PHS 2018-2, Omnibus Solicitation for SBIR/STTR Grant ApplicationsJanuary, 2018
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESPHS 2018-2
OMNIBUS SOLICITATION OF THE
NATIONAL INSTITUTES OF HEALTH,
CENTERS FOR DISEASE CONTROL AND PREVENTION, AND
FOOD AND DRUG ADMINISTRATIONFOR
SMALL BUSINESS INNOVATION
RESEARCH (SBIR)
AND
SMALL BUSINESS TECHNOLOGY TRANSFER (STTR)
GRANT APPLICATIONS
NIH, CDC, and FDA Program Descriptions and
Research Topics
Submission Dates
April 5, 2018, September 5, 2018, January 7, 2019, and april 5, 2019
National Institutes of Health (SBIR and STTR)
Centers for Disease Control and Prevention(SBIR)
Food and Drug Administration (SBIR)
TABLE OF CONTENTS
NIH, CDC, AND FDA Program Descriptions and Research Topics
NATIONAL INSTITUTES OF HEALTH (NIH)
Trans-NIH Research Programs
Phase IIB Competing Renewal Awards
Research Supplements to Promote Diversity in Health-Related Research
Technical Assistance Programs (Subject to Change)
Niche Assessment Program
Commercialization Accelerator Program (CAP)
National Institute on Aging (NIA)
Phase IIB Competing Renewal Awards
Research Topics of Interest to NIA
NIA Non-Clinical Trials Topics:
Division of Behavioral and Social Research (DBSR)
Division of Aging Biology (DAB)
Division of Neuroscience (DN)
Division of Geriatrics and Clinical Gerontology (DGCG)
NIA Clinical Trials Topics:
Division of Behavioral and Social Research (DBSR)
Division of Aging Biology (DAB)
Division of Neuroscience (DN)
Division of Geriatrics and Clinical Gerontology (DGCG)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Limited Amount of Award
Phase IIB Competing Renewal Awards
Commercialization Assistance Programs
Research Topics of Interest to NIAAA
NIAAA Non-Clinical Trials Topics:
Medications Development
Technological Methods for the Treatment of Hazardous Drinking and Alcohol Use Disorders
Prevention
Improving the Delivery of Alcohol Treatment Services
Fetal Alcohol Spectrum Disorder (FASD) and Alcohol-Related Birth Defects
Development of Clinical Biomarkers of Alcohol Exposure and Alcohol-Induced Organ Damage
Alcohol Biosensors
Alcohol Use and HIV Infection, and HIV Co-infection with HCV, HBV, or TB
Electronic Diagnostic Clinical Assessment of Frailty among HIV+ Individuals with Past and/or Current Alcohol Use Disorders: Severity and Patterns
Monitoring Alcohol Use among HIV+ Patients
Stem Cell Research for Alcohol-induced Disorders
Role of Non-coding RNAs in the Neuroadaptation to Alcoholism
In vivo Detection of Neuromodulators in Behaving Animals
Ex vivo Efficacy Screens to Identify Pharmacotherapies for Alcohol Dependence
Develop Network Pharmacology Strategy for Preclinical Medication Development
Novel Tools and Technologies to Detect the Effects of Alcohol on the CNS Structure and Activities
Research Tools
Roadside Driver Tests to Detect Marijuana or Other Drug Use Immediately Before Driving
NIAAA Clinical Trials Topics:
Medications Development
Innovative Technologies to Measure and Increase Medication Adherence in Clinical Trials
Technological Methods for the Treatment of Hazardous Drinking and Alcohol Use Disorders
Prevention
Improving the Delivery of Alcohol Treatment Services
Development of Clinical Biomarkers of Alcohol Exposure and Alcohol-Induced Organ Damage
Alcohol Biosensors
Alcohol Use and HIV Infection, and HIV Co-infection with HCV, HBV, or TB
Electronic Diagnostic Clinical Assessment of Frailty among HIV+ Individuals with Past and/or Current Alcohol Use Disorders: Severity and Patterns
Monitoring Alcohol Use among HIV+ Patients
Roadside Driver Tests to Detect Marijuana or Other Drug Use Immediately Before Driving
National Institute of Allergy and Infectious Diseases (NIAID)
Limited Total Amounts for Phase I and Phase II Awards
Phase IIB Competing Renewal Awards
Research Topics of Interest to NIAID
NIAID Non-Clinical Trials Topics:
Division of AIDS
Basic Sciences Program
Vaccine Research Program
Therapeutics Research Program
Prevention Science Program
Division of Allergy, Immunology, and Transplantation
Division of Microbiology and Infectious Diseases
NIAID Clinical Trials Topics:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Limited Amount of Award
Research Topics of Interest to NIAMS
NIAMS Non-Clinical Trials Topics:
Arthritis and Musculoskeletal and Skin Diseases
Special Emphasis Areas of Interest to Small Businesses:
NIAMS Clinical Trials Topics:
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Research Topics of Interest to NIBIB
NIBIB Non-Clinical Trials Topics:
NIBIB Clinical Trials Topics:
National Cancer Institute (NCI)
Major NCI SBIR/STTR Portfolio Areas:
Limited Amount of Award
Phase IIB Competing Renewal Awards
Research Topics of Interest to NCI
NCI Non-Clinical Trials Topics:
NCI Clinical Trials Topics:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phase IIB Competing Renewal Awards
NICHD Supported Funding Opportunity Announcements (FOAs)
Research Topics of Interest to NICHD
NICHD Non-Clinical Trials Topics:
NICHD Clinical Trials Topics:
National Institute on Drug Abuse (NIDA)
Limited Amount of Award
Fast-Track Applications
Phase IIB Competing Renewal Awards
Research Topics of Interest to NIDA
NIDA Non-Clinical Trials Topics:
High Programmatic Priority Research Topics
NIDA Clinical Trials Topics:
High Programmatic Priority Research Topics
Division of Neuroscience and Behavior
Division of Therapeutics and Medical Consequences
Division of Epidemiology, Services and Prevention Research
Special Research Topics
National Institute on Deafness and Other Communication Disorders (NIDCD)
Limited Amount of Award
Phase IIB Competing Renewal Awards
Research Topics of Interest to NIDCD
NIDCD Non-Clinical Trials Topics:
Hearing and Balance Program
Voice, Speech, and Language Programs
Taste and Smell Program
NIDCD Clinical Trials Topics:
National Institute of Dental and Craniofacial Research (NIDCR)
Research Topics of Interest to NIDCR
NIDCR Non-Clinical Trials Topics:
Developmental Biology and Mammalian Genetics
Infectious Diseases and Immunity
Oral, Oropharyngeal and Salivary Gland Cancers
Temporomandibular Disorders and Orofacial Pain
Saliva, Salivary Diagnostics, and Salivary Gland Diseases
Biotechnology, Biomaterials, and Applications for Regeneration and Restoration of Oral, Dental and Craniofacial Tissues
Preclinical Research
NIDCR Clinical Trials Topics:
Biomedical Clinical Research
Behavioral Clinical Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Limited Amount of Award
Phase IIB Competing Renewal Awards
Final Progress Reports
Additional Programs and Services for NIDDK SBIR/STTR Awardees
Research Topics of Interest to NIDDK
NIDDK Non-Clinical Trials Topics:
Diabetes, Endocrinology and Metabolic Diseases
Digestive Diseases and Nutrition
Kidney, Urologic and Hematologic Diseases
NIDDK Clinical Trials Topics:
National Institute of Environmental Health Sciences (NIEHS)
Research Topics of Interest to NIEHS
NIEHS Non-Clinical Trials Topics:
Exposure Assessment Tools
Nano Environmental Health and Safety
Toxicity Screening, Testing, and Modeling
Biomarkers of Exposure and Response
Intervention Technologies
Education/Outreach
Hazardous Substances Remediation and Site Characterization SBIR Program
Worker Training Program
NIEHS Clinical Trials Topics:
National Eye Institute (NEI)
Limited Amount of Award
Phase IIB Competing Renewal Awards
Research Topics of Interest to NEI
NEI Non-Clinical Trials Topics:
NEI Clinical Trials Topics:
Additional Information
National Institute of General Medical Sciences (NIGMS)
Limited Amount of Award
Phase IIB Competing Renewal Awards
Research Topics of Interest to NIGMS
NIGMS Non-Clinical Trials Topics:
Division of Cell Biology and Biophysics
Division of Genetics and Developmental Biology
Division of Pharmacology, Physiology, and Biological Chemistry
Division of Biomedical Technology, Bioinformatics, and Computational Biology
Division of Training, Workforce Development, and Diversity
Center for Research Capacity Building
NIGMS Clinical Trials Topics:
National Heart, Lung, and Blood Institute (NHLBI)
Phase II Applications
NHLBI-Supported Funding Opportunity Announcements (FOAs)
Phase IIB Competing Renewal Awards
Limited Amount of Award
Final Progress Reports
Programs and Services for NHLBI Small Business Awardees
Research Topics of Interest to NHLBI
NHLBI Non-Clinical Trials Topics:
Cardiovascular Sciences
Lung Diseases
Blood Diseases and Resources
Center for Translation Research and Implementation Science
NHLBI Clinical Trials Topics:
Cardiovascular Sciences
Lung Diseases
Blood Diseases and Resources
Center for Translation Research and Implementation Science
National Human Genome Research Institute (NHGRI)
Research Topics of Interest to NHGRI
NHGRI Non-Clinical Trials Topics:
NHGRI Clinical Trials Topics:
National Institute of Mental Health (NIMH)
Phase IIB Competing Renewal Awards
Research Topics of Interest to NIMH
NIMH Non-Clinical Trials Topics:
Division of Neuroscience and Basic Behavioral Science (DNBBS)
Division of Translational Research (DTR)
Division of AIDS Research (DAR)
Division of Services and Intervention Research (DSIR)
NIMH Clinical Trials Topics:
Division of Neuroscience and Basic Behavioral Science (DNBBS)
Division of Translational Research (DTR)
Division of AIDS Research (DAR)
Division of Services and Intervention Research (DSIR)
National Institute on Minority Health and Health Disparities (NIMHD)
Research Topics of Interest to NIMHD
NIMHD Non-Clinical Trials Topics:
NIMHD Clinical Trials Topics:
National Institute of Neurological Disorders and Stroke (NINDS)
Limited Amount of Award and Budget Waivers
Phase IIB Competing Renewal Awards
Research Topics of Interest to NINDS
NINDS Non-Clinical Trials Topics:
General Areas of Interest
NINDS Priorities
Translational Research
Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative
NINDS Clinical Trials Topics:
National Institute of Nursing Research (NINR)
Limited Amount of Award
Research Topics of Interest to NINR
NINR Non-Clinical Trials Topics:
NINR Clinical Trials Topics:
National Center For Advancing Translational Sciences (NCATS)
Limited Amount of Award
Phase IIB Competing Renewal Awards
Research Topics of Interest to NCATS
NCATS Non-Clinical Trials Topics:
Drug Discovery and Development
Biomedical, Clinical, & Health Research Informatics
Clinical, Dissemination and Implementation Research
NCATS Clinical Trials Topics:
National Center for Complementary and Integrative Health (NCCIH)
Research Topics of Interest to NCCIH
NCCIH Non-Clinical Trials Topics
NCCIH Clinical Trials Topics:
National Library of Medicine (NLM)
Research Topics of Interest to NLM
NLM Non-Clinical Trials Topics:
NLM Clinical Trials Topics:
Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of Research Infrastructure Programs (ORIP)
Phase IIB Competing Renewal Awards
Research Topics of Interest to ORIP
ORIP Non-Clinical Trials Topics:
Division of Comparative Medicine
Division of Construction and Instruments
ORIP Clinical Trials Topics:
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
Research Topics of Interest to CDC
CDC Non-Clinical Trials Topics:
Center For Global Health (CGH)
(1) Portable Multi-function System for Assessing NTD Program Impact
(2) Development of Immersive Virtual or Augmented Reality Laboratory (AR/VR) Training Modules
National Center on Birth Defects and Developmental Disabilities (NCBDDD)
(3) Computer-assisted diagnostic assessment to improve identification of childhood mental disorders
(4) Improving Newborn Screening of Coarctation of the Aorta
(5) Innovation in Measurement of Head Circumference at Birth
(6) Technology-Assisted In-Office Screening for Mental, Emotional and Behavioral Disorders in Pediatric Practices
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)
(7) Clinical Decision Support for Contraception Practice Guidelines
(8) Electronic transmission of assisted reproductive technology pregnancy outcome data
(9) Food Service Guidelines Algorithmic Database Processing and ID Tool
(10) Innovative Approaches for Maternal and Infant Safety in Maternity Hospitals
(11) Population Health Data Using Blockchain Technology
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
(12) Antibiotic Resistant Healthcare-Associate Infections
(13) Detection, Transmission, Ecology, and Prevention of Antimicrobial Resistance in Enteric Bacteria
(14) Rapid Diagnostic Test for Candida species Identification and Multidrug Resistance Profiling
(15) Vector Borne Diseases: Detection, Prevention, Diagnosis and Response
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
(16) Improved Diagnostic Tests for HIV, STDs, Hepatitis and TB
National Center for Immunization and Respiratory Diseases (NCIRD)
(17) Prevention and Diagnosis of Acute Respiratory Infections in the US and Globally
National Center for Injury Prevention and Control (NCIPC)
(18) Improving Platforms for Data Linkage in Drug Overdose Prevention
(19) Innovations to Reduce Motor Vehicle-Related Deaths and Injuries
(20) Innovative Technology or Media to Prevent Violence
(21) Technological Tools for Monitoring Children’s Symptoms after Traumatic Brain Injury
National Institute for Occupational Safety and Health (NIOSH)
(22) Control Technology and Personal Protective Equipment for High Risk Occupations
(23) Exposure Assessment Methods for High Risk Occupations
(24) Work-related Injuries from Motor Vehicle Crashes
FOOD AND DRUG ADMINISTRATION (FDA)
Research Topics of Interest to FDA
FDA Non-Clinical Trials Topics:
Center for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation and Research (CDER)
Center for Food Safety and Applied Nutrition (CFSAN)
Center for Devices and Radiological Health (CDRH)
Center for Veterinary Medicine (CVM)
Office of Critical Path Programs
Office of Orphan Products Development
APPENDIX A: National Institutes of Health SBA-Approved SBIR/STTR Topics for Awards over Statutory Budget Limitations
National Cancer Institute (NCI)
National Center For Advancing Translational Sciences (NCATS)
National Center for Complementary and Integrative Health (NCCIH)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Library of Medicine (NLM)
Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of Research Infrastructure Programs (ORIP)
Funding Opportunity Announcements, Application Instructions, and Appendices are contained in separate files. Follow the links below to view these documents.
Funding Opportunity Announcements
REMINDER: ALL APPLICATIONS MUST BE SUBMITTED IN RESPONSE TO A FUNDING OPPORTUNITY ANNOUNCEMENT THROUGH GRANTS.GOV
PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications(Parent SBIR [R43/R44] Clinical Trial Not Allowed)
PHS 2018-02 OMNIBUS Solicitation of the NIH for Small Business Technology TransferGrant Applications(Parent STTR [R41/R42] Clinical Trial Not Allowed)
PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)
Additional Special Announcements for Small Business Research Opportunities
Application Instructions
SF424 (R&R) Application INSTRUCTIONS and Electronic Submission Information ()
Appendices
STTR Model Agreement (MS Word)
Extramural Invention Reporting Compliance Responsibilties
()
NIH, CDC, and FDA Program Descriptions and Research Topics1
PHS 2018-2, Omnibus Solicitation for SBIR/STTR Grant ApplicationsJanuary, 2018
PROGRAM DESCRIPTIONS AND RESEARCH GRANT TOPICS
The research topics shown in this solicitation represent program areas that may be of interest to applicant small business concerns in the development of projects that have potential for commercialization. Small business concerns are encouraged to submit SBIR/STTR grant applications in these areas.
APPLICABLE TO NIH ONLY: SBIR and STTR grant applications will be accepted and considered in any area within the mission of the awarding components (i.e., Institutes and Centers (ICs)) identified in this solicitation.
Applicants are strongly encouraged to subscribe to the NIH Guide for Grants and Contracts LISTSERV ( or query program administrators periodically via email to learn of new or emerging scientific interests of the NIH, CDC, and FDA awarding components.
You may also subscribe to the SBIR-STTR LISTSERV list to get timely information about the NIH SBIR/STTR Programs (
Additional information on each of the awarding components (ICs) and their research interests is available electronically on the home pages shown throughout the “Research Topics” section of the solicitation.
The Fogarty International Center, which provides support only for conferences, postdoctoral fellowships for research in the United States and abroad, and senior scientist exchanges between the United States and other countries, does not participate in the SBIR/STTR program.
NATIONAL INSTITUTES OF HEALTH (NIH)
NIH is the steward of medical and behavioral research for the Nation. Its mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability.
The goals of the agency are as follows:
1.to foster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health;
2.to develop, maintain, and renew scientific human and physical resources that will assure the Nation's capability to prevent disease;