HHS Small Business Innovation Research (SBIR) Program Contract Solicitation (PHS 2016-1) Now Available

Notice Number: NOT-OD-15-130

Key Dates
Release Date:   July 24, 2015

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 2016-1) with a receipt date of October 16, 2015, 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 2.9 percent (for FY 2015) of their extramural research or R&D budgets for an SBIR program. (The NIH SBIR set-aside requirement for FY 2015 is $691 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 13, 2015 at 2:00 PM Eastern Daylight Time.  This informational webinar will discuss the PHS 2016-1 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/1204029371162972674.

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 2016-1 Solicitation:

National Institutes of Health (NIH)
National Cancer Institute (NCI)
341      Development of Metabolomics Data Integration Methods and Software
342      Validation of Mobile Technologies for Clinical Assessment, Monitoring and Intervention
343      An Electronic Platform for Cognitive Assessment in Cancer Patients
344      Technologies for Differential Isolation of Exosomes and Oncosomes
345      Predictive Biomarkers of Adverse Reactions to Radiation Treatment
346      Molecularly Targeted Radiation Therapy For Cancer Treatment
347      Signal Amplification to Enable Attomolar Quantitation in Slide-Based or ELISA Biomarker Immunoassays
348      Identification and Capture of Enriched Tumor Zones with Preservation of Labile Biomarkers from Ultra-Cold Biopsies
349      Proximity Slide Based Sandwich Immunoassay to Visualize Intramolecular Epitopes of Analytes in Tissue Sections
350      Highly Innovative Tools for Quantifying Redox Effector Dynamics in Cancer
351      Modulating the Microbiome to Improve Efficacy of Cancer Therapeutics
352      Cell and Animal-Based Models to Advance Cancer Health Disparity Research
353      Cell-Free Nucleic Acid-Based Assay Development for Cancer Diagnosis
354      Companion Diagnostics for Cancer Immunotherapies

National Center for Advancing Translational Sciences (NCATS)
013      Development of Stem Cell-based Assay for High-Throughput Screening of Chemicals of Toxicological Concern
014      Development of Smart Plate Technology

National Heart, Lung and Blood Institute (NHLBI)
094      Transcatheter Cavopulmonary Bypass Endograft
095      Active MRI Transseptal Needle
096      Bioabsorbable Stents for Neonatal Aortic Coarctation
097      Early Detection and Monitoring of Cardiac Injury Due to Cardiotoxicity

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
015      Development of Novel Compounds to Treat Alcohol Use Disorder

National Institute of Allergy and Infectious Diseases (NIAID)
033      Precision Genome Engineering for HIV Eradication
034      High-Throughput Assay Platform for Quantifying Latent HIV Reservoirs
035      Method for the Detection of Minority Populations of Drug Resistant HIV
036      Simple, Inexpensive Device to Purify DNA from Sputum for Tuberculosis Testing
037      Telemonitoring for Infectious Diseases: A Remote System for Assessing Patient Parameters and Specimen Analysis
038      Innovative Oral Formulations for Anti-Infective Drugs
039      Vaccines against Pathogens with Small Market Potential

National Institute on Drug Abuse (NIDA)
158      Development of Primer and Reference Tool to Assess Neonatal Abstinence Syndrome
159      Therapeutic Cannabidiol Pulmonary Delivery Device (e.g. Nebulizer, Vaporizer or Inhaler)
160      “The Pain Mobile:” Remote Pain Management System

Centers for Disease Control and Prevention (CDC)
Center for Global Health (CGH)
008      Diagnostic Tools to Support the Elimination and Control of Neglected Tropical Diseases

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)
012      De novo assembly of arthropod genomes of public health importance
013      Detecting Lower Intestinal Microbiome Disruption and Multidrug Resistant Organisms

National Center for HIV/AIDs, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
046      Serologic measurement of hepatitis B virus cccDNA
047      Serologic detection and quantification of hepatitis B core antigen

National Center for Immunization and Respiratory Diseases (NCIRD)
031      Transcutaneous immunization against rotavirus using a dissolvable microneedle patch
032      Thermostable Dry Powder Live Attenuated Influenza Vaccine for Nasal Delivery

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 2016-1). 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 2016-1 (PDF [https://grants.nih.gov/grants/funding/SBIRContract/PHS2016-1.pdf] or MS Word [https://grants.nih.gov/grants/funding/SBIRContract/PHS2016-1.docx]). Be sure to use the appropriate CONTRACT PROPOSAL forms as they differ from the SF424 (R&R) GRANT application forms.

Note: The SBIR Phase I 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. Rosemary M. Hamill
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
E-mail: schmidtjr@mail.nih.gov

National Heart, Lung, and Blood Institute (NHLBI)

Mr. John Taylor
Phone: 301-435-0327
Fax: 301-480-3338
E-mail: taylorjc@nhlbi.nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Katharine C. Minker
Acting Branch Chief
Contracts Management Branch, NIAAA
E-mail: minkerk@mail.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
Phone: (240) 669-5175
Email: Charles.Jackson@nih.gov

National Institute on Drug Abuse (NIDA)

Ms. Lisa Bielen
Phone: 301-443-6677
Fax: 301-443-7595
E-mail: lisa.bielen@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
E-mail:  SGriffiths@cdc.gov

Diana Bartlett, MPH, MPP
Office of Technology and Innovation
Office of the Associate Director for Science
Phone: 404-639-4938
Fax: 404-639-4903
E-mail: DBartlett@cdc.gov

Center for Global Health (CGH)

Theresa Routh-Murphy
Contracting Officer
Phone: 770-488-2713
Fax: (770) 488-2778
E-mail:  TRouthMurphy@cdc.gov

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)

Stephen Lester
Contracting Officer
Centers for Disease Control and Prevention
Procurement and Grants Office
Phone: (770) 488-1998
Fax: (770) 488-2670
E-mail:  SLester@cdc.gov

National Center for HIV/AIDs, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)

Stephen Lester
Contracting Officer
Centers for Disease Control and Prevention
Procurement and Grants Office
Phone: (770) 488-1998
Fax: (770) 488-2670
E-mail:  SLester@cdc.gov

National Center for Immunization and Respiratory Diseases (NCIRD)

Alan Sims
Contracting Officer
Centers for Disease Control and Prevention
Procurement and Grants Office
Phone: (770) 488-2896
Fax: (770) 488-2670
E-mail:  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 2015-2).

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