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SBIR Topic 156 "Development of a Standardized Electronic Cigarette for Clinical Research"

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Agency: Department of Health and Human Services
Program/Year: SBIR / 2014
Solicitation Number: N43DA-15-8921
Release Date: June 23, 2014
Open Date: June 23, 2014
Close Date: September 30, 2014 (closing in 63 days)
001: Synopsis
Description:

The National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), Bethesda, MD 20892 will be soliciting proposals from small business concerns that possess the research and development (R&D) expertise to conduct innovative research that will contribute toward meeting the program objectives.

NIDA has an interest in understanding the consequences of nicotine addiction and promoting research into smoking cessation and reduction of harm caused by smoking. Electronic nicotine delivery systems (ENDS, also known as electronic cigarettes) are recently developed devices that deliver nicotine along with other constituents and flavorings in an inhalable aerosol. NIDA has an interest in supporting research into ENDS because their use is rapidly increasing in adults and youth, and they may also represent a valuable opportunity for harm reduction and smoking cessation. The currently available research data on ENDS is insufficient to fully inform public policy or to assess their overall impact on public health. Research is hampered for several reasons, including the limited information available on the nicotine delivery characteristics and uncertainty that any specific model will be available for the full term of a multi-year study. Furthermore, currently available devices do not have the product data and manufacturing documentation required for Investigational New Drug (IND) approval, thereby preventing their use in many clinical studies. In order to accelerate ENDS research, NIDA is seeking proposals to develop a standardized ENDS to be used in clinical research. This request for proposals may be most relevant (but not limited) to current ENDS manufacturers, provided they are eligible to apply to the SBIR program.

The solicitation will be available electronically on or about June 16, 2014. You will access the solicitation through the FedBizOpps (URL: http://www.fbo.gov) or through the NIDA website: (URL: http://www.nida.nih.gov/RFP/RFPList.html). All information required for the submission of a proposal is contained in or accessible through the solicitation package. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract. NIDA plans a closing date of September 30, 2014, for receipt of proposals. The solicitation will be available ONLY via electronic means. Printed copies of the solicitation will not be distributed. Potential offerors are encouraged to check the fedbizopps.gov for updates on the program. Any updates or corrections to the solicitation will be posted there.
The purposes of the SBIR program are to: (a) stimulate technological innovation in the private sector; (b) strengthen the role of small business in meeting Federal research/research & development (R/R&D) needs; (c) increase the commercial application of Federally-supported research results; (d) foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns; and improve the return on investment from Federally-funded research for economic and social benefits to the Nation. For purposes of the SBIR program, a small business concern is any business concern that, on the date of award, (1) is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; (2) is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture; (3) more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern AND (4) has, including its affiliates, no more than 500 employees.