HHS Small Business Innovation Research (SBIR) Program Contract Solicitation (PHS 2020-1) Now Available

Notice Number: NOT-OD-19-121

Key Dates
Release Date: July 10, 2019

Related Announcements
None

Issued by
National Institutes of Health (NIH)
Centers for Disease Control and Prevention (CDC)

Purpose

Innovative technologies and methodologies fuel progress in biomedical and behavioral research and represent an increasingly important area of the economy. The Small Business Innovation Research (SBIR) program provides support for research and development (R&D) of new or improved technologies and methodologies that have the potential to succeed as commercial products.

The purpose of this notice is to (1) announce the issuance of the Solicitation of the National Institutes of Health and the Centers for Disease Control and Prevention for Small Business Innovation Research Contract Proposals (PHS 2020-1) with a receipt date of October 23, 2019, 5:00PM EDT; and (2) inform the public about the opportunities that the SBIR program offers to small business concerns as well as to scientists at research institutions.

The SBIR legislation requires the Public Health Service (PHS), Department of Health and Human Services, and certain other Federal agencies to reserve 3.2 percent (for FY 2019) of their extramural research or R&D budgets for an SBIR program. (The NIH SBIR set-aside requirement for FY 2019 is $1 billion.)

The offeror organization must be a small business concern as defined by the Small Business Administration and described in the Contract Solicitation. The primary employment of the principal investigator MUST be with the small business concern at the time of award and during the conduct of the proposed project. In accord with the intent of the SBIR program to increase private sector commercialization of innovations derived from Federal R&D, scientists at research institutions can play an important role in an SBIR project by serving as consultants and/or subcontractors to the small business concern. Generally, up to 1/3 of the Phase I budget may be spent on consultant and/or subcontractual costs, and, generally, up to 1/2 of the Phase II budget may be spent on such costs. In this manner, a small business concern with limited expertise and/or research facilities may benefit from teaming with a scientist(s) at a research institution; for the scientist(s) at a research institution, this team effort provides support for R&D not otherwise obtained. The SBIR program consists of the following three phases:

PHASE I: The objective of this phase is to determine the scientific and technical merit and feasibility and potential for commercialization of the proposed research or R&D efforts and the quality of performance of the small business concern, before consideration of further Federal support in Phase II. Generally, Phase I SBIR awards do not exceed $150,000 for direct costs, Facilities and Administrative (F&A) costs, and negotiated fixed fee for a period generally not to exceed six months.

PHASE II: The objective of this phase 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 are eligible to apply for Phase II grant or contract funding and will be informed of Phase II opportunities. (However, see "Fast-Track" Initiative and "Direct to Phase II" below.) Generally, Phase II awards do not exceed $1,000,000 for direct costs, F&A costs, and negotiated fixed fee for a period generally not to exceed two years.

PHASE III: The objective of this phase is for the small business concern to pursue, with non-SBIR funds, the commercialization of the results of the research or R&D funded in Phases I and II.

"FAST-TRACK": (Applicable only to proposals submitted to the NIH and only if an awarding component indicates that it is accepting Fast-Track proposals for a particular topic.)

The Fast-Track initiative is an opportunity for small business concerns to submit both a Phase I and Phase II proposal for concurrent peer review. This initiative also has the potential to minimize any funding gap between Phase I and Phase II. Proposals must be prepared in accordance with Phase I and Phase II proposal preparation instructions.

DIRECT TO PHASE II: (Applicable only to proposals submitted to the NIH and only if an awarding component indicates that it is accepting Direct to Phase II proposals for a particular topic.)

SBIR Direct to Phase II is a pilot authority under P.L. 112-81 that allows NIH to issue a Phase II award to a small business concern that did not receive a Phase I award for that research/research & development. Certain NIH topics will allow Direct to Phase II SBIR proposals in this solicitation. Proposals must be prepared in accordance with the Phase II proposal preparation instructions.

Submission Process: Offerors are responsible for submitting proposals, including any revisions or modifications to the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov/sbirsttr by the deadline. Offerers must use this electronic transmission method. No other method of proposal submission is permitted. Instructions for electronic submission are provided in the solicitation.

Pre-proposal webinar: HHS will hold a pre-proposal conference, via webinar, on August 7, 2019 at 1:00 PM Eastern Daylight Time. This informational webinar will discuss the PHS 2020-1 solicitation, and in particular will discuss the electronic contract proposal submission (eCPS) website. For this solicitation, proposals will only be accepted via the eCPS website.

Offerors may register for the webinar at:

HHS SBIR PHS 2020-1 Contract Webinar

Please register for HHS SBIR PHS 2020-1 Contract Webinar on Aug 7, 2019 1:00 PM EDT at:

https://attendee.gotowebinar.com/register/7505039171902241027
After registering, you will receive a confirmation email containing information about joining the webinar.

Following registration, a confirmation e-mail will be sent containing information about joining the webinar. Presentation material from this webinar shall be posted on FedBizOpps and the NIH SBIR/STTR webpage following its completion.

Following are the research topics contained in the PHS 2020-1 Solicitation:

National Institutes of Health (NIH)

National Center for Advancing Translational Sciences (NCATS)
019 Alternatives to commercially available cell culture insert membranes and manufacturing techniques

National Cancer Institute (NCI)
397 Manufacturing Innovation for the Production of Cell-Based Cancer Immunotherapies
398 Development of Senolytic Agents for Cancer Treatment
399 Combinatory Treatment Utilizing Radiation to Locally Activate Systemically Delivered Therapeutics
400 Sensing Tools to Measure Biological Response to Radiotherapy
401 Quantitative Biomimetic Phantoms for Cancer Imaging
402 Artificial Intelligence-Aided Imaging for Cancer Prevention, Diagnosis, and Monitoring
403 Spatial Sequencing Technologies with Single Cell Resolution for Cancer Research
404 Subcellular Microscopy and -Omics in Cancer Cell Biology
405 Intra-Tumor Sensing Technologies for Tumor Pharmacotyping
406 Software for Patient Navigation Through the Cancer Care Continuum
407 Cloud-Based Software for the Cancer Research Data Commons
408 Tools and Technologies for Visualizing Multi-Scale Data
409 Software for Automated Analysis of Images for Improved Cancer Health
410 Cancer Clinical Trials Recruitment and Retention Tools for Participant Engagement
411 De-Identification Software Tools for Cancer Imaging Research
412 Software Enabling Data Integration from Wearable Sensors for Cancer Patients

National Heart, Lung and Blood Institute (NHLBI)
109 Transcatheter trileaflet tricuspid suture repair system
110 MRI myocardial biopsy system

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
018 Alcohol Biosensor Development for Continuous Alcohol Consumption Monitoring
019 Data Science Tools for Accelerating Alcohol Research

National Institute of Allergy and Infectious Diseases (NIAID)
076 Co-delivery and Formulation of Adjuvants for HIV Vaccine Development
077 Particle-based Co-delivery of HIV immunogens as Next-generation HIV Vaccines
078 Sequence-based Assays to Quantify the Replication-Competent HIV Reservoir
079 Small Molecule Targeting of HIV RNA
080 Adjuvant Discovery for Vaccines against Infectious or Immune-mediated Diseases
081 Adjuvant Development for Vaccines against Infectious or Immune-mediated Diseases
082 Production of Adjuvants
083 Reagents for Immunologic Analysis of Non-mammalian and Underrepresented Mammalian Models
084 Antiviral drugs to cure chronic hepatitis B virus infection
085 Broad spectrum antibody against human enteroviruses
086 Development of rapid fungal diagnostics for select endemic dimorphic fungi

Centers for Disease Control and Prevention (CDC)

National Center for Chronic Disease and Health Promotion (NCCDPHP)
043 Objective Measurement of Opioid Withdrawal in Newborns

National Center for Environmental Health (NCEH)
02 Web-Based Platform for Flooding Vulnerability and HealthCare Access

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)
021 Assay to Detect and Quantify E. Coli O157 in Water Samples
022 Device Development for Microbial Surface Sampling Field Extraction and Collection
023 Diagnostic Testing Platform to Assess Antibiotic Communities of Cystic Fibrosis Patients

National Center for Immunization and Respiratory Diseases (NCIRD)
034 Accelerating Time to Detection of Legionella in Environmental Samples

Inquiries

Please direct all inquiries to:

Eligibility requirements, definitions, submission procedures, review considerations, contract proposal forms and instructions, and other pertinent information, including the "Fast-Track" Initiative, are contained in the Solicitation (PHS 2020-1). The Solicitation, including contract proposal forms, is available electronically through the NIH "Small Business Research Funding Opportunities Web site. See SBIR Phase I Contract Solicitation PHS 2020-1 (PDF [http://grants.nih.gov/grants/funding/SBIRContract/PHS2020-1.pdf] or MS Word [http://grants.nih.gov/grants/funding/SBIRContract/PHS2020-1.docx]). Be sure to use the appropriate CONTRACT PROPOSAL forms as they differ from the SF424 (R&R) GRANT application forms.

Note: The SBIR Contract Solicitation is available ONLY via electronic means. Potential offerors are encouraged to check the NIH Small Business Research Funding Opportunities Web site for updates on the program. Any updates or corrections to the Solicitation will be posted there.

Contracting Officers

Any small business concern that intends to submit an SBIR contract proposal under this Solicitation should provide the appropriate contracting officer(s) with early, written notice of its intent, giving its name, address, e-mail, telephone, and topic number(s). If a topic is modified or canceled before the Solicitation closes, only those companies that have expressed such intent will be notified.

National Institutes of Health (NIH)

National Center for Advancing Translational Sciences (NCATS)

Jessica Adams
Contracting Officer
NIDA Office of Acquisition
Email: jessica.adams@nih.gov

National Cancer Institute (NCI)

Brittany Gibau
Contracts Analyst
Office of Acquisitions, OM, NCI (Contractor)
Telephone: (240) 276-6863
Email: ncioasbir@mail.nih.gov

National Heart, Lung, and Blood Institute (NHLBI)

Kristi Cooper
Office of Acquistions, OM, NHLBI
Telephone: 301-827-7704
Email: kristi.cooper@nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Jeremy White
Contracting Officer
Branch Chief, NIAAA Branch
NICHD Office of Acquisitions
National Institutes of Health, DHHS
Telephone: 301-402-4572
Email: jeremy.white@nih.gov

National Institute of Allergy and Infectious Diseases (NIAID)

Charles H. Jackson, Jr.
Contracting Officer
Office of Acquisitions, DEA, NIAID
Telephone: 240-669-5175
Email: Charles.Jackson@.nih.gov

Centers for Disease Control and Prevention (CDC)

For general administrative SBIR program questions, contact:

Sean David Griffiths, M.P.H.
SBIR Program Manager
Office of Technology and Innovation
Office of Science
Telephone: 404-639-4641
Fax: 404-639-4903
Email: SBIR@cdc.gov

Miriam Kelly, Ph.D.
Office of Technology and Innovation
Office of Science
Telephone: 404-639-4784
Fax: 404-639-4903
Email: SBIR@cdc.gov

National Center for Chronic Disease and Health Promotion (NCCDPHP)

Jerry Outley
Contracting Officer
Centers for Disease Control and Prevention
Office of Financial Resources
Telephone: 770-488-2831
Fax: 770-488-2044
Email: Jmo4@cdc.gov

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)

Priscilla Turner
Contracting Officer
Centers for Disease Control and Prevention
Office of Financial Resources
Telephone: 770-488-2821
Fax: 770-488-2024
Email: PBTurner@cdc.gov

National Center for Environmental Health (NCEH)

Dale Bish
Contracting Officer
Centers for Disease Control and Prevention
Office of Financial Resources
Telephone: 404-498-1312
Fax: 770-488-2847
Email: uwo8@cdc.gov

National Center for Immunization and Respiratory Diseases (NCIRD)

Pellumbeshe Hoxhaj
Contracting Officer
Centers for Disease Control and Prevention
Office of Financial Resources
Office of Acquisition Services
Telephone: 770-488-2805
Fax: 770-488-2847
Email: KFX2@CDC.gov

Those interested in the PHS small business research GRANT programs, where investigator-initiated research ideas are encouraged, are invited to access the Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications (PHS 2019-2).

To understand better the differences between grants and contracts, see https://sbir.nih.gov/apply.