Announcement of Requirements and Registration for “Propose New Ideas For Prescription Drugs Oral Overdose Protection”, 28862-28864 [2013-11689]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28862-28864]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11689]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Announcement of Requirements and Registration for ``Propose New 
Ideas For Prescription Drugs Oral Overdose Protection''

    Authority: 15 U.S.C. 3719.

SUMMARY: Prescription drug abuse is a growing drug problem for America. 
The ``Propose New Ideas For Prescription Drugs Oral Overdose 
Protection'' is a Challenge to find new and creative ways that diminish 
or eliminate overconsumption of intact opioid pills. This notice 
provides information about the requirements and registration for the 
Challenge.

DATES: (1) Submission Period begins May 13, 2013, 12:01 a.m., EDT.
    (2) Submission Period ends June 14, 2013, 11:59 p.m., EDT.
    (3) Judging will take place between June 17-June 30, 2013.
    (4) Winners will be notified and prizes awarded July 8, 2013.

FOR FURTHER INFORMATION CONTACT: Dr. Elena Koustova, Director, Office 
of Translational Initiatives and Program Innovations, Office of 
Director, National Institute on Drug Abuse; NIDA Challenge Manager; 
NIDA SBIR/STTR Coordinator; Phone: 301-496-8768; email: 
koustovae@nida.nih.gov; elena.koustova@nih.gov .

SUPPLEMENTARY INFORMATION: 

Subject of Challenge Competition

    Prescription drugs are the second-most abused category of drugs in 
the United States, following marijuana. The most commonly misused 
prescription drugs fall into three classes:
     Opioids (pain relievers, analgesics) which include 
oxycodone (OxyContin, Roxicodone), hydrocodone (Vicodin, Lortab), and 
methadone (Dolophine);
     Central nervous system (CNS) depressants which include 
butalbital (Fiorinal, Fioricet, Axocet), diazepam (Valium), and 
alprazolam (Xanax);
     Stimulants which include methylphenidate (Ritalin) and 
amphetamine/dextroamphetamine (Adderall)
    Because prescription drugs are legal, they are easily accessible, 
often from a home medicine cabinet. The latest report from the National 
Survey on Drug Use and Health indicates that 70% of people who abuse 
prescription pain relievers got them from friends or relatives. 
Surprisingly, the individuals who abuse prescription drugs, 
particularly teenagers, believe that these

[[Page 28863]]

substances are safer than illicit drugs because they are prescribed by 
a healthcare professional. However, they are just as dangerous and 
deadly as illegal drugs when used improperly and for non-medical 
reasons.
    The possibility that patients will abuse, become addicted to, or 
unlawfully channel their prescribed pharmaceuticals to the illicit 
marketplace is one of the greatest risks associated with prescribing 
opioid medications in pain management practice. Meanwhile, overdoses 
from opiate drugs which were once almost always directly linked to 
illegal heroin use, are now increasingly due to abuse of prescription 
painkillers.
    Prescription pain medication containing opioids can be abused in 
several ways, crushing the pills to facilitate nasal entry into the 
body, dissolving the powder in water to create an injectable substance, 
or taking the pills orally intact (the focus of this Challenge), just 
to name a few. Pharmaceutical industry and academic researchers are 
focusing on drug formulations that limit the availability of drugs that 
can be abused by pill ``crushing,'' injecting and snorting. Abuse of 
prescription drugs by the means of injection and inhalation can be 
limited or prevented when those abuse-deterrent formulation 
technologies are successfully deployed. Unfortunately, the oral (as 
intended) administration, when the drug delivery system is not altered 
by the user, can still lead to addiction and accidental overdose. The 
misuse of prescription drugs by persons who over-consume prescribed 
medications remains less of a research focus.
    NIDA is seeking ideas on how to reduce or eliminate the risk of 
harm from accidentally or intentionally swallowing too many pills at 
the same time. NIDA is particularly interested in approaches that deter 
overdosing on an intact product. This Challenge is a broad question 
formulated to obtain access to new ideas, similar to a global 
brainstorm for producing a breakthrough. This Challenge is not looking 
for ideas to reformulate medication so that an individual would not be 
able (abuse resistance) or would not want (abuse deterrence) to 
manipulate the prescription drug.
    Submitted ideas should take into consideration that the proposed 
approach should also maintain the original drug efficacy, be devoid of 
new safety issues for the intended population, avoid harming a 
potential abuser, and be economically viable.
    This Challenge is in accordance with NIDA's statutory authority, 
described in 42 U.S.C. 285o. The general purpose of the National 
Institute on Drug Abuse is the conduct and support of 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 also in 
accordance with NIDA's strategic goals to prevent the initiation of 
prescription drug abuse and the escalation to addiction in those who 
have already initiated use. Furthermore, this Challenge will serve as a 
vehicle to promote cross-cutting priorities identified in a NIDA's 
current strategic plan to attract new and diverse expertise and 
experiences in various non-traditional areas to drug abuse research 
area, including chemistry, physics, bioengineering, and mathematics. 
Through this Challenge, NIDA hopes that global brainstorming about the 
stoppage of inappropriate use of prescription medications, which is a 
major public health challenge for our nation, will produce breakthrough 
ideas and reinvigorate the addiction research.

Entry Materials

    All Entry Materials, including items a. through d., must be 
submitted to Challenge.gov which is an online challenge platform 
administered by the U.S. General Services Administration (GSA) that 
empowers the U.S. Government and the public to bring the best ideas and 
top talent to bear on our nation's most pressing challenges. Access the 
www.challenge.gov Web site and search for ``Propose New Ideas For 
Prescription Drugs Oral Overdose Protection.''
    Other than providing your contact information as described below, 
please do not submit any other confidential information. Entry 
Materials should include a technological summary as follows of not more 
than 5 pages:
    a. TITLE PAGE (1 page). Include a title and abstract (<350 words) 
for the idea. Each person submitting Entry Materials (each referred to 
herein as a Solver) should include on the title page his or her name, 
phone and fax numbers, email and mailing address.
    b. DESCRIPTION OF THE IDEA (3 pages). Provide a background and 
outline how your idea would function to limit/eliminate overconsumption 
of intact opioid tablets. Use detailed descriptions, specifications, 
supporting precedents, analysis of existing data, drawings, figures, 
movies, and/or other media to define your proposal clearly. Up to 5 
images (.jpg figures), one 3-min video file, or other media files of 
comparable length can be included.
    c. REFERENCES (no page limit). References should be included in 
your submission, but this section will not count toward the overall 
page total.
    d. WRITTEN CONSENT to the eligibility rules upon or before 
submitting an entry.
    Solver is eligible to submit as many distinct entries as she/he 
would like; however, each submission must include a complete package, 
items a through d, as outlined above. All Entry Materials must be in 
English.

Rules for Participating in the Challenge Competition

    To be eligible to win a prize under this Challenge, an individual 
or entity:
    (1) Shall have registered to participate in the Challenge under the 
rules promulgated by the National Institute on Drug Abuse (NIDA);
    (2) Shall have complied with all the requirements under this 
section;
    (3) In the case of a private entity, shall be incorporated in and 
maintain a primary place of business in the United States;
    (4) In the case of an individual, must be at least 18 years old at 
the time of entry;
    (5) Whether participating singly or in a group, individual(s) shall 
be a citizen(s) or permanent resident(s) of the United States;
    (6) May not be a Federal entity or Federal employee acting within 
the scope of their employment;
    (7) Shall not be an HHS employee working on their submission(s) 
during assigned duty hours;
    (8) Shall not be an employee of the National Institutes of Health 
(NIH); however, employees of other Operating Divisions within HHS 
(e.g., Centers for Disease Control and Prevention (CDC), Substance 
Abuse and Mental Services Administration (SAMHSA)) are eligible to 
participate;
    (9) In the case of Federal grantees may not use Federal funds to 
develop a Challenge submission unless it is consistent with the purpose 
of their grant award;
    (10) In the case of Federal contractors may not use Federal funds 
from a contract to develop a Challenge submission or to fund efforts in 
support of a Challenge submission.
    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.

[[Page 28864]]

Process for Registration and Submitting an Entry

    To register for this Challenge, Solvers must access the 
www.challenge.gov Web site and search for ``Propose New Ideas For 
Prescription Drugs Oral Overdose Protection.'' A registration link for 
the Challenge can be found on the landing page under this Challenge 
description.

Amount of the Prize

    Up to three prizes worth a total of $15,000 ($5,000 each) will be 
awarded to submission(s) that satisfy all the Challenge criteria 
(below) and receive the highest cumulative scores.

Payment of the Prize

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

Basis Upon Which the Winner Will Be Selected

    This Challenge is formulated to elicit new ideas, similar to a 
global brainstorm for producing a breakthrough. Submissions will be 
received and reviewed by the judging panel comprised of the experts in 
the area of prescription drug abuse research and pain management. The 
judging panel will evaluate each submission based on the following 
equally-weighted criteria:
    1. Scientific foundation for the proposed idea, e.g. well-founded 
line of thought that is supported by the scientific literature or 
otherwise found to be accurate;
    2. Idea novelty and originality;
    3. Potential for development, including whether the submission will 
or is likely to:
    (1) Preserve the original drug efficacy;
    (2) Avoid new safety issues for the intended population of pain 
patients;
    (3) Avoid harming a potential abuser;
    (4) Be suitable for further research development and be 
commercially viable.
    Scores from each criterion will be weighted equally for a maximum 
score of 120 (40 points each). Entry Materials from all submissions 
will be held until after the deadline is reached for a simultaneous 
review process. The evaluation process will begin by de-identifying the 
submissions and removing those that are not responsive to this 
Challenge or not in compliance with all rules of eligibility. NIDA 
reserves the right to disqualify and remove any submission which is 
deemed, in the judging panel's discretion, inappropriate, offensive, 
defamatory, or demeaning. Judges will examine all submissions in 
accordance with the criteria outlined above and meet to discuss all 
responsive submissions. Final ranking and recommendations will be 
determined by a vote.

Additional Information

Submission Rights

    Solvers must agree that their submission is their original work, 
and that all proposed ideas must be the Solver's original effort. The 
Entry Materials must not violate or infringe the rights of other 
parties, including, but not limited to privacy, publicity, or 
intellectual property rights, or material that constitutes copyright or 
license infringement.

Intellectual Property (IP)

    NIDA does not wish to receive or hold any IP related to submitted 
ideas. Solvers will retain all IP rights; however, each Solver may be 
asked to grant to NIDA a royalty-free non-exclusive worldwide license 
to use, copy for use, perform publicly, and display publicly all parts 
of the submission for the purposes of the Challenge. This statement 
serves as a notice to Solvers that granting this license to NIDA, if 
asked, is a condition of participation.

Liability

    By participating in this Challenge, Solvers agree to assume any and 
all risks and waive claims against the Federal Government and its 
related entities, except in the case of willful misconduct, for any 
injury, death, damage, or loss of property, revenue, or profits, 
whether direct, indirect, or consequential, arising from their 
participation in the Challenge, whether the injury, death, damage, or 
loss arises through negligence or otherwise.

Indemnification

    By participating in this Challenge, Solvers agree to indemnify the 
Federal Government against third party claims for damages arising from 
or related to Challenge activities. This statement serves as a notice 
to Solvers that they are obligated to indemnify the government as a 
condition of participation.

Insurance

    Based on the subject matter of the Challenge, the type of work that 
it will possibly require, as well as an analysis of the likelihood of 
any claims for death, bodily injury, or property damage, or loss 
potentially resulting from Challenge participation, solvers are not 
required to obtain liability insurance or demonstrate financial 
responsibility in order to participate in this Challenge.

    Dated: May 10, 2013.
Nora Volkow,
Director, National Institute on Drug Abuse, National Institutes of 
Health.
[FR Doc. 2013-11689 Filed 5-15-13; 8:45 am]
BILLING CODE 4140-01-P