Request for Information (RFI): Stakeholder Needs and Requirements To Be Addressed by the Small Business Programs of the National Institute on Drug Abuse (NIDA)

Notice Number: NOT-DA-15-043

Key Dates
Release Date: March 16, 2015
Response Date: New Date June 15, 2015 per issuance of NOT-DA-15-069. (Original Date: April 17, 2015)

Related Announcements
NOT-DA-17-049

Issued by
National Institute on Drug Abuse (NIDA)

Purpose

NIDA seeks feedback from its stakeholders about the needs, necessities and requirements which could be addressed by the NIDA’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) Programs.

NIDA is looking for feedback from people who are affected by drug abuse and addiction or who are working towards addiction research, treatment, or prevention. This RFI is published to explore the perspectives of these stakeholders on their needs, reasons for using technology-based products, and the importance of a variety of product and service characteristics.

Background
NIDA is the Federal Government's lead agency for supporting scientific research on drug abuse and addiction. NIDA's mission is to lead the Nation in bringing the power of science to bear on drug abuse and addiction. NIDA-supported science addresses the most fundamental and essential questions about drug abuse, which range from the molecule to managed care and from DNA to community outreach research.

NIDA, as part of the NIH, is required by statute (SBIR/STTR Reauthorization Act of 2011) to reserve a portion of its annual extramural budget for projects under the SBIR and STTR programs. The SBIR and STTR programs are one of the largest sources of early-stage capital for innovative small companies in the United States. These programs allow small businesses to engage in federal research and development (R&D) that has a strong potential for commercialization. Commercialization is the process of introducing a new and valuable product or service into the marketplace. NIDA is interested in using SBIR and STTR programs as a tool to develop and commercialize novel technologies and services to address the immediate needs of the NIDA stakeholders.

NIDA stakeholders include everyone affected or working in the area of substance abuse and addiction. This includes, but is not limited to, NIDA supported researchers (basic and clinical), health professionals, people affected by drug abuse and addiction, patients and their families, caregivers, patient advocates, product distributors, pharmaceutical and biotechnology companies, insurance companies, investors, regulatory agencies and policy makers. They all provide multidimensional contributions to NIDA’s patient-targeted endeavors.

Request for Information

Public comment is sought on all topics in regards to what challenges individual NIDA stakeholders are facing and more specifically what type of technology and methodology NIDA may develop. The RFI is organized, but is not limited to six categories within the substance abuse community:

  • Patients, Drug Users (Including those on Prescription Medications) and their Families
  • Public Health Communities
  • Insurance and payers
  • Drug abuse researchers, R&D and general neuroscience community
  • Public Policy Makers
  • Business Sector

1. Drug Users (Including Prescriptions), Patients, and their Families

  • The effectiveness of current programs at helping people quit
  • The accessibility of current programs.
  • The type of help is currently not available.
  • The questions not being asked by the research community.

2. Public Health Communities

  • The public health community includes, but is not limited to, healthcare professionals, hospitals and emergency response, patient advocacy organizations and schools.

Healthcare Professionals

  • The effectiveness of current resources used by healthcare professionals.
  • The availability of current tools and/or methodology that are needed to help accurately diagnose and treat patients more effectively.
  • Challenges preventing physicians to ensure that patients follow the prescribed treatment plan.

Hospitals and Emergency Response

  • The effectiveness of current addiction- and drug abuse-related resources necessary for hospitals and emergency responders to be successful.
  • The availability of technology and/or methodology that can be improved to help diagnose and treat patients battling substance abuse.
  • Challenges faced by hospitals and the emergency rooms in regards to prescription drug abuse.

Patient Advocacy Organizations

  • The effectiveness of current resources and tools necessary for patient advocacy and other non-profit organizations to be successful.
  • The availability of tools and methodology that are needed to be created or improved to increase awareness about substance abuse.

Schools

  • The effectiveness of prevention programs that are available for educators to help children and young adults learn about the dangers of substance abuse.
  • The success of the resources currently available.
  • The obstacles associated with implementation of the currently available educational products in drug abuse field.
  • The availability of resources necessary for educators to help their students deal with substance abuse.

3. Insurance Carriers and Other Payers

  • The availability of resources (tools, manuals, IT products) that are necessary for insurance companies to successfully impact the covered individuals affected by substance use disorders.
  • The effectiveness of tools and/or methodology that can be improved or created to help educate and support physicians.
  • The effect of the ACA on the insurance companies as it related to people suffering from drug abuse and addiction.

4. Drug Abuse Researchers and Industrial R&D Professionals
We are looking for feedback from all investigators within all sectors of the drug abuse and addiction research community. This includes, but is not limited to, academic, biotechnology, pharmaceutical, and government laboratories.

  • The availability of resources (scientific tools, models, technologies, devices, IT products, etc.) necessary for addiction researchers to be successful.
  • The success of translating scientific discoveries into commercial products.
  • Technology and methodology currently available to develop and further improve the transition of scientific discovery to commercial products. The availability of tools, animal models, technologies, and databases necessary for the researchers and industrial R&D professionals.
  • The availability of human and animal specimen banks or protocols that are to support basic and translational research and to provide biorepository standards.
  • Dissemination of educational programs necessary to provide knowledge to academic researchers for planning and conducting the translational, industry-style, research projects including product commercialization.

5. Public Policy
The public policy sector includes, but is not limited to, the criminal justice system, and the executive and legislative branches of government.

Criminal Justice System

  • Availability of tools and resources that help the criminal justice system to be more successful in impacting the drug use.
  • Availability of tools and resources that are needed to help drug abusing offenders change their attitudes, beliefs and behaviors towards drug abuse, avoid relapse and successfully remove themselves from a life of substance abuse and crime.

Note: The main goals of drug treatment are:

  • Abstinence
  • Functionality in Family, Work and Community
  • Reduced Criminal Behavior
  • Tools and resources are needed to better match treatment services to the needs of the individual for treatment.
  • Diagnostic tools that are needed to help monitor drug use during treatment more effectively or more manageable way.

Executive/Legislature

  • Availability of additional data/reports and database that are needed to make improved executive/legislative decision.
  • Requirements and expectations from constituents back in the home districts.
  • Resources and educational programs that are desired by Federal, State and Local governments.
  • Additional research which is needed to develop a better treatment/management policy for drug treatment. (ex. Reentry, strengths-based case management, drug courts, moral reasoning, break the cycle, cognitive-behavioral treatment).

6. Business Sector
The business sector includes, but is not limited to, small businesses, state economic initiatives, investment firms and pharmaceutical companies.

Small Business

  • Resources necessary to help small businesses improve the application success rate to NIDA and NIH SBIR/STTR program.
  • Access to educational tools would assist small businesses to gain familiarity with NIDA SBIR program.
  • Additional resources or new technologies that small businesses need to move their product more efficiently through development pipeline.
  • Type of tools and methodology that small businesses need to mitigate risk and increase probability of commercialization:
  • Regulatory Evaluation
  • IP Portfolio Evaluation
  • Market Analysis
  • Help with the writing of the Business Plan with Financial Forecasts
  • Exposure of small business companies with important products to Investors.

State Economic Initiatives

  • Resources necessary for state initiatives to be more successful.
  • Tools that are needed by state economic initiatives to increase the number of startups.
  • Tools that are needed by state economic initiatives to help companies successfully develop novel technologies to help combat substance abuse and to grow.

Investors (Angel, Venture Capital Firms, Pharmaceutical Co)

  • Tools and resources that Investors need to identify promising technology-based small businesses.
  • Resources that investors need that would translate to risk mitigation and an increase in investment in more promising companies.
  • Gaps that prevent companies from getting funded (ex. Proper market analysis, IP portfolio) and resources and/or methodology that can be provided by the SBIR/STTR program to address those gaps.

Submitting a Response
NIDA is issuing this RFI to further understand the immediate needs of our community that is working in the area of drug abuse and addiction, or is affected by it. We are grateful for your interest and help. All responses must be submitted via email to NIDASBIR@mail.nih.gov. Please include the Notice number NOT-DA-15-043 in the subject line.

Response to this RFI is voluntary. Responders are free to address any or all of the categories listed above. The submitted information will be reviewed by NIDA staff. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. This request is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government. The NIH does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information. Responses to the RFI may be reflected in future funding opportunity announcements. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). The information provided will be analyzed and may appear in reports. No proprietary, classified, confidential, or sensitive information should be included in your response.

Inquiries

Please direct all inquiries to:

Elena Koustova, PhD, MBA
National Institute on Drug Abuse (NIDA)
Telephone: 301-496-8768
Email: NIDASBIR@mail.nih.gov