[Federal Register Volume 80, Number 100 (Tuesday, May 26, 2015)]
[Notices]
[Pages 30084-30087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12632]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Announcement of Requirements and Registration for: ``Harnessing 
Insights From Other Disciplines To Advance Drug Abuse and Addiction 
Research'' Challenge

    Authority: 15 U.S.C. 3719.

SUMMARY: The National Institute on Drug Abuse (NIDA), a component of 
the National Institutes of Health (NIH), is seeking from the general 
public ideas on how to adapt specialized knowledge from other 
disciplines to inform new directions and discoveries in drug abuse and 
addiction research. With the ``Harnessing insights from other 
disciplines to advance drug abuse and addiction research'' challenge 
(the ``Challenge''), NIDA aims to gain insights into new methods or 
approaches that could transform discovery in order to significantly 
expand our basic knowledge about drug abuse and addiction processes, 
accelerate the development of novel and more effective prevention and 
treatment strategies, and/or enhance our capacity to implement, 
monitor, and improve upon evidence-based interventions.
    This Challenge is soliciting written proposals that outline novel 
approaches to addressing research challenges in the drug use and 
addiction field by leveraging concepts or technologies from other 
disciplines. This Challenge is being issued as part of NIDA's strategic 
planning process for 2016-2020. Winning proposals may be used to guide 
the development of new research programs within NIDA.

DATES: 
(1) Submission Period begins May 26, 2015, 9:00 a.m., EST
(2) Submission Period ends June 22, 2015, 11:59 p.m., EST
(3) Judging Period June 23, 2015 to July 17, 2015
(4) Winners Announced July 30, 2015

FOR FURTHER INFORMATION CONTACT: Dr. Emily Einstein, Ph.D., Science 
Policy Branch, Office of Science Policy and Communication, National 
Institute on Drug Abuse, Phone: 301-443-6071, Email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Subject of the Challenge

    For the past four decades, the National Institute on Drug Abuse 
(NIDA) has led the way in supporting research to prevent and treat drug 
abuse and addiction and to mitigate the impact of their consequences, 
which include the spread of HIV/AIDS and other infectious diseases. To 
confront the most pressing aspects of the complex disease of addiction 
and to tackle its underlying causes, NIDA's strategic approach is 
multipronged and includes research programs in basic, clinical, and 
translational sciences. These programs support studies in genetics, 
functional neuroimaging, social neuroscience, medication and behavioral 
therapies, prevention, and health services, including cost-
effectiveness research. NIDA's evolving portfolio has produced a vast 
body of knowledge that informs strategic directions for future 
research, and this Challenge represents a new approach to broaden the 
pool of testable ideas.
    Scientific knowledge about drug addiction and its treatment has 
increased markedly over the past couple of decades. Today, we have a 
better understanding of the effects of drugs on the brain, as well as 
new and more effective treatments than were available in the past. A 
changing healthcare landscape may provide opportunities to further 
enhance the quality of addiction prevention and treatment. Still, 
addiction remains a pressing public health issue, and this Challenge 
seeks to accelerate progress in the field of drug abuse and addiction 
research by incentivizing a broader community of stakeholders--
including those not formally involved in biomedical or addiction-
related disciplines--to propose new ideas or innovations that leverage 
concepts or technologies from other disciplines to advance drug abuse 
and addiction research.
    While preparing their proposals, applicants should bear in mind 
NIDA's traditional priority areas, persistent roadblocks that hamper 
progress, and evolving and emerging opportunities. Some illustrative 
examples are discussed below; however, proposals may address any 
challenge within the drug use and addiction field.
    NIDA priority areas. NIDA's charge, to bring the power of science 
to bear on drug abuse and addiction, has two critical components. The 
first is the strategic support and conduct of research across a broad 
range of disciplines. The second is ensuring the rapid and effective 
dissemination and implementation of the results of that research to 
significantly improve

[[Page 30085]]

prevention and treatment and to inform policy as it relates to drug use 
and addiction. These aims are currently met by a broad range of 
projects in basic, clinical, and translational sciences. For more 
information on current NIDA research programs please visit 
www.drugabuse.gov.
    Roadblocks to progress in addiction research and its translation. 
There are many scientific and non-scientific roadblocks that hamper 
progress on drug use and addiction research. For example, one of the 
most frequently cited obstacles to clinical advances in the field of 
drug use disorders is the lack of interest by the pharmaceutical 
industry in developing new addiction medications. This is largely due 
to the low success rate of clinical trials for neurotherapeutics and 
the perceived lack of financial incentives to pursue new 
pharmacotherapies for substance use disorders. Other key obstacles 
include the reluctance of some primary care providers to address 
substance abuse with their patients. On the basic research side, 
reproducibility, transparency, data sharing, and training a diverse 
workforce remain areas in need of improvement.
    Emerging Opportunities. New discoveries, technologies, paradigms, 
and ways of thinking play a key role in our efforts to understand 
addiction, to develop better ways to influence addiction trajectories, 
and to mitigate its consequences. The examples below are meant to 
illustrate just a few areas of rapidly evolving technologies and 
emerging opportunities from which the drug use and addiction field 
expects to reap significant benefits in the near future.
    Genomics and Epigenomics. Recent technological developments have 
led to important advances in linking genes and their regulation with 
behavior. We now have an unprecedented capacity to screen for thousands 
of genetic and epigenetic variations and catalogue how they modulate 
substance use disorder risk by influencing gene expression, brain 
maturation, neural architecture, and behavioral patterns. In addition, 
advances in epigenetics research are enabling increased understanding 
of how environmental factors (e.g., parenting style, drug exposure) can 
affect the expression of specific genes to either strengthen or weaken 
risk for substance use and addiction. Similar approaches could be 
applied to leverage advances in metabolomics, proteomics, connectomes, 
transcriptomics and systems biology to better characterize the role of 
these systems in drug use and addiction.
    Big Data. Behavioral disorders including drug use disorders are 
incredibly complex, with multiple biological, environmental, and 
developmental factors contributing to risk. Very large data sets (on 
the scale of tera- or petabytes, typically referred to as ``Big Data'') 
sets are essential platforms for the analysis of such complex systems, 
overlaying genetic, molecular, cellular, environmental, behavioral, and 
structural and functional brain imaging data. Big Data also brings 
analysis opportunities in many other areas, such as social media and 
socio-economic mapping which, when combined with health information, 
could lead to an improved understanding of predictors of psychiatric 
illness risk (including addiction), trajectory, and treatment 
responses. This area of development presents significant opportunities 
for innovation for research.
    Data Sharing. Data sharing is a critical component that allows the 
results of NIDA's research to be distributed to investigators and the 
public in order to promote new research, encourage further analyses, 
and disseminate information to the community. Secondary analyses of 
shared data multiply the scientific contribution of the original 
research. The development of new strategies to facilitate effective 
data sharing and analysis is one area in which new ideas could spur 
significant advancement.
    Informatics. NIDA is already pursuing several avenues to realize 
the research and clinical potential of various informatics tools. 
Notable examples include:
    [cir] Development of a comprehensive clinical decision support 
systems based on advanced database analysis techniques.
    [cir] Research in theoretical and applied areas of medical and 
clinical informatics, including the study of new methods for acquiring, 
representing, processing, and managing data within the Intramural 
Research program (IRP) clinical and research programs.
    [cir] Development of transactional electronic recording and 
telemetry methods for implementation in various research environments 
such as clinical neuroimaging, pharmacology and therapeutics, and 
nicotine psychopharmacology research.
    [cir] Development of innovative, field-deployable tools to measure 
exposures to psychosocial stress and addictive substances within 
geographic contexts in real time.
    [cir] Research into technology based delivery of behavioral 
treatment interventions including contingency management.

Despite these ongoing efforts there is a significant need for new 
strategies for leveraging advances in informatics to advance research 
on drug use and related disorders.
    This Challenge welcomes bold new ideas in these fields within the 
vast scientific, clinical and technological realms. In summary, the 
overarching goal of the present Challenge is to identify and parlay the 
untapped power of other (unexpected) technologies, fields, and 
innovations to inspire transformative advances in the area of addiction 
research.

Statutory Authority

    This Challenge is consistent with and advances the mission of NIDA 
as described in 42 U.S.C. 285o. The general purpose of NIDA is to 
conduct and support biomedical and behavioral research and health 
services research, research training, and health information 
dissemination with respect to the prevention of drug abuse and the 
treatment of drug abusers. Consistent with this authority, one of 
NIDA's strategic goals is to support research to improve the quality of 
addiction treatment. Novel measures, conceptual models or creative, yet 
feasible ideas, and related research agendas that achieve the goals 
underlying this Challenge will help set priorities for future research 
and, accordingly, will support this strategic goal.

Rules for Participating in the Challenge

    1. To be eligible to win a prize under this Challenge, an 
individual or entity:
    a. Shall have registered to participate in the Challenge under the 
rules promulgated by NIDA and published in this Notice;
    b. Shall have complied with all the requirements in this Notice;
    c. 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. However, 
non-U.S. citizens and non-permanent residents can participate as a 
member of a team that otherwise satisfies the eligibility criteria. 
Non-U.S. citizens and non-permanent residents are not eligible to win a 
monetary prize (in whole or in part). Their participation as part of a 
winning team, if applicable, may be recognized when the results are 
announced.
    d. In the case of an individual, whether participating singly or in 
a

[[Page 30086]]

group, must be at least 18 years old at the time of submission;
    e. May not be a Federal entity;
    f. May not be a Federal employee acting within the scope of his/her 
employment, and further, in the case of HHS employees, may not work on 
their submission(s) during assigned duty hours;
    g. May not be an employee of the National Institutes of Health 
(NIH), a judge of the Challenge, or any other party involved with the 
design, production, execution, or distribution of the Challenge or the 
immediate family of such a party (i.e., spouse, parent, step-parent, 
child, or step-child).
    2. Federal grantees may not use Federal funds to develop their 
Challenge submissions unless use of such funds is consistent with the 
purpose of their grant award and specifically requested to do so due to 
the Challenge design.
    3. Federal contractors may not use Federal funds from a contract to 
develop their Challenge submissions or to fund efforts in support of 
their Challenge submission.
    4. Submissions must not infringe upon any copyright or any other 
rights of any third party. Each participant warrants that he or she is 
the sole author and owner of the work and that the work is wholly 
original.
    5. By participating in this Challenge, each individual (whether 
competing singly or in a group) and entity agrees to assume any and all 
risks and to waive claims against the Federal Government and its 
related entities (as defined in the COMPETES Act), 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 their participation in the Challenge, 
whether the injury, death, damage, or loss arises through negligence or 
otherwise.
    6. 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 Challenge participation, no individual 
(whether competing singly or in a group) or entity participating in the 
Challenge is required to obtain liability insurance or demonstrate 
financial responsibility in order to participate in this Challenge.
    7. By participating in this Challenge, each individual (whether 
competing singly or in a group) or entity agrees to indemnify the 
Federal Government against third party claims for damages arising from 
or related to Challenge activities.
    8. An individual or entity shall not be deemed ineligible because 
the individual or entity used Federal facilities or consulted with 
Federal employees during the Challenge if the facilities and employees 
are made available to all individuals and entities participating in the 
Challenge on an equitable basis.
    9. Each individual (whether competing singly or in a group) or 
entity retains title and full ownership in and to their submission and 
each participant expressly reserves all intellectual property rights 
(e.g., copyright) in their submission. However, by participating in 
this Challenge, each participant grants to NIDA, and others acting on 
behalf of NIDA, an irrevocable, paid-up, royalty-free, non-exclusive, 
worldwide license to use, copy for use, and display publicly all parts 
of the submission for the purposes of the Challenge. This license may 
include posting or linking to the submission on the official NIDA Web 
site and making it available for use by the public.
    10. The NIH reserves the right, in its sole discretion, to (a) 
cancel, suspend, or modify the Challenge, and/or (b) not award any 
prizes if no submissions are deemed worthy.
    11. Each individual (whether competing singly or in a group) and 
entity participating in this Challenge agrees to follow applicable 
local, State, and Federal laws and regulations.
    12. Each individual (whether participating singly or in a group) 
and entity participating in this Challenge must comply with all terms 
and conditions of these rules, and participation in this Challenge 
constitutes each such participant's full and unconditional agreement to 
abide by these rules. Winning is contingent upon fulfilling all 
requirements herein.

Submission Requirements

    Each submission for this Challenge should consist of a white paper 
of no more than 6 (double spaced) pages describing a concept for an 
innovative research initiative to advance drug abuse and addiction 
research. The white paper must include but not limited to the 
following:
    1. Cover page: indicate title of the proposal and which of the 
following broadly defined categories would best describe its area of 
applicability: Prevention, Behavioral treatments, Medications 
development, Epidemiology, Basic Sciences, Neuroscience, Services and 
service research, or Other (define).
    2. Executive Summary (250 word limit).
    3. A description of the innovative concept or technology and how it 
was effectively applied within another field.
    4. A proposal for how the concept can be applied to an outstanding 
question in drug abuse/addiction research, including a discussion of 
why that question is important to address.
    5. A cogent rationale for why the proposed concept would work in 
the field of drug use and addiction research.
    The white paper must not contain any information directly 
identifying the participants.
    To register for this Challenge, participants must go to 
www.challenge.gov and search for ``Harnessing insights from other 
disciplines to advance drug abuse and addiction research.'' Click on 
the title to go to the Challenge platform Web site, which contains 
instructions on how to register and submit.
    All submissions must be in English. Each submission must consist of 
a PDF file, containing the white paper document. The PDF documents must 
be formatted to be no larger than 8.5'' by 11.0'', with at least 1 inch 
margins and can include a maximum of two figures. The white paper must 
be no more than 6 pages long. Font size must be no smaller than 11 
point Arial. The participant must not use HHS's logo or official seal 
or the logo of NIH or NIDA in the submission, and must not claim 
federal government endorsement.

Amount of the Prize

    Up to three monetary prizes may be awarded: $15,000 for 1st Place, 
$7,000 for 2nd Place, $3,000 for 3rd Place for a total prize award pool 
of up to $25,000. The names of the winners and the titles of their 
submissions will be posted on the NIDA Web site. The award approving 
official for this Challenge is the Director of the National Institute 
on Drug Abuse.

Payment of the Prize

    Prizes awarded under this Challenge will be paid by electronic 
funds transfer and may be subject to Federal income taxes. The NIH will 
comply with the Internal Revenue Service withholding and reporting 
requirements, where applicable.

Basis Upon Which Winner Will Be Selected

    The judging panel will make recommendations to the Award Approving 
Official based upon the following three criteria and point allocation:
    1. Novelty of the concept (5 points): Concepts shall move the field 
beyond the existing paradigms commonly used

[[Page 30087]]

in addiction research, and focus on novel, underserved, neglected, 
complex, or intractable aspects of the addiction phenomenon. How novel 
is the concept? Does it address important basic or clinical features/
effects that are not currently or adequately addressed and/or with a 
fresh perspective?
    2. Feasibility (5 points): Ideas, concepts and the approaches, 
measures and systems derived from them must be rooted on a rational, 
scientific or otherwise cogent background that would guarantee a 
modicum of feasibility given the current challenges and state of the 
art in the field of addiction. How well does the research agenda 
describe the gaps in the relevant areas of science that need to be 
addressed by this new approach/concept to be achieved and implemented? 
Does the agenda describe a logical, feasible plan and timeframe for 
addressing those gaps?
    3. Importance of the question being addressed/likelihood of impact 
(5 points): How effective would the successful completion of the 
project be in addressing addiction, enhancing prevention, or improving 
clinical outcomes? How well does it consider factors relevant to the 
ultimate success of the concept? How well does it harness innovations 
from other fields to the existing addiction knowledge base toward 
advancing drug abuse and addiction research?
    Scores from each criterion will be weighted equally. The score for 
each submission will be the sum of the scores from each of the 5 voting 
judges, for a maximum of 75 points. NIDA reserves the right to make an 
award to submissions scoring less than 75 points if NIDA deems any 
sufficiently meritorious. All submissions will be held until after the 
deadline is reached for a simultaneous judging process. NIDA reserves 
the right to disqualify and remove any submission that is deemed, in 
NIDA's or the judging panel's discretion, inappropriate, offensive, 
defamatory, or demeaning. NIDA reserves the right not to award any 
prizes in case none is found to be sufficiently meritorious.
    The evaluation process will begin by anonymizing and removing those 
that are not responsive to this Challenge or not in compliance with all 
of the rules of eligibility. Submissions that are responsive and in 
compliance will undergo a preliminary review by the Challenge Judges 
with expertise in the relevant areas of science Challenge Judges will 
examine all responsive and compliant submissions, as well comments from 
program staff, if any, and score the submissions in accordance with the 
judging criteria outlined above. Judges will meet to discuss the most 
meritorious submissions. Final recommendations will be determined by 
electronic (majority) vote of the judges.

Challenge Judges

Dr. Nora Volkow, Director, National Institute on Drug Abuse (NIDA)--Ex 
Officio
Dr. Roger Little, Deputy Director, Division of Basic Neuroscience and 
Behavioral Research, NIDA
Dr. David Epstein, Associate Scientist, Intramural Research Program, 
NIDA
Dr. David Liu, Team Leader, Medical Officer, Center for Clinical Trials 
Network, NIDA
Dr. Maureen Boyle, Chief, Science Policy Branch, Office of Science 
Policy and Communication, NIDA
Dr. Meyer D. Glantz, Associate Director for Science, Division of 
Epidemiology, Services, and Prevention Research
Dr. Ruben Baler, Health Scientist Administrator, Science Policy Branch, 
Office of Science Policy and Communication, NIDA
Dr. Steve Grant, Chief, Clinical Neuroscience Branch, Division of 
Clinical Neuroscience and Behavioral Research, NIDA
Dr. Philip Krieter, Pharmacologist, Division of Pharmacotherapies and 
Medical Consequences of Drug Abuse, NIDA
Dr. Gerald McLaughlin, Chief, Scientific Review Branch, Division of 
Extramural Research, NIDA

    Dated: May 11, 2015.
Nora D. Volkow,
Director, National Institute on Drug Abuse, National Institutes of 
Health.
[FR Doc. 2015-12632 Filed 5-22-15; 8:45 am]
 BILLING CODE 4140-01-P