U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS), THE NATIONAL INSTITUTES OF HEALTH (NIH) AND THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM
PROGRAM SOLICITATION PHS 2017-1
Closing Date: October 21, 2016, 5:00 PM Eastern Daylight Time
Participating HHS Components:
· The National Institutes of Health (NIH)
· The Centers for Disease Control and Prevention (CDC)
IMPORTANT
Deadline for Receipt: Proposals must be received by October 21, 2016, 5:00 PM Eastern Daylight Time.
Please read the entire solicitation carefully prior to submitting your proposal.
IMPORTANT: All proposals must be submitted using the electronic contract proposal submission (eCPS) website.
Paper proposals will not be accepted.
Please go to https://www.sbir.gov/sites/default/files/sbir_pd_with_1-8-14_amendments_2-24-14.pdf to read the SBIR/STTR Policy Directive issued by the Small Business Administration for further information.
Table of Contents
1 INTRODUCTION 1
2 PROGRAM DESCRIPTION 4
2.1 Objectives 4
2.2 Three Phase Program 4
2.3 Fast Track Proposals (NIH Only) 5
2.4 Direct to Phase II Proposals (NIH Only) 5
2.5 Grant Opportunity - Phase IIB Competing Renewal Awards (INFORMATION ONLY) 5
2.6 Awarding Components 6
3 DEFINITIONS 7
3.1 General Definitions 7
3.2 Definitions (Relating to R&D) 10
4 PROPOSAL FUNDAMENTALS 17
4.1 Introduction 17
4.2 Offeror Eligibility and Performance Requirements 17
4.3 Multiple Principal Investigators 18
4.4 Joint Ventures and Limited Partnerships 18
4.5 Majority Ownership in Part by Multiple Venture Capital, Hedge Fund, and Private Equity Firms 18
4.6 Conflicts of Interest 18
4.7 Market Research 19
4.8 OMB Clearance 19
4.9 Research Involving Human Subjects 19
4.10 Inclusion of Women, Minorities, and Children in Clinical Research 20
4.11 Care of Vertebrate Animals 20
4.12 Research Involving Recombinant or Synthetic Nucleic Acid Molecules 20
4.13 Debriefing 21
4.14 Phase I Award Information 21
4.15 Phase II Award Information (For Fast Track and Direct to Phase II Proposals) 22
4.16 Registrations and Certifications 22
4.17 Promotional Materials 23
4.18 Prior, Current, or Pending Support of Similar Proposals or Awards 23
4.19 Fraud and False Statements 23
4.20 State and Other Assistance Available 23
4.21 Payment 24
4.22 Proprietary Information 24
4.23 Identification and Marking of SBIR Technical Data in Proposals 25
5 CONTRACT REQUIREMENTS 26
5.1 Other Contract Requirements 26
5.2 Human Subjects Contract Requirements 28
5.3 Vertebrate Animals Contract Requirements 29
5.4 NIH Policy on Enhancing Reproducibility Through Rigor and Transparency 29
5.5 Copyrights 30
5.6 Technical Data Rights 30
5.7 Patents and Invention Reporting 30
6 METHOD OF EVALUATION 32
6.1 Evaluation Process 32
6.2 Phase I Technical Evaluation Criteria 32
6.3 Phase II Technical Evaluation Criteria 33
6.4 Award Decisions 34
7 PROPOSAL SUBMISSION 36
7.1 Questions 36
7.2 Pre-Proposal Conference 36
7.3 Limitation on the Length of the Technical Proposal (Item 1) 36
7.4 Submission, Modifications, Revision, and Withdrawal of Proposals 36
8 PROPOSAL PREPARATION AND INSTRUCTIONS 39
8.1 Introduction 39
8.2 Fast Track Proposal Instructions (NIH Only) 39
8.3 Phase I Proposal Instructions 39
8.4 Phase II Proposal Instructions 40
8.5 Technical Proposal Cover Sheet (Item 1) 40
8.6 Table of Contents (Item 1) 41
8.7 Abstract of Research Plan (Item 1) 41
8.8 Content of Technical Element (Item 1) 42
8.9 Enhancing Reproducibility through Rigor and Transparency 46
8.10 Human Subjects Research and Protection from Risk 47
8.11 Inclusion of Women, Minorities, and Children in Clinical Research 52
8.11.1 Additional Instructions and Requirements When NIH-Defined Phase III Clinical Trials Are Proposed 54
8.12 Instructions for Completing the PHS Inclusion Enrollment Report(s) for Sex/Gender, Race, and Ethnicity 55
8.12.1.1 When Completing each PHS Inclusion Enrollment Report(s) provide the following information: 55
8.13 Research Involving Human Fetal Tissue 58
8.14 Research Involving Vertebrate Animals 59
8.15 Dual Use Research of Concern 60
8.16 Content of the Pricing Proposal (Item Two). 61
8.17 Reminders 62
9 SUMMARY OF HHS COMPONENTS ANTICIPATED NUMBER OF AWARDS 63
10 CONTRACTING OFFICER POINTS OF CONTACT FOR QUESTIONS RELATED TO SPECIFIC TOPICS 64
National Institutes of Health (NIH) 64
National Cancer Institute (NCI) 64
National Center for Advancing Translational Sciences (NCATS) 64
National Heart, Lung, and Blood Institute (NHLBI) 64
National Institute of Allergy and Infectious Diseases (NIAID) 64
National Institute on Drug Abuse (NIDA) 64
Centers for Disease Control and Prevention (CDC) 65
National Center for Chronic Disease and Health Promotion (NCCDPHP) 65
National Center for Emerging Zoonotic and Infectious Diseases (NCEZID) 65
11 SCIENTIFIC AND TECHNICAL INFORMATION SOURCES 67
12 COMPONENT INSTRUCTIONS AND TECHNICAL TOPIC DESCRIPTIONS 68
National Institutes of Health 68
National Cancer Institute (NCI) 68
National Center for Advancing Translational Sciences (NCATS) 102
National Heart, Lung, and Blood Institute (NHLBI) 105
National Institute of Allergy and Infectious Diseases (NIAID) 119
National Institute on Drug Abuse (NIDA) 132
Centers for Disease Control and Prevention (CDC) 136
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) 136
National Center for Emerging Zoonotic and Infectious Diseases (NCEZID) 137
13 APPENDICES 140
APPENDIX A — PROPOSAL COVER SHEET - USE FOR PHASE I AND FAST-TRACK PROPOSALS 140
APPENDIX B — ABSTRACT OF RESEARCH PLAN - USE FOR PHASE I, PHASE II, AND FAST-TRACK PROPOSALS 140
APPENDIX C — PRICING PROPOSAL - USE FOR PHASE I, PHASE II AND FAST-TRACK PROPOSALS 140
APPENDIX D — PHASE II TECHNICAL PROPOSAL COVER SHEET - USE FOR PHASE II AND FAST-TRACK PROPOSALS 140
APPENDIX E — STATEMENT OF WORK SAMPLE FORMAT - USE FOR PHASE II AND FAST-TRACK PROPOSALS 140
APPENDIX F — SUMMARY OF RELATED ACTIVITIES - USE FOR PHASE I, PHASE II AND FAST- TRACK PROPOSALS 140
APPENDIX G — PROPOSAL SUMMARY AND DATA RECORD - USE FOR PHASE II AND FAST-TRACK PROPOSALS 140
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1 INTRODUCTION
The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) invite small business concerns to submit research proposals under this Small Business Innovation Research (SBIR) Contract Solicitation. Firms with the capability to conduct research and development (R&D) in any of the health related topic areas described in Section 12.0, and to commercialize the results of that R&D, are encouraged to participate.
This solicitation contains opportunities to submit a proposal under a variety of different Topics, which are summarized below. Some Topics allow for only a Phase I proposal to be submitted. Some Topics allow for only a Phase II proposal to be submitted, through the ‘Direct to Phase II’ process. Some Topics allow for ‘Fast Track’ proposals, which include both a Phase I proposal and a Phase II proposal. For more information on the three phrase program and the Fast Track and Direct to Phase II processes, refer to Section 2.
Topic Number / Phase I proposal ALLOWED?(Includes only a Phase I Proposal) / FAST TRACK proposal ALLOWED?
(Includes a Phase I Proposal and a
Phase II Proposal) / DIRECT TO PHASE II ALLOWED?
(Includes only a Phase II Proposal) / Topic Title /
NIH/NCI 355 / Yes / Yes / Yes / Cell and Animal-Based Models to Advance Cancer Health Disparity Research
NIH/NCI 356 / Yes / No / No / Tools and Technologies for Monitoring RNA
NIH/NCI 357 / Yes / Yes / Yes / Innovative Tools for Interrogating Tumor Microenvironment Dynamics
NIH/NCI 358 / Yes / No / No / Modulating the Microbiome to Improve Therapeutic Efficacy of Cancer Therapeutics
NIH/NCI 359 / Yes / No / No / Technologies for Differential Isolation of Exosomes and Oncosomes
NIH/NCI 360 / Yes / Yes / No / Manufacturing Innovation for the Production of Cell-Based Cancer Immunotherapies
NIH/NCI 361 / Yes / No / No / Highly Innovative Tools for Quantifying Redox Effector Dynamics in Cancer
NIH/NCI 362 / Yes / Yes / No / Informatics Tools to Measure Cancer Care Coordination
NIH/NCI 363 / Yes / Yes / No / Connecting Cancer Caregivers to Care Teams: Digital Platforms to Support Informal Cancer Caregiving
NIH/NCI 364 / Yes / Yes / No / Methods and Software for Integration of Cancer Metabolomic Data with Other –Omic and Imaging Data
NIH/NCI 365 / Yes / Yes / No / Imaging Informatics Tools and Resources for Clinical Cancer Research
NIH/NCI 366 / Yes / No / No / Clonogenic High-Throughput Assay for Screening Anti-Cancer Agents and Radiation Modulators
NIH/NCI 367 / Yes / Yes / No / Predictive Biomarkers to Improve Radiation Treatment
NIH/NCI 368 / Yes / Yes / No / Molecularly Targeted Radiation Therapy for Cancer Treatment
NIH/NCI 369 / Yes / Yes / No / Development of Pediatric Cancer Drug Delivery Devices
NIH/NCATS 015 / Yes / No / No / Development of a Drone to be used in Laboratory Automation Projects
NIH/NHLBI 098 / No / Yes / Yes / Testing and Validation of Technologies for Inclusion in the CART Demonstration Project for Collaborative Aging Research
NIH/NHLBI 099 / Yes / Yes / No / Inhalational 5A Apolipoprotein A-I Mimetic Peptide for the Treatment of Asthma (SBIR-TT)
NIH/NHLBI 100 / Yes / Yes / Yes / MRI Myocardial Needle Chemoablation Catheter
NIH/NHLBI 101 / Yes / Yes / Yes / Membranous Ventricular Septal Defect (pmVSD) Transcatheter Occluder System
NIH/NHLBI 102 / Yes / Yes / Yes / Transcatheter Occluder Device for Paravalvular Leaks
NIH/NIAID 040 / Yes / No / Yes / Effective Targeted Delivery of RNA-based Vaccines and Therapeutics
NIH/NIAID 041 / Yes / Yes / No / Simplified Sequencing for TB Drug Resistance Testing
NIH/NIAID 042 / Yes / No / Yes / Qualitative HIV RNA Home Test
NIH/NIAID 043 / Yes / No / Yes / Adjuvant Development
NIH/NIAID 044 / Yes / No / Yes / Vaccine Adjuvant Screening and Discovery
NIH/NIAID 045 / Yes / No / Yes / Database Resources Integration
NIH/NIAID 046 / Yes / Yes / Yes / Rapid Point-of-Care Diagnostics to Detect Serologic Status of Individuals for Select Viral Infections
NIH/NIAID 047 / Yes / Yes / Yes / Development of Microbiome-based Products for Infectious Diseases
NIH/NIAID 048 / Yes / Yes / Yes / Non-Invasive Rapid Diagnostics for Respiratory Diseases in Children
NIH/NIAID 049 / Yes / Yes / Yes / Phage-based Diagnostic Platforms for Rapid Detection of Bacterial Pathogens
NIH/NIDA 161 / Yes / No / No / Virtual Reality Tools to Enhance Evidence Based Treatment of Substance Use Disorders
NIH/NIDA 162 / Yes / Yes / Yes / Analytical Tools and Approaches for (Multidimensional) Scholarly Research Assessment and Decision Support in the Biomedical Enterprise.
CDC/
NCCDPHP 038 / Yes / No / No / Improve Contextual Awareness using Social Network Data
CDC/
NCEZID 014 / Yes / No / No / Multiplexed Digital Counting of Single Molecules for Advanced Molecular Diagnosis
All firms that are awarded Phase I contracts originating from this solicitation will be eligible to participate in Phases II and III. HHS Components will notify Phase I awardees of the Phase II proposal submission requirements. Submission of Phase II proposals will be in accordance with dates provided by individual Component instructions. The details on the due date, content, and submission requirements of the Phase II proposal will be provided by the awarding HHS Component either in the Phase I award or by subsequent notification.
The HHS is not obligated to make any awards under Phase I, Phase II, or Phase III, and all awards are subject to the availability of funds. HHS is not responsible for any monies expended by the offeror before award of any contract.
2 PROGRAM DESCRIPTION
2.1 Objectives
The objectives of the SBIR program include stimulating technological innovation in the private sector, strengthening the role of small business in meeting Federal research or research and development (R/R&D) needs, increasing private sector commercialization of innovations developed through Federal SBIR R&D, increasing small business participation in Federal R&D, and fostering and encouraging participation by socially and economically disadvantaged small business concerns and women-owned small business concerns in the SBIR program.
The basic design of the NIH/CDC SBIR program is in accordance with the Small Business Administration (SBA) SBIR Program Policy Directive dated February 24, 2014. This SBIR Contract solicitation strives to encourage scientific and technical innovation in areas specifically identified by the NIH/CDC awarding components. The guidelines presented in this solicitation reflect the flexibility provided in the Policy Directive to encourage proposals based on scientific and technical approaches most likely to yield results important to the NIH/CDC and to the private sector.
2.2 Three Phase Program
The SBIR program consists of three separate phases.
Phase I: Feasibility
The objective of Phase I is to determine the scientific or technical feasibility and commercial merit of the proposed research or R&D efforts and the quality of performance of the small business concern, prior to providing further Federal support in Phase II.
Phase II: Full R/R&D Effort
The objective of Phase II is to continue the research or R&D efforts initiated in Phase I. Funding shall be based on the results of Phase I and the scientific and technical merit and commercial potential of the Phase II proposal. Phase I contractors will be informed of the opportunity to apply for Phase II, if a Phase II proposal was not submitted concurrently with the initial Phase I proposal under the Fast Track procedure. Only one Phase II award may result from a single Phase I SBIR contract.
Phase III: Commercialization stage without SBIR funds
The objective of Phase III, where appropriate, is for the small business concern to pursue with non-SBIR funds the commercialization objectives resulting from the outcomes of the research or R&D funded in Phases I and II. Phase III may involve follow-on, non-SBIR funded R&D, or production contracts for products or processes intended for use by the U.S. Government.
The competition for SBIR Phase I and Phase II awards satisfies any competition requirement of the Armed Services Procurement Act, the Federal Property and Administrative Services Act, and the Competition in Contracting Act. Therefore, an agency that wishes to fund an SBIR Phase III project is not required to conduct another competition in order to satisfy those statutory provisions. As a result, in conducting actions relative to a Phase III SBIR award, it is sufficient to state for purposes of a Justification and Approval pursuant to FAR 6.302-5 that the project is a SBIR Phase III award that is derived from, extends, or logically concludes efforts performed under prior SBIR funding agreements and is authorized under 10 U.S.C. 2304(b)(2) or 41 U.S.C. 253(b)(2).