Small Business Innovation Research (SBIR) Program Contract Solicitation (PHS 2015-1) Now Available

Notice Number: NOT-OD-14-120

Key Dates
Release Date: August 15, 2014
Contract Proposal Receipt Date: November 5, 2014  

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 2015-1) with a receipt date of November 5, 2014, 4:30 PM ET; 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 2.8 percent (for FY 2014) of their extramural research or R&D budgets for an SBIR program. (The NIH SBIR set-aside requirement for FY 2014 is $663 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" INITIATIVE: (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.

Following are the research topics contained in the PHS 2015-1 Solicitation:

National Institutes of Health (NIH)
National Cancer Institute (NCI)
334      Vacutubes to Preserve the Viability of Circulating Tumor Cells
335      Development of Advanced Culture Systems for Expansion of Cancer Stem Cells
336      Development of Novel Therapeutic Agents That Target Cancer Stem Cells
337      Cell-Free Nucleic Acid-Based Assay Development for Cancer Diagnosis
338      Predictive Biomarkers of Adverse Reactions to Radiation Treatment
339      Systemic Targeted Radionuclide Therapy For Cancer Treatment
340      Validation of Mobile Technologies for Clinical Assessment, Monitoring, and Intervention

National Center for Advancing Translational Sciences (NCATS)
009      Exploring the Potential of CRISPR/CAS Genome-editing Tools
010      Assay Development for High-Throughput Screening of Chemicals of Toxicological Concern
011      Simple and Robust Reaction Progress Analyzer
012      Online Real Time Metals Analysis at Low ppm Level

National Heart, Lung and Blood Institute (NHLBI)
087      Transcatheter Cerclage mitral Annuloplasty (SBIR-TT)
088      Closure Devices for Transcaval Access to the Abdominal Aorta
089      In-bore Defibrillation for Invasive MRI Cardiology Procedures
090      Devices to Close Ductus Arteriosus in Premature Infants
091      Therapeutic Delivery of ADP-ribosylarginine Hydrolase
092      Selective Silencing of Stat3 Signaling to Treat Relapsed Disease After Transplantation
093      Cellular Immunotherapy After Stem Cell Transplantation

National Institute of Allergy and Infectious Diseases (NIAID)
029      Development of Novel Influenza Antivirals
030      Methods of Clinical Sample Preparation for Rapid Detection of Bacterial Pathogens
031      Inhaled Delivery of Clofazimine (CFZ) – An Important Anti-tuberculosis Drug
032      Simple, Inexpensive Unit for Removing Cells from Small Amounts of Blood in Resource-Limited Settings

National Institute on Drug Abuse (NIDA)
157      Mobile Technologies Extending Reach of Primary Care for Substance-Use-Disorders

Centers for Disease Control and Prevention (CDC)
Center for Global Health (CGH)

007      Diagnostic Tools to Support the Elimination and Control of Neglected Tropical Diseases

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)
037      Optical Character Recognition Software for Scanning Nutrition Facts Panel

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)
011      Development of Nanoparticle Dengue Diagnostic Tests

National Center for HIV/AIDs, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
043      Yeast-derived Candidate of Hepatitis E Virus Vaccine
044      Multiplex Assay for Simultaneous Detection of Hepatitis and Other Viruses
045      Improved Antibody Preparation for Post-Exposure Prophylaxis Against Hepatitis A

National Center for Immunization and Respiratory Diseases (NCIRD)
029      Thermostable Dry Vaccine Formulation for Microneedle Administration
030      Thermostable Oral Vaccines to Combat Enteric Diseases

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 2015-1). 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 2015-1 (PDF [http://grants.nih.gov/grants/funding/SBIRContract/PHS2015-1.pdf] or MS Word [http://grants.nih.gov/grants/funding/SBIRContract/PHS2015-1.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. Victoria Cunningham
Phone: 240-276-6286
Fax: 240-276-5431
Email: ncioasbir@mail.nih.gov

National Center for Advancing Translational Sciences (NCATS)
Mr. Bryan Jones 
Phone: 301-594-1852
Email: bryan.jones@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)
Eileen Webster-Cissel
Phone: 301-496-0612
Fax: 301-480-4675
Email: webstere@niaid.nih.gov

National Institute on Drug Abuse (NIDA)
Mr. Brian O’Laughlin
Phone: 301-443-6677
Fax: 301-443-7595
Email: bo50d@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

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

Center for Global Health (CGH)
Carlos Smiley
Contracting Officer
Phone: 770-488-1517
Fax: 770-488-2688
Email: CSmiley1@cdc.gov

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)
Julio Lopez
Contracting Officer
Phone: 770-488-2892
Fax: 770-488-2868
Email:  jlopez3@cdc.gov

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)
Theresa Routh-Murphy
Contracting Officer
Phone: 770-488-2173
Email: TNR3@cdc.gov

National Center for HIV/AIDs, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
Theresa Routh-Murphy
Contracting Officer
Phone: 770-4882173
E-mail:  TNR3@cdc.gov

National Center for Immunization and Respiratory Diseases (NCIRD)
Alan Sims
Contracting Officer, Lead
Phone: 770-488-2647
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 2014-2). There is one grant application due date (December 5, 2014) remaining for calendar year 2014.

To understand better the differences between grants and contracts, see Contracts vs. Grants: What's the difference?

 

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