Genome in a Bottle Consortium-Progress and Planning Workshop, 45194-45195 [2015-18470]

Download as PDF 45194 Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Notices proprietary data to be examined and discussed at the meeting. The Chief Financial Officer and Assistant Secretary for Administration, with the concurrence of the Acting, Assistant General Counsel for Administration, formally determined on May, 19 2015, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended by Section 5(c) of the Government in Sunshine Act, Public Law 94–409, that the meeting of the Judges Panel may be closed to the public in accordance with 5 U.S.C. 552b(c)(4) because the meeting is likely to disclose trade secrets and commercial or financial information obtained from a person which is privileged or confidential and 5 U.S.C. 552b(c)(9)(B) because for a government agency the meeting is likely to disclose information that could significantly frustrate implementation of a proposed agency action. The meeting, which involves examination of current Award applicant data from U.S. organizations and a discussion of these data as compared to the Award criteria in order to recommend Award recipients, will be closed to the public. Richard R. Cavanagh, Acting Associate Director for Laboratory Programs. [FR Doc. 2015–18469 Filed 7–28–15; 8:45 am] BILLING CODE 3510–13–P DEPARTMENT OF COMMERCE National Institute of Standards and Technology Genome in a Bottle Consortium— Progress and Planning Workshop National Institute of Standards & Technology (NIST), Commerce. ACTION: Notice of public workshop. AGENCY: NIST announces the Genome in a Bottle Consortium meeting to be held on Thursday and Friday, August 27 and 28, 2015. The Genome in a Bottle Consortium is developing the reference materials, reference methods, and reference data needed to assess confidence in human whole genome variant calls. A principal motivation for this consortium is to enable performance assessment of sequencing and science-based regulatory oversight of clinical sequencing. The purpose of this meeting is to update participants about progress of the consortium work, continue to get broad input from individual stakeholders to update or refine the consortium work plan, continue to broadly solicit consortium membership from interested tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:33 Jul 28, 2015 Jkt 235001 stakeholders, and invite members to participate in work plan implementation. Topics of discussion at this meeting will include progress and planning of the Analysis Group, which is analyzing and integrating the large variety of sequencing data for four candidate NIST Reference Materials, as well as potential future Reference Materials. The Genome in a Bottle Consortium meeting will be held on Thursday, August 27, 2015 from 9:00 a.m. to 5:30 p.m. Eastern Time and Friday, August 28, 2015 from 9:00 a.m. to 12:45 p.m. Eastern Time. Attendees must register by 5:00 p.m. Eastern Time on Thursday, August 20, 2015. ADDRESSES: The meeting will be held in the Green Auditorium, Building 101, National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899. Please note admittance instructions under the SUPPLEMENTARY INFORMATION section of this notice. FOR FURTHER INFORMATION CONTACT: For further information contact Justin Zook by email at jzook@nist.gov or by phone at (301) 975–4133 or Marc Salit by email at salit@nist.gov or by phone at (650) 350–2338. To register, go to: https:// www-s.nist.gov/CRS/conf_disclosure. cfm?&conf_id=8473. SUPPLEMENTARY INFORMATION: Clinical application of ultra high throughput sequencing (UHTS) for hereditary genetic diseases and oncology is rapidly growing. At present, there are no widely accepted genomic standards or quantitative performance metrics for confidence in variant calling. These standards and quantitative performance metrics are needed to achieve the confidence in measurement results expected for sound, reproducible research and regulated applications in the clinic. On April 13, 2012, NIST convened the workshop ‘‘Genome in a Bottle’’ to initiate a consortium to develop the reference materials, reference methods, and reference data needed to assess confidence in human whole genome variant calls (www.genomeinabottle.org). On August 16–17, 2012, NIST hosted the first large public meeting of the Genome in a Bottle Consortium, with about 100 participants from government, academic, and industry. This meeting was announced in the Federal Register (77 FR 43237) on July 24, 2012. A principal motivation for this consortium is to enable science-based regulatory oversight of clinical sequencing. At the August 2012 meeting, the consortium established work plans for DATES: PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 four technical working groups with the following responsibilities: (1) Reference Material (RM) Selection and Design: Select appropriate sources for whole genome RMs and identify or design synthetic DNA constructs that could be spiked-in to samples for measurement assurance. (2) Measurements for Reference Material Characterization: Design and carry out experiments to characterize the RMs using multiple sequencing methods, other methods, and validation of selected variants using orthogonal technologies. (3) Bioinformatics, Data Integration, and Data Representation: Develop methods to analyze and integrate the data for each RM, as well as select appropriate formats to represent the data. (4) Performance Metrics and Figures of Merit: Develop useful performance metrics and figures of merit that can be obtained through measurement of the RMs. The products of these technical working groups will be a set of wellcharacterized whole genome and synthetic DNA RMs along with the methods (documentary standards) and reference data necessary for use of the RMs. These products will be designed to help enable translation of whole genome sequencing to regulated clinical applications. The pilot NIST whole genome RM was released in May 2015 and is available at http://tinyurl.com/ giabpilot. The consortium is currently analyzing and integrating data from two trios that are candidate NIST RMs. The consortium meets in workshops two times per year, in January at Stanford University in Palo Alto, CA, and in August at the National Institute of Standards and Technology in Gaithersburg, MD. At these workshops, including the last meetings at Stanford in January 2015 and at NIST in August 2014, participants in the consortium have discussed progress developing well-characterized genomes for NIST Reference Materials and planned future experiments and analysis of these genomes (see https://federalregister.gov/ a/2012-18064, https://federalregister. gov/a/2013-18934, https://federal register.gov/a/2014-18841 and https:// federalregister.gov/a/2015-01158 for past workshops at NIST and Stanford). The January 2015 meeting was announced in the Federal Register (80 FR 3220) on January 22, 2015, and the meeting is summarized at https://docs. google.com/document/d/19J6YDg1MH1i D-8Q8mmV9L7wHOfuyUC3aogctZ2 Nh87U/edit?usp=sharing. There is no cost for participating in the consortium. No proprietary E:\FR\FM\29JYN1.SGM 29JYN1 Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Notices information will be shared as part of the consortium, and all research results will be in the public domain. All visitors to the NIST site are required to pre-register to be admitted. Anyone wishing to attend this meeting must pre-register at https://www-s.nist. gov/CRS/conf_disclosure.cfm?&conf_ id=8473 by 5:00 p.m. Eastern Time on Thursday, August 20, 2015, in order to attend. Also, please note that under the REAL ID Act of 2005 (Pub. L. 109–13), federal agencies, including NIST, can only accept a state-issued driver’s license or identification card for access to federal facilities if issued by states that are REAL ID compliant or have an extension. NIST also currently accepts other forms of federal-issued identification in lieu of a state-issued driver’s license. For detailed information please contact Justin Zook at jzook@nist.gov or 301–975–4133, or visit: http://www.nist.gov/public_ affairs/visitor/. Richard R. Cavanagh, Acting Associate Director for Laboratory Programs. [FR Doc. 2015–18470 Filed 7–28–15; 8:45 am] BILLING CODE 3510–13–P DEPARTMENT OF COMMERCE Availability National Oceanic and Atmospheric Administration RIN 0648–XE070 Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Geophysical Surveys in the Atlantic Ocean National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice; receipt of applications for incidental harassment authorization (IHA); request for comments and information. AGENCY: NMFS has received multiple requests for authorization under the Marine Mammal Protection Act (MMPA) to take marine mammals incidental to conducting geophysical survey activity in the Atlantic Ocean. NMFS is announcing receipt of these requests and invites information, suggestions, and comments on the applications. DATES: Comments and information must be received no later than August 28, 2015. ADDRESSES: Comments on the applications should be addressed to Jolie Harrison, Chief, Permits and tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:13 Jul 28, 2015 Jkt 235001 Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Physical comments should be sent to 1315 East-West Highway, Silver Spring, MD 20910 and electronic comments should be sent to ITP.Laws@noaa.gov. Instructions: NMFS is not responsible for comments sent by any other method, to any other address or individual, or received after the end of the comment period. Comments received electronically, including all attachments, must not exceed a 25megabyte file size. Attachments to electronic comments will be accepted in Microsoft Word or Excel or Adobe PDF file formats only. All comments received are a part of the public record and will generally be posted to the Internet at www.nmfs.noaa.gov/pr/ permits/incidental/oilgas.htm without change. All personal identifying information (e.g., name, address) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information. FOR FURTHER INFORMATION CONTACT: Ben Laws, Office of Protected Resources, NMFS, (301) 427–8401. SUPPLEMENTARY INFORMATION: Electronic copies of the applications may be obtained by visiting the Internet at: www.nmfs.noaa.gov/pr/permits/ incidental/oilgas.htm. In 2014, the Bureau of Ocean Energy Management produced a Programmatic Environmental Impact Statement (PEIS) to evaluate potential significant environmental effects of geological and geophysical (G&G) activities on the Midand South Atlantic Outer Continental Shelf (OCS), pursuant to requirements of the National Environmental Policy Act. These activities include geophysical surveys in support of oil and gas exploration and development, as are proposed in the MMPA applications before NMFS. The PEIS is available at: www.boem.gov/Atlantic-GG-PEIS/. Background Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce to allow, upon request by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified area, the incidental, but not intentional, taking of small numbers of marine mammals, providing that certain findings are made and the necessary prescriptions are established. PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 45195 The incidental taking of small numbers of marine mammals may be allowed only if NMFS (through authority delegated by the Secretary) finds that the total taking by the specified activity during the specified time period will (i) have a negligible impact on the species or stock(s) and (ii) not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant). Further, the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such taking must be set forth, either in specific regulations or in an authorization. The allowance of such incidental taking under section 101(a)(5)(A), by harassment (which is defined to include behavioral harassment and injury), serious injury, death, or a combination thereof, requires that regulations be promulgated for the specific activity. Subsequently, a Letter of Authorization may be issued pursuant to the prescriptions established in such regulations, providing that the level of taking will be consistent with the findings made for the total taking allowable under the specific regulations. Under section 101(a)(5)(D), NMFS may authorize such incidental taking by harassment only, for periods of not more than one year, pursuant to requirements and conditions contained within an IHA. The proposed incidental take authorization and establishment of prescriptions through either specific regulations or an IHA requires notice and opportunity for public comment. NMFS has defined ‘‘negligible impact’’ in 50 CFR 216.103 as ‘‘. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.’’ Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines ‘‘harassment’’ as: ‘‘. . . any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].’’ The use of sound sources such as those described in the applications (e.g., airgun arrays) may result in the disturbance of marine mammals through disruption of behavioral patterns or may cause auditory injury of marine E:\FR\FM\29JYN1.SGM 29JYN1

Agencies

[Federal Register Volume 80, Number 145 (Wednesday, July 29, 2015)]
[Notices]
[Pages 45194-45195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18470]


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

DEPARTMENT OF COMMERCE

National Institute of Standards and Technology


Genome in a Bottle Consortium--Progress and Planning Workshop

AGENCY: National Institute of Standards & Technology (NIST), Commerce.

ACTION: Notice of public workshop.

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

SUMMARY: NIST announces the Genome in a Bottle Consortium meeting to be 
held on Thursday and Friday, August 27 and 28, 2015. The Genome in a 
Bottle Consortium is developing the reference materials, reference 
methods, and reference data needed to assess confidence in human whole 
genome variant calls. A principal motivation for this consortium is to 
enable performance assessment of sequencing and science-based 
regulatory oversight of clinical sequencing. The purpose of this 
meeting is to update participants about progress of the consortium 
work, continue to get broad input from individual stakeholders to 
update or refine the consortium work plan, continue to broadly solicit 
consortium membership from interested stakeholders, and invite members 
to participate in work plan implementation. Topics of discussion at 
this meeting will include progress and planning of the Analysis Group, 
which is analyzing and integrating the large variety of sequencing data 
for four candidate NIST Reference Materials, as well as potential 
future Reference Materials.

DATES: The Genome in a Bottle Consortium meeting will be held on 
Thursday, August 27, 2015 from 9:00 a.m. to 5:30 p.m. Eastern Time and 
Friday, August 28, 2015 from 9:00 a.m. to 12:45 p.m. Eastern Time. 
Attendees must register by 5:00 p.m. Eastern Time on Thursday, August 
20, 2015.

ADDRESSES: The meeting will be held in the Green Auditorium, Building 
101, National Institute of Standards and Technology, 100 Bureau Drive, 
Gaithersburg, MD 20899. Please note admittance instructions under the 
SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For further information contact Justin 
Zook by email at jzook@nist.gov or by phone at (301) 975-4133 or Marc 
Salit by email at salit@nist.gov or by phone at (650) 350-2338. To 
register, go to: https://www-s.nist.gov/CRS/conf_disclosure.cfm?&conf_id=8473.

SUPPLEMENTARY INFORMATION: Clinical application of ultra high 
throughput sequencing (UHTS) for hereditary genetic diseases and 
oncology is rapidly growing. At present, there are no widely accepted 
genomic standards or quantitative performance metrics for confidence in 
variant calling. These standards and quantitative performance metrics 
are needed to achieve the confidence in measurement results expected 
for sound, reproducible research and regulated applications in the 
clinic. On April 13, 2012, NIST convened the workshop ``Genome in a 
Bottle'' to initiate a consortium to develop the reference materials, 
reference methods, and reference data needed to assess confidence in 
human whole genome variant calls (www.genomeinabottle.org). On August 
16-17, 2012, NIST hosted the first large public meeting of the Genome 
in a Bottle Consortium, with about 100 participants from government, 
academic, and industry. This meeting was announced in the Federal 
Register (77 FR 43237) on July 24, 2012. A principal motivation for 
this consortium is to enable science-based regulatory oversight of 
clinical sequencing.
    At the August 2012 meeting, the consortium established work plans 
for four technical working groups with the following responsibilities:
    (1) Reference Material (RM) Selection and Design: Select 
appropriate sources for whole genome RMs and identify or design 
synthetic DNA constructs that could be spiked-in to samples for 
measurement assurance.
    (2) Measurements for Reference Material Characterization: Design 
and carry out experiments to characterize the RMs using multiple 
sequencing methods, other methods, and validation of selected variants 
using orthogonal technologies.
    (3) Bioinformatics, Data Integration, and Data Representation: 
Develop methods to analyze and integrate the data for each RM, as well 
as select appropriate formats to represent the data.
    (4) Performance Metrics and Figures of Merit: Develop useful 
performance metrics and figures of merit that can be obtained through 
measurement of the RMs.
    The products of these technical working groups will be a set of 
well-characterized whole genome and synthetic DNA RMs along with the 
methods (documentary standards) and reference data necessary for use of 
the RMs. These products will be designed to help enable translation of 
whole genome sequencing to regulated clinical applications. The pilot 
NIST whole genome RM was released in May 2015 and is available at 
http://tinyurl.com/giabpilot. The consortium is currently analyzing and 
integrating data from two trios that are candidate NIST RMs. The 
consortium meets in workshops two times per year, in January at 
Stanford University in Palo Alto, CA, and in August at the National 
Institute of Standards and Technology in Gaithersburg, MD. At these 
workshops, including the last meetings at Stanford in January 2015 and 
at NIST in August 2014, participants in the consortium have discussed 
progress developing well-characterized genomes for NIST Reference 
Materials and planned future experiments and analysis of these genomes 
(see https://federalregister.gov/a/2012-18064, https://federalregister.gov/a/2013-18934, https://federalregister.gov/a/2014-18841 and https://federalregister.gov/a/2015-01158 for past workshops 
at NIST and Stanford). The January 2015 meeting was announced in the 
Federal Register (80 FR 3220) on January 22, 2015, and the meeting is 
summarized at https://docs.google.com/document/d/19J6YDg1MH1iD-8Q8mmV9L7wHOfuyUC3aogctZ2Nh87U/edit?usp=sharing.
    There is no cost for participating in the consortium. No 
proprietary

[[Page 45195]]

information will be shared as part of the consortium, and all research 
results will be in the public domain.
    All visitors to the NIST site are required to pre-register to be 
admitted. Anyone wishing to attend this meeting must pre-register at 
https://www-s.nist.gov/CRS/conf_disclosure.cfm?&conf_id=8473 by 5:00 
p.m. Eastern Time on Thursday, August 20, 2015, in order to attend. 
Also, please note that under the REAL ID Act of 2005 (Pub. L. 109-13), 
federal agencies, including NIST, can only accept a state-issued 
driver's license or identification card for access to federal 
facilities if issued by states that are REAL ID compliant or have an 
extension. NIST also currently accepts other forms of federal-issued 
identification in lieu of a state-issued driver's license. For detailed 
information please contact Justin Zook at jzook@nist.gov or 301-975-
4133, or visit: http://www.nist.gov/public_affairs/visitor/.

Richard R. Cavanagh,
Acting Associate Director for Laboratory Programs.
[FR Doc. 2015-18470 Filed 7-28-15; 8:45 am]
BILLING CODE 3510-13-P