[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46847-46851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18870]
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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)--http://commonfund.nih.gov/Singlecell/index, a component of the National
Institutes of Health Common Fund--http://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
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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 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.
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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)
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. http://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: http://www.hhs.gov/ocr/privacy/index.html.
Summary of the HIPAA Privacy Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html.
Summary of the HIPAA Security Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html.
Human Subjects--HHS
Office for Human Research Protections: http://www.hhs.gov/ohrp/index.html.
Protection of Human Subjects Regulations: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
Policy & Guidance: http://www.hhs.gov/ohrp/policy/index.html.
Institutional Review Boards & Assurances: http://www.hhs.gov/ohrp/assurances/index.html.
Human Subjects--FDA
Clinical Trials: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.
Office of Good Clinical Practice: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018191.
Consumer Protection--Federal Trade Commission
Bureau of Consumer Protection: http://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.
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