark kit)

Method of DNA Quantitation:

PicoGreen
Spectrophotometer (Nanodrop, etc.)
PCR
Syber Green
Other (qRT-PCR)

Amount of DNA Used for Analysis:

    Other Characterization and Authentication Methods: (example: 
cytogenetic analysis i.e. G-banding or SKY; Microarray analysis; SNP; 
isoenzymology).
    Other Characterization and Authentication Methods: provide 
reference and data.
    Are the cell lines genetically engineered? If yes, explain how.

[[Page 5491]]

    Costs for shipping accepted cell lines to NIST are the 
responsibility of the donating party, and will not be paid for by NIST.
    Review and Selection Process: All submissions will be reviewed to 
determine whether they are complete. All complete submissions will be 
accepted based on date and time of receipt of submission. Up to 15 cell 
lines per submitter or establishment will be accepted, with a final 
limit of 1500 cell lines. No cell lines grown on non-human feeder cells 
will be accepted due to the possibility of cross-species contamination.
    Research Projects Involving Human Subjects, Human Tissue, Data or 
Recordings Involving Human Subjects: NIST has determined that this 
project does not include research involving human subjects that falls 
under the Common Rule for the Protection of Human Subjects.
    Paperwork Reduction Act: This notice contains collection of 
information requirements subject to the Paperwork Reduction Act (PRA). 
The collection of information has been approved by OMB under control 
number 0693-0064, and completion of this information for a single cell 
line is expected to take 2 hours and 30 minutes. Notwithstanding any 
other provision of the law, no person is required to respond to, nor 
shall any person be subject to a penalty for failure to comply with, a 
collection of information, subject to the requirements of the PRA, 
unless that collection of information displays a currently valid OMB 
Control Number.

    Dated: January 27, 2012.
Willie E. May,
Associate Director for Laboratory Programs.
[FR Doc. 2012-2459 Filed 2-2-12; 8:45 am]
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