Notice Number: NOT-DE-14-006
Key Dates
Release Date: June 9, 2014
Response Date: July 31, 2014
None
Issued by
National Institute of Dental and Craniofacial Research (NIDCR)
Purpose
The purpose of this Request for Information (RFI) is to solicit comments from a broad pool of stakeholders in the dental, oral and craniofacial research and business communities as well as other health care professionals and product distributors that may assist NIDCR staff with enriching the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) research programs.
Background
The National Institute of Dental and Craniofacial Research (NIDCR) is the Federal Government's lead agency for supporting scientific research on oral, dental and craniofacial health and disease. NIDCR is one of the National Institutes of Health (NIH) in the U.S. Department of Health and Human Services. NIDCR's mission is to improve oral, dental and craniofacial health through research and research training, and by sharing science-based health information with the public and health care professionals.
The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) research programs as established by law (SBIR/STTR Reauthorization Act of 2011) 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 dental and craniofacial practitioners, other health care professionals and distributors of oral and dental 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 dental, craniofacial and oral health product market space having the greatest impact on advancing health care for all communities. 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 dental products, therapeutics and services and comments for enhancement; specifically:
- Obtaining information to judge adequately the commercial potential of new dental and craniofacial products, 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 NIDCR 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 dental practitioner, other health care professional or distributor of dental products and services:
- Experiences and perceptions regarding the current oral and dental product space particularly to those areas recognized as having either the greatest or least need for new products, therapeutics or services
- How this community would view dental and craniofacial product needs changing over the next 2, 5, or 10 years and in what specific product categories
- Development of products, equipment and supplies for use in non-traditional care settings such as homes, schools and institutions
Submitting a Response
All responses must be submitted via email to NIDCRsmallbusiness@mail.nih.gov by July 31, 2014. Please include the Notice number NOT-DE-14-006 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 NIDCR staff. 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. The NIDCR 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:
R. Dwayne Lunsford, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-2421
Email: lunsfordr@nidcr.nih.gov
and Human Services (HHS)
