Small Business Innovation Research (SBIR) Program Contract Solicitation (PHS 2014-1) Now Available

Notice Number: NOT-OD-13-108

Update: The following update relating to this announcement has been issued:

Key Dates
Release Date: August 28, 2013
Contract Proposal Due Date: (Extended to December 3, 2013 per NOT-OD-14-023), Originally November 13, 2013

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 2014-1) with a receipt date of November 13, 2013; 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 2.7 percent (for FY2013) of their extramural research or R&D budgets for an SBIR program. (The NIH SBIR set-aside requirement for FY 2013 is $617 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 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.

Following are the research topics contained in the PHS 2014-1 Solicitation:

National Institutes of Health (NIH)

National Cancer Institute (NCI)
326      Development of Novel Therapeutic Agents that Target Cancer Stem Cells
327      Reformulation of Failed Chemotherapeutic Drugs
328      Validation of 3D Human Tissue Culture Systems that Mimic the Tumor Microenvironment
329      Proteomic Analysis of Single Cells Isolated from Solid Tumors
330      Generation of Site-Specific Phospho-Threonine Protein Standards for use in Cancer Assays
331      Development of a Biosensor-Based Core Needle Tumor Biopsy Device
332      Development of Radiation Modulators for Use During Radiotherapy
333      Software Tools for the Development of Environmental Measures Related to Cancer Health   
Behaviors and Resources

National Center for Advancing Translational Sciences (NCATS)
005      Development of Biomarkers for Rare Diseases as Endpoints for Clinical Trial Measurements
006      Development of Neurocognitive Pediatric Tools for Measuring and Analyzing Clinical Study
Endpoints in Rare Neurocognitive Disorders
007      Exploring the Potential of CRISPR/CAS Genome-editing Tools
008      Droplet Detection System

National Heart, Lung and Blood Institute (NHLBI)
081      Passive MRI Cardiovascular Guidewire
082      MRI Myocardial Needle Injection Catheter
083      Transcatheter Pulmonary Artery Resist
084      Value of Information Models for Clinical Trial Assessment
085      Development of Molecular Imaging Agents and Methods to Detect High Risk Atherosclerotic Plaque
086      Tools for Educating Children About Clinical Research

National Institute on Aging (NIA)
003      Development of Calorie-restricted and Nutrient-balanced Medicinal Food Products for
Mitigation of Age-related Diseases or Conditions

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
045      Development of a Database of Non-English Measures and Instruments for Use in Alcohol
Research

National Institute of Allergy and Infectious Diseases (NIAID)
025      Biomedical Methods To Quantify Adherence To Prevention Clinical Trial Study ­ Products and
Strategies
026      Simple, Inexpensive Assay for Five Common HIV Resistance Mutations
027      Capreomycin: Formulation for Oral Delivery
028      Adjuvant Development

National Institute on Drug Abuse (NIDA)
151      Web Resource System for Prescription Drug Providers, Researchers and Users:  The
Prescription Drug Abuse Policy System (PDAPS)
152      Technological Tools to Facilitate Implementation of Evidence-Based Substance Abuse
Prevention Interventions among the Military
153      Products to Prevent (Lethal) Drug-induced Respiratory Depression
154      Bundled Service for Designing Methodologically Rigorous Animal Studies
155      Affordable Care Act (ACA) Web Platform to Integrate Behavioral Health & Prevention with
Primary Care

Centers for Disease Control and Prevention (CDC)

Center for Global Health (CGH)

006      Development of Novel Malaria Parasite Metabolite-based Non-invasive Diagnostic Biosensor

National Center on Birth Defects and Developmental Disabilities (NCBDDD)
018      Developing Rapid Test for the Diagnosis of Sickle Cell Disease
019      Development of Rapid, Point-of-care Tests for Cytomegalovirus (CMV)
020      Nutrition Support for Group Homes Serving Individuals with Intellectual Disabilities

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)
034      Promoting Regular Physical Activity for Older Adults through “Wayfinding” Technology
035      Development of Pills or Tablets to Expedite Water Fluoridation
036      Application for Improving Embryo Transfer Practices at Fertility Clinics

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)
006      Distinguishing Infection, Colonization, and Recurrence in Patients with Clostridium difficile
007      Development of Reagents for Diagnosis of Fungal Infections in Formalin-fixed Paraffinized
(FFPE) Tissue Blocks
008      Rapid Detection of Endemic Fungal Infections in the United States
009      Development of Anti-Japanese Encephalitis Virus Human Monoclonal Antibodies Using
Humanized Rodent Models
010      Formulation of Nootkatone in Soaps and Lotions for Lyme Disease Prevention

National Center for HIV/AIDs, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
037      Development of a Rapid Test for Detection Hepatitis C Core Antigen in Clinical Samples
038      Development of a Laboratory Test for Detection of Serum Biomarkers Associated with
Hepatocellular Carcinoma
039      Text My EOB: The Innovative Delivery of Confidential Medical Information
040      Development of a Mobile Application for Homeless Youth and Providers
041      Leveraging Technology to Prevent STIs Using High-Intensity Behavioral Counseling
042      Assessing the Feasibility of e-measure Adoption in an EHR Environment

National Center for Immunization and Respiratory Diseases (NCIRD)
027      Thermostable Dry Vaccine Formulation for Microneedle Administration
028      Development of Anti-diphtheria Antibodies for Use in Humans

Office of Public Health Preparedness and Response (OPHPR)
003      “Plug and Play” Global Health Security Initiative (GHSI) Response Tool
004      Improved Rapid Antimicrobial Susceptibility Testing from Primary Specimens

Inquiries

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 2012-1). 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 2014-1 (PDF [http://grants.nih.gov/grants/funding/SBIRContract/PHS2014-1.pdf] or MS Word [http://grants.nih.gov/grants/funding/SBIRContract/PHS2014-1.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. Elizabeth Shanahan
Telephone: 240-276-5432
Fax: 240-276-5431
E-mail: eshanahan@mail.nih.gov

National Center for Advancing Translational Sciences (NCATS)

Mr. Bryan Jones 
Telephone: 301-594-1852
E-mail: bryan.jones@nih.gov

National Heart, Lung, and Blood Institute (NHLBI)

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

National Institute on Aging (NIA)

Suzanne Stinson
Telephone: 301-443-4116
Fax: 301-443-0501
E-mail: ss704b@nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Mr. Paul D. McFarlane
Telephone: 301-443-3041
Fax: 301-443-3891
Email: paul.mcfarlane@nih.gov

National Institute of Allergy and Infectious Diseases (NIAID)

Eileen Webster-Cissel
Telephone: 301-496-0612
FAX: 301-480-4675
Email: webstere@niaid.nih.gov

National Institute on Drug Abuse (NIDA)

Mr. Brian O’Laughlin
Telephone: 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:

Juliana Cyril, Ph.D., M.P.H.
Director, Office of Technology and Innovation
Office of the Associate Director for Science
Telephone: 404-639-4639
Fax: 404-639-4903
E-mail:  JCyril@cdc.gov

Sean David Griffiths, M.P.H.
Office of Technology and Innovation
Office of the Associate Director for Science
Telephone: 404-639-4641
Fax: 404-639-4903
E-mail:  SGriffiths@cdc.gov

Center for Global Health (CGH)

Carlos Smiley
Contracting Officer
Telephone: 770-488-1517
Fax: 770-488-2688
E-mail: CSmiley1@cdc.gov

National Center for Birth Defects and Developmental Disabilities (NCBDDD)

Julio Lopez
Contracting Officer
Telephone: 770-488-2892
Fax: 770-488-2868
E-mail:  jlopez3@cdc.gov 

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)

Julio Lopez
Contracting Officer
Telephone: 770-488-2892
Fax: 770-488-2868
E-mail:  jlopez3@cdc.gov

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)

Theresa Routh-Murphy
Contracting Officer
Telephone: 770-488-2173
E-mail:  TNR3@cdc.gov

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

Theresa Routh-Murphy
Contracting Officer
Telephone: 770-488-2173
E-mail:  TNR3@cdc.gov

National Center for Immunization and Respiratory Diseases (NCIRD)

Alan Sims
Contracting Officer, Lead
Telephone: 770-488-2647
Fax: 770-488-2670
E-mail:  ASims1@cdc.gov

Office of Public Health Preparedness and Response (OPHPR)

Lawrence (Mac) McCoy, Contracting Officer
Telephone: 770-488-2087
Fax: 770-488-2671
E-mail:  GWG8@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 2013-2). There is one grant application due date (December 5, 2013) remaining for calendar year 2013.

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

 


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