[Federal Register Volume 81, Number 113 (Monday, June 13, 2016)]
[Notices]
[Pages 38193-38195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13936]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Announcement of Requirements and Registration for ``$100,000 for 
Start a SUD Startup'' Challenge

SUMMARY: The National Institute on Drug Abuse (NIDA), one of the 
components of the National Institutes of Health (NIH), announces the 
``$100,000 for Start a SUD Startup'' Challenge. The Challenge goal is 
to support research ideas that would further an understanding of 
neurobiology as it relates to Substance Use Disorders (SUD) and that 
are intended to be the basis for the development of a new and 
potentially successful start-up. NIDA hopes that participation in the 
contest will enable scientists to test the hypothesis that their 
research idea can be fostered into a biotech startup, and that 
eventually any newly created startups will contribute to the pool of 
innovative small business companies that can successfully compete for 
NIDA's Small Business Innovation Research (SBIR) and Small Business 
Technology Transfer (STTR) funding. Each Challenge winner will receive 
$10,000. The Challenge total purse is up to $100,000.

DATES: The Challenge begins June 13, 2016.
    Submission Period: June 13, 2016 to September 16, 2016, 11:59 p.m., 
ET.
    Judging Period: September 19, 2016 to October 21, 2016.
    Winners Announced: October 24, 2016.

FOR FURTHER INFORMATION CONTACT: Irina Sazonova, Ph.D., M.Sc., Health 
Scientist Administrator, Office of Translational Initiatives and 
Program Innovations (OTIPI), NIDA Challenge Administrator, National 
Institute on Drug Abuse (NIDA), 6001 Executive Blvd. Room 4206, MSC 
9555 Bethesda, MD 20892-9555. Phone: (301) 827-9564, Email: 
[email protected].

SUPPLEMENTARY INFORMATION: The Institute's Statutory Authority to 
Conduct the Challenge. NIDA is conducting this Challenge under the 
America Creating Opportunities to Meaningfully Promote Excellence in 
Technology, Education, and Science (COMPETES) Reauthorization Act of 
2010, 15 U.S.C. 3719. The general purpose of NIDA is to conduct and 
support biomedical and behavioral research, health-services research, 
research training, and health-information dissemination with respect to 
the prevention of drug abuse and the treatment of drug abusers. This 
Challenge is consistent with and advances the mission of NIDA as 
described in 42 U.S.C. 285o in that it supports new and potential 
biotech start-ups in the development of research ideas that would 
further an understanding of neurobiology as it relates to SUD.
    Subject of Challenge. NIDA is excited to announce the first 
competition for biomedical scientists with the goal to support research 
ideas that would further an understanding of neurobiology as it relates 
to SUD and that are intended to be the basis for the development of a 
new and potentially successful start-up. NIDA hopes that participation 
in the contest will enable scientists to test whether their research 
ideas can be fostered into a biotech startup. In 2016, NIDA will award 
up to $100,000 in prizes to up to 10 winners of the contest, $10,000 
each.
    Are you a biomedical scientist who believes that he/she has a 
research idea for a biotech start-up? This Challenge is unique because 
NIDA intends to fund the ``would be'' startup Founders much earlier 
than most investors, incubators, or traditional modes of research 
funding (e.g. small business grants).
    What does it take to participate in the Challenge? The team or an 
individual must have a research idea that could further the 
understanding of SUD and is intended to be the basis of the development 
of a new and potentially successful startup. The research ``idea'' is 
the product that your future startup will offer. Here, the term startup 
``product'' is used in its broadest definition. Product is any source 
of value for the people who become customers. Services, subscriptions, 
software as a service (SaaS), physical/tangible products, aggregations, 
etc. could all provide value and thus be considered startup products. 
The startup product could be the result of novel scientific 
discoveries, repurposing an existing technology for a new use, 
extending a research observation into a different area, devising a new 
business model or distribution/delivery channel that unlocks value 
currently concealed, or simply bringing a product or service to 
previously underserved set of customers. The Founder (the teams or an 
individual) must demonstrate through the Submission the passion, drive, 
discipline, ability to work collaboratively and willingness to push 
forward under conditions of extreme business uncertainty.
    The winners of this Challenge are encouraged to use the prize funds 
to develop a minimum viable proof (MVP) as quickly as possible and to 
obtain customer feedback to discover if MVP meets the customer needs. 
If the product prototype is successfully validated, winners are 
encouraged to create or further advance their biotech startup no later 
than 6 months after the prize is awarded. Post Challenge, as with all 
other NIH grant applicants, NIDA staff will provide dedicated 
assistance and guidance about the NIH grant submission process, 
including submissions for the SBIR/STTR grants.
    The research idea must be broad enough to address multiple 
conditions, diseases, or indications consistent with SUD or be specific 
for prevention and treatments of SUD. For example, if your idea can 
only work for cancer or diabetes, entering this Challenge is not 
appropriate. However, if the plan is to test an idea for a research 
tool that would further an understanding of neurobiology or epigenetics 
relevant to SUD to progress faster and with greater fidelity, entering 
this Challenge is appropriate.
    Rules for Participating in the Challenge. The Challenge is open to 
any Founder 18 years of age or older. No prior startup experience is 
necessary. A

[[Page 38194]]

Founder may be (i) an entity or (ii) an individual or group of 
individuals (i.e., a team assembled with the purpose of participating 
in this 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 as published in this Notice;
    b. Shall have complied with all the requirements set forth in this 
Notice;
    c. In the case of a private entity, shall be incorporated in and 
maintain a primary place of business or research activity 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 
otherwise recognized when the results are announced.
    d. May not be a Federal entity;
    e. May not be a Federal employee acting within the scope of the 
employee's employment and further, in the case of HHS employees, may 
not work on their submission(s) during assigned duty hours;
    f. May not be an employee of the 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).
    g. Must be a potential start-up (i.e. not yet formed) or a new 
start-up (i.e. in the early stage of formation and development).
    (2) Federal grantees may not use Federal funds to develop their 
Challenge submissions.
    (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.
    (5) By participating in this Challenge, each Founder (whether 
competing singly or in a group) and entity agrees to assume any and all 
risks and 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 participation in this 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, property damage, or loss 
potentially resulting from Challenge participation, no Founder (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 Founder (whether 
competing singly or in a group) and entity agrees to indemnify the 
Federal government against third party claims for damages arising from 
or related to Challenge activities.
    (8) A Founder or entity shall not be deemed ineligible because the 
Founder 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) By participating in this Challenge, each Founder (whether 
participating 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.
    (10) NIDA reserves the right, in its sole discretion, to (a) 
cancel, suspend, or modify the Challenge, and/or (b) not award any 
prizes if no entries are deemed worthy.
    (11) Each Founder (whether participating singly or in a group) or 
entity agrees to follow all applicable Local, State, and Federal laws 
and regulations.
    (12) Each Founder (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 contestant's full and unconditional agreement to 
abide by these rules. Winning is contingent upon fulfilling all 
requirements herein.
    (13) Scientists working on the projects that are directly 
applicable or adaptable to benefit the SUD field, NIDA's mission area, 
are especially encouraged to apply. A team can also include engineers, 
IT, business or other professionals in the biomedical science/health 
care field;
    (14) Winners are encouraged to submit the minimum viable proof 
(MVP) report 6 months after the prize payment.
    Registration Process for Contestants. To participate in this 
Challenge visit www.challenge.gov, search for ``Start a Startup'' 
Challenge and follow the instructions.
    Submission Requirements. Each submission for this Challenge 
requires a complete ``Submission Package.'' The Submission Package 
includes a 4-page written proposal describing an idea and 5-min video 
introducing the team. Both the idea and the Founders will be evaluated.
    (1) In the proposal:
    1. Describe your research idea that would further an understanding 
of neurobiology as it relates to SUD and that is intended to be the 
basis for a successful start-up. (1 page)
    2. Convince the Challenge reviewers of your technical competence as 
a biomedical scientist. Be brief, selective and persuasive. Do not use 
the NIH Bibliographic Sketch format. (0.5 page)
    3. Describe, in as many details as possible, what the prototype of 
your product would look like. Then, walk the Challenge reviewers 
through the typical use of the product, using simple terms and 
instructions. (1.5 pages)
    4. Explain the methods you will use (how, when, where, whom) to 
determine whether the product is needed by the target audience and 
whether that audience would be willing to pay for the product. (1 page)
    The proposal must consist of a PDF file with at least 1 inch 
margins and no more than four (4) pages long. Font size must be no 
smaller than 11 point Arial. All submissions must be in English. The 
Contestants must not use HHS's logo or official seal or the logo of NIH 
or NIDA in the submissions, and must not claim federal government 
endorsement.
    (2) A brief video (link to YouTube) must be no longer than five (5) 
minutes. If the Challenge submission is from the team of Founders, the 
entire team must participate in the submitted video. In the YouTube 
video:
     Tell NIDA something, in one minute or less, that can 
illustrate the drive or the desire of each founder to develop a product 
that would further an understanding of neurobiology as it relates to 
SUD and that is intended to be the basis for a successful start-up.
     Tell NIDA something about each founder that shows a high 
level of scientific and entrepreneurial ability.
     Tell NIDA something about each founder that shows a high 
level of perseverance and grit.
     Tell NIDA about a time when your great idea was rejected. 
What was your response?

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     Tell NIDA how you design scientific experiments in 
general.
    Amount of the Prize; Award Approving Official. Up to ten monetary 
prizes will be awarded. The total prize award pool is up to $100,000. 
No institutional indirect costs are allowed. 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/NIDA will comply with the Internal Revenue Service 
withholding and reporting requirements, where applicable.
    Basis upon Which the Winner Will Be Selected. The judging panel 
will make recommendations to the award approving official based upon 
the following 5 criteria. Each criterion will be scored with the 
maximum of 10 points.
    (1) Significance and Unmet Needs (0-10 points). Are there 
significant needs for your product or service? Does the project address 
an important problem or a critical barrier to progress in the field of 
drug abuse research? If the aims of the project are achieved, how will 
scientific knowledge, technical capability, service or clinical 
practice be improved?
    (2) Innovation (0-10 points). Does the submission seek to shift 
current paradigms by utilizing novel theoretical concepts, approaches, 
methodologies, instrumentation, service or interventions for drug abuse 
research? Is your product novel in a broad sense? Is a refinement, 
improvement or new application of theoretical concepts, approaches or 
methodologies instrumentation or interventions proposed?
    (3) Approach (0-10 points). Are the overall strategy, methodology, 
and analyses well-reasoned and appropriate to test the proposed idea? 
Has feedback from end users been incorporated into the validity of the 
idea proposed?
    (4) Team expertise (0-10 points). Does the individual or team 
demonstrate high level of ability, perseverance and grit?
    (5) Commercialization (0-10 points). Is there a clear path for the 
product/service to reach the market? Are the product users and 
purchasers clearly identified?
    Submissions that are responsive and comply with the entry 
requirements will be reviewed by a panel of judges consisting of 
federal employees. The responsive and compliant submissions entries 
will be scored in accordance with the judging criteria outlined above. 
Final recommendations will be determined by a vote of the judges based 
on score. Scores from each criterion will be weighted equally, but 
failure to meet a minimum standard for any one criterion might 
disqualify a submission. The score for each submission will be the sum 
of the scores from each of the voting judges.

    Authority:  15 U.S.C. 3719

    Dated: June 7, 2016.
Nora D. Volkow,
Director, National Institute on Drug Abuse, National Institutes of 
Health.
[FR Doc. 2016-13936 Filed 6-10-16; 8:45 am]
 BILLING CODE 4140-01-P