Announcement of Requirements and Registration for “Follow that Cell” Challenge, 46847-46851 [2014-18870]
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Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices
Committee must notify the Contact Person
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93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS).
Dated: August 1, 2014.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–18857 Filed 8–8–14; 8:45 am]
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Dated: August 4, 2014.
David Clary,
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Committee Policy.
[FR Doc. 2014–18849 Filed 8–8–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Announcement of Requirements and
Registration for ‘‘Follow that Cell’’
Challenge
Authority: 15 U.S.C. 3719.
Through the ‘‘Follow that
Cell’’ Challenge (the ‘‘Challenge’’), the
Single Cell Analysis Program (SCAP)—
https://commonfund.nih.gov/Singlecell/
index, a component of the National
Institutes of Health Common Fund—
https://commonfund.nih.gov/about, is
searching for novel methods for
analyzing dynamic states of individual
cells that can serve as the basis for
predicting alterations in cell behavior
and function over time. The goal of the
Challenge is to develop new tools and
methods that allow time-dependent
measurements at the single-cell level in
a complex tissue environment in order
to assess functional changes, provide
information on the health status of a
given cell, and help guide diagnosis and
therapeutic treatments related to human
disease states. Technological
breakthroughs in this arena could allow
researchers and physicians to identify
rare cells in a mixed population, such
as individual cells that can transform
and become cancerous, cells that are
latently infected with a pathogenic
virus, or cells that develop resistance to
drugs over time.
The NIH Common Fund currently
supports SCAP grants, the majority of
which are associated with academic
institutions. This Challenge, structured
in two phases, will strengthen and
complement the existing SCAP grant
portfolio by reaching out to a more
diverse population of innovators and
solvers, including not only those who
are from academic institutions but also
those who are from research and
development communities in the
private sector and those who are outside
biomedical disciplines. The NIH
believes this Challenge will stimulate
investment from both public and private
sectors in single-cell analysis research
and product development, which, in
SUMMARY:
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turn, could lead to the development of
more sensitive, robust, and costeffective assay approaches, reagents,
tools, and devices for basic research and
clinical diagnosis.
DATES:
Phase 1: Effective on August 15, 2014
Phase 1 Submission period ends:
December 15, 2014, 11:59 p.m. ET
Phase 1 Judging Period: December 16,
2014, to February 16, 2015
Phase 1 Winners and other Finalists
Announced: March 16, 2015
Phase 2 begins: March 17, 2015
Phase 2 Submission period ends: March
30, 2017, 11:59 p.m. ET
Phase 2 Judging Period: March 31, 2017,
to June 30, 2017
Phase 2 Winners announced: July 31,
2017
The NIH may shorten the submission
period for Phase 2 and adjust dates for
judging and winner(s) announcement if
the Phase 1 winners’ feasibility
assessments suggest a shorter Phase 2
submission period is possible. The NIH
will announce any changes to the
timeline by amending this Federal
Register notice no later than March 16,
2015. This Challenge will be
administered by InnoCentive, Inc., on
behalf of the NIH
www.innocentive.com/followthatcell.
FOR FURTHER INFORMATION CONTACT:
Yong Yao, Ph.D., NIH, 301–443–6102; or
Erin Shannon, NIH, 301–443–3959.
SUPPLEMENTARY INFORMATION:
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Subject of Challenge
Many biological experiments are
performed under the assumption that all
cells of a particular ‘‘type’’ are identical.
However, recent data suggest that
individual cells within a single
population may differ quite
significantly, and these differences can
drive the health and function of the
entire cell population. Single-cell
analysis comprises a broad field that
covers advanced optical,
electrochemical, mass spectrometry
instrumentation, and sensor technology,
as well as separation and sequencing
techniques. Although the approaches
currently in use can offer snapshots of
single cells, the methods are often not
amenable to longitudinal studies that
monitor changes in individual cells in
situ.
In this Challenge, the NIH is seeking
novel robust methods for analysis of
individual cells that can detect and
assess changes in cell behavior and
function over time, either as a result of
natural state changes or when perturbed
(e.g., by a drug, biological stimulus,
infectious agent, pathological lesion, or
mechanical forces). It is hoped that such
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methods will yield creative and new,
yet feasible, solutions for following a
single cell over time in a complex
multicellular environment to detect
changing cell properties, preferably
using multiple integrated measures.
Solutions submitted to this Challenge
should:
• Include measurements or assays
that are nondestructive and capable of
producing temporal data at the
individual cell level starting with
eukaryotic cells in a complex/mixed cell
population;
• address at least one impactful,
biological, or clinical question proposed
by the Solver;
• demonstrate robust reproducibility;
• address gaps or deficiencies in
current capabilities that may include
but are not limited to:
Æ Tools that provide significant
advances in sensitivity and selectivity
in the spatiotemporal resolution of
molecules/structures/activities within
single cells in situ (e.g., high resolution
imaging of molecular interactions
within single cells, molecular probes
that are at least an order of magnitude
smaller in size than existing versions of
reporter molecules such as fluorescent
proteins);
Æ Automated and scalable assays to
detect meaningful functional changes in
single cells in complex tissue
environments that improve upon
processing time and reduce overall cost;
or
Æ New combinations of tools and
approaches to maximize data generation
over several parameters (e.g., proteins,
lipids, metabolites, signal secretion/
reception/transduction, migratory
changes);
• advance what is currently
considered the state-of-the-art.
Solutions describing existing, wellestablished and/or currently supported
approaches, especially commonly used
strategies are not of interest unless a
compelling case is made that significant,
quantifiable advances are proposed and/
or the methods and measures are used
in unique combinations that have not
been previously tested together for the
analysis of individual cells in complex
environments.
We welcome solutions from
individuals, teams, and entities from all
U.S. sources, including the public
sector, private sector, and nonprofit
groups.
Eligibility Rules for the Challenge
1. To Participate
This Challenge is open to any
‘‘Solver’’ where ‘‘Solver’’ is defined as
an individual, a group of individuals
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(i.e., a team), or an entity. Whether
singly or as part of a group or entity,
each individual participating in the
Challenge must be 18 years of age or
older.
Eligibility to participate in Phase 2 of
the Challenge is conditioned upon
participation in Phase 1 of the Challenge
and being selected as a ‘‘Phase 1
Finalist.’’ Phase 1 Finalists are any and
all Phase 1 prize winners and any
individual, team, and/or entity whose
solution received a meritorious rating
based on the judging criteria.
2. To Win
To be eligible to win a prize under
this Challenge, the Solver—
1. Shall have registered to participate
in the Challenge under the process
identified at the InnoCentive Web site
www.innocentive.com/followthatcell.
2. Shall have complied with all the
requirements under this section on
Eligibility.
3. In the case of a private entity, shall
be incorporated in and maintain a
primary place of business in the United
States; and in the case of an individual,
whether participating singly or in a
group, shall be a citizen or permanent
resident of the United States. Note: NonU.S. citizens and nonpermanent
residents can participate as a member of
a team that otherwise satisfies the
eligibility criteria but will not be eligible
to win a monetary prize (in whole or in
part); however, their participation as
part of a winning team, if applicable,
may be recognized when results are
announced.
4. In the case of an individual, he/she
may not be an employee of the NIH; an
individual involved in formulation of
the Challenge and/or serving on the
technical evaluation panel; any other
individual involved with the design,
production, execution, distribution, or
evaluation of this Challenge; or
members of the individual’s immediate
family (specifically, a parent, stepparent, spouse, domestic partner, child,
sibling, or step-sibling).
5. An individual, team, or entity that
is currently on the Excluded Parties List
(https://www.epls.gov/) will not be
selected as a Finalist or prize winner.
6. In the case of an entity, may not be
a federal entity; and in the case of an
individual, may not be a federal
employee acting within the scope of his
or her employment.
7. Federal employees otherwise
permitted to participate in the Challenge
shall not work on their submission
during assigned duty hours. Note:
Federal ethical conduct rules may
restrict or prohibit federal employees
from engaging in certain outside
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activities, so any federal employee not
excluded under the prior paragraph
seeking to participate in this Challenge
outside the scope of employment should
consult his/her agency’s ethics official
prior to developing a submission.
8. Federal grantees may not use
federal funds to develop Challenge
submissions.
9. Federal contractors may not use
federal funds from a contract to develop
Challenge submissions or to fund efforts
in support of a Challenge submission.
10. An individual shall not be deemed
ineligible to win because the individual
used federal facilities or consulted with
federal employees during the Challenge
provided that such facilities and/or
employees, as applicable, are made
available on an equitable basis to all
individuals and teams participating in
the Challenge.
All questions regarding the Challenge
should be directed to Dr. Yao or Ms.
Shannon, identified above, and answers
will be posted and updated as necessary
at www.innocentive.com/followthatcell
under Frequently Asked Questions.
Questions from Solvers that may reveal
proprietary information related to
solutions under development may be
addressed in the InnoCentive project
room, an online secure and confidential
communication forum.
Submission Requirements
The Challenge has two phases.
Phase 1 (Theoretical)—Phase 1 of the
Challenge requires a written proposed
solution which describes a novel
method for analyzing dynamic states of
individual cells that can serve as the
basis for predicting alterations in cell
behavior and function over time.
The Phase 1 Submission shall
include:
1. A comprehensive description of the
proposed solution in 10 pages or less,
8.5 x 11 inch page, 10-point font or
greater and one inch margins including:
a. A one-paragraph executive
summary that clearly states the
biological or clinical question to be
solved;
b. Background information supporting
the significance of the biological or
clinical question(s) and the proposed
approach, pitfalls, and validation
scheme that addresses efforts to support
reproducibility; if possible, citing
selected peer-reviewed articles that
strengthen the proposed solution. The
full citations for articles should be
included in the references section;
c. Descriptions of methods and
technologies key to implementation;
and
d. A ‘‘State-of-the-Art’’ Statement that
describes approaches currently in use (if
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any) and clearly explains how the
methods and measures proposed
advance existing capabilities.
2. A biographical sketch, in no more
than four pages, of your experience and
relevant expertise required to validate
the proposed solution, including
publications, if applicable. Team
submissions should include a biosketch
for each team member.
3. A feasibility assessment and a
statement describing your ability to
execute the proposed solution in Phase
2 (Reduction to Practice), including the
estimated timeframe, supporting
precedents, and any special resource(s)
you may have or will need. If relevant,
the assessment of feasibility should also
address Protections for Humans
Subjects, compliance with policies
related to the use of vertebrate animals,
biosafety issues, and use of methods/
technologies covered by patents or other
intellectual property protection, as
applicable.
4. List of essential materials and
reagents including their suppliers, if
applicable.
5. Appendices describing existing,
unpublished experimental data that
support your proposed solution may be
included. Please note that while a page
limit is not placed on appendices,
please be concise in your presentation
and include only relevant data in
support of your solution.
6. References.
All Phase 1 Solvers will agree to allow
the executive summaries of their
solutions to be posted on the NIH
Common Fund Web site.
Phase 2 (Reduction to Practice)—All
Phase 1 Finalists will be eligible to
participate as Phase 2 Solvers in the
second phase of the Challenge to
produce proof-of-concept data. Phase 2
Solvers will execute their proposed
solution(s) to Phase 1 of the Challenge
and submit (in the Phase 2 submission)
single cell data addressing significant
biological or clinical question(s) by
measuring changes in a single cell over
time. Phase 2 Solvers are encouraged to
incorporate the expert review feedback
from Phase 1 and form teams/
partnerships to improve the likelihood
of successful solution implementation.
Detailed submission requirements for
Phase 2 of the Challenge will be
available to Phase 2 Solvers no later
than 30 days after the Phase 1 Finalists
are announced.
The Phase 2 submission shall include:
1. Project Description: Detailed
description of materials, methods,
personnel, resources, and schedule.
2. Execution: Successful generation of
time course measurements from a single
cell based on the Phase 1 solution,
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which may also include innovations,
essential alterations in the proposed
plan, and/or trouble-shooting technical
or analytical challenges. Any changes
from the original design (Phase 1
solution) should be documented and
explained.
3. Data: Quality and significance of
the time course data produced; efforts to
assess reproducibility.
Registration and Submission Process
for Solvers
To register and submit for this
Challenge, Solvers may access the
registration and submission platform
from any of the following:
• Access the www.challenge.gov Web
site and search for ‘‘Follow that Cell.’’
• Access the NIH Single Cell Analysis
Web site https://commonfund.nih.gov/
Singlecell/index; a registration link for
the Challenge can be found on the
landing page under Challenge
Description.
• Access the Innocentive Challenge
Web site at www.innocentive.com/
followthatcell.
Amount of the Prize.
Phase 1: $100,000.
Phase 2: $400,000.
As determined by the judges, up to six
prizes may be awarded for Phase 1
solutions from a total prize award pool
of $100,000, and up to 2 prizes may be
awarded for Phase 2 solutions from a
total pool of $400,000.
In addition, any and all Phase 1
Finalists will be acknowledged by the
NIH Common Fund Single Cell Analysis
Program and invited to attend The 3rd
Annual Single Cell Analysis
Investigators Meeting near Bethesda,
Maryland, U.S.A., on April 20–21, 2015,
during which they may be invited to
present their theoretical solution. Any
funds for travel reimbursements for
Phase 1 winners will be counted within
the total prize amounts.
Note that in the event a winning team
includes individual members who are
neither citizens nor permanent residents
of the United States, these individuals
are welcome to attend the meeting and
their names will be listed among the
team members, but they cannot be
reimbursed for their travel and related
expenses.
The NIH reserves the right to cancel,
suspend, and/or modify this Challenge
at any time through amendment to this
Federal Register notice. In addition, the
NIH reserves the right to not award any
prizes if no solutions are deemed
worthy. The award approving official
for Phase 1 and Phase 2 of this
Challenge is the NIH Principal Deputy
Director.
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Basis Upon Which Winners Will Be
Evaluated
Solutions for both phases of the
Challenge will be evaluated by a
Technical Evaluation Panel using the
criteria and rating scales describe below.
NIH scientific staff from the various
Institutes and Centers (ICs), including
the Office of Strategic Coordination, will
review highly rated solutions for
scientific alignment to the single-cell
analysis program, relevance to the NIH
mission, and potential overlap with
existing projects. The judges,
comprising three senior NIH leaders,
will use the technical and programmatic
evaluations to determine the Phase 1
prize winners, those Solvers in Phase 1
who are deemed meritorious, and the
Phase 2 prize winner(s). Prizes will be
approved by the NIH Principal Deputy
Director.
Phase 1 (Theoretical)—The technical
evaluation panel will use the following
criteria and rating scales for evaluating
proposed solutions with high scores
reflecting the mostly highly rated
solutions: (Maximum 100 points; plus
bonus points)
1. Time Course Measurements—Must
permit time course measurements on
the same cell over a biologically
significant period of time rather than a
single, snapshot assessment; provide
rationale for the functional measure(s)
and chosen duration. (0–25 points)
2. Predictability—Approach must
provide technical requirements
(sensitivity, selectivity, spatiotemporal
resolution, signal-to-noise ratio, etc.)
that will adequately support robust
prediction of phenotypic changes in cell
state that occur naturally or in response
to controlled perturbation(s). (0–20
points)
3. Cellular Environment—Must
pertain to single cells in a complex
multicellular environment with
preference for cell types that are
phylogenetically closer to human (a–d
below ordered from highest to lowest in
interest). (0–20 points)
a. Multicellular living organism (15–20
points)
b. Intact tissue (10–15 points)
c. Organoid culture (5–10 points)
d. Cell culture (0–5 points)
4. Significance—Must address a
meaningful biological or clinical
question with high potential impact if
successful; must advance current
capabilities and address issues related
to reproducibility. (0–20 points)
5. Adaptability—Must describe broad
utility and scalability. The approach
should lend itself to more than one
particular cell type. (0–15 points)
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Bonus Points. (Maximum 50 bonus
points)
• Feasibility—Should provide
sufficient details to support the
feasibility that the proposed solution
will be reduced to practice in less than
two years, including published or
unpublished data, scientific basis,
technological capability, and resources.
(Bonus up to 30 points)
• Throughput—Methods that describe
multiplexed analysis to increase
throughput and coverage will be rated
more favorably. (Bonus up to 10 points)
• Data Content—Methods that
promote the collection and integration
of multiple types of data (e.g.,
biochemical, physiologic,
morphological, or ‘omics-level analyses)
on individual cells will be rated more
favorably. (Bonus up to 10 points)
Phase 2 (Reduction to Practice)—
Phase 2 submissions must provide a
clear description of how experiments
were conducted (including use of
appropriate controls, instrument
calibration, etc.) and how the data were
collected. Phase 2 submissions must
include all requisite scientific and
technical details including materials,
methods, protocols, and devices to
demonstrate successful execution of the
proposed solution. It should also
document trouble-shooting: What
technical or analytical challenges were
encountered and how were these
resolved? Has reproducibility of the
approach been demonstrated? What
improvements and/or innovations were
implemented above and beyond what
was proposed in Phase 1?
The technical evaluation panel will
use the following criteria and rating
scales for evaluating proposed Phase 2
solutions, with high scores reflecting the
mostly highly rated solutions.
(Maximum 100 points, plus bonus
points)
1. Time Course Measurements—Must
provide time course measurement data
on the same cell over a biologically
significant period of time with adequate
time intervals. (0–25 points)
2. Predictability—Approach must
provide technical specifications
(sensitivity, selectivity, spatiotemporal
resolution, signal-to-noise ratio, etc.)
that will adequately support robust
prediction of phenotypic changes in cell
state that occur naturally or in response
to controlled perturbation(s). The data
should also support robustness,
stability, and reproducibility of
measurements. (0–20 points)
3. Cellular Environment—Must
provide measurement data pertaining to
single cells in a complex multicellular
environment with preference for cell
types that are phylogenetically closer to
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human; (a–d below ordered from
greatest to least in interest). (0–20
points)
a. Multicellular living organism (15–
20 points)
b. Intact tissue (10–15 points)
c. Organoid culture (5–10 points)
d. Cell culture (0–5 points)
4. Significance—Must address a
meaningful biological or clinical
question with high potential impact if
successful; must make technical
advances and/or improvements to
existing methods and approaches.
Should provide evidence of
reproducibility. (0–20 points)
5. Adaptability—Must describe broad
utility and scalability. The approach
should lend itself to more than one
particular cell type. (0–15 points)
Bonus Points (maximum 20 bonus
points)
• Throughput Methods that promote
multiplexed analysis to increase
throughput and coverage will be rated
more favorably. (Bonus up to 10 points)
• Data Content Methods that collect
and integrate multiple types of data
(e.g., biochemical, physiologic,
morphological, or ‘omics-level analyses)
on individual cells will be rated more
favorably. (Bonus up to 10 points)
As part of the evaluation process, the
panel may request a demonstration of
the technology.
Additional Information
Statutory Authority of the Funding
Source
This Challenge is consistent with and
advances the mission of the NIH
Division of Program Coordination,
Planning, and Strategic Initiatives to
identify research that represents
important areas of emerging scientific
opportunities, rising public health
challenges, or knowledge gaps that
deserve special emphasis, including
coordination of the NIH Common Fund.
The NIH Common Fund was enacted
into law by Congress through the 2006
National Institutes of Health Reform Act
to support cross-cutting, trans-NIH
programs that require participation by at
least two NIH ICs or would otherwise
benefit from strategic planning and
coordination. The requirements for the
NIH Common Fund encourage
collaboration across the ICs while
providing the NIH with flexibility to
determine priorities for Common Fund
support. To date, the Common Fund has
been used to support a series of shortterm, exceptionally high-impact, trans-
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NIH programs. https://
commonfund.nih.gov/about.
Intellectual Property: By submitting
the Submission, each Solver warrants
that he or she is the sole author and
owner of any copyrightable works that
the Submission comprises, that the
works are wholly original with the
Solver (or is an improved version of an
existing work that the Solver has
sufficient rights to use and improve),
and that the Submission does not
infringe any copyright or any other
rights of any third party of which Solver
is aware.
To receive an award, Solvers will not
be required to transfer their exclusive
intellectual property rights to the NIH.
Instead, Solvers will grant to the federal
government a nonexclusive license to
practice their solutions and use the
materials that describe them. To
participate in the Challenge, each Solver
must warrant that there are no legal
obstacles to providing a nonexclusive
license of Solver’s rights to the federal
government. This license will grant to
the United States government a
nonexclusive, nontransferable,
irrevocable, paid-up license to practice
or have practiced for or on behalf of the
United States throughout the world any
invention made by the Solvers that
covers the Submission. In addition, the
license will grant to the federal
government and others acting on its
behalf, a paid-up, nonexclusive,
irrevocable, worldwide license in any
copyrightable works that the
Submission comprises, including the
right to reproduce, prepare derivative
works, distribute copies to the public,
and perform publicly and display
publicly said copyrightable works.
Liability and Indemnification: By
participating in this Challenge, each
Solver agrees to assume any and all
risks and waive claims against the
federal government and its related
entities, except in the case of willful
misconduct, for any injury, death,
damage, or loss of property, revenue, or
profits, whether direct, indirect, or
consequential, arising from
participation in this Challenge, whether
the injury, death, damage, or loss arises
through negligence or otherwise. By
participating in this Challenge, each
Solver agrees to indemnify the federal
government against third party claims
for damages arising from or related to
Challenge activities.
Insurance: Based on the subject
matter of the Challenge, the type of
work that it will possibly require, as
well as an analysis of the likelihood of
any claims for death, bodily injury, or
property damage, or loss potentially
resulting from competition
VerDate Mar<15>2010
17:35 Aug 08, 2014
Jkt 232001
participation, Solvers are not required to
obtain liability insurance or
demonstrate financial responsibility in
order to participate in this Challenge.
Privacy, Data Security, Ethics, and
Compliance: Solvers are required to
identify and address privacy and
security issues in their proposed
projects and describe specific solutions
for meeting them. In addition to
complying with appropriate policies,
procedures, and protections for data that
ensures all privacy requirements and
institutional policies are met, use of
data should not allow the identification
of the individual from whom the data
was collected. Solvers are responsible
for compliance with all applicable
federal, state, local, and institutional
laws, regulations, and policies. These
may include, but are not limited to,
Health Information Portability and
Accountability Act (HIPAA) protections,
Department of Health and Human
Services (HHS) Protection of Human
Subjects regulations, and Food and Drug
Administration (FDA) regulations. If
approvals (e.g., from an Institutional
Review Board) will be required to
initiate project activities in Phase 2, it
is recommended that Solvers apply for
approval at or before the Phase 1
submission deadline. The following
links are intended as a starting point for
addressing regulatory requirements but
should not be interpreted as a complete
list of resources on these issues:
HIPAA
Main link: https://www.hhs.gov/ocr/
privacy/.
Summary of the HIPAA Privacy Rule:
https://www.hhs.gov/ocr/privacy/
hipaa/understanding/summary/
index.html.
Summary of the HIPAA Security Rule:
https://www.hhs.gov/ocr/privacy/
hipaa/understanding/
srsummary.html.
Human Subjects—HHS
Office for Human Research Protections:
https://www.hhs.gov/ohrp/.
Protection of Human Subjects
Regulations: https://www.hhs.gov/
ohrp/humansubjects/guidance/
45cfr46.html.
Policy & Guidance: https://www.hhs.gov/
ohrp/policy/.
Institutional Review Boards &
Assurances: https://www.hhs.gov/
ohrp/assurances/.
Human Subjects—FDA
Clinical Trials: https://www.fda.gov/
ScienceResearch/SpecialTopics/
RunningClinicalTrials/default.htm.
Office of Good Clinical Practice:
https://www.fda.gov/AboutFDA/
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
46851
CentersOffices/OfficeofMedical
ProductsandTobacco/Officeof
ScienceandHealthCoordination/
ucm2018191.
Consumer Protection—Federal Trade
Commission
Bureau of Consumer Protection: https://
business.ftc.gov/privacy-and-security.
Challenge Judges
Director, Division of Program
Coordination, Planning, and Strategic
Initiatives, NIH.
Director, National Institute of Mental
Health.
Director, National Institute of
Biomedical Imaging and
Bioengineering (NIBIB).
Acknowledgements
The National Institutes of Health
Single Cell Analysis Program team
would like to thank the following
Subject Matter Experts for providing
guidance to our contractor, InnoCentive,
as NIH staff developed this Challenge.
Ronald N. Germain, M.D., Ph.D., NIH,
National Institute of Allergy and
Infectious Diseases, Laboratory of
Systems Biology
Leroy Hood, M.D., Ph.D., President,
Institute for Systems Biology
Tom Misteli, Ph.D., NIH, National
Cancer Institute, Laboratory of
Receptor Biology and Gene
Expression
Pamela Gehron Robey, Ph.D., NIH,
National Institute of Dental and
Craniofacial Research, Craniofacial
and Skeletal Diseases Branch
Hari Shroff, Ph.D., NIH, NIBIB, High
Resolution Optical Imaging
Laboratory
Dated: August 4, 2014.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2014–18870 Filed 8–8–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2014–0036]
National Infrastructure Advisory
Council
National Protection and
Programs Directorate, DHS.
ACTION: Committee Management; Notice
of an Open Federal Advisory Committee
Meeting.
AGENCY:
The National Infrastructure
Advisory Council (NIAC) will meet
Friday, September 5, 2014, at the Navy
SUMMARY:
E:\FR\FM\11AUN1.SGM
11AUN1
Agencies
[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46847-46851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18870]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Announcement of Requirements and Registration for ``Follow that
Cell'' Challenge
Authority: 15 U.S.C. 3719.
SUMMARY: Through the ``Follow that Cell'' Challenge (the
``Challenge''), the Single Cell Analysis Program (SCAP)--https://commonfund.nih.gov/Singlecell/index, a component of the National
Institutes of Health Common Fund--https://commonfund.nih.gov/about, is
searching for novel methods for analyzing dynamic states of individual
cells that can serve as the basis for predicting alterations in cell
behavior and function over time. The goal of the Challenge is to
develop new tools and methods that allow time-dependent measurements at
the single-cell level in a complex tissue environment in order to
assess functional changes, provide information on the health status of
a given cell, and help guide diagnosis and therapeutic treatments
related to human disease states. Technological breakthroughs in this
arena could allow researchers and physicians to identify rare cells in
a mixed population, such as individual cells that can transform and
become cancerous, cells that are latently infected with a pathogenic
virus, or cells that develop resistance to drugs over time.
The NIH Common Fund currently supports SCAP grants, the majority of
which are associated with academic institutions. This Challenge,
structured in two phases, will strengthen and complement the existing
SCAP grant portfolio by reaching out to a more diverse population of
innovators and solvers, including not only those who are from academic
institutions but also those who are from research and development
communities in the private sector and those who are outside biomedical
disciplines. The NIH believes this Challenge will stimulate investment
from both public and private sectors in single-cell analysis research
and product development, which, in
[[Page 46848]]
turn, could lead to the development of more sensitive, robust, and
cost-effective assay approaches, reagents, tools, and devices for basic
research and clinical diagnosis.
DATES:
Phase 1: Effective on August 15, 2014
Phase 1 Submission period ends: December 15, 2014, 11:59 p.m. ET
Phase 1 Judging Period: December 16, 2014, to February 16, 2015
Phase 1 Winners and other Finalists Announced: March 16, 2015
Phase 2 begins: March 17, 2015
Phase 2 Submission period ends: March 30, 2017, 11:59 p.m. ET
Phase 2 Judging Period: March 31, 2017, to June 30, 2017
Phase 2 Winners announced: July 31, 2017
The NIH may shorten the submission period for Phase 2 and adjust
dates for judging and winner(s) announcement if the Phase 1 winners'
feasibility assessments suggest a shorter Phase 2 submission period is
possible. The NIH will announce any changes to the timeline by amending
this Federal Register notice no later than March 16, 2015. This
Challenge will be administered by InnoCentive, Inc., on behalf of the
NIH www.innocentive.com/followthatcell.
FOR FURTHER INFORMATION CONTACT: Yong Yao, Ph.D., NIH, 301-443-6102; or
Erin Shannon, NIH, 301-443-3959.
SUPPLEMENTARY INFORMATION:
Subject of Challenge
Many biological experiments are performed under the assumption that
all cells of a particular ``type'' are identical. However, recent data
suggest that individual cells within a single population may differ
quite significantly, and these differences can drive the health and
function of the entire cell population. Single-cell analysis comprises
a broad field that covers advanced optical, electrochemical, mass
spectrometry instrumentation, and sensor technology, as well as
separation and sequencing techniques. Although the approaches currently
in use can offer snapshots of single cells, the methods are often not
amenable to longitudinal studies that monitor changes in individual
cells in situ.
In this Challenge, the NIH is seeking novel robust methods for
analysis of individual cells that can detect and assess changes in cell
behavior and function over time, either as a result of natural state
changes or when perturbed (e.g., by a drug, biological stimulus,
infectious agent, pathological lesion, or mechanical forces). It is
hoped that such methods will yield creative and new, yet feasible,
solutions for following a single cell over time in a complex
multicellular environment to detect changing cell properties,
preferably using multiple integrated measures.
Solutions submitted to this Challenge should:
Include measurements or assays that are nondestructive and
capable of producing temporal data at the individual cell level
starting with eukaryotic cells in a complex/mixed cell population;
address at least one impactful, biological, or clinical
question proposed by the Solver;
demonstrate robust reproducibility;
address gaps or deficiencies in current capabilities that
may include but are not limited to:
[cir] Tools that provide significant advances in sensitivity and
selectivity in the spatiotemporal resolution of molecules/structures/
activities within single cells in situ (e.g., high resolution imaging
of molecular interactions within single cells, molecular probes that
are at least an order of magnitude smaller in size than existing
versions of reporter molecules such as fluorescent proteins);
[cir] Automated and scalable assays to detect meaningful functional
changes in single cells in complex tissue environments that improve
upon processing time and reduce overall cost; or
[cir] New combinations of tools and approaches to maximize data
generation over several parameters (e.g., proteins, lipids,
metabolites, signal secretion/reception/transduction, migratory
changes);
advance what is currently considered the state-of-the-art.
Solutions describing existing, well-established and/or currently
supported approaches, especially commonly used strategies are not of
interest unless a compelling case is made that significant,
quantifiable advances are proposed and/or the methods and measures are
used in unique combinations that have not been previously tested
together for the analysis of individual cells in complex environments.
We welcome solutions from individuals, teams, and entities from all
U.S. sources, including the public sector, private sector, and
nonprofit groups.
Eligibility Rules for the Challenge
1. To Participate
This Challenge is open to any ``Solver'' where ``Solver'' is
defined as an individual, a group of individuals (i.e., a team), or an
entity. Whether singly or as part of a group or entity, each individual
participating in the Challenge must be 18 years of age or older.
Eligibility to participate in Phase 2 of the Challenge is
conditioned upon participation in Phase 1 of the Challenge and being
selected as a ``Phase 1 Finalist.'' Phase 1 Finalists are any and all
Phase 1 prize winners and any individual, team, and/or entity whose
solution received a meritorious rating based on the judging criteria.
2. To Win
To be eligible to win a prize under this Challenge, the Solver--
1. Shall have registered to participate in the Challenge under the
process identified at the InnoCentive Web site www.innocentive.com/followthatcell.
2. Shall have complied with all the requirements under this section
on Eligibility.
3. In the case of a private entity, shall be incorporated in and
maintain a primary place of business in the United States; and in the
case of an individual, whether participating singly or in a group,
shall be a citizen or permanent resident of the United States. Note:
Non-U.S. citizens and nonpermanent residents can participate as a
member of a team that otherwise satisfies the eligibility criteria but
will not be eligible to win a monetary prize (in whole or in part);
however, their participation as part of a winning team, if applicable,
may be recognized when results are announced.
4. In the case of an individual, he/she may not be an employee of
the NIH; an individual involved in formulation of the Challenge and/or
serving on the technical evaluation panel; any other individual
involved with the design, production, execution, distribution, or
evaluation of this Challenge; or members of the individual's immediate
family (specifically, a parent, step-parent, spouse, domestic partner,
child, sibling, or step-sibling).
5. An individual, team, or entity that is currently on the Excluded
Parties List (https://www.epls.gov/) will not be selected as a Finalist
or prize winner.
6. In the case of an entity, may not be a federal entity; and in
the case of an individual, may not be a federal employee acting within
the scope of his or her employment.
7. Federal employees otherwise permitted to participate in the
Challenge shall not work on their submission during assigned duty
hours. Note: Federal ethical conduct rules may restrict or prohibit
federal employees from engaging in certain outside
[[Page 46849]]
activities, so any federal employee not excluded under the prior
paragraph seeking to participate in this Challenge outside the scope of
employment should consult his/her agency's ethics official prior to
developing a submission.
8. Federal grantees may not use federal funds to develop Challenge
submissions.
9. Federal contractors may not use federal funds from a contract to
develop Challenge submissions or to fund efforts in support of a
Challenge submission.
10. An individual shall not be deemed ineligible to win because the
individual used federal facilities or consulted with federal employees
during the Challenge provided that such facilities and/or employees, as
applicable, are made available on an equitable basis to all individuals
and teams participating in the Challenge.
All questions regarding the Challenge should be directed to Dr. Yao
or Ms. Shannon, identified above, and answers will be posted and
updated as necessary at www.innocentive.com/followthatcell under
Frequently Asked Questions. Questions from Solvers that may reveal
proprietary information related to solutions under development may be
addressed in the InnoCentive project room, an online secure and
confidential communication forum.
Submission Requirements
The Challenge has two phases.
Phase 1 (Theoretical)--Phase 1 of the Challenge requires a written
proposed solution which describes a novel method for analyzing dynamic
states of individual cells that can serve as the basis for predicting
alterations in cell behavior and function over time.
The Phase 1 Submission shall include:
1. A comprehensive description of the proposed solution in 10 pages
or less, 8.5 x 11 inch page, 10-point font or greater and one inch
margins including:
a. A one-paragraph executive summary that clearly states the
biological or clinical question to be solved;
b. Background information supporting the significance of the
biological or clinical question(s) and the proposed approach, pitfalls,
and validation scheme that addresses efforts to support
reproducibility; if possible, citing selected peer-reviewed articles
that strengthen the proposed solution. The full citations for articles
should be included in the references section;
c. Descriptions of methods and technologies key to implementation;
and
d. A ``State-of-the-Art'' Statement that describes approaches
currently in use (if any) and clearly explains how the methods and
measures proposed advance existing capabilities.
2. A biographical sketch, in no more than four pages, of your
experience and relevant expertise required to validate the proposed
solution, including publications, if applicable. Team submissions
should include a biosketch for each team member.
3. A feasibility assessment and a statement describing your ability
to execute the proposed solution in Phase 2 (Reduction to Practice),
including the estimated timeframe, supporting precedents, and any
special resource(s) you may have or will need. If relevant, the
assessment of feasibility should also address Protections for Humans
Subjects, compliance with policies related to the use of vertebrate
animals, biosafety issues, and use of methods/technologies covered by
patents or other intellectual property protection, as applicable.
4. List of essential materials and reagents including their
suppliers, if applicable.
5. Appendices describing existing, unpublished experimental data
that support your proposed solution may be included. Please note that
while a page limit is not placed on appendices, please be concise in
your presentation and include only relevant data in support of your
solution.
6. References.
All Phase 1 Solvers will agree to allow the executive summaries of
their solutions to be posted on the NIH Common Fund Web site.
Phase 2 (Reduction to Practice)--All Phase 1 Finalists will be
eligible to participate as Phase 2 Solvers in the second phase of the
Challenge to produce proof-of-concept data. Phase 2 Solvers will
execute their proposed solution(s) to Phase 1 of the Challenge and
submit (in the Phase 2 submission) single cell data addressing
significant biological or clinical question(s) by measuring changes in
a single cell over time. Phase 2 Solvers are encouraged to incorporate
the expert review feedback from Phase 1 and form teams/partnerships to
improve the likelihood of successful solution implementation. Detailed
submission requirements for Phase 2 of the Challenge will be available
to Phase 2 Solvers no later than 30 days after the Phase 1 Finalists
are announced.
The Phase 2 submission shall include:
1. Project Description: Detailed description of materials, methods,
personnel, resources, and schedule.
2. Execution: Successful generation of time course measurements
from a single cell based on the Phase 1 solution, which may also
include innovations, essential alterations in the proposed plan, and/or
trouble-shooting technical or analytical challenges. Any changes from
the original design (Phase 1 solution) should be documented and
explained.
3. Data: Quality and significance of the time course data produced;
efforts to assess reproducibility.
Registration and Submission Process for Solvers
To register and submit for this Challenge, Solvers may access the
registration and submission platform from any of the following:
Access the www.challenge.gov Web site and search for
``Follow that Cell.''
Access the NIH Single Cell Analysis Web site https://commonfund.nih.gov/Singlecell/index; a registration link for the
Challenge can be found on the landing page under Challenge Description.
Access the Innocentive Challenge Web site at
www.innocentive.com/followthatcell.
Amount of the Prize.
Phase 1: $100,000.
Phase 2: $400,000.
As determined by the judges, up to six prizes may be awarded for
Phase 1 solutions from a total prize award pool of $100,000, and up to
2 prizes may be awarded for Phase 2 solutions from a total pool of
$400,000.
In addition, any and all Phase 1 Finalists will be acknowledged by
the NIH Common Fund Single Cell Analysis Program and invited to attend
The 3rd Annual Single Cell Analysis Investigators Meeting near
Bethesda, Maryland, U.S.A., on April 20-21, 2015, during which they may
be invited to present their theoretical solution. Any funds for travel
reimbursements for Phase 1 winners will be counted within the total
prize amounts.
Note that in the event a winning team includes individual members
who are neither citizens nor permanent residents of the United States,
these individuals are welcome to attend the meeting and their names
will be listed among the team members, but they cannot be reimbursed
for their travel and related expenses.
The NIH reserves the right to cancel, suspend, and/or modify this
Challenge at any time through amendment to this Federal Register
notice. In addition, the NIH reserves the right to not award any prizes
if no solutions are deemed worthy. The award approving official for
Phase 1 and Phase 2 of this Challenge is the NIH Principal Deputy
Director.
[[Page 46850]]
Basis Upon Which Winners Will Be Evaluated
Solutions for both phases of the Challenge will be evaluated by a
Technical Evaluation Panel using the criteria and rating scales
describe below. NIH scientific staff from the various Institutes and
Centers (ICs), including the Office of Strategic Coordination, will
review highly rated solutions for scientific alignment to the single-
cell analysis program, relevance to the NIH mission, and potential
overlap with existing projects. The judges, comprising three senior NIH
leaders, will use the technical and programmatic evaluations to
determine the Phase 1 prize winners, those Solvers in Phase 1 who are
deemed meritorious, and the Phase 2 prize winner(s). Prizes will be
approved by the NIH Principal Deputy Director.
Phase 1 (Theoretical)--The technical evaluation panel will use the
following criteria and rating scales for evaluating proposed solutions
with high scores reflecting the mostly highly rated solutions: (Maximum
100 points; plus bonus points)
1. Time Course Measurements--Must permit time course measurements
on the same cell over a biologically significant period of time rather
than a single, snapshot assessment; provide rationale for the
functional measure(s) and chosen duration. (0-25 points)
2. Predictability--Approach must provide technical requirements
(sensitivity, selectivity, spatiotemporal resolution, signal-to-noise
ratio, etc.) that will adequately support robust prediction of
phenotypic changes in cell state that occur naturally or in response to
controlled perturbation(s). (0-20 points)
3. Cellular Environment--Must pertain to single cells in a complex
multicellular environment with preference for cell types that are
phylogenetically closer to human (a-d below ordered from highest to
lowest in interest). (0-20 points)
a. Multicellular living organism (15-20 points)
b. Intact tissue (10-15 points)
c. Organoid culture (5-10 points)
d. Cell culture (0-5 points)
4. Significance--Must address a meaningful biological or clinical
question with high potential impact if successful; must advance current
capabilities and address issues related to reproducibility. (0-20
points)
5. Adaptability--Must describe broad utility and scalability. The
approach should lend itself to more than one particular cell type. (0-
15 points)
Bonus Points. (Maximum 50 bonus points)
Feasibility--Should provide sufficient details to support
the feasibility that the proposed solution will be reduced to practice
in less than two years, including published or unpublished data,
scientific basis, technological capability, and resources. (Bonus up to
30 points)
Throughput--Methods that describe multiplexed analysis to
increase throughput and coverage will be rated more favorably. (Bonus
up to 10 points)
Data Content--Methods that promote the collection and
integration of multiple types of data (e.g., biochemical, physiologic,
morphological, or `omics-level analyses) on individual cells will be
rated more favorably. (Bonus up to 10 points)
Phase 2 (Reduction to Practice)--Phase 2 submissions must provide a
clear description of how experiments were conducted (including use of
appropriate controls, instrument calibration, etc.) and how the data
were collected. Phase 2 submissions must include all requisite
scientific and technical details including materials, methods,
protocols, and devices to demonstrate successful execution of the
proposed solution. It should also document trouble-shooting: What
technical or analytical challenges were encountered and how were these
resolved? Has reproducibility of the approach been demonstrated? What
improvements and/or innovations were implemented above and beyond what
was proposed in Phase 1?
The technical evaluation panel will use the following criteria and
rating scales for evaluating proposed Phase 2 solutions, with high
scores reflecting the mostly highly rated solutions. (Maximum 100
points, plus bonus points)
1. Time Course Measurements--Must provide time course measurement
data on the same cell over a biologically significant period of time
with adequate time intervals. (0-25 points)
2. Predictability--Approach must provide technical specifications
(sensitivity, selectivity, spatiotemporal resolution, signal-to-noise
ratio, etc.) that will adequately support robust prediction of
phenotypic changes in cell state that occur naturally or in response to
controlled perturbation(s). The data should also support robustness,
stability, and reproducibility of measurements. (0-20 points)
3. Cellular Environment--Must provide measurement data pertaining
to single cells in a complex multicellular environment with preference
for cell types that are phylogenetically closer to human; (a-d below
ordered from greatest to least in interest). (0-20 points)
a. Multicellular living organism (15-20 points)
b. Intact tissue (10-15 points)
c. Organoid culture (5-10 points)
d. Cell culture (0-5 points)
4. Significance--Must address a meaningful biological or clinical
question with high potential impact if successful; must make technical
advances and/or improvements to existing methods and approaches. Should
provide evidence of reproducibility. (0-20 points)
5. Adaptability--Must describe broad utility and scalability. The
approach should lend itself to more than one particular cell type. (0-
15 points)
Bonus Points (maximum 20 bonus points)
Throughput Methods that promote multiplexed analysis to
increase throughput and coverage will be rated more favorably. (Bonus
up to 10 points)
Data Content Methods that collect and integrate multiple
types of data (e.g., biochemical, physiologic, morphological, or
`omics-level analyses) on individual cells will be rated more
favorably. (Bonus up to 10 points)
As part of the evaluation process, the panel may request a
demonstration of the technology.
Additional Information
Statutory Authority of the Funding Source
This Challenge is consistent with and advances the mission of the
NIH Division of Program Coordination, Planning, and Strategic
Initiatives to identify research that represents important areas of
emerging scientific opportunities, rising public health challenges, or
knowledge gaps that deserve special emphasis, including coordination of
the NIH Common Fund. The NIH Common Fund was enacted into law by
Congress through the 2006 National Institutes of Health Reform Act to
support cross-cutting, trans-NIH programs that require participation by
at least two NIH ICs or would otherwise benefit from strategic planning
and coordination. The requirements for the NIH Common Fund encourage
collaboration across the ICs while providing the NIH with flexibility
to determine priorities for Common Fund support. To date, the Common
Fund has been used to support a series of short-term, exceptionally
high-impact, trans-
[[Page 46851]]
NIH programs. https://commonfund.nih.gov/about.
Intellectual Property: By submitting the Submission, each Solver
warrants that he or she is the sole author and owner of any
copyrightable works that the Submission comprises, that the works are
wholly original with the Solver (or is an improved version of an
existing work that the Solver has sufficient rights to use and
improve), and that the Submission does not infringe any copyright or
any other rights of any third party of which Solver is aware.
To receive an award, Solvers will not be required to transfer their
exclusive intellectual property rights to the NIH. Instead, Solvers
will grant to the federal government a nonexclusive license to practice
their solutions and use the materials that describe them. To
participate in the Challenge, each Solver must warrant that there are
no legal obstacles to providing a nonexclusive license of Solver's
rights to the federal government. This license will grant to the United
States government a nonexclusive, nontransferable, irrevocable, paid-up
license to practice or have practiced for or on behalf of the United
States throughout the world any invention made by the Solvers that
covers the Submission. In addition, the license will grant to the
federal government and others acting on its behalf, a paid-up,
nonexclusive, irrevocable, worldwide license in any copyrightable works
that the Submission comprises, including the right to reproduce,
prepare derivative works, distribute copies to the public, and perform
publicly and display publicly said copyrightable works.
Liability and Indemnification: By participating in this Challenge,
each Solver agrees to assume any and all risks and waive claims against
the federal government and its related entities, except in the case of
willful misconduct, for any injury, death, damage, or loss of property,
revenue, or profits, whether direct, indirect, or consequential,
arising from participation in this Challenge, whether the injury,
death, damage, or loss arises through negligence or otherwise. By
participating in this Challenge, each Solver agrees to indemnify the
federal government against third party claims for damages arising from
or related to Challenge activities.
Insurance: Based on the subject matter of the Challenge, the type
of work that it will possibly require, as well as an analysis of the
likelihood of any claims for death, bodily injury, or property damage,
or loss potentially resulting from competition participation, Solvers
are not required to obtain liability insurance or demonstrate financial
responsibility in order to participate in this Challenge.
Privacy, Data Security, Ethics, and Compliance: Solvers are
required to identify and address privacy and security issues in their
proposed projects and describe specific solutions for meeting them. In
addition to complying with appropriate policies, procedures, and
protections for data that ensures all privacy requirements and
institutional policies are met, use of data should not allow the
identification of the individual from whom the data was collected.
Solvers are responsible for compliance with all applicable federal,
state, local, and institutional laws, regulations, and policies. These
may include, but are not limited to, Health Information Portability and
Accountability Act (HIPAA) protections, Department of Health and Human
Services (HHS) Protection of Human Subjects regulations, and Food and
Drug Administration (FDA) regulations. If approvals (e.g., from an
Institutional Review Board) will be required to initiate project
activities in Phase 2, it is recommended that Solvers apply for
approval at or before the Phase 1 submission deadline. The following
links are intended as a starting point for addressing regulatory
requirements but should not be interpreted as a complete list of
resources on these issues:
HIPAA
Main link: https://www.hhs.gov/ocr/privacy/.
Summary of the HIPAA Privacy Rule: https://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/.
Summary of the HIPAA Security Rule: https://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html.
Human Subjects--HHS
Office for Human Research Protections: https://www.hhs.gov/ohrp/.
Protection of Human Subjects Regulations: https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
Policy & Guidance: https://www.hhs.gov/ohrp/policy/.
Institutional Review Boards & Assurances: https://www.hhs.gov/ohrp/assurances/.
Human Subjects--FDA
Clinical Trials: https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.
Office of Good Clinical Practice: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018191.
Consumer Protection--Federal Trade Commission
Bureau of Consumer Protection: https://business.ftc.gov/privacy-and-security.
Challenge Judges
Director, Division of Program Coordination, Planning, and Strategic
Initiatives, NIH.
Director, National Institute of Mental Health.
Director, National Institute of Biomedical Imaging and Bioengineering
(NIBIB).
Acknowledgements
The National Institutes of Health Single Cell Analysis Program team
would like to thank the following Subject Matter Experts for providing
guidance to our contractor, InnoCentive, as NIH staff developed this
Challenge.
Ronald N. Germain, M.D., Ph.D., NIH, National Institute of Allergy and
Infectious Diseases, Laboratory of Systems Biology
Leroy Hood, M.D., Ph.D., President, Institute for Systems Biology
Tom Misteli, Ph.D., NIH, National Cancer Institute, Laboratory of
Receptor Biology and Gene Expression
Pamela Gehron Robey, Ph.D., NIH, National Institute of Dental and
Craniofacial Research, Craniofacial and Skeletal Diseases Branch
Hari Shroff, Ph.D., NIH, NIBIB, High Resolution Optical Imaging
Laboratory
Dated: August 4, 2014.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2014-18870 Filed 8-8-14; 8:45 am]
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