Genome in a Bottle Consortium-Progress and Planning Workshop, 45194-45195 [2015-18470]
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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 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 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: https://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
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Fmt 4703
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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
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 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: https://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