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

Solicitation Number: N43DA-15-8921
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute on Drug Abuse
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N43DA-15-8921
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Solicitation
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Added: May 29, 2014 4:59 pm
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.
Added: Jul 07, 2014 11:08 am Modified: Aug 05, 2014 1:26 pmTrack Changes
Added: Jul 16, 2014 11:19 am

Purpose: To establish a due date for proposal intent notices. The proposal intent due date is 8/30/2014. The proposal submission due date remains unchanged. That date remains 9/30/2014.


Page 43 of the RFP is changed to read:


Any small business concern that intends to submit an SBIR contract proposal under this solicitation should provide the appropriate contracting officer(s) with early, written or emailed notice of its intent, giving its name, address, telephone, e-mail, and topic number(s) by 8/30/2014. If a topic is modified or canceled before this solicitation closes, only those companies that have expressed such intent will be notified.

Emailed intent notices can be sent to ecig.sbirinfo@mail.nih.gov


 

Added: Jul 24, 2014 1:04 pm
The presentation slides for the July 29, 2014 webinar are attached. 

Additionally, please notify us by email at: ecig.sbirinfo@mail.nih.gov if you intend to call in to the webinar.  This will assist NIDA in making sure there are enough phone lines. 
Added: Jul 29, 2014 4:43 pm Modified: Aug 05, 2014 1:26 pmTrack Changes

Webinar Presentation [information for applicants] from July 29, 2014. 

Added: Aug 08, 2014 10:35 am
Purpose: To answer a question related to the Soliciation:

Question: Is there any preference for the standardized electronic cigarette to be a (i) disposable e-cigarette, (ii) rechargeable e-cigarette, or (iii) vaping device (with separate liquid which is filled by the user)?

Answer: All device types will be considered. However, for safety reasons it is important that the end user does not have access to the e-liquid and any vaping device would need to use a tank that is not fillable by the end user.
Phase 2 of the project involves a trial that will consider usability, desirability (to the user) and durability of the device and so these characteristics should be considered in the initial application. Please remember the process is competitive and expert reviewers will consider the likely feasibility of the end product.


Added: Sep 04, 2014 3:28 pm

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.


 

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Solicitation 1

Type:
Solicitation
Posted Date:
June 23, 2014
Description: PROGRAM SOLICITATION PHS 2015-3; NIDA REFERENCE NUMBER N43DA-15-8921;
TOPIC 156 "Development of a Standardized Electronic Cigarette for Clinical Research"

Deadline for Receipt: Proposals must be submitted by September 30, 2014, 4:30PM Eastern Time

Presentation Slides

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
Presentation Slides
Posted Date:
July 24, 2014
Description: Presentation Slides

To attach the presentation of the Webinar

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
To attach the presentation of the Webinar
Posted Date:
July 29, 2014
Description: To attach the presentation of the Webinar
Description: To attach the presentation of the Webinar (different format)

Webinar Presentation [information for applicants] from July 29, 2014.

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
Webinar Presentation [information for applicants] from July 29, 2014.
Posted Date:
August 5, 2014
Description: Webinar Presentation [information for applicants] from July 29, 2014.

Webinar Presentation [information for applicants] from July 29, 2014.

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
Webinar Presentation [information for applicants] from July 29, 2014.
Posted Date:
August 5, 2014
Description: Webinar Presentation [information for applicants] from July 29, 2014.
:
6001 Executive Boulevard
Room 4211 - MSC 9559
Bethesda, Maryland 20892
United States
:
Brian H O'Laughlin,
Contracting Officer
Phone: (301) 443-6677
Fax: (301) 443-7595