# Presentation: 351256

## Communication with NIH StaffWho, When, and Why?

- Gregory Milman
- National Institute of Allergy and Infectious Diseases
- gmilman@niaid.nih.gov

**Notes:**
Hello, and welcome. 
I am Greg Milman and I will share with you some advice on NIH small business programs that may help you succeed with your NIH SBIR or STTR application.  
This presentation was updated in April 2005. 
You can send your comments, suggestions on topics you would like added, and criticisms by email to gmilman@niaid.nih.gov.

## Choices To Consider Before Starting An Applicationhttp://www.niaid.nih.gov/ncn/sbir/advice

- What is your product?
- Is your intellectual property protected?
- Which Institute or Center?
- SBIR or STTR – Academic collaborator, partner, or principal investigator?
- Program Announcement or Unsolicited?
- Which receipt date?
- Requested budget (normal or outside guidelines)?
- Normal or Fast-Track?
- Requested time (1 or 2 years)?
- Phase I specific aims and milestones?
- Fee (use of funds)?

**Notes:**
The following are some of the choices you should consider before you start your application.
Do you apply for an SBIR or STTR award? 
Do you need an academic collaborator, partner, or principal investigator?  
Should you submit a normal or Fast-Track application?
Which of the three receipt dates is best?
How should you select which Institute or Center (IC) to target?
Should you respond to a program announcement?
How large a project should you propose?
How much money and time should you request?
What are your specific aims and milestones for Phase I?
Should you ask for a fee?

## Prior to Contacting NIH

- Decide on your product and prepare a business plan.
- Select PI and explore partnerships.
- Explore NIH Internet pages and identify potential NIH support.
- Arrange space & resources.

**Notes:**
On the left is a timeline that runs from your development of a concept for NIH Small Business Funding to our issuing a Notice of Grant Award.  
A yellow rectangle illustrates where we are in the process.
Do your homework before calling NIH.  
Identify your core technology and prepare a business plan. 
Explore the NIH Internet pages and decide on your likely NIH product and your likely NIH source of support.  
Select a Principal Investigator, explore strategic partnerships and arrange for space and resources.  
Now you are ready to contact NIH Staff.

## Focus On Your Product, Not Your Technology

- Core technology builds a business.
- A single use of core technology builds an SBIR/STTR application.
- Advantages of focus on single use.
- Meets needs of specific problem.
- Targets committed reviewers.
- Demonstrates business acuity.
- Allows additional applications using same core technology.
- Describe the public health and financial significance of your product.

**Notes:**
There is a big difference between business strategy and grant writing strategy.  Building core technology that can be used to create many different products is outstanding business strategy but a flawed approach for an SBIR/STTR application. I believe a better strategy is to focus on a single use of your core technology.  
For example, imagine that your technology enables inexpensive rapid genetic tests for susceptibility to cancer, heart disease, infectious diseases and other health problems.  The National Human Genome Research Institute would probably be assigned your application based on this technology but would Genome program staff be supportive?  Would scientific reviewers be supportive?  How would business reviewers evaluate the product when it is not clear what the product will be?  
Consider instead an application focused on applying your technology to breast cancer. The application would be directed to a program in the National Cancer Institute. Cancer reviewers are likely to be enthusiastic about an impact in their area.  Business reviewers are likely to be enthusiastic about product sales.  
Because you focused on a single use, you could submit additional SBIR/STTR applications for other uses based on the same core technology.  For example, an application on cardiac screening could be directed to the National Heart, Lung, and Blood Institute and one on asthma to NIAID. 
In each application, you should focus on the public health significance of the product in that specific area and the financial impact of the product in the market and to your company.

## Program Announcements

- Program Announcements (PAs) are NIH staff "wish lists."
- Review committees usually evaluate an application responding to a PA no differently than any other application.
- You can handicap your application by trying to make it fit a PA.
- Respond to a PA only if the research you want to propose exactly matches the PA request.
- You do not need to respond to PA to request an  award over $100 thousand. About 40% of the applicants that did not respond to a PA received awards over $100 thousand.
- Most, but not all FY2004 multi-year awards went to applications in response to PAs.

**Notes:**
Program Announcements (PAs) are written by NIH extramural program staff to encourage grant applications that will fill gaps in their portfolios.  
Reviewers evaluate an application based on its science and may not even read the PA to which an application responds.  
You may handicap your application if you try to "fit a square peg into a round hole."  
I suggest you respond to a PA if and only if the research you want supported exactly matches the PA request.  
Applicants are attracted to a PA that states that they may request over $100,000 per year and multi-year funding.  You do not need to respond to a PA to request an award over $100,0000.  All ICs will award over $100,000 per year if the request is well justified and approved by the review committee.  In fact, about 40% of the FY2004 applicants who did not respond to a PA received awards over $100,000.
Most, but not all FY2004 multi-year awards went to applications in response to PAs. This could be because few other applicants requested longer time. If you need to apply for a two- or three-year Phase I grant, check first with the appropriate IC staff to learn if your application would be accepted.

## Prior to Submission

- Talk with Program Staff to obtain science advice.
- Identify and talk with other scientists.
- Talk with Grants Management Staff to discuss regulatory and policy issues.
- Talk with CSR Staff to identify likely Institute/Center and review committee assignments.

**Notes:**
Early in the planning stages of your application, you will want to obtain science advice from Program Staff. The more knowledgeable you are the more productive your conversation is likely to be. You may learn that your technology is more relevant to a different program or Institute.  
Ask who you could contact both in and outside NIH to get additional information on your proposed research. Bounce your ideas off as many scientists as possible. Refine your ideas and proposal based on your conversations. 
If there are regulatory or policy issues that may affect your application, you should begin conversations with Grants Management Staff. 
You could also start communications with the Center for Scientific Review Staff to identify likely review committee assignments for your proposal.

## Program Staff

- Discuss the state-of-the-art, research trends, gaps and roadblocks.
- Identify your competition.
- Identify resources to help you.
- Identify other funding opportunities.
- Provide informal and sometimes more blunt feedback from the review.
- Be your advocate in the process.

**Notes:**
Ask Program Staff to help you better understand the state-of-the-art in your research area.  Talk about research trends, gaps and roadblocks, and your competition. 
Also, ask program staff to identify resources you might use and other funding opportunities. 
Although they do not participate in the review process, Program Staff often attend application review meetings. 
When they do attend, they can provide you with informal and sometimes more blunt feedback from the review than you will read in the summary statement. 
If a Program Staff person believes in the value of your proposal, she or he may be your advocate for funding if your application is in the Gray Zone I described previously.

## Grants Management Staff

- Administrative matters
- Budget
- Rules and regulations
- Policy issues

**Notes:**
You will mainly interact with Grants Management Staff during and after preparation of a Notice of Grant Award.  However, you may want to contact Grants Management Staff prior to submitting an application if you have questions on administrative matters.  These include budgets outside the normal levels, rules and regulations, and policy issues on human subjects and vertebrate animals. 

## Learn About Your Review Committee

- _CSR Review Staff_
- _Information on review assignment_
- _Pub Med Central_
- _CRISP - Computer Retrieval of Information on Scientific Projects_

**Notes:**
Many applicants for NIH grants make the big mistake of believing they should please the NIH Institute or Center to which their application will be assigned. Instead, I suggest you think of the review committee as the "primary customer" for your application. Your chance of getting funded is almost totally dependent on their judgment that your application is better than someone else's. 
Due diligence requires that you learn as much as possible about your reviewers. Before you send NIH your application, communicate with CSR staff to identify which SRA and review group is likely to receive it. Ask for a list of committee members who would have reviewed your application if you had submitted it for an earlier receipt date. Many of these same reviewers may be on the committee that will review your application.  
I encourage you to conduct a literature search on potential reviewers to learn their areas of expertise. Pay particular attention to the publications of those reviewers likely to receive primary assignment of your application. It is not a good idea to say something in your application that they would disagree with.  You can use the National Library of Medicine's Pub Med Central site to search for publications by author.
I also encourage you to use the NIH CRISP database.  CRISP stands for Computer Retrieval of Information on Scientific Projects.  You can search CRISP to learn if potential reviewers of your application have NIH funded projects.  If they do, you can read an abstract about their work. Be particularly cautious if the hypotheses in your application differs from one they espouse.

## Application Submission

- Include cover letter to
- Suggest IC and review committee.
- Explain expertise necessary for review.
- Ask that some people be excluded as reviewers.
- Never suggest reviewers.

**Notes:**
When you submit your application you can include a cover letter requesting its assignment to an Institute or Center. Be sure to explain your reasons. 
Also, describe the expertise necessary to review your application.  
You can request the exclusion of particular reviewers, with your reasons for exclusion.  Be careful though! If you exclude too many reviewers, your application may be placed in a panel with little expertise in your scientific area. 
Reviewers who know little about your research area may not appreciate its significance and this can lessen enthusiasm for your proposal.  Do not suggest reviewers for your application because your suggestion will almost certainly guarantee that they will not be asked to serve on the committee.

## eRA Commons (Electronic Research Administration)

- Small business should register with the NIH eRA Commons and grants.gov.
- Registered principal investigators can check assignment and contact information, review outcome, and other important information.
- SBIR/STTR grant applications may be accepted electronically beginning with December 1, 2005 receipt date.

**Notes:**
I suggest that your company and you register with the NIH Electronic Research Administration Commons.  Once registered, you can quickly check review assignments, review outcomes, and other important information such as your Just-in-Time requirements.  In the not too distant future, grant applications will be submitted electronically.

## Application Deadline + 10 Days

- Review CSR letter listing review date, committee, and IC assignment.
- Contact CSR referral office if letter not received or if you are concerned about your  application's assignment.

**Notes:**
About ten working days after the receipt deadline, you should receive a letter from CSR listing your application's assignment to a review panel, the date the panel meets, and the primary assignment to an NIH Institute or Center.  
Call the CSR referral office if you do not receive this letter within three weeks of the receipt deadline, or if you receive the letter but are concerned about your application's assignment. 

## At Least 7 Weeks Prior to Review

- Call or email SRA to ask if updated or supplementary material can be provided, and if so, its latest submission date.
- You can check the CSR Roster site for a list of members on your review panel.

**Notes:**
There is a limited time window after submission, up to seven weeks prior to review, when you may be able to provide additional information or correct or update some information in your application. If you discover such a need, don't wait – contact the SRA as early as possible with your request. 
Also, check the CSR Internet site to see who will be on your application's review panel. This is the time for you to request the exclusion of specific reviewers but you will have to provide good reasons for their exclusion.  Be aware that the SRA is under no obligation to agree to any of your requests. 

## Review Date + 7 to 10 Days

- Call or email Program Staff to ask for Priority Score if not received by mail.
- Ask about payline and probability of being funded.
- If a revision is necessary, ask for advice.
- Contact Grants Management Staff if funding likely to review required Just-in-Time information.

**Notes:**
About ten working days after the review meeting, you should receive a priority score in the mail. You can call or email your program staff (but not the SRA) for the score if you haven't received it within three weeks following the review.  
Ask your Program Staff about the current payline and the probability of your application being funded. 
If you are told that your application is not likely to be funded, ask for advice on preparing a revised application even though you will probably not receive a summary statement for another five to seven weeks. 
If you are told that you are likely to be funded, contact Grants Management Staff to review the Just-in-Time information that you will need to provide prior to our issuing an award.

## Just-in-Time – Our Time, Not Yours

- Other support data for PI and all key personnel.
- Lease agreement.
- PI and applicant institution eligibility verification.
- Human subjects FWA number.
- Institutional review board approval certification date.
- Human subjects education certification.
- Institutional animal care and use committee assurance number and approval date.

**Notes:**
Some application information is required Just-in-Time, meaning at the time NIH wants to award you a grant. 
At that time you will:
Provide NIH a list of other research support for the PI and all key personnel.
Provide a lease agreement or other documentation showing you control your research space.
Verify that an SBIR PI works over half-time for the company and that the company is eligible for SBIR/STTR funding.
If you are conducting human research, provide an FWA number, IRB approval information, and human subjects education certification.
If you are conducting research using vertebrate animals, provide an IACUC assurance number and protocol approval date.
If any of this information is not available when NIH is ready to fund your application, your award will be delayed and if you do not provide the information within a time specified by the funding IC, your application may be administratively inactivated.  

## Review Date + 6 to 8 Weeks

- Call or email Program Staff to ask for Summary Statement if not received by mail.
- Ask about probability of funding.
- Discuss revisions if funding unlikely.
- Contact Grants Management Staff if funding likely to review required Just-in-Time information.

**Notes:**
About six to eight weeks after the review meeting you should receive a summary statement.  
If after eight weeks you haven't received the summary statement, you can contact your program staff to request a copy. 
Again, inquire about the probability of funding.  
Discuss revising your application if funding is unlikely.  
On the other hand, if funding is likely, I want to emphasize again that you should contact Grants Management Staff to review the Just-in-Time information that you will need to provide prior to NIH issuing an award.

## Council Date + 1 to 2 Weeks

- Call or email Program Staff to ask if your application has received secondary review  and, if yes, is it in line for funding.
- Call Grants Management Staff to discuss Just-in-Time information and to provide any other information necessary prior to approval of a Notice of Grant Award.

**Notes:**
Although you will probably have a pretty good idea if your application is in line to be funded based on its priority score and your communication with program staff, there are additional gates your application must pass through before receiving an award.  I described these in the slide on the SBIR/STTR Review and Award process.  Call your program staff to learn if your application has received secondary review and if it is in line for funding.  
The Grants Management Office must verify that you meet all the requirements for funding. This gate is the one where many SBIR or STTR applications are delayed or blocked. If you haven't been contacted by Grants Management Staff by now, this is likely to be your fate too. Call the Grants Management Office to be sure they are satisfied that you meet all requirements for funding and ask when they can issue a Notice of Grant Award.

## CONTACT INFORMATION

**Gregory Milman, Ph. D. ****Division of Extramural Activities****NIAID, NIH, DHHS****6700-B Rockledge Drive; Room 2140****Bethesda, MD 20892-7610 ****Tel (301) 496-8666****Fax (301) 402-0369****Email  gmilman@niaid.nih.gov**

_**http://www.niaid.nih.gov/ncn/sbir/advice**_

**Notes:**
Thank you for watching this presentation.  I hope it improves the success of your SBIR or STTR application. My full contact information is included here.  The best method to reach me is by email to which I try to respond within 48 hours.