NIH webinar for SBIR submissions – Transcript

Note this is sort of raw and unedited….I’ll go back and clean it up later.

I’m cooling my heels waiting for a GoTo Webinar to start; and it hasn’t started yet, and already I’m annoyed…with an obnoxious message every 30 seconds “We’re sorry for the delay as the organizer hasn’t arrived. You will be placed on hold until the organizer arrives. Please remain on the line.”

The webinar consists of a VoIP audio to the computer, and display of a PowerPoint slide deck. Voice quality seems fine. You can submit questions either via a chat entry, and at the end of the webinar, they have been scrolling through the whole log and answering questions. They got a lot of questions….I submitted one at the beginning of the session, ad it looks like it appeared in the top fifth or so of the list..and that is where we are now after about 45 minutes of answering ad-hoc questions.

Page Limits: Phase I 15 pages max, Phase II 25 pages max, to include:

Specific aims
Background and Significance
Preliminary Studies/Progress Report
Research Design and Methods

Phase I one page max, Phase II 3 page max
(I-26 SF424 Application Guide)

You don’t need to identify an institute in the cover letter.
The CSR will assign it appropriately. (I-24)

Do you need approval by the IRB for Human Subjects Assurance at the time of submission?
No. — this is done just in time. (II-1) If they ask about an IRB….be happy…it probably means you’ll receive the award.

Permissible to submit a budget that deviates from the time and dollars normally awarded to Phase I or Phase II?
Yes, but they must be well justified. You are encouraged to discuss budgetary deviations with the program manager.
Average Phase I are $150,000 and average Phase II are $850,000

Difference between a resubmission and a revision?
(I-27) and (I-28)

Subcontractors are required to provide a letter of support which shows their role.

Multiple PIs?
Now allowed. Each PD/PI must have a role and a leadership plan is required (I-51)

F&A – Phase I f you don’t have a negotiated rate, propose a rate not to exceed 40%. They will not normally negotiate a rate.
Phase II will go with a 25% rate. If you request a rate higher than 25% then you will have a negotiated rate for the Phase II project.

E-Submission Survival Tips

Be sure that you have registered both in Grants.gov and in the eRA Commons.
It can take 2-4 weeks or even up to 8 weeks for newly established or foreign businesses.

Follow all of the FOA instructions.
Pay particular attention to Section IV of Application and Submission Information.
Download fresh application forms for each application deadline. For example Adobe Forms are going to replace PureEdge forms. Some of this is to support the peer review. Anything posted with a receipt date after January 31, 2009, will be done with Adobe Forms (hooray!)

After submission, you must track the application in Grants.gov

Errors stop application processing and must be corrected.
Warnings to not stop application submission and are corrected at the discretion of the applicant.

Reviewers never see your warnings. They never see the number of attempts tp submit.

You can correct errors and warnings for 2 business days after the submission deadline.

Common application errors.
Mssing eMail in SF424 (box 5) in the Applicant Information section
Missing PD/PI Commons User name in credential field of Sr/Key Person Profile form

Submit early. You must plan for multiple submission attempts. 60% of small business applicants need to correct errors, compared to 30% of academic submission. There is contention for help-desk resources.

If you can’t view the application in the ERA commons, we can’t review it. You can’t imagine the things that were attached to the application (recipes….etc).

Get connected to receive notifications or process/policy changes and contingency alerts.

Use the eRA Commons help desk and document the issues. It is especially important is issue threatens on-time submission.

http://ithelpdesk.nih.gov/eRA/ – allows you to open a trouble ticket.

Center for Scientific Review

Suzanne E. Fisher, Ph.D. Director of Receipt and Referral.

Advance approval is not given for late applications. A window of consideration is 1 week. Anything received after 1 week will not be reviewed at all.

Format, approved fonts, Arial, Helvetia, palatino, Georgia, type size 1/2 inch margins, Applies to enitre application. This is to be kind to the reviewers.

Cover letter should be used for a number of purposes
Institute/Center Assignment
Suggest review assignment
Identify areas of expertise needed to evaluate the applicaiton
Required for a changed/corrected submission
Cover letter is not shared with the reviewers.

Only 1 resubmission will be required, (right now you can do 2…but that is ending)
You have to change the content, and you have mark changes in the text.
Looking for scientific changes. Think of what would be helpful for the reviewers.

If you don’t see the application in the Commons…..they can’t work on it.

Verify the Activity Code
Request change in writing
Don’t expect us to be mind readers.
Best person to talk to is the person who is available when you call.

Applications reviewed but not discussed a the Scientific Review meeting, about 40% applications fall into that category.

Grants.Gov

support@grants.gov
1 (800) 518-4726
Customer service number and trouble ticket with case notes.

First-timers need to obtain the following:
DUNS number (from Dunn and Bradstreet)
Tax Identification Number (from IRS)
Central Contract Registration (CAGE code)
Grants.gov password

There is a Grants.gov blog (!)
Once a quarter they have a “stakeholder webcast”
CFDA – Catalog for Domestic Assistance
Keyword Search is powered by Google.

Cover sheet shows a list of the mandatory forms.
You can save the forms package to a network drive if multiple people will be working on the package.

Once you submit, you get a Grants.gov email receipt. Then Validation eMail which either says the package was submitted or rejection due to errors. The most common problem is a DUNS number error.
Eventually, you’ll get an eMail showing that the agency has retrieved the application package.
They have three cutomer support reps.

ALL PDF ATTACHMENT FILENAMES MUST BE LESS THAN 50 CHARS AND MAY NOT CONTAIN SPACES

Background and Significant length recommended to 2 or 3 pages.
They have a full list of all validations that they go through. The help desk can direct you to the list of the validation.

The biosketch is the way for you to show to the reviewers that you are capable of performing the research.

Multiple PD/PI leadership plan. Intended for a team approach type of projects. Multiple disciplines. Follow the instruction for the leadership plan. Google on http://grants.nih.gov/grants/multi_pi

Phase I specific aims should include milestones with specific aims

CDC has only about $8 million in their SBIR budget.
NIH has about $650 million
(per year).

Bibliography and References Cited.

Propose a budget and time frame that is reasonable and appropriate for the research, and justify it. You are not limited to the $750,000. (Phase II). Time period and award amounts are guidelines.

Note there is the ability for the small business to request a fee of 7%.
Patent costs are NOT allowed as indirect or direct costs, (but you could perhaps use the fee for this).

Program status: scheduled to be reauthorized by September 2008, but instead it was extended to March 2009. Agencies have been advised to do business as usual. Award amounts remain the same that they were in 1992 (!) (but stay tuned).

They will post the slides on the webinar.

F&A costs they have lots of questions. Section 1 page 96 gives you everything you ever wanted to know about F&A. Usually you are instructed to leave the fringe section blank in the budget form, because it is usually figured as part of indirect costs. Earliest possible start date for people submitting in December would be July.

On Phase I they don’t negotiate an indirect rate.
Phase II they give an option to allow up to 25% without negotiation. If you want to negotiate a rate, then include the estimated rate in the application, and then be prepared to start the negotiation process (which can be 6-12 months!!)
Look in January – they are looking to change these figures.

Is filing a FastTrack substantially reducing my change to get funded compared to a Phase I only?
Works well if you have strong preliminary data, etc. strong milestones, may have letters of interest of commercial partners, for companies who have a commercialization record.

In 2007:
24.1% of Phase I were awarded
19% FastTracks were awarded

Example Phase I and Phase II successfully funded grants are available at the NIH web site.

It is possible to submit preliminary data after the deadline Phase I ? Yes

Negotiation of indirect rates doesn’t happen until you have been selected for an award.

Examples of justification for the 7% fee:
Reality is that it is granted. Typically we don’t negotiate it.

You should mark EACH multiple investigator with PD/PI role.

You need to submit multiple days in advance of the deadline.
Follow the instructions very closely. SF424

PI cannot be a consultant.
STTR requires that the PI put in at least 10% for the project.
SBIR doesn’t require an actual percentage, but typically it is more than 10%

Look at sample collaboration agreement for STTR for dealing with IP

Mac users, Citrix has a capacity of 50 users. Use it off hours. (outside of 10AM-10PM)

(LK – this basically is a disaster…find a PC! hopefully it will be fixed going forward. )

A number of questions from people who said they couldn’t get their letters of support by the deadline. No sympathy here.
This may be a reflection on the applicant. (Translation: Be sure that you have them in a timely manner). However, you can negotiate with the SRO.

Only the contact PI needs to be affiliated with the small business, meeting the 50% employment rule.

Rest of the questions will be posted. NIH Web Site Webinar November.