HHS Small Business Innovation Research (SBIR) Program Contract Solicitation (PHS 2017-1) Now Available

Notice Number: NOT-OD-16-123

Key Dates
Release Date: August 1, 2016

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 2017-1) with a receipt date of October 21, 2016, 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 3.0 percent (for FY 2016) of their extramural research or R&D budgets for an SBIR program. (The NIH SBIR set-aside requirement for FY 2016 is $763 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: (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 new 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.

New 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 24, 2016 at 2:00 PM Eastern Daylight Time.  This informational webinar will discuss the PHS 2017-1 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:
https://attendee.gotowebinar.com/register/6309703982537321475.

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 2017-1 Solicitation:

National Institutes of Health (NIH)

National Cancer Institute (NCI)
355           Cell and Animal-Based Models to Advance Cancer Health Disparity Research.
356           Tools and Technologies for Monitoring RNA.
357           Innovative Tools for Interrogating Tumor Microenvironment Dynamics.
358           Modulating the Microbiome to Improve Therapeutic Efficacy of Cancer Therapeutics.
359           Technologies for Differential Isolation of Exosomes and Oncosomes.
360           Manufacturing Innovation for the Production of Cell-Based Cancer Immunotherapies.
361           Highly Innovative Tools for Quantifying Redox Effector Dynamics in Cancer.
362           Informatics Tools to Measure Cancer Care Coordination.
363           Connecting Cancer Caregivers to Care Teams: Digital Platforms to Support Informal Cancer Caregiving.
364           Methods and Software for Integration of Cancer Metabolomic Data with Other –Omic and Imaging Data.
365           Imaging Informatics Tools and Resources for Clinical Cancer Research.
366           Clonogenic High-Throughput Assay for Screening Anti-Cancer Agents and Radiation Modulators.
367           Predictive Biomarkers to Improve Radiation Treatment.
368           Molecularly Targeted Radiation Therapy for Cancer Treatment.
369           Development of Pediatric Cancer Drug Delivery Devices.

National Center for Advancing Translational Sciences (NCATS)
015           Development of a Drone to be used in Laboratory Automation Projects.

National Heart, Lung and Blood Institute (NHLBI)
098           Testing and Validation of Technologies for Inclusion in the CART Demonstration Project for Collaborative Aging Research.
099           Inhalational 5A Apolipoprotein A-I Mimetic Peptide for the Treatment of Asthma (SBIR-TT).
100           MRI Myocardial Needle Chemoablation Catheter.
101           Membranous Ventricular Septal Defect (pmVSD) Transcatheter Occluder System.
102           Transcatheter Occluder Device for Paravalvular Leaks.

National Institute of Allergy and Infectious Diseases (NIAID)
040           Effective Targeted Delivery of RNA-based Vaccines and Therapeutics.
041           Simplified Sequencing for TB Drug Resistance Testing.
042           Qualitative HIV RNA Home Test.
043           Adjuvant Development.
044           Vaccine Adjuvant Screening and Discovery.
045           Database Resources Integration.
046           Rapid Point-of-Care Diagnostics to Detect Serologic Status of Individuals for Select Viral Infections.
047           Development of Microbiome-based Products for Infectious Diseases.
048           Non-Invasive Rapid Diagnostics for Respiratory Diseases in Children.
049           Phage-based Diagnostic Platforms for Rapid Detection of Bacterial Pathogens.

National Institute on Drug Abuse (NIDA)
161           Virtual Reality Tools to Enhance Evidence Based Treatment of Substance Use Disorders.
162           Analytical Tools and Approaches for (Multidimensional) Scholarly Research Assessment and Decision Support in the Biomedical Enterprise.

Centers for Disease Control and Prevention (CDC)

National Center for Chronic Disease and Health Promotion (NCCDPHP)
038           Improve Contextual Awareness using Social Network Data.

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)
014           Multiplexed Digital Counting of Single Molecules for Advanced Molecular Diagnosis.

Inquiries

Eligibility requirements, definitions, submission procedures, review considerations, contract proposal forms and instructions, and other pertinent information, including the "Fast-Track" Initiative and "Direct to Phase II", are contained in the Solicitation (PHS 2017-1). 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 2017-1 (PDF [https://grants.nih.gov/sites/default/files/PHS2017-1.pdf] or MS Word [https://grants.nih.gov/sites/default/files/PHS2017-1.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 Cancer Institute (NCI)
Ms. Tiffany Chadwick
Procurement Analyst
Office of Acquisitions
National Cancer Institute
Email: ncioasbir@mail.nih.gov

National Center for Advancing Translational Sciences (NCATS)
Jeffrey R. Schmidt
Contracting Officer
NINDS R&D Contracts Management Branch
Neurosciences Offices of Acquisition
Phone: 301-402-1488
Email: schmidtjr@mail.nih.gov

National Heart, Lung, and Blood Institute (NHLBI)
Mr. John Taylor
Phone: 301-435-0327
Fax: 301-480-3338
Email: taylorjc@nhlbi.nih.gov

National Institute of Allergy and Infectious Diseases (NIAID)
Charles H. Jackson, Jr.
Contracting Officer
Office of Acquisitions, DEA
National Institute of Allergy and Infectious Diseases
National Institutes of Health, DHHS
Phone: 240-669-5175
Email: Charles.Jackson@.nih.gov

National Institute on Drug Abuse (NIDA)
Mr. Andrew Hotaling
Contracting Officer
NIDA R&D Contracts Management Branch
Neurosciences Offices of Acquisition
Phone: 301-443-6677
Fax: 301-443-7595
Email: hotalingar@mail.nih.gov  

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
Email:  SGriffiths@cdc.gov

Darlene Forrest, M.A. (Contractor)
SBIR Program and Logistic Specialist
Office of Technology and Innovation
Office of the Associate Director for Science
Phone: 404-639-1023
Fax: 404-639-4903
Email: SBIR@cdc.gov

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: SBIR@cdc.gov

National Center for Chronic Disease and Health Promotion (NCCDPHP)
Julio Lopez
Contracting Officer
Centers for Disease Control and Prevention
Office of Financial Resources
Phone: 770-488-2892
Fax: 770-384-4245
Email:  JLopez3@cdc.gov  

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)
Alan Sims
Contracting Officer
Centers for Disease Control and Prevention
Office of Financial Resources
Phone: 770-488-2896Fax: 770-488-2670
Email:  ASims1@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 2016-2).

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