Identification of Human Cell Lines Project, 5489-5491 [2012-2459]

Download as PDF Federal Register / Vol. 77, No. 23 / Friday, February 3, 2012 / Notices Conclusion In summary, in accordance with section 703(e)(1) of the Act, we find that there is a reasonable basis to believe or suspect that certain subsidy allegations under investigation are inconsistent with the SCM Agreement, and we find that there have been massive imports of solar cells over a relatively short period from Suntech, Trina, and all other producers or exporters. Given the analysis summarized above, and described in more detail in the Preliminary Critical Circumstances Memorandum, we preliminarily determine that critical circumstances exist with respect to imports of solar cells from the PRC for Suntech, Trina, and all other producers or exporters.13 Final Critical Circumstances Determination ITC Notification In accordance with section 703(f) of the Act, we have notified the ITC of our determination. Suspension of Liquidation tkelley on DSK3SPTVN1PROD with NOTICES In accordance with section 703(e)(2) of the Act, because we have preliminarily found that critical circumstances exist with regard to imports exported by Suntech, Trina and all other producers or exporters, if we make an affirmative preliminary determination that countervailable subsidies have been provided to respondents at above de minimis rates,14 we will instruct U.S. Customs and Border Protection (CBP) to suspend liquidation of all entries of solar cells from the PRC, as described in the ‘‘Scope of Investigation’’ section of the Initiation Notice,15 that are entered, or withdrawn from warehouse, for consumption on or after the date that is 90 days prior to the effective date of ‘‘provisional measures’’ (e.g., the date of publication in the Federal Register of the notice of an affirmative preliminary determination that countervailable 13 See Preliminary Critical Circumstances Memorandum. 14 The preliminary determination concerning the provision of countervailable subsidies is currently scheduled for February 13, 2012. 15 See Initiation Notice, 76 FR at 70969; see also Appendix 1. 20:48 Feb 02, 2012 Jkt 226001 Dated: January 27, 2012. Paul Piquado, Assistant Secretary for Import Administration. [FR Doc. 2012–2479 Filed 2–2–12; 8:45 am] BILLING CODE 3510–DS–P DEPARTMENT OF COMMERCE We will make a final determination concerning critical circumstances for solar cells from the PRC when we make our final determination in this CVD investigation. All interested parties will have the opportunity to address this determination further in case briefs to be submitted after completion of the preliminary subsidies determination. VerDate Mar<15>2010 subsidies have been provided to respondents at above de minimis rates). At such time, we will also instruct CBP to require a cash deposit or the posting of a bond equal to the estimated preliminary subsidy rates reflected in the preliminary subsidies determination published in the Federal Register. This suspension of liquidation will remain in effect until further notice. This notice is issued and published pursuant to section 777(i) of the Act. National Institute of Standards and Technology [Docket No. 120104006–2006–01] Identification of Human Cell Lines Project National Institute of Standards and Technology, Commerce. ACTION: Notice. AGENCY: 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). SUMMARY: 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 https://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 Margaret.Kline@nist.gov. DATES: FOR FURTHER INFORMATION CONTACT: Margaret Kline via email at PO 00000 Frm 00010 Fmt 4703 Sfmt 4703 5489 Margaret.Kline@nist.gov 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, E:\FR\FM\03FEN1.SGM 03FEN1 tkelley on DSK3SPTVN1PROD with NOTICES 5490 Federal Register / Vol. 77, No. 23 / Friday, February 3, 2012 / Notices however, that STR profiling cannot detect interspecies cross-contamination. For this reason, cell lines grown on nonhuman 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 VerDate Mar<15>2010 20:48 Feb 02, 2012 Jkt 226001 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 firstcome, 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. PO 00000 Frm 00011 Fmt 4703 Sfmt 4703 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. E:\FR\FM\03FEN1.SGM 03FEN1 Federal Register / Vol. 77, No. 23 / Friday, February 3, 2012 / Notices 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 nonhuman 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] BILLING CODE 3510–13–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648–XA977 Endangered and Threatened Species; Initiation of 5-Year Review for Sei Whales National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice of initiation of 5-year review; request for information. tkelley on DSK3SPTVN1PROD with NOTICES AGENCY: NMFS announces a 5-year review of sei whales (Balaenoptera borealis) under the Endangered Species SUMMARY: VerDate Mar<15>2010 20:48 Feb 02, 2012 Jkt 226001 Act of 1973, as amended (ESA). A 5-year review is based on the best scientific and commercial data available at the time of the review; therefore, we are requesting submission of any such information on sei whales that has become available since that has become available since their last status review in 1999. DATES: To allow us adequate time to conduct this review, we must receive your information no later than April 3, 2012. However, we will continue to accept new information about any listed species at any time. ADDRESSES: You may submit comments on this document, identified by NOAA– NMFS–2012–0014, by any of the following methods: • Electronic Submissions: Submit all electronic public comments via the Federal e-Rulemaking Portal www.regulations.gov. To submit comments via the e-Rulemaking Portal, first click the ‘‘submit a comment’’ icon, then enter NOAA–NMFS–2012–0014 in the keyword search. Locate the document you wish to comment on from the resulting list and click on the ‘‘Submit a Comment’’ icon on the right of that line. • Mail or hand-delivery: Angela Somma, National Marine Fisheries Service, Office of Protected Resources, Endangered Species Division, 1325 East West Highway, Silver Spring, MD 20910. Instructions: Comments must be submitted by one of the above methods to ensure that the comments are received, documented, and considered by NMFS. 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. 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.) submitted voluntarily by the sender will be publicly accessible. Do not submit confidential business information, or otherwise sensitive or protected information. NMFS will accept anonymous comments (enter ‘‘N/A’’ in the required fields if you wish to remain anonymous). Attachments to electronic comments will be accepted in Microsoft Word or Excel, WordPerfect, or Adobe PDF file formats only. FOR FURTHER INFORMATION CONTACT: Shannon Bettridge, Office of Protected Resources, (301) 427–8437; or Larissa Plants, Office of Protected Resources, (301) 427–8471. PO 00000 Frm 00012 Fmt 4703 Sfmt 9990 5491 Section 4(c)(2)(A) of the ESA requires that we conduct a review of listed species at least once every five years. The regulations in 50 CFR 424.21 require that we publish a notice in the Federal Register announcing those species currently under active review. This notice announces our active review of the sei whale currently listed as endangered. SUPPLEMENTARY INFORMATION: Public Solicitation of New Information To ensure that the 5-year review is complete and based on the best available scientific and commercial information, we are soliciting new information from the public, governmental agencies, Tribes, the scientific community, industry, environmental entities, and any other interested parties concerning the status of sei whales. The 5-year review considers the best scientific and commercial data and all new information that has become available since the listing determination or most recent status review. Categories of requested information include: (1) Species biology including, but not limited to, population trends, distribution, abundance, demographics, and genetics; (2) habitat conditions including, but not limited to, amount, distribution, and suitability; (3) conservation measures that have been implemented that benefit the species; (4) status and trends of threats; and (5) other new information, data, or corrections including, but not limited to, taxonomic or nomenclatural changes, identification of erroneous information contained in the List, and improved analytical methods. Any new information will be considered during the 5-year review and will also be useful in evaluating the ongoing recovery program for sei whales. For example, information on conservation measures will assist in tracking implementation of recovery actions. Authority: 16 U.S.C. 1531 et seq. Dated: January 30, 2012. Angela Somma, Chief, Endangered Species Division, Office of Protected Resources, National Marine Fisheries Service. [FR Doc. 2012–2510 Filed 2–2–12; 8:45 am] BILLING CODE 3510–22–P E:\FR\FM\03FEN1.SGM 03FEN1

Agencies

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


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

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.

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

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 https://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 Margaret.Kline@nist.gov.

FOR FURTHER INFORMATION CONTACT: Margaret Kline via email at 
Margaret.Kline@nist.gov 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]
BILLING CODE 3510-13-P
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