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