Notice Number: NOT-AT-14-004
Key Dates
Release Date:
July 2, 2014
Response Date: September 2, 2014
None
Issued by
National Center for Complementary and Integrative Health (NCCIH
formerly NCCAM)
Purpose
The purpose of this Request for Information (RFI) is to solicit comments from a broad pool of stakeholders in the complementary and integrative medicine research (including natural products, probiotics, and mind/body approaches) and business communities as well as other health care professionals and product distributors that may assist NCCAM staff with enriching the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) research programs.
Background
The National Center for Complementary and Alternative Medicine (NCCAM) is the Federal Government's lead agency for scientific research on complementary and integrative medicine. We are 1 of the 27 institutes and centers that make up the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services.
The mission of NCCAM is to define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative medicine interventions and their roles in improving health and health care.
The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) research programs as established by law (SBIR/STTR Reauthorization Act of 2011, P.L. 112-81) are intended to meet the following goals: stimulate technological innovation in the private sector; strengthen the role of small business in meeting Federal research and development (R&D) needs; increase the commercial application of Federally supported research results; foster and encourage participation by socially and economically disadvantaged small business concerns (SBCs) and women-owned business concerns; and improve the return on investment from Federally-funded research for economic and social benefits to the Nation. The SBIR and STTR programs are structured in three phases, the first two of which are supported using Federal funds. The objective of Phase I is to establish the technical/scientific merit and feasibility of the proposed research and development (R&D) effort. The objective of Phase II is to continue the research or R&D efforts initiated in Phase I. The primary objective of the SBIR and STTR programs is to increase private sector commercialization of innovations derived from Federal R&D. The objective of Phase III, where appropriate, is for the SBC to pursue with non-SBIR/STTR funds (either Federal or non-Federal) the commercialization objectives resulting from the results of the research funded in Phases I and II. The SBIR and STTR programs differ in two ways, one relates to the Principal Investigator (PI) and the other relates to a research partner. Under SBIR, the PI must be primarily employed with the SBC at the time of award and for the duration of the project period. Under the STTR Program, primary employment is not stipulated so the PI may be from the small business or the collaborating non-profit research institution. With regard to the research partner, SBIR permits, and in fact, encourages, research partnerships. However, STTR requires that the SBC formally collaborate with a non-profit research institution.
Request for Information
Public comment is sought on the following topics both from the perspective of the SBC as well as complementary and integrative medicine scientists and practitioners, other health care professionals and distributors of complementary and integrative medicine-related products and services. While we recognize that many issues facing small businesses will be universal to many markets and business areas, we ask that responses be directed specifically to the marketing of tools and technologies to advance rigorous research and the safe and effective use of natural products, probiotics, and mind and body interventions. It will help us understand comments if respondents identify their specific business category (i.e., first time SBC applicant, previous SBIR/STTR grantee, entrepreneur, academic partner, venture capital firm, technology transfer office, market analyst, product distributor, etc.).
Possible areas for comment include, but are not limited to the following:
Impediments to innovation and commercialization of complementary and integrative medicine products, therapeutics and services and comments for enhancement; specifically:
- Obtaining information to judge adequately the commercial potential of new tools and technologies, therapeutics or services
- Difficulties encountered due to regulatory approval
- Concerns regarding intellectual property protection
- Concerns regarding cost-of-goods and return on investment
- Difficulties with facilitating and enhancing interactions between entrepreneurs and commercial partners
- Difficulties identifying new market opportunities
Perceived barriers to securing SBIR/STTR grants:
- Awareness of the SBIR/STTR programs and their role in supporting product development and commercialization
- Understanding the differences between Phase I and Phase II in technical requirements and the SBC
- Concerns regarding the size of SBIR/STTR awards and requirements for partnership
- Understanding the NIH peer review process
- Identifying NCCAM priorities and obtaining information through interactions with institute staff
- Finding appropriate collaborators when needed
- Completing application materials and company registrations
- Adapting business activities to the NIH application and grant processes
- Advantages/disadvantages of using government funding versus private capital for product development
Comments relating to the complementary and integrative medicine practitioner, other health care professional or distributor of complementary and integrative medicine-related products and services:
- Experiences and perceptions regarding the current areas of technology recognized as having either the greatest or least need for new products, therapeutics or services
- How this community would view complementary and integrative medicine-related product needs changing over the next 2, 5, or 10 years and in what specific product categories
Comments and ideas related to new, previously unidentified scientific interest areas with the potential for SBIR/STTR awards to make significant improvement and impact to the complementary and integrative medicine field.
Submitting a Response
All responses must be submitted via email to Dr. John Williamson at john.williamson@nih.gov by September 2, 2014. Please include the Notice number NOT-AT-14-004 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 NCCAM staff 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. The NCCAM will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. However, responses to the RFI may be reflected in future funding opportunity announcements. The information provided will be analyzed and may appear in reports. 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. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).Inquiries
Please direct all inquiries to:
John S. Williamson, PhD
National Center for Complementary and Alternative Medicine (NCCAM)
Email: john.williamson@nih.gov
and Human Services (HHS)
