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top JULY 2015

Start Now to Be "Just in Time"

There is always a flurry of questions from our clients who submit SBIR/STTR proposals and then receive "Just-in-Time" (JIT) requests. Just-in-time refers to information an agency asks you to send after your application goes through the initial review process and is being considered for possible funding. This procedure reduces the time to award while ensuring the accuracy and timeliness of information needed to award.

While it is a "hopeful" sign to receive a JIT notification, it is definitely not a guarantee of award. Just as a VC or angel investor does due diligence when considering investing in a company, JIT is a continuation of the federal government's due diligence prior to making a grant or contract "award" decision.

"Just-in-Time" is actually an umbrella term for information requested post-submission. Agencies refer to JIT with various terms, but it generally refers to the same thing. Here are some common JIT requests:
  1. SBIR/STTR Verification - This certifies the Principal Investigator's (PI) primary employment, company ownership and research space, and that all work will performed in the US.
  2. Current & Pending Support - For this, all named key persons provide details of their supported R&D to include level of effort.
  3. Human Subjects - IRB (Institutional Review Boards) approval for the use of human subject and assurance of education for staff members working with human subjects
  4. Animal studies - Animal Care and Use Committee (IACUC) oversight approval
  5. Financial System Review -This certifies that the company's accounting system meets the established requirements for receiving federal dollars.
Additional requests might be for:
  • Indirect Costs or F&A (Finance & Administrative) rate analysis
  • Policies & Procedures
  • Revised budget
Our tips:
  1. When a request is received, respond as quickly as reasonable. An agency will not award funds until their requests for information have been satisfied. If you are not responding someone else might be and a potential award can be lost.
  2. Communicate with the requesting office to confirm receipt of the request, ask for any clarification if necessary and estimate your anticipated response date. Communicate with your key persons and sub-awardees on the need for an updated current and pending support document, or updated biosketches. 
  3. Educate yourself on the IRB procedures, when it meets, how to initiate the process and how to develop a protocol.
usda FY-2016 SBIR Solicitation Open
The U.S. Department of Agriculture's (USDA) National Institute of Food and Agriculture (NIFA) issued its FY-2016 SBIR solicitation on July 2 with a closing date of October 8, 2015. The USDA's priority areas are:
  • Agriculturally-related Manufacturing Technology, and
  • Energy Efficiency and Alternative and Renewable Energy.
USDA's SBIR topic areas are:
8.1 - Forests and Related Resources
8.2 - Plant Production and Protection - Biology
8.3 - Animal Production and Protection
8.4 - Air, Water and Soils
8.5 - Food Science and Nutrition
8.6 - Rural and Community Development
8.7 - Aquaculture
8.8 - Biofuels and Biobased Products
8.12 - Small and Mid-Size Farms
8.13 - Plant Production and Protection - Engineering

The NIFA National Challenge Areas are: 1) Food Security; 2) Climate Variability and Change; 3) Bioenergy; 4) Childhood Obesity; 5) Food Safety; and 6) Water.
View solicitation 

NIH Applicants and Peer Review
For applicants who are experienced in working with NIH and the peer review system it may seem obvious as to what you can and can't do relative to interacting with peer review groups. But for those who are new, you can easily and inadvertently cross the line and potentially cause your proposal to be withdrawn.
In addition to making sure you are knowledgeable about the NIH Peer Review Process, we encourage you to read NIH's recently released notice (NOT-OD-15-106) titled "Applicant Responsibilities in Maintaining the Integrity of NIH Peer Review".

NIH SBIR/STTR and Clinical Trials
We frequently get asked whether or not NIH funds clinical trials under the SBIR and STTR programs. The answer is "yes" but, as with so many questions related to NIH, the clarifier is "depending on the institute". One example of an institute that says yes is the National Institute of Neurological Disorders and Stroke (NINDS). They recently reissued two FOAs titled "NINDS Exploratory Clinical Trials for Small Business", PAR-15-277 (R44 SBIR) and PAR-15-278 (R42 STTR). Note that these solicitations fund Fast Track and Phase II proposals only. They do NOT fund direct to Phase II proposals so only companies that have had a Phase I are eligible to apply for Phase II.

Some Institutes choose to release separate FOAs for clinical trials as in the NINDS examples above. Others will consider funding clinical trials under the SBIR/STTR Omnibus Solicitations, and some institutes won't fund clinical trials at all through the SBIR/STTR mechanisms. Therefore the best advice is to do your homework and then talk to the relevant program director. And remember - time is your best friend or worst enemy. Starting the planning process well in advance of any proposal deadlines will enable you to maximize the interactions you can have with NIH and enable you to draft a competitive proposal. Waiting until the last minute.... well we can leave that for another article.

Early-Bird Registration Open for the NIH SBIR/STTR Conference!
The 17th Annual NIH SBIR/STTR Conference that will be held in Seattle, Washington on Oct. 27-29. This three-day conference is the largest NIH SBIR/STTR event of the year offering a wealth of opportunities to learn more about NIH SBIR/STTR funding, and to receive application-specific advice from key program staff. BBCetc's Managing Partner, Lisa Kurek, will also be on hand to present "Phase I SBIR/STTR Proposal Development" on Oct. 28 and "Phase II SBIR/STTR Proposal Development" on Oct. 29.
 
The agenda is broken into three tracks to meet the needs of varying levels of experience with SBIR/STTR: 
  • Track 1: Navigating through SBIR/STTRs; 
  • Track 2: Circumventing the Hurdles, and 
  • Track 3: Path to Commercialization. 

The conference is ideal for SBIR newcomers, Phase I companies looking to advance to Phase II, and Phase II companies looking for commercial assistance, strategic partnership and investors. 

View the conference website

Early-bird registration rate of $350 is available until Aug. 20.
Connect on Twitter: #SeattleNIHconf
National Economic Impacts from the Air Force SBIR/STTR Program - 2014
The results of a 2014 survey on the national economic impacts from the Air Force SBIR/STTR Program were reported at last month's National SBIR/STTR Conference in Washington, D.C.

This study was undertaken to quantify the Air Force SBIR/STTR Program's overall contribution to the national economy and nation's defense mission. It examined the economic outcomes and impacts from all Air Force SBIR/STTR Phase II awards completed during 2000-2013. It was intended to answer the basic question: "What resulted from the Air Force's SBIR/STTR R&D investment of nearly $4 billion provided to 1,750 companies in 4,524 separate SBIR/STTR contracts? 

 

 
Other Funding Opportunities
National Institutes of Health
Direct Phase II SBIR Grants to Support Extended Development, Hardening, and Dissemination of Technologies in Biomedical Computing, Informatics, and Big Data Science (R44)
  • National Institute of Biomedical Imaging and Bioengineering (NIBIB)
  • National Cancer Institute (NCI)
  • National Human Genome Research Institute (NHGRI)
  • National Institute on Aging (NIA)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Environmental Health Sciences (NIEHS)
  • National Institute of General Medical Sciences (NIGMS)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Center for Complementary and Integrative Health (NCCIH)
  • National Center for Advancing Translational Sciences (NCATS)
  • Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
Also:
and  
NIEHS RFA-ES-15-016 (U44) This RFA has three receipt dates. This funding opportunity provides guidelines on eligibility for future receipt dates. Phase II SBIR and STTR grant and contract awardees are eligible as are Phase II awardees from other NIH Institutes or another Federal Agency. Key dates:
Letters of intent due: October 17, 2015; Oct. 14, 2016; Oct. 13, 2017
Application deadlines: Nov. 17, 2015; Nov. 14, 2016; Nov. 13, 2017

coffee no background Coffee Cup Wisdom
"There is no grantsmanship that will turn a bad idea into a good one, but there are many ways to disguise good one." 

William Raub, Past Deputy Director, NIH

 

  training on tap
Onsite Training 
JUST ADDED: SBIR/STTR 101: Intro & Overview
July 23 - Southfield, MI

Proposal Prep for NSF
July 30 - Houghton, MI

Webinars
Webinars are 1-2 PM
July 15 - SBIR/STTR Step One: How to Get Registered
  solicitationssolicitations  
HHS/NIH Omnibus
Close Sept. 5, 2015, Jan. 5 and April 5, 2016

Closes Oct. 8

DoD SBIR 15.3 and STTR 15.C
Pre-releases Aug. 27; opens Sep. 28; closes Oct. 28
  client progress
NASA Grant will Help Get KU Student's Drone Radar System from Lab to Market
BBCetc client University of Kansas (KU) Innovation and Collaboration recently announced that one of the companies in its SBIR Assistance Program was awarded an SBIR grant from NASA. Kansas University student Lei Shi's start-up company, UAVradars LLC, is developing on-board radar systems to help keep small commercial drones from colliding with other aircraft - a huge safety hurdle that must first be overcome before the unmanned aircraft systems (UAVs) can be commercialized to their full potential.

Shi's company was the first of six KU companies to have gotten help submitting SBIR grant proposals through the SBIR Assistance Program, a new initiative at the university that is funded by a grant from the Kansas Department of Commerce. BBCetc has provided group training as well as one-on-one consulting with companies referred through the program.

  conference
The 2015 Military Health System Research Symposium will be held from 17 Aug to 20 Aug 2015 at the Marriott Harbor Beach Resort, Ft. Lauderdale, FL. To register for the symposium, you must first be registered on the MHSRS website. Click here to register. Already registered on the MHSRS site? Click here and have your username and password ready. On-line registration is open until 9 August. 
 
  air force report
National Economic Impacts from the Air Force SBIR/STTR Program - 2014
The results of a 2014 survey on the national economic impacts from the Air Force SBIR/STTR Program were reported at last month's National SBIR/STTR Conference in Washington, D.C.

This study was undertaken to quantify the Air Force SBIR/STTR Programs' overall contribution to the national economy and nation's defense mission. It examined the economic outcomes and impacts from all Air Force SBIR/STTR Phase II awards completed during 2000-2013. It was intended to answer the basic question: "What resulted from the Air Force's SBIR/STTR R&D investment of nearly $4 billion provided to 1,750 companies in 4,524 separate SBIR/STTR contracts? 
 
  nasa
The NASA Space Technology Mission Directorate (STMD) is conducting online market research to gather information to help strengthen the NASA STMD SBIR technology portfolio. The goal is to receive feedback on the relevance of subtopic descriptions used in previous SBIR solicitations. Responses are required by 7/31/15.
View research areas in the 2015 NASA solicitation
  resources
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who we are
BBCetc is nationally recognized for its expertise in helping technology-based entrepreneurs win federal funding through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs and use it strategically to propel growth. BBCetc capabilities include:

> Commercialization    
   Planning
> Research Grant 
   Assistance
> SBIR/STTR Training 
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