U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS), …

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 2018-1

Closing Date: October 20, 2017, 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 20, 2017, 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 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 ............................................................................................................................ 5

2.5 I-CorpsTM at NIH............................................................................................................................................. 5

2.6 Grant Opportunity - Phase IIB Competing Renewal Awards (INFORMATION ONLY) .............................. 7

2.7 Awarding Components.................................................................................................................................... 8

3 DEFINITIONS.................................................................................................................................................................... 9

3.1 General Definitions ......................................................................................................................................... 9

3.2 Definitions (Relating to R&D) ...................................................................................................................... 12

4 PROPOSAL FUNDAMENTALS .................................................................................................................................... 18

4.1 Introduction ................................................................................................................................................... 18

4.2 Offeror Eligibility and Performance Requirements....................................................................................... 18

4.3 Benchmarks for Progress towards Commercialization ................................................................................. 18

4.4 Multiple Principal Investigators .................................................................................................................... 19

4.5 Joint Ventures and Limited Partnerships....................................................................................................... 19

4.6 Majority Ownership in Part by Multiple Venture Capital, Hedge Fund, and Private Equity Firms.............. 19

4.7 Conflicts of Interest....................................................................................................................................... 19

4.8 Market Research............................................................................................................................................ 20

4.9 Research Involving Human Subjects ............................................................................................................ 20

4.10 Good Clinical Practice Training for NIH Awardees Involved in NIH-Funded Clinical Trials ..................... 21

4.11 Inclusion of Women, Minorities, and Children in Clinical Research............................................................ 21

4.12 Care of Vertebrate Animals........................................................................................................................... 21

4.13 Research Involving Recombinant or Synthetic Nucleic Acid Molecules...................................................... 22

4.14 Debriefing ..................................................................................................................................................... 23

4.15 Phase I Award Information ........................................................................................................................... 23

4.16 Phase II Award Information .......................................................................................................................... 23

4.17 Registrations and Certifications .................................................................................................................... 23

4.18 Promotional Materials ................................................................................................................................... 24

4.19 Prior, Current, or Pending Support of Similar Proposals or Awards............................................................. 24

4.20 Reporting Matters Involving Fraud, Waste, and Abuse ................................................................................ 25

4.21 State Assistance and Technical Assistance ................................................................................................... 25

4.22 Payment......................................................................................................................................................... 25

4.23 Proprietary Information................................................................................................................................. 26

4.24 Identification and Marking of SBIR Technical Data in Contract Reports and Deliverables......................... 26

5 CONTRACT REQUIREMENTS.................................................................................................................................... 27

5.1 Other Contract Requirements........................................................................................................................ 27

5.2 Human Subjects Contract Requirements....................................................................................................... 29

5.3 Vertebrate Animals Contract Requirements.................................................................................................. 30

5.4 NIH Policy on Enhancing Reproducibility Through Rigor and Transparency.............................................. 30

5.5 Copyrights ..................................................................................................................................................... 31

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5.6 Technical Data Rights ................................................................................................................................... 31

5.7 Patents and Invention Reporting ................................................................................................................... 31

6 METHOD OF EVALUATION ....................................................................................................................................... 33

6.1 Evaluation Process ........................................................................................................................................ 33

6.2 Phase I Technical Evaluation Criteria ........................................................................................................... 33

6.3 Phase II Technical Evaluation Criteria.......................................................................................................... 34

6.4 Award Decisions ........................................................................................................................................... 35

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 ............................................................................................... 38

8.1 Introduction ................................................................................................................................................... 38

8.2 Fast Track Proposal Instructions (NIH Only) ............................................................................................... 38

8.3 Phase I Proposal Instructions ........................................................................................................................ 38

8.4 Phase II Proposal Instructions (NIH Only ? For Fast Track Submissions) ................................................... 39

8.5 Technical Proposal Cover Sheet (Item 1)...................................................................................................... 39

8.6 Table of Contents (Item 1) ............................................................................................................................ 40

8.7 Abstract of Research Plan (Item 1) ............................................................................................................... 40

8.8 Content of Technical Element (Item 1) ......................................................................................................... 40

8.9 Enhancing Reproducibility through Rigor and Transparency ....................................................................... 44

8.10 Human Subjects Research and Protection from Risk .................................................................................... 45

8.11 Inclusion of Women, Minorities, and Children in Clinical Research............................................................ 49

8.11.1 Additional Instructions and Requirements When NIH-Defined Phase III Clinical Trials Are

Proposed ......................................................................................................................................... 51

8.12 Instructions for Completing the PHS Inclusion Enrollment Report(s) for Sex/Gender, Race, and Ethnicity52 8.12.1.1 When Completing each PHS Inclusion Enrollment Report(s) provide the following information: 52

8.13 Research Involving Human Fetal Tissue....................................................................................................... 55

8.14 Research Involving Vertebrate Animals ....................................................................................................... 56

8.15 Dual Use Research of Concern ..................................................................................................................... 57

8.16 Content of the Pricing Proposal (Item Two). ................................................................................................ 57

8.17 Reminders ..................................................................................................................................................... 58

9 SUMMARY OF HHS COMPONENTS ANTICIPATED NUMBER OF AWARDS ................................................. 60

10 CONTRACTING OFFICER POINTS OF CONTACT FOR QUESTIONS RELATED TO SPECIFIC TOPICS 61

National Institutes of Health (NIH) ............................................................................................................................. 61

National Cancer Institute (NCI) .................................................................................................................... 61

National Heart, Lung, and Blood Institute (NHLBI)..................................................................................... 61

National Institute of Allergy and Infectious Diseases (NIAID) .................................................................... 61

National Institute on Drug Abuse (NIDA) .................................................................................................... 61

Centers for Disease Control and Prevention (CDC) .................................................................................................... 62

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Center for Global Health (CGH) ................................................................................................................... 62

National Center for Chronic Disease and Health Promotion (NCCDPHP)................................................... 62

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID) ............................................... 63

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)............................. 63

National Center for Immunization and Respiratory Diseases (NCIRD) ....................................................... 63

11 SCIENTIFIC AND TECHNICAL INFORMATION SOURCES ................................................................................ 64

12 COMPONENT INSTRUCTIONS AND TECHNICAL TOPIC DESCRIPTIONS.................................................... 65

National Institutes of Health........................................................................................................................................ 65

National Cancer Institute (NCI) .................................................................................................................... 65

National Heart, Lung, and Blood Institute (NHLBI)..................................................................................... 93

National Institute of Allergy and Infectious Diseases (NIAID) .................................................................... 98

National Institute on Drug Abuse (NIDA) .................................................................................................. 112

Centers for Disease Control and Prevention (CDC) .................................................................................................. 117

Center for Global Health (CGH) ................................................................................................................. 117

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) .............................. 119

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID) ............................................. 123

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)........................... 130

National Center for Immunization and Respiratory Diseases (NCIRD) ..................................................... 135

13 APPENDICES................................................................................................................................................................. 137

APPENDIX A -- PROPOSAL COVER SHEET - USE FOR A PHASE I PROPOSAL......................................... 137

APPENDIX B -- ABSTRACT OF RESEARCH PLAN - USE FOR A PHASE I AND A PHASE II

PROPOSAL ................................................................................................................................................ 137

APPENDIX C -- PRICING PROPOSAL - USE FOR A PHASE I AND A PHASE II PROPOSAL ..................... 137

APPENDIX D -- PHASE II TECHNICAL PROPOSAL COVER SHEET - USE FOR A PHASE II

PROPOSAL ................................................................................................................................................ 137

APPENDIX E -- STATEMENT OF WORK SAMPLE FORMAT - USE FOR A PHASE II PROPOSAL ........... 137

APPENDIX F -- SUMMARY OF RELATED ACTIVITIES - USE FOR A PHASE I AND A PHASE II

PROPOSAL ................................................................................................................................................ 137

APPENDIX G -- PROPOSAL SUMMARY AND DATA RECORD - USE FOR A PHASE II PROPOSAL ....... 137

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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 at this time. Other Topics allow for `Fast Track' submissions, which include both a complete Phase I proposal and a complete Phase II proposal. For more information on the three-phase program and the Fast Track process, refer to Section 2.

TOPIC NUMBER

NIH/NCI 370 NIH/NCI 371 NIH/NCI 372 NIH/NCI 373 NIH/NCI 374 NIH/NCI 375 NIH/NCI 376

NIH/NCI 377 NIH/NCI 378 NIH/NCI 379 NIH/NCI 380 NIH/NCI 381 NIH/NHLBI 103 NIH/NHLBI 104 NIH/NHLBI 105

PHASE I PROPOSAL ALLOWED?

FAST TRACK ALLOWED?

(A Phase I proposal and a Phase II proposal

submitted simultaneously)

TOPIC TITLE

Yes

Yes

Targeted Therapy for Cancer- and Cancer Therapy-Related Cachexia

Yes

Yes

Drugs to Exploit the Immune Response Generated by Radiation Therapy

Yes

Yes

Development and Validation of Non-Mouse Reagents to Enable Preclinical Development of Novel Therapeutics

Yes

No

Tools and Technologies for Monitoring RNA Modifications

Yes

Yes

Novel Approaches for Local Delivery of Chemopreventive Agents

Yes

Yes

Diagnostic Imaging for Cancer Immunotherapies

Imaging-Based Tools for Longitudinal and Multi-

Yes

Yes

Dimensional Mapping of the Tumor and Its

Microenvironment

Bridging the Guideline Implementation Gap:

Yes

Yes

Clinical Decision-Support to Improve Cancer Symptom

Management

Yes

Yes

Mobile Application for Surveillance of Post-Radiation Therapy Health-Related Quality of Life

Yes

Yes

Software Enabling Data Integration from Wearable Sensors to Generate Novel Analytics for Cancer Patients

Yes

Yes

Computer Aided Decision Support for Radiation Oncology

Development of Artificial Intelligence (AI) Tools to

Yes

No

Understand and Duplicate Experts' Radiation Therapy

Planning for Prostate Cancer

Yes

Yes

Devices for Transcatheter Surgery

Yes

Yes

Tapered Guidewires for Transcatheter Electrosurgery

Yes

No

Reagent Development for Small Cell Number ChIC-seq

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