Notice Number: NOT-AT-14-004
Release Date: July 2, 2014
Response Date: September 2, 2014
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.
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.
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:
Perceived barriers to securing SBIR/STTR grants:
Comments relating to the complementary and integrative medicine practitioner, other health care professional or distributor of complementary and integrative medicine-related products and services:
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.
Please direct all inquiries to:
John S. Williamson, PhD
National Center for Complementary and Alternative Medicine (NCCAM)