HHS Small Business Innovation Research (SBIR) Program Contract Solicitation (PHS 2019-1) Now Available

---

Notice Number: NOT-OD-18-209

Key Dates
Release Date: July 18, 2018

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 2019-1) with a receipt date of October 22, 2018, 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 2018) of their extramural research or R&D budgets for an SBIR program. (The NIH SBIR set-aside requirement for FY 2018 is $941 million.)

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: The congressional authority for SBIR Direct Phase II has expired. Accordingly Direct Phase II proposals WILL NOT be accepted for this soliciation.

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 16, 2018 at 2:00 PM Eastern Daylight Time. This informational webinar will discuss the PHS 2019-1 solicitation, and in particular will discuss the new 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 2019-1 Contract Webinar

Please register for HHS SBIR PHS 2019-1 Contract Webinar on Aug 16, 2018 2:00 PM EDT at:

https://attendee.gotowebinar.com/register/4384275519409493762

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 2019-1 Solicitation:

National Institutes of Health (NIH)

National Center for Advancing Translational Sciences (NCATS)

016 Synthetic Technologies for Advancement of Research and Therapeutics (START)

017 Universal Medium/Blood Mimetic for Use in Integrated Organs-on-Chips

018 Non-PDMS Biocompatible Alternatives for Organs-On-Chips

National Cancer Institute (NCI)

382 Integrated Subcellular Microscopy and Omics in Cancer Cell Biology

383 Smart, Multi-Core Biopsy Needle

384 Digital Healthcare Platform to Reduce Financial Hardship for Cancer Patients

385 Leveraging Connected Health Technologies to Address and Improve Health Outcomes of Long Term Cancer Survivors

386 Novel Approaches for Local Delivery of Chemopreventive Agents

387 Multiplexed Preclinical Tools for Longitudinal Characterization of Immunological Status in Tumor and its Microenvironment

388 In vitro Diagnostic for the Liver Flukes Opisthorchis viverrini and Clonorchis sinensis

389 Development of Artificial Intelligence (AI) Tools to Understand and Duplicate Experts Radiation Therapy Planning for Prostate Cancer

390 Clonogenic High-Throughput Assay for Screening Anti-Cancer Agents and Radiation Modulators

391 Drugs or Devices to Exploit the Immune Response Generated by Radiation Therapy

392 Clinical Trials of Systemic Targeted Radionuclide Therapies

393 Sensing Tools to Measure Biological Response to Radiotherapy

394 Combinatory Treatment Modalities Utilizing Radiation to Locally Activate or Release Systemically Delivered Therapeutics

395 Targeted Therapy for Cancer- and Cancer Therapy-Related Cachexia

396 Imaging for Cancer Immunotherapies

National Heart, Lung and Blood Institute (NHLBI)

106 Active MRI Needle

107 Transcatheter Potts Shunt

108 Device System for Transcatheter Repair of Postinfarction Ventricular Septal Defect

National Institute on Alcohol Abuse and Alcoholism (NIAAA))

016 A Wearable Alcohol Biosensor that Quantifies Blood Alcohol Concentration in Real Time

017 Data Science Tools for Alcohol Research

National Institute of Allergy and Infectious Diseases (NIAID)

063 In Vivo Targeted Degradation of HIV Proteins

064 Particle-Based Delivery of HIV Env Immunogens

065 Co-Delivery and Formulation of Adjuvants for HIV Vaccines

066 Effective Targeted Delivery of RNA-based Vaccines and Therapeutics

067 Methods Improving HIV Protein Expression: Cell Substrate and Protein Purification

068 Reagents for Immunologic Analysis of Non-mammalian and Underrepresented Mammalian Models

069 B Cell Receptor and T Cell Receptor Repertoire Computational Tools

070 Development of Sample Sparing Assay

071 Adjuvant Discovery for Vaccines and for Autoimmune and Allergic Diseases

072 Adjuvant Development for Vaccines and for Autoimmune and Allergic Diseases

073 Mobile Health Point-of-Care Diagnostics

074 Development of POC Assays to Quantify anti-Tuberculosis Antibiotics in Blood

075 POC Diagnostic for Gonorrhea and Determination of Antimicrobial Susceptibility

National Institute on Drug Abuse (NIDA)

165 DEA-Compliant Drug Detection and Deactivation Technology to Deter Opioid Theft in Hospitals for Next Generation Controlled Substance Diversion Prevention Program (CSDPP)

166 Leveraging Health IT Solutions to Combat Opioid Misuse

Centers for Disease Control and Prevention (CDC)

Center for Global Health (CGH)

010 Multiplex Detection of Recent and Prior Exposure to Pathogens

011 Preservation of Supply Quality During Unmanned Aerial Vehicle (UAV) Transport

National Center for Chronic Disease and Health Promotion (NCCDPHP)

041 Community Based Worksite Wellness App Linking Employees to Wellness Resources

042 Objective Measurement of Opioid Withdrawal in Newborns

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)

020 Novel Coatings/Surfaces on Indwelling Medical Devices to Prevent Biofilms

National Center for Environmental Health (NCEH)

01 Rapid Field Test to Improve Swimming Pool Water/Air Quality

Office of Public Health Preparedness and Response (OPHPR)

03 Rapid Test for Simultaneous Detection of Influenza (types A and B) and Streptococcus (Group A)

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 2019-1). 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 2019-1 (PDF [http://grants.nih.gov/grants/funding/SBIRContract/PHS2019-1.pdf] or MS Word [http://grants.nih.gov/grants/funding/SBIRContract/PHS2019-1.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)

Jeffrey Schmidt
Contracting Officer
NIDA Office of Acquisition
Phone: (301) 402-1488
Email: [email protected]

Tiffany Chadwick
Procurement Analyst & Contract Officer
Office of Acquisitions
National Cancer Institute
Phone: 240-276-7293
E-mail: [email protected]

Joanna Magginas
Deputy Director, OA, OM, NHLBI
Phone: (301) 827-7740
E-mail: [email protected]

Jeremy White
Contracting Officer
Branch Chief, NIAAA Branch
NICHD Office of Acquisitions
National Institutes of Health, DHHS
Phone: (301) 402-4572
Email: [email protected]

Charles H. Jackson, Jr.
Team Lead, Microbiology and Infectious Diseases
Research Contracts Branch-A (MIDRCB-A)
Office of Acquisitions, DEA, NIAID
Phone: (240) 669-5175
Email: [email protected]

Kenneth Janosko
Contracting Officer
Office of Acquisition, NIDA
Phone: (301) 443-6677
Fax: (301) 443-7595
E-mail: [email protected]

Centers for Disease Control and Prevention (CDC)

For general administrative SBIR program questions, contact:

Sean David Griffiths, M.P.H.
Office of Technology and Innovation
Office of the Associate Director for Science
Phone: 404-639-4641
Fax: 404-639-4903
E-mail: [email protected]

Gwen Barnett, M.P.H.
Deputy Director
Office of Technology and Innovation
Office of the Associate Director for Science
Phone: 404-639-4791
Fax: 404-639-4903
Email: [email protected]

Center for Global Health (CGH)
Theresa Routh-Murphy
Contracting Officer
Centers for Disease Control and Prevention
Office of Financial Resources
Phone: (770) 488-2713
Fax: (770) 488-2778
Email: [email protected]

Julio Lopez
Contracting Officer
Centers for Disease Control and Prevention
Office of Financial Resources
Phone: (770) 488-2892
Fax: (770) 488-2044
E-mail: [email protected]

Priscilla Turner
Contracting Officer
Centers for Disease Control and Prevention
Office of Financial Resources
Phone: (770) 488-2821
Fax: (770) 488-2024
E-mail: [email protected]

Vallerie Redd
Contracting Officer
Center for Disease Control and Prevention
Office of Financial Resources
Phone: (770) 488-2845
Fax: (770) 488-2847
E-mail: [email protected]

Christine Godfrey
Contracting Officer
Centers for Disease Control and Prevention
Office of Financial Resources
Phone: (770) 488-2519
Fax: (770) 488-2024
E-mail: [email protected]

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 2018-2).

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

---

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

---