SBIR/STTR Program Changes

In late January, NIH issued the 2013 omnibus solicitations for the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. As mandated and recently re-authorized by Congress, NIGMS and other NIH components have set aside funds for these programs focused on developing innovative technologies with commercial applications.

Starting with the April 5, 2013, receipt date, all applications must follow the instructions and guidelines in the 2013 solicitations. A few key changes are:

  1. The suggested guidelines for allowable budget requests are now $150,000 in total support for Phase I (R41/R43) and $1,000,000 in total support for Phase II (R42/R44). Note that total support includes the direct and indirect costs and fees for the entire length of the project. With appropriate justification, applicants may exceed the budget guidelines by up to 50 percent ($225,000 in total support for Phase I and $1,500,000 in total support for Phase II, a hard cap). NIH, including NIGMS, has received a limited waiver from the Small Business Administration to exceed the hard cap for specific topics.
  2. As in the past, NIH offers applicants for the SBIR and STTR programs access to various technical assistance programs to help move the funded projects toward commercialization. Alternatively, awardees may now directly request up to $5,000 to use for technical assistance of their own choosing.
  3. All applicant organizations must complete registration with the System for Award Management (SAM) Exit icon, Grants.gov Exit icon and eRA Commons. Soon, all small business concerns seeking SBIR or STTR funding will also need to register with the Small Business Administration Exit icon.

NIH plans to publish guidelines later this year to explain how small businesses with venture capital investors may use the SBIR and STTR funding mechanisms.

The NIH SBIR/STTR Web site has a wealth of information covering all aspects of the two programs, and additional updates will be posted there. I am happy to answer questions and discuss potential proposals with applicants. E-mail me at somerss@nigms.nih.gov or call 301-594-3827.

UPDATE: NIH has reissued the SBIR and STTR funding opportunity announcements. View comments section for details.

Post-Submission Application Materials

NIH has recently updated its policy on what materials can be accepted after an application has been submitted but before initial peer review. Here are the changes:

  1. News of a promotion or positive tenure decision will be accepted if received at least 30 calendar days prior to the review meeting and if confirmed by the authorized organization representative;
  2. Exceptions that previously applied only to requests for applications (RFAs) with a single submission date now apply to the last due date of RFAs with multiple submission deadlines; and
  3. Some specific types of personnel information associated with institutional training and training-related grants will now be accepted.

See NOT-OD-10-115 for all other requirements and exceptions.

JIT Information: How We Use “Other Support” Data

The study section gave your application a competitive score, and now you’ve been asked to submit Just-in-Time (JIT) information about your other sources of funding, including active and pending support for key personnel on the application. Why do we request this information?

First, for all applications that might be funded, we check the JIT information for scientific overlap with the investigators’ active grants from NIH and other funding sources, since we can’t provide support for a project that’s already being funded.

Second, as directed by the NIGMS Advisory Council, we give additional scrutiny to new and competing renewal applications from investigators whose total research support, including the pending award, exceeds $750,000 or more in annual direct costs. These applications require special analysis and documentation from NIGMS staff to justify why the project is highly meritorious, and they are discussed by the Advisory Council.

Finally, we may use the information about other research support to decide which grants to recommend for funding and to establish the budget level of the award. As you may know, NIGMS does not rely solely on a percentile cutoff or “payline” to make funding decisions. We also consider other factors, including career stage, perceived impact of the proposed work, summary statement comments and the other funding available to the investigator.

I hope this post helps provide some context for how we use JIT information and why it is important that your JIT information is complete, accurate and submitted promptly after the request so as not to delay the funding decision. Additional JIT information is available on the NIH and NIGMS Web sites and from your program director.

Compliance with NIH Public Access Reporting Requirements Will Affect Renewals

Since 2008, NIH has required as a condition of all grant awards and cooperative agreements that scientists make their findings publicly accessible through the widely used PubMed Central repository. To increase the number of papers available to the public, NIH has announced that it will delay the processing of noncompeting renewals whose publications are not in compliance with this public access policy. The change will take effect as early as spring 2013, and it will coincide with the required use of the Research Performance Progress Report (RPPR) for SNAP and fellowship awards.

For more discussion on this topic, including how to ensure you meet the policy requirements, read Improving Public Access to Research Results written by NIH’s Sally Rockey.

Guidance on Submitting JIT Information

Over the years, NIH has tried various approaches to make sure advisory council and institute or center (IC) staff members have all the information they need about applications being considered for funding. In March 2012, NIH announced the latest procedures for submission of this “just-in-time” (JIT) information:

  1. All JIT information must be submitted via the NIH Commons.
  2. The JIT function button will be activated for all scored applications, just in case it’s needed. This is neither an indication that you should submit JIT information nor an indication of your application’s likelihood of funding.
  3. If your application has an impact score between 1 and 40, you will receive an automated e-mail, which only tells you to follow the JIT guidelines of the application’s corresponding NIH IC. Receiving this message does not necessarily indicate that you will need to submit JIT information, as noted in the NIGMS guidelines below.

You can find guidelines for most NIGMS applications on the Summary Statement and JIT Actions for Applicants Web page and in the relevant section of the funding opportunity announcement you’re responding to. Our current guidance is:

If your application, with the exception of T32 or R25 applications, received a percentile ranking between 1 and 20, or if a percentile ranking is not specified and the priority score is between 10 and 30, please submit Other Support information within 2 weeks of the availability of the Summary Statement. In addition, if your research involves vertebrate animals or human subjects, you must submit information as described in the above referenced Actions on Applications after Initial Review sheet for instructions on completing this information.

Should there be changes to this guidance, they will be reflected on the Web page, so I encourage you to check it each time you receive a summary statement. We’ve also posted JIT details for Training, Workforce Development, and Diversity grants, fellowships and SCORE grants. If your application’s grant mechanism isn’t covered, please consult the program contact listed on your summary statement for instructions.

In the future, we plan to cover what goes in the “Other Support” document and why we ask for it.

How the Change of Fiscal Year Affects Your NIGMS Grant

It’s autumn: cool, crisp weather; bright-colored leaves; the beginning of another fiscal year for NIGMS.

The new fiscal year brings with it a special set of circumstances for funding applications, activating fellowships and making changes to existing grants. Some of these circumstances are related to the NIGMS budget, while others are related to NIH policies and regulations.

Here are answers to some questions that applicants and grantees often ask after the September Advisory Council meeting and during the beginning of the new fiscal year, which started on October 1. We hope that telling you what to expect will help you plan accordingly.

September Council’s over. My application did well in review. When is my grant going to get funded?

NIGMS funds a very limited number of R01s in September after the Council meets. Most pending applications are funded after January 1, depending on when NIH gets its budget appropriation from Congress. However, if your renewal application did exceptionally well in review and your current award expires on November 30, we may be able to start the renewal on, or close to, December 1.

Would my grant application be funded more quickly if it went to a different Council round?

Most likely, yes. Applications that go to the January or May Council meetings are typically selected for funding and processed sooner, relative to when Council meets, than applications that go to the September Council meeting. If you want to minimize the receipt-to-award time and you have a choice about when to submit your application, you may want to submit it for the June/July or October/November deadlines, so that it goes to the January or May Council meetings, respectively. Be aware, though, that there is a large volume of awards to be made after January and May Council meetings, which may impact award processing time.

Why can’t I activate my NRSA fellowship in October or early November?

Many NIH institutes and centers, including NIGMS, do not activate fellowships during the first 6 weeks of a new fiscal year so that future-year anniversary dates align with the NIH funding guidelines (i.e., continuation awards typically do not start before December 1).

I’m moving from one institution to another on October 1. Can my grant or fellowship be transferred when I move? I want it to start on the day that I arrive or, if that’s not possible, later in October.

For the same reason as above, a change of grantee institution action cannot be processed from October 1 through mid-November. However, if we receive your change of institution request at least 8 weeks before the desired start date, we may be able to make the transfer date retroactive. Contact your grants management specialist for details.

I’ve applied for a diversity supplement for an individual who’s arriving on October 25. Will the supplement be available on the day that she arrives?

No, since NIH generally begins issuing grant awards after mid-November. If the supplement application is received at least 10 weeks prior to the desired start date, then the supplement could be issued as early as mid-November. Your institution most likely has pre-award cost authority, so you may opt to start spending the supplemental funds on October 25, when the candidate arrives. If you’re considering this option, be sure to confirm with the director of the diversity supplement program that your supplement will be funded, since submission of a diversity supplement application does not guarantee funding. You’ll also want to know when the supplement is likely to start and whether the budget has been cut.

My grant’s anniversary date is December 1. Why are the awards late most years?

Two factors may contribute. One is that program and grants management staff must wait, often until mid-November, to start the process for issuing grant awards until funding guidance and financial systems are in place. Another factor is that NIH may be operating on a short-term continuing resolution (CR) at a reduced budget level in lieu of a full-year appropriation, which may affect the award process.

Why was my continuation budget reduced? Is the likelihood of a budget cut higher if my grant’s anniversary date is in the winter? Will the cut funds ever be restored?

If NIH is operating on a CR, it may have implemented temporary across-the-board budget cuts on noncompeting continuation awards (years 2, 3, etc. of a grant). This is because we must fund conservatively in case of a further CR or an appropriation that is at a lower level. The likelihood of a temporary budget cut is highest in December and January, since the probability that NIH will be on a CR is highest at the beginning of a fiscal year. It’s possible that some or all of the budget reductions will be restored after NIH gets an appropriation. However, it may take several weeks or longer after an appropriation bill is passed and signed for your award to be adjusted.

Update on NIH Special Council Review Policy

NIH has announced a new policy whereby applications from investigators who receive more than $1 million in direct research support from active NIH grants will receive additional scrutiny by NIH institute and center (IC) advisory councils. This is a threshold, not a cap: Investigators may still receive additional grant awards if the ICs determine such awards will further their missions.

A few notes: The policy replaces a piloted one that set the threshold at $1.5 million total costs. NIGMS will continue its current practice that sets the threshold for special scrutiny of well-funded investigators at $750,000 or more in direct costs for all research support, regardless of the source.

Below is a chart that outlines some of the differences between the NIH and NIGMS policies. For more discussion on this topic, see comments to my earlier post.

NIH

NIGMS

Funding source

NIH only

NIH and non-NIH

Threshold

$1M direct costs on existing grants

$750K direct costs including the pending application

Exclusions

RFAs, P01s, some multi-PI awards

Resource awards

Acknowledging Our Support

NIH recently modified the funding acknowledgement language in the notice of award to read:

Each publication, press release, or other document about research supported by an NIH award must include an acknowledgment of NIH award support and a disclaimer such as “Research reported in this publication was supported by the National Institute of General Medical Sciences of the National Institutes of Health under award number R01GM085232. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.” Prior to issuing a press release concerning the outcome of this research, please notify the NIH awarding IC in advance to allow for coordination.

A key difference in the new version is the reference to “of the National Institutes of Health” after the name of the funding component. The goal is to make it clear that the funding component is part of NIH and, more broadly, to convey the role and value of NIH support. As always, we recommend that if you have more than one grant, you only cite the one(s) that supported the research described in the document.

For some time now, notices of award have also mentioned the NIH public access policy, which requires you to submit papers accepted for publication to NIH PubMed Central.

For more on communicating about your research, see an April 2012 Rock Talk blog post by NIH’s Sally Rockey and our Attribution of NIH/NIGMS Support page.

NIH Pilot of the $1.5 Million Special Review

There has been considerable discussion on Sally Rockey’s Rock Talk blog and elsewhere about NIH’s pilot advisory council review of applications from investigators who have received more than $1.5 million in NIH research project grant support.

As you may know, NIGMS has a longstanding policy of advisory council review of well-funded laboratories, but it differs from the NIH policy in several respects. At its May meeting, the NIGMS Advisory Council voted to continue our existing policy, which sets the threshold for special review at $750,000 in direct costs for all support.

The chart below outlines some of the differences between the NIH and NIGMS policies.

NIH NIGMS
Funding source NIH only NIH and non-NIH
Threshold $1.5M total costs on existing grants $750K direct costs including the pending application
Exclusions RFAs, P01s, some multi-PI awards Resource awards