81_FR_38306 81 FR 38193 - Announcement of Requirements and Registration for “$100,000 for Start a SUD Startup” Challenge

81 FR 38193 - Announcement of Requirements and Registration for “$100,000 for Start a SUD Startup” Challenge

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 113 (June 13, 2016)

Page Range38193-38195
FR Document2016-13936

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.

Federal Register, Volume 81 Issue 113 (Monday, June 13, 2016)
[Federal Register Volume 81, Number 113 (Monday, June 13, 2016)]
[Notices]
[Pages 38193-38195]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13936]


-----------------------------------------------------------------------

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?

[[Page 38195]]

     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



                                                                               Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Notices                                             38193

                                                  This notice is being published less than 15           Research (SBIR) and Small Business                     or traditional modes of research funding
                                                days prior to the meeting due to the timing             Technology Transfer (STTR) funding.                    (e.g. small business grants).
                                                limitations imposed by the review and                   Each Challenge winner will receive                        What does it take to participate in the
                                                funding cycle.                                                                                                 Challenge? The team or an individual
                                                                                                        $10,000. The Challenge total purse is up
                                                  Name of Committee: National Cancer                    to $100,000.                                           must have a research idea that could
                                                Institute Special Emphasis Panel, Software                                                                     further the understanding of SUD and is
                                                for Measuring Environmental Effects on                  DATES: The Challenge begins June 13,
                                                                                                        2016.                                                  intended to be the basis of the
                                                Cancer.
                                                  Date: June 30, 2016.                                     Submission Period: June 13, 2016 to                 development of a new and potentially
                                                  Time: 1:30 p.m. to 5:00 p.m.                          September 16, 2016, 11:59 p.m., ET.                    successful startup. The research ‘‘idea’’
                                                  Agenda: To review and evaluate contract                  Judging Period: September 19, 2016 to               is the product that your future startup
                                                proposals.                                              October 21, 2016.                                      will offer. Here, the term startup
                                                  Place: National Cancer Institute Shady                   Winners Announced: October 24,                      ‘‘product’’ is used in its broadest
                                                Grove, 9609 Medical Center Drive, Room                  2016.                                                  definition. Product is any source of
                                                4W030 Rockville, MD 20850, (Telephone                                                                          value for the people who become
                                                Conference Call).                                       FOR FURTHER INFORMATION CONTACT: Irina
                                                                                                        Sazonova, Ph.D., M.Sc., Health Scientist               customers. Services, subscriptions,
                                                  Contact Person: Gerard Lacourciere, Ph.D.,
                                                Scientific Review Officer, Research                     Administrator, Office of Translational                 software as a service (SaaS), physical/
                                                Technology and Contract Review Branch,                  Initiatives and Program Innovations                    tangible products, aggregations, etc.
                                                Division of Extramural Activities, National                                                                    could all provide value and thus be
                                                                                                        (OTIPI), NIDA Challenge Administrator,
                                                Cancer Institute, 9609 Medical Center Drive,                                                                   considered startup products. The
                                                                                                        National Institute on Drug Abuse
                                                Room 7W248, Rockville, MD 20892–9750,                                                                          startup product could be the result of
                                                                                                        (NIDA), 6001 Executive Blvd. Room
                                                240–276–5457, gerard.lacourciere@                                                                              novel scientific discoveries, repurposing
                                                mail.nih.gov.                                           4206, MSC 9555 Bethesda, MD 20892–
                                                                                                                                                               an existing technology for a new use,
                                                                                                        9555. Phone: (301) 827–9564, Email:
                                                (Catalogue of Federal Domestic Assistance                                                                      extending a research observation into a
                                                Program Nos. 93.392, Cancer Construction;               irina.sazonova@nih.gov.
                                                                                                                                                               different area, devising a new business
                                                93.393, Cancer Cause and Prevention                     SUPPLEMENTARY INFORMATION: The                         model or distribution/delivery channel
                                                Research; 93.394, Cancer Detection and                  Institute’s Statutory Authority to                     that unlocks value currently concealed,
                                                Diagnosis Research; 93.395, Cancer                      Conduct the Challenge. NIDA is
                                                Treatment Research; 93.396, Cancer Biology
                                                                                                                                                               or simply bringing a product or service
                                                                                                        conducting this Challenge under the                    to previously underserved set of
                                                Research; 93.397, Cancer Centers Support;               America Creating Opportunities to
                                                93.398, Cancer Research Manpower; 93.399,                                                                      customers. The Founder (the teams or
                                                Cancer Control, National Institutes of Health,
                                                                                                        Meaningfully Promote Excellence in                     an individual) must demonstrate
                                                HHS)                                                    Technology, Education, and Science                     through the Submission the passion,
                                                                                                        (COMPETES) Reauthorization Act of                      drive, discipline, ability to work
                                                  Dated: June 8, 2016.                                  2010, 15 U.S.C. 3719. The general
                                                Melanie J. Gray,
                                                                                                                                                               collaboratively and willingness to push
                                                                                                        purpose of NIDA is to conduct and                      forward under conditions of extreme
                                                Program Analyst, Office of Federal Advisory             support biomedical and behavioral                      business uncertainty.
                                                Committee Policy.                                       research, health-services research,                       The winners of this Challenge are
                                                [FR Doc. 2016–13930 Filed 6–10–16; 8:45 am]             research training, and health-                         encouraged to use the prize funds to
                                                BILLING CODE 4140–01–P                                  information dissemination with respect                 develop a minimum viable proof (MVP)
                                                                                                        to the prevention of drug abuse and the                as quickly as possible and to obtain
                                                                                                        treatment of drug abusers. This                        customer feedback to discover if MVP
                                                DEPARTMENT OF HEALTH AND                                Challenge is consistent with and                       meets the customer needs. If the product
                                                HUMAN SERVICES                                          advances the mission of NIDA as                        prototype is successfully validated,
                                                                                                        described in 42 U.S.C. 285o in that it                 winners are encouraged to create or
                                                National Institutes of Health
                                                                                                        supports new and potential biotech                     further advance their biotech startup no
                                                Announcement of Requirements and                        start-ups in the development of research               later than 6 months after the prize is
                                                Registration for ‘‘$100,000 for Start a                 ideas that would further an                            awarded. Post Challenge, as with all
                                                SUD Startup’’ Challenge                                 understanding of neurobiology as it                    other NIH grant applicants, NIDA staff
                                                                                                        relates to SUD.                                        will provide dedicated assistance and
                                                SUMMARY:    The National Institute on                      Subject of Challenge. NIDA is excited               guidance about the NIH grant
                                                Drug Abuse (NIDA), one of the                           to announce the first competition for                  submission process, including
                                                components of the National Institutes of                biomedical scientists with the goal to                 submissions for the SBIR/STTR grants.
                                                Health (NIH), announces the ‘‘$100,000                  support research ideas that would                         The research idea must be broad
                                                for Start a SUD Startup’’ Challenge. The                further an understanding of                            enough to address multiple conditions,
                                                Challenge goal is to support research                   neurobiology as it relates to SUD and                  diseases, or indications consistent with
                                                ideas that would further an                             that are intended to be the basis for the              SUD or be specific for prevention and
                                                understanding of neurobiology as it                     development of a new and potentially                   treatments of SUD. For example, if your
                                                relates to Substance Use Disorders                      successful start-up. NIDA hopes that                   idea can only work for cancer or
                                                (SUD) and that are intended to be the                   participation in the contest will enable               diabetes, entering this Challenge is not
                                                basis for the development of a new and                  scientists to test whether their research              appropriate. However, if the plan is to
                                                potentially successful start-up. NIDA                   ideas can be fostered into a biotech                   test an idea for a research tool that
                                                hopes that participation in the contest                 startup. In 2016, NIDA will award up to                would further an understanding of
                                                will enable scientists to test the                      $100,000 in prizes to up to 10 winners                 neurobiology or epigenetics relevant to
srobinson on DSK5SPTVN1PROD with NOTICES




                                                hypothesis that their research idea can                 of the contest, $10,000 each.                          SUD to progress faster and with greater
                                                be fostered into a biotech startup, and                    Are you a biomedical scientist who                  fidelity, entering this Challenge is
                                                that eventually any newly created                       believes that he/she has a research idea               appropriate.
                                                startups will contribute to the pool of                 for a biotech start-up? This Challenge is                 Rules for Participating in the
                                                innovative small business companies                     unique because NIDA intends to fund                    Challenge. The Challenge is open to any
                                                that can successfully compete for                       the ‘‘would be’’ startup Founders much                 Founder 18 years of age or older. No
                                                NIDA’s Small Business Innovation                        earlier than most investors, incubators,               prior startup experience is necessary. A


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                                                38194                          Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Notices

                                                Founder may be (i) an entity or (ii) an                 indirect, or consequential, arising from               (MVP) report 6 months after the prize
                                                individual or group of individuals (i.e.,               participation in this Challenge, whether               payment.
                                                a team assembled with the purpose of                    the injury, death, damage, or loss arises                 Registration Process for Contestants.
                                                participating in this Challenge).                       through negligence or otherwise.                       To participate in this Challenge visit
                                                   (1) To be eligible to win a prize under                 (6) Based on the subject matter of the              www.challenge.gov, search for ‘‘Start a
                                                this Challenge, an individual or entity:                Challenge, the type of work that it will               Startup’’ Challenge and follow the
                                                   a. Shall have registered to participate              possibly require, as well as an analysis               instructions.
                                                in the Challenge under the rules                        of the likelihood of any claims for death,                Submission Requirements. Each
                                                promulgated by NIDA as published in                     bodily injury, property damage, or loss                submission for this Challenge requires a
                                                this Notice;                                            potentially resulting from Challenge                   complete ‘‘Submission Package.’’ The
                                                   b. Shall have complied with all the                  participation, no Founder (whether                     Submission Package includes a 4-page
                                                requirements set forth in this Notice;                  competing singly or in a group) or entity              written proposal describing an idea and
                                                   c. In the case of a private entity, shall            participating in the Challenge is                      5-min video introducing the team. Both
                                                be incorporated in and maintain a                       required to obtain liability insurance or              the idea and the Founders will be
                                                primary place of business or research                   demonstrate financial responsibility in                evaluated.
                                                activity in the United States, and in the               order to participate in this Challenge.                   (1) In the proposal:
                                                case of an individual, whether                             (7) By participating in this Challenge,                1. Describe your research idea that
                                                participating singly or in a group, shall               each Founder (whether competing                        would further an understanding of
                                                be a citizen or permanent resident of the               singly or in a group) and entity agrees                neurobiology as it relates to SUD and
                                                United States. However, non-U.S.                        to indemnify the Federal government                    that is intended to be the basis for a
                                                citizens and non-permanent residents                    against third party claims for damages                 successful start-up. (1 page)
                                                can participate as a member of a team                   arising from or related to Challenge                      2. Convince the Challenge reviewers
                                                that otherwise satisfies the eligibility                activities.                                            of your technical competence as a
                                                criteria. Non-U.S. citizens and non-                       (8) A Founder or entity shall not be                biomedical scientist. Be brief, selective
                                                permanent residents are not eligible to                 deemed ineligible because the Founder                  and persuasive. Do not use the NIH
                                                win a monetary prize (in whole or in                    or entity used Federal facilities or                   Bibliographic Sketch format. (0.5 page)
                                                part). Their participation as part of a                                                                           3. Describe, in as many details as
                                                                                                        consulted with Federal employees
                                                winning team, if applicable, may be                                                                            possible, what the prototype of your
                                                                                                        during the Challenge if the facilities and
                                                otherwise recognized when the results                                                                          product would look like. Then, walk the
                                                                                                        employees are made available to all
                                                are announced.                                                                                                 Challenge reviewers through the typical
                                                                                                        individuals and entities participating in
                                                   d. May not be a Federal entity;                                                                             use of the product, using simple terms
                                                                                                        the Challenge on an equitable basis.
                                                   e. May not be a Federal employee                                                                            and instructions. (1.5 pages)
                                                                                                           (9) By participating in this Challenge,                4. Explain the methods you will use
                                                acting within the scope of the
                                                                                                        each Founder (whether participating                    (how, when, where, whom) to
                                                employee’s employment and further, in
                                                                                                        singly or in a group) or entity retains                determine whether the product is
                                                the case of HHS employees, may not
                                                                                                        title and full ownership in and to their               needed by the target audience and
                                                work on their submission(s) during
                                                                                                        submission and each participant                        whether that audience would be willing
                                                assigned duty hours;
                                                   f. May not be an employee of the NIH,                expressly reserves all intellectual                    to pay for the product. (1 page)
                                                a judge of the challenge, or any other                  property rights (e.g., copyright) in their                The proposal must consist of a PDF
                                                party involved with the design,                         submission.                                            file with at least 1 inch margins and no
                                                production, execution, or distribution of                  (10) NIDA reserves the right, in its                more than four (4) pages long. Font size
                                                the Challenge or the immediate family                   sole discretion, to (a) cancel, suspend,               must be no smaller than 11 point Arial.
                                                of such a party (i.e., spouse, parent,                  or modify the Challenge, and/or (b) not                All submissions must be in English. The
                                                step-parent, child, or step-child).                     award any prizes if no entries are                     Contestants must not use HHS’s logo or
                                                   g. Must be a potential start-up (i.e. not            deemed worthy.                                         official seal or the logo of NIH or NIDA
                                                yet formed) or a new start-up (i.e. in the                 (11) Each Founder (whether                          in the submissions, and must not claim
                                                early stage of formation and                            participating singly or in a group) or                 federal government endorsement.
                                                development).                                           entity agrees to follow all applicable                    (2) A brief video (link to YouTube)
                                                   (2) Federal grantees may not use                     Local, State, and Federal laws and                     must be no longer than five (5) minutes.
                                                Federal funds to develop their                          regulations.                                           If the Challenge submission is from the
                                                Challenge submissions.                                     (12) Each Founder (whether                          team of Founders, the entire team must
                                                   (3) Federal contractors may not use                  participating singly or in a group) and                participate in the submitted video. In
                                                Federal funds from a contract to develop                entity participating in this Challenge                 the YouTube video:
                                                their Challenge submissions or to fund                  must comply with all terms and                            • Tell NIDA something, in one
                                                efforts in support of their Challenge                   conditions of these rules, and                         minute or less, that can illustrate the
                                                submission.                                             participation in this Challenge                        drive or the desire of each founder to
                                                   (4) Submissions must not infringe                    constitutes each such contestant’s full                develop a product that would further an
                                                upon any copyright or any other rights                  and unconditional agreement to abide                   understanding of neurobiology as it
                                                of any third party.                                     by these rules. Winning is contingent                  relates to SUD and that is intended to
                                                   (5) By participating in this Challenge,              upon fulfilling all requirements herein.               be the basis for a successful start-up.
                                                each Founder (whether competing                            (13) Scientists working on the projects                • Tell NIDA something about each
                                                singly or in a group) and entity agrees                 that are directly applicable or adaptable
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                                                                                                                                                               founder that shows a high level of
                                                to assume any and all risks and waive                   to benefit the SUD field, NIDA’s mission               scientific and entrepreneurial ability.
                                                claims against the Federal government                   area, are especially encouraged to apply.                 • Tell NIDA something about each
                                                and its related entities (as defined in the             A team can also include engineers, IT,                 founder that shows a high level of
                                                COMPETES Act), except in the case of                    business or other professionals in the                 perseverance and grit.
                                                willful misconduct, for any injury,                     biomedical science/health care field;                     • Tell NIDA about a time when your
                                                death, damage, or loss of property,                        (14) Winners are encouraged to                      great idea was rejected. What was your
                                                revenue, or profits, whether direct,                    submit the minimum viable proof                        response?


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                                                                               Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Notices                                                   38195

                                                   • Tell NIDA how you design                           entries will be scored in accordance                     Place: National Institutes of Health, Two
                                                scientific experiments in general.                      with the judging criteria outlined above.              Democracy Plaza, 6707 Democracy
                                                   Amount of the Prize; Award                           Final recommendations will be                          Boulevard, Bethesda, MD 20892 (Telephone
                                                Approving Official. Up to ten monetary                                                                         Conference Call).
                                                                                                        determined by a vote of the judges based
                                                                                                                                                                 Contact Person: Jason D. Hoffert, Ph.D.,
                                                prizes will be awarded. The total prize                 on score. Scores from each criterion will              Scientific Review Officer, Review Branch,
                                                award pool is up to $100,000. No                        be weighted equally, but failure to meet               DEA, NIDDK, National Institutes of Health,
                                                institutional indirect costs are allowed.               a minimum standard for any one                         Room 7343, 6707 Democracy Boulevard,
                                                The names of the winners and the titles                 criterion might disqualify a submission.               Bethesda, MD 20817, 301–496–9010,
                                                of their submissions will be posted on                  The score for each submission will be                  hoffertj@niddk.nih.gov.
                                                the NIDA Web site. The award                            the sum of the scores from each of the                   Name of Committee: National Institute of
                                                approving official for this Challenge is                voting judges.                                         Diabetes and Digestive and Kidney Diseases
                                                the Director of the National Institute on                                                                      Special Emphasis Panel; Minor Endoscopic
                                                                                                          Authority: 15 U.S.C. 3719                            Sphincterotomy for Recurrent Acute
                                                Drug Abuse.
                                                   Payment of the Prize. Prizes awarded                   Dated: June 7, 2016.                                 Pancreatitis with Pancreas Divisum.
                                                under this Challenge will be paid by                    Nora D. Volkow,                                          Date: July 25, 2016.
                                                                                                                                                                 Time: 2:00 p.m. to 3:00 p.m.
                                                electronic funds transfer and may be                    Director, National Institute on Drug Abuse,
                                                                                                                                                                 Agenda: To review and evaluate grant
                                                subject to Federal income taxes. The                    National Institutes of Health.
                                                                                                                                                               applications.
                                                NIH/NIDA will comply with the                           [FR Doc. 2016–13936 Filed 6–10–16; 8:45 am]              Place: National Institutes of Health, Two
                                                Internal Revenue Service withholding                    BILLING CODE 4140–01–P                                 Democracy Plaza, 6707 Democracy
                                                and reporting requirements, where                                                                              Boulevard, Bethesda, MD 20892 (Telephone
                                                applicable.                                                                                                    Conference Call).
                                                   Basis upon Which the Winner Will Be                  DEPARTMENT OF HEALTH AND                                 Contact Person: Paul A. Rushing, Ph.D.,
                                                Selected. The judging panel will make                   HUMAN SERVICES                                         Scientific Review Officer, Review Branch,
                                                recommendations to the award                                                                                   DEA, NIDDK, National Institutes of Health,
                                                                                                        National Institutes of Health                          Room 7345, 6707 Democracy Boulevard,
                                                approving official based upon the                                                                              Bethesda, MD 20892–5452, (301) 594–8895,
                                                following 5 criteria. Each criterion will                                                                      rushingp@extra.niddk.nih.gov.
                                                be scored with the maximum of 10                        National Institute of Diabetes and
                                                                                                        Digestive and Kidney Diseases; Notice                    Name of Committee: National Institute of
                                                points.                                                                                                        Diabetes and Digestive and Kidney Diseases
                                                   (1) Significance and Unmet Needs (0–                 of Closed Meetings
                                                                                                                                                               Special Emphasis Panel; Psychological and
                                                10 points). Are there significant needs                   Pursuant to section 10(d) of the                     Behavioral Mechanisms in Bariatric Surgery
                                                for your product or service? Does the                   Federal Advisory Committee Act, as                     (R01).
                                                project address an important problem or                 amended (5 U.S.C. App.), notice is                       Date: July 26, 2016.
                                                a critical barrier to progress in the field                                                                      Time: 1:00 p.m. to 5:00 p.m.
                                                                                                        hereby given of the following meetings.                  Agenda: To review and evaluate grant
                                                of drug abuse research? If the aims of                    The meetings will be closed to the
                                                the project are achieved, how will                                                                             applications.
                                                                                                        public in accordance with the                            Place: National Institutes of Health, Two
                                                scientific knowledge, technical                         provisions set forth in sections                       Democracy Plaza, 6707 Democracy
                                                capability, service or clinical practice be             552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,             Boulevard, Bethesda, MD 20892 (Telephone
                                                improved?                                               as amended. The grant applications and                 Conference Call).
                                                   (2) Innovation (0–10 points). Does the                                                                        Contact Person: Paul A. Rushing, Ph.D.,
                                                                                                        the discussions could disclose
                                                submission seek to shift current                                                                               Scientific Review Officer, Review Branch,
                                                                                                        confidential trade secrets or commercial
                                                paradigms by utilizing novel theoretical                                                                       DEA, NIDDK, National Institutes of Health,
                                                                                                        property such as patentable material,                  Room 7345, 6707 Democracy Boulevard,
                                                concepts, approaches, methodologies,
                                                                                                        and personal information concerning                    Bethesda, MD 20892–5452, (301) 594–8895,
                                                instrumentation, service or
                                                                                                        individuals associated with the grant                  rushingp@extra.niddk.nih.gov.
                                                interventions for drug abuse research? Is
                                                                                                        applications, the disclosure of which                  (Catalogue of Federal Domestic Assistance
                                                your product novel in a broad sense? Is
                                                                                                        would constitute a clearly unwarranted                 Program Nos. 93.847, Diabetes,
                                                a refinement, improvement or new
                                                                                                        invasion of personal privacy.                          Endocrinology and Metabolic Research;
                                                application of theoretical concepts,                                                                           93.848, Digestive Diseases and Nutrition
                                                approaches or methodologies                                Name of Committee: National Institute of
                                                                                                        Diabetes and Digestive and Kidney Diseases             Research; 93.849, Kidney Diseases, Urology
                                                instrumentation or interventions                                                                               and Hematology Research, National Institutes
                                                                                                        Special Emphasis Panel; RFA DK15–030
                                                proposed?                                                                                                      of Health, HHS)
                                                                                                        Type 1 Diabetes Pathfinder Award (DP2).
                                                   (3) Approach (0–10 points). Are the
                                                                                                           Date: July 14, 2016.                                  Dated: June 6, 2016.
                                                overall strategy, methodology, and                         Time: 8:00 a.m. to 5:00 p.m.                        David Clary,
                                                analyses well-reasoned and appropriate                     Agenda: To review and evaluate grant
                                                to test the proposed idea? Has feedback                                                                        Program Analyst, Office of Federal Advisory
                                                                                                        applications.
                                                                                                                                                               Committee Policy.
                                                from end users been incorporated into                      Place: Residence Inn Bethesda, 7335
                                                the validity of the idea proposed?                      Wisconsin Avenue, Bethesda, MD 20814.                  [FR Doc. 2016–13828 Filed 6–10–16; 8:45 am]
                                                   (4) Team expertise (0–10 points). Does                  Contact Person: Ann A. Jerkins, Ph.D.,              BILLING CODE 4140–01–P
                                                the individual or team demonstrate high                 Scientific Review Officer, Review Branch,
                                                level of ability, perseverance and grit?                DEA, NIDDK, National Institutes of Health,
                                                   (5) Commercialization (0–10 points).                 Room 7119, 6707 Democracy Boulevard,                   DEPARTMENT OF HEALTH AND
                                                Is there a clear path for the product/                  Bethesda, MD 20892–5452, 301–594–2242,                 HUMAN SERVICES
                                                                                                        jerkinsa@niddk.nih.gov.
                                                service to reach the market? Are the
srobinson on DSK5SPTVN1PROD with NOTICES




                                                product users and purchasers clearly                       Name of Committee: National Institute of            National Institutes of Health
                                                                                                        Diabetes and Digestive and Kidney Diseases
                                                identified?                                             Special Emphasis Panel; NIDDK Program                  Center for Scientific Review; Notice of
                                                   Submissions that are responsive and                  Projects (P01).                                        Closed Meetings
                                                comply with the entry requirements will                    Date: July 22, 2016.
                                                be reviewed by a panel of judges                           Time: 2:00 p.m. to 4:00 p.m.                          Pursuant to section 10(d) of the
                                                consisting of federal employees. The                       Agenda: To review and evaluate grant                Federal Advisory Committee Act, as
                                                responsive and compliant submissions                    applications.                                          amended (5 U.S.C. App.), notice is


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Document Created: 2018-02-08 07:40:11
Document Modified: 2018-02-08 07:40:11
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesThe Challenge begins June 13, 2016.
ContactIrina 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]
FR Citation81 FR 38193 

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