Gen IC Justification

Date: September 9, 2013

To: Office of Management and Budget (OMB)

Through: Seleda Perryman

DHHS Report Clearance Officer

From: Lenka Fedorkova, PhD

Small Business Innovation Research (SBIR) and Small Business Technology

Transfer (STTR) Program Office

Office of Extramural Programs (OEP)/Office of Extramural Research (OER)/

Office of the Director (OD)/National Institutes of Health (NIH)

Subject: Generic Sub-Study, “Survey of SBIR and STTR Commercialization Assistance Program (CAP) Participants” (OMB No. 0925-0627)

The SBIR/STTR Office proposes to conduct a feedback survey of SBIR and STTR CAP participants under OMB Control Number 0925-0627, expiration date 2/28/2014. This survey will gather feedback from CAP participants about their experience with the program, including the quality of the services offered and the overall process.

Use of the Information Collected

Information gathered will be used internally by SBIR/STTR Office to identify strengths and areas for improvement in current services, operations, and customer services provided by the CAP that support and promote NIH’s mission as well as congressionally mandated goals. Depending on the results of the survey, information from the survey will be used to help us improve and refine our interactions with, and responsiveness to, the small business community; potentially refocus the strategies that are used to accomplish our CAP objectives; and identify areas in need of improvement and enhancement. The data will not be used to formulate or change policies. Rather, it will be used to enable SBIR/STTR Office to be responsive to its constituents.

Background

The mission of the National Institutes of Health (NIH) is to improve human health through biomedical and behavioral research. The NIH SBIR and STTR Programs implement this mission by supporting U.S. small businesses that conduct innovative, early-stage life sciences research and development in their own laboratories and facilities, with the intention of developing or improving lifesaving technology solutions that have a viable commercial potential. Supporting innovation toward ultimate commercialization of innovative technologies is one of four congressionally mandated goals for the SBIR and STTR Programs. Public Law 112-81 authorizes the SBIR and STTR administering agencies like the NIH to provide business technical assistance programs to its awardees; the Commercialization Assistance Program is one of them and delivers specialized services to Phase II SBIR and STTR awardees. The overarching goal of the program is to leverage NIH’s initial investment through grants and contracts intended to bring innovative technologies closer to a commercializable and market ready technology development stage. Furthermore, the most recent re-authorization of the Programs enacted by P.L. 112-81 gives SBIR and STTR programs the directive to request information from awardees about their commercialization progress. To this end, the SBIR and STTR Office proposes to survey small business awardees that participated in the Commercialization Assistance Program, in this case seeking feedback about their experience and satisfaction in the program.

OER/OD/NIH exercises overall oversight for the policies and procedures governing the award of extramural program financial support. This represents more than 80% of the total NIH budget ($31 billion in FY 2013) to the extramural scientific community and academic research institutions through a variety of mechanisms including the SBIR and STTR grants and contracts awarded to the U.S. small business community, representing 3% of the extramural budget. The goal of the SBIR/STTR programs is to encourage promising early-stage life sciences small business to pursue innovation and develop important health solutions and products for the benefit of the general public. Frequently, early-stage life science companies lack the necessary financial and human resources to be able to organically develop untested, high-risk ideas and inventions. Therefore, the funding and technical assistance provided under the SBIR and STTR programs provides these small business and entrepreneurs with critical support and de-risking platform that can help them survive and thrive in a very competitive environment. Specifically, by training and mentoring US small businesses on how to develop sound business practices and strategies through the CAP, the NIH further supports its biomedical mission, and simultaneously enables these firms to turn innovative ideas into tangible products and services while becoming self-sustaining and profitable businesses.

Plan

A total of 68 SBIR or STTR awarded small businesses participated in the 2013 CAP, and we plan to gather data from a representative of each of these small businesses about their overall experience with the program. The feedback survey will be administered through a secure Internet link to Survey Monkey provided to respondents in an initial email. The email will provide an overview and goals of the survey, and will request participant’s feedback. SurveyMonkey is a user-friendly online platform for gathering participant feedback via questionnaires and surveys. We will include straightforward instructions for filling-out the feedback survey. NIH SBIR/ STTR office staff will be receiving and reviewing all responses.

Individuals who do not complete the survey within two weeks of the invitation email will be sent a second invitation email. Individuals will then have two additional weeks to complete the survey, and once individuals complete the survey and submit it, the link will expire. See Attachment 1 for screenshots of the survey. As requested, a burden statement is included at the beginning of Attachment 1.

Participation is completely voluntary. All participant-identifying information gathered will be kept private to the extent allowed by law. All electronic information will be kept on secure NIH servers and hard copy information will be kept in locked cabinets in locked facilities.

Analysis of data will include summary information on all variables and examination of suggestions for CAP-experience improvement. Comparisons of groups who were and were not

satisfied with their experiences will be conducted in order to guide modifications of relevant CAP operations, processes, services, and/or outreach efforts.

Estimates of Respondent Hour and Cost Burdens
Types of Respondents	Number of Respondents	Frequency of Response	Average Time Per Response (Hours)	Annual Hour Burden	Cost
CAP Participants	68	1	15/60	17	0

Thank you for your consideration of this study proposal.

3