NIDA grant opportunity for small businesses to develop "standardized electronic cigarettes"

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CES

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I received this RFA from NIDA for a grant opportunity for small businesses to develop "standardized electronic cigarettes".

Not many people make it to this subforum, but perhaps someone who is already working on manufacturing and QC will see it. I'd so much rather have an actual small business that understands vaping apply for and get these funds.


https://www.fbo.gov/?s=opportunity&mode=form&id=9d121f4da6d8ecec8e6e668c10050947&tab=core&_cview=0


E-MAIL: bo50d@nih.gov bo50d@nih.gov NAICS: 541990 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 ENDSbecause 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 nicotinedelivery 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 forproposals 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:
NIDA Requests for Contract Proposals (RFPs) | National Institute on Drug Abuse (NIDA)).

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 ofsmall 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 UnitedStates 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. Nosingle 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.CITE:

https://www.fbo.gov/?s=opportunity&mode=form&id=9d121f4da6d8ecec8e6e66
8c10050947&tab=core&_cview=0Posted 05/29/14 (W-SN03379087). (0149)
 

RosaJ

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Most of these are tailored for a particular individual ( i.e. a congressman's nephew ).

Starting a venture like this in the current legal environment would be dancing in a mine field. 8-o

Oh, like when large corporations post a job opening publicly because that's what their HR policy dictates, but it's just an exercise in futility because they already have given the job to someone else?

EDIT: It's a type of nepotism...
 

CES

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So this type of grant application is not something tailored for a congressman's nephew unless the nephew is skilled at grant writing. BT would not be eligible either- there's a max number of employees, so it really is limited to a small business. It's not something that would be easy for a small business to get- but i'd really like to see one at least try.

the application has been recently updated with the following

https://www.fbo.gov/?id=10630809156f193632eca9ec2f87e651

Solicitation Number:
N43DA-15-8921
Notice Type:
Modification/Amendment
Synopsis:
Added: Jul 07, 2014 11:08 am
ANOUNCEMENT: A WEBINAR WILL BE HELD ON TUESDAY JULY 29, 2014 TO PROVIDE ADDITIONAL INFORMATION REGARDING THIS OPPORTUNITY.  ADDITIONAL INFORMATION WILL BE AVAILABLE SOON AND POSTED HERE AT FBO.GOV. 
Contracting Office Address:
6001 Executive Boulevard
Room 4211 - MSC 9559
Bethesda, Maryland 20892
United States
Primary Point of Contact.:
Brian H O'Laughlin,
Contracting Officer
bo50d@nih.gov
Phone: (301) 443-6677
Fax: (301) 443-7595
 

CES

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Here's the latest amendment to the grant RFA

Program Number: 41009
Title: RFP -- Amendment -- SBIR Topic 156 Development of a Standardized Electronic Cigarette for Clinical Research

Sponsor: National Institutes of Health/DHHS

SYNOPSIS: A -- SBIR TOPIC 156 "DEVELOPMENT OF A STANDARDIZED
ELECTRONIC CIGARETTE FOR CLINICAL RESEARCH" SOL N43DA-15-8921 POC
Brian H O'Laughlin, Phone: (301 443-6677 WEB: FBO.gov Permalink https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-15-8921/listing.html
E-MAIL: bo50d@nih.gov bo50d@nih.gov NAICS: 541990 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 ENDSbecause 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 nicotinedelivery 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 forproposals 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:
NIDA Requests for Contract Proposals (RFPs) | National Institute on Drug Abuse (NIDA)). 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 ofsmall 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 UnitedStates 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. Nosingle 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.CITE:
https://www.fbo.gov/?s=opportunity&mode=form&id=9d121f4da6d8ecec8e6e66
8c10050947&tab=core&_cview=0Posted 05/29/14 (W-SN03379087). (0149)

Deadline(s):
Established Date: 05/30/2014
Follow-Up Date: 10/02/2014
Review Date: 07/17/2014

Contact: Brian H O'Laughlin

Address: 6001 Executive Boulevard
Room 4211 - MSC 9559
Bethesda, MD 20892
U.S.A.
E-mail: bo50d@nih.gov

Program URL: https://www.fbo.gov/?s=opportunity&mode=form&id=9d121f4da6d8ecec8e6e668c10050947&tab=core&_cview=0
Tel: 301-443-6677
Fax: 301-443-7595
Deadline Ind: Receipt
Deadline Open: Yes



Award Type(s): Requests For Proposals (FBO)


Citizenship/Country of Applying Institution:
Any/No Restrictions

Locations Tenable: U.S.A. Institution (including U.S. Territories)


Appl Type(s): Individual, Non-Specific
Institution, Non-Specific


Target Group(s): NONE
Funding Limit: $0
Duration: 0
Indirect Costs: Unspecified
Cost Sharing: No
Sponsor Type: NONE

Geo. Restricted: NO RESTRICTIONS

CFDA#:

OBJECTIVES: NOTE: This program has been amended (twice) per the
June 24, 2014 edition of FedBizOpps. Please see below. NOTE:
This program has been amended per the July 8, 2014 edition of FedBizOpps. Please see below. NOTE: This program has been amended per the July 17, 2014 edition of FedBizOpps. Please see below. AMENDMENT: A -- SBIR TOPIC 156 "DEVELOPMENT OF A STANDARDIZED ELECTRONIC CIGARETTE FOR CLINICAL RESEARCH" - SOLICITATION 1SOL N43DA-15-8921 POC Brian H O'Laughli, Phone: (301)
443-6677 WEB: FBO.gov Permalink
https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-15-8921/listing.html
E-MAIL: bo50d@nih.gov bo50d@nih.gov NAICS: 541990 PROGRAM SOLICITATION PHS 2015-3; NIDA REFERENCE NUMBER N43DA-15-8921;CITE:
https://www.fbo.gov/?s=opportunity&mode=form&id=fdeaa13b582592c674970f
2114470f76&tab=core&_cview=0Posted 06/23/14 (W-SN03403454).
(0174) AMENDMENT: A -- SBIR TOPIC 156 "DEVELOPMENT OF A STANDARDIZED ELECTRONIC CIGARETTE FOR CLINICAL RESEARCH"SOL
N43DA-15-8921 POC Brian H O'Laughlin, Phone: (301) 43-6677 WEB:
FBO.gov Permalink
https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-15-8921/listing.html
E-MAIL: bo50d@nih.gov bo50d@nih.gov NAICS: 541990CITE:
https://www.fbo.gov/?s=opportunity&mode=form&id=dc18760b7b97031629d153
440cdf52fe&tab=core&_cview=0Posted 06/23/14 (W-SN03403455).
(0174) AMENDMENT: A -- SBIR TOPIC 156 "DEVELOPMENT OF A
STANDARDIZED ELECTRONIC CIGARETTE FOR CLINICAL RESEARCH" SOL
N43DA-15-8921 POC Brian H O'Laughlin, Phone: (301) 43-6677 WEB:
FBO.gov Permalink
https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-15-8921/listing.html
E-MAIL: bo50d@nih.gov bo50d@nih.gov NAICS: 541990 ANOUNCEMENT:A WEBINAR WILL BE HELD ON TUESDAY JULY 29, 2014 TO PROVIDE ADDITIONAL INFORMATION REGARDING THIS OPPORTUNITY. ADDITIONAL INFORMATION WILL BE AVAILABLE SOON ANDPOSTED HERE AT FBO.GOV.CITE:
https://www.fbo.gov/?s=opportunity&mode=form&id=10630809156f193632eca9
ec2f87e651&tab=core&_cview=0Posted 07/07/14 (W-SN03416684).
(0188)</P> AMENDMENT: A -- SBIR TOPIC 156 "DEVELOPMENT OF A
STANDARDIZED ELECTRONIC CIGARETTE FOR CLINICAL RESEARCH" SOL
N43DA-15-8921 POC Brian H O'Laughlin, Phone: (301) 43-6677 WEB:
FBO.gov Permalink
https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-15-8921/listing.html
E-MAIL: bo50d@nih.gov bo50d@nih.gov NAICS: 541990 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.govCITE:
https://www.fbo.gov/?s=opportunity&mode=form&id=edafcec38fbee20b847532
8de8bb2fd4&tab=core&_cview=0Posted 07/16/14 (W-SN03426913). (0197)



KEYWORDS: Smoking Behavior
Electronic Devices
Nicotine
Translational Research
 

MacTechVpr

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I received this RFA from NIDA for a grant opportunity for small businesses to develop "standardized electronic cigarettes".

Not many people make it to this subforum, but perhaps someone who is already working on manufacturing and QC will see it. I'd so much rather have an actual small business that understands vaping apply for and get these funds.


https://www.fbo.gov/?s=opportunity&mode=form&id=9d121f4da6d8ecec8e6e668c10050947&tab=core&_cview=0

Say what?????

I'd love to act in such an effort, to participate in the formidable activity of defining what constitutes a quantum technical health advantage to people contemplating or in the process of smoking cessation. Were that such an opportunity were legitimate. That would be amazing for someone such as myself too deeply vested in such (self-funded) research presently.

But it would seem to me that those actually disposed to engage in such applications, no doubt on limited research funding would scarcely be capable of cannibalizing their budgets to accomplish a grant request in the (90 day?) window afforded. I would reason such that would are adequately capitalized already, e.g. institutional. So it begs the question where this funding is really intended to go and for what purpose.

Secondly, might we question the generous interest of an institution whose policies and edicts so resolutely invalidate and denounce any advantage to e-cigarettes?

It should, in fact be truly public, i.e. investment. However, I would also note that in the regulatory environment we are facing no one is beating a path to the door of anyone I know whose public and private (profit) objectives are constructive.

I have a simple philosophy regarding public finding. Do not feed the animals (especially when they're out of their cages).

So for the rest of us development continues in the garage.

Good luck.

:)
 
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CES

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So, I work in academia and am required to submit grant applications. But, while i could look at the effects of nicotine, my research isn't about equipment development. I would love to partner with a garage developer to get funding. But you're right in that it's too late now for this application. Which is too bad, since it costs nothing but time (and the ability to jump through hoops) to do an application if there is someone who is already making the equipment.
 

MacTechVpr

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So, I work in academia and am required to submit grant applications. But, while i could look at the effects of nicotine, my research isn't about equipment development. I would love to partner with a garage developer to get funding. But you're right in that it's too late now for this application. Which is too bad, since it costs nothing but time (and the ability to jump through hoops) to do an application if there is someone who is already making the equipment.

Optimistic cynic describes me as well...with a dollop of pragmatism.

Thanks for the ack.

Good luck.

:)
 

Racehorse

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So this type of grant application is not something tailored for a congressman's nephew unless the nephew is skilled at grant writing. BT would not be eligible either- there's a max number of employees, so it really is limited to a small business. It's not something that would be easy for a small business to get- but i'd really like to see one at least try.

Any new news on this.....I would like to see the "try" too.
 

MacTechVpr

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Aug 24, 2013
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I received this RFA from NIDA for a grant opportunity for small businesses to develop "standardized electronic cigarettes".

Not many people make it to this subforum, but perhaps someone who is already working on manufacturing and QC will see it. I'd so much rather have an actual small business that understands vaping apply for and get these funds.

https://www.fbo.gov/?s=opportunity&mode=form&id=9d121f4da6d8ecec8e6e668c10050947&tab=core&_cview=0

Say what?????

I'd love to act in such an effort, to participate in the formidable activity of defining what constitutes a quantum technical health advantage to people contemplating or in the process of smoking cessation. Were that such an opportunity were legitimate. That would be amazing for someone such as myself too deeply vested in such (self-funded) research presently.

But it would seem to me that those actually disposed to engage in such applications, no doubt on limited research funding would scarcely be capable of cannibalizing their budgets to accomplish a grant request in the (90 day?) window afforded. I would reason such that would are adequately capitalized already, e.g. institutional. So it begs the question where this funding is really intended to go and for what purpose.

Secondly, might we question the generous interest of an institution whose policies and edicts so resolutely invalidate and denounce any advantage to e-cigarettes?

It should, in fact be truly public, i.e. investment. However, I would also note that in the regulatory environment we are facing no one is beating a path to the door of anyone I know whose public and private (profit) objectives are constructive.

I have a simple philosophy regarding public finding. Do not feed the animals (especially when they're out of their cages).

So for the rest of us development continues in the garage.

Good luck.

:)

So, I work in academia and am required to submit grant applications. But, while i could look at the effects of nicotine, my research isn't about equipment development. I would love to partner with a garage developer to get funding. But you're right in that it's too late now for this application. Which is too bad, since it costs nothing but time (and the ability to jump through hoops) to do an application if there is someone who is already making the equipment.

I do believe we have seen an award. In true form the NIDS has demonstrated its agenda. And with little doubt the public is once again taken totally unawares thanks to the geologic rate of progression that government undertakes in its intrusive dominance of our existence.

URMC Researchers Awarded $2.1M to Study E-Cigarettes - News Room - University of Rochester Medical Center

“We know that traditional tobacco cigarettes cause numerous diseases,” said Thomas J. Mariani, Ph.D., associate professor of Pediatrics, Medicine, and Environmental Medicine at URMC and the study’s lead researcher. “We intend to determine the disease risk associated with nontraditional tobacco-related products, like e-cigarettes.”

Is it me or isn't he blatantly telegraphing his conclusions? What kind of doctors in science are they raising in Rochester these days?

I definitely could have drafted a grant request with this kind of criteria positing a constructive outcome…ya think?!

"The studies will place an added emphasis on how these products affect newborns and children."

People they've already targeted the presumptive statistically significant syndromic phenomena. Who knows what the name of this acronym will be. But of one thing I'm sure, they'll be sure to let us know. And what we are to do about it.

Apparently there is such a thing as an *ss for every seat.

Congratulations Dr. Mariani! We look forward to your making e-cigarettes for the all of us.

I'm afraid that all the calls to action have merely yielded the bureaucrats a list of where our mods are hidden.

Good luck to us all.

:)

p.s. Folks, this is a big deal I think. It's their declaration of license in development. Thanks for pointing it out CES.
 
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CES

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Sigh....


On one level i know that standardization is a red herring. But still, I wonder if it'd have been different if someone who actually cares about vaping and vapers had applied. While the hypotheses/predictions have to be defined/telegraphed and then tested to see if the data support them, positing a positive outcome shouldn't have been difficult.

it's disheartening.
 
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MacTechVpr

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Sigh....


On one level i know that standardization is a red herring. But still, I wonder if it'd have been different if someone who actually cares about vaping and vapers had applied. While the hypotheses/predictions have to be defined/telegraphed and then tested to see if the data support them, positing a positive outcome shouldn't have been difficult.

it's disheartening.

I know, like you, a great many who would like to make meaningful contributions.

Let's hope.

Good luck C.

:)
 
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