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

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of offers is NOT extended. All other terms and conditions of the Request for Proposals (RFP) remain unchanged.

PURPOSE OF AMENDMENT: To answer additional questions related to the Solicitation.

The questions and answers below are focused on significant clarifying information.  Any question from your inquiry that was not answered is due to the solicitation being clear and accurate on what is required at the completion of Phase 1, or due to the question addressing Phase 2 issues which are outside of this solicitation such as an IND.

Question 4: What is the likely regulatory jurisdiction (CDER or CDRH) that the offeror shall anticipate will manage regulation of the product?

Answer 4: The FDA stated that the primary contact for electronic cigarettes is CDER.  This information can be found here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM225263.pdf

Question 5: In the section “Phase I Activities and Expected Deliverables”, the solicitation states, “A DMF for the device including all liquid formulations, completed to FDA specifications (see Drug Master File: Guidelines).”  Our understanding is that the FDA would require a Master File for Device (MAF), not a DMF.  Please clarify.

Answer 5:   The DMF is not for the device, but covers the liquid formulations and includes characterization of the aerosol generated.   For Phase 1 of the solicitation, only a DMF (not an MAF) is a required deliverable.  The DMF required is a Type II:  Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product. 

Question 6: Please clarify the entity responsible for holding and maintaining the IND and DMF?

Answer 6:  All intellectual property including patents and FDA filings will follow the standard data rights clauses. Please see page(s) 20, 23-24 of the RFP.

Question 7: Should the offeror obtain guidance concerning product characterization from the FDA as a component of the Phase 1 or Phase 2 scope of work?

Answer 7:  Meetings with the FDA may or may not be a deliverable for a Phase 2 award, but are not a deliverable in the Phase 1 solicitation.

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of offers is NOT extended. All other terms and conditions of the Request for Proposals (RFP) remain unchanged.


PURPOSE OF AMENDMENT: To answer additional questions related to the Solicitation.

Question 3. For purposes of responding to this solicitation, will it be sufficient if the applicant describes their manufacturing practices, since there are no established GMPs for e-cigarettes?     

Answer 3. 

It is expected that reagents used in the electronic cigarettes will be USP grade using available cGMP.  Propylene glycol, for example, has standards of purity required for food, cosmetic and pharmaceutical applications which could be considered appropriate even though there is not specific guidance for electronic cigarettes.  If there are reagents you use which do not fit into this category, feel free to explain the standards you are using.

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of offers is NOT extended. All other terms and conditions of the Request for Proposals (RFP) remain unchanged.

PURPOSE OF AMENDMENT: To answer additional questions related to the Solicitation.

Question 2. Is 156b looking specifically at the development of the hardware device, which device could accommodate any of a number of eLiquids, or can the suitability of the hardware device be more or less 'taken for granted, with a specific area of focus being developing an eLiquid formula that has the best characteristics to encourage smoking cessation?

 Answer 2. The RFP is to develop a product that is completely characterized to a level that would satisfy the FDA to allow it to be used in clinical research. These requirements cover both standards used in the manufacture of the device and liquid and characterization of the nicotine and other compounds liberated in the vapor. As such the device and e-liquid need to be considered as a single item.

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of offers is NOT extended. All other terms and conditions of the Request for Proposals (RFP) remain unchanged.

PURPOSE OF AMENDMENT: To answer additional questions related to the Solicitation.

Question 1. Is the ISO 17025 a minimum requirement or an exact requirement for this SBIR?  

Answer 1. If you are referring to the difference between ISO 9001:2008 and the ISO 17025 requirement mentioned in the SBIR solicitation, and whether compliance with ISO 9001:2008 is sufficient, It is our understanding that ISO 17025 goes much further than ISO 9001:2008 in ensuring the quality of a laboratory's work. Therefore, having ISO 9001:2008 is not sufficient to meet the standards of ISO 17025.

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 is planned to be available electronically in January 2015. At the earliest it will be posted 15 days from this notice. 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.

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.