November 8, 2004

Dear Small Business Research Community,

Following are a few SBIR/STTR updates and reminders that you will find of interest.

The newly revised "Application for a DHHS Public Health Service Grant" (PHS 398, rev. 9/04) instructions and forms are now available at http://grants.nih.gov/grants/forms.htm and will be accepted for submission/receipt dates on or after December 1, 2004. All applications received on or after May 10, 2005 must use the new instructions and forms. During the transition period, applications using the previous version (rev. 5/01) of the PHS 398 will be accepted through May 9, 2005. Please be sure to read the major changes and reminders section.

Progress Reports using the newly revised "U.S. Department of Health and Human Services Public Health Service Non-Competing Grant Progress Report" (PHS 2590, rev. 9/04) instructions and forms will be accepted immediately. All progress reports received on or after May 1, 2005 must use the new version. The newly revised instructions and forms are available at http://grants.nih.gov/grants/forms.htm.

In addition to the research topics described in the Omnibus Solicitation of the NIH, CDC and FDA for SBIR/STTR Applications (e.g., PHS 2004-2), NIH uses the NIH Guide for Grants and Contracts to announce additional (and sometimes more specific) SBIR/STTR funding opportunities. If you decide to submit an application in response to a PA or RFA announced through the NIH Guide, please understand that you may not also submit an identical or essentially identical application under the Omnibus Solicitation for SBIR/STTR Grant Applications.

The NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process or service that, with non-substantive modifications, can be applied to a variety of purposes. Likewise, identical or essentially identical grant applications submitted by different applicant organizations will not be accepted.

The SBIR and STTR programs have successfully achieved many of the goals of the Bayh-Dole Act by promoting the utilization of inventions arising from Federally supported research, bringing these products to market and encouraging maximum participation of small business firms. Recently, concern has been expressed that many of the inventions made with SBIR/STTR funding have not been reported to the National Institutes of Health (NIH) in compliance with the Bayh-Dole Act. About four years ago, NIH sent a letter to the small business awardees reminding award recipients of their invention reporting responsibilities to NIH. Please read the letter (http://grants.nih.gov/grants/funding/sbir_sttr_invention_letter.htm), which is still posted on the NIH SBIR/STTR website. Information about invention reporting is also provided in each Notice of Grant Award that is issued. The reporting of inventions can be accomplished electronically through a secure NIH Interagency Edison (IEdison) Invention Reporting System (http://www.iedison.gov), which is designed to ensure that all information submitted is confidential. In addition to fulfilling reporting requirements, IEdison notifies the user of future time-sensitive deadlines with enough lead-time to avoid the possibility of loss of patent rights due to administrative oversight.

This is a highly opportune time to consider seeking funding through the STTR Program, particularly at a time when universities are creating a more robust climate for the commercialization of university intellectual property innovation and entrepreneurship. The goal of the STTR program is to foster the transfer of new technology from an academic setting to the commercial sector. Funds for this program increased from 0.15% to 0.3% of the NIH extramural research and development (R&D) budget during FY2004 (~$67M) and will continue at this level in the future. Potential applicants are encouraged to contact myself or the relevant NIH Institute or Center program administrators identified in the PHS 2004-2 Omnibus SBIR/STTR Grant Solicitation. Any research of interest to NIH as an academic undertaking would be of interest as a small business topic, if it is truly amenable to commercialization.

The SBIR and STTR Programs have many similarities, particularly now that the STTR Phase II statutory guidelines ($750,000) are aligned with SBIR. So it is worth highlighting the two major differences when thinking about which mechanism is best for you: the Principal Investigator and a research partner:

So, as you are thinking about which mechanism would be best for your situation, ask yourself "where does the PI have his/her primary place of employment?" and "how much of the R&D will be/could be subcontracted to a research institution?" Submission dates for STTR are the same as for SBIR: April 1, August 1 and December 1. Additional Program information, including research topic areas, is available on the NIH Small Business Funding Opportunities website (http://grants1.nih.gov/grants/funding/sbir.htm). (Note: CDC and FDA do not participate in the STTR Program).

As NIH moves closer to its goal of electronic grants administration, we are inviting you to register with the NIH ERA Commons. By joining the Commons, you can create user accounts for your institutions staff and check the status of current grant applications. To join the NIH Commons now, click here [https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp] Following is a summary of some of the functions that the NIH Commons offers. For other information, go to the Commons home page.

Status - Allows Principal Investigators to review the current status of all their grant applications and review detailed information associated with their grants. Institution Officials (i.e., Signing Official (SO) or Administrative Official (AO) associated with the institution) can see a summary view of grant applications, review the Notice of Grant Award, and access the Progress Report face page.

• Just-In-Time - Within Status, users will find a feature to submit Just-In-Time information when requested by the NIH. NIH policy allows the submission of certain elements of a competing application to be deferred. Through this module, institutions can electronically submit the information that is requested after the review, but before award.
• No-Cost Extension - Within Status, users will find a feature to automatically extend grants that are eligible for a one-time extension of the final budget period of a project period without additional NIH funds through the eRA Commons. The system will automatically change the end date for the grant and notify the appropriate NIH staff.

eSNAP - Allows an institution to review non-competing grant data and submit a progress report online.

Financial Status Reports (FSR) - Allows electronic submission of financial information associated with a grant.

Administration - Provides the ability for an institution to create and manage user accounts associated with its institution. Additionally, it allows the institution's Signing Official (SO) to maintain the institution information on file at the NIH.

Demo Facility - Demo Facility allows you to try most of the capabilities of the NIH eRA Commons in a sample environment

The Society of Research Administrators International (SRA International) has been working diligently with SBIR administrators to provide education, professional development, and training programs for SBIR administrators and grant recipients. SRA International is a nonprofit association dedicated to the education of hospital, college & university, government agency, not-for-profit & for-profit administrators in the proper preparation of applications and the management of research awards. At the recent National SRA meeting in Salt Lake City, Utah, a number of sessions were geared toward "Education for Small Businesses" in the administration of their SBIR/STTR awards. Future meetings will continue to offer the same or similar sessions, so I want to invite you to consider becoming a member of the SRA organization. Several attendees noted that they became members because "there really is no other place to get such timely and thorough information about the administrative aspects of an SBIR/STTR award. We want to be proactive in learning what to do and what not to do with Federal funds..." In light of the number of recent audit findings, boosting your education and knowledge in the area of post award administration could avoid potential for this to happen to your company. Additional details about SRA can be found on their web site at: http://www.srainternational.org. Below are some titles of the sessions that were held and will likely be provided again in future SRA conferences:

• "Small Business/University Partners: Opportunity/Obstacles"
• "SBIR/STTR Post Award Administration"
• "University/Industry Contracting"
• "The Basics of Subcontracting"
• "Pre and Post Award Administration for Small Businesses"
• "MTAs (Material Transfer Agreements) & NDA's (Non-Disclosure Agreements)"
• "Legal Issues in Research Administration"
• "Start Ups: It's All in the Details"
• "Preparing for Audit"
• "Management Principles"
• "Writing Successful Grants: Twelve Step Program"
• "Responsible Conduct of Research: Introductory Perspectives"
• "National Science Foundation Update"
• "Department of Defense Update"
• "Department of Agriculture Update"

I hope that you find this information timely and useful.

Sincerely,

Subscribe to the SBIR-STTR Listserv list to get timely information about the NIH SBIR/STTR Programs. Send an email to LISTSERV@LIST.NIH.GOV with the following text in the message body: subscribe SBIR-STTR <your name> (e.g., subscribe SBIR-STTR Jane Doe). (The LISTSERV will retrieve your email address from the "From:" section of your email message.)

NIH is moving towards electronic files and communication. In order to help facilitate this, please register in the NIH ERA Commons https://commons.era.nih.gov/commons/.

Small Business Funding Opportunities (SBIR/STTR Solicitations): http://grants.nih.gov/grants/funding/sbir.htm

SBIR/STTR Collaboration Opportunities and Research Partnerships: http://grants.nih.gov/grants/funding/corp.htm

Success Stories: http://grants.nih.gov/grants/funding/sbir_successes/sbir_successes.htm

SBIR/STTR State Support Entities: http://www.sba.gov/SBIR/indexfast.html

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