Supporting Statement A for
Title of Study: Application to be Accepted in the National Institutes of Health (NIH) Technical Assistance Programs: Commercialization Accelerator Program (CAP)
Date: September 5, 2017
Name: John (JP) Kim
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)
6705 Rockledge Drive, Suite 350; Bethesda, Maryland 20892-7963
Office: 301-435-0189
Fax: 301-480-0146
Email: jpkim@mail.nih.gov
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Table of contents
A. JUSTIFICATION
A.1 Circumstances Making the Collection of Information Necessary
A.2. Purpose and Use of the Information COLLECTION
A.3 Use of Information Technology and Burden Reduction
A.4 Efforts to Identify Duplication and Use of Similar Information
A.5 Impact on Small Businesses or Other Small Entities
A.6 Consequences of Collecting the Information Less Frequently
A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency
A.9 Explanation of Any Payment of Gift to Respondents
A.10 Assurance of Confidentiality Provided to Respondents
A.11 Justification for Sensitive Questions
A.12 Estimates of Hour Burden Including Annualized Hourly Costs
A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record keepers
A.14 Annualized Cost to the Federal Government
A.15 Explanation for Program Changes or Adjustments
A.16 Plans for Tabulation and Publication and Project Time Schedule
A.17 Reason(s) Display of OMB Expiration Date is Inappropriate
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions
ATTACHMENTS
Application
Privacy Memo
PIA
A. Justification
The National Institutes of Health (NIH) Commercialization Accelerator Program (CAP) has been offered annually since 2004 (previously known as the Commercialization Assistance Program), and is designed to help some of the agency’s most promising small life science and healthcare Phase II awardees develop their commercial businesses and transition their SBIR/STTR-funded technologies into the marketplace. Applicants are selected via a competitive process for a limited number of slots in the program. Funded by NIH and managed through a contract, the CAP provides selected participants with individualized assistance toward accomplishing key commercialization goals. This is achieved through individual mentoring and consulting sessions, training workshops, access to domain experts, and focus on outcomes that will enhance the commercialization profile and readiness of participating awardees.
A.1 Circumstances Making the Collection of Information Necessary
The Small Business Innovation Research Program, codified at §9 of the Small Business Act, 15 U.S.C. §638, and extended through 2022, congressionally-mandates the SBIR and STTR Programs across federal agencies. These programs are implemented as part of the NIH’s mission by supporting U.S. small businesses that conduct early-stage life sciences research, with the intention of developing lifesaving technology with commercial potential. The Commercialization Accelerator Program (CAP) is a three-track customized technical assistance program, conducted virtually and in-person as appropriate, and designed to serve the needs of up to 80 HHS/NIH SBIR/STTR Phase II awardees at different levels of commercialization experience and expertise.
This application will gather information from small businesses funded under Phase II NIH SBIR/STTR awards that want to participate in the NIH CAP. [See Attachment 1, Application]
Information gathered will be used internally by the NIH SBIR/STTR staff to identify and select small businesses that would most benefit if selected as participants in the NIH Commercialization Accelerator Program (CAP) for 3 years. The data will not be used to formulate or change policies. Rather, it will be used to enable NIH SBIR/STTR staff to be responsive to its constituents by offering commercialization training to meet the goals of the Phase II small business NIH awardees. The form will be online for any potential CAP applicant companies and completed electronically.
A.3 Use of Information Technology and Burden Reduction
The application form will be administered through an Internet link to the NIH CAP contractor’s website. The link will be available to interested companies via the NIH SBIR/STTR main website (http://sbir.nih.gov) and will include a webinar about CAP. The webinar will provide an overview and goals of the NIH Commercialization Accelerator Program (CAP), and will request interested parties to complete the application. The application provides straightforward instructions for filling-out the application form. NIH SBIR/STTR staff will be receiving and reviewing all applications. Using electronic application forms is less time intensive and burdensome than for NIH to mail paper forms and encourage the small business to mail them back. [See Attachment 3, PIA]
The NIH SBIR/STTR Office manages the Commercialization Accelerator Program and will be the only program to collect this data. The program managers will ensure that duplicative assessments are not conducted.
A.5 Impact on Small Businesses or Other Small Entities
This form will be available online to any small businesses that have received HHS/NIH Phase II SBIR awards and wish to be considered as a participant in the NIH CAP. Only small business seeking to be included in the CAP will access the form.
This information has never been collected before and is essential for identifying and selecting qualified CAP participants from interested small business applicants.
This application will be implemented in a manner that fully complies with 5 C.F.R. 1320.5.
Judy Hsieh, Programs Director
Larta Institute
606 S. Olive Street, Suite 650
Los Angeles, CA 90014
Fax 213.622.6230
A.9 Explanation of Any Payment of Gift to Respondents
No gifts will be provided for participation.
A.10 Assurance of Confidentiality Provided to Respondents
All information will be private to the extent permitted by law. Although Personally Identifiable Information (PII) will be collected, the Privacy Act does not apply because none of the data elements will be retrieved to identify the individual. [See Attachment 2, Privacy Act Memo.]
A.11 Justification for Sensitive Questions
No sensitive information will be collected.
A.12 Estimates of Hour Burden Including Annualized Hourly Costs
Table 12-1 Estimated Annualized Burden Hours
Form Name |
Type of Respondents |
Number of Respondents |
Number of Responses per Respondent |
Average Burden Per Response (in hours) |
Total Annual Burden Hours |
A |
SBIR Phase II Awardees |
100 |
1 |
90/60 |
150 |
Total |
|
100 |
100 |
|
150 |
A.12-2 Annual Cost to respondent
Table 12-2 Annualized Cost to Respondents
Type of Respondents |
Total Annual Burden Hours |
Hourly Respondent Wage Rate* |
Respondent Cost |
Phase II Awardee |
100 |
$48.22 |
$4,822.00
|
TOTAL |
100 |
|
$4,822.00 |
*Bureau of Labor Statistics: The General Public rate was obtained from the http://www.bls.gov/oes/2013/may/oes_nat.htm#00-0000
The Health Professionals wage rate was obtained from http://www.bls.gov/oes/2013/may/oes290000.htm
Occupation title “Healthcare Practitioners and Technical Occupations”, occupation code 29-0000;
Health Educators wage rate was obtained from http://www.bls.gov/oes/current/oes211091.htm, occupation code 21-1091.
A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers
None-N/A.
The annualized cost to the federal government is $27, 848.60.
Cost Descriptions |
Grade/Step |
Salary |
% of Effort |
Fringe (if applicable) |
Total Cost to Gov’t |
Federal Oversight |
|
|
|
|
|
Program Manager |
GS 14-10 |
$145,629 |
2% |
|
$2,912.58 |
Contractor Cost |
|
|
|
|
|
LARTA |
N/A |
1,246,801 |
2% |
|
24,936.02 |
Travel |
|
|
|
|
|
Other Cost |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
A.15 Explanation for Program Changes or Adjustments
This program application is existing without approval as administrators were unaware that OMB Clearance was required.
Annually and on average, the application will be made available to respondents in late July or early August and collection will end during the last business week of August. Applicants will be selected for program entry in September. The projected time between when the online application may be accessed, submitted, and respondents receive a response in no less than 60 days.
A.17 Reason(s) Display of OMB Expiration Date is Inappropriate
We are not requesting an exemption to the display of the OMB Expiration date.
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions
This application will comply with the requirements in 5 CFR 1320.9.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Subject | Supporting Statement A |
| Author | Lopez, Maria (NIH/NICHD) [E] |
| File Modified | 0000-00-00 |
| File Created | 2021-01-22 |