Genome in a Bottle Consortium-Progress and Planning Workshop, 57564-57565 [2016-20120]

Download as PDF 57564 Federal Register / Vol. 81, No. 163 / Tuesday, August 23, 2016 / Notices NIST, 100 Bureau Drive, MS 1060, Gaithersburg, Maryland 20899, via fax at 301–216–0529 or electronically by email to stephanie.shaw@nist.gov. All visitors to the NIST site are required to pre-register to be admitted. Please submit your name, time of arrival, email address and phone number to Serena Martinez by 5:00 p.m. Eastern Time, Tuesday, October 11, 2016. Non-U.S. citizens must submit additional information; please contact Mrs. Martinez. Mrs. Martinez’s email address is serena.martinez@nist.gov and her phone number is 301–975–2661. For participants attending in person, please note that federal agencies, including NIST, can only accept a state-issued driver’s license or identification card for access to federal facilities if such license or identification card is issued by a state that is compliant with the REAL ID Act of 2005 (Pub. L. 109–13), or by a state that has an extension for REAL ID compliance. NIST currently accepts other forms of federal-issued identification in lieu of a state-issued driver’s license. For detailed information please contact Mrs. Martinez at 301–975–2661 or visit: https://nist.gov/public_affairs/visitor/. Kent Rochford, Associate Director for Laboratory Programs. [FR Doc. 2016–20121 Filed 8–22–16; 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 (GIAB) Consortium meeting to be held on Thursday and Friday, September 15 and 16, 2016. 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 sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:56 Aug 22, 2016 Jkt 238001 from interested stakeholders, and invite members to participate in work plan implementation. September 15 will be a new sample thinkshop to discuss new GIAB genomes in parallel with a data jamboree to develop high-confidence calls for difficult variants and difficult regions. September 16 will be the plenary session to present GIAB progress updates and emerging technical work. DATES: The Genome in a Bottle Consortium meeting will be held on Thursday, September 15, 2016 from 9:00 a.m. to 5:30 p.m. Eastern Time and Friday, September 16, 2016 from 8:30 a.m. to 2:00 p.m. Eastern Time. Attendees must register by 5:00 p.m. Eastern Time on Thursday, September 8, 2016. ADDRESSES: The meeting will be held in Lecture Room A, Lecture Room B, and 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:// appam.certain.com/profile/form/ index.cfm?PKformID=0x311041593. SUPPLEMENTARY INFORMATION: Clinical application of ultra-high throughput sequencing 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 institutions, 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. PO 00000 Frm 00006 Fmt 4703 Sfmt 4703 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 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 8398 was released in May 2015 and is available at https:// 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 2016 and at NIST in August 2015, participants in the consortium have discussed progress in 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/201318934, https://federalregister.gov/a/ 2014-18841, https://federalregister.gov/ a/2015-01158, and https:// www.federalregister.gov/articles/2016/ 01/05/2015-33140/genome-in-a-bottleconsortium-progress-and-planningworkshop for announcements of past workshops at NIST and Stanford). The January 2016 meeting was announced in the Federal Register (81 FR 226) on E:\FR\FM\23AUN1.SGM 23AUN1 Federal Register / Vol. 81, No. 163 / Tuesday, August 23, 2016 / Notices January 5, 2016, and the meeting is summarized at https://docs.google.com/ document/d/1VdP96SYCPcZZvX prowMq8rp6FURCxSh1uo4Dd1tTpJY/ edit?usp=drive_web. There is no cost for participating in the consortium. No proprietary information will be shared as part of the consortium, and all research results will be in the public domain. All attendees are required to preregister. Anyone wishing to attend this meeting must pre-register at https:// appam.certain.com/profile/form/ index.cfm?PKformID=0x311041593 by 5:00 p.m. Eastern Time on Thursday, September 8, 2016, in order to attend. Kent Rochford, Associate Director for Laboratory Programs. [FR Doc. 2016–20120 Filed 8–22–16; 8:45 am] BILLING CODE 3510–13–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; South Pacific Tuna Act National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice. AGENCY: The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. DATES: Written comments must be submitted on or before October 24, 2016. SUMMARY: Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at JJessup@doc.gov). FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the information collection instrument and instructions should be directed to Tom Graham, (808) 725– 5032 or tom.graham@noaa.gov. SUPPLEMENTARY INFORMATION: sradovich on DSK3GMQ082PROD with NOTICES ADDRESSES: I. Abstract The National Oceanic and Atmospheric Administration (NOAA) collects vessel license, vessel VerDate Sep<11>2014 18:56 Aug 22, 2016 Jkt 238001 registration, catch, and unloading information from operators of United States (U.S.) purse seine vessels fishing within a large region of the western and central Pacific Ocean, which is governed by the Treaty on Fisheries between the Governments of Certain Pacific Island States and the Government of the United States of America. The Treaty, along with its annexes, schedules and implementing agreements, was signed in Port Moresby, Papua New Guinea, in 1987. This collection of information is required to meet U.S. obligations under the Treaty. The Treaty authorizes U.S. tuna vessels to fish within fishing zones of a large region of the Pacific Ocean. The South Pacific Tuna Act of 1988 (16 U.S.C. 973–973r) and U.S. implementing regulations (50 CFR part 300, subpart D) authorize the collection of information from participants in the Treaty fishery. Vessel operators who wish to participate in the Treaty Fishery must submit annual vessel license and registration (including registration of vessel monitoring system (VMS) units) applications and periodic written reports of catch and unloading of fish from licensed vessels. They are also required to ensure the continued operation of VMS units on board licensed vessels, which is expected to require periodic maintenance of the units. The information collected is submitted to the Pacific Islands Forum Fisheries Agency (FFA) through the U.S. government, NOAA’s National Marine Fisheries Service (NMFS). The license and registration application information is used by the FFA to determine the operational capability and financial responsibility of a vessel operator interested in participating in the Treaty fishery. Information obtained from vessel catch and unloading reports is used by the FFA to assess fishing effort and fishery resources in the region and to track the amount of fish caught within each Pacific island state’s exclusive economic zone for fair disbursement of Treaty monies. Maintenance of VMS units is needed to ensure the continuous operation of the VMS units, which, as part of the VMS administered by the FFA, are used as an enforcement tool. If the information is not collected, the U.S. government will not meet its obligations under the Treaty, and the lack of fishing information will result in poor management of the fishery resources. All information should be submitted in hard copy via mail. PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 III. Data OMB Control Number: 0648–0218. Form Number(s): None. Type of Review: Regular submission (extension of a currently approved collection). Affected Public: Business or other forprofit organizations. Estimated Number of Respondents: 41. Estimated Time per Response: License application, 15 minutes; VMS registration application, 45 minutes; catch report, 1 hour; and unloading logsheet, 30 minutes. Estimated Total Annual Burden Hours: 402. Estimated Total Annual Cost to Public: $143,121 in recordkeeping/ reporting costs. IV. Request for Comments Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record. Dated: August 18, 2016. Sarah Brabson, NOAA PRA Clearance Officer. [FR Doc. 2016–20080 Filed 8–22–16; 8:45 am] BILLING CODE 3510–22–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648–XE794 Atlantic Highly Migratory Species; Advisory Panel for Atlantic Highly Migratory Species Southeast Data, Assessment, and Review Workshops National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. AGENCY: II. Method of Collection 57565 E:\FR\FM\23AUN1.SGM 23AUN1

Agencies

[Federal Register Volume 81, Number 163 (Tuesday, August 23, 2016)]
[Notices]
[Pages 57564-57565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20120]


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

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 (GIAB) Consortium 
meeting to be held on Thursday and Friday, September 15 and 16, 2016. 
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. September 15 
will be a new sample thinkshop to discuss new GIAB genomes in parallel 
with a data jamboree to develop high-confidence calls for difficult 
variants and difficult regions. September 16 will be the plenary 
session to present GIAB progress updates and emerging technical work.

DATES: The Genome in a Bottle Consortium meeting will be held on 
Thursday, September 15, 2016 from 9:00 a.m. to 5:30 p.m. Eastern Time 
and Friday, September 16, 2016 from 8:30 a.m. to 2:00 p.m. Eastern 
Time. Attendees must register by 5:00 p.m. Eastern Time on Thursday, 
September 8, 2016.

ADDRESSES: The meeting will be held in Lecture Room A, Lecture Room B, 
and 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://appam.certain.com/profile/form/index.cfm?PKformID=0x311041593.

SUPPLEMENTARY INFORMATION: Clinical application of ultra-high 
throughput sequencing 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 
institutions, 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 8398 was released in May 2015 and is available at 
https://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 2016 and 
at NIST in August 2015, participants in the consortium have discussed 
progress in 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, https://federalregister.gov/a/2015-01158, and https://www.federalregister.gov/articles/2016/01/05/2015-33140/genome-in-a-bottle-consortium-progress-and-planning-workshop for announcements of 
past workshops at NIST and Stanford). The January 2016 meeting was 
announced in the Federal Register (81 FR 226) on

[[Page 57565]]

January 5, 2016, and the meeting is summarized at https://docs.google.com/document/d/1VdP96SYCPcZZvXprowMq8rp6FURCxSh1uo4Dd1tTpJY/edit?usp=drive_web.
    There is no cost for participating in the consortium. No 
proprietary information will be shared as part of the consortium, and 
all research results will be in the public domain.
    All attendees are required to pre-register. Anyone wishing to 
attend this meeting must pre-register at https://appam.certain.com/profile/form/index.cfm?PKformID=0x311041593 by 5:00 p.m. Eastern Time 
on Thursday, September 8, 2016, in order to attend.

Kent Rochford,
Associate Director for Laboratory Programs.
[FR Doc. 2016-20120 Filed 8-22-16; 8:45 am]
BILLING CODE 3510-13-P
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