SBIR Topic 156 "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. If, by virtue of this amendment, you desire to change an offer already submitted, you may make such change by letter, provided each letter makes reference to the solicitation and this amendment and is received by NIDA at the place designated for the receipt of offers prior to the due date and hour specified. 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. It seems the language of the call for submissions and the July 2014 webcast give the impression that funds will be awarded exclusively for the development of selected NEW designs; if this is the case, do we assume that existing e-cig and vaping models are precluded from consideration? Answer 1. The limited resources available for these awards are such that they are most likely to attract an offeror who already has a design and can use the funds to perform the characterization required. However, any device might be acceptable so long as the design meets the required criteria. Question 2. There are more than two viable vaping models on the market; ultimately, only two models will be chosen for the final phase of the study. Is it a foregone conclusion that only one model will win out (with maybe two versions of that winning model being represented)? Answer 2. It is not a foregone conclusion. This SBIR Contract solicitation strives to encourage scientific and technical innovation in areas specifically identified by the Government. As such at the end of Phase II, it will be up to each company to determine if it wants to take its device forward into the marketplace. Question 3. How does the schedule run from here? When does NIH expect the final selection(s) to be made? Answer 3. Proposals are due September 30, 2014, 4:30PM Eastern Time. The anticipated Scientific and Technical Merit Review date is October/November 2014. The anticipated award date is March 2015. Question 4. Is there any overlap or collaboration between NIH's selection of a testing standard for e-cigarettes and the FDA-contracted work being done to recommend regulations on e-cigarettes? Answer 4. This solicitation is an offering from only NIDA/NIH, as such there is no collaboration or known overlap with FDA on this solicitation. Question 5. Is NIH funding this selection program entirely on government funds, or are private/corporate funds included? This is an SBIR contract, as opposed to a government supply contract. Answer 5. NIH is funding this SBIR program entirely with Government funds. Question 6. With about a week to go before the August deadline, how many notices of intent to submit have been received? Answer 6. NIDA cannot release this information (Procurement Sensitive Information). Question 7. Have there been complaints or push-back on the program, perhaps with manufacturers claiming that the commitment to produce a given line for five years may not be profitable, or that foreign-made e-liquids are impossible to guarantee? This is a general question to see if the industry has chaffed over the demands of creating a test-worthy model. Answer 7. No, all inquiries have been by potential applicants seeking additional details of the solicitation. When inquiries by potential applicants seeking additional details of the solicitation have resulted in answers that provide new information or clarification, NIDA released this information as a formal amendment to the solicitation in order to ensure all applicants have access to the same information. Question 8. Is your goal to find a single, clear choice, whether it is a mod, or a cig-a-like e-cig, or a tobacco vaporizer like the Ploom/PAX model, or could one of the final two selections be a Ploom/PAX style selection and the other a mod with a contained tank, or an e-cig, etc.] Answer 8. The solicitation only seeks devices that use nicotine dissolved in a liquid.