Announcement of Requirements and Registration for “Follow that Cell” Challenge, 46847-46851 [2014-18870]

Download as PDF Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices Committee must notify the Contact Person listed on this notice by 5:00 p.m. ET on Friday, September 12, 2014, with their request to present oral comments at the meeting. Interested individuals and representatives of organizations must submit a written/electronic copy of the oral statement/comments including a brief description of the organization represented by 5:00 p.m. ET on Wednesday, September 17, 2014. 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] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke mstockstill on DSK4VPTVN1PROD with NOTICES Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of an Interagency Pain Research Coordinating Committee (IPRCC) meeting. The meeting will feature invited speakers and discussions of committee business items including strategic planning for Federal pain research and the National Pain Strategy. The meeting will be open to the public and accessible by live webcast and conference call. Name of Committee: Interagency Pain Research Coordinating Committee. Type of meeting: Open Meeting. Date: September 24, 2014. Time: 8:30 a.m. to 5:00 p.m. *Eastern Time*—Approximate end time. Agenda: The meeting will feature invited speakers and discussions of Committee business items including the National Pain Strategy and long term strategic planning for Federal pain research. Place: National Institutes of Health, Building 31, C Wing, 6th Floor, Conference Room 10, 31 Center Drive, Bethesda, MD 20892. Call in Teleconference Line (Listen Only): Dial: 888–945–5891, Participant Passcode: 1242293. Cost: The meeting is free and open to the public. Webcast Live: http://videocast.nih.gov/. Deadlines: Notification of intent to present oral comments: Friday, September 12, 2014, by 5:00 p.m. ET. Submission of written/electronic statement for oral comments: Wednesday, September 17, 2014, by 5:00 p.m. ET. Submission of written comments: Friday, September 19, 2014, by 5:00 p.m. ET. Access: Medical Center Metro (Red Line), Visitor Information: http://www.nih.gov/ about/visitor/index.htm. Contact Person: Linda L. Porter, Ph.D., Pain Policy Advisor, Office of Pain Policy, Officer of the Director, National Institute of Neurological Disorders and Stroke, NIH, 31 Center Drive, Room 8A03, Bethesda, MD 20892, Phone: (301) 451–4460, Email: Linda.Porter@nih.gov. Please Note: Any member of the public interested in presenting oral comments to the VerDate Mar<15>2010 17:35 Aug 08, 2014 Jkt 232001 Statements submitted will become a part of the public record. Only one representative of an organization will be allowed to present oral comments on behalf of that organization, and presentations will be limited to three to five minutes per speaker, depending on number of speakers to be accommodated within the allotted time. Speakers will be assigned a time to speak in the order of the date and time when their request to speak is received, along with the required submission of the written/ electronic statement by the specified deadline. If special accommodations are needed, please email the Contact Person listed above. In addition, any interested person may submit written comments to the IPRCC prior to the meeting by sending the comments to the Contact Person listed on this notice by 5:00 p.m. ET, Friday, September 19, 2014. The comments should include the name and, when applicable, the business or professional affiliation of the interested person. All written comments received by the deadlines for both oral and written public comments will be provided to the IPRCC for their consideration and will become part of the public record. The meeting will be open to the public through a conference call phone number and webcast live on the Internet. Members of the public who participate using the conference call phone number will be able to listen to the meeting but will not be heard. If you experience any technical problems with the conference call or webcast, please call Operator Service on (301) 496–4517 for conference call issues and the NIH IT Service Desk at (301) 496–4357, toll free (866) 319–4357, for webcast issues. Individuals who participate in person or by using these electronic services and who need special assistance, such as captioning of the conference call or other reasonable accommodations, should submit a request to the Contact Person listed on this notice at least seven days prior to the meeting. As a part of security procedures, attendees should be prepared to present a photo ID during the security process to get on the NIH campus. For a full description, please see: http:// www.nih.gov/about/visitorsecurity.htm. PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 46847 Information about the IPRCC is available on the Web site: http:// iprcc.nih.gov/. Dated: August 4, 2014. David Clary, Program Analyst, Office of Federal Advisory 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)— 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 SUMMARY: E:\FR\FM\11AUN1.SGM 11AUN1 46848 Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices 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: mstockstill on DSK4VPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 17:35 Aug 08, 2014 Jkt 232001 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 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 (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 E:\FR\FM\11AUN1.SGM 11AUN1 Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 17:35 Aug 08, 2014 Jkt 232001 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, PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 46849 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. E:\FR\FM\11AUN1.SGM 11AUN1 46850 Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES 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) VerDate Mar<15>2010 17:35 Aug 08, 2014 Jkt 232001 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 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 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- E:\FR\FM\11AUN1.SGM 11AUN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices 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 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: 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/ PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 46851 CentersOffices/OfficeofMedical ProductsandTobacco/Officeof ScienceandHealthCoordination/ 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. [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)--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

[[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. 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.
[FR Doc. 2014-18870 Filed 8-8-14; 8:45 am]
BILLING CODE 4140-01-P